Rockville (MD), April 11, 2017 — Kalorama said that in vitro diagnostic procedures are exceeding 21 billion globally in its latest report. The healthcare market research firm said that an estimated 80% of all conditions diagnosed by physicians worldwide are based at least partially on the results of in vitro diagnostic (IVD) procedures. Information provided by these tests is also used to assess the progression of diseases, monitor the effectiveness of drug therapies, and develop personalized medicine regimens. IVD testing technology has progressed significantly over the past few years, spurred by advances in functional genomics and proteomics as well as by innovations in automated instruments, bioinformatics, and telecommunications.
The in vitro diagnostic market is healthy according to the firm, as global volume of IVD procedures, excluding the over-the counter (OTC) point of care (POC) market and professional POC glucose monitoring activity, reached 21.4 billion in 2016 according to Kalorama’s most recent report: Worldwide IVD Market: Procedure Volume and Pricing Analysis.
“Growth in procedures means growth in reagents and instruments sold in general terms,” said Bruce Carlson, Publisher of Kalorama Information. “Specific growth rates and markets will vary from test category to test category, and our report has identified procedure volume estimates for each category.
Ten large, multinational corporations controlled almost 70% of the global market in 2016. Except for Alere, which specializes in products for point-of-care (POC) markets, all of the other industry leaders – Roche, Abbott Laboratories, Siemens, Danaher, Thermo Fisher Scientific, Becton Dickinson, Sysmex, Ortho Clinical Diagnostics, and bioMérieux – compete in multiple product segments and achieved their strong competitive positions by supplementing internal research and development activities with acquisitions and external collaborative agreements.
Developments in IVD testing technology are expanding the availability of new tools for the detection and analysis of major worldwide health problems, including cancer, diabetes, heart disorders, and infectious diseases. Evolving global epidemiological patterns, along with changing patient care approaches, are boosting demand for a full range of routine and esoteric IVD procedures.
The selection of IVD procedures by medical providers depends on a number of factors. Among the key influences are the nature of the healthcare activity involved, the presence or absence of obvious patient symptoms, patient characteristics and history, and, increasingly, cost and third-party reimbursement eligibility. Based on broad detection capabilities, core laboratories – which consolidate routine tests from multiple disciplines, chemistry, immunoassay, urinalysis, microbiology, coagulation, HPV cytology – generated the largest share of global IVD procedure volume in 2016. These establishments apply clinical chemistry and immunoassays to the high throughput analysis of blood samples. Both techniques are able to detect or measure several target markers simultaneously. As a result, a single clinical chemistry or immunoassay test can involve multiple IVD procedures.
Increasing applications in the testing of hospital patients, patients undergoing physical examinations and periodic healthcare checkups, and patients suspected of ingesting toxic substances will boost the volume of core laboratory procedures implemented worldwide. However, growth in this activity will slow from historical levels as many countries see shorter hospital stays and tighter health insurance restrictions on outpatient testing. Moreover, increasing competition from POC, molecular, and histology/cytology diagnostics will eliminate the need for some core laboratory tests. Aging population trends and a rising level of diseases and disorders will continue to boost the volume of patient testing conducted in most countries. The adaptation of molecular and other advanced life science technologies to new and improved reagents and instruments will broaden IVD capabilities in detecting medical conditions. Medical providers throughout the world will rely increasingly on POC and clinical laboratory tests to identify patient health problems in early stages and prescribe appropriate therapies.
The IVD industry includes approximately 500 participants, ranging in size from small, narrowly focused firms to large diversified multinational companies. Since IVD products serve healthcare applications, producers are subject to strict government regulations and serve highly price-sensitive markets. Overall success in the industry requires an effective balancing of research and development, productivity, manufacturing efficiencies, effective marketing and distribution, and responsive customer service. In general, the competitive structure of the global IVD industry is relatively concentrated at the top tier.
Worldwide IVD Market: Procedure Volume and Pricing Analysis contains regional procedure volume data for 2016-2021 for North America, the United States, Canada and Mexico, Western Europe, Asia/Pacific, China, India, Japan, Central and South America, Brazil, other South America, Eastern Europe, Russia, and Africa/Mideast. The report also provides the following data points with forecasts to 2021:
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on www.marketresearch.com and www.profound.com.
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