Biological Safety Testing Products & Services Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2028

The global Biological Safety Testing Products & Services market size was valued at US$ 2.80 billion in 2020 and is anticipated to grow at a CAGR of 12.7% during forecast period 2021 to 2028.

Growth Factors

The market is primarily driven by the increasing production of new-generation biologics by major pharmaceutical and biotechnology companies. The high prevalence of target diseases globally has encouraged companies to increase the production of advanced biologics.

The rising need for biologics has resulted in unprecedented growth in the number of biopharmaceutical companies. Increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve aspects of manufacturing processes such as productivity and cost-efficiency. Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of the production cycle, thereby aiding the market growth.

The rising number of government initiatives to promote biological safety testing products and services is anticipated to drive overall growth over the forecast period. The high rate of microbial contamination and bioburden while manufacturing pharmaceuticals and biologics is expected to drive government and private organizations to improve underlying biological safety practices.

Report Highlights

Reagents and kits accounted for the largest market share, based on the product, in 2020. Reagents are a major component in biological safety testing and hence are extensively used in research and clinical laboratories. These reagents are antibiotics, attachments & matrix factors, biological buffers, freezing & dissociation reagents, and miscellaneous reagents. Rapid advancements and modifications in the formulation of reagents and kits are expected to increase their adoption by laboratory technicians, especially in toxicology assessment.

The instruments segment is expected to grow during the forecast period due to rising demand in biological safety testing laboratories. Besides, rising pressure from regulatory bodies on biopharmaceutical companies to implement safety guidelines is also boosting the demand for instruments. These are used in biological assays to perform toxicology and bioburden tests, among others.

This segment is also anticipated to grow at a lucrative rate during the forecast period owing to factors such as a significant increase in disease outbreaks over the years. The increasing need for vaccines to prevent diseases is supporting the adoption of biological safety tools. Moreover, is expected to exhibit growth at a significant rate during the forecast period owing to the high risk of contamination with residual DNA. Residual DNA might be considered to pose a potential risk to the final product due to high infectivity potential.

Endotoxin tests dominated the biological safety testing products and services market in terms of revenue in 2020. The substantial share can be attributed to the rising usage of these tests in various areas such as the manufacturing and production of drugs to reduce the threat of endotoxins. Also, the availability of numerous types of endotoxin tests, such as gel clot endotoxin testing, turbidimetric method, and USP chromogenic endotoxin testing, which are designed to meet different requirements, is likely to boost segment growth.

The bioburden tests segment is expected to grow at a lucrative rate over the forecast period. This can be attributed to the high adoption of these tests to determine the bioburden limit in a wide range of biologics and medical devices. Moreover, the integration of advanced colorimetric methods and computation has enabled the rapid generation of results and precise bioburden quantification. Rapid advancements in this segment are further expected to aid in segment growth.

The presence of major market players undertaking extensive expansion strategies is also expected to boost the market. Moreover, the increasing burden of chronic diseases in this region is anticipated to increase the usage of advanced technologies by researchers and healthcare professionals. This is further anticipated to widen the scope for growth.

Key Players

Charles River Laboratories International, Inc.; BSL Bioservice Scientific Laboratories GmbH; Lonza Group AG; Milliporesigma; Sartorius Stedim BioOutsource Limited; Samsung BioLogics.

Market Segmentation

  • Product Outlook 

    • Reagents & kits

    • Instruments

    • Services

  • Application Outlook

    • Vaccines & Therapeutics

    • Blood & Blood-based Products

    • Gene Therapy

    • Tissue & Tissue-based Products

    • Stem Cell

  • Test Type Outlook

    • Endotoxin Tests

    • Sterility Tests

    • Cell Line Authentication & Characterization Tests

    • Bioburden Tests

    • Adventitious Agent Detection Tests

    • Residual Host Contamination Detection Tests

    • Others

  • Regional Outlook

    • North America

      • The U.S.

      • Canada

    • Europe

      • Germany

      • U.K.

      • France

      • Italy

      • Spain

      • Russia

    • Asia Pacific

      • Japan

      • China

      • India

      • South Korea

      • Australia

      • Singapore

    • Latin America

      • Brazil

      • Mexico

      • Argentina

    • MEA

      • South Africa

      • Saudi Arabia

      • UAE

The Biological Safety Testing Products & Services market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. 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 provides size (in terms of volume and value) of Biological Safety Testing Products & Services market for the base year 2020 and the forecast between 2021 and 2028. 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.

This report focuses on the global Biological Safety Testing Products & Services market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Biological Safety Testing Products & Services market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Biological Safety Testing Products & Services market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Biological Safety Testing Products & Services capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Biological Safety Testing Products & Services by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Biological Safety Testing Products & Services market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Biological Safety Testing Products & Services market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Biological Safety Testing Products & Services market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Biological Safety Testing Products & Services industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Biological Safety Testing Products & Services market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Biological Safety Testing Products & Services market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Biological Safety Testing Products & Services market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Biological Safety Testing Products & Services market. These factors have benefited the growth of the global market for Biological Safety Testing Products & Services. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Biological Safety Testing Products & Services. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Biological Safety Testing Products & Services are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2028

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

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

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2028);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

Chapter 1.  Introduction

1.1.  Research Objective

1.2.  Scope of the Study

1.3.  Definition

Chapter 2.  Research Methodology

2.1.  Research Approach

2.2.  Data Sources

2.3.  Assumptions & Limitations

Chapter 3.  Executive Summary

3.1.  Market Snapshot

Chapter 4.  Market Variables and Scope

4.1.  Introduction

4.2.  Market Classification and Scope

4.3.  Industry Value Chain Analysis

4.3.1.    Raw Material Procurement Analysis

4.3.2.    Sales and Distribution Channel Analysis

4.3.3.    Downstream Buyer Analysis

Chapter 5.  Market Dynamics Analysis and Trends

5.1.  Market Dynamics

5.1.1.    Market Drivers

5.1.2.    Market Restraints

5.1.3.    Market Opportunities

5.2.  Porter’s Five Forces Analysis

5.2.1.    Bargaining power of suppliers

5.2.2.    Bargaining power of buyers

5.2.3.    Threat of substitute

5.2.4.    Threat of new entrants

5.2.5.    Degree of competition

Chapter 6.  Competitive Landscape

6.1.1.    Company Market Share/Positioning Analysis

6.1.2.    Key Strategies Adopted by Players

6.1.3.    Vendor Landscape

6.1.3.1.        List of Suppliers

6.1.3.2.        List of Buyers

Chapter 7.  Global Biological Safety Testing Products & Services Market, By Product

7.1.  Biological Safety Testing Products & Services Market, By Product, 2021-2028

7.1.1.    Reagents & kits

7.1.1.1.        Market Revenue and Forecast (2016-2028)

7.1.2.    Instruments

7.1.2.1.        Market Revenue and Forecast (2016-2028)

7.1.3.    Services

7.1.3.1.        Market Revenue and Forecast (2016-2028)

Chapter 8.  Global Biological Safety Testing Products & Services Market, By Application

8.1.  Biological Safety Testing Products & Services Market, by Application, 2021-2028

8.1.1.    Vaccines & Therapeutics

8.1.1.1.        Market Revenue and Forecast (2016-2028)

8.1.2.    Blood & Blood-based Products

8.1.2.1.        Market Revenue and Forecast (2016-2028)

8.1.3.    Gene Therapy

8.1.3.1.        Market Revenue and Forecast (2016-2028)

8.1.4.    Tissue & Tissue-based Products

8.1.4.1.        Market Revenue and Forecast (2016-2028)

8.1.5.    Stem Cell

8.1.5.1.        Market Revenue and Forecast (2016-2028)

Chapter 9.  Global Biological Safety Testing Products & Services Market, By Test Type

9.1.  Biological Safety Testing Products & Services Market, By Test Type, 2021-2028

9.1.1.    Endotoxin Tests

9.1.1.1.        Market Revenue and Forecast (2016-2028)

9.1.2.    Sterility Tests

9.1.2.1.        Market Revenue and Forecast (2016-2028)

9.1.3.    Cell Line Authentication & Characterization Tests

9.1.3.1.        Market Revenue and Forecast (2016-2028)

9.1.4.    Bioburden Tests

9.1.4.1.        Market Revenue and Forecast (2016-2028)

9.1.5.    Adventitious Agent Detection Tests

9.1.5.1.        Market Revenue and Forecast (2016-2028)

9.1.6.    Residual Host Contamination Detection Tests

9.1.6.1.        Market Revenue and Forecast (2016-2028)

9.1.7.    Others

9.1.7.1.        Market Revenue and Forecast (2016-2028)

Chapter 10.      Global Biological Safety Testing Products & Services Market, Regional Estimates and Trend Forecast

10.1.        North America

10.1.1.  Market Revenue and Forecast, By Product (2016-2028)

10.1.2.  Market Revenue and Forecast, by Application (2016-2028)

10.1.3.  Market Revenue and Forecast, By Test Type (2016-2028)

10.1.4.  U.S.

10.1.4.1.      Market Revenue and Forecast, By Product (2016-2028)

10.1.4.2.      Market Revenue and Forecast, by Application (2016-2028)

10.1.4.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.1.5.  Rest of North America

10.1.5.1.      Market Revenue and Forecast, By Product (2016-2028)

10.1.5.2.      Market Revenue and Forecast, by Application (2016-2028)

10.1.5.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.2.        Europe

10.2.1.  Market Revenue and Forecast, By Product (2016-2028)

10.2.2.  Market Revenue and Forecast, by Application (2016-2028)

10.2.3.  Market Revenue and Forecast, By Test Type (2016-2028)

10.2.4.  UK

10.2.4.1.      Market Revenue and Forecast, By Product (2016-2028)

10.2.4.2.      Market Revenue and Forecast, by Application (2016-2028)

10.2.4.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.2.5.  Germany

10.2.5.1.      Market Revenue and Forecast, By Product (2016-2028)

10.2.5.2.      Market Revenue and Forecast, by Application (2016-2028)

10.2.5.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.2.6.  France

10.2.6.1.      Market Revenue and Forecast, By Product (2016-2028)

10.2.6.2.      Market Revenue and Forecast, by Application (2016-2028)

10.2.6.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.2.7.  Rest of Europe

10.2.7.1.      Market Revenue and Forecast, By Product (2016-2028)

10.2.7.2.      Market Revenue and Forecast, by Application (2016-2028)

10.2.7.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.3.        APAC

10.3.1.  Market Revenue and Forecast, By Product (2016-2028)

10.3.2.  Market Revenue and Forecast, by Application (2016-2028)

10.3.3.  Market Revenue and Forecast, By Test Type (2016-2028)

10.3.4.  India

10.3.4.1.      Market Revenue and Forecast, By Product (2016-2028)

10.3.4.2.      Market Revenue and Forecast, by Application (2016-2028)

10.3.4.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.3.5.  China

10.3.5.1.      Market Revenue and Forecast, By Product (2016-2028)

10.3.5.2.      Market Revenue and Forecast, by Application (2016-2028)

10.3.5.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.3.6.  Japan

10.3.6.1.      Market Revenue and Forecast, By Product (2016-2028)

10.3.6.2.      Market Revenue and Forecast, by Application (2016-2028)

10.3.6.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.3.7.  Rest of APAC

10.3.7.1.      Market Revenue and Forecast, By Product (2016-2028)

10.3.7.2.      Market Revenue and Forecast, by Application (2016-2028)

10.3.7.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.4.        MEA

10.4.1.  Market Revenue and Forecast, By Product (2016-2028)

10.4.2.  Market Revenue and Forecast, by Application (2016-2028)

10.4.3.  Market Revenue and Forecast, By Test Type (2016-2028)

10.4.4.  GCC

10.4.4.1.      Market Revenue and Forecast, By Product (2016-2028)

10.4.4.2.      Market Revenue and Forecast, by Application (2016-2028)

10.4.4.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.4.5.  North Africa

10.4.5.1.      Market Revenue and Forecast, By Product (2016-2028)

10.4.5.2.      Market Revenue and Forecast, by Application (2016-2028)

10.4.5.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.4.6.  South Africa

10.4.6.1.      Market Revenue and Forecast, By Product (2016-2028)

10.4.6.2.      Market Revenue and Forecast, by Application (2016-2028)

10.4.6.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.4.7.  Rest of MEA

10.4.7.1.      Market Revenue and Forecast, By Product (2016-2028)

10.4.7.2.      Market Revenue and Forecast, by Application (2016-2028)

10.4.7.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.5.        Latin America

10.5.1.  Market Revenue and Forecast, By Product (2016-2028)

10.5.2.  Market Revenue and Forecast, by Application (2016-2028)

10.5.3.  Market Revenue and Forecast, By Test Type (2016-2028)

10.5.4.  Brazil

10.5.4.1.      Market Revenue and Forecast, By Product (2016-2028)

10.5.4.2.      Market Revenue and Forecast, by Application (2016-2028)

10.5.4.3.      Market Revenue and Forecast, By Test Type (2016-2028)

10.5.5.  Rest of LATAM

10.5.5.1.      Market Revenue and Forecast, By Product (2016-2028)

10.5.5.2.      Market Revenue and Forecast, by Application (2016-2028)

10.5.5.3.      Market Revenue and Forecast, By Test Type (2016-2028)

Chapter 11.  Company Profiles

11.1.              Charles River Laboratories International, Inc.

11.1.1.  Company Overview

11.1.2.  Product Offerings

11.1.3.  Financial Performance

11.1.4.  Recent Initiatives

11.2.              BSL Bioservice Scientific Laboratories GmbH

11.2.1.  Company Overview

11.2.2.  Product Offerings

11.2.3.  Financial Performance

11.2.4.  Recent Initiatives

11.3.              Lonza Group AG

11.3.1.  Company Overview

11.3.2.  Product Offerings

11.3.3.  Financial Performance

11.3.4.  Recent Initiatives

11.4.              Milliporesigma

11.4.1.  Company Overview

11.4.2.  Product Offerings

11.4.3.  Financial Performance

11.4.4.  Recent Initiatives

11.5.              Sartorius Stedim BioOutsource Limited

11.5.1.  Company Overview

11.5.2.  Product Offerings

11.5.3.  Financial Performance

11.5.4.  Recent Initiatives

11.5.5.  Recent Initiatives

11.6.              Samsung BioLogics.

11.6.1.  Company Overview

11.6.2.  Product Offerings

11.6.3.  Financial Performance

11.6.4.  Recent Initiatives

Chapter 12.  Research Methodology

12.1.              Primary Research

12.2.              Secondary Research

12.3.              Assumptions

Chapter 13.  Appendix

13.1.              About Us

Glossary of Terms

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