Biological Safety Testing Products & Services Market Analysis by Product (Reagents, Instruments), by Application (Blood-Based, Vaccines, Tissue-Based, Gene Therapy, Stem Cell), by Test-Type (Sterility, Endotoxin, Cell Line Authentication), and by Region - Forecast to 2029

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The global biological safety testing products & services market size is estimated to be USD 3,710.4 million in 2021 and is expected to witness a CAGR of 14.56% during the forecast period. Rising manufacturing of novel biologics by biopharmaceutical and biotechnology companies is a key driver for the growth of the global biological safety testing products & services market. Additionally, increasing prevalence of target diseases, cross-infection cases during the COVID-19 pandemic, stringent safety regulation enforcement by governing bodies, and growing demand for biologics for the treatment of chronic diseases are some of the other drivers propelling the market growth. However, lengthy product approval process and ambulatory regulatory framework are expected to restrain the global market growth.

Global Biological Safety Testing Products & Services Market Size (USD Million), 2021-2029

Source: Erevna Healthcare

By Product

Based on product, the market is categorized into reagents & kits, instruments, and services. In 2021, reagents and kits accounted for the largest revenue share due to repurchase and frequent use of reagents and kits for diagnostics and clinical research purposes, worldwide. The instrument segment is anticipated to grow at the fastest CAGR during the forecast period, due to the increasing need for biological safety in testing laboratories and growing demand for contamination-free biologic products.

By Application

Based on application, the market is segmented into blood & blood-based products, vaccines & therapeutics, tissue & tissue-based products, gene therapy, and stem cell. In 2021, the vaccines & therapeutics segment accounted for a significant revenue share and is expected to grow with a lucrative CAGR during the forecast period. This can be attributed to the increasing research of biologic and their application for disease prevention coupled with the need for novel vaccines worldwide. Gene therapy segment is projected to grow at a profitable CAGR during the forecast period. This is attributed to the rising technological advancement by biopharmaceutical companies in the field of gene therapy application.

By Test Type

Based on test-type, the market is categorized into sterility tests, endotoxin tests, cell line authentication & characterization tests, adventitious agent detection tests, bioburden tests, and residual host contamination detection tests, and others. The endotoxin tests segment accounted for the highest revenue in 2021 and is projected to maintain its dominance over the forecast period. The availability of endotoxin tests due to the increasing application in multiple research areas is a key factor that drives the segment growth.

Regional Insights

In 2021, North America accounted for the highest revenue share in the global market and is expected to maintain its dominance during the forecast period. This is attributed to the high investments in R&D, presence of leading clinical diagnostics companies, and stringent regulatory framework for product quality standards in this region. Asia Pacific market is projected to exhibit the fastest CAGR over the forecast period owing to the rising medical expenditure, increasing demand for advanced medication and treatment, and operational expansion by biopharmaceutical companies in this region.

Competitor Insights

Some of the key players in the biological safety testing products & services market are Toyobo Co., Ltd. (Japan); Charles River Laboratories, Inc., (U.S.); Lonza Group (Switzerland); Avance Biosciences, Inc. (U.S.); BSL BIOSERVICE Scientific Laboratories Munich GmbH (Germany); SGS S.A. (Switzerland); WuXi Biologics (China); Toxikon Corporation (U.S.); Shenzhen Hepalink Pharmaceutical Co., Ltd., (China); Sartorius Stedim BioOutsource Ltd. (U.K.) and Merck KGaA (Germany). The leading players operating in the biological safety testing products & services industry are adopting various strategies including R&D investments, adoption of advanced techniques, mergers & acquisitions, and regional expansions to capture a maximum revenue share.

This exhaustive research report focuses on market size and forecast at global, segmental, regional and country level along with key market trends and dynamics from 2021 to 2029. The biological safety testing products & services market report is categorized into the following segments and subsegments:

Biological Safety Testing Products & Services Market, By Product (Revenue, USD Million, 2021 – 2029)

  • Reagents & Kits
  • Instruments
  • Services

Biological Safety Testing Products & Services Market, By Application (Revenue, USD Million, 2021 – 2029)

  • Blood & Blood-based Products
  • Vaccines & Therapeutics
  • Tissue & Tissue-based Products
  • Gene Therapy
  • Stem Cell

Biological Safety Testing Products & Services Market, By Test-Type (Revenue, USD Million, 2021 – 2029)

  • Sterility Tests
  • Endotoxin Tests
  • Cell Line Authentication & Characterization Tests
  • Adventitious Agent Detection Tests
  • Bioburden Tests
  • Residual Host Contamination Detection Tests
  • Others

Biological Safety Testing Products & Services Market, By Region (Revenue, USD Million, 2021 – 2029)

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • France
    • UK
    • Spain
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of APAC
  • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Rest of LATAM
  • Middle East & Africa
    • South Africa
    • Saudi Arabia

Scope of Biological Safety Testing Products & Services Market Report:

Key Parameters Details
Base Year
  • 2021
Forecast Period
  • 2022-2029
Study Coverage
  • Global and regional market size and revenue forecast
  • Segment market size and revenue forecast at global, regional, and country level
  • Competitive landscape (company share analysis, company profiles, recent development, competitive map analysis)
  • Conclusion and recommendations
Qualitative Analysis
  • Market drivers
  • Market restraints
  • Market opportunities
  • Recent market trends
  • Market challenges
  • Porter’s Five Forces analysis
  • PEST analysis
  • Value-chain analysis
  • COVID-19 impact analysis
Regional Market Scope
  • North America (U.S. and Canada)
  • Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
  • Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
  • Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
  • MEA (South Africa, GCC, Rest of MEA)
Company Profiles
  • Exhaustive profiles of top 15 players
  • 50+ other major players listing
15% Free Customization Available
  • You can customize the study scope to meet your exact requirement. Click here for more details

Table of Contents: Biological testing products and services Market 2020-2031

  1. Research Methodology
    1. Study Objectives
    2. Study Scope
    3. Research Assumptions
    4. Research Framework
      1. Research Models
        1. Bottom-up Approach
        2. Top-down Approach
        3. Data Triangulation
      2. Data Procurement
        1. Internal Database
        2. Secondary Research
        3. Purchased Database
        4. Primary Research
      3. Data Analysis
        1. Data Validation
        2. Market Size Estimation
        3. Market Forecast Model
      4. Quality Assessment
  1. Introduction: Biological testing products and services
  2. Executive Summary
    1. Global Market Scenario
    2. Segment Market Scenario
    3. Geographic Market Scenario
    4. COVID-19 Impact
    5. Competitive Landscape
  3. Market Dynamics
    1. Market Drivers
      1. Rising problems about cell culture contamination
      2. Incresing R&D and funding in biopharma
      3. increased emergence of new-generation biologics by major pharmaceutical and biotechnology firms
  1. Market Restraint
    1. Lack of qualified professionals
    2. Lack of awareness regarding products and services
  2. Market Opportunities
    1. Market growth opportunities in developing countries
    2. Introduction of new drugs in the market
    3. Growing investment in R&D activities for new product development
  3. Market Trends
    1. Market growth opportunities in developing countries
    2. Introduction of new drugs in the market
    3. Growing investment in R&D activities for new product development
  4. Market Challenges
    1. Market growth opportunities in developing countries
    2. Introduction of new drugs in the market
    3. Growing investment in R&D activities for new product development
  1. Market Environment Analysis
    1. Porter’s 5 Forces Analysis
    2. PESTEL Analysis
    3. Value Chain Analysis
    4. SWOT Analysis
    5. Benchmark
  2. COVID-19 Impact Analysis: Biological testing products and services Market
    1. COVID-19: Overview
    2. COVID-19 Impact on the Global Market
    3. COVID-19 Impact on the Regional Markets
  3. Market Analysis by Product
    1. Services
      1. Services Market Forecast, 2020-2031 (USD Million)
    2. Reagents & Kits
      1. Reagents & Kits Market Forecast, 2020-2031 (USD Million)
    3. Instruments
      1. Instruments Market Forecast, 2020-2031 (USD Million)
  1. Market Analysis by Application
    1. Gene Therapy
      1. Gene Therapy Market Forecast, 2020-2031 (USD Million)
    2. Vaccines & Therapeutics
      1. Vaccines & Therapeutics Market Forecast, 2020-2031 (USD Million)
    3. Stem Cell
      1. Stem Cell Market Forecast, 2020-2031 (USD Million)
    4. Tissue & tissue-based products
      1. Tissue & tissue-based products Market Forecast, 2020-2031 (USD Million)
  1. Market Analysis by Test type
    1. Sterility tests
      1. Sterility tests Market Forecast, 2020-2031 (USD Million)
    2. Endotoxin tests
      1. Endotoxin tests Market Forecast, 2020-2031 (USD Million)
    3. Residual host contamination detection tests
      1. Residual host contamination detection tests Market Forecast, 2020-2031 (USD Million)
    4. Adventitious agent detection tests
      1. Adventitious agent detection tests Market Forecast, 2020-2031 (USD Million)
    5. Bioburden tests
      1. Bioburden tests Market Forecast, 2020-2031 (USD Million)
  1. Regional Market Analysis
    1. Regional Market Trends
    2. Regional Market: Comparative Analysis
  2. North America Biological testing products and services Market
    1. North America Biological testing products and services Market
      1. North America Market Size and Forecast, 2020-2031 (USD Million)
        1. Market Size and Forecast by Product, 2020-2031 (USD Million)
        2. Market Size and Forecast by Application, 2020-2031 (USD Million)
        3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
      2. S. Biological testing products and services Market
        1. S. Market Size and Forecast, 2020-2031 (USD Million)
          1. Market Size and Forecast by Product, 2020-2031 (USD Million)
          2. Market Size and Forecast by Application, 2020-2031 (USD Million)
          3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
        2. Canada Biological testing products and services Market
          1. Canada Market Size and Forecast, 2020-2031 (USD Million)
            1. Market Size and Forecast by Product, 2020-2031 (USD Million)
            2. Market Size and Forecast by Application, 2020-2031 (USD Million)
            3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
  1. Europe Biological testing products and services Market
    1. Europe Biological testing products and services Market
      1. Europe Market Size and Forecast, 2020-2031 (USD Million)
        1. Market Size and Forecast by Product, 2020-2031 (USD Million)
        2. Market Size and Forecast by Application, 2020-2031 (USD Million)
        3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
      2. Germany Biological testing products and services Market
        1. Germany Market Size and Forecast, 2020-2031 (USD Million)
          1. Market Size and Forecast by Product, 2020-2031 (USD Million)
          2. Market Size and Forecast by Application, 2020-2031 (USD Million)
          3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
        2. UK Biological testing products and services Market
          1. UK Market Size and Forecast, 2020-2031 (USD Million)
            1. Market Size and Forecast by Product, 2020-2031 (USD Million)
            2. Market Size and Forecast by Application, 2020-2031 (USD Million)
            3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
          2. France Biological testing products and services Market
            1. France Market Size and Forecast, 2020-2031 (USD Million)
              1. Market Size and Forecast by Product, 2020-2031 (USD Million)
              2. Market Size and Forecast by Application, 2020-2031 (USD Million)
              3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
            2. Spain Biological testing products and services Market
              1. Spain Market Size and Forecast, 2020-2031 (USD Million)
                1. Market Size and Forecast by Product, 2020-2031 (USD Million)
                2. Market Size and Forecast by Application, 2020-2031 (USD Million)
                3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
              2. Italy Biological testing products and services Market
                1. Italy Market Size and Forecast, 2020-2031 (USD Million)
                  1. Market Size and Forecast by Product, 2020-2031 (USD Million)
                  2. Market Size and Forecast by Application, 2020-2031 (USD Million)
                  3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
                2. Rest of Europe Biological testing products and services Market
                  1. Rest of Europe Market Size and Forecast, 2020-2031 (USD Million)
                    1. Market Size and Forecast by Product, 2020-2031 (USD Million)
                    2. Market Size and Forecast by Application, 2020-2031 (USD Million)
                    3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
  1. Asia Pacific Biological testing products and services Market
    1. Asia Pacific Biological testing products and services Market
      1. Asia Pacific Market Size and Forecast, 2020-2031 (USD Million)
        1. Market Size and Forecast by Product, 2020-2031 (USD Million)
        2. Market Size and Forecast by Application, 2020-2031 (USD Million)
        3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
      2. Japan Biological testing products and services Market
        1. Japan Market Size and Forecast, 2020-2031 (USD Million)
          1. Market Size and Forecast by Product, 2020-2031 (USD Million)
          2. Market Size and Forecast by Application, 2020-2031 (USD Million)
          3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
        2. China Biological testing products and services Market
          1. China Market Size and Forecast, 2020-2031 (USD Million)
            1. Market Size and Forecast by Product, 2020-2031 (USD Million)
            2. Market Size and Forecast by Application, 2020-2031 (USD Million)
            3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
          2. India Biological testing products and services Market
            1. India Market Size and Forecast, 2020-2031 (USD Million)
              1. Market Size and Forecast by Product, 2020-2031 (USD Million)
              2. Market Size and Forecast by Application, 2020-2031 (USD Million)
              3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
            2. South Korea Biological testing products and services Market
              1. South Korea Market Size and Forecast, 2020-2031 (USD Million)
                1. Market Size and Forecast by Product, 2020-2031 (USD Million)
                2. Market Size and Forecast by Application, 2020-2031 (USD Million)
                3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
              2. Australia Biological testing products and servicesMarket
                1. Australia Market Size and Forecast, 2020-2031 (USD Million)
                  1. Market Size and Forecast by Product, 2020-2031 (USD Million)
                  2. Market Size and Forecast by Application, 2020-2031 (USD Million)
                  3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
                2. Rest of Asia Pacific Biological testing products and services Market
                  1. Rest of Asia Pacific Market Size and Forecast, 2020-2031 (USD Million)
                    1. Market Size and Forecast by Product, 2020-2031 (USD Million)
                    2. Market Size and Forecast by Application, 2020-2031 (USD Million)
                    3. Market Size and Forecast by Test Typel, 2020-2031 (USD Million)
  1. Latin America Biological testing products and services Market
    1. Latin America Biological testing products and services Market
      1. Latin America Market Size and Forecast, 2020-2031 (USD Million)
        1. Market Size and Forecast by Product, 2020-2031 (USD Million)
        2. Market Size and Forecast by Application, 2020-2031 (USD Million)
        3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
      2. Brazil Biological testing products and services Market
        1. Brazil Market Size and Forecast, 2020-2031 (USD Million)
          1. Market Size and Forecast by Product, 2020-2031 (USD Million)
          2. Market Size and Forecast by Application, 2020-2031 (USD Million)
          3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
        2. Mexico Biological testing products and services Market
          1. Mexico Market Size and Forecast, 2020-2031 (USD Million)
            1. Market Size and Forecast by Product, 2020-2031 (USD Million)
            2. Market Size and Forecast by Application, 2020-2031 (USD Million)
            3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
          2. Argentina Biological testing products and services Market
            1. Argentina Market Size and Forecast, 2020-2031 (USD Million)
              1. Market Size and Forecast by Product, 2020-2031 (USD Million)
              2. Market Size and Forecast by Application, 2020-2031 (USD Million)
              3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
            2. Rest of Latin America Biological testing products and services Market
              1. Rest of Latin America Market Size and Forecast, 2020-2031 (USD Million)
                1. Market Size and Forecast by Product, 2020-2031 (USD Million)
                2. Market Size and Forecast by Application, 2020-2031 (USD Million)
                3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
  1. MEA Biological testing products and services Market
    1. MEA Biological testing products and services Market
      1. MEA Market Size and Forecast, 2020-2031 (USD Million)
        1. Market Size and Forecast by Product, 2020-2031 (USD Million)
        2. Market Size and Forecast by Application, 2020-2031 (USD Million)
        3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
      2. GCC Biological testing products and services Market
        1. GCC Market Size and Forecast, 2020-2031 (USD Million)
          1. Market Size and Forecast by Product, 2020-2031 (USD Million)
          2. Market Size and Forecast by Application, 2020-2031 (USD Million)
          3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
        2. South Africa Biological testing products and services Market
          1. South Africa Market Size and Forecast, 2020-2031 (USD Million)
            1. Market Size and Forecast by Product, 2020-2031 (USD Million)
            2. Market Size and Forecast by Application, 2020-2031 (USD Million)
            3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
          2. Rest of MEA Biological testing products and services Market
            1. Rest of MEA Market Size and Forecast, 2020-2031 (USD Million)
              1. Market Size and Forecast by Product, 2020-2031 (USD Million)
              2. Market Size and Forecast by Application, 2020-2031 (USD Million)
              3. Market Size and Forecast by Test Type, 2020-2031 (USD Million)
  1. Competitor Analysis
    1. Market Share Analysis, 2020 & 2031
    2. Competitive Mapping
    3. Key Players Market Place Analysis
    4. Major Recent Developments
  2. Company Profiles
    1. Maravai Lifesciences (US)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    2. Associates of Cape Cod, Inc. (US)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    3. bioMérieux SA (France)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    4. Sartorius AG (Germany)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    5. Hoffmann-La Roche Ltd. (Switzerland)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    6. Nelson Laboratories, LLC (US)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    7. Bio-Rad Laboratories, Inc. (US)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    8. QIAGEN (Germany)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    9. Agilent Technologies, Inc. (US)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments
    10. Pacific BioLabs (US)
      1. Company Snapshot
      2. Company Overview
      3. Financials
      4. Product Benchmarking
      5. Recent Developments

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