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    US Host Cell Protein Testing Market

    ID: MRFR/LS/14736-HCR
    100 Pages
    Garvit Vyas
    October 2025

    US Host Cell Protein Testing Market Research Report By Type (PCR-Based Assays, ELISA-based Assays, Mass Spectrometry-Based Assays, Others) and By End User (Contract Research Organizations, Biopharmaceutical Companies, Others) - Forecast to 2035

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    US Host Cell Protein Testing Market Infographic
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    US Host Cell Protein Testing Market Summary

    The US Host Cell Protein Testing market is projected to grow from 222 million USD in 2024 to 409 million USD by 2035.

    Key Market Trends & Highlights

    US Host Cell Protein Testing Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 5.71 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 409 million USD, indicating robust growth potential.
    • In 2024, the market is valued at 222 million USD, reflecting a solid foundation for future expansion.
    • Growing adoption of advanced testing technologies due to increasing regulatory requirements is a major market driver.

    Market Size & Forecast

    2024 Market Size 222 (USD Million)
    2035 Market Size 409 (USD Million)
    CAGR (2025-2035) 5.71%

    Major Players

    Agilent Technologies, MilliporeSigma, Celerion, Eurofins Scientific, BioRad Laboratories, Roche, Charles River Laboratories, PerkinElmer, Labcorp, Promega Corporation, Thermo Fisher Scientific, Sartorius AG, ATCC, Genedata, Fitzgerald Industries International

    US Host Cell Protein Testing Market Trends

    The US Host Cell Protein Testing Market is showcasing notable trends resulting from the rising focus on biopharmaceuticals. With the expansion of the biopharmaceutical market within the US, there is greater focus and expectation on the safety and efficacy of biologics, leading to the greater need for host cell protein testing.

    Due to the stringent regulations set by the FDA about the testing of biopharmaceuticals, there is an alert within the sector to comply. These are signs that there is testing that needs to be done in order to assure product and patient safety, which shall be essential. Businesses are starting to position themselves in the popularized markets of advanced testing innovations.

    As newer methods of testing continue to emerge, automated and high-throughput methods are taking center stage as they optimize efficiency and accuracy. Furthermore, the constant progress being made in proteomics and other related fields will bring about better detection and analytical methods in host cell protein testing, making this segment ready for improvement.

    There is significant evidence of a recent uptake in the use of risk-based testing strategies. Organizations based in the US are progressively applying these strategies in order to refine the balance of cost and comprehensiveness in their compliance.

    Market Segment Insights

    Host Cell Protein Testing Market Type Insights

    The US Host Cell Protein Testing Market is characterized by a diverse array of assay types that cater to the growing demand for accuracy and reliability in biopharmaceutical manufacturing processes. With increasing regulatory scrutiny and the need for compliance in drug development, PCR-Based Assays have emerged as a prominent focus due to their sensitivity and specificity in detecting host cell proteins.

    These assays play a crucial role in ensuring product safety and quality, thus fostering trust among consumers in the pharmaceutical industry. In conjunction, ELISA-based Assays are also significant contributors to the market, renowned for their ability to quantify host cell proteins, making them invaluable for downstream processing in bioproduction.

    Their widespread adoption in quality control laboratories underscores their importance in validating the purity of biopharmaceuticals. The Mass Spectrometry-Based Assays segment has gained traction owing to its advanced analytical capabilities, providing in-depth molecular analysis that is paramount for understanding the intricacies of protein interactions in production processes.

    This technique's ability to distinguish between proteins with high precision enables researchers to understand potential contamination sources better, thereby ensuring the integrity of the final product. Additionally, the category of 'Others' encompasses a variety of emerging technologies and methodologies that contribute to the US Host Cell Protein Testing Market's innovation landscape.

    This segment reflects the ongoing advancements in testing technologies and methodologies that address specific needs in the biopharmaceutical industry, offering flexibility and adaptability. Collectively, the market segmentation contributes significantly to the overall robustness of host cell protein testing while aligning with consumer safety measures and regulatory requirements.

    Host Cell Protein Testing Market End User Insights

    The US Host Cell Protein Testing Market encompasses various End Users, primarily driven by the demand for safety and efficacy in biologics. Within this landscape, Contract Research Organizations (CROs) play a crucial role, often acting as facilitators for biopharmaceutical companies through their specialized testing services.

    Biopharmaceutical Companies dominate the market, seeking stringent testing protocols to ensure compliance with regulatory standards. This segment is significant due to the increasing pipeline of biologics requiring thorough host cell protein evaluation.

    Additionally, Other end users, including academic institutions and research laboratories, contribute by fostering innovation and advancing methodologies in host cell protein testing. The growing emphasis on biopharmaceutical purity and the rising number of drug approvals are pivotal market drivers bolstered by the need for advanced testing to mitigate potential risks associated with host cell proteins.

    Overall, the segment holds substantial importance in shaping industry standards and promoting advancements in biological therapies within the US market, thus reflecting the ongoing shift towards more rigorous testing frameworks.

    Get more detailed insights about US Host Cell Protein Testing Market Research Report — Forecast till 2035

    Key Players and Competitive Insights

    The US Host Cell Protein Testing Market is characterized by its growing significance in biopharmaceuticals, driven by the increasing emphasis on quality control and regulatory compliance in biologics manufacturing. With the rise in monoclonal antibody production and cell-based therapies, the demand for host cell protein testing has surged, making it a critical component in ensuring product safety and efficacy.

    The competitive landscape of this market is shaped by various players who specialize in providing innovative solutions, including assays, analytical instruments, and reagents tailored to detect contaminants stemming from the production process. These companies continuously adapt to evolving regulations and technological advancements, creating a dynamic environment that fosters growth opportunities and strategic collaborations.

    Agilent Technologies has established a strong presence in the US Host Cell Protein Testing Market, recognized for its comprehensive range of analytical tools and services. The company leverages its expertise in mass spectrometry, chromatography, and bioanalytical testing to offer high-quality solutions that cater specifically to the needs of biopharmaceutical manufacturers.

    One of Agilent Technologies' key strengths lies in its commitment to innovation, consistently introducing new technologies that help clients address complex challenges in protein analysis. With a robust support system and established relationships within the biotech and pharmaceutical sectors, Agilent Technologies continues to enhance its influence in the market by providing reliable testing methodologies and superior customer service.

    MilliporeSigma is another key player in the US Host Cell Protein Testing Market, offering a diverse portfolio of products and services designed for biopharmaceutical manufacturing and quality control. The company provides reagents, kits, and analytical solutions that facilitate the accurate detection and quantification of host cell proteins in various biological samples.

    MilliporeSigma's strengths lie in its extensive research and development capabilities, which ensure that its offerings are aligned with the latest scientific advancements and regulatory standards. The company's market presence is bolstered by strategic mergers and acquisitions that have expanded its product range and technological expertise.

    MilliporeSigma's commitment to innovation and customer collaboration has positioned it favorably within the US market, allowing it to meet the growing demands of the biopharmaceutical industry effectively.

    Key Companies in the US Host Cell Protein Testing Market market include

    Industry Developments

    In recent developments within the US Host Cell Protein Testing Market, companies like MilliporeSigma and Thermo Fisher Scientific have announced advancements in their testing methodologies, enhancing the sensitivity and specificity of their assays to detect host cell proteins in biopharmaceuticals better.

    Notably, in March 2023, Agilent Technologies introduced new software for data analysis that streamlines the interpretation of host cell protein data, aiding laboratories in compliance with FDA regulations. The market has seen notable growth valuations, with analysts citing a rise of over 15% in the last two years as the demand for biologics is increasing.

    In terms of mergers and acquisitions, in May 2023, Roche acquired a stake in a prominent biotech firm specializing in protein analysis, which is expected to bolster their capabilities in host cell protein testing. Furthermore, significant awareness about regulatory guidelines drives investments in innovative testing solutions among companies like Charles River Laboratories and Labcorp.

    The surge in investment in this sector indicates an evolving landscape, particularly as biopharmaceutical companies emphasize the need for stringent quality control measures in manufacturing processes.

    Market Segmentation

    Host Cell Protein Testing Market Type Outlook

    • PCR-Based Assays
    • ELISA-based Assays
    • Mass Spectrometry-Based Assays
    • Others

    Host Cell Protein Testing Market End User Outlook

    • Contract Research Organizations
    • Biopharmaceutical Companies
    • Others

    Report Scope

    Report Attribute/Metric Details
    Market Size 2018 209.6(USD Million)
    Market Size 2024 222.0(USD Million)
    Market Size 2035 409.0(USD Million)
    Compound Annual Growth Rate (CAGR) 5.712% (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 Million
    Key Companies Profiled Agilent Technologies, MilliporeSigma, Celerion, Eurofins Scientific, BioRad Laboratories, Roche, Charles River Laboratories, PerkinElmer, Labcorp, Promega Corporation, Thermo Fisher Scientific, Sartorius AG, ATCC, Genedata, Fitzgerald Industries International
    Segments Covered Type, End User
    Key Market Opportunities Increased biopharmaceutical production, Advancements in analytical technologies, Rising regulatory compliance requirements, growth in the biosimilars market, Expanding therapeutic applications of proteins
    Key Market Dynamics Increasing biopharmaceutical development, Rising regulatory requirements, Advancements in testing technologies, Growing focus on biosimilars, Increasing investments in R
    Countries Covered US

    FAQs

    What is the expected market size of the US Host Cell Protein Testing Market in 2024?

    The US Host Cell Protein Testing Market is expected to be valued at 222.0 million USD in 2024.

    What will the market size of the US Host Cell Protein Testing Market be by 2035?

    By 2035, the US Host Cell Protein Testing Market is anticipated to reach a value of 409.0 million USD.

    What is the expected CAGR for the US Host Cell Protein Testing Market from 2025 to 2035?

    The market is expected to grow at a CAGR of 5.712% from 2025 to 2035.

    Which type of assays is projected to dominate the US Host Cell Protein Testing Market in 2024?

    In 2024, PCR-Based Assays are projected to be valued at 76.0 million USD, establishing a significant presence in the market.

    What are the estimated revenues for ELISA-based Assays in 2035 in the US Host Cell Protein Testing Market?

    ELISA-based Assays are expected to generate revenues of 162.0 million USD by 2035.

    Which companies are considered major players in the US Host Cell Protein Testing Market?

    Key players in the market include Agilent Technologies, MilliporeSigma, Celerion, Eurofins Scientific, and BioRad Laboratories among others.

    What is the expected market size for Mass Spectrometry-Based Assays in 2024?

    The market size for Mass Spectrometry-Based Assays is estimated to be 41.0 million USD in 2024.

    What is projected for the Others category in the US Host Cell Protein Testing Market by 2035?

    The Others category is projected to reach a valuation of 34.0 million USD by 2035.

    What significant trends are contributing to the growth of the US Host Cell Protein Testing Market?

    Emerging trends include advancements in assay technology and increasing focus on biopharmaceutical development, driving market growth.

    Are there any challenges facing the US Host Cell Protein Testing Market?

    Challenges include the need for stringent regulatory compliance and the complexity of testing processes in the biopharmaceutical industry.

    What is the projected market size of the US Host Cell Protein Testing Market in 2024?

    The US Host Cell Protein Testing Market is expected to be valued at 220.8 million USD in 2024.

    What will be the projected market value of the US Host Cell Protein Testing Market by 2035?

    By 2035, the US Host Cell Protein Testing Market is projected to reach 372.64 million USD.

    What is the expected compound annual growth rate (CAGR) for the US Host Cell Protein Testing Market from 2025 to 2035?

    The market is expected to grow at a CAGR of 4.873% from 2025 to 2035.

    Which type of assays is expected to have the highest market value in 2024?

    PCR-Based Assays are anticipated to have the highest market value at 70.0 million USD in 2024.

    What will be the market value for Mass Spectrometry-Based Assays in 2035?

    The market value for Mass Spectrometry-Based Assays is projected to reach 90.0 million USD in 2035.

    Who are the key players in the US Host Cell Protein Testing Market?

    Major players in the market include companies like AB Sciex, BioRad Laboratories, Lonza, and Thermo Fisher Scientific.

    What is the expected market size for ELISA-based Assays in 2024?

    ELISA-based Assays are expected to have a market size of 65.0 million USD in 2024.

    How much is the Others segment expected to grow from 2024 to 2035?

    The Others segment is projected to grow from 30.8 million USD in 2024 to 52.64 million USD in 2035.

    What are the anticipated growth drivers for the US Host Cell Protein Testing Market?

    Growth drivers include the increasing demand for biopharmaceuticals and advancements in testing technologies.

    How does the market size vary between PCR-Based Assays and ELISA-based Assays in 2035?

    In 2035, PCR-Based Assays are expected to reach 120.0 million USD, while ELISA-based Assays will be valued at 110.0 million USD.

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