Biological Safety Testing Market Key Vendors, Trends and Forecast by 2031

Historic Data: 2021-2023   |   Base Year: 2024   |   Forecast Period: 2025-2031

Coverage: Biological Safety Testing Market covers analysis by Product (Reagents and Kits, Instruments, Services); Application (Stem Cell, Tissue and Tissue-Based Products, Gene Therapy, Blood and Blood-Based Therapy, Vaccines and Therapeutics); Test Type (Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Endotoxin Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests, Others) , and Geography (North America, Europe, Asia Pacific, and South and Central America)

  • Report Date : Aug 2025
  • Report Code : TIPRE00004475
  • Category : Life Sciences
  • Status : Upcoming
  • Available Report Formats : pdf-format excel-format
  • No. of Pages : 150

MARKET INTRODUCTION


Biological safety testing refers to bio-analytical tests performed by pharmaceutical and biotechnology companies or contract research organizations for pharmaceutical manufacturing/packaging arena and can involve multiple disciplines such as pharmacology, toxicology, microbiology and others. These test procedures majorly focuses on the safety of the material from raw material stage, to intermediate to final products.

MARKET DYNAMICS


The biological safety tests market is anticipated to grow in the forecast, owing to rising production of new generation biologics and rising prevalence of target diseases. In addition, the opportunities from developing economies is expected to offer significant growth opportunities in the market during the forecast period.

MARKET SCOPE


The "Global Biological Safety Tests Market Analysis to 2031" is a specialized and in-depth study of the biotechnology industry with a special focus on the global market trend analysis. The report aims to provide an overview of biological safety tests market with detailed market segmentation by product, application, test type and geography. The global biological safety tests market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading biological safety tests market players and offers key trends and opportunities in the market.

MARKET SEGMENTATION


The global biological safety tests market is segmented on the basis of product, application, and test type. Based on product, the market is segmented as, reagents and kits, instruments, services. Based on application, the market is segmented in to stem cell, tissue and tissue-based products, gene therapy, blood and blood-based therapy, vaccines and therapeutics. On the basis of test type, the biological safety tests market is categorized as per, sterility tests, cell line authentication and characterization tests, bio-burden tests, endotoxin tests, adventitious agent detection tests, residual host contamination detection tests, and others.

  • This FREE sample will include data analysis, ranging from market trends to estimates and forecasts.

REGIONAL FRAMEWORK


The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global biological safety tests market based on various segments. It also provides market size and forecast estimates from year 2021 to 2031 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. The biological safety tests market by each region is later sub-segmented by respective countries and segments. The report covers analysis and forecast of 18 countries globally along with current trend and opportunities prevailing in the region.

The report analyzes factors affecting biological safety tests market from both demand and supply side and further evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA and South & Central America after evaluating political, economic, social and technological factors effecting the biological safety tests market in these regions.

  • This FREE sample will include data analysis, ranging from market trends to estimates and forecasts.

MARKET PLAYERS


The reports cover key developments in the biological safety tests market as organic and inorganic growth strategies. Various companies are focusing on organic growth strategies such as product launches, product approvals and others such as patents and events. Inorganic growth strategies activities witnessed in the market were acquisitions, and partnership & collaborations. These activities have paved way for expansion of business and customer base of market players. The market payers from biological safety tests market are anticipated to lucrative growth opportunities in the future with the rising demand for biological safety tests market in the global market. Below mentioned is the list of few companies engaged in the biological safety tests market.

The report also includes the profiles of key biological safety tests market companies along with their SWOT analysis and market strategies. In addition, the report focuses on leading industry players with information such as company profiles, components and services offered, financial information of last 3 years, key development in past five years.
  •  Charles River
  •  Lonza
  •  BSL Bioservice
  •  Cytovance Biologics
  •  Merck KGaA
  •  SGS S.A.
  •  Toxikon, Inc.
  •  Wuxi Pharmatech (Cayman) Inc.
  •  Avance Biosciences, Inc.
  •  Paragon Bioservices, Inc.
The Insight Partner's dedicated research and analysis team consist of experienced professionals with advanced statistical expertise and offer various customization options in the existing study.
  • This FREE sample will include data analysis, ranging from market trends to estimates and forecasts.

Biological Safety Testing Report Scope

Report Attribute Details
Market size in 2024 US$ XX million
Market Size by 2031 US$ XX Million
Global CAGR (2025 - 2031) XX%
Historical Data 2021-2023
Forecast period 2025-2031
Segments Covered By Product
  • Reagents and Kits
  • Instruments
  • Services
By Application
  • Stem Cell
  • Tissue and Tissue-Based Products
  • Gene Therapy
  • Blood and Blood-Based Therapy
  • Vaccines and Therapeutics
By Test Type
  • Sterility Tests
  • Cell Line Authentication and Characterization Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Adventitious Agent Detection Tests
  • Residual Host Contamination Detection Tests
Regions and Countries Covered North America
  • US
  • Canada
  • Mexico
Europe
  • UK
  • Germany
  • France
  • Russia
  • Italy
  • Rest of Europe
Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
South and Central America
  • Brazil
  • Argentina
  • Rest of South and Central America
Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa
Market leaders and key company profiles
  • Charles River
  • Lonza
  • BSL Bioservice
  • Cytovance Biologics
  • Merck KGaA
  • SGS S. A.
  • Toxikon, Inc.
  • Wuxi Pharmatech (Cayman) Inc.
  • Avance Biosciences, Inc.
  • Mrinal Kerhalkar
    Mrinal Kerhalkar
    Manager,
    Market Research & Consulting

    Mrinal is a seasoned research analyst with over 8 years of experience in Life Sciences Market Intelligence and Consulting. With a strategic mindset and unwavering commitment to excellence, she has built deep expertise in pharmaceutical forecasting, market opportunity assessment, and developing industry benchmarks. Her work is anchored in delivering actionable insights that empower clients to make informed strategic decisions.

    Mrinal’s core strength lies in translating complex quantitative datasets into meaningful business intelligence. Her analytical acumen is instrumental in shaping go-to-market (GTM) strategies and uncovering growth opportunities across the pharmaceutical and medical device sectors. As a trusted consultant, she consistently focuses on streamlining workflow processes and establishing best practices, thereby driving innovation and operational efficiency for her clients.

    • Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
    • PEST and SWOT Analysis
    • Market Size Value / Volume - Global, Regional, Country
    • Industry and Competitive Landscape
    • Excel Dataset

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    Our Clients
    The List of Companies

    1. Charles River
    2. Lonza
    3. BSL Bioservice
    4. Cytovance Biologics
    5. Merck KGaA
    6. SGS S. A.
    7. Toxikon, Inc.
    8. Wuxi Pharmatech (Cayman) Inc.
    9. Avance Biosciences, Inc.
    10. Paragon Bioservices, Inc.
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