- Reagents and Kits
- Instruments
- Services
Biologics Safety Testing Market size was valued at USD 4.18 billion in 2022 and is poised to grow at a CAGR of 12.18% from 2023-2029. 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
2023-29
Base Year
2022
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.
North-America Got Significant Share of
Biologics Safety Testing Market Regional Analysis
Geographically, global biologics safety testing market segmented into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. North America biologics safety testing market expected to hold dominant share owing to increase in R&D activities by the market players, presence of huge number of market players, and well-developed healthcare infrastructure. Europe biologics safety testing market has a significant share owing to adoption of newer technologies, expansion of business by market players in Germany and UK, and increase in funding for R&D activities for the development of newer biologics. For instance, in 2013, European Research Council awarded $830 Mn for life sciences research in Europe. Asia Pacific biologics safety testing market is projected to grow due to rise in awareness about biologics safety testing, favorable regulatory policies, and increase in healthcare expenditure.
Latin America
Europe
Asia Pacific
Middle East
North America
Key Features of the Reports
- The biologics safety testing market report provides granular level information about the market size, regional market share, historic market (2018 to 2022) and forecast (2023 to 2029)
- 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 startup’s details that are actively working in the market
- The report provides plethora of information about market entry strategies, regulatory framework and reimbursement scenario
- The report analyses the impact of socio-political environment through PESTLE Analysis and competition through Porter’s Five Force Analysis in addition to recent technology advancements and innovations in the market
Biologics Safety Testing Market Segmentation
By Product Type
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 2022
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.)
| 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, 2018 - 2022 and Forecast 2023 - 2029 |
| 4.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
| 5.1. Reagents and Kits |
| 5.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
| 6.1. Sterility Tests |
| 6.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
| 7.1. Cellular and Gene Therapy |
| 7.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
| 8.1. Pharmaceutical Companies |
| 8.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
| 9.1. North America |
| 9.1.1. Market Analysis, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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, 2018 - 2022 and Forecast, 2023 - 2029, (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 ,2018 - 2022 and Forecast 2023 - 2029 (Sales Value USD Million) |
| 10.1. Product Type Analysis 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 ,2018 - 2022 and Forecast 2023 - 2029 (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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 ,2018 - 2022 and Forecast 2023 - 2029 (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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 ,2018 - 2022 and Forecast 2023 - 2029 (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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 ,2018 - 2022 and Forecast 2023 - 2029 (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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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 2018 - 2022 and Forecast 2023 - 2029 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.)