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

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 on Contract Manufacturing in IVD:

The market will grow at double the rate of the overall IVD market, meaning that the more IVD products are created, the greater the amount of manufacturing that simply must go to partners.

Contract Manufacturing in IVD Report, Kalorama

Accounting for total revenues of $15.6 billion in 2021, this segment is well positioned to generate favorable long-term growth. Most leading worldwide of 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.

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.   

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.