Industry Outlook
The biological safety testing market is set to reach US$ 8,935.4 Mn by 2026 from US$ 3,120.8 Mn in 2017 growing at an impressive pace with a compounded annual growth rate (CAGR) of 12.5% during the forecast period from 2018 to 2026. The primary features responsible for the biological safety testing market are rising prevalence of chronic diseases and rapid growth in the clinical laboratories worldwide. Global healthcare agencies have sanctioned stringent regulatory norms for the safety and efficacy of medicinal substances. Biologics and gene therapy are the medicine of the future due to rise in personalized medicine and severe adverse effects associated with current allopathic drugs. The limitations associated with this market are dearth of skilled workforce and gross negligence of health in developing countries.
Market Synopsis
Technological advancement and rampant growth in clinical laboratories to support reagents and kits market growth
Reagents and kits are currently leading the products segment for biological safety testing market. The key factors responsible for the dominance of reagents and kits are the rising prevalence of chronic disease and rampant growth in clinical laboratories throughout the globe. Technological advancement has resulted in quick interpretation of biological samples under investigation. Instruments are set to highlight magnificent growth during the forecast period on account of factors such as impressive ergonomic designs, easy to operate and quick turnaround time related to sample analysis and interpretation.
Rise in infectious disease and sanction of stringent regulatory norms drive the vaccines and therapeutics market growth
Vaccines and therapeutics segment will be the leading and fastest growing application segment for biological safety testing market. Rise in infectious disease and stringent regulatory norms sanctioned by healthcare agencies pertaining to safety and efficacy drive the vaccines therapeutics market. Gene therapy will register impressive growth during the forecast period on account of increasing number of patients suffering with advanced stage cancer and severe side effects associated with chemotherapy. There is burgeoning requirement of targeted drug therapy to ensure maximum patient compliance and less side effects.
Availability of diverse range of endotoxin tests is responsible for its supremacy in the test segment
In the present scenario endotoxin tests are dominating the market on account of factors such as increasing adoption by pharmaceutical and biotechnology industries and availability of diverse range of endotoxin tests. Turbidimetric method, gel clot endotoxin test and USP chromogenic endotoxin testing are employed during in process quality control to validate the sterility of manufacturing operation. Bioburden tests propose lucrative market growth during the forecast period due to its enhanced adoption in determining the bioburden limits biologics and medical devices. The recent integration of calorimetric method with bioburden testing has resulted in quick and precise bioburden quantification.
Flourishing biopharmaceutical industries and rising prevalence of chronic disease drive the market growth in North America
North America currently leads the regional segment for biological safety testing market with 35 % share. The features responsible for the impressive market growth in North America are flourishing biopharmaceutical industries and rising prevalence of chronic disease. Domicile of major players such as Charles Rivers Laboratories International, Inc., and Merck & Co., Inc. etc. contributes towards the dominance of North America. In Europe the market growth is determined by factors such as stringent regulatory norms stipulated by European Medical Agency (EMA) primarily focusing on medicine safety and efficacy. Presence of market leaders pioneering in analytical instruments propel the market growth in Europe region. Asia Pacific will progress at a steady pace during the forecast period on account of factors such as increasing demand for biologics, supportive regulatory environment and competitive scenario created by emerging local players.
Historical & Forecast Period
2016 – Historical Year
2017 – Base Year
2018-2026 – Forecast Period
This research report presents the analysis of each segment from 2016 to 2026 considering 2017 as the base year for the research. Compounded annual growth rate (CAGR) for each respective segments are calculated for the forecast period from 2018 to 2026.
Report Scope by Segments
Compounded annual growth rate and market estimation for the forecast period 2018 to 2026 was determined by studying the current market trends prevalent in the biological safety testing market. In the scope of the report the market segmentation is based on by product, application, test and geography.
By Product (2016–2026; US$ Mn)
By Application (2016–2026; US$ Mn)
By Test (2016–2026; US$ Mn)
Geography Segment (2016–2026; US$ Mn)
Medical device manufacturers providing biological safety testing products are Avance Biosciences, Inc., Bsl Biosciences, Charles River Laboratories International, Inc., Cytovance Biologics, Inc., Lonza Group, Merck & Co., Inc., Sigma-Aldrich Corporation, SGS S.A., Toxikon Corporation and Wuxi Pharmatech (Cayman), Inc.
Key questions answered in this report
Chapter 1. Preface
1.1. Report Scope and Description
1.1.1. Purpose of the Report
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology
1.3.1. Phase I-Secondary Research
1.3.2. Phase II-Primary Research
1.3.3. Approach Adopted
1.3.4. Top-down Approach
1.3.5. Bottom-up Approach
1.3.6. Phase III-Expert Panel Review
1.3.7. Assumptions
1.4. Market Segmentation
Chapter 2. Executive Summary
2.1. Global Biological Safety Testing Market Portraiture
2.2. Global Biological Safety Testing Market, by Product, 2017 (US$ Mn)
2.3. Global Biological Safety Testing Market, by Application, 2017 (US$ Mn)
2.4. Global Biological Safety Testing Market, by Test, 2017 (US$ Mn)
2.5. Global Biological Safety Testing Market, by Geography, 2017 (US$ Mn)
Chapter 3. Biological Safety Testing Market: Dynamics and Future Outlook
3.1. Market Overview
3.2. Drivers
3.3. Challenges
3.4. Opportunities
3.5. Attractive Investment Proposition, by Geography, 2017
3.6. Competitive Analysis: Global Biological Safety Testing Market, by Key Players, 2017
Chapter 4. Global Biological Safety Testing Market, by Product
4.1. Overview
4.2. Instruments
4.3. Services
4.4. Reagents and Kits
Chapter 5. Global Biological Safety Testing Market, by Application
5.1. Overview
5.2. Gene Therapy
5.3. Stem Cells
5.4. Tissue & Tissue Based Products
5.5. Blood & Blood Based Products
5.6. Vaccines & Therapeutics
Chapter 6. Global Biological Safety Testing Market, by Test
6.1. Overview
6.2. Sterility Test
6.3. Cell Line Authentication and Characterization Test
6.4. Bioburden Test
6.5. Endotoxin Test
6.6. Adventitious Agent Detection Test
6.7. Residual Host Contamination Detection Test
6.8. Others
Chapter 7. Global Biological Safety Testing Market, by Geography
7.1. Overview
7.2. North America Biological Safety Testing Market Analysis, 2016 – 2026
7.2.1. North America Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
7.2.2. North America Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.2.3. North America Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
7.2.4. North America Biological Safety Testing Market, by Country, 2016 – 2026 (US$ Mn)
7.2.4.1. U.S.
7.2.4.2. Canada
7.3. Europe Biological Safety Testing Market Analysis, 2016 – 2026
7.3.1. Europe Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
7.3.2. Europe Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.3.3. Europe Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
7.3.4. Europe Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
7.3.4.1. U.K.
7.3.4.2. Germany
7.3.4.3. Rest of Europe
7.4. Asia Pacific Biological Safety Testing Market Analysis, 2016 – 2026
7.4.1. Asia Pacific Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
7.4.2. Asia Pacific Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.4.3. Asia Pacific Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
7.4.4. Asia Pacific Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
7.4.4.1. China
7.4.4.2. Japan
7.4.4.3. Rest of Asia Pacific
7.5. Latin America Biological Safety Testing Market Analysis, 2016 – 2026
7.5.1. Latin America Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
7.5.2. Latin America Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.5.3. Latin America Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
7.5.4. Latin America Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
7.5.4.1. Brazil
7.5.4.2. Mexico
7.5.4.3. Rest of Latin America
7.6. Middle East and Africa Biological Safety Testing Market Analysis, 2016 – 2026
7.6.1. MEA Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
7.6.2. MEA Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
7.6.3. MEA Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
7.6.4. MEA Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
7.6.4.1. GCC
7.6.4.2. Rest of MEA
Chapter 8. Company Profiles
8.1. Avance Biosciences, Inc.
8.1.1. Business Description
8.1.2. Financial Information (Subject to data availability)
8.1.3. Product Portfolio
8.1.4. News Coverage
8.2. Bsl Bioservice
8.3. Charles River Laboratories International, Inc.
8.4. Cytovance Biologics, Inc.
8.5. Lonza Group
8.6. Merck & Co., Inc.
8.7. Sigma-Aldrich Corporation
8.8. SGS S.A.
8.9. Toxikon Corporation
8.10. Wuxi Pharmatech (Cayman), Inc.
FIG. 1 Biological Safety Testing Market: Research Methodology
FIG. 2 Biological Safety Testing: Market Segmentation
FIG. 3 Global Biological Safety Testing Market, by Product, 2017 (US$ Mn)
FIG. 4 Global Biological Safety Testing Market, by Application, 2017 (US$ Mn)
FIG. 5 Global Biological Safety Testing Market, by Test, 2017 (US$ Mn)
FIG. 6 Global Biological Safety Testing Market, by Geography, 2017 (US$ Mn)
FIG. 7 Attractive Investment Proposition: by Geography, 2017
FIG. 8 Competitive Analysis: Global Biological Safety Testing Market, by Key Players, 2017
FIG. 9 Global Instruments Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 10 Global Services Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 11 Global Reagents and Kits Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 12 Global Gene Therapy Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 13 Global Stem Cells Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 14 Global Tissue & Tissue Based Products Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 15 Global Blood & Blood Based Products Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 16 Global Vaccine & Therapeutics Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 17 Global Sterility Test Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 18 Global Cell Line Authentication & Characterization Test Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 19 Global Bioburden Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 20 Global Endotoxin Test Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 21 Global Adventitious Agent Detection Test Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 22 Global Residual Host Contamination Detection Test Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 23 Global Other Tests Market for Biological Safety Testing, 2016 – 2026 (US$ Mn)
FIG. 24 U.S. Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 25 Canada Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 26 U.K. Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 27 Germany Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 28 Rest of Europe Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 29 China Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 30 Japan Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 31 Rest of Asia Pacific Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 32 Brazil Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 33 Mexico Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 34 Rest of Latin America Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 35 GCC Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
FIG. 36 Rest of MEA Biological Safety Testing Market, 2016 – 2026 (US$ Mn)
TABLE 1 Global Biological Safety Testing Market Portraiture
TABLE 2 Global Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
TABLE 3 Global Biological Safety Testing Market , by Application, 2016 – 2026 (US$ Mn)
TABLE 4 Global Biological Safety Testing Market , by Test, 2016 – 2026 (US$ Mn)
TABLE 5 Global Biological Safety Testing Market, by Geography, 2016 – 2026 (US$ Mn)
TABLE 6 North America Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
TABLE 7 North America Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
TABLE 8 North America Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
TABLE 9 North America Biological Safety Testing Market, by Country, 2016 – 2026 (US$ Mn)
TABLE 10 Europe Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
TABLE 11 Europe Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
TABLE 12 Europe Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
TABLE 13 Europe Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 14 Asia Pacific Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
TABLE 15 Asia Pacific Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
TABLE 16 Asia Pacific Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
TABLE 17 Asia Pacific Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 18 Latin America Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
TABLE 19 Latin America Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
TABLE 20 Latin America Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
TABLE 21 Latin America Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 22 Middle East and Africa Biological Safety Testing Market, by Product, 2016 – 2026 (US$ Mn)
TABLE 23 Middle East and Africa Biological Safety Testing Market, by Application, 2016 – 2026 (US$ Mn)
TABLE 24 Middle East and Africa Biological Safety Testing Market, by Test, 2016 – 2026 (US$ Mn)
TABLE 25 Middle East and Africa Biological Safety Testing Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 26 Avance Biosciences, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 27 Bsl Bioservices: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 28 Charles River Laboratories International, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 29 Cytovance Biologics, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 30 Lonza Group: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 31 Merck & Co., Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 32 Sigma-Aldrich Corporation: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 33 SGS S.A.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 34 Toxikon Corporation: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 35 Wuxi Pharmatech (Cayman), Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
