Biological Safety Testing Market

Industry Outlook

The biological safety testing market is expected to reach US$ 8,935.4 million by 2026, up from US$ 3,120.8 million in 2017, with a compounded annual growth rate (CAGR) of 12.5% from 2018 to 2026. The primary features responsible for the biological safety testing market are the rising prevalence of chronic diseases and the rapid growth of 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 the rise of personalized medicine and the severe adverse effects associated with current allopathic drugs. The limitations associated with this market are the dearth of a skilled workforce and the gross negligence of health in developing countries.

Market Synopsis

Technological advancement and rampant growth in clinical laboratories support the growth of the market for reagents and kits.

Reagents and kits are currently leading the product segment for the biological safety testing market. The key factors responsible for the dominance of reagents and kits are the rising prevalence of chronic disease and the rampant growth of clinical laboratories throughout the globe. Technological advancement has resulted in the 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, ease of operation, and quick turnaround time related to sample analysis and interpretation.

The rise in infectious diseases and the implementation of stringent regulatory standards drive the vaccine and therapeutics market.

The vaccines and therapeutics segment will be the leading and fastest-growing application segment for the biological safety testing market. The rise in infectious diseases and stringent regulatory norms sanctioned by healthcare agencies pertaining to safety and efficacy drive the vaccine therapeutics market. Gene therapy will register impressive growth during the forecast period on account of the increasing number of patients suffering from advanced-stage cancer and the severe side effects associated with chemotherapy. There is a burgeoning requirement for targeted drug therapy to ensure maximum patient compliance with fewer side effects.

The availability of a 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 the pharmaceutical and biotechnology industries and the availability of a diverse range of endotoxin tests. The turbidimetric method, gel clot endotoxin test, and USP chromogenic endotoxin test are employed during in-process quality control to validate the sterility of manufacturing operations. Bioburden tests propose lucrative market growth during the forecast period due to their enhanced adoption in determining the bioburden limits of biologics and medical devices. The recent integration of the calorimetric method with bioburden testing has resulted in quick and precise bioburden quantification.

Flourishing biopharmaceutical industries and the rising prevalence of chronic disease drive market growth in North America.

North America currently leads the regional segment for the biological safety testing market with 35 %of the market. The flourishing biopharmaceutical industries and the rising prevalence of chronic diseases are the factors driving North America’s impressive market growth.The domicile of major players such as CharlesRivers Laboratories International, Inc., Merck & Co., Inc., etc., contributes to the dominance of North America. In Europ,e-market growth is determined by factors such as stringent regulatory norms stipulated by the European Medical Agency(EMA),) primarily focusing on medicine safety and efficacy. The presence of market leaders who are pioneers in analytical instruments drives the market growth in Europe. Asia Pacific will progress at a steady pace during the forecast period on account of factors such as increasing demand for biologics, a supportive regulatory environment, and ad competitive scenario created by emerging local players.

Periods of History and Forecast

2016 is a historic 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. The compound annual growth rate (CAGR) for each of the respective segments is calculated for the forecast period from 2018 to 2026.

Report Scope by Segments

The compound annual growth rate and market estimation for the forecast period of 2018 to 2026 were 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 product, application, test, and geography.

By Product (2016-2026; US Dollar Millions)

• Instruments
• Services
• Reagents and Kits

According to Application (2016-2026; US$ Mn)

• Gene Therapy
• Stem Cells
• Tissue and Tissue-Based Products
• Blood and Blood-Based Products
• Vaccines and Therapeutics

By test (2016-2026; millions of dollars)

• Sterility Test
• Cell Line Authentication and Characterization Test
• Bioburden Test
• Endotoxin Test
• Adventitious Agent Detection Test
• Residual Host Contamination Detection Test
• Others

Geography Segment (2016-2026; millions of dollars)

• North America

• • United States
  • Canada
• Europe
  • United Kingdom
  • Germany
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • Rest of Asia Pacific
• Latin America (LATAM)
  • Brazil
  • Mexico
  • rest of Latin America
• Middle East and Africa (MEA)
  • GCC
  • the remainder of MEA

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 are answered in this report.

• What are the drivers, restraints, and opportunities related to the biological safety testing market?
• Who are the key players providing biological safety testing products?
• Which is the leading and fastest-growing product segment for the biological safety testing market?
• Which is the leading and fastest-growing test segment for the biological safety testing market?
• Which is the largest and fastest-growing application segment for the biological safety testing market?
• Which is the largest and fastest-growing regional segment for the biological safety testing market?

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.

List of Figures

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)

List of Tables

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)