Overview


According to FutureWise analysis the market for biologics safety testing in 2023 is US$ 4.08 billion, and is expected to reach US$ 11.18 billion by 2031 at a CAGR of 13.4%.

FutureWise Market Research has included an in-depth analysis in the Global Biologics Safety Testing Market. It offers an extensive summary of global biologics safety testing market trends affecting the proliferation of the market. Furthermore, this report includes profitability graph and regional augmentation, key insights pertaining to the global market share and SWOT analysis of this business. Furthermore, the report illustrates the status of key market players in the competitive landscape of the market, while simultaneously expanding their corporate strategies and product provisions.

The market is predicted to attain substantial growth over the forecast period as per the research study. The report further explains that this business is projected to register a noteworthy growth rate over the forecast timeframe. This report also includes instrumental insights regarding the overall valuation currently held by this industry and it lists the segmentation of the global biologics safety testing market coupled with the opportunities for augmentation across this business vertical.

  • Charles River Laboratories International, Inc.
  • Merck KGaA
  • Lonza Group Ltd.
  • SGS S.A.
  • Thermo Fisher Scientific Inc.
  • Wuxi Apptec
  • Sartorius AG
  • Cytovance Biologics, Inc.
  • Pace Analytical Services Inc.
  • Toxikon Corporation
  • Eurofins Scientific Se
  • Avance Biosciences Inc.
  • Source Bioscience

By Product and Service

  • Kits and Reagents
  • Services
  • Instruments

By Test Type

  • Endotoxin Tests
  • Sterility Tests
  • Cell Line Authentication and Characterization Tests
  • Bioburden Tests
  • Sterility Tests
  • Cell Line Authentication and Characterization Tests

By Application

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

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

  • Tier 1 players-established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the global market By Product and Service, By Test Type, By Application and By Region
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions (along with countries)— North America, Europe, Asia Pacific, Latin America and Middle East and Africa
  • To record evaluate and competitive landscape mapping- product launches, technological advancements, mergers and expansions

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Biologics Safety Testing Market Variables, Trends and Scope

    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Biologics Safety Testing Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Biologics Safety Testing Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Biologics Safety Testing Market, By Product and Service Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Kits and Reagents 
        2. Services
        3. Instruments

  • 8.   Biologics Safety Testing Market, By Test Type Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Endotoxin Tests
        2. Sterility Tests
        3. Cell Line Authentication and Characterization Tests
        4. Bioburden Tests
        5. Sterility Tests
        6. Cell Line Authentication and Characterization Tests

  • 9.   Biologics Safety Testing Market, By Application Historical Analysis and Forecast 2023-2031 (USD Million)

    •   1. Vaccine and 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

  • 10.   North America Biologics Safety Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 11.   Latin America Biologics Safety Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 12.   Europe Biologics Safety Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 13.   Asia Pacific Biologics Safety Testing Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 14.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)

    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 15.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 16.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)

    •   1. Charles River Laboratories International, Inc.
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Merck KGaA
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Lonza Group Ltd.
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. SGS S.A.
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Thermo Fisher Scientific Inc.
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Wuxi Apptec
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Sartorius AG
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Cytovance Biologics, Inc.
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. Pace Analytical Services Inc.
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
          10. Toxikon Corporation
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview
          11. Eurofins Scientific Se
         11.1. Company Overview
         11.2. Product Portfolio
         11.3. SWOT Analysis
         11.4. Financial Overview
         11.5. Strategic Overview
          12. Avance Biosciences Inc
         12.1. Company Overview
         12.2. Product Portfolio
         12.3. SWOT Analysis
         12.4. Financial Overview
         12.5. Strategic Overview
          13. Source Bioscience
         13.1. Company Overview
         13.2. Product Portfolio
         13.3. SWOT Analysis
         13.4. Financial Overview
         13.5. Strategic Overview

  • 17.   Pre and Post COVID-19 Impact

    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the regulations initiated by healthcare
                  administrations
        5. The overall economic slowdown of the developing and developed nations

  • 18.   FutureWise SME Key Takeaway Points for Client

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