Home Healthcare Medical Devices United States IVD Raw Materials Market

United States IVD Raw Materials Market Size, Share & Trends Analysis Report By Product (Antibody, Antigens, Proteins, Enzymes, Biological Buffers, Substrates, Others), By Technology (Molecular Diagnostics, Clinical Chemistry, Immunochemistry, Others), By End User (Diagnostic Laboratories, Pharmaceutical & Biotechnological Companies, Others) and Forecasts, 2026-2034

Last Updated: September 01, 2026 | Author: Debashree Bora | Format:

United States Ivd Raw Materials Market Size

The United States IVD Raw Materials Market size was valued at USD 1.94 billion in 2025 and is projected to grow from USD 2.12 billion in 2026 to reach USD 4.24 billion by 2034, growing at a CAGR of 9.08% during the forecast period 2026–2034.

The increasing focus on personalized medicine, advancements in diagnostic tools, and the rising prevalence of chronic diseases are key factors driving market growth. Technological advancements, along with rising investments in research and development (R&D), are further bolstering the development of innovative diagnostic solutions for IVD raw materials in the United States.

United States IVD Raw Materials Market Size

Download a Free Sample To learn more about this report.

Product Type Insights

Antibody dominates the product type segment and is expected to grow at a CAGR of 11.9% over the forecast period. Antibodies are critical to the U.S. IVD raw materials market, primarily used in immunoassays and molecular diagnostics. The demand for monoclonal and polyclonal antibodies is rising due to the increasing prevalence of cancer and autoimmune diseases. Hospitals and diagnostic labs are expanding their use of antibody-based tests, particularly for cancer diagnostics such as immunohistochemistry (IHC), driving growth in this segment.

United States IVD Raw Materials Market Size By Segments

Request Customizationto receive a tailored report.

Technology Insights

Immunochemistry dominates the technology segment and is expected to grow at a CAGR of 12.3% through 2033. Immunochemistry technologies are widely adopted in point-of-care testing and home diagnostics in the U.S. Their growing popularity is attributed to advancements in automated platforms and reagent systems that reduce diagnostic time and improve accuracy. The high demand for chemiluminescence immunoassays (CLIA) in detecting biomarkers with precision is expected to sustain the segment's growth throughout the forecast period.

End-User Insights

Pharmaceutical and biotechnological companies dominate the end-user segment and is expected to grow at a CAGR of 12.9%. Pharmaceutical and biotechnological companies are significant end-users of IVD raw materials in the U.S., where the push for personalized medicine is accelerating collaborations between diagnostic manufacturers and pharmaceutical firms. This trend is particularly robust in immuno-oncology, where the focus on biomarker-driven drug development is expected to boost demand for high-quality IVD materials in clinical trials.

United States IVD Raw Materials Market Share By Segments

Speak to an Analystto discuss market opportunities.

United States Ivd Raw Materials Market Regional Insights

The United States IVD raw materials market’s advanced healthcare infrastructure, high investment in biotechnology, and increasing prevalence of chronic diseases are key drivers of market growth. Moreover, the U.S. government’s focus on expanding diagnostic capabilities through personalized medicine and early disease detection has accelerated the demand for high-quality IVD raw materials. The U.S. leads the global market in innovation and development of diagnostic technologies, ensuring a steady demand for key raw materials like antibodies, antigens, and enzymes.

  • New York City, with its advanced healthcare infrastructure, remains a crucial player in the adoption of IVD technologies. The city's strong presence of academic research institutions and pharmaceutical companies contributes to the high demand for IVD raw materials. In 2024, NYC saw a 9% increase in diagnostic testing due to expanding its healthcare services and establishing new diagnostic labs.
  • Los Angeles, a hub for biotechnology companies, is witnessing strong growth in the demand for molecular diagnostics. The city’s diverse population has spurred the need for advanced testing for genetic disorders and infectious diseases. In 2024, the town reported a 7% increase in healthcare spending, driven by a surge in biotechnology investments and a rising demand for personalized diagnostic tools.
  • Chicago’s strategic location as a healthcare and logistics hub makes it an essential market for IVD raw materials. The city has a strong presence of research labs and hospitals that contribute to its demand for diagnostic tools. In 2024, Chicago saw a 10% growth in its diagnostics sector due to the increasing adoption of advanced testing technologies like next-generation sequencing (NGS).
  • Houston, home to the Texas Medical Center, significantly contributes to the U.S. IVD market. The city’s focus on medical research and its large population base make it a thriving diagnostic test market. In 2024, Houston witnessed a 12% rise in diagnostic testing, particularly in oncology and infectious diseases.
  • San Francisco's strong biotechnology sector and focus on digital health innovation make it a key player in the U.S. IVD market. The city’s emphasis on molecular diagnostics and personalized medicine is expected to result in continued demand for IVD raw materials. In 2024, diagnostic testing in the city grew by 8%, supported by increased investments in biopharmaceutical R&D.

List of Key and Emerging Players in United States IVD Raw Materials Market

Creative Diagnostics
Merck KGaA
Thermo Fisher Scientfic Inc.
OYC Americas, Inc.
Fapon Biotech Inc.
Biosynth
F. Hoffmann-La Roche Ltd
Sysmex Corporation
Shenzhen AIVD Biotechnology Co., LTD.
Glentham®f Life Sciences Limited
Neogen Corporation

Key Industry Developments

June 2026
Merck KGaA (MilliporeSigma) expanded its U.S. life science manufacturing capabilities by increasing production capacity for high-purity antibodies, enzymes, buffers, and specialty reagents used in in vitro diagnostic (IVD) assay development.
May 2026
Thermo Fisher Scientific introduced an expanded portfolio of recombinant proteins, antibodies, and diagnostic-grade raw materials to support next-generation molecular and immunodiagnostic assay manufacturers in the U.S.
March 2026
Bio-Techne Corporation expanded its diagnostic raw material offerings with new recombinant antigens and monoclonal antibodies designed for infectious disease and oncology IVD applications.
October 2025
SeraCare Life Sciences launched new diagnostic-quality reference materials and controls to support assay validation and quality assurance for molecular and immunoassay developers.

Report Scope

Segmentation

By Product 7
  • Antibody
  • Antigens
  • Proteins
  • Enzymes
  • Biological Buffers
  • Substrates
  • Others
By Technology 4
  • Molecular Diagnostics
  • Clinical Chemistry
  • Immunochemistry
  • Others
By End User 3
  • Diagnostic Laboratories
  • Pharmaceutical & Biotechnological Companies
  • Others
Competitive Coverage Creative Diagnostics · Merck KGaA · Thermo Fisher Scientfic Inc. · OYC Americas, Inc. · Fapon Biotech Inc.
Research Deliverables Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends

Customize This Report to Match Your Strategic Objectives

Frequently Asked Questions (FAQs)

Straits research predicts that the United States IVD Raw Materials Market size was valued at USD 1.94 billion in 2025 and is projected to grow from USD 2.12 billion in 2026 to reach USD 4.24 billion by 2034.
The United States market growth rate growing at a 9.08% from 2026 to 2034.
The growing prevalence of chronic diseases and infectious outbreaks, is a key growth factor driving advancements in IVD raw materials.
Currently, the pharmaceutical and biotechnological companies segment dominates the market, fueled by rising focus on precision medicine.
About the Author
Debashree Bora
Debashree Bora
Healthcare Lead

Debashree Bora is a strategic healthcare research professional with nearly eight years of hands on experience in market intelligence, encompassing primary research, secondary research, market estimation, and consulting engagements. She specializes in pharmaceutical, biotechnology, medical devices, healthcare services, clinical trials, and healthcare outsourcing sectors, providing actionable insights on evolving industry trends, regulatory landscapes, and competitive dynamics.
Debashree’s research helps global clients evaluate market potential, identify growth opportunities, strengthen commercial strategies, and make informed business decisions.

Report Details
−
Trusted by Industry Leaders
LG Electronics AMCAD Engineering KOBE STEEL LTD. Hindustan National Glass & Industries Limited Voith Group International Paper Hansol Paper Whirlpool Corporation Sony Samsung Electronics Qualcomm Google Fiserv Veto-Pharma Nippon Becton Dickinson Merck Argon Medical Devices Abbott Ajinomoto Denon Doosan Meiji Seika Kaisha Ltd LG Chemicals LCY chemical group Bayer Airrane BASF Toyota Industries Nissan Motors Neenah Mitsubishi Hyundai Motor Company Honda CRP Industries Inc pewag LGE Panasonic Lubrizol Corporation Leonardo Johnson & Johnson HB Fuller MITSUBISHI CHEMICAL Hyundai Mobis Amazon
Request Sample Order Report Now