The in vitro diagnostics (IVD) market attracts considerable interest. There are hundreds of participating companies, competing in multiple areas of testing. Each IVD segment could be said to function as an industry in and of itself. There are companies who specialize in one area and companies who participate across segments. There are myriad products, from routine blood tests to complicated molecular assays and new sequencing based technologies. It's often necessary for competitors to know about all of the segments of testing as different technologies can often compete. This single volume Kalorama Information report has been written and updated for over a decade in nine editions, with the purpose of keeping readers informed about developments in clinical testing. It covers the entirety of the clinical testing market, reports on hundreds of competitors, details deals and acquisitions and computes market size statistics for important segments. Published every two years, this volume includes recent market size and forecasts to 2018 for the most important aspects of all of the major segments of clinical lab testing, including
- Clinical Chemistry and "Core Lab" Markets (including sub segment revenues for General Chemistries, Workstations, Analyzers Blood Gases, Urinalysis, Critical Care)
- Near-Patient and 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)
- Tissue-Based Testing - Histology and Cytology (Pap, ISH, IHC, HPV)
- Microbiology Immunoassay Testing (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)
- Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
- 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)
- 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)
No other report provides an similar sense of the world diagnostics market. Shara Rosen (MBA, RT) has edited nine editions of this superior work intended to provide IVD market coverage in a world perspective. A month's long research effort creates authoritative market estimates and forecasted growth models for in vitro diagnostic (IVD) testing products throughout the world.
This is a global report. The following IVD markets are included:
- North America
- Europe (with total IVD market sizes for EU countries)
- Asia (China, Japan, India)
- Latin America
- Emerging Markets
- Rest of World
Not Just "Who Did What?" This Report Answers "What are the Reasons Behind the Results"
The report does just report on deals, events in the industry, laboratory trends and corporate results. It provides that information, but it also analyzes why trends are occurring, and what readers can expect in the future.
The Worldwide Market for In Vitro Diagnostic Tests is a testament to the Kalorama methodology. It is the result of months of painstaking work by an IVD industry veteran, who has tracked hundreds of companies for developments, trends and financial results. This research is compiled along with the opinion, observations and insights of industry experts to produce an unparalleled vision of the industry as it is in 2014. The report includes data in a sizeable number of IVD segments and detailed discussion of the trends that are impacting the industry. The report also provides a realistic forecast five years into the future for companies already participating in or considering entry into this growing industry. Many top IVD companies have purchase this volume and use the data within for their business planning efforts.
The same business intelligence top companies possess is available to purchasers of this unique report.
The report contains detailed profiles of the top players in IVD. Profiling in this report describes the developments in each significant division of their business. A number of secondary players are also extensively profiled, as well as specialty companies with expertise in one testing area.
- Abbott Diagnostics
- Alere Inc.
- Beckman Coulter, Inc.
- Becton, Dickinson and Company (BD)
- bioMérieux Inc.
- Bio-Rad Laboratories, Inc.
- Danaher Corporation
- Hologic, Inc.
- Ortho Clinical Diagnostics (OCD)
- QIAGEN N.V.
- Siemens Healthcare Diagnostics
- Sysmex Corporation
- Thermo Fisher Scientific Inc.
- Affymetrix Inc.
- Eiken Chemical Co., Ltd
- ERBA Diagnostics, Inc.
- DiaSorin S.p.A
- Fujirebio Diagnostics, Inc.
- Luminex Corporation
- Roche Diagnostics
- Wako Pure Chemical Industries
And hundreds of other companies...
All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the in vitro diagnostic market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.
The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the IVD industry.
New Report Says In Vitro Diagnostic Market Reaches 54.6Billion
NEW YORK, N.Y. - The world marketfor diagnostics is estimated at $54.6 billion in 2013, according to KaloramaInformation. The market is expected to grow 4% annually and reach $65billion by 2018. This includes all laboratory and hospital-basedproducts, and OTC product sales. Kalorama revealed the market estimatesin its biennial survey of the IVD industry, The Worldwide Market for In Vitro DiagnosticTests, 9th Edition.
New technology is leading thecharge, according to Kalorama. Diagnostic laboratory technology haschanged dramatically in the past few years, due to the publication of the humangenome project and advances in functional genomics, bioinformatics,miniaturization and microelectronics.
“Not three years ago it would havebeen almost inconceivable to see research technologies such as genomesequencing and mass spectroscopy play a pivotal role in improving labmedicine,” said Shara Rosen, Kalorama’s lead diagnostic analyst and the authorof the report. “Their influence is felt in personalized medicine,inherited diseases, pathogen detection, antibiotic resistance testing, bloodbanking and much more to come.”
According to the report, thisphenomenon has seen the major vendors of these technologies enter the IVDmarket. Life Technologies, Illumina, Affymetrix, Bruker Daltonics,PerkinElmer/Caliper and others have all launched clinical tests and testservices.
Commentary on LDT Regulatory changes
The 8th edition of this report published in 2012 discussed the possible regulation of lab developed tests (LDTs). Well in 2014, the possible is a reality. In the beginning …. September 2006, the FDA issued a draft guidance on analyte specific reagents (ASRs), which are commercially available reagents used in lab developed tests (LDTs). The FDA decided to use enforcement discretion and excluded laboratory-developed tests from the ASR rule based on confidence in a high-complexity laboratory’s ability to use them.
LDTs are developed within the laboratory and do not currently require FDA clearance. They are currently regulated under CLIA as highly complex tests and thus are subject to in-house validation and cGMP quality documentation requirements.
August 1, 2014, the FDA announced plans to implement a risk-based regulation of laboratory-developed tests over the course of nine years. The FDA also said it plans to release its draft guidance in 60 days. The FDA’s announcement comes out at a time when the agency has come under increasing pressure from congressional and federal advisory committees, consumer groups and the industry to expand its oversight of in-house developed testing. The FDA announcement stated that LDTs have become an intrinsic part of personalized medicine and that inaccurate test results could cause patients to seek unnecessary treatment, or delay and sometimes forgo treatment altogether. Further the policy change “demonstrates the agency's commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”
The statement also stated that the FDA would implement the regulations over a nine-year period and would focus on tests where a wrong result would pose the highest risk for patients. It also said it would exempt tests for which there is no approved alternative and tests for rare diseases.
The FDA says it intends to require pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market. The draft guidance also proposed that LDTs would be classified as Class I, II, or III depending on risk. The agency will first focus on high-risk devices that have the same intended use as cleared or approved companion diagnostics.
It is expected that the classification may take the form of a proposal submitted by the American College of Medical Genetics and Genomics. In 3013, the American College of Medical Genetics and Genomics (ACMG, www.acmg.net/) released a framework to standardize risk classification of laboratory developed tests (LDTs) for inherited conditions. The approach represents a regulatory context that the group hopes will be used to assist federal agencies and policymakers. The ACMG presented risk-based classification that aligns risk with the medical decisions made based on the test results and how an incorrect result or interpretation might impact patients.