The Market for Contract Manufacturing in IVD

The demand for in vitro diagnostic (IVD) products that can detect disease, inform therapy decisions, and improve outcomes has led to a corresponding demand for services to make those products efficiently and at scale. Contract manufacturing organizations (CMOs) in the IVD sector play a crucial role in this ecosystem by offering the production capabilities, regulatory expertise, and scalability needed for rapid, reliable test manufacturing. As IVD companies strive to meet growing demands, they often rely on these CMOs to expedite product availability, manage costs, and ensure consistent quality—all essential for launching effective diagnostic solutions in a competitive market.

This report, Contract Manufacturing in IVD, provides a comprehensive look at the marketplace for these services. As contract manufacturers do not generally publish revenues, this report is assembled as the result of interviews with contract organizations manufacturing for OEMs, assessed and synthesized by a knowledgeable IVD expert with contacts in manufacturing. As part of its coverage, the report includes;

• Executive Summary: Trends, Market Growth and Overall Observations
• Markets by Product: Immunoassays, Clinical Chemistry, Hematology, Molecular, Microbiology, Histology, Coagulation, Blood Banking and Other IVD Contract Demand. ($ millions) with Forecasts to 2029.
• Markets by Country: United States, Canada, Mexico, UK, Italy, France, Spain, Germany, Other Western Europe, Eastern Europe, China, Japan, India, Latin America, Africa/Mideast
• COVID-19 Contract Manufacturing Estimated to 2029
• Testing Category Markets, Including:
  • Instruments
  • Components
  • Supplies
• Companies in the Market

CMOs in IVD offer specialized services like assay development, packaging, and kitting, as well as unique insights into regulatory compliance across different global markets. By partnering with a CMO, IVD companies can focus on their core competencies, such as research and development, while leveraging the CMO’s manufacturing infrastructure and expertise. This approach allows companies to scale up production swiftly in response to public health needs, as seen with COVID-19 testing, where CMOs were essential to meet unprecedented demand. In essence, contract manufacturing in IVD is a vital component that helps bring innovative diagnostics to market more efficiently, ultimately supporting better patient outcomes and public health management.

This report provides an unparalleled resource for those conducting business planning in the contract manufacturing industry.