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Biological Safety Testing Market

Global Biological Safety Testing Market Growth, Forecast: By Product Type: Reagents and Kits, Instruments, Other Products; By Test: Sterility Tests, Bioburden Tests, Endotoxin Tests, Other Tests; By Application: Vaccines and Therapeutics, Cellular and Gene Therapy, Others; Regional Analysis; Market Dynamics; Supplier Landscape; 2024-2032

Global Biological Safety Testing Market Outlook:

The global biological safety testing market size was valued at USD 4 billion in 2023, driven by the increasing number of cases of infectious diseases across the globe. The market size is anticipated to grow at a CAGR of 13.2% during the forecast period of 2024-2032 to achieve a value of USD 12.2 billion by 2032.

 

Biological Safety Testing: Introduction

Biological safety testing refers to a set of procedures and assessments conducted to ensure the safety of biopharmaceuticals, medical devices, and other products derived from biological sources. This testing aims to evaluate potential risks associated with these products, including contamination and adverse biological effects, ensuring compliance with regulatory standards. Techniques such as sterility testing, endotoxin testing, and cell-based assays are employed to assess the purity, potency, and safety of biological materials.

 

By rigorously examining these factors, biological safety testing guarantees the integrity and quality of biologically derived products, safeguarding public health and adhering to regulatory guidelines in the pharmaceutical and healthcare industries.

 

Global Biological Safety Testing Market Analysis

The increasing number of biopharmaceutical firms and laboratories in the market is one of the major factors bolstering the market growth. With more biopharmaceutical firms and laboratories, the market is also expected to experience an increase in the production of new biologics, which will further contribute to the rising biological safety testing market demand.

 

The recent strategic moves by Charles River Laboratories International, Inc. (CRL) and Merck are poised to significantly contribute to the growth of the global market for biological safety testing during the forecast period. Charles River's acquisition of SAMDI Tech, a provider of label-free high-throughput screening solutions for drug discovery research, expands its capabilities in biochemical analysis and binding interaction identification. This move aligns with the increasing demand for advanced technologies in drug development, driving the adoption of high-quality screening solutions.

 

The market growth is fostered by the rising interest of key players in investing in research and development activities. For example, Merck's substantial investment of 35 million euros in biosafety testing at its Glasgow and Stirling sites in Scotland underscores the industry's commitment to ensuring the safety and efficacy of pharmaceutical products. The expansion not only enhances Merck's capacity for biosafety testing but also creates job opportunities, reflecting a positive economic impact, and bolstering the global biological safety testing market growth.

 

These strategic initiatives collectively contribute to the strengthening of capabilities in drug development and manufacturing, emphasizing the importance of rigorous biosafety testing. As the pharmaceutical industry continues to advance, the global market is expected to experience growth, driven by increased demand for safety assurance in drug development processes and adherence to regulatory standards.

 

Global Biological Safety Testing Market Segmentations

Market Breakup by Product Type

  • Reagents and Kits
  • Instruments
  • Other Products

 

Market Breakup by Test

  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Other Tests

 

Market Breakup by Application

  • Vaccines and Therapeutics
  • Cellular and Gene Therapy
  • Blood and Blood-Based Therapy
  • Other Applications

 

Market Breakup by Region

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

 

Global Biological Safety Testing Market Overview

The market is driven by the increased research and development activities in the pharmaceuticals and biotechnology field. The increasing awareness of the benefits and importance of quality control in the healthcare sector is a major factor responsible for the market growth. The escalating demand for improved testing methods such as nucleic acid amplification and sequencing techniques and the increasing prevalence of infectious diseases are also driving the global biological safety market growth. The increasing awareness of sterility tests among pharmaceutical and biotechnological firms due to the stringent regulatory guidelines is collectively bolstering the market growth in the forecast period. The increasing production of pharmaceutical products due to the increasing prevalence of infectious medical conditions is a major factor responsible for market growth.

 

Geographically, North America is leading the market and is expected to drive the market in the forecast period. The regional market can be attributed to the increasing presence of biotechnology and pharmaceutical companies due to rising innovative technologies and the presence of favourable government initiatives.

 

Global Biological Safety Testing Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

 

  • Avance Biosciences 
  • Cytovance Biologics 
  • Eurofins Scientific 
  • Lonza 
  • Merck KGaA 
  • Promega Corporation 
  • Thermo Fisher Scientific 
  • Toxikon 
  • WuXi AppTec 
  • Biomerieux SA 
  • Nelson Laboratories, LLC 
  • Almac Group 
  • GenScript 
  • InvivoGen 
  • Maravai LifeSciences

 

Please note that this only represents a partial list of companies, and the complete list has been provided in the report.

 

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product Type
  • Test
  • Application
  • Region
Breakup by Product Type
  • Reagents and Kits
  • Instruments
  • Other Products
Breakup by Test
  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Other Tests
Breakup by Application
  • Vaccines and Therapeutics
  • Cellular and Gene Therapy
  • Blood and Blood-Based Therapy
  • Other Applications
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Competitive Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Avance Biosciences
  • Cytovance Biologics
  • Eurofins Scientific
  • Lonza
  • Merck KGaA
  • Promega Corporation
  • Thermo Fisher Scientific
  • Toxikon
  • WuXi AppTec
  • Biomerieux SA
  • Nelson Laboratories, LLC
  • Almac Group
  • GenScript
  • InvivoGen
  • Maravai LifeSciences

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface
    1.1    Objectives of the Study
    1.2    Key Assumptions 
    1.3    Report Coverage – Key Segmentation and Scope  
    1.4    Research Methodology
2    Executive Summary
3    Global Biological Safety Testing Market Overview
 
    3.1    Global Biological Safety Testing Market Historical Value (2017-2023) 
    3.2    Global Biological Safety Testing Market Forecast Value (2024-2032)
4    Global Biological Safety Testing Market Landscape
    4.1    Global Biological Safety Testing Developers Landscape
        4.1.1    Analysis by Year of Establishment
        4.1.2    Analysis by Company Size
        4.1.3    Analysis by Region
    4.2    Global Biological Safety Testing Product Landscape
        4.2.1    Analysis by Type
        4.2.2    Analysis by Technology 
        4.2.3    Analysis by Application
5    Global Biological Safety Testing Market Dynamics
    5.1    Market Drivers and Constraints
    5.2    SWOT Analysis
    5.3    Porter’s Five Forces Model 
    5.4    Key Demand Indicators
    5.5    Key Price Indicators
    5.6    Industry Events, Initiatives, and Trends 
    5.7    Value Chain Analysis
6    Global Biological Safety Testing Market Segmentation 
    6.1    Global Biological Safety Testing Market by Product Type
        6.1.1    Market Overview
        6.1.2    Reagents and Kits
        6.1.3    Instruments
        6.1.4    Other Products
    6.2    Global Biological Safety Testing Market by Test
        6.2.1    Market Overview
        6.2.2    Sterility Tests
        6.2.3    Bioburden Tests
        6.2.4    Endotoxin Tests
        6.2.5    Other Tests
    6.3    Global Biological Safety Testing Market by Application
        6.3.1    Market Overview
        6.3.2    Vaccines and Therapeutics
        6.3.3    Cellular and Gene Therapy
        6.3.4    Blood and Blood-Based Therapy
        6.3.5    Other Applications
    6.4    Global Biological Safety Testing Market by Region
        6.4.1    Market Overview
        6.4.2    North America 
        6.4.3    Europe
        6.4.4    Asia Pacific
        6.4.5    Latin America
        6.4.6    Middle East and Africa
7    North America Biological Safety Testing Market
    7.1    Market Share by Country
    7.2    United States of America
    7.3    Canada
8    Europe Biological Safety Testing Market
    8.1    Market Share by Country
    8.2    United Kingdom
    8.3    Germany
    8.4    France
    8.5    Italy
    8.6    Others
9    Asia Pacific Biological Safety Testing Market
    9.1    Market Share by Country
    9.2    China
    9.3    Japan
    9.4    India
    9.5    ASEAN
    9.6    Australia
    9.7    Others
10    Latin America Biological Safety Testing Market
    10.1    Market Share by Country
    10.2    Brazil
    10.3    Argentina
    10.4    Mexico
    10.5    Others
11    Middle East and Africa Biological Safety Testing Market
    11.1    Market Share by Country
    11.2    Saudi Arabia
    11.3    United Arab Emirates
    11.4    Nigeria
    11.5    South Africa
    11.6    Others
12    Patent Analysis
    12.1    Analysis by Type of Patent
    12.2    Analysis by Publication year
    12.3    Analysis by Issuing Authority
    12.4    Analysis by Patent Age
    12.5    Analysis by CPC Analysis
    12.6    Analysis by Patent Valuation 
    12.7    Analysis by Key Players
13    Grants Analysis
    13.1    Analysis by year
    13.2    Analysis by Amount Awarded
    13.3    Analysis by Issuing Authority
    13.4    Analysis by Grant Application
    13.5    Analysis by Funding Institute
    13.6    Analysis by NIH Departments
    13.7    Analysis by Recipient Organization 
14    Funding Analysis
    14.1    Analysis by Funding Instances
    14.2    Analysis by Type of Funding
    14.3    Analysis by Funding Amount
    14.4    Analysis by Leading Players
    14.5    Analysis by Leading Investors
    14.6    Analysis by Geography
15    Partnership and Collaborations Analysis
    15.1    Analysis by Partnership Instances
    15.2    Analysis by Type of Partnership
    15.3    Analysis by Leading Players
    15.4    Analysis by Geography
16    Regulatory Framework
    16.1    Regulatory Overview
        16.1.1    US FDA
        16.1.2    EU EMA
        16.1.3    INDIA CDSCO
        16.1.4    JAPAN PMDA
        16.1.5    Others
17    Supplier Landscape
    17.1    Avance Biosciences
        17.1.1    Financial Analysis
        17.1.2    Product Portfolio
        17.1.3    Demographic Reach and Achievements
        17.1.4    Mergers and Acquisition
        17.1.5    Certifications
    17.2    Cytovance Biologics
        17.2.1    Financial Analysis
        17.2.2    Product Portfolio
        17.2.3    Demographic Reach and Achievements
        17.2.4    Mergers and Acquisition
        17.2.5    Certifications
    17.3    Eurofins Scientific
        17.3.1    Financial Analysis
        17.3.2    Product Portfolio
        17.3.3    Demographic Reach and Achievements
        17.3.4    Mergers and Acquisition
        17.3.5    Certifications
    17.4    Lonza
        17.4.1    Financial Analysis
        17.4.2    Product Portfolio
        17.4.3    Demographic Reach and Achievements
        17.4.4    Mergers and Acquisition
        17.4.5    Certifications
    17.5    Merck KGaA
        17.5.1    Financial Analysis
        17.5.2    Product Portfolio
        17.5.3    Demographic Reach and Achievements
        17.5.4    Mergers and Acquisition
        17.5.5    Certifications
    17.6    Promega Corporation
        17.6.1    Financial Analysis
        17.6.2    Product Portfolio
        17.6.3    Demographic Reach and Achievements
        17.6.4    Mergers and Acquisition
        17.6.5    Certifications
    17.7    Thermo Fisher Scientific
        17.7.1    Financial Analysis
        17.7.2    Product Portfolio
        17.7.3    Demographic Reach and Achievements
        17.7.4    Mergers and Acquisition
        17.7.5    Certifications
    17.8    Toxikon
        17.8.1    Financial Analysis
        17.8.2    Product Portfolio
        17.8.3    Demographic Reach and Achievements
        17.8.4    Mergers and Acquisition
        17.8.5    Certifications
    17.9    WuXi AppTec
        17.9.1    Financial Analysis
        17.9.2    Product Portfolio
        17.9.3    Demographic Reach and Achievements
        17.9.4    Mergers and Acquisition
        17.9.5    Certifications
    17.10    Biomerieux SA
        17.10.1    Financial Analysis
        17.10.2    Product Portfolio
        17.10.3    Demographic Reach and Achievements
        17.10.4    Mergers and Acquisition
        17.10.5    Certifications
    17.11    Nelson Laboratories, LLC
        17.11.1    Financial Analysis
        17.11.2    Product Portfolio
        17.11.3    Demographic Reach and Achievements
        17.11.4    Mergers and Acquisition
        17.11.5    Certifications
    17.12    Almac Group
        17.12.1    Financial Analysis
        17.12.2    Product Portfolio
        17.12.3    Demographic Reach and Achievements
        17.12.4    Mergers and Acquisition
        17.12.5    Certifications
    17.13    GenScript
        17.13.1    Financial Analysis
        17.13.2    Product Portfolio
        17.13.3    Demographic Reach and Achievements
        17.13.4    Mergers and Acquisition
        17.13.5    Certifications
    17.14    InvivoGen
        17.14.1    Financial Analysis
        17.14.2    Product Portfolio
        17.14.3    Demographic Reach and Achievements
        17.14.4    Mergers and Acquisition
        17.14.5    Certifications
    17.15    Maravai LifeSciences
        17.15.1    Financial Analysis
        17.15.2    Product Portfolio
        17.15.3    Demographic Reach and Achievements
        17.15.4    Mergers and Acquisition
        17.15.5    Certifications
18    Global Biological Safety Testing Market - Distribution Model (Additional Insight)
    18.1    Overview 
    18.2    Potential Distributors 
    18.3    Key Parameters for Distribution Partner Assessment 
19    Key Opinion Leaders (KOL) Insights (Additional Insight)
20    Company Competitiveness Analysis (Additional Insight)

    20.1    Very Small Companies
    20.2    Small Companies
    20.3    Mid-Sized Companies
    20.4    Large Companies
    20.5    Very Large Companies
21    Payment Methods (Additional Insight)
    21.1    Government Funded
    21.2    Private Insurance
    21.3    Out-of-Pocket


*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

The market attained a value of about USD 4 billion in 2023, driven by increased investments in the market.

The market is anticipated to grow at a CAGR of 13.2% during the forecast period of 2024-2032 and is likely to reach a market value of USD 12.2 billion by 2032.

The increasing number of biopharmaceutical firms and laboratories, along with the increasing awareness about the importance of biological safety and product sterility, are among the major factors driving the market growth.

Increasing acquisitions and investments by key players are among the key trends influencing the market growth.

The major regions of the market include North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America is currently leading the global market.

Different product types include instruments, reagents and kits, among other products.

Different tests in the market can be categorised into sterility tests, bioburden tests, and endotoxin tests, among others.

They find wide applications in vaccines and therapeutics, cellular and gene therapy, blood and blood-based therapy, among other applications.

Key players involved in the market are Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, WuXi AppTec, Biomerieux SA, Nelson Laboratories, LLC, Almac Group, GenScript, InvivoGen, and Maravai LifeSciences.

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