Bio safety Testing Market, By Product (Reagents and Kits, Instruments, and Other Products), By Test (Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Endotoxin Tests, Adventitious Agent Detection Tests, and Other Tests), By Application (Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, and Other Applications), and By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) - Trends, Analysis, and Forecast till 2029

Report Code: PMI427820 | Publish Date: May 2023 | No. of Pages: 180

Global Bio Safety Testing Market Overview

Bio safety testing deals with testing methods that are carried out to confirm non-contamination of biopharmaceuticals and vaccines and to comply with regulations concerning the same. This includes several types of characterization tests, sterility tests, cell line authentication and bioburden tests, adventitious agent detection tests, endotoxin tests, and residual host contamination detection tests, among others. The bio safety testing market accounted for US$ 3.1 billion in 2019 and is estimated to be US$ 10.5 billion by 2029 and is anticipated to register a CAGR of 13.1%.

Impact of Covid-19 pandemic on market

Number of patients suffering from Covid-19 is rising day by day. Major biotech companies are in the center of a race to investigate the Sars-Cov-2 genome and prepare a feasible vaccine for the same. Bio safety testing materials are at the forefront of the human response to the coronavirus pandemic. The government and private sectors are projected to work in unison for the forecast period, till a vaccine is developed for Covid-19. This report will quantify the impact of this pandemic on the bio safety testing market.

Global Bio Safety Testing Market Dynamics

Unprecedented growth has been observed in the number of biopharmaceutical companies due to rising need for biologics. Manufacturers are involved in improving aspects of manufacturing processes such as cost-efficiency and productivity in order to growing competition to develop therapeutically advanced drugs on a large scale. Therefore, key player are implementing good manufacturing practices involving thorough biological testing at numerous levels of production cycle, thereby propelling market growth. Companies are providing services such as bioburden testing, toxicology testing, and analytical testing, which assess products on parameters such as specificity, accuracy, range, and linearity.

High rate of microbial contamination and bioburden while manufacturing pharmaceuticals and biologics is projected to fuel government and private organizations to enhance underlying biological safety practices. Further, increasing number of government initiatives to indorse biological safety testing products and services is expected to motivate overall growth in the coming years.

Conversely, there remain some potential safety concerns, which usually rise from the manufacturing processes and structural characteristics and complex biological of these products. Further, time-consuming approval process also hampers growth of the target market.

Global Bio Safety Testing Market Segmentation

The global bio safety testing market is segmented based on product, test, application, and region.

On the basis of product, the global bio safety testing market is segmented into reagents and kits, instruments, and other products. Based on test, the target market is segmented into sterility tests, cell line authentication and characterization tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and other tests. On the basis of application, the target market is segmented into vaccines and therapeutics, cellular and gene therapy, blood and blood-based therapy, and other applications.

Regional Insights:

Disclaimer: This data is only a representation. Actual data may vary and will be available in the report.

On region the global bio safety testing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounts highest share of the global market in 2019, owing to increased adoption in cancer research, high investments in biotechnology, and development of new vaccines, drugs, & biologics. Additionally, growing number of R&D investments by companies is one of the factors accountable for growth. Presence of major market players adopting extensive expansion strategies is also projected to drive the target market. Also, growing burden of chronic diseases is expected to increase the usage of advanced technologies by healthcare professionals and researchers in this region.  The Asia Pacific market is expected to grow at a lucrative CAGR in the coming years due to growing healthcare spending and rising awareness about the benefits of these products. Moreover, Asia?Pacific Biosafety Association trains concerned professionals on biosafety principles and practices across the region, therefore spreading growth prospects in this region.

Report Scope:

Attribute

Details

Base year for estimation

2019

Forecast period

2019 – 2029

Market representation

Revenue in USD Million & CAGR from 2019 – 2029

Market Segmentation

By Product- Reagents and Kits, Instruments, and Other Products

By Test– Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Endotoxin Tests, Adventitious Agent Detection Tests, and Other Tests

By Application– Vaccines and Therapeutics, Cellular and Gene Therapy, Blood and Blood-based Therapy, and Other Applications

Regional scope

North America - U.S., Canada

Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe

Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific

Latin America - Brazil, Mexico, Argentina, Rest of Latin America

Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2019 to 2029. For the purpose of this study, has segmented the global bio safety testing market report based on product, test, application, and region.

Global Bio safety Testing Market, By Product:

  • Reagents and Kits
  • Instruments
  • Other Products

Global Bio safety Testing Market, By Test:

  • Sterility Tests
  • Cell Line Authentication and Characterization Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Adventitious Agent Detection Tests
  • Other Tests

Global Bio safety Testing Market, By Application:

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

 

Global Bio safety Testing Market, By Region:

  • North America
        • U.S.
        • Canada
      • Europe
        • Germany
        • UK
        • France
        • Russia
        • Italy
        • Rest of Europe
      • Asia Pacific
        • China
        • India
        • Japan
        • South Korea
        • Rest of Asia Pacific
      • Latin America
        • Brazil
        • Mexico
        • Rest of Latin America
      • Middle East & Africa
        • GCC
        • Israel
        • South Africa
        • Rest of Middle East & Africa

Global Bio Safety Testing Market Key Players

The key players operating in the global bio safety testing market includes Avance Biosciences, Cytovance Biologics, Thermo Fisher Scientific, Merck KGaA, Eurofins Scientific, Lonza, Promega Corporation, Toxikon, and WuXi AppTec. Companies are engaged in extensive R&D for producing technologically advanced testing and cost-efficient products. Additionally, various strategies are being adopted by these companies to improve market presence are projected to create lucrative growth opportunities in the near future. For instance, in 2018, Charles River Laboratories, Inc. acquired MPI Research, increasing its ability to offer drug discovery and development services.

Global Bio Safety Testing Market Company Profile

  • Avance Biosciences
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Cytovance Biologics
  • Thermo Fisher Scientific
  • Merck KGaA
  • Eurofins Scientific
  • Lonza
  • Promega Corporation
  • Toxikon
  • WuXi AppTec

 “*” marked represents similar segmentation in other categories in the respective section

Global Bio Safety Testing Market Table of Contents

  1. Research Objective and Assumption
    • Preface
    • Research Objectives
    • Study Scope
    • Years Considered for the study
    • Assumptions
    • Abbreviations
  2. Research Methodology
    • Research data
    • Primary Data
      • Primary Interviews
      • Primary Breakdown
      • Key data from Primary Sources
      • Key Thickness Insights
    • Secondary Data
      • Major Secondary Sources
      • Secondary Sources
    • Market Estimation
    • Top-Down Approach
      • Approach for estimating Market Share by Top-Down Analysis (Supply Side)
    • Bottom-Up Approach
      • Approach for estimating market share by Bottom-up Analysis (Demand Side)
    • Market Breakdown and Data Triangulation
    • Research Assumptions
  3. Market Purview
    • Executive Summary
    • Key Findings—Global Outlook for Bio safety Testing Strategies
      • Key Questions this Study will Answer
      • Market Snippet, By Product
      • Market Snippet, By Test
      • Market Snippet, By Application
      • Market Snippet, By Region
    • Opportunity Map Analysis
    • Executive Summary—3 Big Predictions
  4. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
      • Market Trends
    • DR Impact Analysis
    • PEST Analysis
    • Porter’s Five Forces Analysis
    • Opportunity Orbit
    • Market Investment Feasibility Index
    • Macroeconomic Factor Analysis
  5. Global Bio safety Testing Market, By Product, 2019 – 2029, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 – 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Segment Trends
    • Reagents and Kits
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Instruments
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Others
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
  6. Global Bio safety Testing Market, By Test, 2019 – 2029, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 – 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Segment Trends
    • Sterility Tests
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Cell Line Authentication and Characterization Tests
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Bioburden Tests
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Endotoxin Tests
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Adventitious Agent Detection Tests
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Other Tests
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
  7. Global Bio safety Testing Market, By Application, 2019 – 2029, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 – 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Segment Trends
    • Vaccines and Therapeutics
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Cellular and Gene Therapy
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Blood and Blood-based Therapy
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
    • Other Applications
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2019 – 2029
  8. Global Bio safety Testing Market, By Region, 2019 – 2029, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2019 – 2029
      • Y-o-Y Growth Analysis (%), 2019 – 2029
      • Regional Trends
    • North America
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Application, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Application, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • Germany
        • UK
        • France
        • Russia
        • Italy
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Application, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • China
        • India
        • Japan
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Application, 2019 – 2029
      • Market Size  and Forecast (US$ Mn), By Country, 2019 – 2029
        • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East & Africa
      • Market Size and Forecast (US$ Mn), By Product, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Test, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Application, 2019 – 2029
      • Market Size and Forecast (US$ Mn), By Country, 2019 – 2029
        • GCC
        • Israel
        • South Africa
        • Rest of Middle East
  9. Competitive Landscape
    • Heat Map Analysis
    • Market Presence and Specificity Analysis
  10. Company Profiles
      • Avance Biosciences
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
        • Business Strategies
      • Cytovance Biologics
      • Thermo Fisher Scientific
      • Merck KGaA
      • Eurofins Scientific
      • Lonza
      • Promega Corporation
      • Toxikon,
      • WuXi AppTec
  11. The Last Word
    • Future Impact
    • About Us
    • Contact

FAQs

The global bio safety testing market is segmented based on product, test, application, and region.

Growth in the manufacturing processes of bio-pharmaceutical companies is the major propelling factor for the growth of the target market.

North America accounts highest share of the global market in 2019, owing to increased adoption in cancer research, high investments in biotechnology, and development of new vaccines, drugs, & biologics.

In 2018, Charles River Laboratories, Inc. acquired MPI Research, increasing its ability to offer drug discovery and development services.