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Examining Global IVD Market Factors

Market research indicates optimism for the future for global IVD markets, yet industry consolidation, reimbursement, and excise taxes could slow growth.

This photo shows an example of an advanced IVD test.
This photo shows an example of an advanced IVD test.

The rising prevalence of chronic diseases, increases in disability-adjusted life years, advances in medical devices, an aging population, and emerging markets represent key reasons for growth of medical device technologies, such as in-vitro diagnostics (IVDs). Yet, uncertainty in reimbursement and the excise tax on medical devices in the U.S. restrain market growth.

That’s according to a MarketsAndMarkets report on the global top 10 medical device technologies market. MarketsAndMarkets expects growth in the global top 10 medical device technologies market to reach US$428.97 billion by 2020, at a CAGR of 5.5% from 2015 to 2020.

The report segments the market into in vitro diagnostics (IVD) devices, cardiology devices, diagnostic imaging devices, orthopedic devices, ophthalmology devices, endoscopy devices, diabetes care devices, wound management devices, kidney/dialysis devices, and anesthesia & respiratory care devices. The IVD devices segment accounted for the largest share of approximately 17.1% of the top 10 medical device technologies market, owing to the increase in the prevalence of diabetes, cardiovascular diseases, and cancer.

The report identifies key players in this market as Johnson & Johnson (U.S.), GE Healthcare (U.K.), Siemens Healthcare (Germany), Medtronic (U.S.), Philips Healthcare (Netherlands), Roche Diagnostics (Switzerland), Abbott Laboratories Inc. (U.S.), Smith & Nephew plc (U.K.), Stryker (U.S.), and Boston Scientific (U.S.).

IVDs, as defined by the U.S. Food and Drug Administration, are “those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae [aftereffect or secondary result]. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.”

IVD testing is classified into three main types, according to EDMA Diagnostics For Health: Clinical laboratory, near-patient testing by healthcare pros, and self-testing. Product types include reagents, analytical instruments, and accessory products.

Global markets

BCC Research’s report, “In Vitro Diagnostics: Technologies and Global Markets” forecasts the global IVD products market to rise at a compound annual growth rate (CAGR) of 6.1% between 2015 and 2020, reaching $81.1 billion by 2020.

An Evaluate Group report predicts the global medtech market will reach $477 billion by 2020. By then, the worldwide medical device market will be worth $514 billion, predicts Evaluate.

Industry consolidation is slowing the sector’s growth rate, says Evaluate. However, it notes, “One area within medtech above all else is defying this….IVDs [are] “predicted to become by far the largest segment in 2020, with sales of $71.6 billion.”

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