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Global Biological Safety Testing Market: By Product: Reagents and Kits, Services, Instruments; By Application: Stem Cell, Tissue and Tissue-based Products, Gene Therapy, Others; By Test Type; Regional Analysis; Historical Market and Forecast (2018-2028); Market Dynamics; Competitive Landscape; Industry Events and Developments
Global Biological Safety Testing Market Outlook
The global biological safety testing market stood at a value of around USD 3.5 billion in 2021. The market is further expected to grow in the forecast period of 2023-2028 at a CAGR of 12.50% to reach USD 7.1 billion by 2027.
Increasing Demand for Testing Services to Bolster the Global Biological Safety Testing Industry
Based on product, the services segment accounts for a significant share in the market owing to the growing emphasis on biosafety training and risk assessment. Biological safety testing services offer efficient emergency response plans and gap assessments for existing methods. In addition to this, the services segment offers expert advice and consultation services to firms involved in designing laboratory facilities. Moreover, biological safety testing services include the development of protocols, policies, and training programmes according to the OSHA, ISO, NIH, and CDC guidelines.
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North America Accounts for a Significant Share in the Market
The biological safety testing industry in North America is driven by factors such as the growing research and development (R&D) activities especially after the COVID-19 outbreak and rising investments in the biopharmaceutical industry. The stringent safety regulations imposed by the government in the United States and Canada pertaining to the health and safety of citizens are likely to bolster the market growth in the forecast period. Furthermore, increasing awareness among the population in the region about product safety is anticipated to further augment the market.
Biological Safety Testing: Market Segmentation
Biological safety testing is defined as a process which ensures the non-contamination of medicines, laboratories, biopharmaceuticals, and vaccines, among others in order to comply with the safety regulations.
Based on product, the market can be segmented into:
- Reagents and Kits
- Services
- Instruments
The major applications of biological safety testing include:
- Stem Cell
- Tissue and Tissue-based Products
- Gene Therapy
- Blood and Blood-based Products
- Vaccines and Therapeutics
On the basis of test type, the market is divided into:
- Sterility Tests
- Cell Line Authentication and Characterisation Tests
- Bioburden Tests
- Endotoxin Tests
- Adventitious Agent Detection Tests
- Residual Host Contamination Detection Tests
- Others
The regional markets for the product include North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa.
Advancements in Gene Therapy to Boost the Growth of the Biological Safety Testing Industry
The rising demand for biological safety testing to ensure the safety and efficacy of novel gene therapies is driving the market. This is being supported by the stringent government regulations to ensure the safety and authenticity of biological products. Additionally, a rise in demand for gene therapy to treat disorders, such as Albinism, Angelman syndrome, ankylosing spondylitis, Apert syndrome, and cystic fibrosis, among others, has been propelling the biological safety testing industry growth. Furthermore, the thriving pharmaceutical and biotechnology industries, coupled with the rising investment towards the development of advanced laboratories, are anticipated to boost the market growth in the forecast period.
Key Industry Players in the Global Biological Safety Testing Market
The report gives a detailed analysis of the following key players in the global biological safety testing market, covering their competitive landscape, capacity, and latest developments like mergers, acquisitions, and investments, expansions of capacity, and plant turnarounds:
- Charles River Laboratories International, Inc.
- Toxikon Corporation
- Avance Biosciences
- Merck KGaA
- SGS SA
- Others
The comprehensive EMR report provides an in-depth assessment of the market based on the Porter's five forces model along with giving a SWOT analysis.
| REPORT FEATURES | DETAILS |
|---|---|
| Base Year | 2022 |
| Historical Period | 2018-2022 |
| Forecast Period | 2023-2028 |
| Scope of the Report | Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment- Product, Application, Test Type, Region |
| Breakup by Product | Reagents and Kits, Services, Instruments |
| Breakup by Application | Stem Cell, Tissue and Tissue-based Products, Gene Therapy, Blood and Blood-based Products, Vaccines and Therapeutics |
| Breakup by Test Type | Sterility Tests, Cell Line Authentication and Characterisation Tests, Bioburden Tests, Endotoxin Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests, Others |
| Breakup by Region | North America, Europe, Asia Pacific, Latin America, Middle East and Africa |
| Market Dynamics | SWOT, Porter's Five Forces, Key Indicators for Price and Demand |
| Competitive Landscape | Market Structure, Company Profiles- Company Overview, Product Portfolio, Demographic Reach and Achievements, Certifications |
| Companies Covered | Charles River Laboratories International, Inc., Toxikon Corporation, Avance Biosciences, Merck KGaA, SGS SA, Others |
| Report Price and Purchase Option | Explore our purchase options that are best suited to your resources and industry needs. |
| Delivery Format | Delivered as an attached PDF and Excel through email, with an option of receiving an editable PPT, according to the purchase option. |
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
2 Report Coverage – Key Segmentation and Scope
3 Report Description
3.1 Market Definition and Outlook
3.2 Properties and Applications
3.3 Market Analysis
3.4 Key Players
4 Key Assumptions
5 Executive Summary
5.1 Overview
5.2 Key Drivers
5.3 Key Developments
5.4 Competitive Structure
5.5 Key Industrial Trends
6 Snapshot
6.1 Global
6.2 Regional
7 Opportunities and Challenges in the Market
8 Global Biological Safety Testing Market Analysis
8.1 Key Industry Highlights
8.2 Global Biological Safety Testing Historical Market (2018-2022)
8.3 Global Biological Safety Testing Market Forecast (2023-2028)
8.4 Global Biological Safety Testing Market by Product
8.4.1 Reagents and Kits
8.4.1.1 Market Share
8.4.1.2 Historical Trend (2018-2022)
8.4.1.3 Forecast Trend (2023-2028)
8.4.2 Services
8.4.2.1 Market Share
8.4.2.2 Historical Trend (2018-2022)
8.4.2.3 Forecast Trend (2023-2028)
8.4.3 Instruments
8.4.3.1 Market Share
8.4.3.2 Historical Trend (2018-2022)
8.4.3.3 Forecast Trend (2023-2028)
8.5 Global Biological Safety Testing Market by Application
8.5.1 Stem Cell
8.5.1.1 Market Share
8.5.1.2 Historical Trend (2018-2022)
8.5.1.3 Forecast Trend (2023-2028)
8.5.2 Tissue and Tissue-based Products
8.5.2.1 Market Share
8.5.2.2 Historical Trend (2018-2022)
8.5.2.3 Forecast Trend (2023-2028)
8.5.3 Gene Therapy
8.5.3.1 Market Share
8.5.3.2 Historical Trend (2018-2022)
8.5.3.3 Forecast Trend (2023-2028)
8.5.4 Blood and Blood-based Products
8.5.4.1 Market Share
8.5.4.2 Historical Trend (2018-2022)
8.5.4.3 Forecast Trend (2023-2028)
8.5.5 Vaccines and Therapeutics
8.5.5.1 Market Share
8.5.5.2 Historical Trend (2018-2022)
8.5.5.3 Forecast Trend (2023-2028)
8.6 Global Biological Safety Testing Market by Test Type
8.6.1 Sterility Tests
8.6.1.1 Market Share
8.6.1.2 Historical Trend (2018-2022)
8.6.1.3 Forecast Trend (2023-2028)
8.6.2 Cell Line Authentication and Characterisation Tests
8.6.2.1 Market Share
8.6.2.2 Historical Trend (2018-2022)
8.6.2.3 Forecast Trend (2023-2028)
8.6.3 Bioburden Tests
8.6.3.1 Market Share
8.6.3.2 Historical Trend (2018-2022)
8.6.3.3 Forecast Trend (2023-2028)
8.6.4 Endotoxin Tests
8.6.4.1 Market Share
8.6.4.2 Historical Trend (2018-2022)
8.6.4.3 Forecast Trend (2023-2028)
8.6.5 Adventitious Agent Detection Tests
8.6.5.1 Market Share
8.6.5.2 Historical Trend (2018-2022)
8.6.5.3 Forecast Trend (2023-2028)
8.6.6 Residual Host Contamination Detection Tests
8.6.6.1 Market Share
8.6.6.2 Historical Trend (2018-2022)
8.6.6.3 Forecast Trend (2023-2028)
8.6.7 Others
8.7 Global Biological Safety Testing Market by Region
8.7.1 North America
8.7.1.1 Market Share
8.7.1.2 Historical Trend (2018-2022)
8.7.1.3 Forecast Trend (2023-2028)
8.7.2 Europe
8.7.2.1 Market Share
8.7.2.2 Historical Trend (2018-2022)
8.7.2.3 Forecast Trend (2023-2028)
8.7.3 Asia Pacific
8.7.3.1 Market Share
8.7.3.2 Historical Trend (2018-2022)
8.7.3.3 Forecast Trend (2023-2028)
8.7.4 Latin America
8.7.4.1 Market Share
8.7.4.2 Historical Trend (2018-2022)
8.7.4.3 Forecast Trend (2023-2028)
8.7.5 Middle East and Africa
8.7.5.1 Market Share
8.7.5.2 Historical Trend (2018-2022)
8.7.5.3 Forecast Trend (2023-2028)
9 North America Biological Safety Testing Market Analysis
9.1 United States of America
9.1.1 Market Share
9.1.2 Historical Trend (2018-2022)
9.1.3 Forecast Trend (2023-2028)
9.2 Canada
9.2.1 Market Share
9.2.2 Historical Trend (2018-2022)
9.2.3 Forecast Trend (2023-2028)
10 Europe Biological Safety Testing Market Analysis
10.1 United Kingdom
10.1.1 Market Share
10.1.2 Historical Trend (2018-2022)
10.1.3 Forecast Trend (2023-2028)
10.2 Germany
10.2.1 Market Share
10.2.2 Historical Trend (2018-2022)
10.2.3 Forecast Trend (2023-2028)
10.3 France
10.3.1 Market Share
10.3.2 Historical Trend (2018-2022)
10.3.3 Forecast Trend (2023-2028)
10.4 Italy
10.4.1 Market Share
10.4.2 Historical Trend (2018-2022)
10.4.3 Forecast Trend (2023-2028)
10.5 Others
11 Asia Pacific Biological Safety Testing Market Analysis
11.1 China
11.1.1 Market Share
11.1.2 Historical Trend (2018-2022)
11.1.3 Forecast Trend (2023-2028)
11.2 Japan
11.2.1 Market Share
11.2.2 Historical Trend (2018-2022)
11.2.3 Forecast Trend (2023-2028)
11.3 India
11.3.1 Market Share
11.3.2 Historical Trend (2018-2022)
11.3.3 Forecast Trend (2023-2028)
11.4 ASEAN
11.4.1 Market Share
11.4.2 Historical Trend (2018-2022)
11.4.3 Forecast Trend (2023-2028)
11.5 Australia
11.5.1 Market Share
11.5.2 Historical Trend (2018-2022)
11.5.3 Forecast Trend (2023-2028)
11.6 Others
12 Latin America Biological Safety Testing Market Analysis
12.1 Brazil
12.1.1 Market Share
12.1.2 Historical Trend (2018-2022)
12.1.3 Forecast Trend (2023-2028)
12.2 Argentina
12.2.1 Market Share
12.2.2 Historical Trend (2018-2022)
12.2.3 Forecast Trend (2023-2028)
12.3 Mexico
12.3.1 Market Share
12.3.2 Historical Trend (2018-2022)
12.3.3 Forecast Trend (2023-2028)
12.4 Others
13 Middle East and Africa Biological Safety Testing Market Analysis
13.1 Saudi Arabia
13.1.1 Market Share
13.1.2 Historical Trend (2018-2022)
13.1.3 Forecast Trend (2023-2028)
13.2 United Arab Emirates
13.2.1 Market Share
13.2.2 Historical Trend (2018-2022)
13.2.3 Forecast Trend (2023-2028)
13.3 Nigeria
13.3.1 Market Share
13.3.2 Historical Trend (2018-2022)
13.3.3 Forecast Trend (2023-2028)
13.4 South Africa
13.4.1 Market Share
13.4.2 Historical Trend (2018-2022)
13.4.3 Forecast Trend (2023-2028)
13.5 Others
14 Market Dynamics
14.1 SWOT Analysis
14.1.1 Strengths
14.1.2 Weaknesses
14.1.3 Opportunities
14.1.4 Threats
14.2 Porter’s Five Forces Analysis
14.2.1 Supplier’s Power
14.2.2 Buyer’s Power
14.2.3 Threat of New Entrants
14.2.4 Degree of Rivalry
14.2.5 Threat of Substitutes
14.3 Key Indicators for Demand
14.4 Key Indicators for Price
15 Value Chain Analysis
16 Competitive Landscape
16.1 Market Structure
16.2 Company Profiles
16.2.1 Charles River Laboratories International, Inc.
16.2.1.1 Company Overview
16.2.1.2 Product Portfolio
16.2.1.3 Demographic Reach and Achievements
16.2.1.4 Certifications
16.2.2 Toxikon Corporation
16.2.2.1 Company Overview
16.2.2.2 Product Portfolio
16.2.2.3 Demographic Reach and Achievements
16.2.2.4 Certifications
16.2.3 Avance Biosciences
16.2.3.1 Company Overview
16.2.3.2 Product Portfolio
16.2.3.3 Demographic Reach and Achievements
16.2.3.4 Certifications
16.2.4 Merck KGaA
16.2.4.1 Company Overview
16.2.4.2 Product Portfolio
16.2.4.3 Demographic Reach and Achievements
16.2.4.4 Certifications
16.2.5 SGS SA
16.2.5.1 Company Overview
16.2.5.2 Product Portfolio
16.2.5.3 Demographic Reach and Achievements
16.2.5.4 Certifications
16.2.6 Others
17 Key Trends and Developments in the Market
List of Key Figures and Tables
1. Global Biological Safety Testing Market: Key Industry Highlights, 2018 and 2028
2. Global Biological Safety Testing Historical Market: Breakup by Product (USD Billion), 2018-2022
3. Global Biological Safety Testing Market Forecast: Breakup by Product (USD Billion), 2023-2028
4. Global Biological Safety Testing Historical Market: Breakup by Application (USD Billion), 2018-2022
5. Global Biological Safety Testing Market Forecast: Breakup by Application (USD Billion), 2023-2028
6. Global Biological Safety Testing Historical Market: Breakup by Test Type (USD Billion), 2018-2022
7. Global Biological Safety Testing Market Forecast: Breakup by Test Type (USD Billion), 2023-2028
8. Global Biological Safety Testing Historical Market: Breakup by Region (USD Billion), 2018-2022
9. Global Biological Safety Testing Market Forecast: Breakup by Region (USD Billion), 2023-2028
10. North America Biological Safety Testing Historical Market: Breakup by Country (USD Billion), 2018-2022
11. North America Biological Safety Testing Market Forecast: Breakup by Country (USD Billion), 2023-2028
12. Europe Biological Safety Testing Historical Market: Breakup by Country (USD Billion), 2018-2022
13. Europe Biological Safety Testing Market Forecast: Breakup by Country (USD Billion), 2023-2028
14. Asia Pacific Biological Safety Testing Historical Market: Breakup by Country (USD Billion), 2018-2022
15. Asia Pacific Biological Safety Testing Market Forecast: Breakup by Country (USD Billion), 2023-2028
16. Latin America Biological Safety Testing Historical Market: Breakup by Country (USD Billion), 2018-2022
17. Latin America Biological Safety Testing Market Forecast: Breakup by Country (USD Billion), 2023-2028
18. Middle East and Africa Biological Safety Testing Historical Market: Breakup by Country (USD Billion), 2018-2022
19. Middle East and Africa Biological Safety Testing Market Forecast: Breakup by Country (USD Billion), 2023-2028
20. Global Biological Safety Testing Market Structure
Key Questions Answered in the Report
In 2021, the global biological safety testing market attained a value of nearly USD 3.5 billion.
The market is estimated to grow at a CAGR of 12.50% between 2023 and 2028.
The market is estimated to witness a healthy growth in the forecast period of 2023-2028 to reach USD 7.1 billion by 2027.
The major regions in the industry are North America, Latin America, the Middle East and Africa, Europe, and the Asia Pacific.
The major drivers of the industry, such as the rising cases of chronic illness, thriving healthcare industry, favourable government initiatives, and growing research and development activities and clinical trials, are expected to aid the market growth.
The key market trends guiding the growth of the industry include the rapid technological advancements in the biopharmaceutical industry.
Reagents and kits, services, and instruments are the major products included in the market report.
Stem cell, tissue and tissue-based products, gene therapy, blood and blood-based products, and vaccines and therapeutics are the different applications of biological safety testing.
Sterility tests, cell line authentication and characterisation tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and residual host contamination detection tests, among others are the major segments based on test type.
The major players in the industry are Charles River Laboratories International, Inc., Toxikon Corporation, Avance Biosciences, Merck KGaA, and SGS SA, among others.
Analyst Review
The global biological safety testing market attained a value of USD 3.5 billion in 2021, driven by the thriving biopharmaceutical industry. Aided by the increasing efforts by pharmaceutical and life sciences companies to receive FDA approval of biosimilar and other products to treat chronic diseases, the market is expected to witness a further growth in the forecast period of 2023-2028, growing at a CAGR of 12.50%. The market is projected to reach USD 7.1 billion by 2027.
EMR’s meticulous research methodology delves deep into the market, covering the macro and micro aspects of the industry. Based on product, the market is divided into reagents and kits, services, and instruments. On the basis of application, the market is divided into stem cell, tissue and tissue-based products, gene therapy, blood and blood-based products, and vaccines and therapeutics. By test type, the market has been divided into sterility tests, cell line authentication and characterisation tests, bioburden tests, endotoxin tests, adventitious agent detection tests, and residual host contamination detection tests, among others. The major regional markets for biological safety testing are North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa. The key players in the above market include Charles River Laboratories International, Inc., Toxikon Corporation, Avance Biosciences, Merck KGaA, and SGS SA, among others.
EMR’s research methodology uses a combination of cutting-edge analytical tools and the expertise of their highly accomplished team, thus, providing their customers with market insights that are accurate, actionable, and help them remain ahead of their competition.
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