Biological Safety Testing Market - Global Industry Analysis

According to the report published by Zion Market Research, global demand for biological safety testing market was valued at approximately USD 2,200 Million in 2019, and is expected to generate revenue of around USD 4,658 Million by end of 2026, growing at a CAGR of around 12.5% between 2020 and 2026.

Global Biological Safety Testing Market: Overview

Biologics are products made from living organisms and have a unique set of properties. The safety of biologics is of utmost importance and specialized evaluation of the same is necessary. Biological safety testing is important for launching new products. Biological safety testing is done in order to ensure the safety quality and non-contamination of vaccines and biopharmaceuticals and to comply with the regulations for the same. Some of the major biological tests are sterility testing, residual host contaminant detection tests, bioburden testing, and endotoxin tests. Biological safety testing is used in cellular, vaccine and gene therapy products, tissue and tissue products, blood and blood products and others. Better living standards, increased funding for life science research and a rising number of pharmaceutical and biological firms are major factors that have been driving the biological safety testing market globally.

Global Biological Safety Testing Market: Growth Factors

Rising number of pharmaceutical and biological firms, the increase in government and private funds and a growing number of biologics products are some of the major factors driving the biological safety testing market globally. Growth in the biological safety testing market will also be visible owing to a strong pharmaceutical product pipeline and increasing support from government for biological and pharmaceutical industries. Regulatory bodies are working towards enforcing important standards for biological safety to ensure patient safety. Hence, biological safety testing market has a growing importance and has a potential for growth in the coming future. However, stringent regulations and the complicated procedure to obtain FDA approval may act as a restraining factor for the biological safety testing market.

Global Biological Safety Testing Market: Segmentation

The global biological safety testing market is segmented into its product, type of test, application, and geography. Based on the product, the biological safety testing market is divided into instruments, services and kits and reagent. Based on the type of test, the segregation is seen as adventitious agents detection test, cell line authentication and characterization tests, bioburden testing, endotoxin tests, sterility testing, residual host contaminant detection tests and other tests such as efficacy tests, stability tests, and toxicity test. On the basis of application, the market segmentation is seen into blood and blood products, stem cell products, cellular and gene therapy products, tissues and tissue products and vaccines and therapeutics. Regional diversification is seen into Asia, North America, Europe and Rest of the World.

Global Biological Safety Testing Market: Regional Analysis

Geographically, the global biological safety testing market is segmented into North America, Europe, Asia Pacific, and the Rest of the World. North America is the largest contender in the biological safety testing market. Countries such as Canada and the U.S. have major markets in the North American region. Rising demand for biological safety testing market is also seen in Asia Pacific region, especially in countries such as China, Japan and India. China and India are the fastest-growing market in the Asia-Pacific region. Demand for biological safety testing is seen to be steadily rising in Europe as well.

Global Biological Safety Testing Market: Competitive Players

Some of the major companies in the biological safety testing market are Charles River Laboratories International Inc., Sigma-Aldrich Corporation, Lonza Group, SGS SA, Avance Biosciences Inc., WuXiPharmaTech Inc., BSL Bioservice, Merck KGaA, Cytovance Biologics Inc., and Toxikon Corporation.

Biological Safety Testing Market: Regional Segment Analysis

• North America

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

• Chapter 1.Preface
  • 1.1.Report Description
  • 1.2.Report Scope
• Chapter 2.Research Methodology
  • 2.1.Research Methodology
  • 2.2.Secondary Research
  • 2.3.Primary Research
  • 2.4.Models
    • 2.4.1.Company Share Analysis Model
    • 2.4.2.Revenue Based Modelling
  • 2.5.Research Limitations
• Chapter 3.Executive Summary
  • 3.1.Global Biulogical Safety Testing Market, 2016 – 2026 (USD Million)
  • 3.2.Global Biulogical Safety Testing Market: Snapshot
• Chapter 4.Biulogical Safety Testing Market – Industry Analysis
  • 4.1.Introduction
  • 4.2.Market Drivers
    • 4.2.1.Driving Factor 1 Analysis
    • 4.2.2.Driving Factor 2 Analysis:
  • 4.3.Market Restraints
    • 4.3.1.Restraining Factor Analysis
  • 4.4.Market Opportunities
    • 4.4.1.Market Opportunity & Use-case Analysis
    • 4.4.2.Use – Cases for Biulogical Safety Testing
  • 4.5.Porter’s Five Forces Analysis
  • 4.6.COVID 19 Impact Analysis
    • 4.6.1.1.Impact on Product Development and Technology Adoption
    • 4.6.1.2.Gap Analysis

• Chapter 5.Investment Proposition Analysis
  • 5.1.Global Biulogical Safety Testing Market Attractiveness, By Product
  • 5.2.Global Biulogical Safety Testing Market Attractiveness, By Type of Test
  • 5.3.Global Biulogical Safety Testing Market Attractiveness, By Application
  • 5.4.Global Biulogical Safety Testing Market Attractiveness, By Region
• Chapter 6.Competitive Landscape
  • 6.1.Company Market Share Analysis - 2019
    • 6.1.1.Global Biulogical Safety Testing Market: Company Market Share, 2019
  • 6.2.Strategic Developments
  • 7.1.Global Biulogical Safety Testing Market Overview: By Product
    • 7.1.1.Global Biulogical Safety Testing Market Revenue Share, By Product, 2019 & 2026
  • 7.2.Global Biulogical Safety Testing Market Analysis/Overview – By Product
    • 7.2.1.Instruments – Overview/Analysis
    • 7.2.2.Services & Kits – Overview/Analysis
    • 7.2.3.Reagent – Overview/Analysis
  • 7.3.Instruments
    • 7.3.1.Global Biulogical Safety Testing Market for Instruments, Revenue (USD Million) 2016 - 2026
  • 7.4.Services & Kits
    • 7.4.1.Global Biulogical Safety Testing Market for Services & Kits, Revenue (USD Million) 2016 - 2026
  • 7.5.Reagent
    • 7.5.1.Global Biulogical Safety Testing Market for Reagent, Revenue (USD Million) 2016 - 2026
  • 8.1.Global Biulogical Safety Testing Market Overview: By Type of Test
    • 8.1.1.Global Biulogical Safety Testing Market Revenue Share, By Type of Test, 2019 & 2026
  • 8.2.Global Biulogical Safety Testing Market Analysis/Overview – By Type of Test
    • 8.2.1.Agent Detection Test – Overview/Analysis
    • 8.2.2.Cell Line Authentication & Characterization Test – Overview/Analysis
    • 8.2.3.Bioburden Test – Overview/Analysis
    • 8.2.4.Endotoxin Test – Overview/Analysis
    • 8.2.5.Sterility Test – Overview/Analysis
    • 8.2.6.Other – Overview/Analysis
  • 8.3.Agent Detection Test
    • 8.3.1.Global Biulogical Safety Testing Market for Agent Detection Test, Revenue (USD Million) 2016 - 2026
  • 8.4.Cell Line Authentication & Characterization Test
    • 8.4.1.Global Biulogical Safety Testing Market for Cell Line Authentication & Characterization Test, Revenue (USD Million) 2016 - 2026
  • 8.5.Bioburden Test
    • 8.5.1.Global Biulogical Safety Testing Market for Bioburden Test, Revenue (USD Million) 2016 - 2026
  • 8.6.Endotoxin Test
    • 8.6.1.Global Biulogical Safety Testing Market for Endotoxin Test, Revenue (USD Million) 2016 - 2026
  • 8.7.Sterility Test
    • 8.7.1.Global Biulogical Safety Testing Market for Sterility Test, Revenue (USD Million) 2016 - 2026
  • 8.8.Other
    • 8.8.1.Global Biulogical Safety Testing Market for Other, Revenue (USD Million) 2016 - 2026
  • 9.1.Global Biulogical Safety Testing Market Overview: By Application
    • 9.1.1.Global Biulogical Safety Testing Market Revenue Share, By Application, 2019 & 2026
  • 9.2.Global Biulogical Safety Testing Market Analysis/Overview – By Application
    • 9.2.1.Blood & Blood Products – Overview/Analysis
    • 9.2.2.Stem Cell Products – Overview/Analysis
    • 9.2.3.Cellular & Gene Therapy Products – Overview/Analysis
    • 9.2.4.Therapeutics – Overview/Analysis
  • 9.3.Blood & Blood Products
    • 9.3.1.Global Biulogical Safety Testing Market for Blood & Blood Products, Revenue (USD Million) 2016 - 2026
  • 9.4.Stem Cell Products
    • 9.4.1.Global Biulogical Safety Testing Market for Stem Cell Products, Revenue (USD Million) 2016 - 2026
  • 9.5.Cellular & Gene Therapy Products
    • 9.5.1.Global Biulogical Safety Testing Market for Cellular & Gene Therapy Products, Revenue (USD Million) 2016 - 2026
  • 9.6.Therapeutics
    • 9.6.1.Global Biulogical Safety Testing Market for Therapeutics, Revenue (USD Million) 2016 - 2026
• Chapter 10.Biulogical Safety Testing Market – Regional Analysis
  • 10.1.Global Biulogical Safety Testing Market: Regional Overview
    • 10.1.1.Global Biulogical Safety Testing Market Revenue Share, by Region, 2019 & 2026
    • 10.1.2.Global Biulogical Safety Testing Market Revenue, by Region, 2016 – 2026 (USD Million)
  • 10.2.North America
    • 10.2.1.North America Biulogical Safety Testing Market Revenue, 2016 - 2026 (USD Million)
    • 10.2.2.North America Biulogical Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
    • 10.2.3.North America Biulogical Safety Testing Market Revenue, By Product, 2016 – 2026
    • 10.2.4.North America Biulogical Safety Testing Market Revenue, By Type of Test, 2016 – 2026
    • 10.2.5.North America Biulogical Safety Testing Market Revenue, By Application, 2016 – 2026
    • 10.2.6. U.S.
    • 10.2.7.Canada
  • 10.3.Europe
    • 10.3.1.Europe Biulogical Safety Testing Market Revenue, 2016 - 2026 (USD Million)
    • 10.3.2.Europe Biulogical Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
    • 10.3.3.Europe Biulogical Safety Testing Market Revenue, By Product, 2016 – 2026
    • 10.3.4.Europe Biulogical Safety Testing Market Revenue, By Type of Test, 2016 – 2026
    • 10.3.5.Europe Biulogical Safety Testing Market Revenue, By Application, 2016 – 2026
    • 10.3.6.Germany
    • 10.3.7.France
    • 10.3.8. U.K.
    • 10.3.9.Italy
    • 10.3.10.Spain
    • 10.3.11.Rest of Europe
  • 10.4.Asia Pacific
    • 10.4.1.Asia Pacific Biulogical Safety Testing Market Revenue, 2016 - 2026 (USD Million)
    • 10.4.2.Asia Pacific Biulogical Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
    • 10.4.3.Asia Pacific Biulogical Safety Testing Market Revenue, By Product, 2016 – 2026
    • 10.4.4.Asia Pacific Biulogical Safety Testing Market Revenue, By Type of Test, 2016 – 2026
    • 10.4.5.Asia Pacific Biulogical Safety Testing Market Revenue, By Application, 2016 – 2026
    • 10.4.6.China
    • 10.4.7.Japan
    • 10.4.8.India
    • 10.4.9.South Korea
    • 10.4.10.South-East Asia
    • 10.4.11.Rest of Asia Pacific
  • 10.5.Latin America
    • 10.5.1.Latin America Biulogical Safety Testing Market Revenue, 2016 - 2026 (USD Million)
    • 10.5.2.Latin America Biulogical Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
    • 10.5.3.Latin America Biulogical Safety Testing Market Revenue, By Product, 2016 – 2026
    • 10.5.4.Latin America Biulogical Safety Testing Market Revenue, By Type of Test, 2016 – 2026
    • 10.5.5.Latin America Biulogical Safety Testing Market Revenue, By Application, 2016 – 2026
    • 10.5.6.Brazil
    • 10.5.7.Mexico
    • 10.5.8.Rest of Latin America
  • 10.6.The Middle-East and Africa
    • 10.6.1.The Middle-East and Africa Biulogical Safety Testing Market Revenue, 2016 - 2026 (USD Million)
    • 10.6.2.The Middle-East and Africa Biulogical Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
    • 10.6.3.The Middle-East and Africa Biulogical Safety Testing Market Revenue, By Product, 2016 – 2026
    • 10.6.4.The Middle-East and Africa Biulogical Safety Testing Market Revenue, By Type of Test, 2016 – 2026
    • 10.6.5.The Middle-East and Africa Biulogical Safety Testing Market Revenue, By Application, 2016 – 2026
    • 10.6.6.GCC Countries
    • 10.6.7.South Africa
    • 10.6.8.Rest of Middle-East Africa
• Chapter 11.Company Profiles
  • 11.1.Sigma-Aldrich Corporation
    • 11.1.1.Company Overview
    • 11.1.2.Financial Overview
    • 11.1.3.Product Portfolio
    • 11.1.4.Business Strategy
    • 11.1.5.Recent Developments
  • 11.2.Lonza Group
  • 11.3.SGS SA
  • 11.4.Avance Biosciences Inc.
  • 11.5.WuXiPharmaTech Inc.
  • 11.6.BSL Bioservice
  • 11.7.Merck KGa
  • 11.8.Cytovance Biulogics Inc.
  • 11.9.Toxikon Corporation

Table Of Figures

List of Figures 

FIG. 1 Research Methodology
FIG. 2 Research Methodology – Basic Overview
FIG. 3 Research Methodology – Detailed View
FIG. 4 Global Biological Safety Testing Market Revenue, 2016 - 2026 (USD Million)
FIG. 5 Porter’s Five Forces Analysis for Global Biological Safety Testing Market
FIG. 6 Global Biological Safety Testing Market Attractiveness, By Product
FIG. 7 Global Biological Safety Testing Market Attractiveness, By Type of Test
FIG. 8 Global Biological Safety Testing Market Attractiveness, By Application
FIG. 9 Global Biological Safety Testing Market Attractiveness, By End-User
FIG. 10 Company Share Analysis, 2019
FIG. 11 Global Biological Safety Testing Market Revenue Share, By Product, 2019 & 2026
FIG. 12 Global Biological Safety Testing Market for Instruments, Revenue (USD Million) 2016 - 2026
FIG. 13 Global Biological Safety Testing Market for Services & Kits, Revenue (USD Million) 2016 - 2026
FIG. 14 Global Biological Safety Testing Market for Reagent, Revenue (USD Million) 2016 - 2026
FIG. 15 Global Biological Safety Testing Market Revenue Share, By Type of Test, 2019 & 2026
FIG. 16 Global Biological Safety Testing Market for Agent Detection Test, Revenue (USD Million) 2016 - 2026
FIG. 17 Global Biological Safety Testing Market for Cell Line Authentication & Characterization Test, Revenue (USD Million) 2016 - 2026
FIG. 18 Global Biological Safety Testing Market for Bioburden Test, Revenue (USD Million) 2016 - 2026
FIG. 19 Global Biological Safety Testing Market for Endotoxin Test, Revenue (USD Million) 2016 - 2026
FIG. 20 Global Biological Safety Testing Market for Sterility Test, Revenue (USD Million) 2016 - 2026
FIG. 21 Global Biological Safety Testing Market for Other, Revenue (USD Million) 2016 - 2026
FIG. 22 Global Biological Safety Testing Market Revenue Share, By Application, 2019 & 2026
FIG. 23 Global Biological Safety Testing Market for Blood & Blood Products, Revenue (USD Million) 2016 - 2026
FIG. 24 Global Biological Safety Testing Market for Stem Cell Products, Revenue (USD Million) 2016 - 2026
FIG. 25 Global Biological Safety Testing Market for Cellular & Gene Therapy Products, Revenue (USD Million) 2016 - 2026
FIG. 26 Global Biological Safety Testing Market for Therapeutics, Revenue (USD Million) 2016 - 2026
FIG. 27 Global Biological Safety Testing Market Revenue Share, by Region, 2019 & 2026
FIG. 28 North America Biological Safety Testing Market Revenue, 2016 - 2026 (USD Million)
FIG. 29 Europe Biological Safety Testing Market Revenue, 2016 - 2026 (USD Million)
FIG. 30 Asia Pacific Biological Safety Testing Market Revenue, 2016 - 2026 (USD Million)
FIG. 31 Latin America Biological Safety Testing Market Revenue, 2016 - 2026 (USD Million)
FIG. 32 The Middle-East and Africa Biological Safety Testing Market Revenue, 2016 - 2026 (USD Million)
FIG. 33 Sigma-Aldrich Corporation Business Segment Revenue Share, 2018 (%)
FIG. 34 Sigma-Aldrich Corporation Geographical Segment Revenue Share, 2018 (%)

Table Of Tables

List of Tables

TABLE 1 Global Biological Safety Testing Market: Snapshot
TABLE 2 Drivers of the Biological Safety Testing Market: Impact Analysis
TABLE 3 Restraints for the Biological Safety Testing Market: Impact Analysis
TABLE 4 Global Biological Safety Testing Market Revenue, by Region, 2016 – 2026 (USD Million)
TABLE 5 North America Biological Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
TABLE 6 North America Biological Safety Testing Market Revenue, By Product, 2016 – 2026 (USD Million)
TABLE 7 North America Biological Safety Testing Market Revenue, By Type of Test, 2016 – 2026 (USD Million)
TABLE 8 North America Biological Safety Testing Market Revenue, By Application, 2016 – 2026 (USD Million)
TABLE 9 Europe Biological Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
TABLE 10 Europe Biological Safety Testing Market Revenue, By Product, 2016 – 2026 (USD Million)
TABLE 11 Europe Biological Safety Testing Market Revenue, By Type of Test, 2016 – 2026 (USD Million)
TABLE 12 Europe Biological Safety Testing Market Revenue, By Application, 2016 – 2026 (USD Million)
TABLE 13 Asia Pacific Biological Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
TABLE 14 Asia Pacific Biological Safety Testing Market Revenue, By Product, 2016 – 2026 (USD Million)
TABLE 15 Asia Pacific Biological Safety Testing Market Revenue, By Type of Test, 2016 – 2026 (USD Million)
TABLE 16 Asia Pacific Biological Safety Testing Market Revenue, By Application, 2016 – 2026 (USD Million)
TABLE 17 Latin America Biological Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
TABLE 18 Latin America Biological Safety Testing Market Revenue, By Product, 2016 – 2026 (USD Million)
TABLE 19 Latin America Biological Safety Testing Market Revenue, By Type of Test, 2016 – 2026 (USD Million)
TABLE 20 Latin America Biological Safety Testing Market Revenue, By Application, 2016 – 2026 (USD Million)
TABLE 21 The Middle-East and Africa Biological Safety Testing Market Revenue, by Country, 2016 – 2026 (USD Million)
TABLE 22 The Middle-East and Africa Biological Safety Testing Market Revenue, By Product, 2016 – 2026 (USD Million)
TABLE 23 The Middle-East and Africa Biological Safety Testing Market Revenue, By Type of Test, 2016 – 2026 (USD Million)
TABLE 24 The Middle-East and Africa Biological Safety Testing Market Revenue, By Application, 2016 – 2026 (USD Million)