The global biologics safety testing market is expected to grow at a CAGR of around 11.7% from forecast period 2019 to 2026 and expected to reach value of around US$ 4.8 Bn by 2026.
Biologics is manufactured or produced from biological sources such as nucleic acid, living orgasms, and protein and combination of these substances. The main functions of biologics safety testing are to ensure non contamination of vaccines and biopharmaceuticals and to comply the standards and regulations regarding the same. Biologics safety testing is very important to for introducing or launching new products. Based on product type, different types of biologics safety testing such as autoclaves, laboratory centrifuges, and biological safety cabinet are used.
Market Dynamics
The growth of the biologics safety testing market is primarily driven by growing number of drug launches, stringent government regulations regarding biologics, increase in chronic diseases across the globe, and technological advancements in biologics safety testing. Furthermore, increase in number of new biologics by biotechnology and pharmaceutical key players and expanding base of various dieses patients worldwide, is estimated to boost the market growth. According to National Center for Biotechnology Information (NCBI) the number of products launched increased from 29 in 2003 to 56 in 2013. According to world Health Organization (WHO) and The International Agency for Research on Cancer (ICRA), around 19.3 million new cancer cases will be diagnosed per year, by 2025. Moreover, changing lifestyles of consumers across developed countries, growing pharmaceutical and medical industry, technological advancement and increase in the number of applications are expected to create opportunities for the manufacturers in the global market over the forecast period. However, high cost of research and development and risks associated for skilled professionals are expected to hamper the growth of the global biologics safety testing market in the coming years.
By Product Type, kits & reagents dominated the biologics safety testing market
The kits & reagents segment accounted for approximately 54% of the share in the global biologics safety testing market in 2018. Increase in demand for kits and reagents for performing blood and blood-related products testing, tissue and tissue-related products testing and cellular and gene therapy, and repeated and regular sales of kits & reagents as compared to instruments is further expected to raise segment over the forecast period.
By Application, vaccine and therapeutics development segment dominated the biologics safety testing market
The vaccine and therapeutics development segment accounted for approximately 32% of the share in the global biologics safety testing market in 2018. Growing demand for biologics safety testing for various diseases and cataract procedures and growing investment for vaccine and therapeutics development, and initiatives for immunization is further expected to raise segment over the forecast period. Owing to its growing number of applications, growing number of new drug launches, and supportive government initiatives for biologics safety testing in research and development centres further grows the demand for biologics safety testing in vaccine and therapeutics development applications during the forecast period.
By Test Type, endotoxin tests segment dominated the biologics safety testing market
The endotoxin tests segment accounted for approximately 27% of the share in the global biologics safety testing market in 2018. Rising prevalence of these tests in manufacturing and production of drugs and growing incidence of endotoxin testing, and rising demand for safe test is further expected to raise segment over the forecast period.
The market research study on “Biologics Safety Testing Market– Global Industry Analysis, Market Size, Opportunities and Forecast, 2019 – 2026”, offers a detailed insight into the global biologics safety testing market entailing insights on its different market segments. Market dynamics with drivers, restraints, and opportunities with their impact are provided in the report. The report provides insights into the global biologics safety testing market, its product type, application, test type, and major geographic regions. The report covers basic development policies and layouts of technology development processes. Secondly, the report covers global biologics safety testing market size and volume, and segment markets by product type, application, test type, and geography along with the information on companies operating in the market. The biologics safety testing market analysis is provided for major regional markets including North America, Europe, Asia Pacific, Latin America and Middle East and Africa. For each region, the market size and volume for different segments have been covered under the scope of the report.
In 2018, North America dominated the regional market with a maximum market share
North America accounted for the high market share of the biologics safety testing market and the region is also expected to maintain its dominance over the forecast period. The region is experiencing the maximum growth owing to the rapid consumption of biologics safety testing in various applications, presence of biologics safety testing companies, favorable reimbursement policies, and increased adoption in cancer research. High research and development in biotechnology and pharmaceutical, development and launching of new biologics and drugs, and developed healthcare infrastructure in the North America region are one of the key factors driving the consumption of biologics safety testing in this region. Moreover, highly skilled surgeons, growing number of laboratory and research centers in key countries such as US and Canada are also propelling the growth of biologics safety testing in the North America region. Europe is followed by the North America region in the biologics safety testing market.
Asia-Pacific is expected to hold the highest CAGR in the global market during the forecast period. The growing pharmaceutical and biotechnology and industry increase in innovation and development in biologics safety testing, and growing outsourcing industry, are expected to enhance the market growth in the global biologics safety testing market during the forecast.
The players profiled in the report include Charles River Laboratories, SGS SA, Lonza Group LTD, Merck KGaA, and WuXi Apptec, Thermo Fisher Scientific Inc., Sartorius AG, Cytovance Biologics, Inc., Pace Analytical Services Inc., Eurofins Scientific Se, Avance Biosciences Inc., Source Bioscience, and Toxikon Corporation among others. The companies are involved in mergers and acquisitions and new product development for expanding their market share and also for gaining competitive advantages over its competitors.
Market Segmentation
Market By Product Type
- Kits & Reagents
- Instruments
Market By Application
- Blood and Blood-related Products Testing
- Vaccine and Therapeutics Development
- Cellular and Gene Therapy
- Tissue and Tissue-related Products Testing
- Stem Cell Research
Market By Test Type
- Endotoxin Tests
- Sterility Tests
- Cell Line Authentication and Characterization Tests
- Residual Host Contamination Detection Tests
- Adventitious Agent Detection Tests
- Bioburden tests
- Other Tests
Market By Geography
- North America
- Europe
- UK
- Germany
- France
- Spain
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
- GCC
- South Africa
- Rest of Middle East & Africa
Table Of Content
CHAPTER 1. INDUSTRY OVERVIEW
1.1. Definition and Scope
1.1.1. Definition of Biologics Safety Testing
1.1.2. Market Segmentation
1.1.3. List of Abbreviations
1.2. Summary
1.2.1. Market Snapshot
1.2.2. Biologics Safety Testing Market By Application
1.2.2.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison By Application (2015-2026)
1.2.2.2. Global Biologics Safety Testing Market Revenue Share By Application in 2017
1.2.2.3. Vaccine and Therapeutics Development
1.2.2.4. Blood and Blood-related Products Testing
1.2.2.5. Cellular and Gene Therapy
1.2.2.6. Tissue and Tissue-related Products Testing
1.2.2.7. Stem Cell Research
1.2.3. Biologics Safety Testing Market By Product Type
1.2.3.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison By Product Type (2015-2026)
1.2.3.2. Global Biologics Safety Testing Market Revenue Share By Product Type in 2017
1.2.3.3. Kits & Reagents
1.2.3.4. Instruments
1.2.4. Biologics Safety Testing Market By Test Type
1.2.4.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison By Test Type (2015-2026)
1.2.4.2. Global Biologics Safety Testing Market Revenue Share By Test Type in 2017
1.2.4.3. Sterility Tests
1.2.4.4. Endotoxin Tests
1.2.4.5. Cell Line Authentication and Characterization Tests
1.2.4.6. Residual Host Contamination Detection Tests
1.2.4.7. Adventitious Agent Detection Tests
1.2.4.8. Bioburden tests
1.2.4.9. Others
1.2.5. Biologics Safety Testing Market By Geography
1.2.5.1. Global Biologics Safety Testing Market Revenue and Growth Rate Comparison by Geography (2015-2026)
1.2.5.2. North America Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.3. Europe Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.4. Asia-Pacific Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.5. Latin America Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
1.2.5.6. Middle East and Africa (MEA) Biologics Safety Testing Market Revenue and Growth Rate (2015-2026)
CHAPTER 2. MARKET DYNAMICS AND COMPETITION ANALYSIS
2.1. Market Drivers
2.2. Restraints and Challenges
2.3. Growth Opportunities
2.4. Porter’s Five Forces Analysis
2.4.1. Bargaining Power of Suppliers
2.4.2. Bargaining Power of Buyers
2.4.3. Threat of Substitute
2.4.4. Threat of New Entrants
2.4.5. Degree of Competition
2.5. Value Chain Analysis
2.6. Cost Structure Analysis
2.6.1. Raw Material and Suppliers
2.6.2. Manufacturing Process Analysis
2.7. Regulatory Compliance
2.8. Competitive Landscape, 2017
2.8.1. Player Positioning Analysis
2.8.2. Key Strategies Adopted By Leading Players
CHAPTER 3. MANUFACTURING PLANTS ANALYSIS
3.1. Capacity and Commercial Production Date of Global Biologics Safety Testing Major Manufacturers in 2017
3.2. Manufacturing Plants Distribution of Global Biologics Safety Testing Major Manufacturers in 2017
3.3. R&D Status and Technology Source of Global Biologics Safety Testing Major Manufacturers in 2017
3.4. Raw Materials Sources Analysis of Global Biologics Safety Testing Major Manufacturers in 2017
CHAPTER 4. BIOLOGICS SAFETY TESTING MARKET BY APPLICATION
4.1. Global Biologics Safety Testing Revenue By Application
4.2. Vaccine and Therapeutics Development
4.2.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.2.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.3. Blood and Blood-related Products Testing
4.3.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.3.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.4. Cellular and Gene Therapy
4.4.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.4.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.5. Tissue and Tissue-related Products Testing
4.5.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.5.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
4.6. Stem Cell Research
4.6.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
4.6.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
CHAPTER 5. BIOLOGICS SAFETY TESTING MARKET BY PRODUCT TYPE
5.1. Global Biologics Safety Testing Revenue By Product Type
5.2. Kits & Reagents
5.2.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
5.2.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
5.3. Instruments
5.3.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
5.3.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
CHAPTER 6. BIOLOGICS SAFETY TESTING MARKET BY TEST TYPE
6.1. Global Biologics Safety Testing Revenue By Test Type
6.2. Sterility Tests
6.2.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.2.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.3. Endotoxin Tests
6.3.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.3.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.4. Cell Line Authentication and Characterization Tests
6.4.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.4.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.5. Residual Host Contamination Detection Tests
6.5.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.5.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.6. Adventitious Agent Detection Tests
6.6.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.6.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.7. Bioburden tests
6.7.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.7.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
6.8. Others
6.8.1. Market Revenue and Growth Rate, 2015 - 2026 ($Million)
6.8.2. Market Revenue and Forecast, By Region, 2015 - 2026 ($Million)
CHAPTER 7. NORTH AMERICA BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
7.1. North America Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
7.2. North America Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
7.3. U.S.
7.3.1. U.S. Biologics Safety Testing Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
7.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
7.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
7.4. Canada
7.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
7.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
7.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 8. EUROPE BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
8.1. Europe Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
8.2. Europe Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
8.3. UK
8.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.4. Germany
8.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.5. France
8.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.6. Spain
8.6.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.6.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.6.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
8.7. Rest of Europe
8.7.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
8.7.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
8.7.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 9. ASIA-PACIFIC BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
9.1. Asia-Pacific Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
9.2. Asia-Pacific Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
9.3. China
9.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.4. Japan
9.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.5. India
9.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.6. Australia
9.6.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.6.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.6.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.7. South Korea
9.7.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.7.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.7.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
9.8. Rest of Asia-Pacific
9.8.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
9.8.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
9.8.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 10. LATIN AMERICA BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
10.1. Latin America Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
10.2. Latin America Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
10.3. Brazil
10.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
10.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
10.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
10.4. Mexico
10.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
10.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
10.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
10.5. Rest of Latin America
10.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
10.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
10.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 11. MIDDLE EAST & AFRICA BIOLOGICS SAFETY TESTING MARKET BY COUNTRY
11.1. Middle East & Africa Biologics Safety Testing Market Revenue and Growth Rate, 2015 - 2026 ($Million)
11.2. Middle East & Africa Biologics Safety Testing Market Revenue Share Comparison, 2015 & 2026 (%)
11.3. GCC
11.3.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
11.3.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
11.3.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
11.4. Saudi Africa
11.4.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
11.4.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
11.4.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
11.5. Rest of Middle East & Africa
11.5.1. Market Revenue and Forecast By Application, 2015 - 2026 ($Million)
11.5.2. Market Revenue and Forecast By Product Type, 2015 - 2026 ($Million)
11.5.3. Market Revenue and Forecast By Test Type, 2015 - 2026 ($Million)
CHAPTER 12. COMPANY PROFILE
12.1. Charles River Laboratories
12.1.1. Company Snapshot
12.1.2. Overview
12.1.3. Financial Overview
12.1.4. Product Portfolio
12.1.5. Key Developments
12.1.6. Strategies
12.2. SGS SA
12.2.1. Company Snapshot
12.2.2. Overview
12.2.3. Financial Overview
12.2.4. Product Portfolio
12.2.5. Key Developments
12.2.6. Strategies
12.3. Lonza Group LTD
12.3.1. Company Snapshot
12.3.2. Overview
12.3.3. Financial Overview
12.3.4. Product Portfolio
12.3.5. Key Developments
12.3.6. Strategies
12.4. Merck KGaA
12.4.1. Company Snapshot
12.4.2. Overview
12.4.3. Financial Overview
12.4.4. Product Portfolio
12.4.5. Key Developments
12.4.6. Strategies
12.5. WuXi Apptec
12.5.1. Company Snapshot
12.5.2. Overview
12.5.3. Financial Overview
12.5.4. Product Portfolio
12.5.5. Key Developments
12.5.6. Strategies
12.6. Thermo Fisher Scientific Inc.
12.6.1. Company Snapshot
12.6.2. Overview
12.6.3. Financial Overview
12.6.4. Product Portfolio
12.6.5. Key Developments
12.6.6. Strategies
12.7. Sartorius AG
12.7.1. Company Snapshot
12.7.2. Overview
12.7.3. Financial Overview
12.7.4. Product Portfolio
12.7.5. Key Developments
12.7.6. Strategies
12.8. Cytovance Biologics, Inc.
12.8.1. Company Snapshot
12.8.2. Overview
12.8.3. Financial Overview
12.8.4. Product Portfolio
12.8.5. Key Developments
12.8.6. Strategies
12.9. Pace Analytical Services Inc.
12.9.1. Company Snapshot
12.9.2. Overview
12.9.3. Financial Overview
12.9.4. Product Portfolio
12.9.5. Key Developments
12.9.6. Strategies
12.10. Eurofins Scientific Se
12.10.1. Company Snapshot
12.10.2. Overview
12.10.3. Financial Overview
12.10.4. Product Portfolio
12.10.5. Key Developments
12.10.6. Strategies
12.11. Avance Biosciences Inc.
12.11.1. Company Snapshot
12.11.2. Overview
12.11.3. Financial Overview
12.11.4. Product Portfolio
12.11.5. Key Developments
12.11.6. Strategies
12.12. Source Bioscience
12.12.1. Company Snapshot
12.12.2. Overview
12.12.3. Financial Overview
12.12.4. Product Portfolio
12.12.5. Key Developments
12.12.6. Strategies
12.13. Toxikon Corporation
12.13.1. Company Snapshot
12.13.2. Overview
12.13.3. Financial Overview
12.13.4. Product Portfolio
12.13.5. Key Developments
12.13.6. Strategies
12.14. Others
12.14.1. Company Snapshot
12.14.2. Overview
12.14.3. Financial Overview
12.14.4. Product Portfolio
12.14.5. Key Developments
12.14.6. Strategies
CHAPTER 13. RESEARCH APPROACH
13.1. Research Methodology
13.1.1. Initial Data Search
13.1.2. Secondary Research
13.1.3. Primary Research
13.2. Assumptions and Scope
