IVD Raw Materials

Global IVD Raw Materials Market to Reach US$35.8 Billion by 2030

The global market for IVD Raw Materials estimated at US$27.7 Billion in the year 2024, is expected to reach US$35.8 Billion by 2030, growing at a CAGR of 4.3% over the analysis period 2024-2030. IVD Antibody & Antigens, one of the segments analyzed in the report, is expected to record a 3.8% CAGR and reach US$13.0 Billion by the end of the analysis period. Growth in the IVD Enzymes segment is estimated at 5.0% CAGR over the analysis period.

The U.S. Market is Estimated at US$7.6 Billion While China is Forecast to Grow at 7.8% CAGR

The IVD Raw Materials market in the U.S. is estimated at US$7.6 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$7.3 Billion by the year 2030 trailing a CAGR of 7.8% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 1.8% and 3.4% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 2.5% CAGR.

Global IVD Raw Materials Market - Key Trends & Drivers Summarized

What Role Do Raw Materials Play in the Reliability of In Vitro Diagnostics?

IVD raw materials refer to the essential biological, chemical, and synthetic components used in the manufacture of in vitro diagnostic tests and kits. These include antibodies, antigens, enzymes, nucleotides, reagents, buffers, stabilizers, and control materials. The quality, consistency, and performance of these raw inputs directly impact the sensitivity, specificity, and reproducibility of diagnostic assays used for disease detection, monitoring, and screening.

Demand for reliable IVD raw materials has surged with the rise in molecular diagnostics, point-of-care testing, and infectious disease surveillance. Manufacturers are under pressure to source high-purity, lot-consistent raw materials to ensure regulatory compliance and assay reliability. Biotech firms and research labs also depend on IVD-grade materials for developing new test formats in oncology, cardiology, and infectious diseases.

What Innovations Are Transforming Material Sourcing and Quality Assurance?

Suppliers of IVD raw materials are investing in advanced purification processes, expression systems, and recombinant production technologies to meet stringent quality standards. Monoclonal antibody production, synthetic peptide synthesis, and enzyme engineering are being refined to deliver high-yield, reproducible batches. Recombinant antigens and nucleic acid probes are being used to replace variable biological materials in high-precision test kits.

Material suppliers are also offering pre-validated raw inputs with stability testing, performance documentation, and traceable lot records to streamline regulatory filings by IVD manufacturers. GMP-compliant manufacturing, ISO certifications, and global distribution capabilities are becoming prerequisites as test developers seek reliable, scalable, and audit-ready suppliers. Some companies are developing vertically integrated production lines to ensure uninterrupted supply during public health crises or demand surges.

Where Is Demand Concentrated, and Who Are the Leading Buyers?

Demand is strongest among diagnostic kit manufacturers, molecular test developers, and reference laboratories. Companies developing PCR-based diagnostics, ELISA kits, lateral flow assays, and sequencing platforms rely on a wide range of raw materials tailored to specific detection targets. Research organizations and biotech firms also purchase IVD-grade materials for assay development and clinical validation.

North America and Europe remain key markets due to the concentration of diagnostics firms and regulatory stringency. Asia Pacific is growing rapidly, driven by local manufacturing initiatives, expanding disease surveillance, and increasing export capacity. Public health laboratories, academic institutions, and contract diagnostic manufacturers are expanding their raw material usage as global diagnostic capacity grows.

What Is Driving Growth in the IVD Raw Materials Market?

Growth in the IVD raw materials market is driven by several factors including rising global demand for diagnostic testing, increasing complexity of assay formats, and heightened regulatory scrutiny of material quality. Advances in recombinant production, synthetic chemistry, and expression systems are enabling reliable, scalable supply of high-performance components.

End-use expansion in molecular diagnostics, infectious disease testing, and personalized medicine is creating recurring demand for highly specific and stable raw materials. Emergence of new pathogens, focus on decentralized testing, and growing investment in lab infrastructure are further boosting usage. As diagnostics become central to preventive and precision medicine, the need for high-quality IVD raw materials continues to grow in both established and emerging healthcare markets.

SCOPE OF STUDY:

The report analyzes the IVD Raw Materials market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product (IVD Antibody & Antigens, IVD Enzymes, IVD Proteins, IVD Biological Buffers, Other Products); Technology (Clinical Chemistry Technology, Immunochemistry Technology, Molecular Diagnostics Technology, Other Technologies); End-Use (Pharma & Biotech Companies End-Use, Diagnostic Laboratories End-Use, Other End-Uses)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 39 Featured) -

• Aalto Bio Reagents Ltd.
• AMSBIO (AMS Biotechnology)
• BBI Solutions
• Bio-Rad Laboratories, Inc.
• Bio-Check (UK) Ltd
• Bioporto Diagnostics
• Diarect AG
• EastCoast Bio
• Fitzgerald Industries Intl.
• Fujirebio
• HyTest Ltd
• Jena Bioscience GmbH
• Medix Biochemica
• Meridian Bioscience, Inc.
• MyBiosource, Inc.
• QuidelOrtho Corporation
• RayBiotech, Inc.
• Rockland Immunochemicals, Inc.
• Scripps Laboratories, Inc.
• Sekisui Diagnostics

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