Biologics Safety Testing Market by Product (Instruments, Services, Kits & Reagents), Test (Endotoxin, Sterility Test, Cell Line Authentication, Bioburden), Application (Vaccine Development, Blood Products, Stem Cell Research) - Global Forecast to 2022
[139 Pages Report] Biologics are pharmaceutical products that are extracted from biological sources. Biologics safety testing is carried out by manufacturers to detect contaminants like bacterial toxins, mycoplasma, and viruses. It is a mandatory process in these companies for the quality control of raw materials as well as for process control and validation of end products. The global biologics safety testing market is expected to reach USD 4.90 Billion by 2022 from USD 2.75 Billion in 2017, at a CAGR of 12.2% during forecast period. The major factors driving the growth of this market are the growth in pharmaceutical & biotechnology industry driven by government support, the positive trend of R&D investment in the life science sector, increasing number of drug launches, and high incidence & large economic burden of chronic diseases. In the coming years, emerging markets and increasing pharmaceutical outsourcing are expected to offer growth opportunities for players in the biologics safety testing market.
By product, kits & reagents segment is expected to grow at the highest growth rate during the forecast period
The kits & reagents segment is projected to register the highest during the forecast period. The growth of this market segment is driven by repeat purchase of kits and reagents as compared to instruments and increasing adoption of kit-based testing.
By application, Vaccine and Therapeutics Development segment to record the highest CAGR during the forecast period
Vaccine and Therapeutics Development segment is projected to register a higher CAGR during the forecast period. Factors such as the rising prevalence of diseases, increasing initiatives for immunization, and increasing company investments in vaccine development are expected to drive the growth of this market segment.
By test type, endotoxin test segment to record the highest CAGR during the forecast period
Endotoxin test segment is projected to register a higher CAGR during the forecast period. The market is mainly driven by the increase in disease prevalence and growth in the number of drug launches. Moreover, Endotoxin testing is used in cell therapy, monoclonal antibody testing, vaccine testing, gene therapy, and drug development.
North America to account for the largest market size during the forecast period.
North America is expected to account for the largest share of this market. The strong R&D trend in life sciences and growth in pharmaceutical industries will drive the biologics safety testing market in the North American region.
Market Dynamics
Driver: Growth in pharmaceutical and biotechnology industries driven by government support
Pharmaceutical and biotechnology companies are the largest end users in the biologics safety testing market. Biologics safety testing is carried out at all levels of manufacturing to minimize the risk of product contamination in these industries. According to the International Trade Administration, the global pharmaceuticals market is projected to grow from USD 1 trillion in 2015 to USD 1.3 trillion by 2020, at a CAGR of 4.9%.
- According to the India Brand Equity Foundation, the Indian biotech industry market is expected to reach USD 100 billion by 2020 from USD 11 billion in 2016.
- According to the India Brand Equity Foundation, the Indian pharmaceuticals market is expected to reach USD 55 billion by 2020 from USD 36.7 billion in 2016, at a CAGR of 15.92%
Such funding activities help increase the purchasing power of major research institutes, which, in turn, drives the market for biologics safety testing.
Opportunity: Increasing pharmaceutical outsourcing
CROs act as outsourcing partners for pharmaceutical & biotechnology companies and academic institutes. CROs provide a number of services such as cell and virus bank characterization, genetic stability testing, raw material testing, bulk-lot release testing, final product release testing, sterility testing services, analytical services for biologics, biodistribution studies, immunoassay & cell-based assay services, cleaning validation studies, biorepository services, next-generation sequencing, and endotoxin determination. Several pharmaceutical & biotechnology companies and academic institutes opt to outsource numerous core functions like manufacturing, clinical trial management, and portions of drug discovery to CROs. This is done because the emergence of new technologies has made it unfeasible for companies to undertake all testing functions in-house. CROs can afford to invest in extensive drug discovery infrastructure as they cater to multiple clients. Thus, through outsourcing various functions to CROs, pharmaceutical and biotechnology companies can reduce their operational costs and R&D budgets. Cost savings, commercial sustainability, and optimal staffing are some of the key advantages driving the outsourcing of analytical testing and clinical trial services for large companies. In addition, expanding pipelines of pharmaceutical and biopharmaceutical companies is further expected to drive the outsourcing of biologics safety testing to CROs.
Challenge: Dearth of skilled professionals
The success of biological safety tests depends mainly on the expertise of the analysts themselves as much as the environmental conditions under which the test is performed. For optimal efficacy, biologics safety testing needs to be conducted by skilled professionals with sufficient knowledge of the nuances of this field. Handling the instruments used in biologics safety testing also requires expertise. Consequently, the lack of a skilled workforce poses a key challenge to the growth of the biologics safety testing marketScope of the Report
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Report Metric |
Details |
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Market size available for years |
20162022 |
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Base year considered |
2016 |
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Forecast period |
20172022 |
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Forecast units |
Million (USD) |
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Segments covered |
Product and Services
By Test Type
By Application
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Geographies covered |
North America, Europe, Asia, RoW |
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Companies covered |
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The research report categorizes the biologics safety testing market into the following segments and subsegments:
By Product
- Kits & Reagents
- Services
- Instruments
By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
By Region
- North America
- US
- Canada
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe (RoE)
- Asia
- Japan
- China
- India
- Rest of Asia
- RoW
- South America, Central America, And the Caribbean
- Pacific and Oceania
- Africa
Key Market Players
Lonza Group LTD, Charles River Laboratories, Merck KGaA, SGS SA, WuXi Apptec, Thermo Fisher Scientific Inc, Sartorius AG, Cytovance Biologics, Inc, Pace Analytical Services Inc, and Toxikon Corporation.
Recent Developments
Critical questions the report answers:
- Where will all these developments take the industry in the long term?
- What are the upcoming trends for the biologics safety testing market?
- Which segment provides the most opportunity for growth?
- Who are the leading vendors operating in this market?
- What are the opportunities for new market entrants?
To speak to our analyst for a discussion on the above findings, click Speak to Analyst
Table Of Contents
1 Introduction (Page No. - 13)
1.1 Objectives of The Study
1.2 Market Definition
1.2.1 Markets Covered
1.2.2 Years Considered for The Study
1.3 Currency
1.4 Limitations
1.5 Stakeholders
2 Research Methodology (Page No. - 16)
2.1 Research Approach
2.2 Research Data
2.2.1 Secondary Sources
2.2.1.1 Key Data From Secondary Sources
2.2.2 Primary Sources
2.2.2.1 Key Data From Primary Sources
2.2.2.2 Breakdown of Primary Interviews
2.3 Market Size Estimation
2.4 Market Breakdown and Data Triangulation
2.5 Research Assumptions
3 Executive Summary (Page No. - 23)
4 Premium Insights (Page No. - 27)
4.1 Biologics Safety Testing: Market Overview
4.2 Geographic Analysis: Biologics Safety Testing Market,By Product & Service (2017)
4.3 Geographic Snapshot of The Biologics Safety Testing Market
4.4 Biologics Safety Testing Market,By Application 2017 vs 2022
5 Market Overview (Page No. - 31)
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Growth in Pharmaceutical and Biotechnology Industries Driven By Government Support
5.2.1.2 Positive Trend of R&D Investments in Life Science
5.2.1.3 Increase in Number of Drug Launches
5.2.1.4 High Incidence and Large Economic Burden of Chronic Diseases
5.2.2 Opportunities
5.2.2.1 Emerging Markets
5.2.2.2 Increasing Pharmaceutical Outsourcing
5.2.3 Challenge
5.2.3.1 Dearth of Skilled Professionals
6 Biologics Safety Testing Market,By Product and Service (Page No. - 36)
6.1 Introduction
6.2 Kits & Reagents
6.3 Services
6.4 Instruments
7 Biologics Safety Testing Market, By Test Type (Page No. - 40)
7.1 Introduction
7.2 Endotoxin Tests
7.3 Sterility Tests
7.4 Cell Line Authentication and Characterization Tests
7.5 Bioburden Tests
7.6 Residual Host Contaminant Detection Tests
7.7 Adventitious Agent Detection Tests
7.8 Other Tests
8 Biologics Safety Testing Market, By Application (Page No. - 47)
8.1 Introduction
8.2 Vaccine & Therapeutics Development
8.3 Blood and Blood-Related Products Testing
8.4 Cellular and Gene Therapy
8.5 Tissue and Tissue-Related Products Testing
8.6 Stem Cell Research
9 Biologics Safety Testing Market, By Region (Page No. - 53)
9.1 Introduction
9.2 North America
9.2.1 U.S.
9.2.2 Canada
9.3 Europe
9.3.1 Germany
9.3.2 U.K.
9.3.3 France
9.3.4 Italy
9.3.5 Spain
9.3.6 Rest of Europe (RoE)
9.4 Asia
9.4.1 China
9.4.2 Japan
9.4.3 India
9.4.4 Rest of Asia
9.5 Rest of the World
9.5.1 South America,Central America, and the Caribbean
9.5.2 Pacific and Oceania
9.5.3 Africa
10 Competitive Landscape (Page No. - 91)
10.1 Overview
10.1.1 Visionary Leaders
10.1.2 Innovators
10.1.3 Dynamic Differentiators
10.1.4 Emerging Companies
10.2 Competitive Benchmarking
10.2.1 Strength of Product Portfolio
10.2.2 Business Strategy Excellence
10.3 Market Share Analysis
*Top 25 Companies Analyzed for This Studies are - Sartorius AG (Germany),SGS SA (Switzerland),Thermo Fisher Scientific,Inc. (U.S.),Lonza Group LTD (Switzerland),Charles River Laboratories,Inc. (U.S.),Merck KGaA (Germany),Eurofins Scientific Se (Luxembourg),Source Bioscience (U.K.),F. Hoffmann-La Roche LTD. (Switzerland),Cytovance Biologics (U.S.),Toxikon Corporation (U.S.),Avance Biosciences Inc. (U.S.),Pace Analytical Services LLC. (U.S.),Wuxi Apptec (China),Biomιrieux Sa (France),Sterigenics International LLC (U.S.),Clean Cells (France),Bsl Bioservice Scientific Laboratories Munich GmbH (Germany),North American Science Associates Inc. (U.S.),Promocell GmbH (Germany),Genscript (China),Gibraltar Laboratories (U.S.),Invivogen (U.S.),Neopharm Labs Inc. (Canada),Virusure GmbH (Austria)
11 Company Profiles (Page No. - 97)
(Overview,Products Offered,Product Offering Scorecard,Business Strategy Scorecard,Recent Developments)*
11.1 Charles River Laboratories International,Inc.
11.1.1 Overview
11.1.2 Product Offering Scorecard
11.1.3 Business Srategy Scorecard
11.1.4 Recent Development
11.2 Merck KGaA
11.2.1 Overview
11.2.2 Product Offering Scorecard
11.2.3 Business Srategy Scorecard
11.2.4 Recent Development
11.3 Lonza Group LTD.
11.3.1 Overview
11.3.2 Product Offering Scorecard
11.3.3 Business Srategy Scorecard
11.3.4 Recent Development
11.4 SGS S.A.
11.1.1 Overview
11.1.2 Product/Service Offering Scorecard
11.1.3 Business Srategy Scorecard
11.1.4 Recent Development
11.5 Thermo Fisher Scientific Inc.
11.5.1 Overview
11.5.2 Product Offering Scorecard
11.5.3 Business Srategy Scorecard
11.5.4 Recent Development
11.6 Wuxi Apptec
11.7 Sartorius AG
11.8 Cytovance Biologics,Inc.
11.9 Pace Analytical Services Inc.
11.10 Toxikon Corporation
11.11 Eurofins Scientific Se
11.12 Avance Biosciences Inc.
11.13 Source Bioscience
*Details on Marketsandmarkets View,Overview,Products Offered,Product Offering Scorecard,Business Strategy Scorecard,And Recent Developments Might Not Be Captured in Case of Unlisted Companies.
12 Appendix (Page No. - 131)
12.1 Insights of Industry Experts
12.2 Discussion Guide
12.1 Knowledge Store: Marketsandmarkets Subscription Portal
12.2 Introducing RT: Real-Time Market Intelligence
12.3 Available Customizations
12.4 Related Reports
12.5 Author Details
List of Tables (66 Tables)
Table 1 Biologics Safety Testing Market Summary
Table 2 Biologics Safety Testing Market,By Product and Service,20152022 (USD Million)
Table 3 Biologics Safety Testing Kits and Reagents Market,By Region,20152022 (USD Million)
Table 4 Biologics Safety Testing Services Market,By Region,20152022 (USD Million)
Table 5 Biologics Safety Testing Instruments Market,By Region,20152022 (USD Million)
Table 6 Biologics Safety Testing Market Size,By Test Type,20152022 (USD Million)
Table 7 Endotoxin Tests Market,By Region,20152022 (USD Million)
Table 8 Sterility Tests Market,By Region,20152022 (USD Million)
Table 9 Cell Line Authentication and Characterization Tests Market,By Region,20152022 (USD Million)
Table 10 Bioburden Tests Market,By Region,20152022 (USD Million)
Table 11 Residual Host Contaminant Detection Tests Market,By Region,20152022 (USD Million)
Table 12 Adventitious Agent Detection Tests Market,By Region,20152022 (USD Million)
Table 13 Other Biologics Safety Tests Market,By Region,20152022 (USD Million)
Table 14 Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 15 Biologics Safety Testing Market for Vaccine and Therapeutics Development,By Region,20152022 (USD Million)
Table 16 Biologics Safety Testing Market for Blood and Blood-Related Products Testing,By Region,20152022 (USD Million)
Table 17 Biologics Safety Testing Market for Cellular and Gene Therapy Products,By Region,20152022 (USD Million)
Table 18 Biologics Safety Testing Market for Tissue and Tissue-Related Products Testing,By Region,20152022 (USD Million)
Table 19 Biologics Safety Testing Market for Stem Cell Research,By Region,20152022 (USD Million)
Table 20 Biologics Safety Testing Market,By Region,20152022 (USD Million)
Table 21 North America: Biologics Safety Testing Market,By Country,20152022 (USD Million)
Table 22 North America: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 23 North America: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 24 North America: Biologics Safety Testing Market,By Test Type,20152022 (USD Million)
Table 25 U.S.: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 26 U.S.: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 27 Canada: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 28 Canada: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 29 Europe: Biologics Safety Testing Market,By Country,20152022 (USD Million)
Table 30 Europe: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 31 Europe: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 32 Europe: Biologics Safety Testing Market,By Test Type,20152022 (USD Million)
Table 33 Germany: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 34 Germany: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 35 U.K.: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 36 U.K.: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 37 France: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 38 France: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 39 Italy: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 40 Italy: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 41 Spain: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 42 Spain: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 43 RoE: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 44 RoE: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 45 Asia: Biologics Safety Testing Market,By Country,20152022 (USD Million)
Table 46 Asia: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 47 Asia: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 48 Asia: Biologics Safety Testing Market,By Test Type,20152022 (USD Million)
Table 49 China: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 50 China: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 51 Japan: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 52 Japan: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 53 India: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 54 India: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 55 Rest of Asia: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 56 Rest of Asia: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 57 RoW: Biologics Safety Testing Market,By Region,20152022 (USD Million)
Table 58 RoW: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 59 RoW: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 60 RoW: Biologics Safety Testing Market,By Test Type,20152022 (USD Million)
Table 61 South America,Central America,& The Caribbean: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 62 South America,Central America,& The Caribbean: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 63 Pacific and Oceania: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 64 Pacific and Oceania: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
Table 65 Africa: Biologics Safety Testing Market,By Application,20152022 (USD Million)
Table 66 Africa: Biologics Safety Testing Market,By Product & Service,20152022 (USD Million)
List of Figures (35 Figures)
Figure 1 Research Design
Figure 2 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 3 Market Size Estimation Methodology: Bottom-Up Approach
Figure 4 Market Size Estimation Methodology: Top-Down Approach
Figure 5 Data Triangulation Methodology
Figure 6 Biologics Safety Testing Market Size, By Product & Service,2017 vs 2022 (USD Million)
Figure 7 Biologics Safety Testing Market Size, By Application,2017 vs 2022 (USD Million)
Figure 8 Biologics Safety Testing Market Size, By Test Type,2017 vs 2022 (USD Million)
Figure 9 Biologics Safety Testing Market Size, By Region,2017 vs 2022 (USD Million)
Figure 10 Biologics Safety Testing Market to Register A High, Double-Digit Growth Rate in The Forecast Period
Figure 11 Kits & Reagents Segment to Dominate The Biologics Safety Testing Market in 2017
Figure 12 Asia to Register The Highest CAGR During The Forecast Period
Figure 13 Vaccine and Therapeutics Development Will Continue to Dominate The Biologics Safety Testing Market 2022
Figure 14 Biologics Safety Testing Market: Drivers,Restraints,Opportunities,& Challenges
Figure 15 Kits & Reagents Segment to Dominate The Biologics Safety Testing Market During The Forecast Period
Figure 16 Endotoxin Tests Segment to Dominate The Biologics Safety Testing Market During The Forecast Period
Figure 17 Vaccine & Therapeutics Development to Dominate The Biologics Safety Testing Market During The Forecast Period
Figure 18 North America to Dominate The Biologics Safety Testing Market in 2017
Figure 19 Asia to Register The Highest CAGR During The Forecast Period (20172022)
Figure 20 U.S. to Witness The Highest Growth Rate in The North American Biologics Safety Testing Market During The Forecast Period (20172022)
Figure 21 North America: Biologics Safety Testing Market Snapshot
Figure 22 Germany to Witness The Highest Growth Rate in The European Biologics Safety Testing Market During The Forecast Period (20172022)
Figure 23 Asia: Biologics Safety Testing Market, By Country (2017)
Figure 24 Asia: Biologics Safety Testing Market Snapshot
Figure 25 Rest of The World: Biologics Safety Testing Market, By Region (2017)
Figure 26 Biologics Safety Testing Market (Global) Competitiv e Leadership Mapping,2017
Figure 27 Biologics Safety Testing Market: Market Share (2016)
Figure 28 Charles River Laboratories International, Inc.: Company Snapshot (2016)
Figure 29 Merck KGaA: Company Snapshot (2016)
Figure 30 Lonza Group LTD.: Company Snapshot (2016)
Figure 31 SGS S.A.: Company Snapshot (2016)
Figure 32 Thermo Fisher Scientific Inc.: Company Snapshot (2016)
Figure 33 Sartorius AG: Company Snapshot (2016)
Figure 34 Eurofins Scientific Se: Company Snapshot (2016)
Figure 35 Source Bioscience: Company Snapshot (2015)
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