Healthcare Market Desk

Biological Safety Testing Market Size, Share, Company Analysis and Forecast 2019-2026

Press release   •   Nov 04, 2019 10:11 EST

The Biological Safety Testing Market size is expected to reach USD 7 Billion by 2026 with CAGR of 5.1% over the forecast period 2019 to 2026. Increase in disposable income coupled with rising concerns about healthcare.

This can be mainly associated with the increasing predominance of lifestyle-associated chronic diseases such as diabetes and cancer that serves as an essential contributing factor towards improving drug development and their following commercialization which are expected to drive the market growth. This is supposed to increase the need to study and ensure the safety of targeted and specific therapies, circumvent probable shortcomings and evaluate their outcomes. As a result of high manufacturing effectiveness, pharmaceutical and biotechnology companies are including biological safety testing tools to offer highly effective and contamination-free biologics to provide to the large population experiencing from target diseases.

Biologics are products manufactured from living organisms and has a unique set of features. Safety of biologics and specialized evaluation of the same is of the highest importance. Biological safety testing is essential for new products launching. Biological safety testing is performed to assure a safe quality and non-contamination of vaccines and biopharmaceuticals.

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Accelerated growth in biotechnology and pharmaceutical industries, increasing prevalence of chronic diseases, rise in population, rise in R&D investment in life sciences, increasing number of innovative product launches, and increasing government support for biotechnology and pharmaceutical industries are some important factors for the North America region to account for the largest share of 37.3% of the market in 2018.

The report analyzes and forecasts the biological safety testing market at global and regional levels. The market has been forecast based on volume (Tons) and value (US$ Mn) from 2019 to 2026. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report comprises a detailed value chain analysis, which provides a comprehensive view of the global biological safety testing market. The Porter’s Five Forces model has also been included to help understand the competitive landscape of the market. The study encompasses market attractiveness analysis, wherein various applications have been benchmarked based on their market size, growth rate, and general attractiveness.

The study provides a decisive view of the biological safety testing market by segmenting it in terms of form and application. The segment has been analyzed based on the present and future trends. Regional segmentation includes the current and projected demand in North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

The report provides size (in terms of volume and value) of biological safety testing market for the base year 2018 and the forecast between 2019 and 2026. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

The main objective of this report is to aid the user in understanding the market as a whole, its definitions, segmentation, market potential, influential trends, and the barriers that it is facing. Meticulous research and analysis were an important part of the report preparation. Those reading the report will be able to get a detailed understanding about the market. Industry experts have verified and checked the data and information that have been taken from credible sources like websites, annual reports of companies, journals, and other resources. In order give the facts and data a pictorial form, diagrams, graphs, pie charts, and other representations have been used. That augments the visual appeal of the report and makes understanding it much easier.

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Key Players:

Key participants include Charles River Laboratories International Inc., SGS SA, Lonza Group, Sigma-Aldrich Corporation, WuXiPharmaTech Inc., Avance Biosciences Inc., BSL Bioservice, Merck KGaA, Cytovance Biologics Inc., and Toxikon Corporation, among others.

Key financial developments of a particular company and product & company overview are some of the elements that help in acquiring information about top vendors in the market. This particular section has also included a SWOT analysis of the companies featured in the report. This will help the audience in knowing about opportunities, strengths, threats and weaknesses that are facing by the key vendors in the chemical and material industry across the world. As the competitive landscape is the most valuable part of any report, it consists of all the required information for the detailed study of top players functioning in the industries. It is also an interesting part to find how exactly these key manufacturers implement various strategies to secure the top rank in the industry. Such an in-depth information is useful for the new entrants into the industry as they would be able to learn a bit from these key vendors. Similarly, the information provided in the research report will also be valuable for the renowned key players as well, as they come to know the strategies of their counterparts to sustain in the competitive industry.

Market Segmentation:

Product Outlook (Revenue, USD Million; 2016-2026)

  • Reagents & kits
  • Instruments
  • Services

Application Outlook (Revenue, USD Million; 2016-2026)

  • Vaccines & therapeutics
  • Stem cell
  • Tissue & tissue-based products
  • Gene therapy
  • Blood & blood-based therapy

Test Type Outlook (Revenue, USD Million; 2016-2026)

  • Endotoxin tests
  • Bioburden tests
  • Adventitious agent detection tests
  • Residual host contamination detection tests
  • Sterility tests
  • Cell line authentication and characterization tests
  • Others

Report coverage

  • Analysis Period: 2015 – 2026
  • Base Year: 2018
  • Forecast Data: 2019 – 2026
  • Regional Scope: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
  • Report Coverage: Market Trends, Drivers, Restraints, Competitive Analysis, Player Profiling, Regulation Analysis

Further key findings from the report suggest

  • Due to increasing demand from biological safety testing laboratories, the instruments product segment accounts for a market share of 31.2% in 2018.
  • Instruments are used to perform bioburden and toxicology tests among the other type of tests.
  • The increasing demand is due to the growing influence of regulatory bodies to implement safety guidelines by the biopharma companies.
  • Reagents and kits product segment is estimated to reach USD 2.73 billion by 2026 at a CAGR of 12.1% during the forecast period.
  • These reagents are attachments and matrix factors, freezing and dissociation reagents, antibiotics, biological buffers, and miscellaneous reagents.
  • Growing advancements and modifications in the formulation of reagents and kits will encourage laboratory technicians in including these products, specifically in toxicology assessment.
  • The increased demand for vaccine and therapeutic segment is due to clearly defined guidelines ensuring the safety of developed vaccines along with the unaltered therapeutic value and decreased toxicity.
  • Regulatory organizations are working towards implementing relevant standards for biological safety to ensure the patient’s safety.
  • Vaccine and therapeutic application is estimated to reach USD 2.62 billion by 2026.
  • Endotoxin tests type accounted for the largest share of 27.6% of the market in 2018.
  • The abundant share is due to the increasing incorporation of these tests in an extensive range of areas of drug manufacturing to decrease the threat of endotoxins during the biopharmaceutical manufacture.
  • Also, availability of various types of endotoxin tests, such as turbidimetric method, gel clot endotoxin testing, and USP chromogenic endotoxin testing, which are intended to suit different requirements, are expected to boost the growth of this segment.
  • Asia Pacific is forecasted to witness the fastest CAGR of 12.6% during the forecast period. Rising healthcare expenditure and increasing concerns due to various benefits of these tools are the significant growth drivers for the market in this region.
  • Economic development coupled with continually increasing per capita healthcare investment in emerging countries such as India, China, and Singapore is expected to create high growth opportunities.
  • Innovations and technological trends in treatment and increased healthcare facilities are expected to drive the growth further

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

Primary research represents a bulk of research efforts, supplemented by extensive secondary research. Annual reports, press releases, and relevant documents of key players operating in various application areas have been reviewed for competition analysis and market understanding.

Secondary research also includes recent trends, technical writing, Internet sources, and statistical data from government websites, trade associations, and agencies. These have proved to be reliable, effective, and successful approaches for obtaining precise market data, capturing market participants’ insights, and recognizing business opportunities.

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Table of Content

Chapter 1. Market Synopsis
1.1. Market Definition
1.2. Research Scope & Premise
1.3. Methodology
1.4. Market Estimation Technique
Chapter 2. Executive Summary
2.1. Summary Snapshot, 2018-2026
Chapter 3. Indicative Metrics
Chapter 4. Biological Safety Testing Market Segmentation & Impact Analysis
4.1. Biological Safety Testing Market Segmentation Analysis
4.2. Industrial Outlook
4.2.1. Market indicators analysis
4.2.2. Market drivers analysis
4.2.2.1. Rising number of biological and pharmaceutical industries
4.2.2.2. Growing R&D investments by government
4.2.3. Market restraints analysis
4.2.3.1. Lack of skilled professionals
4.3. Technological Insights
4.4. Regulatory Framework
4.5. ETOP Analysis
4.6. Porter’s Five Forces Analysis
4.7. Competitive Metric Space Analysis
4.8. Price trend Analysis
Chapter 5. Biological Safety Testing Market By Product Insights & Trends
5.1. Product dynamics & Market Share, 2019 & 2026
5.2. Reagents & kits
5.2.1. Market estimates and forecast, 2016 – 2026 (USD Million)
5.2.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
5.3. Instruments
5.3.1. Market estimates and forecast, 2016 – 2026 (USD Million)
5.3.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
5.4. Services
5.4.1. Market estimates and forecast, 2016 – 2026 (USD Million)
5.4.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
Chapter 6. Biological Safety Testing Market By Test Type Insights & Trends
6.1. Test Type dynamics & Market Share, 2019 & 2026
6.2. Endotoxin tests
6.2.1. Market estimates and forecast, 2016 – 2026 (USD Million)
6.2.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
6.3. Bioburden tests
6.3.1. Market estimates and forecast, 2016 – 2026 (USD Million)
6.3.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
6.4. Adventitious agent detection tests
6.4.1. Market estimates and forecast, 2016 – 2026 (USD Million)
6.4.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
6.5. Residual host contamination detection tests
6.5.1. Market estimates and forecast, 2016 – 2026 (USD Million)
6.5.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
6.6. Sterility tests
6.6.1. Market estimates and forecast, 2016 – 2026 (USD Million)
6.6.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
6.7. Cell line authentication and characterization tests
6.7.1. Market estimates and forecast, 2016 – 2026 (USD Million)
6.7.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
6.8. Others
6.8.1. Market estimates and forecast, 2016 – 2026 (USD Million)
6.8.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
Chapter 7. Biological Safety Testing Market By Application Insights & Trends
7.1. Application dynamics & Market Share, 2019 & 2026
7.2. Vaccines & therapeutics
7.2.1. Market estimates and forecast, 2016 – 2026 (USD Million)
7.2.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
7.3. Stem cell
7.3.1. Market estimates and forecast, 2016 – 2026 (USD Million)
7.3.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
7.4. Tissue & tissue-based products
7.4.1. Market estimates and forecast, 2016 – 2026 (USD Million)
7.4.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
7.5. Gene therapy
7.5.1. Market estimates and forecast, 2016 – 2026 (USD Million)
7.5.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
7.6. Blood & blood-based therapy
7.6.1. Market estimates and forecast, 2016 – 2026 (USD Million)
7.6.2. Market estimates and forecast, by region, 2016 – 2026 (USD Million)
Chapter 8. Biological Safety Testing Market Regional Outlook
8.1. Biological Safety Testing Market share by region, 2019 & 2026
8.2. North America
8.2.1. North America Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.2.2. North America Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.2.3. North America Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.2.4. North America Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.2.5. US
8.2.5.1. US Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.2.5.2. US Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.2.5.3. US Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.2.5.4. US Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.3. Europe
8.3.1. Europe Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.3.2. Europe Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.3.3. Europe Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.3.4. Europe Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.3.5. UK
8.3.5.1. UK Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.3.5.2. UK Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.3.5.3. UK Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.3.5.4. UK Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.3.6. France
8.3.6.1. France Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.3.6.2. France Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.3.6.3. France Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.3.6.4. France Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.4. Asia-Pacific
8.4.1. Asia-Pacific Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.4.2. Asia-Pacific Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.4.3. Asia-Pacific Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.4.4. Asia-Pacific Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.4.5. China
8.4.5.1. China Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.4.5.2. China Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.4.5.3. China Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.4.5.4. China Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.4.6. India
8.4.6.1. India Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.4.6.2. India Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.4.6.3. India Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.4.6.4. India Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.4.7. Japan
8.4.7.1. Japan Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.4.7.2. Japan Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.4.7.3. Japan Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.4.7.4. Japan Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.5. Middle East and Africa
8.5.1. Middle East and Africa Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.5.2. Middle East and Africa Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.5.3. Middle East and Africa Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.5.4. Middle East and Africa Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.6. Latin America
8.6.1. Latin America Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.6.2. Latin America Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.6.3. Latin America Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.6.4. Latin America Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
8.6.5. Brazil
8.6.5.1. Brazil Biological Safety Testing Market estimates and forecast, 2016 – 2026, (USD Million)
8.6.5.2. Brazil Biological Safety Testing Market estimates and forecast By Product, 2016 –2026, (USD Million)
8.6.5.3. Brazil Biological Safety Testing Market estimates and forecast by Test Type, 2016 –2026, (USD Million)
8.6.5.4. Brazil Biological Safety Testing Market estimates and forecast by Application, 2016 –2026, (USD Million)
Chapter 9. Competitive Landscape
9.1. Market Revenue Share by Manufacturers
9.2. Manufacturing Cost Breakdown Analysis
9.3. Mergers & Acquisitions
9.4. Market positioning
9.5. Strategy Benchmarking
9.6. Vendor Landscape
Chapter 10. Company Profiles
10.1. Charles River Laboratories International Inc
10.1.1. Company Overview
10.1.2. Financial Performance
10.1.3. Product Insights
10.1.4. Strategic Initiatives
10.2. Lonza Group
10.2.1. Company Overview
10.2.2. Financial Performance
10.2.3. Product Insights
10.2.4. Strategic Initiatives
10.3. Sigma-Aldrich Corporation
10.3.1. Company Overview
10.3.2. Financial Performance
10.3.3. Product Insights
10.3.4. Strategic Initiatives
10.4. SGS SA
10.4.1. Company Overview
10.4.2. Financial Performance
10.4.3. Product Insights
10.4.4. Strategic Initiatives
10.5. WuXiPharmaTech Inc
10.5.1. Company Overview
10.5.2. Financial Performance
10.5.3. Product Insights
10.5.4. Strategic Initiatives
10.6. Avance Biosciences Inc
10.6.1. Company Overview
10.6.2. Financial Performance
10.6.3. Product Insights
10.6.4. Strategic Initiatives
10.7. BSL Bioservice
10.7.1. Company Overview
10.7.2. Financial Performance
10.7.3. Product Insights
10.7.4. Strategic Initiatives
10.8. Merck KGaA
10.8.1. Company Overview
10.8.2. Financial Performance
10.8.3. Product Insights
10.8.4. Strategic Initiatives
10.9. Cytovance Biologics Inc
10.9.1. Company Overview
10.9.2. Financial Performance
10.9.3. Product Insights
10.9.4. Strategic Initiatives
10.10. Toxikon Corporation
10.10.1. Company Overview
10.10.2. Financial Performance
10.10.3. Product Insights
10.10.4. Strategic Initiatives

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