Pittcon 2019 now in its 70th year, meets in Philadelphia this week.  The meeting is an opportunity to showcase improvements in laboratory technology.  While mass spectrometry and liquid chromatography are key areas for vendors, this year’s meeting will feature a large demonstration space where vendors will show off spectrometry, software and even analyze common everyday beverages to demonstrate their system features.

Bioinformatics Inc., Kalorama Information and related companies will be present with a large team.  Kalorama Information’s partner publication SDi (STRATEGIC DIRECTIONS INTERNATIONAL)  recently published its 80+ instrument market analysis report, Global Assessment 2019, https://bioinfoinc.com/product/2019-sdi-global-report-analytical-life-science-industry/.  The report covers the bulk of the industry at the meeting.

A few noticeable early announcements are on our radar:

 Bruker Biosciences will exhibit a new inert gas fusion (IGF) analyzer.  The new G6 LEONARDOTM is an economic, robust and precise inert gas fusion (IGF) analyzer for oxygen, nitrogen and hydrogen (ONH) concentration measurements in inorganic samples.  With its pre-calibrated standard methods and argon gas instead of helium, the G6 LEONARDO addresses the needs of industrial process and QC for easy and cost-effective operation.

Bruker also announced a new software acquisition intended to help manage pharamceutical projects.  Bruker announced that it has acquired Arxspan LLC , a provider of cloud-based scientific software and workflow solutions. Arxspan is known for its line of cloud-based products for the management of research data, with a focus on serving pharmaceutical and biopharma customers.

“Known-Knowns” and “Unknown-Unknowns”

Among many other show developments and announcements, Thermo Fisher Scientific will host two seminars dedicated to small-molecule.  The company will inform attendees of its new software solutions coupled to a new Orbitrap HRAM mass spectrometer to tackle the challenge of capturing sufficient, high-quality MSn fragmentation spectra for each component within complex samples. The company says these new solutions revolutionize the process and effectiveness of confident compound characterization of known-knowns, known-unknowns, and unknown-unknowns.

In another seminar, Thermo will feature New dual-LC technology and single-quadrupole MS provide opportunities to increase throughput by analyzing samples more efficiently and reduce operational costs by optimizing bench space. Learn how these systems can be used for efficient characterization of (bio)pharmaceuticals, fast method development, and comprehensive separation and detection of complex samples.  The Vanquish Duo for Dual LC houses two flow paths in one system to save space and improve returns.

Waters Corp. will demonstrate it’s Automated PeakTracker in Fusion QbD for Advanced LC and LC/MS Method Development a new platform that dramatically advances chromatographic method development:   Waters Empower CDS with Fusion QbD® Software containing PeakTracker™, the Waters ACQUITY H-Class PLUS UPLC, PDA detection, and ACQUITY QDa Mass Detector.

The company says that PeakTracker is a new automated peak tracking technology that optimizes and simplifies mass detection in the method development workflow. Complex separation challenges addressed includes.  Partially co-eluted peaks assigned the same mass, Completely co-eluted peaks resulting in missing data.

“Beverage Identification” on Display

 Waters is hosting a “Kool Aid Never Looked So Good” Separation Challenge to test sample preparation skills on the exhibit floor Thursday.  Participants will be given two “mystery” samples and some clues about the products. Using solid-phase extraction, they will guess the food dyes, order of elution and complete a separation in less than one minute.   Judging will be based on the accuracy of your guesses and the performance of separation.

PITTCONN Philadelphia will boast two live demo areas where attendees can participate in 20-minute, interactive product demonstrations. The dedicated areas will cover topics such as air monitoring, new techniques in water testing, innovative products to increase lab efficiency, and recent developments in spectroscopy, spectral databases, and techniques for using hazardous materials.  Among the events at the  “Live Demo” areas include:

  • Is your coffee really decaf? Lumex Instruments will test that, using capillary electrophoresis technology.
  • Trajan Scientific and Medical will demonstrate its two automated systems for performing Liquid-Liquid extractions [LLE] on a micro scale. They can be applied as effective alternatives to the time-consuming manual processes
  • Sartorius will exhibit its “Next-Generation” balances for high performance lab use.  Balances feature a 0.1 mg resolution at 64 g, 124 g, or 224 g. capacities.  Each is available with or without an internal calibration weight.
  • Shimadzu Scientific Instruments will display its Elemental Analysis: EDX-7000 X-ray Fluorescence Spectrometer Bench-top energy dispersive X-ray fluorescence instrumentation can provide a safe, fast and easy alternative to more difficult and expensive technologies like Atomic Absorption (AA), Optical Emission Spectroscopy (ICP-OES) and Mass Spectrometry (ICP-MS).
  • Bio-Rad Laboratories will demonstrate its Bio-Rad’s KnowItAll® Solutions, combining  IR & Raman spectroscopy with spectral analysis software
  • HORIBA Scientific will demonstrate in nanoparticle identification, quantification, and sizing by nanoparticle tracking
  • Cerno Bioscience will present its GC/MS Compound ID Using Accurate Mass and Automated Mixture Detection

 

 

 

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.

News came this week that the Department of Veterans Affairs awarded Foundation Medicine, a Cambridge, MA- based molecular testing company, a significant contract to provide genomic profiling for veterans helps to validate the growing use of NGS and liquid biopsy for diagnostics.

The contract was reported to be at 111.5 million over five years. It covers several of Roche-owned Foundation’s tests including Foundation One CDx, Foundation One Liquid, Foundation One Heme. These tests provide profiles that can be used in precision cancer, therapy-matching approaches. The VA said the goal of the program is to provide tumor sequencing for all veterans. 60 hospitals reportedly provide specimens for sequencing, with expansion planned. Prostate cancer is a particular target area, because of the need for early detection and treatment action, according to the agency.
“The development is a validation for the use of these tests, and more broadly, for the approach of performing comprehensive analysis, versus single-gene or small gene panel approaches,” said Justin Saeks, Kalorama Information’s Next Generation Sequencing Survey report that the firm published last year.
Kalorama believes it is good news for Roche, with large potential for service revenues; the company has seen its NGS market share slip consistently despite acquisitions and collaborations.

“The company actually had first-to-market advantage initially in the NGS market, but its share diminished over the years as competitors introduced higher performing, more economical systems and continuously provided upgrades,” Saeks said.
For more information, Kalorama Information’s most recent Next Generation Sequencing Market is located at: https://www.kaloramainformation.com/Generation-Sequencing-Instrumentation-Consumables-Services-Competitive-Trends-11594541/

The size and prestige of the VA could even portend an increased tendency towards services for diagnostics testing, sending tests out to labs, as opposed to the common practice of medical centers running NGS tests in-house. This would be more likely for comprehensive analysis, which requires more sequences to be covered than the tests that analyze small sets of genes

Retail clinics, small clinics usually staffed by a nurse practitioner or physician assistant, offer competitive hours and convenience to clients, and a great bonus for retailers. But how are they faring? Kalorama’s report “Retail Clinics 2019 Forecast: Locations, Revenues, Supplier Sales, Trends, Consumer Survey” notes the following: 

  • They’re Growing Locations and Revenues: By the end of 2018, the number of clinics in the U.S. is expected to reach 2,040 clinics and clinics should earn $940 million in total revenues. “Overall, the market has seen rapid growth since we started covering these clinics in 2007,” said Bruce Carlson, Publisher of New York City-based Kalorama Information, part of Bioinformatics Inc. “That figure includes just direct or earned revenues — there are indirect benefits to these stores bringing or retaining consumers to the store who buy more products.”
  • They’re Right in Time to Fill Physician Shortages: The Association of American Medical Colleges projects that physician shortages for primary care physicians will reach more than 49,000 by 2030. This creates a need for additional healthcare providers to serve patients in the U.S.
  • They’re Popular: Patient satisfaction was high for retail clinic visitors in the most recent survey. In Kalorama’s 2018 survey, 92% of respondents said they were satisfied with their most recent visit to a retail medical clinic, and numbers like this have been consistent for the past few years.
  • They’re IT-Equipped: Newer than physician offices, retail clinics didn’t have to convert to information technology, they were born with it. Most retail clinics offer mobile appointment setting and virtual waiting room service. MinuteClinic and Walgreens Healthcare Clinic both use electronic healthcare record systems from Epic Systems, the most widely used electronic healthcare records system in the U.S.
  • They’re In Most Areas, But Not on Every Corner: While the concept has expanded, and stores are finding ways to increase revenues, there is a certain maturity to the market as well, as competition from urgent cares and physician offices are present. Clinic location growth was particularly fast in the 2013 to 2015 period. However, as the retail clinic industry has shifted from an early, emerging growth pattern to a more mature stage, the market gains, in terms of clinic locations. “We won’t say the word plateau, not given the announced plans of major retailers and their popularity” Carlson says, ” But there are limits to any market, and our report gets into how growth in revenues will happen with existing clinic locations.”

Kalorama’s report contains detailed market estimates and forecasts for both retail clinic sales, indirect sales by stores that host them, and sales suppliers make selling IVD tests and pharmaceuticals to them. The report can be found on Kalorama Information’s website. https://www.kaloramainformation.com/Retail-Clinics-Forecasts-Locations-Revenues-Supplier-Sales-Trends-Consumer-Survey-12019249/

Next-generation sequencing (NGS) in diagnostics is rapidly growing, having made great strides since the conclusion of the Human Genome Project fifteen years ago. Increasingly rapid and effective testing capabilities for hereditary diseases, cancers, cardiac and respiratory conditions, neurodegenerative disorders, and even infectious disease, are either on the horizon or have arrived. The promise of DNA sequencing through this methodology alone has attracted many companies, researchers, and investors.The Worldwide Market forIn VitroDiagnostics, 11th Edition, has been released recently, and features a significant section on molecular diagnostics, including NGS. Below is a selection of developments that have arisen in the period since our report’s August publication.

In July, Genepath Laboratories (Chatswood, NSW, Australia) launched their NextGen test, a genetic screening test for use in detecting multiple treatable conditions, in conjunction with the heel-prick newborn screening test. NextGen can screen for over 60 serious medical conditions—50 of which were not previously tested in Australia—including conditions associated with sudden infant death syndrome (SIDS), life threatening conditions like tyrosinemia and familial hemophagocytic lymphohistiocytosis, conditions that cause developmental disabilities in both physical growth and intellect, conditions leading to heart and lung diseases, and rare cancers. Sample collection for the NGS panel is a simple mouth swab that can be performed on patients of any age, but is best for newborns as the targeted conditions usually appear in the first year of life. Among the conditions tested is familial hypercholesterolemia, a condition—easily treated through diet and medication—that significantly increases risk for myocardial infarction in young adults, and is estimated to be severely underdiagnosed in Australia.

Women’s health company NxGen MDx (Grand Rapids, MI) also announced in July that they had developed a new method of DNA tagging, called active molecular identification (AMI), to track samples and prevent laboratory errors, using synthetic DNA to tag a patient’s sample at the beginning of the testing process. AMI tagging accompanies and identifies the patient’s sample throughout the entire process, and connects it to the final test results, reducing the incidence of sample mixups. Validation studies were conducted to ensure that the synthetic DNA used in the methodology does not affect testing.

Meanwhile, it was announced in August that a five-year NIH grant valued at over $8 million had been awarded for research on the clinical and economic benefits of conducting NGS testing in newborns at multiple institutions, including Cincinnati Children’s Hospital, Mt. Sinai Hospital, Rady Institute for Genomic Medicine, Tufts Medical Center, University of North Carolina-Chapel Hill, and the University of Pittsburgh. Four hundred newborns known to be at high-risk for genetic diseases, but have not yet been diagnosed, will be enrolled in the study and will receive whole-genome and targeted genomic sequencing to test for over 1,700 genetic disorders. The multiplex panel is under development with Quest Diagnostics. Results will be compared with more conventional diagnostic procedures, with focus on time to diagnosis, time to treatment, and the total costs associated with each methodology.

An article to be published in theJournal of Global Antimicrobial Resistance (DOI:10.1016/j.jgar.2018.08.018; available online, currently in press), illustrates the potential of whole-genome sequencing in more rapid and comprehensive diagnosis of drug resistant tuberculosis. A study conducted in Indonesia, which has the world’s second highest TB burden, involved the use of WGS on over 300 samples from HIV-negative TB patients, among which, nearly 16% were found to have drug-resistant strains of the disease. The concurrence rate between WGS-based testing and more conventional phenotypic drug susceptibility testing was high for rifampicin and isoniazid, but less so for streptomycin and ethambutol. A potential advantage of WGS-based testing is that testing by more conventional means has been shown to be poorly corresponded with reported prior treatment for TB, due to clinicians targeting only patients with previous treatment or other risk factors, resulting in many undetected drug-resistant cases. WGS-based testing is potentially helpful in limiting the spread of drug resistant TB by testing patients who lack such risk factors.

In August, Novogene Bioinformatics Technology (Beijing) announced approval for its NovoFocus NSCLC CDx assay by the China Food and Drug Administration. The NGS-based diagnostic analyzes tumor samples for multiple genomic mutations associated with non-small cell lung cancer, which accounts for approximately 80% of all lung cancer cases in China. Results from sequencing and analysis of ROS1, EGFR, and ALK can be used to identify NSCLC patients eligible for treatment with CFDA-approved cancer therapies including Crizotinib (XALKORI), Gefitinib (IRESSA), and Osimertinib (TAGRISSO), respectively. Other genes targeted in the panel are KRAS, BRAF, and PIK3CA. NovoFocus NSCLC CDx was developed on the Thermo Fisher Ion Proton sequencing platform.

Asuragen (Austin, TX) announced in September the expansion of its own oncology portfolio with the launch of their newly CE-markedQuantideX NGS DNA Hotspot 21 Kit. The kit is a next-generation sequencing panel designed to detect numerous tumor types, including those in colorectal cancer, melanoma, and non-small cell lung cancer. QuantideX NGS DNA Hotspot 21 uses Asuragen’s NGS-in-a-Box design and the company’s Sample-Aware bioinformatics software, which determines whether a sample has sufficient DNA that can be amplified. The panel is indicated for use on Illumina’s MiSeq platform.

IDbyDNA (San Francisco) signed a licensing agreement mid-September with Fleury Group (São Paulo, Brazil) to offer the company’sExplify platform for clinical metagenomic testing in South America, with Fleury integrating the platform into its own laboratory operations. Fleury will also develop a full suite of clinical tests for Explify, beginning with a respiratory panel that detects over 200 common, rare, and novel bacterial, viral, and fungal pathogens in respiratory specimens.

IDbyDNA, which developed Explify in collaboration with ARUP Laboratories (Salt Lake City), is in another partnership, begun in January with Locus Biosciences (Morrisville, NC), to develop a diagnostic test for the Explify platform to detect Pseudomonas æruginosa. Locus will use the test to recruit and select patients for its clinical trial for LBx-PA01, a CRISPR-based antimicrobial product that targets the pathogen, which is associated with sepsis and a number of nosocomial infections.

Jerusalem-based NovellusDx will merge with a newly-formed Israeli subsidiary of Cancer Genomics (Rutherford, NJ), which will combine the former’s expansive cancer test portfolio and large tumor biology dataset with the latter’s proprietary NGS and machine learning tech. Cancer Genomics will be the surviving entity, but NovellusDx shareholders will gain a 49% stake in the company as part of the merger agreement.

Miami-based Igenomix has developed the Analysis of Infectious Chronic Endometritis (ALICE), an NGS-based diagnostic for the uterine infection that can lead to infertility in women. As traditional diagnostic methods do not accurately identify the bacteria in endometritis, nonspecific antibiotics are often prescribed and will not always be as effective as the infection requires. ALICE requires just a small endometrial sample from which DNA is extracted; the sample undergoes bacterial analysis through next-generation sequencing. With ALICE, clinicians can detect the correct culprit and prescribe the right pro- and antibiotic to treat the infection, and improve women’s reproductive success.

Again, for the latest market analysis of next-generation sequencing-based IVD, see the eleventh edition of our flagship report,The Worldwide Market forIn VitroDiagnostics, published in August.

China’s IVD market reached $3,200 million in 2017, in line with growth estimates published by Kalorama and elsewhere, and the fast pace of market growth is expected to continue. Supporting growth will be a modernizing healthcare infrastructure and steady migration from manual to automated processes. This was the conclusion of Kalorama Information’s recent report, IVD in China.  China as an IVD market opportunity is defined by its standing next to other populous countries with demonstrated economic promise for over the past decade – Brazil, Russia and India; collectively with China referred to as one of the important, rapidly growing “BRIC” nations. The country and its healthcare system are confronted by challenges shared by less developed countries, but also burdens common among developed middle-income and affluent countries such as diabetes, cardiovascular disease, and diseases of aging.

As an in vitro diagnostics (IVD) market, China trails only the populous, developed economy markets of the United States, western European countries, and Japan. As the figures below indicate, there is expected marginal growth in China’s IVD market compared to the overall IVD market.

China’s IVD Market Snapshot

MARKET SIZE: 3.2 BN
FORECASTED GROWTH: 13.2%
OVERALL GROWTH OF IVD MARKET 3.5%
MARGINAL GROWTH IN CHINESE MARKET +9.7%

The market in China can be defined in terms of several IVD disciplines including reagents, consumables, calibrators and controls of the following sub-segments:

Clinical Chemistry: routine lab testing; substrates, enzymes, homogeneous immunoassays, proteins, ISE (non-POC), HBA1c (non-POC), includes urinalysis and blood chemistry testing.
Immunoassays: hormones and thyroid function, tumor markers, allergy, anemia, neonatal tests, prenatal tests, interleukins, PCT, toxicology and common infectious diseases (HIV, hepatitis, influenza)

Microbiology and Molecular Testing: manual and automated tests, culture media (to be prepared or ready to use), latex tests, transport media, blood culture, sensitivity discs, Gram and other stains, MTB culture, Mycoplasma, Ureaplasma, nucleic acid testing.

Point-of-Care Testing: all POC tests for cardiology, toxicology, coagulation, diabetes, infectious diseases, including POC and non-POC blood gas and electrolytes, and glucose self-monitoring tests.

Histology/Cytology: PAP, HE, IHC, ISH, FISH, primary and secondary antibodies. Included in the report are trends influencing the industry and country-level data including incidence of disease, life expectancy, population demographics, economic status, healthcare utilization and other market influences.

Population Trends in China

The People’s Republic of China is the world’s largest country with more than 1.4 billion people. Of these, more than 1.39 billion live in mainland China and about 7 million live in Hong Kong. At present, the Chinese population is growing at an annual rate of 0.5% per year. The government’s goal is to stabilize the population and population growth early in the 21st century, with some current projections estimating a population of about 11 billion by 2050.

At the end of 2017, the median age of the population was roughly 37 years for men and women combined, with about 12% of the total population aged 65 and over. The world’s population of older people represents the fastest growing age segment and is centrally relevant to healthcare challenges worldwide, there is no exception with the population in China. By 2050, approximately 348.1 million people in China will be above the age of 65. This trend is important because an aging population in China will increase healthcare costs, forcing major increases in public spending that could impair economic growth. It also creates important opportunities for the providers of products and services utilized by older persons, including healthcare.

The distribution of the population is expected to shift toward the 65 and over population to account for 27% of the total Chinese population by 2050, up from less than 3% in 2010. Both the 15-64 population group the 0-14 population is declining considerably, accounting for 60% and 13% of the population in 2050 respectively; this is down from 73% and 18%, respectively, in 2010. The two most impactful reasons for the changing demographics include:
1. Lower number of births
2. Increasing life expectancy

Demographic aging puts pressure on a nation’s ability to support its elderly citizens. A commonly used indicator of this pressure is the elderly support ratio, calculated as the number of working-age people ages 15 to 64 divided by the number of persons 65 or older. This ratio serves as a rough indicator of the number of potential providers of support (including healthcare costs) per potential elderly dependent. In 1950, there were 12 working age people for every elderly person in the world. By 2010, this ratio declined to 9, with the largest decline occurring in more developed countries. However, China and other BRIC economies are expected to feature elderly support ratios in 2050 near or below those of developed countries such as France and the United States, where stable fertility rates and immigration will stabilize ratios that otherwise declined in past decades.

Elderly Dependency Ratio – Workers to Elderly Citizens 
Ratio in 2010 vs. 2050
Brazil 10 vs. 3
Canada 5 vs. 2
China 9 vs. 2
United States 5 vs. 3
World 9 vs. 4

Disease Demographics in China

Greater elderly populations in China and other developing countries emphasize the need for extremely efficient tests and systems for chronic diseases of the aging, even at a time when emerging viruses and infectious diseases are still an ongoing concern. The World Health Organization (WHO) estimates that about 60% of all deaths worldwide are attributable to chronic diseases, and 80% of such deaths occur in low- and middle-income countries.

Diabetes
Globally, diabetes is emerging as one of the chief public health challenges of the 21st century as it is a major risk factor for many serious complications including kidney and heart disease. Unlike type 1 diabetes, which is present at birth, type 2 diabetes is acquired during a person’s lifetime and impairs the body’s ability to properly use the blood sugar-regulating hormone insulin. Both forms of the disease involve abnormally high blood sugar levels that can damage blood vessels, the heart and other organs. Diabetes and its sequelae are already a major source of low life expectancy in many developing countries where once infectious diseases were thought to be the leading disease burdens.
Rates of the disease have soared in many countries around the world mainly because of lifestyle changes including increased calorie intake and reduction in physical activity that come with economic progress. According to the International Diabetes Federation (IDF), there were about 425 million diabetic patients in 2017 worldwide and IDF projects that more than 629 million people will have diabetes by 2045. The regions with the highest comparative prevalence rates are North America, where 11% of the adult population has diabetes, followed by the Middle East and North Africa with 10.8%. The regions with the highest number of people living with diabetes are Western Pacific, where some 159 million people have diabetes and South East Asia with 82 million diabetics. China has the most people with diabetes, with a current figure of more than 114 million, followed by India with about 73 million, the United States (30 million); Brazil (12.5 million); Mexico (12.0 million); Indonesia (10.3 million); the Russian Federation (8.5 million); Egypt (8.2 million); Germany (7.5 million); and Pakistan (7.5 million) rounding out the top 10.

The financial burden borne by people with diabetes and their families as a result of their disease depends on their economic status and the social insurance policies of their countries.
In the poorest countries, people with diabetes and their families bear almost the entire cost of medical care, with family finances putting an effective limit on treatment.
Slowly, governments are stepping up to the plate but not quickly enough. Hospitals have traditionally been the major consumers of blood glucose strips and meters. However, as more middle-class people develop diabetes, the market for glucose self-testing products has grown considerably. So much so that the blood glucose market in developing countries is growing by at least 15% per year. As discussed above, China represents the single largest population of diabetes patients in the world by a large margin. It is estimated that in 2017, the market for blood glucose testing, both professional and self-testing, is valued at more than $600 million in China.

Cancer
China faces cancer as a mounting health challenge, as cancer is believed to be the leading cause of death in China. The burden of several forms of cancer – lung, stomach, liver, colorectal and esophageal – proportional to population are significantly above global averages. Among urban Chinese, cancer is the leading killer with lung cancer as the most dominant contributor.
This reflects a rising public health threat from cancer throughout both developed and developing nations. According to the American Cancer Society, 1 in 8 deaths worldwide are due to cancer, and globally, cancer causes more deaths than HIV/AIDS, tuberculosis, and malaria combined. It is the leading cause of death in economically developed countries and the second leading cause of death in developing countries; and imposes a substantial burden on the world economy.

Tobacco is one of the main culprits for much of the increase in cancer in developing countries, especially in the Asia-Pacific, where one third of the world’s smokers live. China alone is home to 370 million smokers. According to a report from the International Agency for Research on Cancer (IARC), about 15% of cancers in low- and middle-income countries are linked to tobacco use, and that figure is expected to climb sharply. People in developing countries are also picking up other Western habits, such as eating too much and exercising too little. Meanwhile, they have less access to resources for prevention and treatment. In China, the country with the world’s highest population of smokers, annual lung cancer mortality rates have risen by 500% over the past 25 years, representing about 600,000 lung cancer deaths annually.

Cervical cancer is a disease that has just about disappeared in many developed countries but remains a major killer in the developing world. Despite being a preventable cancer with a known primary cause and established diagnostic procedures, cervical cancer claims roughly 270,000 lives every year, with 85% of these deaths occurring in developing countries. Cervical cancer is the second most common cancer in women living in less developed region.

India has more cervical cancer cases than any other country in the world, followed by China. The World Health Organization (WHO) estimated in 2012 that more than 123,000 Indian women were diagnosed with cervical cancer and approximately 62,000 were diagnosed in China. The WHO estimates that only about 5% of women in the developing world have been screened for cervical disease in the previous five years, compared to 40% – 50% in the developed world.

The heart of cervical cancer control is regular Pap testing as performed in developed countries. In developing countries, the test is available to women who can afford it in urban areas but is largely unavailable to those living in the rural areas of even higher income developing countries. There is a huge need for company-supported initiatives in this area.
In China, more than 12 million Pap tests are performed every year, mostly through private labs. The immediate available market is the 300 million women aged 30 to 50 who have at a minimum basic health coverage under government insurance programs. Recent screening rates were boosted by the central government-led free screening program for 10 million rural Chinese women as part of healthcare reform. Free and subsidized screening for cancer is a likely feature of Chinese reform and government insurance expansion programs through 2020.

Cardiovascular Disease
The prevalence of lifestyle diseases – non-communicable chronic diseases associated with risk factors such as inactivity, smoking, diet and urban air quality – has risen across the Chinese population in the past several decades due to modernization and income mobility. The scourge of diabetes has already been noted in this chapter. Cardiovascular disease has also seen significant movement in the past decade or has remained elevated in the Chinese population relative to global averages.
The morbidity rate of hypertension in the Chinese urban population nearly doubled between 2003 and 2008 from 54.7 to 100.8 per 1000 persons. In 2013, the president of the World Hypertension League stated that one out of every three adults in China (more than 330 million individuals) has hypertension. In 2012, WHO reported 248,200 deaths due to hypertensive heart disease; roughly 2.8% of all deaths in the country.
In China, cerebrovascular disease or stroke increased in its morbidity rate by nearly 50% in the early to mid-2000s. Furthermore, in 2012 the leading cause of death, excluding combined neoplasm deaths, was reported by WHO for stroke, which accounted for 23.7% of deaths in the country or 2.3 million.
Cardiovascular diseases are largely established health threats in China. Government healthcare resources are being marshaled largely for preventative healthcare and screening, though the majority of cardiovascular disease sufferers remain undiagnosed. Triage or emergency rapid tests also represent a significant market in the country.

Infectious Disease Threats

The globalization of emerging infectious diseases poses another healthcare challenge and opportunity for clinical diagnostics. Emerging or emergent infectious diseases are characterized by new pathogenicity in the human population or significant growth in the incidence of the pathogen’s associated disease in a region or across regions. Emerging viruses are often zoonotic, sometimes newly so through a novel viral strain, with initial transmission into the human population through animal vectors. Significant demands are placed on national, regional and global healthcare and public health systems with the emergence of a new disease threat that often necessitates the development of new diagnostic, vaccination and treatment products.

In addition to the intensifying globalization of trade and travel, emerging diseases are seeing more widespread and higher incidence due to increased antimicrobial (drug) resistance (sometimes resulting from improper or overuse of antibiotics) and climatic changes that are increasing the viable range of pathogens, often through the expansion of mosquitoes’’ habitats.
Significant emerging diseases that have spurred development of new rapid and point-of-care (POC) diagnostic tests are reviewed below. Diseases endemic to China are included in this report, though also other significant emerging infectious diseases in the developing world that may be addressed by the Chinese IVD industry.

5 Conclusions about the Chinese IVD Market

The following are among the main conclusions of our report IVD in China

1. China represents the most attractive IVD market in the developing world and among BRIC nations. Additionally, the Chinese IVD market has been and is projected to be the fastest growing among the top-ten national IVD markets.

2 Urban healthcare markets in China – defined by better-equipped and better-funded city hospitals and patients seeking medical care at such institutions – are significantly more lucrative opportunities for international IVD companies than rural healthcare markets.The relative strength of urban healthcare markets is due to the superior financial resources and spending power of middle-class and affluent patients, greater reimbursement and coverage features under government insurance programs for urban residents, and greater existing representation by international companies in major cities and China’s directly-controlled municipalities.

3. Major international IVD companies already have a significant presence in the Chinese market and represent potential competitive barriers to prospective market entrants. Major companies enjoy significantly greater financial resources to afford costs associated with product certification, clinical trials, and agent representation. Certification or registration of products under different provinces in the fragmented Chinese market also favors larger companies able to build distribution more rapidly. Additionally, larger companies are more able to make the acquisitions necessary to establish direct distribution and local manufacturing operations.

4.  A large number of domestic Chinese IVD companies are also active in this market, and benefit from established relationships within the health care infrastructure as well as relatively low operating costs.

5. Product opportunities for international IVD companies in the Chinese market are diverse; they include rugged, easy-to-use rapid tests with built-in high specificity and sensitivity for applications in rural healthcare; instrumentation in advanced diagnostics, including sequencers and molecular test analyzers; microarrays and other multi-analyte molecular assays; and multi-tool analyzers capable of running hematology and immunodiagnostic assays. Rural health care largely represents an inaccessible market to new entrants and companies without substantial domestic manufacturing or distribution operations.

Kalorama Information notes 4 trends in monoclonal antibodies (mAbs) – large protein molecules produced by white blood cells that seek out and destroy harmful foreign substances – topped $100 billion in 2017, according to Kalorama Information What’s Trending in Monoclonal Antibodies, examines the several types of monoclonal antibodies on the market and in development, looking at the mAbs market by structure, by target, and by indication.

  • Humanized mAbs Grow: Advancements in human and humanized monoclonal antibodies will be the major areas of development and growth through 2022.  Humanized mAbs will outpace all other structure types with compound annual growth of 13.5%.  More than $20 billion in revenues will be generated from new approvals in humanized mAbs over the forecast.
  • Watch for growth from PD-1 and PD-L1 mAbs.  These segments will show some of the strongest increases over the forecast.  Cancer indications are driving sales in these categories and are expected to maintain pace, increasing at CAGR of 38.4% for PD-1 and 21.5% for PD-L1 from 2017-2022.  Interleukin mAbs will also enjoy strong adoption.  More than $25 billion will come from developments and approvals between 2018 and 2022.
  • Neuro mAbs a Particular Focus: Steady growth is expected from oncology and autoimmune disease categories, as expected.  But new growth is projected in the neurological  segment with many mAb development programs moving froward in the area of Alzheimer’s disease.
  • United States First: The U.S. is the strongest mAb market with 56% market share and expected to maintain growth, accounting for 57% of the market in 2022, or $97 billion, an increase of 11.6%.

Further, the report discusses the several factors contributing to the strong growth of the monoclonal antibodies market. Company profiles of the major participants in the mAbs market are provided as well. What’s Trending in Monoclonal Antibodies (Markets by Structure, by Target, and by Indication) can be found at: https://www.kaloramainformation.com/Trending-Monoclonal-Antibodies-Structure-Target-Indication-11440829/.

 

It’s late January, 2018. It’s the centenary of the opening salvos of the “Spanish” Flu Pandemic, the unsung (and misnomered) villain of the later days of The Great War.  With cases on the rise right now, the 2017-’18 flu season has yet to reach its peak[1], surpassing that of the 2012-’13 season, and young people are being hit particularly hard. Let’s talk flu diagnostics.

(Especially, as Kalorama has just completed a study on molecular point-of-care systems, which is one of several technologies used for flu testing).

The typical way to diagnose an infection by the influenza virus in emergency facilities is with lateral flow immunochromatographic assays; they’re simple, they’re quick, and most importantly, they’re inexpensive. The problem with these tests (also called rapid influenza diagnostic tests, or RIDTs), however, is that they aren’t good. Their sensitivity has been deemed “sub-optimal” by the Centers for Disease Control: in a letter to the New England Journal of Medicine[2], one of their studies evaluated one such test at 51%, and cited in the letter was a study[3] that found another RIDT’s sensitivity rate to be a staggering 27%. While the latter figure seems to be an extreme example, a meta-analysis[4] conducted in 2012 found that RIDTs had, on average, sensitivities of 62.3%.

The gold standard for diagnostics is real-time PCR, but this has a few things going against it. Actually, it’s the diametric opposite of RIDTs: PCR is complex, requiring a lot of preparation and technical knowledge to operate; PCR is time-consuming, because of the preparation and the complexity of its mechanism; PCR is also expensive because of its complexity, but also in terms of patient isolation and management, because of the time it takes to get results.

So for a few years now, big biotech firms have been working on better solutions, employing nucleic acid amplification techniques that make PCR so accurate and engineering them into relatively tiny and simple packages, and as it turns out, they really are much better than RIDTs, and much faster and simpler than PCR. The devices are cartridge-based, requiring minimal input from the user; they turn results out in well under an hour, with most in the 15-30 minute range.

Alere’s Influenza A&B assay for its isothermal i platform, was among the first of its kind to be given a CLIA waiver, allowing the test to be performed at the point of care, where RIDTs are the usual go-to diagnostic solution. The i uses a technique called Nicking Enzyme Amplification Reaction (NEAR), which depends on, as the name implies, nicking enzyme to replicate the nucleic acid at a constant temperature range of 55-59°C. thus eliminating the need for the thermal cycler necessary in PCR. The device is therefore less complex, and the process consumes less time and energy as there is no need to denature DNA into single strands. The Influenza A&B assay produces results from nasal swab in approximately 15 minutes, and Alere reports sensitivities of 97.9% and 92.5% for influenza A (IFV-A) and influenza B (IFV-B), respectively, compared to cell culture.[5]

Cepheid’s Xpert Xpress Flu cartridge, for the GeneXpert platform, was granted a CLIA waiver just weeks ago, on 9 January. Cepheid also produces a joint flu/RSV Xpert assay, on which the studies reviewed for this article focus. The assay, Xpert Xpress Flu/RSV, has been CLIA-waived since 2015, and requires samples to be collected via nasopharyngeal swab (the newer IFV-only is indicated for sample collection with a less invasive nasal swab). Cepheid reports 98.2% and 100% positive agreement for IFV-A and IFV-B, respectively, between the Xpert Xpress Flu/RSV and conventional PCR; positive results are reported in twenty minutes.[6] The GeneXpert system is based on more conventional real-time PCR methodology than the aforementioned isothermal Alere i, but uses solid state heating and forced-air cooling, operating at a temperature range of 50-95°C.[7] There are currently four variants of the system, each named for the number of cartridges that can be simultaneously analyzed – I, II, IV, and XVI – and the Omni, a fully portable system that can operate solely on battery power, is anticipated for a second quarter 2018 launch.

Last, but not least, is Roche’s cobas Liat, which was developed from IQuum’s Lab-in-a-Tube analyzer. Like the GeneXpert, the cobas Liat operates on the more conventional real-time PCR methodology, and while the reagents of the system’s assays are in a compartmentalized tube, it operates on the same principle as the cartridge-based systems, in that the assays are fully self-contained and require minimal user interaction. The cobas Influenza A/B assay was granted a CLIA waiver in September 2015; results from nasopharyngeal swabs are reported in twenty minutes or less. Roche reports 100% sensitivity for both IFV-A and -B, and 96.8% and 94.1% specificity, respectively.[8]

Clinical researchers have conducted evaluations of each of these instruments, and in the literature reviewed for this entry, there is consensus that the devices compare favorably with conventional PCR methodology and are much more reliable than RIDTs.

  • Using PCR as the sole reference of comparison, Cepheid’s Xpert Flu/RSV test was found to have an overall sensitivity of 97.8% (A: 97.0%, B: 100%) and 100% specificity across the board.[9] One 2016 study compared the Xpert Flu/RSV to bioMérieux’s BioFire FilmArray, with an overall positive agreement of 97.3% (100% and 92.3% for IFV-A and IFV-B, respectively),[10] with the investigators concluding that the Xpert Xpress would be useful for diagnosing immunocompetent patients during peak flu season, while the FilmArray, being a more extensive multiplex panel diagnostic, should be designated for sicker patients and those coming in during decreased flu prevalence.

Concern over decreasing test sensitivity due to viral genetic drift in some commercially available flu diagnostics was the basis of a 2016 study, which looked at the Xpert Flu/RSV in addition to a multiplex PCR test that had been reformulated in the wake of the 2014-’15 flu season to be more sensitive. Cepheid’s test was found to have 100% sensitivity and 94.3% specificity for IFV when compared to PCR, though no distinction was made between A and B types.[11]

Finally, a 2017 review compared the Xpert Flu/RSV test to the performance of the ARIES Flu A/B & RSV test by Luminex; the BioFire FilmArray was the reference test used in the comparison.[12] Both assays were found to have 100% sensitivity to both A and B virus types; Cepheid’s test fell slightly short of the ARIES in test specificity, with 95.4%for IFV-A. However, the report’s authors did state that the Xpert has an edge over the ARIES for its substantially quicker turnaround time (20min vs two hours), though both devices require the same hands-on time and are equally easy to use.

  • A direct comparison in 2016 of Roche’s cobas Liat and Alere’s i platforms (using the BioFire FilmArray for reference) found the cobas test to be 100% sensitive and specific across the board in detecting both influenza types.[13] Alere had a relatively poor showing, with 71.3% sensitivity for IFV-A; however, this is likely attributed to low viral load due to samples being collected late in patients’ illnesses. The researchers found the cobas Liat to be a robust platform with performance that favors comparably with that of the FilmArray, though it should be noted that bioMérieux’s multiplex-capable assay detected some comorbidities with respiratory syncytial virus (RSV) and other respiratory pathogens that neither of the other platforms would have picked up. This is significant, as RSV could potentially impact treatment and management of influenza infection.

Another 2016 study also found the cobas Flu A/B test to have high sensitivity and specificity specs. The test detected only two false negatives, both for IFV-A, which were caught by the Cepheid Xpert Flu assay. The errors were likely due to low viral load resulting from the freeze-thaw cycle in sample preparation. The investigators noted two shortcomings of the platform and test: one, only a single test can be conducted at a time, and two, the test is not capable of IFV-A subtyping, unable to distinguish between the various hemagglutinin and neuraminidase proteins found on the viruses’ surfaces.[14]

A larger-scale (n > 1600), multicenter evaluation conducted in 2017[15] also regarded the cobas Flu A/B highly, with >99% sensitivity for both virus types, with the researchers’ summary basically being that the use of POC devices can be a potential boon for patient care as improvement in turnaround times provide a great potential to reduce time to treatment and to reduce length of stay, which will in turn reduce costs to care facilities.

  • A 2014 multicenter evaluation (n > 500) of the Alere i Influenza A&B test analyzed direct nasal swab samples taken from seven sites during the 2012-’13 flu season, compared against R-mix shell vial viral culture.[16] After discrepancy analysis, the i Influenza A&B was reported to have 99.3% and 97.6% sensitivities and 98.1% and 100% specificities for influenza types A and B, respectively.

In 2015, performance of the i was tested using Cepheid’s flu assay for reference,[17] but the results were not favorable to Alere’s test: the i had 80% sensitivity compared to the Xpert for IFV-A, and it fared worse with IFV-B, resulting with 33.3% compared to Xpert and 46.4% compared to conventional PCR. The author of the article said that the i is reasonably sensitive, but that low-viral load specimens contributed to poor detection, especially in the IFV-B test, due possibly to an additional freeze-thaw cycle to which the samples were exposed, resulting in degraded viral DNA, and that it should also be noted that the RIDTs with which these assays are ultimately meant to compete would have returned much worse performance as they are typically reported to show sensitivities in the 10-80% themselves.

An evaluation conducted in 2016 returned better results (93.8%/100% sensitivity for types A and B, respectively)[18] and was more positive in its review, adding that previous studies that have reported poor showings by the assay and others of its type were likely to have done so due to a lack of pediatric samples, which are well known to have higher viral loads than adult samples, and also because many of these studies were undertaken using previously frozen samples, which will have some degree of nucleic acid decay. Sensitivities should be considerably better than what is reported in these studies as care facilities will be using fresh patient samples.

In 2017 a cost analysis was conducted that compared the cost of patient isolation and treatment across multiple treatment centers in the United Kingdom using the Alere i platform and conventional PCR.[19] While sensitivity for the i averaged 77% for both viral types across the four centers, the speed of the results made the real difference; PCR results average an additional 1.1 days over the POC device without proper diagnosis (viz. false positive or negative), meaning 1.1 extra days of isolation and treatment for patients misdiagnosed as being infected, or 1.1 extra days without management for those misdiagnosed as being clear of infection. All told, the Alere i was determined to save £43,000 per 1,000 patients compared to PCR; if assuming 100% accuracy in patient isolation, that figure potentially increases to £261,600. The relatively low sensitivity reflected in the results appeared to be due to human error, involving the use of throat swabs and, to some extent, the storage and handling of reagents.

It can be concluded that molecular POC solutions have great potential over the more commonly used RIDTs, as they are far superior in sensitivity, on par with conventional PCR but with all the speed. There do seem to be caveats, however. These devices are touted to be so simple to use that they require no laboratory expertise. But there appears to be an ongoing theme in these studies that the devices still do require a degree of care to be taken when operating them, as handling reagents and samples a certain way can indeed have a negative impact on an assay’s efficacy, which was especially apparent with the Alere i flu test. Of course, some of this can be mitigated by using fresh patient specimens, which will most often be the case, but it still appears that there yet needs to be a bit of education in protocol, as fool-proof as the tests are supposed to be.

The other issue is cost effectiveness. Frederick Nolte, director of clinical laboratories at the Medical University of South Carolina, and the author of the 2016 report on the direct comparison between Alere’s and Roche’s offerings, said in a recent interview[20] that POC tests are “essentially one hundred percent sensitive” compared to the 80% sensitivity of lateral flow test, but they “[come] at a cost that is four times as much.” There was a cost-benefit study with the Alere i published just last year, but it was in a comparison against conventional PCR, not against the RIDTs that the i is supposed to replace. With the time it takes to prepare and operate a PCR run, it’s almost a given that these tests are going to be more cost effective, this is the wrong contest to hold. Because while RIDTs are not quite the gold standard that PCR is, they are so commonly used because they are cheap, fast, and good enough. These molecular tests are undoubtedly far better than their immunochromatographic counterparts, but the question is, are they better enough? Comparisons against lateral flow tests is where the cost analyses need to be focused. Until then, clinical facilities may not be convinced, even if the science guys are.

[1] United States Centers for Disease Control and Prevention (CDC). 2017-2018 Influenza Season Week 2 ending January 13, 2018.Updated 19 January 2018.

[2] Faix DJ, Sherman SS, Waterman SH. (2009) Rapid-Test Sensitivity for Novel Swine-Origin Influenza A (H1N1) Virus in Humans. New England Journal of Medicine; 361, 728-9. DOI: 10.1056/NEJMc0904264

[3] Uyeki TM, Ramakrishna P, Vukotich C, Stebbins S, Rinaldo CR, Ferng Y, Morse SS, Larson EL, Aiello AE, Davis B, and Monto AS. (2009) Low Sensitivity of Rapid Diagnostic Test for Influenza. Clinical Infectious Diseases; 48(9), e89-e92. DOI: 10.1086/597828

[4] Chartand C, Leeflang MM, Minion J, Brewer T, and Pai M. (2012) Accuracy of Rapid Influenza Diagnostic Tests: A Meta-analysis. Annals of Internal Medicine; 156(7), 500-11. DOI: 10.7326/0003-4819-154-7-201204030-00403

[5]Alere i Influenza A & B product page

[6]Xpert Xpress Flu/RSV datasheet

[7]GeneXpert product brochure

[8]Roche cobas Liat product page

[9] Salez N, Nougairede A, Ninove L, Zandotti C, de Lamballerie X, and Charrel RN. (2015) Prospective and retrospective evaluation of the Cepheid Xpert® Flu/RSV XC assay for rapid detection of influenza A, influenza B, and respiratory syncytial virus. Diagnostic Microbiology and Infectious Disease; 81(4), 256-8. DOI: 10.1016/j.diagmicrobio.2015.01.008

[10] Wahrenbrock MG, Matushek S, Boonlayangoor S, Tesic V, Beavis KG, and Charnot-Katsikas A. (2016) Comparison of Cepheid Xpert Flu/RSV XC and BioFire FilmArray for Detection of Influenza A, Influenza B, and Respiratory Syncytial Virus. Journal of Clinical Microbiology; 54(7), 1902-3. DOI: 10.1128/JCM.00084-16

[11] Huzly D, Korn K, Bierbaum S, Eberle B, Falcone V, Knöll A, Steininger P, and Panning M. (2016) Influenza A virus drift variants reduced the detection sensitivity of a commercial multiplex nucleic acid amplification assay in the season 2014/15. Archives of Virology; 161(9), 2417-23. DOI: 10.1007/s00705-016-2930-8

[12] McMullen P, Boonlayangoor S, Charnot-Katsikas A, Beavis KG, and Tesic V. (2017) The performance of Luminex ARIES® Flu A/B & RSV and Cepheid Xpert® Flu/RSV XC for the detection of influenza A, influenza B, and respiratory syncytial virus in prospective patient samples. Journal of Clinical Virology; 95, 84-5. DOI: 10.1016/j.jcv2017.08.018

[13] Nolte FS, Gauld L, and Barrett SB. (2016) Direct Comparison of Alere i and cobas Liat Influenza A and B Tests for Rapid Detection of Influenza Virus Infection. Journal of Clinical Microbiology; 54(11), 2763-6. DOI: 10.1128/JCM.01586-16.Editor

[14] Melchers WJG, Kuijpers J, Jackson Sickler J, and Rahamat-Langendoen J. (2016) Lab-in-a-tube: Real-time molecular point-of-care diagnostics for influenza A and B using the cobas® Liat® system. Journal of Medical Virology; 89, 1382-6. DOIL 10.1002/jmv.24796

[15] Gibson J, Schecter-Perkins EM, Mitchell P, Mace S, Tian Y, Williams K, Luo R, and Yen-Lieberman B. (2017) Multi-center evaluation of the cobas® Liat® Influenza A/B & RSV assay for rapid point-of-care diagnosis. Journal of Clinical Virology; 95, 5-9. DOI: 10.1016/j.jcv.2017.08.004

[16] Bell J, Bonner A, Cohen DC, Birkhahn R, Yogev R, Triner W, Cohen J, Palavecino E, and Selvarangan R. (2014) Multicenter clinical evaluation of the Alere™ i Influenza A&B isothermal nucleic acid amplification test. Journal of Clinical Virology; 61, 81-6. DOI: 10.1016/j.jcv.2015.06.001

[17] Jokela P, Vuorinen T, Waris M, and Manninen R. (2015) Performance of the Alere i influenza A&B assay and mariPOC test for the rapid detection of influenza A and B viruses. Journal of Clinical Virology; 70, 72-6. DOI: 10.1016/j.jcv.2015.07.294

[18] Nguyen Van JC, Caméléna F, Dahoun M, Pilmis B, Mizrahi A, Lourtet J, Behillil S, Enouf V, and Le Monnier A. (2016) Prospective evaluation of the Alere i Influenza A&B nucleic acid amplification versus XPert Flu/RSV. Diagnostic Microbiology and Infectious Disease; 85, 19-22. DOI: 10.1016/j.diagmicrobio.2015.11.012

[19] Davis S, Allen AJ, O’Leary R, Power M, Price DA, Simpson AJ, Tunbridge A, Vale L, Whiteside M, Evans C, and Raza M. (2017) Diagnostic accuracy and cost analysis of the Alere i Influenza A&B near-patient test using throat swabs. Journal of Hospital Infection; 97(3), 301-9. DOI: 10.1016/j.jhin.2017.05.017

[20] Johnson M. “Cepheid’s CLIA-Waived Multi-Module System Ups Competition in POC MDx; Barriers to Uptake Linger.” GenomeWeb. Published online 11 January 2018.

 New York City-based healthcare market researcher Kalorama Information details the top 10 liquid biopsy companies and their activities in a new report.  The market, Kalorama says, is heterogeneous and very fragmented, with many companies commercializing various liquid biopsy diagnostic products and developing new ones for a broad range of applications.  But a few top competitors can be expected to stay in long-term.  Roche, Qiagen, Biocept and Myriad Genetics are among the companies on the list.  The report indicates that in 2017, more than 40 companies are active in the global market for liquid biopsy diagnostic and monitoring tests.  These are detailed in the report, The Worldwide Market for Liquid Biopsy, the first major study to look at the market and define competitor performance and market sizing from an independent, healthcare specialist market research firm.


ROCKVILLE, Med in recent years as a result of new product introductions, and is projected to continue to increase within the next five years, as many companies are developing new products that are expected to reach the market in the near future.  The market growth will be influenced by factors such as the rising incidence and prevalence of cancer at the global level, increasing use of personalized medicine, regulatory hurdles, reimbursement considerations, and adoption and integration issues of these.

Kalorama Information’s Report The Worldwide Market for Liquid Biopsy (by Analyte [ctDNA, cfDNA, Other], by Application – Screening/Drug Monitoring/Diagnostic, by Region [US, EuropeAsia, ROW] and by Type of Cancer) is available at: https://www.kaloramainformation.com/prod-toc/Worldwide-Liquid-Biopsy-Analyte-ctDNA-cfDNA-Application-Screening-Drug-Monitoring-Diagnostic-Region-Europe-Asia-ROW-Type-Cancer-10975987/.

Make sure to visit our In Vitro Diagnostics page, Kalorama’s all-in-one resource covering the IVD market. 

Infectious Disease Molecular IVD Market: Fastest Growth of Any Molecular Test Segment

Infectious Disease is the best-selling and fastest-growing part of molecular testing, as Kalorama notes in its report Infectious Disease Diagnostics.     Molecular diagnostics’ performance and applicability is unparalleled among IVD technologies in the market for infectious disease testing and the overall healthcare market. Microarray, next-generation sequencing and development-stage isothermal amplification methods represent promising contributions to the molecular diagnostics market.

Several trends make molecular diagnostics the most dynamic segment of the infectious disease diagnostics market:

  • Decentralization of testing to include hospital labs and near-patient points using sample-to-answer or integrated analyzers
  • Development of molecular assays as a first response for testing of emerging disease threats
  • Rising availability of antiviral therapies, both in commercial therapies introduced and worldwide public health campaigns
  • Aggressive healthcare response to nosocomial or hospital-acquired infections (HAIs)
  • Penetration of next-generation sequencing (NGS) into healthcare with potential for clinical sequencing in the area of critical infections

Regional Market Share in Molecular Diagnostics Used for Infectious Disease Detection

The regional market picture is important in consideration of molecular diagnostics.  Kalorama Information estimates that developed markets of the United States, Europe and Japan account for roughly 90% of the global molecular infectious disease test market.  The U.S. market is expected to significantly outperform the European and Japanese markets based on its unique growth factors including strong demand for hepatitis testing and care among retirees and younger at-risk populations; molecular respiratory infection screening including multiplex ID panels and rapid near-patient assays; development of the molecular POC market; and the continued penetration of stand-alone HPV screens. Macroeconomic and demographic conditions in Japan and Western Europe have also inhibited demand for new molecular diagnostic technologies in infectious disease.

Outside of the success of vendors such as Cepheid with its HBDC program, the developing world is relatively limited as a market for molecular infectious disease tests. Middle-income countries such as China, Brazil and others in East Asia and Latin America are leading targets for market development. National priorities in the improvement of healthcare systems and healthcare availability could lift testing markets relating to antiviral therapy, molecular screening, and inpatient care. The low relative weight of these regions in the global market has been the result of low reliance on molecular testing methods and the prevalence of “homebrew” testing to meet limited demand concentrated among reference labs and medical hubs.

The rest of the world (ROW) – outside of the largest developed markets, China and Latin America – currently represents only 2% of the global market for molecular infectious disease diagnostics. However, low-income developing countries have potential as markets for molecular POC platforms, especially those incorporating isothermal or alternative amplification methods and other low-cost detection components. To successfully penetrate developing world markets, molecular POC platforms will need to make significant reductions in reagent and instrument component costs and be distributed with concessional pricing for public health programs. The over market projected for molecular infectious disease diagnostics in ROW countries by 2021 will feature a heavy mix of molecular POC products for HIV, TB, malaria, HPV, hepatitis C, and other tropical and neglected diseases.

Molecular Diagnostic Technologies in Infectious Disease Testing

In the healthcare market the pace of technological development in clinical molecular diagnostics has kept clinicians, payers, and regulars struggling to keep up. Because of an explosion of clinical molecular tests into the U.S. marketplace an overhaul in billing codes was instated to provide payers greater transparency into what is being ordered for which patients.   Confronted with major healthcare cost drivers in demographic aging and the introduction of medical technologies, payers often subject molecular diagnostic tests to a great deal of scrutiny, temporarily halting payments, or ending coverage for whole groups of tests. Payments continue where definitive clinical utility has been found, particularly for prognostic and companion assays in oncology. Proponents in the industry argue for an expanded definition of clinical utility used to make coverage decisions and are working to succeed with tests that offer accurate predictive capacities. Labs and other test develops hope to overcome regulatory hurdles for innovative molecular testing by introducing tests as services or “lab developed tests” rather than test kits or medical devices.

Molecular Infectious Disease Testing: Both a Revolutionary Technology and an Established One

Despite its prospects as an evolving and performance-leading field, with a fair amount of potential in many areas, molecular testing holds several established positions in developed healthcare systems:

  • Molecular assays play a crucial role in antiviral therapy monitoring because of their unmatched quantitative performance of real-time PCR in viral load testing. The value of antiviral therapy is still being realized in emerging markets and the developing world, providing continued market growth.
  • Other major application markets for molecular diagnostics and infectious disease testing include HAI/AMR testing and HPV. The decoupling of routine HPV testing from the traditional Pap smear as well as improved clinician and payer reception to the preventive health benefits o HPV screening have been breakthroughs for the molecular HPV market, and the commercialization of high-throughput molecular screening assays for HPV have supplanted prior FISH HPV assays and contributed significant market value.
  • Respiratory tract infections represent the newest major application market for molecular diagnostics used in infectious disease testing. The market for rapid respiratory assays at outpatient points of care and hospitals is currently served primarily by immunoassays.

The introduction of CLIA-waived molecular assays for the most market-significant respiratory infections – influenza and strep A – qualifies molecular diagnostics in rapid testing markets, but higher test costs remain a deterrent to client conversion to rapid molecular methods, and currently targeting the molecular conversion of the entire rapid respiratory test market is too ambitious when using current products.