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The Market for the Making of IVD Products is $15 Billion: Kalorama Information Report

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Immunoassay testing products, led by antibodies, antigens, and related instruments, will post the largest share of contract demand through 2026.


ARLINGTON, Va. (PRWEB)

The global in vitro diagnostic (IVD) industry incorporates a sizable contract manufacturing segment that supplies a full range of reagents and test kits, instruments and systems, and testing accessories. This according to Kalorama Information’s latest report “The Market for Contract Manufacturing in In Vitro Diagnostics (IVD)”. Accounting for total revenues of $15.6 billion in 2021, this segment is well positioned to generate favorable long-term growth. Most leading worldwide producers of proprietary IVD systems will increase their reliance on outside contractors as a cost-effective means to:


  • expand existing product lines

  • broaden access to IVD testing technologies

  • increase access to manufacturing capacity without capital investment

  • quickly introduce tests and testing systems for newly emerging diseases and disorders (e.g., COVID-19, Monkeypox, etc.)

  • gain support for regulatory filings

  • penetrate high-growth applications, especially in the area of point-of-care (POC) testing

  • meet the specialized testing needs of major end users

Contract manufacturing also enables new and smaller IVD producers to build up product lines and increase competitiveness in the marketplace. Moreover, the segment is the major source of private label tests, instruments, and accessories sold by medical supply and device distributors, home healthcare outlets, and drug stores. Private label applications have expanded considerably over the past few years largely due to the impact of the COVID-19 pandemic.

“IVD manufacturers require high quality, controlled manufacturing process and over the years have kept a high volume of production in-house,” said Bruce Carlson, V.P. of Science and Medicine Group which owns Kalorama Information. “With COVID-19 and cancer testing and the enhanced volumes they require, IVD firms must find manufacturing partners.”

In total, the global value of contract IVD manufacturing services is forecast to increase 3.8% annually to $18.8 billion in 2026. This amount will correlate to 13.8% of total worldwide IVD product demand, up from 12.8% in 2021.

“That’s growth that is about double the IVD market. So as IVD goes up, contract manufacturing markets for IVD go up even faster,” Carlson said. “We detail this trend in the report.”

Immunoassay testing products, led by antibodies, antigens, and related instruments, will post the largest share of contract demand through 2026 based largely on infectious disease and other POC applications but will lose some growth momentum as the volume of COVID-19 tests decreases gradually over the next several years. The report covers contract manufacturing markets for every major category of IVD, including clinical chemistry, molecular diagnostics, point-of-care testing products, hematology, and other IVD contract manufacturing opportunity markets.

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