Table of Contents
Overview
New York, NY – June 11, 2025 – Global IVD Raw Materials Market size is expected to be worth around US$ 38.44 billion by 2034 from US$ 18.65 billion in 2024, growing at a CAGR of 7.5% during the forecast period 2025 to 2034. In 2023, North America led the market, achieving over 34.8% share with a revenue of US$ 6.49 Billion.
The global In Vitro Diagnostic (IVD) Raw Materials market is experiencing steady growth, driven by the increasing need for accurate and early disease detection. As healthcare systems place greater emphasis on preventive care and precision diagnostics, the demand for high-quality raw materials used in IVD tests continues to rise. These raw materials include antibodies, antigens, enzymes, and proteins that are essential for developing reliable diagnostic assays.
Among the product types, antibodies are widely used due to their ability to provide targeted and sensitive detection. Molecular diagnostics remains a leading technology segment, owing to its ability to offer rapid and accurate results, especially in the detection of infectious and genetic diseases. The market is also supported by the growing use of immunochemistry and clinical chemistry technologies.
Diagnostic laboratories represent the largest end-user segment, followed by pharmaceutical and biotechnology companies and contract research organizations. The increasing reliance on laboratory-based testing and the expanding scope of diagnostic services have strengthened this demand. Regionally, North America holds a leading position, attributed to advanced healthcare infrastructure and strong investment in diagnostic research. Other regions are also showing significant growth as awareness around early diagnosis and personalized medicine increases.
Overall, the IVD raw materials market is expected to maintain positive momentum, supported by ongoing technological innovations and growing global healthcare needs.
Key Takeaways
- In 2024, the IVD Raw Materials market generated a revenue of US$ 65 billion and is projected to grow at a compound annual growth rate (CAGR) of 7.5%, reaching approximately US$ 38.44 billion by 2033.
- By product type, the market is segmented into Antibodies, Antigens, Enzymes, and Proteins. Among these, Antibodies emerged as the leading segment in 2023, accounting for a market share of 31.1%, due to their critical role in diagnostic assay development and disease-specific testing.
- Based on technology, the market is categorized into Molecular Diagnostics, Clinical Chemistry, Immunochemistry, and Others. Molecular Diagnostics dominated the technology segment, capturing 37.4% of the market share, driven by its increasing use in infectious disease testing, cancer screening, and genetic analysis.
- In terms of end users, the market is divided into Pharmaceutical and Biotechnology Companies, Diagnostic Laboratories, Contract Research Organizations (CROs), and Others. Diagnostic Laboratories held the largest share at 38.3%, reflecting their extensive demand for high-quality raw materials to support diverse diagnostic applications.
- Regionally, North America led the global market in 2023, accounting for a 34.8% share, supported by advanced healthcare infrastructure, robust diagnostic testing demand, and strong investment in laboratory innovation.
Segmentation Analysis
- Product Analysis: Antibodies are the dominant segment in the IVD Raw Materials market due to their essential role in immunoassays, including ELISA and lateral flow tests. They facilitate the precise detection of biomarkers in various diagnostic applications such as infectious disease testing, cancer diagnostics, and autoimmune disorder detection. The growing trend toward personalized medicine, combined with an increased burden of chronic and infectious diseases, reinforces the importance of antibodies. Recent industry innovations further underscore their pivotal function in advancing early-stage cancer drug development and patient care.
- Technology Analysis: Molecular diagnostics represents a major technological segment in the IVD Raw Materials market, driven by the need for rapid, sensitive, and precise testing methods for genetic disorders, infections, and cancer. Consolidation activities in the industry highlight its strategic importance. Techniques such as PCR and next-generation sequencing have enhanced the demand for critical raw materials like nucleotides, enzymes, and reagents. Immunochemistry and clinical chemistry also maintain strong positions, though their growth is comparatively slower than that of molecular diagnostics.
- End-User Analysis: Diagnostic laboratories constitute the largest end-user segment by leveraging IVD raw materials for routine and specialized testing. Their central role in addressing the challenges of chronic diseases, infectious conditions, and aging population demands supports sustained market reliance on antibodies, enzymes, and reagents. Pharmaceutical and biotechnology companies maintain a significant presence, driven by requirements in drug development and clinical research, while contract research organizations further contribute by supplying essential support services to these sectors.
Market Segments
By Product
- Antibodies
- Antigens
- Enzymes
- Proteins
- Biological Buffers
- Others
By Technology
- Molecular Diagnostics
- Clinical Chemistry
- Immunochemistry
- Others
By End User
- Pharmaceutical and Biotechnology Companies
- Diagnostic Laboratories
- Contract Research Organizations
- Others
Regional Analysis
North America continues to lead the global IVD raw materials market, driven by its well-established healthcare infrastructure, increasing diagnostic testing demand, and high prevalence of chronic diseases. In 2024, the region accounted for the largest share, with the United States serving as the primary contributor due to rising healthcare expenditure and widespread adoption of point-of-care testing and companion diagnostics.
The growing burden of chronic illnesses has significantly contributed to the region’s market expansion. According to a study published in Frontiers in Public Health in January 2023, a substantial portion of the U.S. population aged 50 and above is expected to be affected by at least one chronic disease by 2050. This demographic shift is projected to escalate the need for diagnostic solutions, directly boosting the demand for IVD raw materials used in test development and laboratory workflows.
Moreover, continuous product innovation and regulatory approvals are reinforcing market growth. For instance, in May 2022, BioMérieux received regulatory clearance in Canada for its BioFire Blood Culture Identification 2 (BCID2) panel. This next-generation diagnostic tool enhances detection capabilities with expanded pathogen coverage and updated resistance gene targets, supporting more effective infection management.
Overall, North America’s proactive healthcare environment and sustained investment in diagnostic technologies position it as a key driver in the global IVD raw materials landscape.
Emerging Trends
- Enhanced Supply-Chain Traceability: It has been observed that regulatory bodies have increased focus on raw-material traceability throughout the IVD supply chain. Under the FDA’s Medical Device Single Audit Program (MDSAP), manufacturers are required to establish procedures that ensure critical raw materials and components can be traced “from raw materials to lot release,” with a level of rigor proportional to the risk posed by the device’s failure. This trend is driven by the need to improve recall management and to enhance patient safety.
- Growth in Versatile Transport Media: A marked increase in the use of versatile transport media has been noted, as preparedness for emerging infectious diseases has become a priority. The CDC’s 2024 Infectious Diseases Laboratory Test Directory (Version 30.0) specifies that viral transport media (VTM) can support at least seven specimen types including nasopharyngeal, oropharyngeal, nasal, rectal, conjunctival, lesion swabs, and stool samples and that specimens may be stored at 2–8 °C for up to seven days before processing. This flexibility has been instrumental in expanding testing capacity during outbreaks.
- Adoption of Recombinant and Synthetic Reagents: It has been noted that IVD manufacturers are increasingly substituting animal-derived materials with recombinant proteins, synthetic peptides, and chemically defined biocides. According to WHO Technical Guidance Series Annex TGS–2, the stability of components made from new raw materials—such as detergents, biologicals, and biocides must be established to the same standard as traditional materials. This practice reduces batch-to-batch variability and enhances assay reproducibility.
- Standardized Quality Assessment via Prequalification: The WHO Prequalification of In Vitro Diagnostics programme has been expanded to include rigorous assessment of raw materials. It has been documented that a standardized procedure is now applied to evaluate incoming lots of antibodies, antigens, and enzymes, ensuring material quality before lot release. This harmonization is intended to facilitate global procurement by UN agencies and partner countries, thereby improving access to reliable diagnostics.
Use Cases
- Molecular Diagnostic Assay Kits: IVD raw materials such as primers, probes, and controls are fundamental to real-time reverse transcription PCR (rRT-PCR) kits. For example, the CDC’s H7N9 virus detection kit includes sufficient rRT-PCR reagents for 200 reactions, enabling rapid identification of avian influenza strains in clinical laboratories. Such kits are critical for early outbreak detection and surveillance activities.
- Specimen Transport and Preservation: Viral transport media (VTM) is a core raw material for specimen collection. The CDC’s directory specifies its use with at least seven specimen types including NP/OP swabs and lesion swabs and mandates storage at 2–8 °C for up to seven days before freezing or analysis. This capability supports high-throughput testing in both centralized and remote laboratory settings.
- Quality Control Panels for Assay Validation: WHO’s Technical Guidance Series (TGS–6) outlines methods for preparing validated QA/QC panels using standardized raw materials. These panels include reference strains, antigen preparations, and controls that are used by IVD manufacturers to verify sensitivity and specificity before product release. Adoption of such panels has been linked to more consistent lot-to-lot performance across global markets.
- Broad-Panel Diagnostic Test Directories: The CDC’s 2024 Infectious Diseases Laboratory Test Directory (Version 30.0) catalogues over 400 laboratory tests, each specifying required raw materials such as culture media, molecular reagents, and antigen-specific antibodies for accurate pathogen detection. This directory serves as a reference for clinical laboratories when sourcing materials and designing test workflows.
Conclusion
The global IVD Raw Materials market is poised for sustained growth, driven by rising diagnostic demands, technological innovation, and expanding applications in disease detection and patient management. Key segments such as antibodies and molecular diagnostics continue to lead due to their critical roles in assay development.
The market benefits from strong regional leadership in North America and global standardization efforts from organizations like WHO and CDC. Emerging trends, including enhanced supply-chain traceability and the adoption of recombinant reagents, are reshaping industry practices. Overall, the market is set to evolve with advancements that ensure reliability, accessibility, and quality in diagnostic testing worldwide.
Discuss your needs with our analyst
Please share your requirements with more details so our analyst can check if they can solve your problem(s)
