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    US IVD Contract Manufacturing Market

    ID: MRFR/HC/51268-HCR
    200 Pages
    Rahul Gotadki
    September 2025

    US IVD Contract Manufacturing Market Research Report By Product Type (Reagents, Diagnostic Devices, Assay Kits, Consumables), By Technology (Molecular Diagnostics, Immunoassays, Clinical Chemistry, Microbiology), By End-user (Hospitals, Diagnostic Laboratories, Research Institutions, Home Care), and By Service Type (Manufacturing Services, Research and Development Services, Packaging Services) - Forecast to 2035

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    US IVD Contract Manufacturing Market Infographic
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    US IVD Contract Manufacturing Market Summary

    The United States IVD Contract Manufacturing market is projected to grow from 1.95 USD Billion in 2024 to 3.49 USD Billion by 2035.

    Key Market Trends & Highlights

    US IVD Contract Manufacturing Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 5.43% from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 3.49 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 1.95 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of advanced diagnostic technologies due to increasing demand for personalized medicine is a major market driver.

    Market Size & Forecast

    2024 Market Size 1.95 (USD Billion)
    2035 Market Size 3.49 (USD Billion)
    CAGR (2025-2035) 5.43%

    Major Players

    Abbott Laboratories, Thermo Fisher Scientific, Siemens Healthineers, Danaher Corporation, PerkinElmer, Beckman Coulter, Chembio Diagnostics, BDBioRad Laboratories, Hologic, Genomatica, Quest Diagnostics, Ortho Clinical Diagnostics, Medtronic, Roche Diagnostics

    US IVD Contract Manufacturing Market Trends

    The growing need for personalised medicine, regulatory changes, and technological improvements are driving a number of significant trends in the US IVD (In Vitro Diagnostic) Contract Manufacturing Market. The increasing focus on diagnostics as vital instruments for illness management and prevention, especially in light of the COVID-19 pandemic, is one major market driver.

    As a result, there is now a strong ecosystem for IVD producers, with both the public and commercial sectors investing more in research and development. Furthermore, contract manufacturers must adjust to meet the growing demand for more advanced diagnostic tests due to the increased incidence of chronic diseases in the US.

    Utilising automation and digital technology to increase manufacturing efficiency and shorten the time to market for novel diagnostic tests is one of the market's opportunities. Contract manufacturers can benefit from the need for compliance in product development and quality assurance procedures as regulatory agencies such as the FDA continue to update their rules for medical devices.

    There is also a big chance to improve quality control and expedite processes by using artificial intelligence and data analytics into manufacturing processes. There has been a noticeable shift in recent years towards cooperation and partnerships between US academic institutions, biotech businesses, and IVD producers.

    Smaller businesses with cutting-edge technology can launch their solutions faster thanks to this cooperative strategy, which also helps to speed up product development. Additionally, because keeping in-house production facilities is expensive, there is a shift towards outsourcing manufacturing skills.

    Stakeholders in the US IVD Contract Manufacturing Market can strategically position themselves to meet changing client needs and spur growth in a competitive market by concentrating on these developing trends.

    Market Segment Insights

    US IVD Contract Manufacturing Market Segment Insights

    US IVD Contract Manufacturing Market Segment Insights

    IVD Contract Manufacturing Market Product Type Insights

    IVD Contract Manufacturing Market Product Type Insights

    The US IVD Contract Manufacturing Market encompasses various product types, each playing a crucial role in the overall landscape of diagnostic testing and medical technology. Among these, reagents are vital as they facilitate the biochemical reactions necessary for diagnostic processes, establishing their significance in the overall market.

    They are commonly used in a wide range of tests, including infectious diseases, immunology, and genetics, thus driving significant demand and innovation in this field. Diagnostic devices, another key product type, include instruments and systems utilized to perform tests for the detection and diagnosis of diseases.

    Their technological advancement, such as the integration of artificial intelligence and automation, is reshaping how diagnostics are conducted, leading to more accurate and quicker results, which are paramount in today's healthcare environment.

    Assay kits, designed for specific testing needs, are integral to laboratories and clinics, enabling efficient and reliable analysis of samples. Their importance lies in the capacity to deliver precise results, which can lead to timely and effective treatment plans.

    IVD Contract Manufacturing Market Technology Insights

    IVD Contract Manufacturing Market Technology Insights

    The Technology segment of the US IVD Contract Manufacturing Market plays a crucial role in the broader healthcare landscape, facilitating advancements in disease detection and monitoring. This segment encompasses various areas, including Molecular Diagnostics, Immunoassays, Clinical Chemistry, and Microbiology, which are essential for developing precise and timely diagnostic solutions.

    Molecular Diagnostics is particularly significant as it leverages genetic and molecular information, driving innovations in personalized medicine and targeted therapies. Immunoassays dominate the market by offering rapid and accurate results for a range of diseases, significantly enhancing patient management.

    Clinical Chemistry remains a cornerstone of routine laboratory testing, ensuring the availability of vital biochemical data that informs clinical decisions. Meanwhile, Microbiology serves a fundamental purpose in identifying infectious agents, which is essential for public health safety and effective treatment strategies.

    This diverse Technology landscape contributes to the overall enhancement of diagnostic accuracy and accessibility, meeting the increasing demand for efficient and reliable testing solutions in the US.

    IVD Contract Manufacturing Market End-user Insights

    IVD Contract Manufacturing Market End-user Insights

    The End-user segment of the US IVD Contract Manufacturing Market encompasses a variety of key players, including Hospitals, Diagnostic Laboratories, Research Institutions, and Home Care settings. Hospitals are crucial as they often require continuous supply of in-vitro diagnostic products to ensure accurate patient care.

    This segment is characterized by advanced technological infrastructure that demands high-quality manufacturing standards, making them a significant contributor to the overall market dynamics. Diagnostic Laboratories play a vital role, representing the core of testing services and often exhibiting a majority holding due to their need for diverse IVD solutions tailored for varied diseases.

    Research Institutions are also integral, as they drive innovation and new product development, facilitating advancements in the diagnostic field which can lead to growth opportunities. In recent years, the Home Care segment has gained prominence, underscoring the trend toward at-home testing solutions, aligning with the growing consumer preference for convenience and remote health management.

    Collectively, these segments reflect the diverse applications of IVD products, highlighting a dynamically evolving landscape driven by technological advancements and changing healthcare needs in the US.

    IVD Contract Manufacturing Market Service Type Insights

    IVD Contract Manufacturing Market Service Type Insights

    The US IVD Contract Manufacturing Market focuses on various Service Type segments essential for producing in vitro diagnostic devices. Among these, Manufacturing Services encompass a wide range of processes, including assembly and quality control, which are critical for meeting strict regulatory standards in the US healthcare landscape.

    Research and Development Services play a significant role by driving innovation and enhancing product efficacy through extensive testing and validation processes, aiding manufacturers in staying competitive. Packaging Services are crucial as they ensure product integrity, comply with regulatory requirements, and enhance marketability.

    The growing demand for personalized medicine and increased prevalence of chronic diseases in the US are driving growth and investment in these service segments. Overall, the segmentation demonstrates an intricate interdependence among these services, with each contributing significantly to the overall efficiency, safety, and quality of IVD products in the market.

    The engagement in technology advancements and focus on regulatory compliance are essential in maintaining market dynamics and addressing the challenges posed by ever-evolving healthcare demands.

    Get more detailed insights about US IVD Contract Manufacturing Market Research Report- Forecast To 2035

    Key Players and Competitive Insights

    The US IVD Contract Manufacturing Market has been experiencing dynamic changes, driven by advancements in technology, increasing demand for diagnostic tests, and a shift towards personalized medicine. The competitive landscape features numerous players who provide essential services from product development to regulatory compliance.

    This sector is characterized by collaborations, joint ventures, and partnerships, as companies strive to enhance their capabilities and market reach. The growing prevalence of chronic diseases and a greater emphasis on preventive healthcare have further stimulated demand, creating opportunities for both established firms and new entrants.

    The emergence of innovative diagnostic solutions and the push for rapid testing methods position this market at the forefront of healthcare strategy in the US.

    Abbott Laboratories stands out in the US IVD Contract Manufacturing Market due to its vast expertise and solid brand reputation. The company leverages its extensive portfolio of diagnostic products, which include immunoassays, molecular diagnostics, and point-of-care testing solutions.

    Abbott's strengths are exemplified by its robust research and development capabilities, allowing it to consistently introduce cutting-edge technologies that meet evolving healthcare needs. The company's established relationships with healthcare providers and its commitment to quality assurance further bolster its market presence.

    By maintaining a strong focus on innovation and customer service, Abbott Laboratories reinforces its leadership position within the competitive frame of the US IVD sector, effectively addressing the increasing demand for efficient and reliable diagnostic solutions.

    Thermo Fisher Scientific has a significant foothold in the US IVD Contract Manufacturing Market, recognized for its comprehensive array of laboratory and diagnostic solutions. The company specializes in various key products, including analyzers, reagents, and software services tailored for diagnostic applications.

    With a focus on enhancing operational efficiencies and automating processes, Thermo Fisher fosters innovation in IVD manufacturing. Strengths such as extensive global reach, advanced technologies, and a wide service offering have positioned Thermo Fisher as a formidable player in the market.

    The company's strategy involves strategic mergers and acquisitions to enhance its portfolio and expand market share. This proactive approach enables Thermo Fisher Scientific to stay ahead of the curve in a competitive landscape, ultimately driving growth and meeting the diverse needs of healthcare providers in the United States.

    Key Companies in the US IVD Contract Manufacturing Market market include

    Industry Developments

    The US IVD (In Vitro Diagnostic) Contract Manufacturing Market has recently seen significant developments. Notably, Abbott Laboratories and Danaher Corporation have reported substantial growth in their manufacturing capabilities, driven by rising demand for diagnostic testing amid ongoing public health challenges.

    Siemens Healthineers launched a new production line to enhance its capacity for point-of-care testing, while Thermo Fisher Scientific has expanded its portfolio through strategic research initiatives. On the acquisition front, in March 2023, Roche Diagnostics announced the acquisition of a notable biosensor company to strengthen its market position, backed by consistent media coverage.

    Additionally, Beckman Coulter has focused on increasing its automation in manufacturing to improve efficiency. The market has been buoyed by partnerships between IVD companies and technology providers to innovate new diagnostic solutions.

    Major events in the last few years include the surge in testing requirements during the COVID-19 pandemic, leading to an uptick in manufacturing activities. Currently, the market shows positive valuation growth, driven by advancements in biotechnology and increasing healthcare investments, which support the continuous evolution of IVD contract manufacturing in the US.

    Market Segmentation

    IVD Contract Manufacturing Market End-user Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Research Institutions
    • Home Care

    IVD Contract Manufacturing Market Technology Outlook

    • Molecular Diagnostics
    • Immunoassays
    • Clinical Chemistry
    • Microbiology

    IVD Contract Manufacturing Market Service Type Outlook

    • Manufacturing Services
    • Research and Development Services
    • Packaging Services

    Report Scope

    Report Attribute/Metric Details
    Market Size 2023 1.74(USD Billion)
    Market Size 2024 1.95(USD Billion)
    Market Size 2035 3.49(USD Billion)
    Compound Annual Growth Rate (CAGR) 5.411% (2025 - 2035)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2019 - 2024
    Market Forecast Units USD Billion
    Key Companies Profiled Abbott Laboratories, Thermo Fisher Scientific, Siemens Healthineers, Danaher Corporation, PerkinElmer, Beckman Coulter, Chembio Diagnostics, BD, BioRad Laboratories, Hologic, Genomatica, Quest Diagnostics, Ortho Clinical Diagnostics, Medtronic, Roche Diagnostics
    Segments Covered Product Type, Technology, End-user, Service Type
    Key Market Opportunities Increased demand for personalized medicine, Growth in point-of-care testing, Advancements in automation technology, Rising focus on regulatory compliance, Expansion of home diagnostic testing
    Key Market Dynamics rising demand for personalized medicine, technological advancements in diagnostics, regulatory compliance challenges, cost efficiency in production, increasing outsourcing trends
    Countries Covered US

    FAQs

    What was the market size of the US IVD Contract Manufacturing Market in 2024?

    The market size of the US IVD Contract Manufacturing Market in 2024 was valued at 1.95 billion USD.

    What will the market size be in 2035 for the US IVD Contract Manufacturing Market?

    By 2035, the US IVD Contract Manufacturing Market is projected to reach a value of about 3.49 billion USD.

    What is the expected compound annual growth rate (CAGR) for the US IVD Contract Manufacturing Market from 2025 to 2035?

    The expected CAGR for the US IVD Contract Manufacturing Market from 2025 to 2035 is approximately 5.411%.

    Which product segments are expected to dominate the US IVD Contract Manufacturing Market?

    The major product segments expected to dominate include Reagents, Diagnostic Devices, Assay Kits, and Consumables.

    What was the market value for reagents in the US IVD Contract Manufacturing Market in 2024?

    In 2024, the market value for reagents in the US IVD Contract Manufacturing Market was expected to be around 0.55 billion USD.

    How much is the Diagnostic Devices segment expected to be valued in 2035?

    The Diagnostic Devices segment is expected to be valued at approximately 1.2 billion USD by 2035.

    Who are the key players in the US IVD Contract Manufacturing Market?

    Key players in the market include Abbott Laboratories, Thermo Fisher Scientific, Siemens Healthineers, and Danaher Corporation.

    What challenges might the US IVD Contract Manufacturing Market face in the upcoming years?

    The US IVD Contract Manufacturing Market may face challenges such as regulatory hurdles and supply chain disruptions.

    What opportunities exist for growth in the US IVD Contract Manufacturing Market?

    The market presents opportunities driven by advancements in diagnostic technologies and increasing demand for personalized medicine.

    What will the Consumables segment be valued at in 2035?

    The Consumables segment is projected to be valued at around 0.49 billion USD in 2035.

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