Biologics Safety Testing Market: By Product Type (Reagents and Kits, Instruments, Services), By Test Type (Sterility Tests, Bioburden Tests, Endotoxin Tests, Residual Host Contamination detection Tests, Cell Line Authentication and Characterization Tests, Others), By Application (Cellular and Gene Therapy, Vaccine and Therapeutics Development, Tissue and Tissue-Related Products Testing, Blood and Blood-Related Products Testing, Stem Cell Research), By End-User (Pharmaceutical Companies, Biotechnology Companies), and Geography

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Biologics Safety Testing Market size was valued at USD 4.18 billion in 2023 and is poised to grow at a CAGR of 12.18% from 2024-2030. Biologics are the large and complex molecules derived from the genes of living organisms by advanced DNA technologies. Biologics are commonly used in the treatment of chronic diseases such as rheumatoid arthritis, cancer, and other chronic diseases. These biologics are complex molecules such as recombinant proteins and monoclonal antibodies among others. Biologics safety testing is carried out to ensure patient safety. Biological safety testing is carried out by using various tests such as sterility tests, endotoxins tests, residual host contamination detection tests, and bioburden tests among others.

The biologics safety testing market exhibiting lucrative growth, which is attributed to an increase in the R&D for the development of newer biologics by pharmaceutical and biopharmaceutical companies for the treatment of chronic diseases such as diabetes, and cancer and the innovation of newer biologics safety tests. Moreover, a rise in funding from the government, and an increase in the prevalence of chronic diseases are anticipated to fuel the market over the forecast period. Furthermore, acquisitions and mergers, collaborations, and the launching of newer tests by market players also immensely boost the biologics safety testing market.

Biologics Safety Testing Market Key Developments:
  • In June 2016, Charles River Laboratories acquired Blue Stream Laboratories to strengthen its capabilities in biologics development and safety assessments.
  • In  March 2016, Abreos Biosciences collaborated with True Diagnostics to develop point-of-care tests for biologics.

Biologics Safety Testing Market Summary

Study Period

2024-2030

Base Year

2023

CAGR

12.18%

Largest Market

North America

Fastest Growing Market

Asia Pacific
Biologics Safety Testing Market Dynamics

Growing biologic products launches, rise R&D activities by pharmaceutical and biotechnology companies, technological advancements of biologics safety testing methods, stringent regulatory guidelines for product approval, and rise in funding from public and private sectors for the development of newer biologics are exepcted to boost the biologics safety testing market over the forecast period. However, high cost of biologics safety testing, and lack of well-developed healthcare in underdeveloped countries are hamper the growth of biologics safety testing market.

Biologics Safety Testing Market Segmentation

By Product Type
  • Reagents and Kits
  • Instruments
  • Services
By Test
  • Sterility Tests
  • Bioburden Tests
  • Endotoxin Tests
  • Residual Host Contamination detection Tests
  • Cell Line Authentication and Characterization Tests
  • Others
By Application
  • Cellular and Gene Therapy
  • Vaccine and Therapeutics Development
  • Tissue and Tissue-related Products Testing
  • Blood and Blood-related Products Testing
  • Stem Cell Research
By End User
  • Pharmaceutical Companies
  • Biotechnology Companies

Frequently Asked Questions

The biologics safety testing market size was valued USD 4.18 billion in 2023

The report covers the five regions and 15+ countries market data: North America (United States, Canada), Europe (Germany, France, Italy, Spain, and United Kingdom (UK), Asia Pacific (China, India, Japan, Australia & New Zealand), Latin America (Brazil, Mexico, Argentina) and Middle East and Africa (Saudi Arabia, United Arab Emirates, South Africa).

Charles River Laboratories (U.S.), Pace Analytical Services Inc. (U.S.) Thermo Fisher Scientific Inc. (U.S.) WuXi Apptec (China) Sartorius AG (Germany) Toxikon Corporation (U.S.) Cytovance Biologics, Inc. (U.S.)

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor's overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
1.Executive Summary
2.Global Biologics Safety Testing Market Introduction 
2.1.Global Biologics Safety Testing Market  - Taxonomy
2.2.Global Biologics Safety Testing Market  - Definitions
2.2.1.Product Type
2.2.2.Test
2.2.3.Application
2.2.4.End User
2.2.5.Region
3.Global Biologics Safety Testing Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4.Global Biologics Safety Testing Market Analysis, 2019 - 2023 and Forecast 2024 - 2030
4.1.  Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5.Global Biologics Safety Testing Market  By Product Type, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
5.1. Reagents and Kits
5.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
5.2. Instruments
5.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.2.3. Market Opportunity Analysis 
5.3. Services
5.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.3.3. Market Opportunity Analysis 
6.Global Biologics Safety Testing Market  By Test, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
6.1. Sterility Tests
6.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. Bioburden Tests
6.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
6.3. Endotoxin Tests
6.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.3.3. Market Opportunity Analysis 
6.4. Residual Host Contamination detection Tests
6.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.4.3. Market Opportunity Analysis 
6.5. Cell Line Authentication and Characterization Tests
6.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.5.3. Market Opportunity Analysis 
6.6. Others
6.6.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.6.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.6.3. Market Opportunity Analysis 
7.Global Biologics Safety Testing Market  By Application, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
7.1. Cellular and Gene Therapy
7.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.1.3. Market Opportunity Analysis 
7.2. Vaccine and Therapeutics Development
7.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.2.3. Market Opportunity Analysis 
7.3. Tissue and Tissue-related Products Testing
7.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.3.3. Market Opportunity Analysis 
7.4. Blood and Blood-related Products Testing
7.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.4.3. Market Opportunity Analysis 
7.5. Stem Cell Research
7.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.5.3. Market Opportunity Analysis 
8.Global Biologics Safety Testing Market  By End User, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
8.1. Pharmaceutical Companies
8.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.1.3. Market Opportunity Analysis 
8.2. Biotechnology Companies
8.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.2.3. Market Opportunity Analysis 
9.Global Biologics Safety Testing Market  By Region, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
9.1. North America
9.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.1.3. Market Opportunity Analysis 
9.2. Europe
9.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.2.3. Market Opportunity Analysis 
9.3. Asia Pacific (APAC)
9.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.3.3. Market Opportunity Analysis 
9.4. Middle East and Africa (MEA)
9.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.4.3. Market Opportunity Analysis 
9.5. Latin America
9.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.5.3. Market Opportunity Analysis 
10.North America Biologics Safety Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
10.1. Product Type Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.Reagents and Kits
10.1.2.Instruments
10.1.3.Services
10.2.  Test Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.Sterility Tests
10.2.2.Bioburden Tests
10.2.3.Endotoxin Tests
10.2.4.Residual Host Contamination detection Tests
10.2.5.Cell Line Authentication and Characterization Tests
10.2.6.Others
10.3.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.3.1.Cellular and Gene Therapy
10.3.2.Vaccine and Therapeutics Development
10.3.3.Tissue and Tissue-related Products Testing
10.3.4.Blood and Blood-related Products Testing
10.3.5.Stem Cell Research
10.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.4.1.Pharmaceutical Companies
10.4.2.Biotechnology Companies
10.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.5.1.United States of America (USA)
10.5.2.Canada
11.Europe Biologics Safety Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
11.1. Product Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.Reagents and Kits
11.1.2.Instruments
11.1.3.Services
11.2.  Test Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Sterility Tests
11.2.2.Bioburden Tests
11.2.3.Endotoxin Tests
11.2.4.Residual Host Contamination detection Tests
11.2.5.Cell Line Authentication and Characterization Tests
11.2.6.Others
11.3.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.3.1.Cellular and Gene Therapy
11.3.2.Vaccine and Therapeutics Development
11.3.3.Tissue and Tissue-related Products Testing
11.3.4.Blood and Blood-related Products Testing
11.3.5.Stem Cell Research
11.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.4.1.Pharmaceutical Companies
11.4.2.Biotechnology Companies
11.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.5.1.Germany
11.5.2.France
11.5.3.Italy
11.5.4.United Kingdom (UK)
11.5.5.Spain
11.5.6.Rest of EU
12.Asia Pacific (APAC) Biologics Safety Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
12.1. Product Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.1.1.Reagents and Kits
12.1.2.Instruments
12.1.3.Services
12.2.  Test Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.2.1.Sterility Tests
12.2.2.Bioburden Tests
12.2.3.Endotoxin Tests
12.2.4.Residual Host Contamination detection Tests
12.2.5.Cell Line Authentication and Characterization Tests
12.2.6.Others
12.3.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.3.1.Cellular and Gene Therapy
12.3.2.Vaccine and Therapeutics Development
12.3.3.Tissue and Tissue-related Products Testing
12.3.4.Blood and Blood-related Products Testing
12.3.5.Stem Cell Research
12.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.4.1.Pharmaceutical Companies
12.4.2.Biotechnology Companies
12.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.5.1.China
12.5.2.India
12.5.3.Australia and New Zealand (ANZ)
12.5.4.Japan
12.5.5.Rest of APAC
13.Middle East and Africa (MEA) Biologics Safety Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
13.1. Product Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.1.1.Reagents and Kits
13.1.2.Instruments
13.1.3.Services
13.2.  Test Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.2.1.Sterility Tests
13.2.2.Bioburden Tests
13.2.3.Endotoxin Tests
13.2.4.Residual Host Contamination detection Tests
13.2.5.Cell Line Authentication and Characterization Tests
13.2.6.Others
13.3.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.3.1.Cellular and Gene Therapy
13.3.2.Vaccine and Therapeutics Development
13.3.3.Tissue and Tissue-related Products Testing
13.3.4.Blood and Blood-related Products Testing
13.3.5.Stem Cell Research
13.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.4.1.Pharmaceutical Companies
13.4.2.Biotechnology Companies
13.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.5.1.GCC Countries
13.5.2.South Africa
13.5.3.Rest of MEA
14.Latin America Biologics Safety Testing Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
14.1. Product Type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.1.1.Reagents and Kits
14.1.2.Instruments
14.1.3.Services
14.2.  Test Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.2.1.Sterility Tests
14.2.2.Bioburden Tests
14.2.3.Endotoxin Tests
14.2.4.Residual Host Contamination detection Tests
14.2.5.Cell Line Authentication and Characterization Tests
14.2.6.Others
14.3.  Application Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.3.1.Cellular and Gene Therapy
14.3.2.Vaccine and Therapeutics Development
14.3.3.Tissue and Tissue-related Products Testing
14.3.4.Blood and Blood-related Products Testing
14.3.5.Stem Cell Research
14.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.4.1.Pharmaceutical Companies
14.4.2.Biotechnology Companies
14.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.5.1.Brazil
14.5.2.Mexico
14.5.3.Rest of LA
15. Competition Landscape
15.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
15.2.1.Charles River Laboratories (U.S.),
15.2.2.Pace Analytical Services Inc. (U.S.)
15.2.3.Thermo Fisher Scientific Inc. (U.S.)
15.2.4.WuXi Apptec (China)
15.2.5.Sartorius AG (Germany)
15.2.6.Toxikon Corporation (U.S.)
15.2.7.Cytovance Biologics, Inc. (U.S.)
15.2.8.SGS SA (Switzerland)
15.2.9.Merck KGaA (Germany)
15.2.10.Sterigenics International, LLC (U.S.)
15.2.11.Abreos Biosciences (U.S.)
15.2.12.True Diagnostics, Inc. (U.S.)
16. Research Methodology 
17. Appendix and Abbreviations 
  • Charles River Laboratories (U.S.),
  • Pace Analytical Services Inc. (U.S.)
  • Thermo Fisher Scientific Inc. (U.S.)
  • WuXi Apptec (China)
  • Sartorius AG (Germany)
  • Toxikon Corporation (U.S.)
  • Cytovance Biologics, Inc. (U.S.)
  • SGS SA (Switzerland)
  • Merck KGaA (Germany)
  • Sterigenics International, LLC (U.S.)
  • Abreos Biosciences (U.S.)
  • True Diagnostics, Inc. (U.S.)

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