IVD Raw Materials - Global Strategic Business Report

The global market for IVD Raw Materials was valued at US$27.7 Billion in 2024 and is projected to reach US$35.8 Billion by 2030, growing at a CAGR of 4.3% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the IVD Raw Materials market.

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 the Report

The report analyzes the IVD Raw Materials market, presented in terms of market value (USD). The analysis covers the key segments and geographic regions outlined below:

• 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.

Key Insights:

• Market Growth: Understand the significant growth trajectory of the IVD Antibody & Antigens segment, which is expected to reach US$13.0 Billion by 2030 with a CAGR of a 3.8%. The IVD Enzymes segment is also set to grow at 5.0% CAGR over the analysis period.
• Regional Analysis: Gain insights into the U.S. market, valued at $7.6 Billion in 2024, and China, forecasted to grow at an impressive 7.8% CAGR to reach $7.3 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

• Detailed Market Analysis: Access a thorough analysis of the Global IVD Raw Materials Market, covering all major geographic regions and market segments.
• Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
• Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global IVD Raw Materials Market.
• Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

• How is the Global IVD Raw Materials Market expected to evolve by 2030?
• What are the main drivers and restraints affecting the market?
• Which market segments will grow the most over the forecast period?
• How will market shares for different regions and segments change by 2030?
• Who are the leading players in the market, and what are their prospects?

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as Aalto Bio Reagents Ltd., AMSBIO (AMS Biotechnology), BBI Solutions, Bio-Rad Laboratories, Inc., Bio-Check (UK) Ltd and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 39 companies featured in this IVD Raw Materials market report include:

• 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

This edition integrates the latest global trade and economic shifts into comprehensive market analysis. Key updates include:

• Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
• Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes historical analysis from 2015 to 2023.
• Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
• Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
• Competitive Intelligence: Updated global market share estimates for 2025 (E), competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
• Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.