The global biological safety testing market size was estimated to be USD 3.82 billion in 2023 and is expected to reach at USD 16.5 billion by 2033 with a CAGR of 14.21% during the forecast period 2023-2033. Surge in development of biologics & biosimilars, growing concerns over cell culture contamination, rising biopharmaceutical R&D investments, increasing outsourcing of biopharmaceutical activities to CROs, surge in research & development activities, growing investment by government & private bodies in clinical research, rising focus on expansion by major market players, and increasing launch of innovative biological testing products are some of the key factors boosting the market growth.
Increasing launch of innovative biological testing products is predicted to boost the market growth during the forecast period. For instance, in December 2022, Charles River Laboratories International, Inc. introduces the Endosafe Nexus 200, which enhances its extensive endotoxin testing range. The Nexus 200 is the most recent innovation in Charles River's fully automated instrument, ensuring data integrity compliance. It has the ability to process undiluted or complex serial dilutions for water, in-process, and final product testing, utilizing Endosafe Limulus Amebocyte Lysate (LAL) cartridge technology in a fully enclosed system.
By Product, Reagents & kits was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the rising applications of biosciences & biotechnology within pharmaceutical & healthcare, and increasing usage of reagents & kits in biopharmaceutical companies. Additionally, Services is predicted to grow at fastest CAGR during the forecast period owing to the rising technological advancements, growing investment on expansion by market players. For instance, in November 2022, Merck KGaA (Germany) has made an investment to enhance its biosafety testing capacity in Rockville, Maryland, US. The expanded site will now offer biosafety testing and analytical development services in the United States.
By Application, Vaccines & therapeutics was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the growing number of infectious diseases, and the requirement for biologics safety testing as a quality control method to guarantee patient safety. Additionally, Monoclonal antibodies therapy is predicted to grow at fastest CAGR during the forecast period owing to the rising prevalence of various diseases, increasing government initiatives for the development of monoclonal antibody therapies, and growing development of new biologics due to the high disease burden In February 2021, AbbVie has disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for Humira (adalimumab) to be used in treating moderately to severely active ulcerative colitis in pediatric patients aged 5 years and older.
By Test, Bioburden test was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the increasing validation & revalidation of sterilization processes, surge in routine monitoring of manufacturing processes, & overall environmental monitoring programs, and rising development of new products. For instance, In December 2020, Redberry launched a groundbreaking product called 'Red One Automated Bioburden Detection,' specifically designed for rapid and real-time detection of microorganisms in water and pharmaceutical testing. Additionally, Endotoxin test is predicted to grow at fastest CAGR during the forecast period owing to the rising microbial contamination during pharmaceutical and biologics manufacturing and increasing introduction of innovative products by major market players.
By End-user, Pharmaceutical & biotechnology companies was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the surge in number of biotechnology & pharmaceutical companies, increasing prevalence of chronic diseases, and rising launch of innovative product. For instance, In June 2022, Lonza (Switzerland) has introduced the PyroCell Monocyte Activation Test, a new method for detecting non-endotoxin pyrogens. This innovative test aims to decrease interferences from complex drug products, particularly biologics-based pharmaceuticals. Additionally, Research & Academia is predicted to grow at fastest CAGR during the forecast period owing to the rising funding for clinical research by government & private bodies, and installing cutting-edge technology is necessary for academic institutions to meet biosafety laws, which are becoming more prevalent.
North America region is anticipated for the highest revenue share during the forecast period owing to the increasing spending on research & development activities, rising biotechnology and pharmaceutical industries, growing development of innovative technologies, surge in favourable government initiatives, increasing need for validation of drugs & devices process of manufacturing, and rising introduction of innovative technologies. For instance, in February 2021, Thermo Fisher Scientific has unveiled a new series of Class II Biological Safety Cabinets (BSCs) known as Herasafe 2025 BSC. These BSCs come equipped with the state-of-the-art SmartFlow Plus technology from Thermo Scientific, which includes dual blower motors capable of dynamically regulating and maintaining airflow velocities within the cabinet in real-time. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the surge in healthcare investment, rising research & development activities, increasing innovation of new products, growing technological advancements, and surge in partnership & collaboration within market players. For instance, in January 2021, Charles River Laboratories, Inc. (US) has joined forces with JADE Biomedical to enhance its biological testing solutions and broaden its geographical reach, addressing the growing demand for biologics therapeutics, particularly cell and gene therapies. Through this strategic collaboration, JADE will expand its existing global Good Manufacturing Practice (GMP) product testing operations in Shanghai, establishing a second facility to bolster its comprehensive biologics quality management and testing services.
Increasing launch of innovative biological testing products is predicted to boost the market growth during the forecast period. For instance, in December 2022, Charles River Laboratories International, Inc. introduces the Endosafe Nexus 200, which enhances its extensive endotoxin testing range. The Nexus 200 is the most recent innovation in Charles River's fully automated instrument, ensuring data integrity compliance. It has the ability to process undiluted or complex serial dilutions for water, in-process, and final product testing, utilizing Endosafe Limulus Amebocyte Lysate (LAL) cartridge technology in a fully enclosed system.
By Product, Reagents & kits was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the rising applications of biosciences & biotechnology within pharmaceutical & healthcare, and increasing usage of reagents & kits in biopharmaceutical companies. Additionally, Services is predicted to grow at fastest CAGR during the forecast period owing to the rising technological advancements, growing investment on expansion by market players. For instance, in November 2022, Merck KGaA (Germany) has made an investment to enhance its biosafety testing capacity in Rockville, Maryland, US. The expanded site will now offer biosafety testing and analytical development services in the United States.
By Application, Vaccines & therapeutics was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the growing number of infectious diseases, and the requirement for biologics safety testing as a quality control method to guarantee patient safety. Additionally, Monoclonal antibodies therapy is predicted to grow at fastest CAGR during the forecast period owing to the rising prevalence of various diseases, increasing government initiatives for the development of monoclonal antibody therapies, and growing development of new biologics due to the high disease burden In February 2021, AbbVie has disclosed that the U.S. Food and Drug Administration (FDA) has granted approval for Humira (adalimumab) to be used in treating moderately to severely active ulcerative colitis in pediatric patients aged 5 years and older.
By Test, Bioburden test was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the increasing validation & revalidation of sterilization processes, surge in routine monitoring of manufacturing processes, & overall environmental monitoring programs, and rising development of new products. For instance, In December 2020, Redberry launched a groundbreaking product called 'Red One Automated Bioburden Detection,' specifically designed for rapid and real-time detection of microorganisms in water and pharmaceutical testing. Additionally, Endotoxin test is predicted to grow at fastest CAGR during the forecast period owing to the rising microbial contamination during pharmaceutical and biologics manufacturing and increasing introduction of innovative products by major market players.
By End-user, Pharmaceutical & biotechnology companies was the highest revenue-grossing segment in the global biological safety testing market in 2022 owing to the surge in number of biotechnology & pharmaceutical companies, increasing prevalence of chronic diseases, and rising launch of innovative product. For instance, In June 2022, Lonza (Switzerland) has introduced the PyroCell Monocyte Activation Test, a new method for detecting non-endotoxin pyrogens. This innovative test aims to decrease interferences from complex drug products, particularly biologics-based pharmaceuticals. Additionally, Research & Academia is predicted to grow at fastest CAGR during the forecast period owing to the rising funding for clinical research by government & private bodies, and installing cutting-edge technology is necessary for academic institutions to meet biosafety laws, which are becoming more prevalent.
North America region is anticipated for the highest revenue share during the forecast period owing to the increasing spending on research & development activities, rising biotechnology and pharmaceutical industries, growing development of innovative technologies, surge in favourable government initiatives, increasing need for validation of drugs & devices process of manufacturing, and rising introduction of innovative technologies. For instance, in February 2021, Thermo Fisher Scientific has unveiled a new series of Class II Biological Safety Cabinets (BSCs) known as Herasafe 2025 BSC. These BSCs come equipped with the state-of-the-art SmartFlow Plus technology from Thermo Scientific, which includes dual blower motors capable of dynamically regulating and maintaining airflow velocities within the cabinet in real-time. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the surge in healthcare investment, rising research & development activities, increasing innovation of new products, growing technological advancements, and surge in partnership & collaboration within market players. For instance, in January 2021, Charles River Laboratories, Inc. (US) has joined forces with JADE Biomedical to enhance its biological testing solutions and broaden its geographical reach, addressing the growing demand for biologics therapeutics, particularly cell and gene therapies. Through this strategic collaboration, JADE will expand its existing global Good Manufacturing Practice (GMP) product testing operations in Shanghai, establishing a second facility to bolster its comprehensive biologics quality management and testing services.
Segmentation: Biological Safety Testing Market Report 2022 - 2033
Biological Safety Testing Market Analysis & Forecast by Product 2022 - 2033 (Revenue USD Bn)
- Instruments
- Reagents & Kits
- Services
- Others
Biological Safety Testing Market Analysis & Forecast by Application 2022 - 2033 (Revenue USD Bn)
- Cellular & Gene Therapy
- Blood & Blood-based Therapy
- Vaccines & Therapeutics
- Monoclonal Antibodies Therapy
- Others
Biological Safety Testing Market Analysis & Forecast by Test 2022 - 2033 (Revenue USD Bn)
- Bioburden Tests
- Sterility Tests
- Endotoxin Test
- Mycoplasma Test
- Virus Safety Test
- Others
Biological Safety Testing Market Analysis & Forecast by End-user 2022 - 2033 (Revenue USD Bn)
- Research & Academia
- Pharmaceutical & Biotechnology Companies
- Contract Development & Manufacturing Companies
Biological Safety Testing Market Analysis & Forecast by Region 2022 - 2033 (Revenue USD Bn)
North America
- U.S.
- Canada
Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Biological Safety Testing Market: Product Estimates & Trend Analysis
8. Biological Safety Testing Market: Application Estimates & Trend Analysis
9. Biological Safety Testing Market: Test Estimates & Trend Analysis
10. Biological Safety Testing Market: End-user Estimates & Trend Analysis
11. Regional Market Analysis
12. North America Biological Safety Testing Market
13. Europe Global Biological Safety Testing Market
14. Asia Pacific Global Biological Safety Testing Market
15. Latin America Global Biological Safety Testing Market
16. MEA Global Biological Safety Testing Market
17. Competitor Analysis
18. Company Profiles
Companies Mentioned
- Cytovance Biologics
- Toxikon
- Avance Biosciences
- Merck KGaA
- WuXi AppTec
- Thermo Fisher Scientific
- Lonza
- Eurofins Scientific
- Promega Corporation
- Charlers River Laboratories Inc
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 145 |
| Published | August 2023 |
| Forecast Period | 2022 - 2033 |
| Estimated Market Value ( USD | $ 3.82 Billion |
| Forecasted Market Value ( USD | $ 16.5 Billion |
| Compound Annual Growth Rate | 14.2% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
