Tuesday, 02 January 2024 12:17 GMT

IVD Raw Material Market Report Now Available - Forecasts Market Growth From $21.5B (2026) To $31.1B By 2031, Profiling Merck Kgaa, Thermo Fisher, Bio-Techne, Fapon Biotech, And 21 Other Key Players


(MENAFN- GlobeNewsWire - Nasdaq) 500-Page Report Ranks Suppliers by Competitive Position Across the Company Evaluation Matrix as Infectious Disease Testing Drives the Largest Application Segment

Dublin, Sept. 08, 2026 (GLOBE NEWSWIRE) -- The "IVD Raw Material Market by Product Type, Technology, Application, Supply Source, Origin, End User - Global Forecast to 2031" has been added to ResearchAndMarkets.com's offering.

The global in vitro diagnostics (IVD) raw material market is projected to grow from USD 21.5 billion in 2026 to USD 31.1 billion by 2031, registering a compound annual growth rate (CAGR) of 7.7%. Market expansion is being supported by the rising prevalence of chronic and infectious diseases, growing demand for early and accurate diagnosis, and broader adoption of advanced diagnostic technologies.

Increasing use of PCR, next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), and loop-mediated isothermal amplification (LAMP) is strengthening demand for high-quality oligonucleotides, nucleic acids, enzymes, and specialized reagents. The rapid expansion of point-of-care testing is also increasing requirements for antibodies, antigens, membranes, labels, and detection materials used in rapid diagnostic assays.

Advances in recombinant technologies, protein engineering, assay development, and diagnostic automation are improving test sensitivity, performance, and reliability. These developments are enabling IVD manufacturers to introduce more accurate and efficient diagnostic solutions while supporting sustained demand across the global IVD raw materials ecosystem.

Infectious Disease Testing Leads the IVD Raw Material Market by Application

Infectious disease testing is expected to account for the largest application share during the forecast period. The segment's position reflects the high global burden of bacterial, viral, fungal, and parasitic infections, alongside demand for rapid, accurate, and scalable diagnostic testing.

Diagnostic manufacturers rely on antibodies, antigens, enzymes, oligonucleotides, nucleic acids, and detection reagents to produce immunoassays, molecular diagnostic tests, and point-of-care solutions. Investments in public health programs, greater awareness of early diagnosis, and continued adoption of molecular diagnostic technologies are further increasing demand for high-quality IVD raw materials.

Other applications covered include oncology and cancer markers, cardiac markers, diabetes and metabolic disorders, autoimmune disease, blood screening, women's health and fertility, genetic and rare disease testing, and additional diagnostic applications.

Immunoassay Technology Holds the Largest Market Share

Immunoassay is expected to remain the largest technology segment in the IVD raw material market. Its leading position is supported by widespread use across infectious disease testing, oncology, cardiac markers, autoimmune disorders, and hormone testing. High testing volumes and the expansion of automated immunoassay analyzers are generating substantial demand for antibodies, antigens, proteins, enzymes, labels, and detection reagents.

Continuous assay development and demand for rapid, sensitive, specific, and cost-effective diagnostic solutions are expected to sustain adoption. Other technologies evaluated include molecular diagnostics, clinical chemistry, hematology, microbiology and culture, coagulation, point-of-care testing, flow cytometry, and additional platforms.

Asia Pacific Forecast to Record the Fastest Regional Growth

Asia Pacific is projected to register the highest regional CAGR between 2026 and 2031. Growth is being driven by increasing chronic and infectious disease prevalence, expanding healthcare infrastructure, investment in diagnostic technologies, and rising demand for early and accurate testing.

China is strengthening domestic diagnostic manufacturing through healthcare modernization initiatives and increased biotechnology and life sciences investment. India is recording higher diagnostic testing volumes as clinical laboratories and molecular diagnostic facilities expand and point-of-care testing adoption increases. In Japan, an advanced healthcare system, aging population, and strong focus on precision medicine continue to support demand for high-quality diagnostic assays and associated raw materials.

The regional analysis also covers North America, Europe, Latin America, and the Middle East and Africa.

Competitive Landscape

Key companies operating in the global IVD raw material market include Merck KGaA (Germany), Thermo Fisher Scientific Inc. (U.S.), Medix Biochemica (Finland), Bio-Techne Corporation (U.S.), Fapon Biotech Inc. (China), Meridian Bioscience, Inc. (U.S.), BBI Solutions (U.K.), Toyobo Co., Ltd. (Japan), Roche CustomBiotech (Switzerland), Integrated DNA Technologies, Inc. (U.S.), Cytiva (U.S.), Sartorius AG (Germany), LGC Biosearch Technologies (U.S.), Fitzgerald Industries International (U.S.), and Bangs Laboratories, Inc. (U.S.).

The competitive assessment examines market shares, product portfolios, and strategies including acquisitions, partnerships, collaborations, capacity expansions, and product launches. It also evaluates recent developments involving established businesses, emerging companies, and other participants across the IVD raw materials ecosystem.

Research Scope and Market Segmentation

The report categorizes the IVD raw material market across the following areas:

  • Product type: Antibodies; antigens and proteins; enzymes and substrates; oligonucleotides and nucleic acids; beads and particles; membranes; labels and detection materials; buffers and diluents; and other products.
  • Technology: Immunoassay, molecular diagnostics, clinical chemistry, hematology, microbiology and culture, coagulation, point-of-care testing, flow cytometry, and other technologies.
  • Application: Infectious disease testing, oncology and cancer markers, cardiac markers, diabetes and metabolic disorders, autoimmune disease, blood screening, women's health and fertility, genetic and rare disease testing, and other applications.
  • Supply source: In-house manufacturing or captive supply and third-party or merchant supply.
  • Source or origin: Biological or natural sources, recombinant or synthetic sources, and others.
  • End user: IVD manufacturers, contract research organizations, academic and research institutes, pharmaceutical and biotechnology companies, and others.
  • Region: North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

Market Drivers, Opportunities, Restraints, and Challenges

Primary growth drivers include the expanding geriatric population and related rise in chronic diseases, increasing awareness of early diagnosis in emerging economies, adoption of rapid point-of-care technologies and automated analyzers, and growing preference for personalized medicine.

Market opportunities include disease-specific biomarkers and tests, the increasing significance of companion diagnostics, expansion in developing countries, improvements in immunoassay diagnostic technologies, and healthcare digitalization. Key restraints include unfavorable reimbursement conditions and stringent regulatory requirements. Challenges include maintaining batch-to-batch consistency and raw material quality, as well as supply chain disruptions affecting critical biological and synthetic reagents.

The research also provides analysis of upcoming technologies, research and development activity, new product launches, untapped geographies, investments, market diversification, and high-growth regional opportunities.

Primary Research Participant Profile

  • By company type: Tier 1, 40%; Tier 2, 30%; and Tier 3, 30%.
  • By designation: C-level executives, 27%; directors, 18%; and others, 55%.
  • By region: North America, 51%; Europe, 21%; Asia Pacific, 18%; Latin America, 6%; and the Middle East and Africa, 4%.

The report provides market leaders and new entrants with revenue estimates for the overall IVD raw material market and its subsegments. It also offers competitive intelligence designed to support business positioning, investment planning, product development, and go-to-market strategies through analysis of market drivers, restraints, opportunities, challenges, and industry developments.

Key Attributes:

Report Attribute Details
No. of Pages 500
Forecast Period 2026 - 2031
Estimated Market Value (USD) in 2026 $21.5 Billion
Forecasted Market Value (USD) by 2031 $31.1 Billion
Compound Annual Growth Rate 7.7%


Key Topics Covered:
Market Dynamics

  • Drivers
    • Rising Prevalence of Chronic and Infectious Diseases
    • Growing Adoption of Personalized Medicine and Companion Diagnostics
    • Increasing Use of Recombinant Antibodies, Proteins, and Enzymes
    • Growing Demand for Raw Materials Supporting Decentralized and Rapid Diagnostics
  • Challenges
    • Restraints
      • High Validation and Quality-Control Costs
      • Long Supplier Qualification Cycles
      • Limited Availability of Specialized Biological Raw Materials
    • Challenges
      • Maintaining Batch-to-Batch Consistency
      • Building Resilient Supply Chains for Critical Biological Inputs
      • Meeting Evolving Ivdr/Fda Supplier Documentation Requirements
  • Opportunities
    • Adoption of Recombinant and Animal-Free Raw Materials
    • Localization of Raw Material Manufacturing in Emerging Markets
    • Development of Next-Generation Molecular Diagnostic Reagents

Company Profiles

  • Merck Kgaa
  • Thermo Fisher Scientific
  • Bio-Techne Corporation
  • Fapon Biotech
  • Meridian Bioscience
  • Medix Biochemica
  • Roche Custombiotech
  • Danaher Corporation
  • Sartorius AG
  • Hytest Ltd.
  • Toyobo Co. Ltd.
  • Lgc Biosearch Technologies
  • Bbi Solutions
  • Surmodics IVD
  • Ahlstrom Oyj
  • Bangs Laboratories
  • Scripps Laboratories, Inc.
  • Mikrogen GmbH
  • Advanced Microdevices Pvt. Ltd.
  • Sekisui Diagnostics
  • Randox Laboratories Ltd.
  • Himedia Laboratories
  • Sino Biological
  • Biosynth
  • New England Biolabs, Inc.

For more information about this report visit

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