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    GMP Testing Market

    ID: MRFR/HC/20517-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    GMP Testing Market Research Report Information By Service Type (Product Validation Testing, Bioanalytical Services, Packaging and Shelf-Life Testing, And Other Service Types), By End-Use (Pharmaceutical and Biopharmaceutical Companies And Medical Devices Companies), And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2035

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    GMP Testing Market Infographic
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    GMP Testing Market Summary

    As per Market Research Future Analysis, the GMP Testing Market was valued at USD 2.00 Billion in 2024 and is projected to grow to USD 4.21 Billion by 2035, with a CAGR of 7.00% from 2025 to 2035. Key drivers include increasing focus on product safety and technological advancements in testing methodologies. The market is significantly influenced by rising consumer awareness regarding product quality and safety, particularly in the food and healthcare sectors. The pharmaceutical and biopharmaceutical industries are major contributors to market growth, driven by new drug developments and outsourcing trends. North America leads the market, followed by Europe and Asia-Pacific, with the latter expected to grow at the fastest rate during the forecast period.

    Key Market Trends & Highlights

    Key trends driving the GMP Testing Market include technological advancements and increasing consumer expectations.

    • GMP Testing Market Size in 2024: USD 2.00 Billion.
    • Projected Market Size by 2035: USD 4.21 Billion.
    • CAGR from 2025 to 2035: 7.00%.
    • North America held the largest market share in 2023.

    Market Size & Forecast

    2024 Market Size USD 2.00 Billion
    2035 Market Size USD 4.21 Billion
    CAGR (2024-2035) 7.00%

    Major Players

    Key players include Eurofins Scientific, PPD Inc., Microchem Laboratory, Sartorius AG, and Charles River Laboratories.

    GMP Testing Market Trends

    Increasing Consumer Awareness and Expectations Drive Market Growth

    One of the main factors propelling the market CAGR in the GMP testing market is the growing customer expectation and awareness. A significant shift in consumer behavior has resulted from the broad availability of digital technologies. Customers are also given information about the products they use, including information on the materials and the moral dilemmas surrounding their production. As a result of this growing awareness, standards for product efficacy, safety, and quality have increased, especially in sectors like food and healthcare.

    Moreover, buyers are increasingly prepared to pay more for goods that promise these characteristics, putting more pressure on producers to fulfil quality standards. GMP testing services give companies in such a market an authentic way to show their dedication to quality and safety. Purchase decisions may be influenced and trusted by third-party GMP certification. Increased consumer knowledge and expectations are, therefore, a key factor in the growth of the GMP testing services industry.

    Rapid technological improvements in analytical methodologies and equipment are also a major industry driver. Moreover, the development of cutting-edge technologies such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry, and Next-Generation Sequencing enables more precise, efficient, and thorough testing processes. These technologies enable a better understanding of product composition and potential contaminants, which is critical for assuring quality and safety. Furthermore, the use of this modern technology allows GMP testing services to deliver more exact and timely results.

    This efficiency shortens product development time and allows producers to detect and address any quality issues swiftly, lowering the risk of product recalls or legal action. Furthermore, organizations are increasingly relying on GMP testing services that use cutting-edge technology to achieve ever-increasing quality standards.

    According to the Food and Drug Administration (FDA) Drug Recall Statistics published in July 2021, roughly 1,279 medications are recalled each year worldwide, with 94% of FDA drug recalls occurring in the United States and 4% in Canada. The FDA issued 12,028 drug recalls in the United States between 2012 and 2021. It requires GMP testing of production plants and a guarantee of public safety before they may be marketed. Thus, driving the GMP Testing Market revenue.

    The increasing emphasis on regulatory compliance and quality assurance in the pharmaceutical and biotechnology sectors appears to drive the demand for GMP testing services, reflecting a broader commitment to patient safety and product integrity.

    U.S. Food and Drug Administration (FDA)

    GMP Testing Market Drivers

    Market Growth Projections

    The Global GMP Testing Market Industry is poised for substantial growth, with projections indicating a rise from 2 USD Billion in 2024 to 3.92 USD Billion by 2035. This growth trajectory reflects a compound annual growth rate (CAGR) of 6.31% from 2025 to 2035. The increasing emphasis on regulatory compliance, coupled with the rising demand for biopharmaceuticals and advancements in testing technologies, is likely to drive this expansion. As the industry evolves, stakeholders must adapt to changing market dynamics and invest in GMP testing services to remain competitive in a rapidly growing landscape.

    Regulatory Compliance Pressure

    The Global GMP Testing Market Industry is increasingly driven by stringent regulatory requirements imposed by health authorities worldwide. Regulatory bodies such as the FDA and EMA mandate rigorous testing protocols to ensure product safety and efficacy. This compliance pressure compels pharmaceutical and biotechnology companies to invest in GMP testing services, which are essential for maintaining market access. As a result, the market is projected to reach 2 USD Billion in 2024, reflecting the growing need for adherence to these regulations. Companies that fail to comply risk significant penalties and loss of reputation, further emphasizing the importance of GMP testing in the industry.

    Rising Demand for Biopharmaceuticals

    The Global GMP Testing Market Industry experiences substantial growth due to the rising demand for biopharmaceuticals. As the biopharmaceutical sector expands, the need for rigorous testing to ensure product quality and safety becomes paramount. Biologics, which often require complex manufacturing processes, necessitate comprehensive GMP testing to meet regulatory standards. This trend is expected to contribute to the market's growth, with projections indicating an increase to 3.92 USD Billion by 2035. The biopharmaceutical industry's expansion is likely to drive investments in GMP testing services, as companies seek to ensure compliance and maintain consumer trust.

    Increasing Focus on Quality Assurance

    Quality assurance remains a critical driver in the Global GMP Testing Market Industry. Companies are increasingly prioritizing quality management systems to ensure that their products meet the highest standards of safety and efficacy. This focus on quality is driven by consumer demand for reliable and safe products, as well as the need to comply with regulatory requirements. As organizations enhance their quality assurance practices, the demand for GMP testing services rises correspondingly. This trend is likely to sustain the market's growth, as companies recognize that robust quality assurance frameworks are essential for long-term success.

    Global Expansion of Pharmaceutical Markets

    The Global GMP Testing Market Industry is significantly influenced by the global expansion of pharmaceutical markets. Emerging economies are witnessing rapid growth in their pharmaceutical sectors, driven by increasing healthcare access and rising consumer awareness. As these markets expand, the demand for GMP testing services grows, as companies seek to ensure compliance with international standards. This trend is expected to bolster the market, with projections indicating a steady increase in demand for GMP testing services. The globalization of pharmaceutical operations necessitates adherence to GMP standards, further reinforcing the importance of testing in maintaining product integrity.

    Technological Advancements in Testing Methods

    Technological advancements play a pivotal role in shaping the Global GMP Testing Market Industry. Innovations such as automation, real-time monitoring, and advanced analytical techniques enhance the efficiency and accuracy of GMP testing processes. These developments not only streamline operations but also reduce the time required for testing, enabling companies to bring products to market more swiftly. As a result, organizations are increasingly adopting these technologies to remain competitive. The integration of cutting-edge technologies is expected to support the market's growth trajectory, aligning with the projected CAGR of 6.31% from 2025 to 2035.

    Market Segment Insights

    GMP Testing Service Type

    The GMP Testing Market segmentation, based on Service Type, includes product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. In 2023, the product validation testing segment dominated the global GMP Testing Service Market, and this trend is likely to continue over the forecast period. The segment's growth is being driven by increased demand for higher-quality and safer service management. In addition, the growing number of medicine production plants has an impact on market segment growth.

    The bioanalytical service sector is predicted to hold the biggest market share during the forecast period, owing to an increasing emphasis on the development of bioanalytical testing services, which is a key driver of market growth.

    GMP Testing End-use Insights

    The GMP Testing Market segmentation, based on End-use, includes Pharmaceutical and Biopharmaceutical Companies and Medical Devices Companies. Pharmaceutical and biopharmaceutical companies accounted for the vast majority of the worldwide market in 2023. The segment's growth is being driven by greater innovation and the introduction of new services.

    The pharmaceutical and biopharmaceutical industry segment is expected to expand during the forecast period, owing to biopharmaceutical companies' preference to outsource manufacturing in markets where they lack expertise at various stages of the value chain, particularly at the end, where CDMOs' presence in a specific region provides them with access to a vast distribution network as well as knowledge of existing regulatory guidelines.

    Get more detailed insights about GMP Testing Market

    Regional Insights

    By region, the study provides the market insights into North America, Europe, Asia-Pacific and the Rest of the World. North America dominated the GMP testing service market in 2023 and is likely to continue to do so during the forecast period. This was linked to the presence of large biotech and pharmaceutical companies in countries like the United States. Furthermore, the increased frequency of major pharmaceutical businesses and their R&D activities will fuel demand for GMP testing in the region throughout the projection period.

    Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

    Figure 2: GMP TESTING MARKET SHARE BY REGION 2023 (USD Billion)

    GMP Testing Market, by Service Type, 2023 & 2032

    Source: Secondary Research, Primary Research, Market Research Future Database and Analyst Review

    Europe GMP Testing Market accounts for the second-largest market share. The growing burden of chronic diseases is predicted to drive up demand for innovative pharmaceuticals, resulting in greater drug manufacturing activity and market growth. Further, the German GMP Testing Market held the largest market share, and the UK GMP Testing Market was the fastest-growing market in the European region.

    The Asia-Pacific GMP Testing Market is expected to grow at the fastest CAGR from 2024 to 2032. This is primarily due to an increase in the import and selling of pharmaceuticals prepared in accordance with internationally recognized GMP standards. Moreover, China’s GMP Testing Market held the largest market share, and the Indian GMP Testing Market was the fastest growing market in the Asia-Pacific region.

    Key Players and Competitive Insights

    Leading market players are investing heavily in research and development in order to expand their product lines, which will help the GMP Testing Market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, GMP Testing industry must offer cost-effective items.

    Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global GMP Testing industry to benefit clients and increase the market sector. In recent years, the GMP Testing industry has offered some of the most significant advantages to medicine. Major players in the GMP Testing Market, including Eurofins Scientific, PPD Inc., Microchem Laboratory, Sartorius AG, North American Science Associates Inc. and others, are attempting to increase market demand by investing in research and development operations.

    Eurofins Scientific SE is a French laboratory organization with headquarters in Luxembourg that provides testing and support services to the pharmaceutical, food, environmental, agriscience, and consumer products industries, as well as governments. Eurofins Group offers an international network of over 900 laboratories in 62 countries, as well as a portfolio of more than 200,000 certified analytical procedures for determining the safety, identification, purity, composition, authenticity, and provenance of goods and biological substances. Eurofins also offers clinical diagnostic testing services and in vitro diagnostic products.

    In December 2021, Eurofins announced that the Biopharma product testing network of laboratories has expanded its footprint of GMP testing laboratories with the recent acquisition of Astellas Analytical Science Laboratories, Inc. With this acquisition, ASL developed Eurofins, Japan's first good manufacturing practice (GMP) testing center.

    Charles River Laboratories International, Inc. is an American pharmaceutical firm that provides a wide range of preclinical and clinical laboratory, gene therapy, and cell therapy services to the pharmaceutical, medical device, and biotechnology sectors. It also provides a variety of biomedical products, outsourcing services, and animals for pharmaceutical research and development (such as contract research organization services), as well as assistance in the fields of basic research, drug discovery, safety and efficacy, clinical support, and manufacturing. In August 2023, Charles River Laboratories International Inc. partnered with Fondazione Telethon to produce high-quality (HQ) plasmids.

    Key Companies in the GMP Testing Market market include

    Industry Developments

    In March 2022, Thermo Fisher Scientific, the world leader in science service, announced the extension of its capabilities from development to commercial manufacturing in France. The early development hub features a 430-square-meter (4,600-square-foot) research and development facility for preclinical non-GMP operations, as well as expanded good manufacturing practices (GMP) capabilities.

    In April 2021, PPD Inc., a renowned global contract research organization, announced plans to expand its Good Manufacturing Practice facility in Ireland to improve biopharmaceutical testing capabilities.

    In September 2020, Almac Group expanded its analytical services portfolio to include biologics testing solutions. To aid customers' drug substance and drug product programs for new biologics and biosimilars, the company announced that its services would now include GMP lot release and stability services.

    Future Outlook

    GMP Testing Market Future Outlook

    The Global GMP Testing Market is projected to grow at a 7.00% CAGR from 2025 to 2035, driven by increasing regulatory demands, technological advancements, and rising biopharmaceutical production.

    New opportunities lie in:

    • Invest in automation technologies to enhance testing efficiency and reduce operational costs. Develop specialized testing services for emerging biopharmaceuticals and personalized medicine. Expand into emerging markets with tailored GMP testing solutions to capture new customer segments.

    By 2035, the Global GMP Testing Market is expected to be robust, reflecting substantial growth and innovation.

    Market Segmentation

    Outlook

    • Pharmaceutical and Biopharmaceutical Companies
    • Medical Devices Companies

    GMP Testing Regional Outlook

    • US
    • Canada
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
    • Middle East
    • Africa
    • Latin America

     GMP Testing By End-use Outlook

    • Pharmaceutical and Biopharmaceutical Companies
    • Medical Devices Companies

    GMP Testing By Service Type Outlook

    • Product Validation Testing
    • Bioanalytical Services
    • Packaging and Shelf-Life Testing
    • Other Service Types

    Report Scope

    Market Size 2024USD 2.0 Billion
    Market Size 20354.21 (Value (USD Billion))
    Compound Annual Growth Rate (CAGR)7.00% (2025 - 2035)
    Base Year2024
    Market Forecast Period2025 - 2035
    Historical Data2019-2022
    Market Forecast UnitsValue (USD Billion)
    Report CoverageRevenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments CoveredService Type, End-use, and Region
    Geographies CoveredNorth America, Europe, Asia Pacific, and the Rest of the World
    Countries CoveredThe US, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil
    Key Companies Profiled Eurofins Scientific, PPD Inc., Microchem Laboratory, Sartorius AG, North American Science Associates Inc., Laboratory Corporation of America Holdings (Covance Inc.), Sotera Health (Nelson Laboratories LLC), Almac Group, Pace Analytical, Wuxi AppTec, Intertek Group PLC, Charles River Laboratories
    Key Market Opportunities·         The growing complexity of manufacturing processes will fuel the demand for GMP testing services.
    Key Market Dynamics·         Development of biosimilars
    Market Size 20252.14 (Value (USD Billion))

    FAQs

    What is the projected growth of the GMP Testing market?

    The GMP Testing market is the expected increase in total market value of 4.21 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

    What is the size of the GMP Testing market?

    GMP Testing market size was valued at approximately 2 billion USD in 2024. This figure will reach 4.21 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

    What is the CAGR of the GMP Testing market?

    GMP Testing market is expected to grow at a CAGR of 7% between 2025 and 2035.

    How much will the GMP Testing market be worth by 2035?

    GMP Testing market is expected to be worth of 4.21 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the GMP Testing market perform over the next 10 years?

    Over the next 10 years the GMP Testing market is expected to shift from usd billion 2 to 4.21 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

    Which region held the largest market share in the GMP Testing Market?

    North America had the largest share in the global market

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