The In Vitro Diagnostics Market

Welcome to Kalorama Information’s In Vitro Diagnostics page! You’ll find all the information you need concerning the in vitro diagnostics industry through our market research reports, blog posts, press releases, videos, and multimedia, consolidated for your convenience.

In vitro diagnostics (IVD) – testing from a patient or test sample for clinical purposes – has long attracted leading healthcare concerns, government pays, and investors. Kalorama Information estimated the IVD instruments, kits, reagents, and related supplies market at $69.2  billion, and projects growth to $85.2 billion by 2024.

Who is Watching In Vitro Diagnostics?

IVD companies see opportunities in developing countries’ rising incomes, living standards, and demand for quality health care. Kalorama notes these IVD market growth trends:

  • Aging world population
  • Hospital demand in developing world
  • Peoples aged 45-75 consuming more health care
  • Demands for faster detection
  • Rising disease incidence
  • New diseases, rare diseases, biomarker discovery
  • Better technologies and faster and less operator-dependent systems.

Stable in vitro diagnostics market growth is expected in developed countries. Private healthcare services will place pricing pressure on medical devices, including devices in the diagnostic testing market.The healthcare industry will experience gradual change in IVD instrument and reagent market segments over the next 5-10 years. Kalorama notes these IVD market forecasts:

  • Fast growth in developing countries
  • Developing countries’ focus on chronic conditions
  • Testing at-risk patients’ genetic factors during evaluations
  • Testing links between genes and disease risk
  • Worldwide privatization of healthcare services

“Emerged” IVD markets – China, Brazil, India – are demanding more healthcare services. Foundations developing treatment programs for infectious diseases are creating test devices markets for diagnosing and monitoring disease treatment.

Obamacare, IVD, and the AHCA

Kalorama noted mixed opinions on the AHCA, and that the IVD industry has larger priorities.

The AHCA attracted industry support amid lingering concern over continued healthcare insurance provision. Diagnostics companies seek to resolve several main policy issues, according to industry analysts and public statements.

Currently, a suspended medical tax imposes a 2.3% excise tax on medical device sales, except for certain medical devices sold at retail. The tax would not apply to medical device sales starting in 2018. IVD industry analysts seek other routes to suspend the excise tax.

Spending on core lab systems spiked between 2013 and 2015 in anticipation of the ACA. Rising demand for core laboratory tests and surging test volumees could shrink if enough Americans lose healthcare.

The 69th American Association for Clinical Chemistry (AACC) Annual Scientfic Meeting and Clinical Lab Expo took place this year in San Diego from July 30th to August 3rd, 2007. This meeting had record-breaking attendance with over 21,300 atendees. The Clinical Lab Expo also broke records with 789 exhibitors covering 246,000 net square feet…

In Vitro Diagnostics’ Growth Drivers, Companies & Trends

1.Clinical Medicine & Medical Tech:

Clinical lab medicine is crucial to disease management. Essential diagnostic medical technologies including genome sequencing and mass spectrometry were unheard of in clinical practice several years ago. Personalized medicine, inherited diseases, pathogen detection, antibiotic resistance testing, and blood banking exist because of medical technology innovation.

Diagnostic test marketers want to gain the support of newer diagnostics through the consumer lobby. Commercializing new IVD products and diagnostic technologies will drive high price tags, which most countries’ payment infrastructures cannot meet. Because medtech usually outpaces healthcare regulations and reimbursement plans, diagnostic device manufacturers must provide their medical devices’ efficacy and cost-efficiency.

Top in vitro diagnostics companies developing medical research techniques used in academia are entering the general IVD market. Life Technologies (now part of Thermo Fisher Scientific), Illumina, Affymetrix (now part of Thermo Fisher Scientific), Bruker Daltonics, PerkinElmer and others have launched clinical tests and test services. They join Roche, Abbott, Siemens, Danaher, and other traditional market competitors.

2. Declining Human Resources & Automation: 

The in vitro diagnostics market requires lab technologists. Human resources essential to molecular and histological tests & immunoassays are decreasing, and test & lab automations that remove HR from pre-analytical and sample-tracking tasks are launching to make room for more sophisticated tasks. Automation is becoming common in hematology, blood banking, microbiology, and histology.

Lab diagnostics automation is more common; assays in coagulation, infectious diseases, proteins, diabetes, and HPV are developed for automated clinical analyzers. Systems for urinalysis, coagulation, and microbiology taking their places alongside the hematology, chemistry, and immunoassay instruments within a single core lab.

In Vitro Diagnostics Industry News

One area of in vitro diagnostics that is receiving a high amount of attention is direct to consumer IVD testing. 23andMe and and providing healthcare tests along with ancestr DNA testing. This is popular with some consumers but can be concerning for healthcare providers and regulators.

Watch Point of Care

Point of care (POC) testing attractions heavy venture capital and company interest. POC testing blends clinical & traditional medical engineering with telecommunications, information, and computer science, opening niche markets for POC testing and devices.

Diagnostics and patient monitoring will play a larger role in POC testing. Newer technologies entering developing countries, such as smartphone-linked diagnostic devices, can make huge differences.

POC testing’s past success hinged on developing tests that employed user-friendly techniques and alternative samples. Future success for point of care testing depends on value-added dimensions to POC tests, already in progress. Currently, all high-end glucose monitoring devices offer software and connectivity that allows diabetics to better manage their health. Test services for HbA1c, paternity, coagulation, and other tests provide physician consultation apps.

POC testing has contributed heavily to diagnostics market growth over the past 10 years. Health insurance giants Aetna, UnitedHealth, Kasier Permanente – together with research organizations and IT companies – are collaborating to personalize medicine using big data.

POC testing has contributed heavily to diagnostics market growth over the past 10 years. Health insurance giants Aetna, UnitedHealth, Kasier Permanente – together with research organizations and IT companies – are collaborating to personalize medicine using big data.

Immunoassays Hang In

Immunoassays are important in the IVD instrument market and have been crucial in clinical lab medicine since the mid-1960s. Immunoassays are used to diagnose and monitor diseases & conditions. Among the different types of immunoassays:

  • Automated
  • Manual
  • ELISAs
  • Enzyme Immunoassays
  • Bead Arrays
  • Microarrays
  • Immunoassays employing mass spectrometry

Since the publication of the human genome, immunoassays have been revitalized, generally referred to as post-genomic medicine. Post-genomic medicine employs tests based on protein, and nucelic acid targets derived from human genome research. Gene identification comes first, followed by detecting physiological elements such as proteins, hormones, and enzymes expressed by genes.

Proteins, enzymes, coenzymes, and other cellular elements are major players in metabolic pathways that promote and predict disease evolution. This combination of genes, proteins, and pathways makes for a comprehensive toolbox for post-genomic science.

Coagulation: A Mixed Bag

Hemostasis (stopping blood flow) regulates blood flow and clot formation with enzymes and proteins, relying on coagulation, fibrinolysis, and platelet aggregation. Anticoagulant drugs prevent platelets from clumping, reducing the risk of arteries clogging and in turn stroke or heart attack.

The coagulation discipline is in the limelight thanks thanks to the discovery that coagulation factors are independent from the development of myocardial infections, strokes and deep vein thrombosis, cancer, inflammatory syndromes, and obstetric complcations. Conditions in which coagulation factors are implicated include:

  • Post-surgical bleeding due to Aspirin or Plavix
  • Spontaneous abortion
  • Pregnancy issues

In vitro diagnostics market’s coagulation segment is a mixed bag of routine tests and intensive investigation of abnormal tests with genetic markers and special immunoassays run on dedicated coagulation analyzers and core lab chemistry & immunoassay instruments.

Histology: Traditional Key to Cancer Testing Threatened

Histology and cytology study tissues and cells, respectively. Histoligical analyses of tissue involve pre-analytical sample preparation and advanced staining.

Histology processes cervical fluids, sputum, and tissue that has been biopsied. Specimens are stained on glass slides to characterize targeted cellular constructions, tissue morphology, and cell componenets. Technologists read the slides using microscropy, while pathogists examine slides with suspicious cells. Histological tests primarily test tissue for cancer, or cervical fluid for infectious agents. Biopsied organs or tissues are processed and analyzed similarly.

Pathologists identify tumor sources in most cancer cases, sometimes confirming cancer without finding the sources. Pathologists employ different techniques  to improvide difficult diagnoses, including in situ hybridization (ISH), immunohistochemistry (IHC), immunofluorescence (IF), and molecular analysis of tumor cells.

In Vitro Diagnostics Market Research

The latest in IVD market research covered in Kalorama Information’s reports.

From Patients to Providers: Transmitting Information in IVD

Diagnostics are about information delivery. Transmitting usable, valid info to healthcare providers and patients is crucial to lab operations. Significant trends in IVD include:

  • Worldwide reorganization of decentralized healthcare delivery
  • Advancement of outcomes-based disease management within test economics
  • Access to worldwide databases & experts via smartphone

Kalorama’s clinical testing market reports address these trends in detail.

Core Lab’s Expansion

Routine laboratory tests in chemistry, immunoassays, urinalysis, microbiology, coagulation, and HPV cytology are consolidating into the core lab. More analytes previously found only on dedicated immunoanalyzers have migated to consolidated work stations, including

  • D-Dimer (coagulation)
  • Vitamin D
  • HgA1c (diabetes)
  • BNP
  • NGAL
  • anti-CCP
  • hsCRP
  • cystatin
  • HIV
  • HCV
  • procalcitonin
  • HE4 cancer marker
  • Markers for Graves’ dease

Traditional specialization barriers including microbiology, hematology, blood banking, immunology, and anatomical pathology are fading, making the core laboratory a lab medicine hub. Economic pressures, labor shortages, and continual additions of new diagnostic tests to lab menus are expanding the core laboratory. At least 80 immunoassays are currently available in clinical workstations. The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 10th Edition  predicts that automation is likely in the core lab’s future.

Smaller hospitals are amalgamating routine tests from different disciplines into one core laboratory. New tabletop diagnostic instruments for small labs are multianalyte workstations running chemistries and many immunoassays. Current diagnostic instruments for clinical chemistry, immunoassays, hematlogy, coagulation, urinalysis, and microbiology can link to laboratory information systems and central lab tracks.

1. Traditional Biology: The mature traditional biology sector employs tests using microorganism culture techniques and necessary ancillaries. Traditional biology is being automated and refreshed in response to new molecular and rapid techniques that threaten its position. Traditional biology employs rapid tests performed on bacteria colonies grown on cultured media, and tests performed on uncultured specimens (direct).

2. Nucleic Acid testing (DNA Testing):  DNA testing has decreased test turnarounds from as long as a week to days (sometimes from days  to hours). DNA testing provides specific genus/species information for pathogens necessary in epidemiological studies and for therapeutic decisions.

Microbiology detects pathogens and determines appropriate antimicrobial treatments. Microbiology’s standard has always been individualized therapy, whereas most lab segments are just now folowing suit. Microbiology testing is time-sensitive; early infection detection and treatment often makes the difference between life and death or morbity.

Infectious diseases are often associated with developing countries, but they are also major causes of morbidity in Europe and the United States. A worldwide effort is necessary to stymie the effects of emerging pathogens, mass migration, global travelers, misuse of antibiotics, and co-infection.

New pathogens strains develop annually, so infectious disease diagnostics will always drive the diagnostic testing market segment; microbiology is currently one of the most dynamic IVD market segments, reported in Kalorama’s The World Molecular Diagnostics Market, 7th Edition.