Reserve Your Copy of The 12th Edition of The World Market for In Vitro Diagnostic Tests

ARLINGTON, VA., The world market for diagnostics is estimated at $69.2 billion in 2019 and is expected to grow a little more than 4% annually to reach $85.2 billion by 2024. This is according to an upcoming report by market researcher Kalorama Information, part of Science and Medicine Group. This estimate includes all laboratory and hospital-based in vitro diagnostic tests instruments and reagents, and OTC product sales.

Kalorama Information released the 12th edition of its 2,000-page  Worldwide Market for In Vitro Diagnostic Tests and has made a special offer available exclusively on its site.

Kalorama cited companion testing and demand for personalized medicine, demand for improved infectious disease testing, and sales to China and other nations as reasons for increasing sales. There are limits to growth however; such as the actions of developed-nation governments to reduce reimbursements and the severe drop in the glucose market recently due to cheaper meter competition.  Consolidation of labs continues to be a market limiter as well.  The market is also boosted by the aging world population and the stream of new test innovations – this is a field where double-digit percentages of sales invested back in R&D is not uncommon – and the market is offset by reimbursement cuts worldwide and slower buying in mature sectors.  Mass spectrometry has arrived, the report said. Once an instrument in research it is now an essential part of microorganism identification, drug testing and other applications.  For the second time, we include reporting on mass spectrometry clinical testing in the report. and it makes a contribution to the market and to growth.

The firm includes hundreds of firms in in its report but said that Roche, Abbott Diagnostics, Siemens Healthcare, Danaher, Thermo Fisher Scientiic, bioMerieux and Ortho Clinical Diagnostics are among top tier competitors.

Some other findings of the report:

  •  Roche leads, Abbott is 2nd.  But no company, not even these large IVD companies, owns all the technology to compete in an increasingly complex world. Chapter 2 of the report lists over 60 recent mergers and acquisitions related to IVD. Significant recent deals. Last year Abbott brought POC leader Alere into its operations, completing an acquisition finalized in 2017.  Recently, Meridian Biosciences purchased GenePOC.
  • Major chemistry vendors are developing improved models selling their existing customers on staying with them – to preserve and expand revenue, as well as create barrier entry against other vendors in a shrinking lab environment. Footprint improvements, IT enhancements, EMR, automation and expanded menus are part of this change.
  • Mass spectrometry has gone from a research tool to a significant category in the market, especially in developed markets, for the identification of bacteria, fungi and mycobacteria. The MALDI-TOF market has exploded in recent years in microbiology labs, thanks largely to the IVD regulatory approval of the VITEK MS and MALDI Biotyper.  There are limitations, throughput and operator experience among them.|
  • A clear majority of the market is outside the United States. All of the major IVD companies reported double-digit increases in their sales in China with growth in the other top emerging markets: Brazil, Turkey, Korea, India, Saudi Arabia and Mexico. Other emerging markets of interest for IVD vendors were Colombia, UAE, South Africa and the Eastern Europe region. These countries continue to invest in healthcare infrastructure and insurance coverage for a growing more affluent middle class.
  • The market continues to grow, but what the dollars represent is changing. Twenty years ago, clinical chemistry and immunoassays were most of testing. Still today, the traditional core lab test segments – chemistry/immunoassay, hematology and coagulation – make up 34% of the dollar value of the IVD market in 2019, while they are over sixty percent of tests run. As molecular, infectious disease, and cancer tests increase in importance, the market share of these core tests will decrease to 29% in 2024.
  • Sepsis is a growing problem and early detection is crucial for patients. Approximately 1.7 million individuals in the US develop sepsis each year and there is currently no gold standard for diagnosis in the clinical setting. Procalcitonin (PCT) and lactate are two established biomarkers for sepsis, but there are limitations. Several European studies have reported reduction in antibiotic usage with PCT-guided decision making, but a large multi-center US discussion did not show results. A novel marker, Human Neutrophil Lipocalin (HNL), a glycoprotein released from activated neutrophils during bacterial infections, has attracted some attention.

Kalorama Information attended the American Association of Clinical Chemistry in Anaheim this year.    We analyzed products and trends, interviewed vendors and experts, and gathered information for our 12 Edition Worldwide Market for In Vitro Diagnostics Tests report, due out this month.

Time is of the essence, it is said, and that was the case in Anaheim at the latest AACC.  As in other years, Kalorama found that vendors emphasized time-savings in their pitches.  That meant saving lab staff time, increasing walkaway time, reducing sample-to-result time, increasing test-to-treatment time.  Faster tests were on display, and “better” tests too.   Tests that are more sensitive, more precise, test instruments with operator assists such as decision aids, management IT and automated features.  These are features that vendors hope will help retain customers in a shrinking lab environment. In the scientific sessions and on the Clinical Expo floor, vendors and speakers focused on improvements in testing and patient care.  There was a clear demand for biomarkers that can really inform therapy, and a need for a better solution on sepsis.

Developments of note in the first day of the Clinical Expo include.

“Disruptive” Sepsis System wins Prize.   Sepsis is oft misdiagnosed; hence the plethora of discussion and exhibits on the disease at AACC over the years.   Inflammatix’s in-dev 30 minute sepsis test attracted attention and an award.  Their product  HostDx Sepsis, a highly specific diagnostic test that can identify the type and severity of a patient’s infection in less than 20 minutes.  The company claims the product enables early detection of both bloodstream and non-bloodstream infections.   The product uses mRNA and gene signature technology, and according to the makers, detecting changes in gene expression across a range of messenger genes  creates greater granularity than markers such as PCT.   The intention is to direct better treatment.   The product is in the early stages and clinical trials are not yet performed.

Improvements to dPCR, colon cancer testing and mass spectrometry were also among the innovative tests that received Disruptive Technology awards.   CombiNATI is  an in-dev 16 sample-per-plate dPCR platform that aims to compete with market leaders Bio-Rad and Thermo in the burgeoning dPCR field.  The company was a semi-finalist in the awards.  La Jolla-based Singelera Genomics was a finalist for their ColonES colorectal cancer screening assay. The circulating tumor methylated DNA (ctmDNA) test.   The company claims ColonES is an accurate test that is non-invasive and uses blood samples rather than stool  the sample used for Cologuard and other fecal occult blood-based tests.   The award might be indicative of a need for a simpler sampling method.

AACC President Touts POC Platform, Takes on PAMA: In an interview with LabPulse.com  AACC 2019 President Carmen Wiley, PhD talked about top presentations at the conference, as well as some of the major issues facing clinical chemistry right now.   She previewed important plenary sessions; presented the LabTestsOnline.com website, which is meant for the layperson and efforts of AACC to go to Capitol Hill and meet with representatives.

“The A in PAMA is supposed to represent access, and it actually does the opposite. The most vulnerable patients are going to be affected, because they won’t be able to obtain the tests they need. ”
-AACC President, Carmen Wiley, PhD, LabPulse Video Interview

She also mentioned the grass-roots efforts to get members to write to their representatives about laboratory medicine issues, and touted the POC certification program that has 32 diplomates already: “Testing is leaving the core laboratory and going out into other areas, and we want them to have a strong foundation,” she said.   Wiley also promoted the work the organization is doing with PAMA. “The A in PAMA is supposed to represent access, and it actually does the opposite. The most vulnerable patients are going to be affected, because they won’t be able to obtain the tests they need. ”

Roche Bets on Precision, Deep Analytics, Presents Tumor Board Review Tool:  Roche Diagnostics is the #1 IVD company in the world according to Kalorama Information’s The Worldwide Market for In Vitro Diagnostics.  They compete in all major sectors, but with traditional in vitro segments such as chemistry and glucose at low-growth levels, the company made a noticeable shift to possibly game changers like big data and deep analytics.    This was evident at its press conference on Tuesday of the meeting, which Kalorama attended.   VP Rod Cotton and VP for Information Diagnostics Ketan Paranjape presented their solutions to enhance teams of doctors participating in tumor board review.  “Scientific knowledge doubles every 80 to 90 days,” said Paranjape.  “We have to find meaningful ways to add value.”

Roche’s foray in this area is the NAVIFY Tumor Board 2.0, a cloud-based product resulting from a partnership with GE Healthcare, integrates and presents patient data along with relevant scientific data. A single, standardized dashboard with GE enables viewing of DICOM and manually uploaded digital image files.   And the seamlessly incorporated application ecosystem enhances tumor board preparation and presentation to support the clinical decision making of oncology teams.

In other news, Roche announced that longtime CEO of Roche Diagnostics’ North American operations Jack J. Phillips was leaving the company.  Media reports indicate he left to join Accelerate Diagnostics.

Roche announced instrument system additions as well, including their cobas  Pro Integrated Solution— An integrated mid-to-high volume solution for clinical chemistry and immunochemistry testing needs that is designed to achieve reduced maintenance and increased throughput through a scalable and modular system.  The system is not available for use in the U.S. pending 510(k) clearance.  They also featured cobas Prime — A pre-analytical system designed for standard processing and cross-contamination control of molecular samples. This system is also not available for use in the U.S.

Pro-Keto Diet Study Unveiled at AACC – In recent years, numerous contradictory dietary guidelines have come out, leaving the public confused about what is truly healthy to eat. The American Heart Association recommends an ideal upper salt intake limit of 1.5 g/day for adults in order to prevent high blood pressure and cardiovascular disease. However, in 2013, the Institute of Medicine came out against cutting sodium levels below 2.3 g/day. So which organization is correct? The answer turns out to depend on an individual’s genetically determined salt sensitivity.

By the end of the study, mean blood glucose and HbA1c levels had dropped for 110 of the participants, going down to 137 mg/dL and 6.43%, respectively.

This new test and a second study showing that the ketogenic diet improves diabetes symptoms were presented   Kanchana Lakshmi Prasanna Angati, MD and other researchers recruited 115 Indian type 2 diabetes patients to follow the keto diet for 3 months. At the start of the study, participants’ mean blood glucose and hemoglobin A1c (HbA1c) levels—both of which reflect blood sugar levels—were 169 mg/dL and 7.8%, respectively. By the end of the study, mean blood glucose and HbA1c levels had dropped for 110 of the participants, going down to 137 mg/dL and 6.43%, respectively.

Ortho Clinical Diagnostics Wins Service Awards:  for the fourth consecutive year, its Ortho Care™ service and support program was ranked No. 1 in the diagnostics industry. The rankings were published in three IMV 2019 ServiceTrak™ reports, which are based on opinions of laboratory professionals working in U.S. hospitals representing more than 3,000 systems.

Kalorama spoke with Michael S. Iskra, President of North America Commercial Operations for Ortho, as well as Clinical Lab Portfolio head Piper Antimarino.  The company unveiled the VITROS XT 3400, which is currently under development and is intended for smaller laboratories that do not require the full menu and full throughput of the VITROS XT 7600. The company says the VITROS XT 3400 will also employ Ortho’s dry-slide technology that eliminates washing and other steps, which can normally introduce errors in testing.

Ortho’s message: Automation of basic tests contributes to precision.  Freeing up bread-and-butter tasks performed by laboratory staff can ensure that laboratorians have time for novel testing that needs to be done.

While awaiting FDA clearance, the product boasts a 3x performance boost over the company’s existing VITROS model, while saving space.  “In order for labs to perform more novel tests, we want to free up labs from the the bread and butter tasks,” Iskra told Kalorama.

Ortho Clinical Diagnostics Unveiled its Ortho’s VITROS XT MicroSlide which uses an advanced digital imaging optics technology that allows labs to simultaneously perform two tests that are commonly ordered together from a single small blood sample. The company claims this new tech gleans significantly more information from each test than before, improving performance, saving time and space in the lab, and increasing productivity, with less patient sample required for testing. Ortho’s VITROS XT MicroSlides, which include VITROS XT UREA-CREA, TRIG-CHOL and GLU-Ca Slides, have received CE Mark and are available on the VITROS XT 7600 Integrated System.

Solving Disease Mysteries with Precision Med– Millions of individuals in the U.S live with a rare disease. Using genome sequencing, some of them have received answers. Euan Ashley, MB ChB, DPhil, of the Stanford Center for Inherited Cardiovascular Diseases, highlighted new genomic sequencing technologies that could drive precision medicine forward, while also exploring precision medicine’s likely near-term uses—such as in solving the mystery of unidentifiable diseases. Dr. Ashley presented compelling cases from the Undiagnosed Disease Network that demonstrated the potential of precision medicine to better characterize rare diseases. The network diagnosed 200 patients that previously had an unknown disease. Of those, 40 patients were able to find a targeted therapy to treat the disease. These are small numbers, relative to the total number of patients, but indicative of what larger funded efforts could do.

70-Second BMP: Instrumentation Laboratory (IL) today announced the unveiling of their latest innovation, the GEM Premier ChemSTAT.  The system is a whole-blood analyzer designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital Emergency Departments (EDs) and Clinical Laboratories.  The system provides laboratory-quality results on-demand, in less than 70 seconds, from venous or arterial whole blood samples, with no preparation required.

Laboratory-quality BMP results on-demand, in less than 70 seconds, one of several products aiming to slice test time.

 

Three-Minute HbA1c Test On Display:  HbA1c is an established marker, but its important to note the developments in the interfaces and formats for A1c tests.  Abbott displayed its recently FDA-cleared Afinion™ HbA1c Dx assay is now available for use on the Afinion 2 and AS100 Analyzers.  Abbott says the Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients’ risk of developing the condition.  The test delivers accurate and precise glycated hemoglobin (HbA1c) results in only three minutes, enabling clinicians to diagnose patients and help them formulate individualized care plans during a single doctor’s office visit.

90-Second Lipid-Glucose Combo: PTS Diagnostics presented a CardioChek Plus analyzer and PTS Panels Lipid Panel + eGLU Smart Bundle. The company says these products help clinicians save time by simultaneously testing lipid panel and glucose.

Game Changer on Lyme Disease? Lyme Disease cases are up, public awareness has grown, and tests are simply inadequate to detect the disease in most patients — too many false negatives to call existing products successful. This has been widely acknowledged. Genetic tests are in development. But another way is to take the existing technologies and double them up.   ZEUS Scientific promoted ZUES MITT – a double immunoassay system which the company claims can detect 30% more acute cases than the immuno/WesternBlot combo.

AACC Aims at Africa:  AACC announced an expansion of The Global Lab Quality Initiative (GLQI) to Africa next year.  The program circulates testing best practices, providing method verification workshops and other training and education.  For 8 years, the GLQI has worked with partner associations in Latin America and the Pacific region.   A quality control workshop is slated for Ethiopia in 2020, and a newborn screening workshop is planned in Morocco in the coming year.

More than half of global population growth between now and 2050 is expected to occur in Africa, according to the U.N.

As lab quality, tools and possibly information systems better take root in these countries, Kalorama sees an important marketplace to watch long-term.  The African Federation of Clinical Chemistry (www.afccafrica.org) counts labs in fifteen countries among her members.   Kenya, Nigeria and South Africa are among countries with established clinical chemistry societies of their own.

Biomarker Discovery is Not Enough: Researchers may be developing more biomarkers than needed.   And there are thousands of tests of dubious value.  This was the conclusion of a plenary talk by David Walt, PhD – “Biomarker Discovery from Technology Development to Clinical Application” emphasized that the genertic technology he helped to foster (Walt is the developer of microwell technology) is creating an overwhelming amount of biomarkers, but not yet optimizing patient care.   Dr. Walt told two “stories of technology development” that illustrate how long it can take research technology to reach the diagnostics market, asking “how can we bring transformative technology to the clinic?” By the time such companies begin to address the diagnostics market, their revenue stream is already strongly tied to research markets. He said few companies participate in both the research and diagnostics markets.He went on to propose an alternative that would see the process reversed.

By the time research companies begin to address the diagnostics market, their revenue stream is already strongly tied to research markets.

He emphasized that developers need to start with an unmet clinical need and approach with an eye to clinical utility.    Innovation does not always improve the clinical work up.  More detail and analysis of Dr. Walt’s talk is provided in Instrument Business Outlook. 

Testing for CBN and THC Differs, Study Shows: A study of immunoassays used for detecting tetrahydrocannabinol (THC) — the psychoactive part of marijuana — found that other types of cannabinoids have the potential to give a positive result, researchers reported on August 5.  Cannabinol (CBN), which is marketed as an over-the-counter sleep aid, gave a positive result on one of two THC immunoassays tested in a study of urine samples taken at Arup Laboratories, a nationwide clinical and anatomical pathology reference laboratory and a nonprofit arm of the University of Utah.    The researchers also tested three other types of cannabinoids in urine samples — cannabidiol (CBD), cannabichromene (CBC), and cannabigerol (CBG) — but did not identify the same cross-reactivity issues reported for CBN.  The study shows the unknowns for consumers and laboratories alike regarding effects of cannabinoids and risks for false positives in drug tests. The legalization of marijuana in some U.S. states and the first approval by the Food and Drug Administration of a prescription-grade formulation of CBD (GW Pharmaceuticals) for a rare form of epilepsy has given a stamp of legitimacy to cannabis-derived products. CBD may be stealing the headlines nowadays, but according to the University of Utah researchers, CBN is also commonly used and may affect lab results.

Quest for Sepsis Silver Bullet Continues: procalcitonin (PCT) and lactate are two established biomarkers for sepsis, but there are limitations.  A Session entitled  “The Journal of Applied Medicine Hot Topics of 2019” discussed these limitations, and the progress on new markers.  Several European studies have reported reduction in antibiotic usage with PCT-guided decision making, but a large multi-center U.S. discussion did not show results.   A novel marker, Human Neturophil Lipocalin (HNL) was discussed.  HNL is a glycoprotein released from activated neutrophils during bacterial infections. It can distinguish between bactertial and viral infections with greater than 90% accuracy, according to Robert Christenson, PhD, Editor in Chief of The Journal of Applied Laboratory Medicine.  bioMerieux, Diazyme, iCubate, Nova Biomedical, Response Biomedical, VITRO, Joinstar Biomedical Technology Co. are among the companies that presented sepsis products at the meeting.

The understanding of sepsis is changing.  A recent JAMA study, based on EHRs, which found that sepsis has at least four types labelled alpha (α), beta (β), gamma (γ), and delta (δ) — with different demographics, laboratory values, and patterns of organ dysfunction.(https://www.medpagetoday.com/meetingcoverage/ats/79

Opioids: AACC released a position statement at AACC calling for increased collaboration between clinical laboratories, the healthcare community, and federal agencies to end the opioid epidemic. The statement emphasizes that labs are critical to preventing opioid abuse and urges the medical community and government to leverage the expertise of clinical laboratory professionals to curb soaring drug overdoses in the U.S.

From 2016 to 2017, fatal overdoses caused by synthetic opioids jumped by 46%, a surge that contributed heavily to the more than 70,000 drug overdose-related deaths in 2017. Synthetic opioids are so deadly because of their extreme potency, but also because common tests often can’t detect them. This makes it difficult to determine whether synthetic opioids are the cause of a drug overdose and to detect when a patient is abusing synthetic opioids. The AACC is betting that laboratories with the appropriate experts and the right instrumentation and tests can identify many synthetic opioids that would otherwise be missed. Without this information, patients might not get crucial addiction or overdose treatment. Clinicians especially need to know if an overdose is due to a long-lasting synthetic opioid, because in these cases patients may need additional doses of the opioid antidote naloxone to prevent a relapse of overdose symptoms.

Quidel Promotes New Drug Test: launched its Triage TOX Drug Screen, a fluorescence immunoassay to be used with the Quidel Triage MeterPro System for detection of   acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.  The MeterPro is a comprehensive test menu a diverse immunoassay menu in a variety of tests including BNP, CK-MB, d-dimer, myoglobin, troponin I.

Boosted Mass Spec with New Emitter: For Mass spectrometry (MS) to work in clinical diagnostics two enabling developments will be required. Throughput for the clinical environment, and the adaptation to immunoassays.  Newomics, a semi-finalist at the AACC Most Disruptive Technology Awards claims to have done both, and was recognized by the association for their work.  They have developed a novel, sensitive, robust, and fast MS assay to quantify intact proteins directly from human plasma without immunoprecipitation or digestion. Newomics has developed a top-down parallel reaction monitoring-MS (PRM-MS) assay that the company claims has a sensitivity (0.1−1.0 fmole) and speed (1−5 min) on par with ELISA.

For mass spectrometry to work in clinical diagnostics, throughput for the clinical environment, and the adaptation to immunoassays will be required.

Newomics produces emitters (M3 emitters) that they say enable optimization of sensitivity, throughput and robustness for LC-MS by splitting the LC eluent evenly into multiple flows at the emitter, thereby dramatically enhancing the ionization efficiency. The first commercially-available M3 emitter has been optimized for microflow LC – nanospray MS and can easily be configured for the Thermo Scientific microflow LC-MS systems and the Thermo Scientific Nanospray Flex ion source. The company has a co-marketing agreement with Thermo Fisher Scientific.

Molecular Point of Care:  PCR systems at the near-patient level are one of the more innovative technologies in IVD. Kalorama Information’s report estimated a more than $400 million-dollar market for PCR and other NAAT-based tests at the point of care. Abbott, Cepheid, BioFire (bioMerieux) and Roche lead in this segment, but Quidel, Meridian, Mesa Biotech, and Biocartis are among those with offerings as well. Credo Biomedical, a Singapore-based developer of systems for veterinary diagnostics, launched their new molecular diagnostic platform, VitaPCR, and its Influenza A/B assay. Credo is boasting cost-advantages, the system delivers lab- accurate results in less than 20 minutes with only 2 minutes hand-on time at the same price level as traditional lateral flow tests. The product is especially aimed at NGO markets, and is under development pending approval from major authorities.

Diabetes: Given the unfortunate incident rates and the severity of the disease, this is an important area for test innovation and this was evident at AACC 2019.   Revised American Diabetes Association standards since the last AACC annual meeting – https://www.aacc.org/publications/cln/cln-stat/2019/january/17/new-diabetes-standards-of-care-what-labs-need-to-know. may increase vendor focus on new hbA1C testing systems. The annual National Glycohemoglobin Standardization Program and IFCC Manufacturer Forum met at the Hilton Anaheim during the meeting.   The group sets test certification standards.  In terms of vendors, EKF Diagnostics displayed their now FDA-cleared glycated albumin test, used for intermediate term monitoring of glycemic control in diabetes patients. Glycated albumin is measured when diabetes therapy is initiated to determine medication regimens and doses and to assess overall therapy efficacy. Nova Biomedical offered several seminars at the meeting related to diabetes, including “Regulatory Requirements and Legal Consequences of Off-label Glucose Testing Rapid Diagnostics for Electrolyte Imbalances in Sepsis”,” Rapid Diagnostics for Electrolyte Imbalances in Sepsis”, and “Regulatory Requirements and Legal Consequences of Off-label Glucose Testing” Roche Diagnostics promoted its Accu-Chek® Inform II system The company says the wireless meter and test strip technology, along with its connectivity solution work together to provide reliable results in 5 seconds.

NAFLD and NASH: Nonalcoholic fatty liver disease (NAFLD), in which fat deposits in the liver, affects over 1 billion people globally and is projected to become the leading cause of liver-related mortality within 20 years. Siemens Healthineers sponsored a “Managing Patient Pathways and Improving Outcomes in NAFLD and NASH” Tuesday, August 6 in the Exhibit Hall. Of note: According to the National Institute of Diabetes and Digestive and Kidney Diseases, the prevalence of this disease is more significant in the U.S. NAFLD affects between 30% and 40% of American adults. NAFLD is one of the most common causes of liver disease in the United States. Most people with NAFLD have simple fatty liver. Only a small number of people with NAFLD have NASH. Experts estimate that about 20 percent of people with NAFLD have NASH. Caspase-generated fragments such as cytokeratin-18 (CK-18) in patients with various hepatic impairments are investigated as markers for diagnosis and assessment of disease severity. cytokeratin-18 (CK-18) CK-18 is the most extensively evaluated analyte for NASH diagnosis. Ray Biotech, Arup, Millipore Sigma and Thermo Fisher were among vendors with CK-18 antibody products.

Alzheimer’s Disease Progress: Blood metabolites could one day help predict which patients with Alzheimer’s disease will experience relief from cognitive symptoms through exercise therapy, based on preliminary data presented on August 5 at the American Association for Clinical Chemistry (AACC) conference in Anaheim, CA.  A team of researchers led by Danni Li, PhD, and Fang Yu, PhD, both from the department of laboratory medicine and pathology at the University of Minnesota, identified the metabolites in a study of 26 patients.

Prior research has suggested that exercise enhances cognition in Alzheimer’s disease and reduces the accumulation of amyloid plaques in the brain. In light of the many failures of drug treatment, exercise has become an increasingly important area of research for this common and disabling condition. In the U.S., one of every three seniors has Alzheimer’s or another form of dementia at the time of death.

While the research is encouraging, authors emphasized that it is still preliminary; the results must be validated and replicated. A new follow-up clinical trial of 120 patients that will combine exercise and cognitive training as an intervention for cognitive impairment is in the planning stages. The follow-up trial will also look for metabolites associated with improvements in patients’ cognitive abilities.

 

Biotin: A session at AACC 2019 “Beautiful Skin and Erroneous Lab Results” dealt with biotin or B7 and its interference with testing some immunoassay methods.  Biotin is an issue as it is in some foods but also in commonly consumed supplement products for hair, skin and nails.  The supplements can be higher than US RDA and throw off testing results.  The session suggested ways to deal with interference, such as testing for biotin and adjusting results.  That doesn’t mean all labs will do that, thus this trend is one where some vendors can prosper:  Tosoh Bioscience presented its biotin free assay menu ST AIA-PACK.  The increase in biotin supplementation use combined with the limitations in many immunoassays, the company says, has led to false lab results, misdiagnosis and mismanagement of patients.  The FDA to issue a warning against biotin interfering with some lab tests.  Abbott diagnostic tests are also biotin-interference-free, according to the company.

Testing and Transgender Patients:  Laboratorians should be aware of transgender patients and how hormone therapy can change lab values, due to the lack of test reference values for this subset of the population, according to a pathologist who presented long-term data on August 5 at the American Association for Clinical Chemistry (AACC) conference in Anaheim, CA.   The retrospective study examined lab test results from charts of 147 healthy transgender people over five years, including a comprehensive metabolic panel, complete blood count, and lipids.  Hormone therapy can affect lab values — for example, low-density lipoprotein cholesterol, red blood cell count, and kidney function — and it’s an issue for those who transitioned to female and are on estrogen therapy, as well as for male patients taking testosterone.

Laboratorians should be aware of transgender patients and how hormone therapy can change lab values, due to the lack of test reference values for this subset of the population.

New Sickle Cell Rapid – Fast diagnosis of sickle cell disease is necessary RBCs containing evidence of the disease live only about 16 days compared to 120 days for normal red blood cells. To initiate life-saving therapies, early diagnosis of SCD is key.   Absent treatment, severe complications can occur.  BioMedomics launched its Sickle SCAN —  a multiplexed, qualitative, point-of-care immunoassay used for the rapid diagnosis of sickle cell disorders. The test is made up of three indicators which detect the presence of hemoglobins A, S, and C, allowing the user to rapidly distinguish between normal, carrier, and sickle cell disease samples.

 

CRP Rapid: Orion Diagnostica presented its FDA-cleared QuikRead Go CRP, an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma, and in serum sample. The company says that QuikRead Go makes it easy to add patient and/or operator identification information together with the result which is automatically stored in the instrument’s internal memory.

Automation Developments for Mid-Size Labs: Analyzers with automated features were a common offering at AACC – ERBA Mannheim unveiled its NEXUS next generation automation at AACC 2019. Erba’s Hematology system uses unique combination of ultra-high definition imaging, artificial intelligence (AI) and traditional methods to analyse thousands of blood cells per minute to improve turn-around time Immunoassay system uses high sensitivity CLIA technology with proprietary magnetic bead design with menu of over 100 parameters Chemistry system uses advanced thick-film ISE analysis technology and innovative reagent management to deliver improved workflow and enhanced analytical result quality.  Festo introduced a new low-weight, high-accuracy 96-channel bulk dispense head, which offers an economically effective way to distribute bulk reagents at high throughput. The system can be made compatible with various liquid handling robots or supplied as a standalone automated sample preparation system. The company said Most bulk-dispense heads are heavier and require more costly motion units to handle the greater torque requirements.

Beckman Provides Automation Across Lab Sizes, Wins Performance Award:  Beckman Coulter introduced its “Automation for All” strategy that includes a scalable workflow solution that complies with the cost and space requirement s of small to large clinical laboratories.  The new automation products include:  Command for larger labs, Advance for medium-sized labs, Connect for small labs.

Beckman Coulter announced that its MicroScan WalkAway family of instruments has once again received IMV ServiceTrak’s “Best System Performance” award in the AST/ID category. ServiceTrak™ Clinical Laboratory Awards are based on interviews conducted with respondents in 2,075 clinical testing locations. The award in each category is given to manufacturers that receive the highest percentage of highly satisfied customer responses. The Best System Performance award was presented to Beckman Coulter today at the 71st AACC Annual Scientific Meeting & Clinical Lab Expo in Anaheim, Calif.

Benchtop Automated AST System:  Thermo launched a benchtop automated reading and incubation system for antimicrobial susceptibility testing (AST) and new sustainable culture media plate technology at this week’s American Association for Clinical Chemistry (AACC) annual meeting in Anaheim, CA.   Sensititre Aris HiQ AST from Thermo Fisher Scientific is a new benchtop automated reading and incubation system for antimicrobial susceptibility testing.

Thermo Fisher Scientific said that it has collaborated with pharmaceutical companies to include a large selection of antimicrobials, enabling access to new therapies for multidrug-resistant infections.

Thermo Fisher Scientific said that it has collaborated with pharmaceutical companies to include a large selection of antimicrobials, enabling access to new therapies for multidrug-resistant infections. Laboratories can also use the system to create their own custom AST plates from more than 300 antimicrobials in broad dilution ranges to consolidate and reduce offline testing, according to the firm.

bioMérieux Highlights Decision-Making Aids: PhenoMATRIX for WASPLab that allows labs to take their automated processes to “the next level” with artificial intelligence and interpretative algorithms for sample interpretation and automated sorting. PhenoMATRIX evaluates growth on a media plate through user-defined custom rules, allowing staff to spend less time reading plates and focus on those that are positive. And its AGILIST advanced analytic platform which securely connects and integrates siloed systems into a single source focused on operational efficiency, antimicrobial stewardship and surveillance, analyzing data in real-time, addressing problems, providing reliable information, and improving communications among key stakeholders.

Raising the Profile of Lab Professionals: Alan Wu, PhD, a professor of lab medicine at the University of California, San Francisco, has a few ideas that he shared with LabPulse.com Editor-in-Chief Emily Hayes at this week’s American Association for Clinical Chemistry (AACC) meeting.  Most laboratory professionals would agree that the public is generally unaware of what they really do. But what’s the best way to change the discipline’s low profile?  Video interview here:  https://www.labpulse.com/index.aspx?sec=nws&sub=rad&pag=dis&ItemID=800269

 

 

 

 

 

 

 

We have just published our latest report, The World Market for Biomarkers. Biomarkers are biological or biochemical molecules, genetic changes, or other characteristics that can be measured; they indicate or predict a condition, risk, or likely biological response. Biomarkers can be used for a range of diagnostic applications including predicting disease risk, diagnosis, predicting prognosis, identifying appropriate therapy for an individual, monitoring disease or for return of a disease, and other applications. These tests are extremely important, since lab test results inform 60% – 70% of all critical clinical decisions, such as whether to admit, discharge and/or initiate therapy for a patient. Biomarkers are also extremely important in the development of new drugs, as they can be used to generate data that may eventually be part of the regulatory submission package.

The biomarker market is extremely large, reflecting the large market for diagnostic tests based on these biomarkers, and also the ongoing efforts to discovery, validate, and commercialize new biomarkers. This market is fueled by factors that are supporting growth of both the research and the diagnostics markets, including:

  • Aging of the population
  • Rising rates of obesity
  • Growing number of cancer therapies
  • Longer lifespans of cancer patients
  • Advances in technology, improving our ability to analyze the increasing number of biomarkers
  • Advances in bioinformatics

In addition, market growth is being fueled by the identification, validation, and introduction of new biomarkers, and products based on these new biomarkers. These include safety and efficacy biomarkers being used in drug discovery and development, and other applications in addition to diagnostics.

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.

Many different technologies have been developed and are used in biomarker discovery, and also for detection and analysis of known biomarkers. These include traditional technologies, some of which have been used for decades. In addition, many new technologies developed for other applications are now being applied in this field. These include mass spectrometry and next generation DNA sequencing. Many tests performed using newer technologies are currently being done primarily as laboratory developed tests (LDTs) or by organizations performing clinical tests for pharmaceutical companies developing new drugs; however, some companies plan to eventually develop IVD test kits based on their laboratory assays. Selected examples of companies using these various technologies are discussed in this report, including key players in the market:

  • Companies Using Immunoassays for Detection and Analysis of Biomarkers
  • Companies with Immunohistochemistry Tests for Detection of Biomarkers
  • Companies Using In Situ Hybridization for Detection and Analysis of Biomarkers
  • Companies Using PCR or Other Nucleic Acid Amplification-Based Technologies for Biomarker Assays
  • Companies Analyzing Gene Signatures
  • Companies Using Microarrays to Detect and Analyze Biomarkers
  • Diagnostics Companies and Clinical Laboratories with Sequencing-Based Biomarkers
  • Companies Using Mass Spectrometry

Companies, clinical laboratories, researchers, and others do not generally purchase “biomarkers.” One exception is in settings in which companies or clinical laboratories acquired rights to use specific biomarkers for certain applications. The application may be development of reagents or assays that can be sold to researchers who are studying the biomarker, or who are using the biomarker in their research. These research applications could include using the biomarker as a safety marker, or as a surrogate marker for clinical efficacy, or a different research application. Alternatively, applications of new biomarkers may be to develop diagnostic assays that will be used in clinical setting for diagnosis, predicting prognosis, monitoring, determining the optimal therapy, or other clinical application. In addition, some biomarkers may prove valuable as potential targets for novel new therapies.

VialsIn our report, the market for biomarkers focuses on the applications of biomarkers. This includes both research and diagnostic applications of biomarkers. The potential market for biomarkers being evaluated as potential drug targets is not included in this market analysis, as that therapeutic market would be determined by the potential market for new therapies targeting the biomarker drug target. Key biomarker categories with 2019-2024 market estimates include the following:

  • Cardiac Markers [cTn, HscTn, Acute CK-MB/BNP, Others]
  • Tumor Markers [PSA, CEA, CA 125, AFP, PSA Rapid, Others]
  • Coagulation Markers [PT/INR, D-dimer]
  • Infectious Disease Markers [including Sepsis]
  • Immunological Disease [Autoimmune/Allergy]
  • Neurological Markers
  • C-Reactive Protein and Other Markers

The World Market for Biomarkers estimates the world markets for biomarkers and biomarker tests from 2014 to 2024, with 2019 as the base year, providing global biomarker market forecasts for the total biomarker market, the market by application (clinical diagnostic biomarker market, research biomarker market), and the market by geographical distribution:

  • Total Global Biomarker Market by Application, 2014 – 2024, in $Millions (Clinical Diagnostic, Research, Total)
  • Biomarker Market Segments by Application, 2014, 2019, 2024, by Share (%) (Clinical Diagnostic, Research)
  • Total Global Biomarker Market by Region 2014 – 2024, in $Millions (North America, European Union, Japan, China, India, ROW, Total)
  • Global Market Segments by Region, 2014, 2019, 2024, by Share (%) (North America, European Union, Japan, China, India, ROW)

The World Market for Biomarkers includes profiles of companies active in the discovery and/or commercialization of biomarkers. This includes companies commercializing in vitro diagnostic tests for detection and analysis of biomarkers, selected diagnostic companies commercializing diagnostic tests in their own CLIA certified laboratories for detection and analysis of biomarkers, and selected other players. The report’s focus is on companies with commercialized products and/or very advanced development programs. The diagnostics market is a highly competitive market, and there are many additional diagnostic companies that offer tests based on biomarkers discussed in this report. Companies profiled in the report range from large, multinational companies to smaller companies in or entering this market, including the following:

  • 20/20 Genesystems
  • Abacus Diagnostica
  • Abbott Laboratories
  • Act Genomics
  • Adaptive Biotechnologies
  • Admera Health
  • Agena Bioscience
  • Agendia
  • Agilent Technologies
  • Alpco
  • Ambry Genetics
  • Athena Diagnostics /Quest
  • Banyan Biomarkers
  • Beckman Coulter
  • Becton, Dickinson
  • Biofire Diagnostics/Biomerieux
  • Biohit
  • Biomérieux
  • Bio-Rad Laboratories
  • Cancer Genetics
  • Caris Life Sciences
  • Cepheid
  • Curetis
  • Exact Sciences
  • Foundation Medicine
  • Fujirebio
  • Genomic Health
  • Hologic
  • Illumina
  • Myriad Genetics
  • Neogenomics
  • Ortho-Clinical Diagnostics
  • Qiagen N.V.
  • Roche
  • Siemens Healthineers
  • Sysmex Corp.
  • Thermo Fisher Scientific
  • Ventana Medical Systems/Roche
  • Zeus Scientific

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.

We recently published a customer experience survey.  This blog highlights discusses the report and highlights the major findings of the report, including important recommendations for the clinical diagnostics industry.  For specific vendor performance and user ratings, a purchase of the report is suggested.

Clinical laboratory customers have become increasingly sophisticated and typically have multiple suppliers in every product category from which to choose. Leading diagnostics suppliers seek to differentiate themselves by improving both the tangible and intangible ways they interact with their customers. With the high cost of customer acquisition, the easiest way to increase profitability is to develop one’s current customer accounts. Improving the customer experience through innovation, mass customization and customer intimacy programs is a key strategy many life science companies are pursuing.

Innovation is not limited to developing revolutionary new products. Innovation can also be incorporated in the ways customers find, buy and use your products.

Smart companies continually evaluate customer reactions to multiple touchpoints so that they can offer the kind of experience that inspires customers to want to come back. Diagnostics suppliers will be challenged as to how to get beyond “better sameness” to create truly memorable customer experiences. The question becomes one of how to best to enhance the quality of the customer experience in a remarkably homogenous marketplace.

In our latest report, Benchmarking for 2019: Understanding the Clinical Diagnostics Customer Experience, we asked more than 300 clinical lab professionals to evaluate 21 different diagnostics companies on 18 critical customer touchpoints. Here at Kalorama Information, we have developed a customer experience model for the diagnostics market. Every time a laboratory professional interacts with a supplier in any way, that moment is a customer experience touchpoint and as such, a branding opportunity. The scope of our report spans the pre-purchase, product-usage and post-purchase customer experience over the course of the purchasing life cycle. It is summarized in the following graphic:

The questions we developed to cover each touchpoint were designed to capture the attributes that are valued by clinical lab professionals. Touchpoints encompass the time spent researching products, the selection process and after the sale is made. Within each touchpoint, we asked customers multiple questions to capture the attributes valued by clinical diagnostics customers. These touchpoints encompass the experiences that lead to repurchase and recommendation of clinical diagnostic equipment and consumables.

Purchasing life cycle questions were asked on an 11-point scale (some with a not applicable option) where “Positive” is a rating of 9-10 and “Negative” is a rating of 0 to 6. Performance is calculated using a Net Promoter Score (NPS)-like methodology; that is, Performance = percentage of Positive responses minus the percentage of Negative responses. This provides a respondent-level view of touchpoint performance. Values for every vendor at each touchpoint are compared to an industry-specific average to provide an understanding as to how each supplier is perceived compared to this average. An awareness of the importance assigned to each touchpoint allowed us to create a weighted overall Customer Experience Score for each supplier, as well as establish an industry-specific standard that is used as a benchmark throughout this report.

Awareness of the breadth of a supplier’s product line has the lowest industry average value. This suggests suppliers must continue to invest in resources to fulfill this need for information, a need that is especially acute during the pre-purchase phase of the purchasing cycle. These investments range from user-friendly and intuitive website design, search engine optimization, and the development of comprehensive website content. This will also assist in the Product Selection touchpoint where the industry is clearly under-performing.

Suppliers who focus their customer experience efforts on outperforming the industry’s averages are those who will achieve the competitive advantage and differentiation they seek.

The suppliers evaluated in our report are:

  • Abbott
  • Agilent
  • BD Biosciences
  • Beckman Coulter
  • Bio-Rad
  • bioMerieux
  • Bruker
  • Cepheid
  • DiaSorin
  • GenMark Diagnostics
  • Illumina
  • Luminex
  • Ortho Clinical Diagnostics
  • Quidel
  • Roche
  • Sekisui Diagnostics
  • Siemens Healthineers
  • Sysmex
  • Thermo Fisher Scientific

How did your company compare to the industry average at each touchpoint? The full report contains detailed profiles and comparisons of 21 leading suppliers. In addition, a companion interactive report gives you the ability to filter the data by company, market segment, region and touchpoint to conduct your own analysis and presentations.

 

Please download our complimentary report summary.

By Emily Hayes, LabPulse.com editor in chief
FROM Kalorama’s partner publication Lab Pulse.com 

Testing for the tau protein in blood could help predict the outlook for the rare and deadly Creutzfeldt-Jakob disease (CJD), a discovery that also has implications for research in Alzheimer’s disease and other neurodegenerative disorders, researchers reported in JAMA Neurology on May 6.

Tau is a protein associated with neuronal damage, and previous research has found elevated tau levels in patients with CJD. But tau levels are typically obtained through cerebrospinal fluid (CSF), acquired via lumbar puncture — an invasive procedure. What if tau could be measured through blood samples instead?

Blood testing of total tau (t-tau) was found to be a unique predictor of survival in patients with sporadic CJD (sCJD), and it is more convenient than other methods for estimating a patient’s prognosis, reported a team led by Adam Staffaroni, PhD, a neuropsychologist at the University of California, San Francisco (UCSF) Memory and Aging Center.

“These findings further bolster the value of blood-based biomarkers based on their minimally invasive and relatively inexpensive nature and build on prior studies that suggested patients with sCJD and controls can be discriminated with relatively high accuracy using blood-based assays,” the group wrote.

The results promise to improve clinical care and help ensure that clinical trials in neurodegenerative diseases are adequately powered, according to the researchers. However, the findings still need to be validated in larger studies before they can be put into practice.

Getting a handle on a grim diagnosis

CJD belongs to a family of human and animal prion (abnormal forms of cellular proteins) diseases. Like Alzheimer’s and Huntington’s disease, it causes psychiatric symptoms and decline, but it does so much more quickly.

According to the U.S. National Institutes of Health (NIH), only 350 cases of CJD are reported annually; on average, CJD occurs at about age 60, and individuals with the disease rarely live past a year. The sporadic type of CJD is the most common, accounting for 85% of cases. CJD is typically diagnosed through electroencephalography, CSF diagnostics, and MRI, with confirmation in autopsy after death.

Baseline total tau on CSF tests and a polymorphism at the codon 129 genotype are currently used to help predict how long patients will live, but there has been interest and some research published about the potential for blood testing as a noninvasive biomarker for CJD and other neurological disorders, Staffaroni and colleagues noted.

In the current study, the researchers sought to determine the utility of plasma and CSF biomarkers compared with other characteristics of CJD by evaluating patients referred to the UCSF Memory and Aging Center with probable or pathology-proven disease between 2004 and 2018. On average, CJD patients live for four months, but lifespan is highly variable, with some surviving for weeks and others for years, the authors noted.

“Accurate prediction of disease duration has implications for clinical management, helping patients and families prepare for the disease course,” they wrote. “Accurate prediction of survival time also affects clinical trial design, as stratifying patients based on expected disease course can improve a trial’s power, thereby reducing costs and ultimately maximizing the number of trials that can be funded. This is especially germane in sCJD, given the rarity of the disease and variable survival time.”

In addition to blood and CSF tests, the researchers assessed five other factors associated with survival:

  • Sex
  • Age
  • Genotyping of the prion protein gene at codon 129
  • The Barthel index, a measure of ability to carry out daily life activities
  • The Medical Research Council (MRC) prion disease rating scale, which assesses cognitive function as well as life activities

Of these five factors, three — codon 129 genotyping and scores on the Barthel index and the Medical Research Council scale — significantly correlated with the length of survival, with lower levels of function predicting a faster disease course, Staffaroni and colleagues reported.

The plasma total tau level and the Barthel index each had independent value for predicting length of life, a statistically significant finding, they wrote. And as with plasma biomarkers, the CSF t-tau level remained associated with survival after controlling for the Barthel index and codon 129 genotype, the researchers noted.

“The correlation between CSF and plasma t-tau level, together with the concordance of CSF and plasma t-tau level in predicting survival time, further strengthens our finding that plasma tau level may be a useful biomarker in this cohort,” they wrote.

Building the evidence base for plasma tau

The UCSF investigators wrote that the data are in line with prior research, in that plasma t-tau correlated with the rate of disease progression, matching a study of 45 patients by Thompson et al (Journal of Neurology, Neurosurgery & Psychiatry, September 2018, Vol. 89:9, pp. 955-961). Plasma t-tau did not correlate with survival in that study, they noted, but Thompson and colleagues had not controlled for baseline functional severity.

In the UCSF study, the plasma t-tau level did correlate with survival regardless of functional severity at baseline. Furthermore, the researchers found that the level of plasma neurofilament light (NfL), the level of CSF t-tau, the ratio of t-tau to phosphorylated tau, and the level of neuron-specific enolase (NSE) were also significantly associated with the length of survival, but less so than plasma t-tau.

“Importantly, when baseline functional status and plasma t-tau levels were modeled together, both were strong, independent predictors of survival time,” the group wrote. “This suggests that clinical measures and plasma t-tau level could be combined to further improve prediction accuracy.”

What this means for Alzheimer’s

The results still need to be validated in a larger cohort, and assays are currently only available for research use, though commercial tests are in development. Elevated plasma t-tau is found in patients with many other conditions, including the neurodegenerative diseases Alzheimer’s and frontotemporal dementia, as well as acute brain injuries. However, its value as a biomarker has been questioned in other diseases like Alzheimer’s partly because the plasma t-tau levels did not match the CSF t-tau levels, Staffaroni and colleagues wrote.

“One explanation for the high correlation between CSF and plasma tau level in sCJD is that the rapidity and amount of neurodegeneration may result in continuous, high quantities of tau in the periphery that overcome the peripheral mechanisms of elimination,” the researchers wrote. “Others have argued that higher plasma t-tau concentrations in sCJD may be driven by preterminal cases having higher t-tau levels.”

CJD is an excellent model for treatments targeting the prion-like pathogenesis of neurodegeneration, Staffaroni et al wrote, adding that “rapid decline in prion disease may allow clinical trials to detect a drug effect more quickly than trials enrolling patients with slowly progressing conditions.”

“This study adds to research in other dementia disorders, such as Alzheimer disease, suggesting that blood-based assays may revolutionize the way that neurodegenerative diseases are diagnosed and monitored,” they wrote.

As with Alzheimer’s, the field needs to standardize methods for testing, optimize cutoff points, and replicate the research before moving these biomarkers into the clinic or using them in clinical trials, the authors advised.

 

Introducing accurate test results to the place where patient care is occurring is a compelling concept for improved care.  And that is reflected in the growing year-over-year revenues for products that are successful at getting that done.  POC has not converted in every category, and it’s not for everything.  Indeed, lab-based tests remain stalwart in clinical diagnosis in major market hospitals, where they offer superior sensitivity and specificity and volume advantages.

Yet it the POC market grows larger every year, and 2018 was no exception.  This according to Kalorama Information’s latest point of care market study: https://kaloramainformation.com/product/worldwide-market-for-point-of-care-testing/

There are cost concerns, there are adoption challenges.  And there are technology limitations.  But Kalorama finds each year these boundaries are pushed.  POC markets grow faster than non-POC markets, and faster than the average of the in vitro diagnostics industry.    In 2018, sales of POC testing reached $22.3 billion, increasing 7.5% from $20.7 billion in 2017. That’s fast, more than twice as fast as the whole market grew.  New technologies and increased demand contributed to growth in the markets. A contributing factor to slower growth in some segments was pricing strategies that continued to discount the cost of POC diagnostic testing in some segments and higher cost in other segments of testing.  In 2023, the total global POC diagnostic testing market is expected to reach $30 billion, displaying growth of 6.1% over the forecast period 2018-2023.

“In 2018, sales of POC testing reached $22.3 billion, increasing 7.5% from $20.7 billion in 2017.  That’s fast, more than twice as fast as the whole market grew.  “

Diagnostic tests performed outside the central laboratory or decentralized testing is generally known as point-of-care (POC). Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments including the workplace, home, disaster care and most recently, convenience clinics.

The menu for POC continues to expand.  In the past 5-10 years, POC products were developed in the following categories: HbA1c, B-Type Natriuretic Peptide (BNP), whole-blood lactate, D-Dimer, C-Reactive Protein (CRP).

Moreover, POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. More diagnostic manufacturers have pursued CLIA waiver status for their POC devices and CE Mark for POC or self-use.  At the same time more, decentralized test venues invest in non-waived rapid tests and instruments.  POC testing appe

ars to be headed for an even bigger role in diagnosis and monitoring patient care.  New technologies are allowing POC devices to produce quantitative lab-quality test results that can be transferred automatically to an information system, a remote caregiver service for consultation or an electronic medical record.

Molecular POC tests in physician office are already available for respiratory infections and more.  The capacity to provide precise answers for time sensitive tests such as sexually transmissible diseases and other infections will drive the market for POC molecular test devices.  Ease of use is a plus for hospital labs.  Worldwide, lab budgets are being cut for test send-outs and there are not enough trained technologists to run molecular tests in their present configuration.

Diagnostics are generally a market of focus – the new pharma model tailors therapy to the individual’s particular disease physiology often determined by the results of a diagnostic test.  So, more tests – molecular and immunoassays – will come to market, some will have a high price tag and some not.  Price will not be the deciding factor.  Test adoption in this scenario is based on performance data, contribution to patient outcome and cost/benefit analysis.

A major factor in achieving this goal of more precise and personalized therapeutic options is the use of advanced algorithm driven information technologies that can turn test data into actionable medical decision-making information.  This trend is driven by the involvement of major information technology companies and payers that are tired of paying for drugs that often have limited positive patient outcome.

Information about diseases, therapies and tests is readily available via the Internet and a growing number of apps on personal digital assistants (PDAs) including all sorts of smart phones.  Wearable devices participate in this area by collecting vital sign data that are then analyzed by IT tools to provide health care improvement instructions.

Kalorama Information’s report can be found at: https://kaloramainformation.com/product/worldwide-market-for-point-of-care-testing/

 

 

[by Christina Chew]  It is increasingly common to test in panels to gain clarity on disease while treatment will be most effective.  Numerous multiplex products are on the market, and their effectiveness has been shown in studies, but there are challenges with reimbursement.   In this article, we will look at the current status of syndromic testing.   Syndromic and other microbiology diagnostic markets are covered in our report The Worldwide Microbiology Market (Traditional Microbiology, Microbiology/Infectious Disease Immunoassays, Molecular Microbiology, Mass Spectrometry in Microbiology)

“With these FDA clearances and new tests being introduced over the last decade, companies are placing bets on syndromic testing taking off. Siemens Healthineers, for example, is betting that syndromic testing will boost its diagnostics franchise by acquiring Luxembourg-based Fast Track Diagnostics in 2018.”

Since the discovery of duplex DNA in 1953 by Watson and Crick, the diagnostics area has witnessed tremendous growth in the field of molecular diagnostics, particularly in areas such as improved sensitivity, versatility of technology and automation. In the past decade, molecular diagnostics has resulted in a paradigm shift in clinical practice by enabling rapid detection of pathogens in blood cultures, respiratory specimens, stool, etc. During this time, we have also witnessed the launch of a single molecular test, such as the Abbott ID NOW (formerly Alere i) to a multiplex molecular panels with more than five targets, such as the FilmArray Blood Culture Identification (BCID) panel by BioFire Diagnostics, LLC (a Biomerieux company). This revolutionary multiplex tests enable rapid diagnosis of certain infections thus allowing healthcare providers make clinical management decisions in a timely manner.

The word syndromic comes from the root syndrome meaning a set of medical signs and symptoms that are correlated with each other or with a specific health-related cause. Often, patients can present with symptoms that are non-specific, but a combination of them can suggest certain diagnoses.

There have been a number of multiplex respiratory panels that can detect 5 or more pathogens simultaneously that have been FDA cleared. Upper respiratory infection is very common and afflicts millions of people in the US each year. It is the most cited reason for doctors’ visits. The first multiplex panel to receive FDA clearance was the Luminex xTAG RVP v1, which received clearance in 2008. This was followed by the Luminex xTAG-RVP Fast clearance three years later. They test 12 and 8 targets, respectively, with turnaround time of 8 and 6 hours. The NxTAG RPP (Luminex), which was cleared in 2015 can detect 20 pathogens at once with a turnaround time of 4 hours. GenMark Diagnostics’ eSensor RVP assay is performed on the XT-8 system and targets 14 pathogens with a turnaround time of 8 hours. Of all the commercialized respiratory multiplex tests, BioFire’s FilmArray respiratory panel (FA-RP) provides results in an hour, the fastest among its competitors.

Another growing infectious disease multiplex molecular test is in the gastrointestinal (GI) area. Conventional test methods for GI pathogens, such as culture, antigen tests and microscopic exams are not only time consuming but also costly and have limited sensitivity. According to the World Gastroenterology Organization, there are 2 billion new cases annually, resulting in 1.9 billion deaths among children under 5 years old. And according to the Centers for Disease Control and Prevention (CDC), GI illnesses account for 76 million emergency department (ED) visits and hospitalizations in the US each year. The severity of foodborne illnesses makes the case for faster and more sensitive molecular tests.

There are three FDA cleared multiplex assays that can detest more than 5 stool pathogens – xTAG GI pathogen panel and Verigene Enteric Pathogens by Luminex and BioFire FilmArray GI panel from BioFire. A study conducted at the University of Texas Medical Branch found that the BioFire FilmArray GI panel improved patient care due to its ability to identify a broad range of pathogens in an hour, allowing for proper treatment while reducing the need for further diagnostic tests and hospitalization. The authors also found that overall health care cost could have been reduced by almost $300 per patient if the FilmArray GI panel was used. This study definitely makes a compelling case for the need of GI multiplex syndromic tests.

With these FDA clearances and new tests being introduced over the last decade, companies are placing bets on syndromic testing taking off. Siemens Healthineers, for example, is betting that syndromic testing will boost its diagnostics franchise by acquiring Luxembourg-based Fast Track Diagnostics in 2018. Siemens Healthineers currently does not have commercialized molecular tests for infectious diseases. Fast Track Diagnostics (FTD) offers a wide range of tests, such as respiratory, GI, STI, and touts its capability to distinguish between viral or bacterial infection in one test. So far, FTD has not received FDA clearances for its tests yet.

However, reimbursement remains a challenging topic with syndromic multiplex testing. Multiplex assays are assigned various billing codes related to the number of targets in the tests. However, in late 2018, Palmetto deemed the multiplex viral panels do not meet Medicare’s “reasonable and necessary” criteria. Palmetto also stated that there is a lack of clinical utility when it comes to rapid and sensitive nucleic acid testing in decreasing the use of antibiotics. Finally, the Medicare contractor determined that syndromic surveillance isn’t part of Medicare benefits. This is a set back for syndromic testing. It may take years of clinical studies to prove the clinical utility and ROI of syndromic tests to gain a reversal of this decision.

Syndromic multiplex testing is relatively new to the market and is performed in a clinical microbiology setting. It is anticipated that it will become increasingly common over time and can be used in point-of-care settings. Given that reimbursement is a challenge, it may not be adopted as readily as many had hoped. The long turnaround time, lack of flexibility in some panels and cost considerations may delay POC adoption. Kalorama’s prediction of growth in the molecular POC space hasn’t materialized. Until the reimbursement challenges is resolved, growth in syndromic molecular multiplex testing could be slowed.
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Christina Chew

Special Projects Analyst, Kalorama Information

The CDC reports a late peak and possible second wave to what was previously thought to be a weaker flu season compared to recent years. This is important for IVD makers, as respiratory IVD markets are driven to a great extent by the severity of the flu season. While the total number of cases remains below 30M, and thus less than last year, recent weeks saw a small peak and there’s a new strain that is demonstrating virulence.

The CDC reports a late peak and possible second wave to what was previously thought to be a weaker flu season compared to recent years. This is important for IVD makers, as respiratory IVD markets are driven to a great extent by the severity of the flu season. The chart  accompanying depicts the flu cases in thousands for the weeks of 2019.  instead of fully declining, there was a late peak in February. While the total number of cases remains below 30M, and thus less than last year, recent weeks saw a small peak and there’s a new strain that is demonstrating virulence.

Per the CDC:  Since October 1, there have been nearly 26.3 million cases of the flu, as many as 12.4 million flu-related medical visits, and up to 31,200 deaths caused by the flu. Nine children died from the flu last week, bringing the total of pediatric deaths this season to 64. There are two main groups of influenza viruses: influenza A and influenza B.

Respiratory systems such as those that detect flu are a key component of the true molecular point of care market, representing decentralized rapid or CLIA waived systesm. And revenues for respiratory represents nearly sixty percent of this market according to the Market and Potential for Molecular Point of Care Diagnostic Tests 2019
https://kaloramainformation.com/product/the-market-and-potential-for-molecular-point-of-care-diagnostic-tests-2019/

According to that report, the flu season’s severity in 2017/18 created an opportunity for new systems.  This year, a new strain is concerning.  The H3N2 strain belongs to the influenza A family. In addition to the typical symptoms of flu, which include fevers, chills, body aches, and rigors [shaking chills], it additionally has the potential of causing several severe complications, including very high fevers.

CDC estimates that the burden of illness during the 2017–2018 season was also high with an estimated 48.8 million people getting sick with influenza, 22.7 million people going to a health care provider, 959,000 hospitalizations, and 79,400 deaths from influenza (Table 1). The number of cases of influenza-associated illness that occurred last season was the highest since the 2009 H1N1 pandemic, when an estimated 60 million people were sick with influenza6.

While this flu season has not been quite as severe as seasons past, there has been a recent uptick in a less common flu strain, the H3N2 virus, now accounting for over 50 percent of new cases, according to recent data from the CDC. There have been 350,000 hospitalizations according to the agency.

Since near patient-testing systems using PCR technology first appeared on the market, the leading IVD market research publisher Kalorama Information has provided sound market estimates and forecasts for their usage. As these systems move from novel to closer to a routine usage, our 2019 update provides essential information for marketers in IVD.

Kalorama’s report is a true look at the clinical market for molecular systems, both CLIA-waived and those CLIA-moderate that can be used in an office visit. The report incorporates systems in development as of 2019 and updates on competitor laggards in previous editions that have not produced products.

Companies in the molecular point-of-care market include: Abbott, Roche, Biomerieux BioFire and Danaher’s Cepheid, among others.

Detection of infectious disease promptly and accurately is important because the burden of infectious disease is high.  In the United States, chronic lower respiratory diseases were the third leading cause of death in 2015, behind only heart disease and cancer.  The Center for Disease Control and Prevention (CDC) reports that 155,041 people died in the United States in 2015 due to chronic lower respiratory diseases.

Infectious diseases are all the more troubling because they may harm long after the disease is treated.  These secondary effects – cancer, heart disease – increase the stakes and suggest the need for testing. 

Clinical microbiology laboratories perform tests to detect, isolate, identify and characterize microorganisms that cause infectious diseases, and also perform antibiotic susceptibility tests.   Traditional microbiology, including culture, microscopy, use of stains plus fluorogenic and chromogenic substrates, and other technologies has b used for several decades in microbiology laboratories.  Microbiology tests may be performed using traditional microbiology techniques, or by using newer technologies including immunoassays, molecular microbiology (PCR or other nucleic acid amplification methods), or mass spectrometry.

The following represent recent developments in microbiology that are innovative.  For each, we’ve detailed the company, the area the development is in (disease being treated or general procedure such as blood culture), the location of the company so that interested readers can pursue them, and the detail on the innovation and the status (FDA or CE cleared, market = marketed for some time, service, RUO or other).

This table represents some recent innovations in infectious disease diagnostics.  For more analysis please see our Infectious Disease World Market Analysis report.

Company Location Area Details Stats
Abbott Abbott Park, IL flu a/b, strep A ID NOW CLIA Waived POC FDA
Abbott Diagnostics U.S. various Iridica molecular-testing platform CE
Abbott Diagnostics U.S. HIV ARCHITECT HIV Ag/Ab Combo assay FDA
Accelerate Diagnostics U.S. blood culture CRE in blood culture dev
Accelerate Diagnostics U.S. blood culture BacAccelerate ID/AST Blood Culture Assay CE
Advanced Biological Lab Luxembourg HCV Anti-E1/E2-based ELISA for HCV management dev
AdvanDx U.S. blood culture Candida QuickFISH CE
AdvanDx U.S. blood culture gram-positive/negative QuickFISH CE
AdvanDx U.S. HAIs mecA XpressFISH, MRSA FDA
Alere U.S. HAIs BinaxNOW PBP2a test CE, FDA
Alifax Italy blood culture Automated blood culture FDA,CE
Aperiomics U.S. microbiome Absolute-Biome, microbiome sequencing RUO
Aseptika Limited UK resp inf bacterial protein in sputum, CF, asthma, COPD CE
Atomo Diagnostics Australia panel AtomoRapid dengue and chikungunya dev
Beckman Coulter Brea, CA Sepsis Early Sepsis Indicator DxH900 Hematology System CE
Biocartis Switzerland ebola Ebola test with Janssen Diagnostics on Idylla dev
Biohit OYJ Finland microbiome Genetic Analysis AS’s Dysbiosis microbiome for IBD CE
BioInnovation Solutions Switzerland filoviruses, such as Ebola and Marburg dev
bioMereiux France various AE-180 /AE-240 mid throughput immunoassay system FDA
bioMereiux France pneumonia 18 bacteria/8virus/7gene panel
bioMérieux France mass spec assays for Knome sequencing platform dev
bioMérieux France ID/AST VITEK MS, ID/AST on Shimadzu mass spec CE, FDA
bioMérieux France ID/AST BacT/ALERT Virtuo, 15 min result mkt
Bioneer Corp Korea Ebola AccuPower EBOV real-time RT-PCR RUO
Bioneer Corp Korea Zika AccuPower ZIKV Multiplex Zika, dengue, CHIKV CE
Bioneer Corp. Korea Ebola AccuPower EBOV real-time RT-PCR Nigeria
Bio-Rad Hercules, CA malaria multiplex MAG PIX FDA
Bruker Biosciences U.S. blood culture MALDI Sepsityper Solution, positive blood culture CE
Bruker Biosciences U.S. blood culture integrate MALDI Biotyper with BD Phoenix dev
Cajetmo Heredin University Lima, Peru chagas qPCR on clot samples low blood leads dev
Canon BioMedical U.S. Lyme with T2 Biosystems, Lyme Disease, PCR dev
Cepheid U.S. TB Xpert MTB/RIF, TB & rifampin-resistance FDA
Cepheid U.S. TB Xpert XDR-TB, extensive drug resistance, PCR dev
Cepheid U.S. ebola Xpert Ebola, PCR EUA
Cepheid U.S. MRSA Xpert MRSA/SA Blood Culture (BC) FDA
Cepheid/Danaher HIV Gene Expert HIV-1 Qual FDA
Ceres Nanosciences U.S. lyme Nanotrap Lyme Antigen (LA) Test srvc
Chembio Diagnostics U.S. ebola DPP Ebola with Integrated BioTherapeutics dev
Chembio Diagnostics U.S. zika zika added to DPP Fever Panel assay dev
Chembio Diagnostics U.S. malaria DPP Malaria dev
ChromaCode Carlsbad, CA tick-borne 12 spiecies tick panel service
Co-Diagnostics HBDC U.S. TB LogixSma-RT TB Kit mkt
Coris BioConcept Belgium chagas T. cruzi satDNA OligoC-TesT, PCR mkt
CTK Biotech U.S. CHICKV OnSite Chikungunya IgM Combo Rapid Test CE
Curetis AG Germany response Acumen’s AcuSept panel, sepsis immune response dev
DiaSorin Italy campy LIAISON Campylobacter stool test mkt
DiaSorin Italy GI Liaison bacterial stool-testing panel CE
Diaxonhit France avidity portfolio active vs older infections mkt
Diaxonhit France sepsis BJI InoPlex test staph antibodies in blood CE
DiscoGnosis Project EU panel LabDisk 12 pathogens- malaria, dengue, CHICKV dev
DNA Genotek/OraSure Canada microbiome OMNIgene•GUT microbiome collection kit, stool self collect CE, RUO
DPZ Diagnostics Germany ebola Diagnostics-in-a-Suitcase dev
DxNA U.S. Valley Fever Valley Fever (coccidioidomycosis) dev
Dynamiker Biotechnology China fungi ELISA invasive fungal disease CE
EKF Diagnostics UK sepsis Stanbio LiquiColor Procalcitonin, automated analyzers CE
EliTech Group South Logan, UT HSV 2 multiplex six channel test
Enigma Diagnostics UK TB MDR-TB on Enigma Mini Laboratory dev
Epistem Holdings UK TB Genedrive TB and resistance CE
Fast-Track Diagnostics Luxembourg Ebola FTD Ebola assay CE
Fio Corporation Canada ebola Corgenix ReEBOV Ebola antigen on Deki Reader EUA; FDA
Fio Corporation Canada lassa Corgenix ReLASV Lassa virus antigen on Deki Reader CE
Fio Corporation Canada micro Deki Reader Malaria & Dengue, LF CE
GBDbio U.S. TB TB REaD POC test, fluorescent beta lactamase enzyme dev
Genalyte Inc. U.S. ebola Ebola antigens and IgM/IgG antibodies dev
Genalyte Inc. U.S. ebola Ebola antigens and IgM/IgG antibodies dev
GenArraytion U.S. zika MultiFlex Mosquito-borne Panel, zika etc RUO
GeneDrive Manchester, UK Hepatitis C Genedrive POC HCV ID Kit CE
GeneDrive Manchester, UK
GeneDrive Manchester, UK hep C 100% specificity test CE
Genetic Analysis Norway microbiome Dysbiosis test microbiome imbalance in irritated bowel syndrome CE
Global BioDiagnostics UK TB TB, Reporter Enzyme Fluorescence dev
Globavir Biosciences U.S. dengue PanGlob RT-PCR Dengue market
Gold Standard Diagnostics U.S. syphilis AIX1000 Rapid Plasma Reagin (RPR) Automated FDA
Great Basin Scientific U.S. PCR Staph ID/R Blood Culture Panel FDA
Hain Lifescience Germany TB GenoType MTBDRsl, colonies & sputum CE
ICDPR Dhaka, Bangledesh cholera Cholkit Dipstick Assay market
Inflamatix Burlingame, CA Sepsis multigene sepsis panel dev
Institute for Preventitive Research Gottigen, Germany treporema Pallidum LAMP technology dev
Jena University Jena Germany MIC MIC determinaion in two hours with LOC tech. dev
LabCorp U.S. Zika Altona’s RealStar Zika Virus RT-PCR Kit srvc
Luminex Austin, TX flu a/b Aries FDA
Luminex Austin, TX GI Verigene II GI assay dev
Luminex U.S. panel GenArraytion MultiFlex Mosquito-borne Panel- Zika, CHICKV, Dengue dev
Lumora UK malaria malaria test, LAMP, with FIND and Eiken mkt
Magnolia Medical San Mateo, CA blood culture U South Car. Study shows 4 fold decrease in contaminiation study
Mass. Institute of Technology U.S. panel Matrix Multiplexed Diagnostic – ebola, dengue, yellow fever dev
Mayo Medical Lab U.S. microbiome microbiome diagnostics on Whole Biome’s Complete Biome Test service
MBio Diagnostics U.S. malaria LightDeck Malaria cartridge dev
MBio Diagnostics U.S. malaria LightDeck Malaria cartridge dev
MBio Diagnostics U.S. instr LightDeck, multiplexed immunoassay platform, cartridge dev
Medical Innovation Ventures Malaysia dengue ProDetect Dengue tests CE
MeMed Diagnostics Israel response ImmunoXpert pathogen immune response proteins CE
Meridian Bioscience Cincinatti, OH CMV Althethia CMV Test FDA
Meridian Biosciences U.S. TB illumigene Mycoplasma Direct assay, improved CE, FDA
Meridian Biosciences U.S. dengue TruQuik CE
Meridian Biosciences U.S. malaria illumigene Malaria CE
Milford Molecular Diagnostics U.S. ebola Ebola RT-PCR srvc
MIT Cambridge, MA gene editing SHERLOCK Diagnostic Platform cas13 dev
Nanologix U.S. instr NanoLogix N-Assay, ELISA dev
OmniBiome Therapeutics U.S. microbiome maternal infections that lead to preterm labor service
OraSure Technologies U.S. ebola OraQuick Ebola Rapid Antigen Test EUA
Ortho Clinical Diagnostics Raritan, N.J. HIV HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) FDA
Quansys Biosciences U.S. resp 14‐plex Pneumococcal Array dev
Quidel San Diego, CA h. pylori Quick chaser test
Quidel San Diego, CA viral gastroenteritis Solana GAS assay small footprint
Quidel U.S. resp Sofia RSV Fluorescent Immunoassay waived
Quidel U.S. resp Sofia Strep A+ Fluorescent Immunoassay waived
Qvella Corp Canada sample Field Activated Sample Treatment pathogen concentration & Dx dev
Research & Diagnostic Antibodies U.S. sepsis PliNOSa Assay Kit CE
Response Biomedical Canada sepsis RAMP Procalcitonin CE
Roche Indianapolis, IN zika cobas zika test 6800/8800 pooled assay FDA
Roche Indianapolis, IN CT/NG RT PCR cobas FDA, CE
Roche Indianapolis, IN HPV cobas 6800/8800 FDA
Sandia National Labs Livermore, CA choldera, staph, e.coli combined immunoassay and NAAT service
Siemens Healthineers Tarrytown, NY hep/HIV HIV, CHIV, EHIV and viral hep. Tests for Attelica Solution pre-market approval FDA
Singulex U.S. pathogens single-molecule counting technology dev
Stellenbosch University South Africa TB Risk 4 test for TB dev
Sysmex Kobe, Japan various UF-5000 blue laser flow cytometry market
Thermo Fisher Scientific U.S. MERS Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA
Thermo Fisher Scientific U.S. flu CDC’s influenza A (H7/N9) virus EUA
Transasia Bio-Medicals India STD ErbaLisa Syphilis mkt
U. of California, Irvine U.S. HCV HCV-AGS EIA acute HCV in urine dev
uBiome U.S. microbiome SmartGut, fecal sample seq for a microbiome study of the gut service
University Hopsital Cologne, Germany HAIs rapid test for carbapenmases dev
University of Hong Kong Hong Kong RSV saliva test for respiratory disease dev
USC Los Angeles, CA malaria PODS early stage malraia optics technology dev
ViroCyt U.S. sample ViroTag & Virus Counter 3100 dev

1.5 Billion Yet-Unclaimed Revenue in The LATAM IVD Market: Report

There is IVD sold almost everywhere in the world but revenue growth is not found everywhere. For most of the top IVD companies, adding scores of millions in growth would be helpful to business plans. That’s why growth regions such as Latin America offer promise beyond their market size. The maturation of IVD markets in developed countries (growth rate 1%-2%) has IVD companies casting their nets in developing countries where rising incomes and standards of living are anticipated to spark a new health consciousness population with growing demands for quality medical care.

A New Report From Kalorama Information Projects $1.5 Billion in as-yet-unclaimed market dollars in the Latin American in vitro diagnostics market in the next five years.

Latin America (LATAM) is a key target for IVD manufacturers.  Kalorama’s report, IVD in Latin America, focuses on the market for reagents and instruments in the most important countries of the continent. Argentina, Brazil, Chile, Colombia, Mexico, and Peru are singled out for a deeper level of analysis; the countries of Bolivia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras, Nicaragua, Panama, Paraguay, and Uruguay are also considered to provide a complete overview of the region. Combined, these countries represent a population of 626.5 million; a large potential IVD market audience. Brazil and Mexico represent the two largest countries in terms of population, accounting for more than half of LATAM total population. For this reason, these two countries have been the focus for many IVD suppliers in recent years.

However, as economic conditions strengthen in other countries and demand increases for quality health services, there are additional opportunities in countries such as Argentina and Chile.

The estimated GDP for the countries studied in this research is an average of 0.1% annual growth for the year 2017 but consists of a declining GDP for Venezuela; excluding Venezuela, the region records 2.2%. GDP per capita is reported at $16,635 on average for the region.

Inequalities and social deprivation are always present in Latin America, where poverty is not declining; in fact, it sometimes increases. Although not all the countries in Latin America present similar circumstances or have the same players, there is a permanent and historical social inequality present in all countries of the region. Throughout the region there are highly educated citizens with high economic income; while there are also citizens without or with low education with financial struggles.

Over the last years, the countries in the Atlantic zone grew more rapidly than those in the Pacific zone, basically because of the rise in the price in commodities, currently slowing and declining. Venezuelan, Argentinian and Brazilian currencies have experiences wide currency fluctuations, mostly declining in value. Additionally, both Argentina and Venezuela are going through a high inflation rate process.

The total revenues calculating the IVD market in LATAM are generated by the sales of reagents, consumables, controls, calibrators and solutions categorized in well-defined segments. The market for IVD in Latin America is estimated at $2.4 billion in 2018 and will grow at 8.4%. That’s nearly one billion and a half dollars of extra market value that companies will compete for. Population growth, government insurance, newly insured patients and updated healthcare facilities will drive growth.

Brazil is the largest in vitro diagnostics market within Latin America and represents 45% of the market. Mexico ranks second with an estimated 19%.  Brazil, Chile and Colombia are among the highest growers.

Key IVD Market Competitors in Latin America

Abbott

Abbott Laboratories is a global, diversified healthcare company active in pharmaceuticals, nutritionals, devices and diagnostics. Abbott’s diagnostic product strength is its sheer presence worldwide. In LATAM, the company dominates in immunoassay-based microbiology and molecular microbiology, and is competitive in all countries in immunoassays.

Market Share for IVD Players in Latin America with rankings can be found in Kalorama Information’s New Research Report on Latin American IVD

Danaher

Beckman Coulter, Inc., a subsidiary of Danaher Corporation (DHR), has developed, manufactured, and marketed IVD tests for more than 75 years. The company reports that more than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents.   Beckman Coulter’s strength is in chemistries, immunoassays, flow cytometry and hematology.   Danaher also operates the blood analyzer leader, Radiometer, and histology leader Leica Biosystems.

Becton Dickinson

Becton Dickinson (BD) is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry, and the general public.  BD has operated in China since 1994 and in India since 1996. In LATAM, the company specializes in microbiology, flow cytometry, and molecular solutions.

bioMérieux

bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. bioMérieux is best known for its microbiology business that includes immunoassays, traditional microbiology, and chromogenic media; however, the company is moving to capitalize on its acquisition of Organon Technika’s molecular technology, BOOM, and NASBA technologies.

Roche

Roche Diagnostics dominates clinical chemistry, urinalysis, POC, and hematology and is competitive in molecular and immunoassays. Roche is the world’s largest supplier of clinical diagnostics products; Roche’s global product sales are still almost twice its nearest competitor. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools for patient disease management. Roche’s Ventana Medical Systems business also contributes to their market strength.

Siemens Healthineers

The Siemens Healthineers business is one of the world’s largest suppliers to the healthcare industry and a major player in medical imaging, laboratory diagnostics, medical information technology, and hearing aids. The diagnostics division includes products for clinical chemistry, drug testing, hematology, coagulation, immunoassay, infectious diseases, microbiology, molecular diagnostics, plasma proteins, point of care testing, blood gases/electrolytes, and urinalysis. In addition, Siemens operates a clinical laboratory and offers laboratory informatics and automation.