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Global Biological Safety Testing Products & Services Market by Product (Reagents & Kits, Instruments, Services) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

  • Report ID: NT-73392
  • Author: Up Market Research
  • Rating: 4.9
  • Total Reviews: 79
  • No. Of Pages: 219
  • Format:
  • Pub. Date: 2021-10-21
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Summary of the Report

Global market for biological safety testing products and services was worth USD 2.77 billion in 2018. It is forecast to grow at 12.3% CAGR over the forecast period. Major pharmaceutical and biotech companies are driving the market. Companies have increased production of advanced biologics due to the high prevalence of target diseases worldwide.

Biopharmaceutical companies have seen unprecedented growth due to the rising demand for biologics. Manufacturers are being forced to improve their manufacturing processes in order to increase productivity and reduce costs. In order to help market growth, companies are implementing best manufacturing practices that include thorough biological testing at all levels of the production process.

Over the forecast period, overall growth is expected to be driven by increasing government initiatives to promote biosafety testing products and services. Government and private companies will be encouraged to improve their biological safety procedures due to the high incidence of bioburden and microbial contamination in manufacturing biologics and pharmaceuticals.

The presence of regulatory authorities that enforce safety standards is expected to increase the adoption of testing tools. These authorities issue strict guidelines and recommendations that increase the adoption of testing tools by quality assurance technicians, thereby boosting market growth.

By confirming that there are no bacterial contaminants, biological safety testing services can be used to verify the safety of vaccines. Many companies offer services like toxicology testing and bioburden testing. Analytic testing is used to assess products on parameters like accuracy, specificity and range.

Product Insights

Based on product, kits and reactants accounted for the largest market share in 2018. Based on the product, reagents and kits accounted for the largest market share in 2018. These reagents include antibiotics, attachments and matrix factors, biological buffers as well as miscellaneous. Laboratory technicians will be more likely to use reagents and kit formulations that have undergone rapid changes and modifications, particularly in toxicology assessment.

Due to the rising demand for biological safety testing laboratories, the instruments segment will grow over time. The demand for instruments is also increasing due to the increased pressure from regulators on biopharmaceutical businesses to follow safety guidelines. They are used, among other things, in biological assays that perform toxicology and bioburden testing.

Application Insights

Based on their application in 2018, vaccine and therapeutics accounted for the largest percentage. This segment holds the largest share due to clearly defined guidelines that ensure safety of vaccines, with unchanged therapeutic value and lower toxicity. Segment growth is expected to be driven by several guidelines and recommendations from regulatory agencies such as the U.S. FDA regarding the qualification and characterisation of materials used in vaccine production for infectious disease indications.

The forecast period will see this segment grow at a profitable rate due to factors like an increase in disease incidences. Biological safety tools are being supported by the growing demand for vaccines to protect against diseases. Due to the high risk of contamination by residual DNA, gene treatment will likely grow at a rapid pace during the forecast period. High infectivity and residual DNA could pose a risk to the final product.

Test Type Insights

In 2018, the market for biological safety testing products & services was dominated by endotoxin test revenue. This large share can be attributed largely to the increasing use of these tests in many areas, such as the production and manufacturing of drugs to lower the risk of endotoxins. The availability of many types of endotoxin test, including gel clot, turbidimetric, and USP-chromogenic, will likely boost segment growth.

Over the forecast period, the bioburden testing segment is expected to expand at a profitable rate. These tests are widely used to determine the bioburden limit for a variety of medical devices and biologics. The integration of advanced colorimetric and computational methods has allowed for rapid results and precise bioburden quantification. Segment growth will be further supported by rapid advancements in this area.

Regional Insights

In 2018, North America accounted for the largest portion of the global market. This dominant market share can be attributed in large part to the high level of biotechnology investments, increased cancer research adoption, and the development of new biologics, drugs, and vaccines. Companies are making increasing investments in R&D to drive growth.

Market growth is expected to be boosted by the presence of market leaders who are pursuing extensive expansion plans. The increasing prevalence of chronic diseases in the region will likely increase the use of advanced technologies by healthcare professionals and researchers. This will also increase the potential for growth.

Over the forecast period, the Asia Pacific market will grow at a high CAGR. Growth is expected to be driven by a variety of factors, including rising healthcare spending and increased awareness about the potential benefits of these products. Asia?Pacific Biosafety Association provides training to professionals in the region about biosafety principles, practices, and thus increases growth opportunities.

Market Share in Biological Safety Testing Products & Services

It is highly competitive, and there are many players in the market. Charles River Laboratories is Lonza Group and MilliporeSigma are some of the market leaders. They have a wide range of products and hold significant market share.

For the production of cost-effective and technologically advanced products, market leaders engage in extensive R&D. These companies are also expected to reap lucrative growth opportunities through various strategies such as mergers and acquisitions. Charles River Laboratories, Inc. purchased MPI Research in 2018 to expand its capabilities for drug discovery and development.

Market Report Scope on Biological Safety Testing Products & Services

The Report Covers Certain Segments

This report forecasts revenue growth at the global, regional, and country levels. It also provides analysis of industry trends and potential opportunities in each sub-segment from 2015 to 2026. Grand View Research has divided the market report on biological safety testing products and services based on product, region, test type, and application.

  • Product Outlook (Revenue USD Million, 2015-2026)

    • Kits and Reagents

    • Instruments

    • Services

  • Application Outlook (Revenue USD Million, 2015-2026)

    • Vaccines & Therapeutics

    • Blood and blood-based products

    • Gene Therapy

    • Tissue and tissue-based products

    • Stem Cells

  • Type Outlook Test (Revenue, USD million, 2015-2026)

    • Endotoxin Testing

    • Sterility tests

    • Cell Line Characterization & Authentication Tests

    • Bioburden Tests

    • Adventitious Agent Detection Tests

    • Residual Host Contamination Tests

    • Other

  • Regional Outlook (Revenue USD Million, 2015-2026)

    • 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

These are the most frequently asked questions about this report

b. Global market for biological safety testing products and services was valued at USD 3.11 Billion in 2019. It is projected to grow to USD 3.50 Billion by 2020.

b. Global biological safety testing products and services market will grow at 12.4% compound annual growth rate between 2019-2026, to reach USD 6.90 Billion by 2026.

b. With a 38.68% share in 2019, North America was the dominant market for biological safety testing products and services. The presence of major market players that are expanding their markets is a key reason for this dominance.

b. Charles River Laboratories International, Inc., BSL Bioservice Scientific Laboratories GmbH, Lonza Group AG, Milliporesigma, Sartorius Stedim BioOutsource Limited, and Samsung BioLogics are some of the key players in the market for biological safety testing products and services.

b. The market for biological safety testing products and services is growing due to two key factors: the increase in production by major biotechnology and pharmaceutical companies, and the increasing prevalence of target diseases worldwide.

Up Market Research published a new report titled “Biological Safety Testing Products & Services Market research report which is segmented by Product (Reagents & Kits, Instruments, Services), By Players/Companies Charles River Laboratories International, Inc; BSL Bioservice Scientific Laboratories GmbH; Lonza Group AG; Milliporesigma; Sartorius Stedim BioOutsource Limited; and Samsung BioLogics”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.


Report AttributesReport Details
Report TitleBiological Safety Testing Products & Services Market Research Report
By ProductReagents & Kits, Instruments, Services
By CompaniesCharles River Laboratories International, Inc; BSL Bioservice Scientific Laboratories GmbH; Lonza Group AG; Milliporesigma; Sartorius Stedim BioOutsource Limited; and Samsung BioLogics
Regions CoveredNorth America, Europe, APAC, Latin America, MEA
Base Year2020
Historical Year2018 to 2019 (Data from 2010 can be provided as per availability)
Forecast Year2028
Number of Pages219
Number of Tables & Figures154
Customization AvailableYes, the report can be customized as per your need.

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.


Global Biological Safety Testing Products   Services Industry Outlook

Global Biological Safety Testing Products & Services Market Report Segments:

The market is segmented by Product (Reagents & Kits, Instruments, Services).

Biological Safety Testing Products & Services Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.


Key Benefits for Industry Participants & Stakeholders:

  • Industry drivers, restraints, and opportunities covered in the study
  • Neutral perspective on the market performance
  • Recent industry trends and developments
  • Competitive landscape & strategies of key players
  • Potential & niche segments and regions exhibiting promising growth covered
  • Historical, current, and projected market size, in terms of value
  • In-depth analysis of the Biological Safety Testing Products & Services Market

Overview of the regional outlook of the Biological Safety Testing Products & Services Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.


Biological Safety Testing Products   Services Market Overview

Highlights of The Biological Safety Testing Products & Services Market Report:

  1. The market structure and projections for the coming years.
  2. Drivers, restraints, opportunities, and current trends of Biological Safety Testing Products & Services Market.
  3. Historical data and forecast.
  4. Estimations for the forecast period 2028.
  5. Developments and trends in the market.
        6. By Product:

                1. Reagents & Kits

                2. Instruments

                3. Services

  1. Market scenario by region, sub-region, and country.
  2. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
  3. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
  4. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the Biological Safety Testing Products & Services Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.


How you may use our products:

  • Correctly Positioning New Products
  • Market Entry Strategies
  • Business Expansion Strategies
  • Consumer Insights
  • Understanding Competition Scenario
  • Product & Brand Management
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Biological Safety Testing Products   Services Market Trends

Reasons to Purchase the Biological Safety Testing Products & Services Market Report:

  • The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
  • Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
  • Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
  • The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
  • Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.
Chapter 1 Executive Summary
Chapter 2 Assumptions and Acronyms Used
Chapter 3 Research Methodology
Chapter 4 Biological Safety Testing Products & Services Market Overview
   4.1 Introduction 
      4.1.1 Market Taxonomy 
      4.1.2 Market Definition 
      4.1.3 Macro-Economic Factors Impacting the Market Growth 
   4.2 Biological Safety Testing Products & Services Market Dynamics 
      4.2.1 Market Drivers 
      4.2.2 Market Restraints 
      4.2.3 Market Opportunity 
   4.3 Biological Safety Testing Products & Services Market - Supply Chain Analysis 
      4.3.1 List of Key Suppliers 
      4.3.2 List of Key Distributors 
      4.3.3 List of Key Consumers 
   4.4 Key Forces Shaping the Biological Safety Testing Products & Services Market 
      4.4.1 Bargaining Power of Suppliers 
      4.4.2 Bargaining Power of Buyers 
      4.4.3 Threat of Substitution 
      4.4.4 Threat of New Entrants 
      4.4.5 Competitive Rivalry 
   4.5 Global Biological Safety Testing Products & Services Market Size & Forecast, 2018-2028 
      4.5.1 Biological Safety Testing Products & Services Market Size and Y-o-Y Growth 
      4.5.2 Biological Safety Testing Products & Services Market Absolute $ Opportunity 


Chapter 5 Global Biological Safety Testing Products & Services Market Analysis and Forecast by Product
   5.1 Introduction
      5.1.1 Key Market Trends & Growth Opportunities by Product
      5.1.2 Basis Point Share (BPS) Analysis by Product
      5.1.3 Absolute $ Opportunity Assessment by Product
   5.2 Biological Safety Testing Products & Services Market Size Forecast by Product
      5.2.1 Reagents & Kits
      5.2.2 Instruments
      5.2.3 Services
   5.3 Market Attractiveness Analysis by Product

Chapter 6 Global Biological Safety Testing Products & Services Market Analysis and Forecast by Region
   6.1 Introduction
      6.1.1 Key Market Trends & Growth Opportunities by Region
      6.1.2 Basis Point Share (BPS) Analysis by Region
      6.1.3 Absolute $ Opportunity Assessment by Region
   6.2 Biological Safety Testing Products & Services Market Size Forecast by Region
      6.2.1 North America
      6.2.2 Europe
      6.2.3 Asia Pacific
      6.2.4 Latin America
      6.2.5 Middle East & Africa (MEA)
   6.3 Market Attractiveness Analysis by Region

Chapter 7 Coronavirus Disease (COVID-19) Impact 
   7.1 Introduction 
   7.2 Current & Future Impact Analysis 
   7.3 Economic Impact Analysis 
   7.4 Government Policies 
   7.5 Investment Scenario

Chapter 8 North America Biological Safety Testing Products & Services Analysis and Forecast
   8.1 Introduction
   8.2 North America Biological Safety Testing Products & Services Market Size Forecast by Country
      8.2.1 U.S.
      8.2.2 Canada
   8.3 Basis Point Share (BPS) Analysis by Country
   8.4 Absolute $ Opportunity Assessment by Country
   8.5 Market Attractiveness Analysis by Country
   8.6 North America Biological Safety Testing Products & Services Market Size Forecast by Product
      8.6.1 Reagents & Kits
      8.6.2 Instruments
      8.6.3 Services
   8.7 Basis Point Share (BPS) Analysis by Product 
   8.8 Absolute $ Opportunity Assessment by Product 
   8.9 Market Attractiveness Analysis by Product

Chapter 9 Europe Biological Safety Testing Products & Services Analysis and Forecast
   9.1 Introduction
   9.2 Europe Biological Safety Testing Products & Services Market Size Forecast by Country
      9.2.1 Germany
      9.2.2 France
      9.2.3 Italy
      9.2.4 U.K.
      9.2.5 Spain
      9.2.6 Russia
      9.2.7 Rest of Europe
   9.3 Basis Point Share (BPS) Analysis by Country
   9.4 Absolute $ Opportunity Assessment by Country
   9.5 Market Attractiveness Analysis by Country
   9.6 Europe Biological Safety Testing Products & Services Market Size Forecast by Product
      9.6.1 Reagents & Kits
      9.6.2 Instruments
      9.6.3 Services
   9.7 Basis Point Share (BPS) Analysis by Product 
   9.8 Absolute $ Opportunity Assessment by Product 
   9.9 Market Attractiveness Analysis by Product

Chapter 10 Asia Pacific Biological Safety Testing Products & Services Analysis and Forecast
   10.1 Introduction
   10.2 Asia Pacific Biological Safety Testing Products & Services Market Size Forecast by Country
      10.2.1 China
      10.2.2 Japan
      10.2.3 South Korea
      10.2.4 India
      10.2.5 Australia
      10.2.6 South East Asia (SEA)
      10.2.7 Rest of Asia Pacific (APAC)
   10.3 Basis Point Share (BPS) Analysis by Country
   10.4 Absolute $ Opportunity Assessment by Country
   10.5 Market Attractiveness Analysis by Country
   10.6 Asia Pacific Biological Safety Testing Products & Services Market Size Forecast by Product
      10.6.1 Reagents & Kits
      10.6.2 Instruments
      10.6.3 Services
   10.7 Basis Point Share (BPS) Analysis by Product 
   10.8 Absolute $ Opportunity Assessment by Product 
   10.9 Market Attractiveness Analysis by Product

Chapter 11 Latin America Biological Safety Testing Products & Services Analysis and Forecast
   11.1 Introduction
   11.2 Latin America Biological Safety Testing Products & Services Market Size Forecast by Country
      11.2.1 Brazil
      11.2.2 Mexico
      11.2.3 Rest of Latin America (LATAM)
   11.3 Basis Point Share (BPS) Analysis by Country
   11.4 Absolute $ Opportunity Assessment by Country
   11.5 Market Attractiveness Analysis by Country
   11.6 Latin America Biological Safety Testing Products & Services Market Size Forecast by Product
      11.6.1 Reagents & Kits
      11.6.2 Instruments
      11.6.3 Services
   11.7 Basis Point Share (BPS) Analysis by Product 
   11.8 Absolute $ Opportunity Assessment by Product 
   11.9 Market Attractiveness Analysis by Product

Chapter 12 Middle East & Africa (MEA) Biological Safety Testing Products & Services Analysis and Forecast
   12.1 Introduction
   12.2 Middle East & Africa (MEA) Biological Safety Testing Products & Services Market Size Forecast by Country
      12.2.1 Saudi Arabia
      12.2.2 South Africa
      12.2.3 UAE
      12.2.4 Rest of Middle East & Africa (MEA)
   12.3 Basis Point Share (BPS) Analysis by Country
   12.4 Absolute $ Opportunity Assessment by Country
   12.5 Market Attractiveness Analysis by Country
   12.6 Middle East & Africa (MEA) Biological Safety Testing Products & Services Market Size Forecast by Product
      12.6.1 Reagents & Kits
      12.6.2 Instruments
      12.6.3 Services
   12.7 Basis Point Share (BPS) Analysis by Product 
   12.8 Absolute $ Opportunity Assessment by Product 
   12.9 Market Attractiveness Analysis by Product

Chapter 13 Competition Landscape 
   13.1 Biological Safety Testing Products & Services Market: Competitive Dashboard
   13.2 Global Biological Safety Testing Products & Services Market: Market Share Analysis, 2019
   13.3 Company Profiles (Details – Overview, Financials, Developments, Strategy) 
      13.3.1 Charles River Laboratories International
      13.3.2 Inc; BSL Bioservice Scientific Laboratories GmbH; Lonza Group AG; Milliporesigma; Sartorius Stedim BioOutsource Limited; and Samsung BioLogics
Segments Covered in the Report
The global Biological Safety Testing Products & Services market has been segmented based on

By Product
  • Reagents & Kits
  • Instruments
  • Services
Regions
  • Asia Pacific
  • North America
  • Latin America
  • Europe
  • Middle East & Africa
Key Players
  • Charles River Laboratories International
  • Inc; BSL Bioservice Scientific Laboratories GmbH; Lonza Group AG; Milliporesigma; Sartorius Stedim BioOutsource Limited; and Samsung BioLogics

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