• by Bruce Carlson
  • August 28 2018


$77.8 Billion-Dollar IVD Market by 2023: New Report

$77.8 Billion-Dollar IVD Market by 2023: New Report

In vitro diagnostics is a fast-growing field, one with the promise to improve patient outcomes and possibly reduce costs for the healthcare system. Every two years, Kalorama Information examines the market in detail and they recently released their latest report. The report, The Worldwide Market for In Vitro Diagnostic Tests, projects that the world market for diagnostics is expected to grow 4% annually to $77.8 billion by 2023. Among the findings of the firm’s large-scale market study was the following:

 Microbiology and Cancer Lead: Infectious disease testing and testing for cancer detection or personalized cancer treatment remain the high-growth areas of IVD.

 The top four companies in IVD are Roche, Abbott, Danaher and Siemens Healthineers, with Roche in first. This will not surprise readers. However, there is a bit of movement within the group: Abbott finalized with Alere, easily taking the number two spot in the IVD market and number one in several categories, notably point of care. The other two players were not passive. Danaher has demonstrated growth with its Beckman Coulter and Cepheid units, and Siemens Healthineers launched new tests and announced an IPO.

 US PAMA Law Helps Cancer Tests, Hurts Microbiology: In the largest market, The Protecting Access to Medicare Act (PAMA) signed four years ago, took effect. PAMA establishes a market-based pricing system for lab tests where Medicare payment for a test equals the weighted median of private payer rates. IVD Companies are expecting a reduction in payments due to the upcoming changes. Not all the news was bad: PAMA created a new category of assays, called advanced diagnostic laboratory tests, that have seen increases. Hard hit in the plan is infectious disease testing.

Europe Improvement, Eastern Europe Opportunity: There is improvement and spending in particular by German, Netherlands and Swiss laboratories. Still, this was once a region that in 2004 contributed 30% of the market; now it is 20%. Not surprisingly, many companies are seeking out Eastern Europe as a place to make larger gains. Kalorama points out Poland, Slovenia, Albania and Romania as the higher-growth markets in the region.


New Applications for Biomarkers: IVD thrives on innovation and novel biomarkers proving out will be the determinant of future growth, in 2018 advances were made towards tests in categories not normally thought of for IVD. Recently biomarkers for Alzheimer’s and Traumatic Brain Injury (TBI) have entered the fold. In July 2018, the FDA granted breakthrough device designation to Roche's Elecsys beta-amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF assays, both in vitro diagnostic immunoassays in cerebral spinal fluid to evaluate patients for Alzheimer's disease and other causes of dementia. In February 2018, Banyan Biomarkers (San Diego, CA) was granted a De Novo request for the commercialization of its in vitro diagnostic, Banyan BTI (Brain Trauma Indicator), a blood test designed to aid in assessing patients suspected of having suffered traumatic brain injury.

Kalorama’s report said that while 70 percent of critical healthcare decisions are made with the aid of a clinical test, testing amounts for a small portion of total healthcare spending. And testing has the ability to better target therapy and lower costs. For this reason, the report projects that there are many years ahead of sales and interest from healthcare providers and investors interest.

More findings and specific market estimates and projections 2018-2023 can be found in Kalorama Information’s report, The Worldwide market for In Vitro Diagnostics: https://www.kaloramainformation.com/Worldwide-Vitro-Diagnostic-Tests-11th-Edition-11723890/.