Global Biologics Safety Testing Market Growth, Share, Size, Trends and Forecast (2024 - 2030)

By Product and Service;

Kits & Reagents , Services, and Instruments.

By Test Type;

Endotoxin Tests , Sterility Tests , Cell Line Authentication and Characterization Tests , Bioburden Tests , Residual Host Contaminant Detection Tests , Adventitious Agent Detection Tests, and Others.

By Application;

Vaccine & Therapeutics Development , Blood and Blood-Related Products Testing , Cellular and Gene Therapy , Tissue and Tissue-Related Products Testing, and Stem Cell Research.

By Geography;

North America, Europe, Asia Pacific, Middle East and Africa, and Latin America - Report Timeline (2020 - 2030).
Report ID: Rn643689879 Published Date: May, 2024 Updated Date: June, 2024


Global Biologics Safety Testing Market (USD Million), 2020 - 2030

In the year 2023, the Global Biologics Safety Testing Market was valued at USD 5,659.86 million. The size of this market is expected to increase to USD 11,750.78 million by the year 2030, while growing biologics market size at a Compounded Annual Growth Rate (CAGR) of 11.0%.

The global biologics safety testing market stands at the forefront of ensuring the safety, efficacy, and quality of biopharmaceutical products critical for human health. As the biologics sector continues to expand rapidly, driven by advancements in biotechnology and an increasing number of biologics entering the market, the demand for robust safety testing procedures has never been greater. Biologics, which include vaccines, monoclonal antibodies, gene therapies, and cell-based therapies, present unique challenges compared to traditional small molecule drugs, necessitating specialized testing protocols to assess their safety profile comprehensively.

In this dynamic landscape, the biologics safety testing market encompasses a broad spectrum of testing services and technologies aimed at detecting and mitigating potential risks associated with biopharmaceutical products. From assessing the purity and potency of raw materials to evaluating the safety and efficacy of final drug products, biologics safety testing plays a critical role in ensuring regulatory compliance and safeguarding public health. Moreover, with the emergence of novel biologic modalities and personalized medicine approaches, there is a growing need for innovative testing solutions capable of addressing evolving regulatory requirements and technological advancements.

Amidst the opportunities presented by the expanding biologics market, challenges such as stringent regulatory scrutiny, complex manufacturing processes, and the need for specialized expertise pose significant hurdles for stakeholders in the biologics safety testing industry. Regulatory agencies worldwide impose stringent requirements for biologics safety testing to mitigate the risks of contamination, immunogenicity, and adverse effects associated with biopharmaceutical products. Consequently, manufacturers and testing laboratories must invest in state-of-the-art facilities, validated methodologies, and highly skilled personnel to ensure compliance with regulatory standards and maintain the integrity of the biologics supply chain. As the biologics safety testing market continues to evolve in tandem with advances in biotechnology and regulatory frameworks, stakeholders must navigate these challenges adeptly to capitalize on emerging opportunities and contribute to the advancement of biopharmaceutical innovation and patient care.

  1. Introduction
    1. Research Objectives and Assumptions
    2. Research Methodology
    3. Abbreviations
  2. Market Definition & Study Scope
  3. Executive Summary
    1. Market Snapshot, By Product and Service
    2. Market Snapshot, By Test Type
    3. Market Snapshot, By Application
    4. Market Snapshot, By Region
  4. Global Biologics Safety Testing Market Dynamics
    1. Drivers, Restraints and Opportunities
      1. Drivers
        1. Positive Trend of R&D Investments in Life Science
        2. Increase in Number of Drug Launches
        3. High Incidence and Large Economic Burden of Chronic Diseases
        4. Growing Adoption of Biologic Therapies
      2. Restraints
        1. High Cost of Testing
        2. Ethical and Legal Considerations
        3. Limited Availability of Skilled Workforce
      3. Opportunities
        1. Outsourcing Trends
        2. Increasing Demand for Biologics
    2. PEST Analysis
      1. Political Analysis
      2. Economic Analysis
      3. Social Analysis
      4. Technological Analysis
    3. Porter's Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of Substitutes
      4. Threat of New Entrants
      5. Competitive Rivalry
  5. Market Segmentation
    1. Global Biologics Safety Testing Market,By Product and Service, 2020 - 2030 (USD Million)
      1. Kits & Reagents
      2. Services
      3. Instruments
    2. Global Biologics Safety Testing Market, By Test Type, 2020 - 2030 (USD Million)
      1. Endotoxin Tests
      2. Sterility Tests
      3. Cell Line Authentication and Characterization Tests
      4. Bioburden Tests
      5. Residual Host Contaminant Detection Tests
      6. Adventitious Agent Detection Tests
      7. Others
    3. Global Biologics Safety Testing Market, By Application, 2020 - 2030 (USD Million)
      1. Vaccine & Therapeutics Development
      2. Blood and Blood-Related Products Testing
      3. Cellular and Gene Therapy
      4. Tissue and Tissue-Related Products Testing
      5. Stem Cell Research
    4. Global Biologics Safety Testing Market, By Geography, 2020 - 2030 (USD Million)
      1. North America
        1. United States
        2. Canada
      2. Europe
        1. Germany
        2. United Kingdom
        3. France
        4. Italy
        5. Spain
        6. Nordic
        7. Benelux
        8. Rest of Europe
      3. Asia Pacific
        1. Japan
        2. China
        3. India
        4. Australia & New Zealand
        5. South Korea
        6. ASEAN (Association of South East Asian Countries)
        7. Rest of Asia Pacific
      4. Middle East & Africa
        1. GCC
        2. Israel
        3. South Africa
        4. Rest of Middle East & Africa
      5. Latin America
        1. Brazil
        2. Mexico
        3. Argentina
        4. Rest of Latin America
  6. Competitive Landscape
    1. Company Profiles
      1. Charles River Laboratories International, Inc.
      2. Merck KGaA
      3. Lonza Group Ltd.
      4. SGS S.A.
      5. Thermo Fisher Scientific Inc.
      6. Wuxi Apptec
      7. Sartorius AG
      8. Cytovance Biologics, Inc.
      9. Pace Analytical Services Inc.
      10. Toxikon Corporation
      11. Eurofins Scientific Se
      12. Avance Biosciences Inc.
      13. Source Bioscience
  7. Analyst Views
  8. Future Outlook of the Market