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. Already a multi-billion dollar market, this segment is well positioned to generate favorable long-term growth, as detailed in this report, The Market for Contract Manufacturing in IVD. 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.

Scope and Methodology

This report examines global trends in the contract IVD manufacturing business.  The analysis is divided into:

• technology (immunoassay, clinical chemistry, molecular assays, microbiology, hematology, histology/cytology, coagulation, blood grouping, and other),
• product (reagents and test kits, instruments and systems, and accessories),
• and end-use applications (point-of-care and clinical laboratory). 

The report also discusses contract IVD services in non-manufacturing areas such as assay development, instrument design, regulatory filings, and packaging.   

Principal customers for contract IVD manufacturing and non-manufacturing services include traditional IVD product producers, medical supply distributors, drug stores and mass merchandisers, and Internet and mail order enterprises. Global revenues generated by these services are expressed in current United States dollars and reflect estimates for the year 2021 and forecasts for each year in the 2022 to 2026 period.