The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 10th Edition (Core Lab, POC, Glucose, Infectious Disease Testing, Histology, Hematology, NGS, Blood Screening/Typing, Coagulation Tests, Other Markets and Trends)
What is the Size of the World In Vitro Diagnostic Test Market?
Visit our 'In Vitro Diagnostics' curated page for all-in-one industry coverage.The global in vitro diagnostics (IVD) market is currently 60.5 billion dollars. The IVD market segment for IVD reagents, kits, and instruments will grow, but in a complex pattern that involves challenges to growth in traditional categories and reliable large markets combined with opportunities in novel tests and growth nations. This is the finding of Kalorama Information’s comprehensive report, The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 10th edition, based on a study of IVD released every 2 years that analyzes every segment of IVD testing with trend analysis, IVD market forecasts and company profiles. The 1,600-page study is used by the IVD industry for business planning efforts.
In Vitro Diagnostic Growth Factors Include:
- Aging Population
- Disease Incidence, Notably Cancer and Infectious Disease
- New Biomarkers
- Increased Insurance and Spending in Emerging Nations
Important Segment Markets in the In Vitro Diagnostic Market
- Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
- Clinical Chemistry and "Core Lab" Markets (including sub segment revenues for General Chemistries, Workstations, Analyzers Blood Gases, Urinalysis, Critical Care)
- Point-of-Care Testing (POC), (Professional and Self-Testing, Glucose Testing, Pregnancy Tests, drugs of abuse, HIV, H. pylori, Other, OTC/Self Total, Professional POC, Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other)
- Microbiology and Virology by Test Type (Immunoassays, ID/AST, Infectious Diseases - DNA; ID/AST: Panels and Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies)
- Blood Banking (Grouping, Immunoassay Screens, NAT Screens)
- Tissue-Based Testing - Histology and Cytology (Pap, ISH, IHC, HPV)
- Infectious Disease Immunoassay Testing (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)
- Molecular Tests in Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others
- Non-Infectious Disease Immunoassay Sales by Analyte Type (Cardiac markers, Tumor markers, Diabetes/HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic drugs, Tox/Drugs of abuse, Vitamin D)
- Coagulation Tests (Lab-Based, POC, Genetic Markers)
- Sequencing and Flow Cytometry
Regional and Country IVD Markets
- Saudi Arabia
- Latin America
- Eastern Europe
- Emerging Markets
- Rest of World
In Vitro Diagnostic Company Profiles
Top Tier In Vitro Diagnostic Companies:These are the dominant companies in the in vitro diagnostics industry. For each company, extensive, discussion of recent financial performance is provided. These IVD manufacturers' main products are detailed and any significant company strategies, partnerships and acquisitions are considered:
- Abbott Diagnostics
- Alere Inc
- Beckman Coulter, Inc. / Danaher
- Becton, Dickinson and Company (BD)
- bioMérieux Inc.
- Bio-Rad Laboratories
- Instrumentation Laboratory (IL)
- Ortho Clinical Diagnostics (OCD)
- QIAGEN N.V
- Roche Diagnostics
- Siemens Healthineers
- Sysmex Corporation
- Thermo FisherScientific
- Werfen Group S.A.
Next Tier In Vitro Diagnostic Companies:Growth-oriented companies that have significant market presence in one or several areas are profiled and their new products and strategies discussed in the report. Among these:
- Affymetrix Inc.
- ERBA Diagnostics, Inc
- DiaSorin S.p.A
- Luminex Corporation
- Menarini Diagnostics.
- Mindray Medical International Limited
- Myriad Genetics
- Perkin Elmer, Inc. (PE)
- Quidel Corporation
- Randox Laboratories Ltd
- Royal Philips
- TOSOH Corporation
- Trinity Biotech
- Wako Pure Chemical Industries
Specialist In Vitro Diagnostic Companies:While these IVD manufacturers and companies focus on one segment of the in vitro diagnostic market, they can often be dominant in the market as well. They are important to watch because they can often develop products in new areas of testing and move categories.
- Molecular Specialists
- Blood Banking Specialists
- Point of Care Specialists
- Prenatal Test Service Providers
- Quality Control and Pretreatment Specialists
- Histology and Cytology Specialists
- Microbiology Specialists
- IT SolutionsCompanies
- CTC and Liquid Biopsy Specialists
Deep Understanding of In Vitro Diagnostic Market Trends
- The revolution in bioinformatics is allowing clinical and traditional medical engineering to blend with components derived from the telecommunications, information and computer sciences industries. This opens new niche markets for POC test devices, which will have a positive impact on diagnostic testing.
- Getting information to care givers and patients is now not an added plus, it is a prerequisite of all lab operations. Thus the next 3-5 years will see an intensification of the healthcare industry's emphasis on informatics, wireless communications, data networking and cost/effective healthcare delivery.
- In the area of test economics, outcomes based disease management establishes guidelines and directives for patient care. This is having a significant effect on the use of new tests, which have to prove their added value to patient care. It also affects how many and which tests are recommended and thus reimbursed for a specific disease group.
- Top 20 In Vitro Diagnostic Companies and Niche Players 2012-2016
- Acquisitions in the in vitro diagnostic Market
- NGS, LC-MS and Other Novel Testing
- Lab Market Segmentation (Hospital, Independent, POLs)
- Emerging Markets
- Digital Technology, IT and Big Data
- Gene Editing
- Europe and Austerity
- Status of LDTs
- State of Biomarker Discovery
- Test Services Trend
- Distribution Agreements
- Role of Sequencing
- Non-Blood Sampling
- LDT Regulatory Picture
- New Product Launches
- Near-Patient Testing
- DTC Testing
- New Testing Venues
Shifts in the Industry from 20 Years of Studying IVD
- A summary of the IVD industry from 1995 to the present. Amazingly, a lot has changed – new tests and technologies have come to market but the very same major in vitro diagnostic companies generate about 90% of product sales.
- Demographics: A number of world events bode well for the future of in vitro diagnostic technology: an aging worldwide population and demand for new hospitals in developing countries. Increasing numbers of people between the ages of 45 and 75 years in the industrialized world consume more healthcare services such as heart and cancer tests. In vitro diagnostic companies are casting their nets in developing countries, where rising incomes and standards of living have sparked a new health consciousness and growing demands for quality medical care. The next five to ten years or so will see moderate and gradual change in IVD product markets.
- Changing Core Lab: Not 10-15 years ago, most microbiology and anatomic pathology labs were tucked away somewhere in the basement. The major test areas similarly were separated by impenetrable walls. Those days are long gone: imagine a centralized hospital lab where clinical chemistry, immunoassays, hematology, coagulation, urinalysis, some microbiology, some cytology tests are all performed in one room and often on instrumentation that are linked by an automated track line and all in the same room. More importantly tests are carried out by a lab information system that consolidates test results to an electronic patient record, or EMR.
- Emerging Markets: High growth countries, primarily Saudi Arabia, Brazil, China and India are experiencing in vitro diagnostics market growth of double digits. This is fueled by privatization and health insurance initiatives by governments and employers. However this growth has a negligible effect to compensate for the lack of significant growth in major healthcare markets of Europe, Japan and the U.S.
- IVD-Focused Government Initiatives: New healthcare disease screening and health insurance initiatives proposed by the new U.S.administration under the guidance of President Barack Obama further bolster the use of in vitro diagnostic technology, but continued economic difficulties has U.S. citizens forgo elective procedures because the co-payments may be somewhat unaffordable.
- Automation: There is also a lack of trained lab technologists, so there is a decreasing availability of human resources needed to run the more complex new set of molecular and histological tests and immunoassays. Therefore there has been a proliferation of test and lab automation tools launched that remove precious human resources from mundane pre-analytical and sample-tracking tasks to make time for more sophisticated ones. This phenomenon was once thought to be the purview of core lab biochemistry and immunoassays but automation is becoming a common feature hematology, blood banking,microbiology, and histology. Demand for healthcare and thus in vitro diagnostic tests in all the major healthcare markets is driven by aging populations and increased incidence of conditions such as: cancer, diabetes,cardiovascular disease, arthritis and obesity. In light of the demand for these IVD tests, they have been reformulated for automated analyzers where the cost per test is traditionally low.
- New Sampling: No more blood sampling: be prepared for an in vitro diagnostic market of breath tests for conditions that includes respiratory infections,gastrointestinal disorders, cancer and even chronic diseases. Wearable patch sensors have been commercialized for glucose and vital signs monitoring; more and more applications are in development.
- Sequencing Enters the Clinic: In the 21st century, understanding a patient’s personal genomic profile equips physicians with valuable information to better diagnose, predict, treat and prevent disease. Personalized medicine using genomic information improves patient outcomes and reduces healthcare costs and adverse drug reactions. The NGS data analysis market includes the market by product (software and services) and by applications such as whole genome sequencing, exome sequencing, targeted re-sequencing, de novo sequencing, RNA-Seq, ChIP-Seq and Methyl-Seq. As experience with sequencing intensifies, researchers are beginning to discover some of the ways in which the technology can be used. It is generally anticipated that whole genome sequencing is most appropriate for broad research looking for linkages between gene mutations and disease development.
Several In Vitro Diagnostic Market Trends to Significantly Impact Evolution of Disease Diagnostics:
- Demand for healthcare and thus diagnostic tests in all the major markets is driven by aging populations and increased incidence of conditions such as: cancer, diabetes, cardiovascular disease, arthritis and obesity. In light of the demand for these tests, they have been reformulated for automated analyzers where the cost per test is traditionally low.
- IVD manufacturers' product choices have been a boon for medical care. But it also puts a great deal of pressure on physicians to make the right choices and for payers to pay for new technologies that may still be unproven. As an aging society begins to use more healthcare services, cost efficiency imperatives continue to put pressure on payers, providers and suppliers. As a result healthcare organizations have developed strict cost/performance and care guideline directives. One of the ways to achieve these directives is to use medical and financial data to evaluate and prescribe the use of medical devices.
- What does all this mean for IVD marketers? Data, data, and more data accompanied by the inevitable use of data to evaluate the medical usefulness and necessity of using a specific device. Medical device usage will be based on performance data, peer review research articles, contribution to patient outcome and a cost/benefit analysis. Wide dissemination of medical information in the media and on the Internet has spawned a more informed population that is prepared to seek out new technologies.
- There is also a lack of trained lab technologists, so there is a decreasing availability of human resources needed to run the more complex new set of molecular and histological tests and immunoassays. Therefore there has been a proliferation of test and lab automation tools launched that remove precious human resources from mundane pre-analytical and sample-tracking tasks to make time for more sophisticated ones. This phenomenon was once thought to be the purview of core lab biochemistry and immunoassays but automation is becoming a common feature hematology, blood banking, microbiology, and histology.
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