Global bioprocess validation market is anticipated to undergo a double digit CAGR during the forecast period owing to high demand for outsourcing of bioprocess validation services and increasing R&D spending by life science industry. Furthermore, advancements in the field of pharmaceutical manufacturing and emphasis on reducing production cost across pharmaceutical and food companies are acting as major growth drivers for global bioprocess validation market. Stringent safety and quality regulations related to product certification and testing across biopharmaceutical and pharmaceutical industries is also a key factor for market growth.

Moreover, launch of new drugs in the pharmaceutical sector and growing use of use of sophisticated facilities in the pharmaceutical industry are boosting the growth of bioprocess validation market. The market is also facing a growing demand from emerging economies such as India and China.

Global bioprocess validation market can be segmented based on test type, process component, end user and region. Based on process component, the market is segmented into bioreactors, filter elements, freezing and thawing process bags, media containers and bags, mixing systems and transfer systems. Among them, filter elements segment is anticipated to witness high demand during the forecast period owing to increasing usage of a variety of filters in bioprocessing. They ensure the safety and efficacy of biopharmaceutical products, which is acting as a major growth driver for this segment.

Based on end user, the global bioprocess validation market is categorized into Contract Development & Manufacturing Organizations (CDMO), biotechnology and pharmaceutical companies. Among them, pharmaceutical companies are expected to account for largest market share through 2025 owing to increasing production of biopharmaceuticals and presence of regulations regarding the quality and validity of bioprocesses involved in the production.

Based on region, Asia Pacific is anticipated to hold largest market share through 2025 owing to increasing number of biopharmaceutical manufacturing companies in Asian countries and high demand for outsourcing bioprocess validation.

Major companies operating in global bioprocess validation market include Sartorius Stedim Biotech S.A., Pall Corporation, Eurofins Scientific, SGS S.A., Cobetter Filtration Equipment Co., Ltd., Merck KGaA, Thermo Fisher Scientific Inc., Toxikon Corporation, Meissner Filtration Products, Inc., Doc S.R.L., Hangzhou Anow Microfiltration Co., Ltd., Almac Group, Tianshan Precision Filter Material Co., Ltd. and Porvair plc, among others. The companies are investing on R&D activities to launch novel and superior quality products into the global market.

Years considered for this report:

Historical Years: 2015-2018

Base Year: 2019

Estimated Year: 2020

Forecast Period: 2021–2025

Objective of the Study:

  • To analyze and forecast the market size of global bioprocess validation market.
  • To forecast global bioprocess validation market based on test type, process component, end user, company and regional distribution.
  • To identify drivers and challenges for global bioprocess validation market.
  • To examine competitive developments such as expansions, new product launches, mergers & acquisitions etc. in global bioprocess validation market.
  • To identify and analyze the profile of leading players operating in the global bioprocess validation market.


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TechSci Research performed both primary as well as exhaustive secondary research for this study. Initially, TechSci Research sourced a list of bioprocess validation companies across the globe. Subsequently, TechSci Research conducted primary research surveys with the identified companies. While interviewing, the respondents were also enquired about their competitors. Through this technique, TechSci Research could include the companies which could not be identified due to the limitations of secondary research.

TechSci Research calculated global bioprocess validation market size using a bottom-up approach, where data for various end user industries and its application across various product types were recorded and forecast for the future years. TechSci Research sourced these values from the industry experts and company representatives and externally validated through analyzing historical data of these product types and applications for getting an appropriate, overall market size. Various secondary sources such as company websites, news articles, press releases, company annual reports, investor presentations and financial reports were also used by TechSci Research.


Key Target Audience:

  • Bioprocess validation companies/partners, service providers and other stakeholders
  • Government bodies such as regulating authorities and policy makers
  • Organizations, industry associations, forums and alliances related to bioprocess validation
  • Market research and consulting firms

The study is useful in providing answers to several critical questions that are important for the industry stakeholders such as bioprocess validation companies, end users etc., besides allowing them in strategizing investments and capitalizing on market opportunities.

Report Scope:

In this report, global bioprocess validation market has been segmented into following categories, in addition to the industry trends which have also been detailed below:

  • Global Bioprocess Validation Market, By Test Type:
    • Bacterial Retention
    • Extractables & Leachables
    • Integrity Testing
    • Compatibility Testing
    • Microbiology Testing
    • Patent Safety Evaluation
  • Global Bioprocess Validation Market, By Process Component:
    • Bioreactors
    • Filter Elements
    • Freezing and Thawing Process Bags
    • Media Containers and Bags
    • Mixing Systems
    • Transfer Systems
  • Global Bioprocess Validation Market, By End User:
    • Contract Development & Manufacturing Organizations (CDMO)
    • Biotechnology
    • Pharmaceutical Companies
  • Global Bioprocess Validation Market, By Region:
    • Asia-Pacific
      • China
      • Japan
      • India 
      • South Korea
      • Australia
      • Singapore
    • Europe
      • France
      • Germany
      • United Kingdom
      • Italy
      • Spain
    • North America
      • United States
      • Mexico
      • Canada
    • South America
      • Brazil
      • Argentina
      • Colombia
    • Middle East & Africa
      • South Africa
      • Saudi Arabia
      • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in global bioprocess validation market.

Available Customizations:

With the given market data, TechSci Research offers customizations according to a company’s specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Profit Margin Analysis

  • Profit margin analysis in case of direct and indirect sales channel.
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1.    Product Overview

2.    Research Methodology

3.    Impact of COVID-19 on Global Bioprocess Validation Market

4.    Executive Summary

5.    Voice of Customer

6.    Global Bioprocess Validation Market Outlook

6.1.  Market Size & Forecast

6.1.1.     By Value

6.2.  Market Share & Forecast

6.2.1.     By Test Type (Bacterial Retention, Extractables & Leachables, Integrity Testing, Compatibility Testing, Microbiology Testing, Patent Safety Evaluation)

6.2.2.     By Process Component (Bioreactors, Filter Elements, Freezing and Thawing Process Bags, Media Containers and Bags, Mixing Systems, Transfer Systems)

6.2.3.     By End User (Contract Development & Manufacturing Organizations (CDMO), Biotechnology, Pharmaceutical Companies)

6.2.4.     By Company (2019)

6.2.5.     By Region

6.3.  Market Attractiveness Index

7.    Asia-Pacific Bioprocess Validation Market Outlook

7.1.  Market Size & Forecast          

7.1.1.     By Value

7.2.  Market Share & Forecast

7.2.1.     By Test Type

7.2.2.     By Process Component

7.2.3.     By End-User

7.2.4.     By Country

7.3.  Market Attractiveness Index

7.4.  Asia-Pacific: Country Analysis

7.4.1.     China Bioprocess Validation Market Outlook

7.4.1.1.         Market Size & Forecast

7.4.1.1.1.             By Value

7.4.1.2.         Market Share & Forecast

7.4.1.2.1.             By Test Type

7.4.1.2.2.             By Process Component

7.4.1.2.3.             By End-User

7.4.2.     India Bioprocess Validation Market Outlook

7.4.2.1.         Market Size & Forecast

7.4.2.1.1.             By Value

7.4.2.2.         Market Share & Forecast

7.4.2.2.1.             By Test Type

7.4.2.2.2.             By Process Component

7.4.2.2.3.             By End-User

7.4.3.     Japan Bioprocess Validation Market Outlook

7.4.3.1.         Market Size & Forecast

7.4.3.1.1.             By Value

7.4.3.2.         Market Share & Forecast

7.4.3.2.1.             By Test Type

7.4.3.2.2.             By Process Component

7.4.3.2.3.             By End-User

7.4.4.     South Korea Bioprocess Validation Market Outlook

7.4.4.1.         Market Size & Forecast

7.4.4.1.1.             By Value

7.4.4.2.         Market Share & Forecast

7.4.4.2.1.             By Test Type

7.4.4.2.2.             By Process Component

7.4.4.2.3.             By End-User

7.4.5.     Singapore Bioprocess Validation Market Outlook

7.4.5.1.         Market Size & Forecast

7.4.5.1.1.             By Value

7.4.5.2.         Market Share & Forecast

7.4.5.2.1.             By Test Type

7.4.5.2.2.             By Process Component

7.4.5.2.3.             By End-User

7.4.6.     Australia Bioprocess Validation Market Outlook

7.4.6.1.         Market Size & Forecast

7.4.6.1.1.             By Value

7.4.6.2.         Market Share & Forecast

7.4.6.2.1.             By Test Type

7.4.6.2.2.             By Process Component

7.4.6.2.3.             By End-User

8.    Europe Bioprocess Validation Market Outlook

8.1.  Market Size & Forecast          

8.1.1.     By Value

8.2.  Market Share & Forecast

8.2.1.     By Test Type

8.2.2.     By Process Component

8.2.3.     By End-User

8.2.4.     By Country

8.3.  Market Attractiveness Index

8.4.  Europe: Country Analysis

8.4.1.     France Bioprocess Validation Market Outlook

8.4.1.1.         Market Size & Forecast

8.4.1.1.1.             By Value

8.4.1.2.         Market Share & Forecast

8.4.1.2.1.             By Test Type

8.4.1.2.2.             By Process Component

8.4.1.2.3.             By End-User

8.4.2.     Germany Bioprocess Validation Market Outlook

8.4.2.1.         Market Size & Forecast

8.4.2.1.1.             By Value

8.4.2.2.         Market Share & Forecast

8.4.2.2.1.             By Test Type

8.4.2.2.2.             By Process Component

8.4.2.2.3.             By End-User

8.4.3.     United Kingdom Bioprocess Validation Market Outlook

8.4.3.1.         Market Size & Forecast

8.4.3.1.1.             By Value

8.4.3.2.         Market Share & Forecast

8.4.3.2.1.             By Test Type

8.4.3.2.2.             By Process Component

8.4.3.2.3.             By End-User

8.4.4.     Italy Bioprocess Validation Market Outlook

8.4.4.1.         Market Size & Forecast

8.4.4.1.1.             By Value

8.4.4.2.         Market Share & Forecast

8.4.4.2.1.             By Test Type

8.4.4.2.2.             By Process Component

8.4.4.2.3.             By End-User

8.4.5.     Spain Bioprocess Validation Market Outlook

8.4.5.1.         Market Size & Forecast

8.4.5.1.1.             By Value

8.4.5.2.         Market Share & Forecast

8.4.5.2.1.             By Test Type

8.4.5.2.2.             By Process Component

8.4.5.2.3.             By End-User

9.    North America Bioprocess Validation Market Outlook

9.1.  Market Size & Forecast          

9.1.1.     By Value

9.2.  Market Share & Forecast

9.2.1.     By Test Type

9.2.2.     By Process Component

9.2.3.     By End-User

9.2.4.     By Country

9.3.  Market Attractiveness Index

9.4.  North America: Country Analysis

9.4.1.     United States Bioprocess Validation Market Outlook

9.4.1.1.         Market Size & Forecast

9.4.1.1.1.             By Value

9.4.1.2.         Market Share & Forecast

9.4.1.2.1.             By Test Type

9.4.1.2.2.             By Process Component

9.4.1.2.3.             By End-User

9.4.2.     Mexico Bioprocess Validation Market Outlook

9.4.2.1.         Market Size & Forecast

9.4.2.1.1.             By Value

9.4.2.2.         Market Share & Forecast

9.4.2.2.1.             By Test Type

9.4.2.2.2.             By Process Component

9.4.2.2.3.             By End-User

9.4.3.     Canada Bioprocess Validation Market Outlook

9.4.3.1.         Market Size & Forecast

9.4.3.1.1.             By Value

9.4.3.2.         Market Share & Forecast

9.4.3.2.1.             By Test Type

9.4.3.2.2.             By Process Component

9.4.3.2.3.             By End-User

10.  South America Bioprocess Validation Market Outlook

10.1.              Market Size & Forecast

10.1.1.  By Value

10.2.              Market Share & Forecast

10.2.1.  By Test Type

10.2.2.  By Process Component

10.2.3.  By End-User

10.2.4.  By Country

10.3.              Market Attractiveness Index

10.4.              South America: Country Analysis

10.4.1.  Brazil Bioprocess Validation Market Outlook

10.4.1.1.      Market Size & Forecast

10.4.1.1.1.           By Value

10.4.1.2.      Market Share & Forecast

10.4.1.2.1.           By Test Type

10.4.1.2.2.           By Process Component

10.4.1.2.3.           By End-User

10.4.2.  Argentina Bioprocess Validation Market Outlook

10.4.2.1.      Market Size & Forecast

10.4.2.1.1.           By Value

10.4.2.2.      Market Share & Forecast

10.4.2.2.1.           By Test Type

10.4.2.2.2.           By Process Component

10.4.2.2.3.           By End-User

10.4.3.  Colombia Bioprocess Validation Market Outlook

10.4.3.1.      Market Size & Forecast

10.4.3.1.1.           By Value

10.4.3.2.      Market Share & Forecast

10.4.3.2.1.           By Test Type

10.4.3.2.2.           By Process Component

10.4.3.2.3.           By End-User

11.  Middle East and Africa Bioprocess Validation Market Outlook

11.1.              Market Size & Forecast

11.1.1.  By Value

11.2.              Market Share & Forecast

11.2.1.  By Test Type

11.2.2.  By Process Component

11.2.3.  By End-User

11.2.4.  By Country

11.3.              Market Attractiveness Index

11.4.              MEA: Country Analysis

11.4.1.  South Africa Bioprocess Validation Market Outlook

11.4.1.1.      Market Size & Forecast

11.4.1.1.1.           By Value

11.4.1.2.      Market Share & Forecast

11.4.1.2.1.           By Test Type

11.4.1.2.2.           By Process Component

11.4.1.2.3.           By End-User

11.4.2.  Saudi Arabia Bioprocess Validation Market Outlook

11.4.2.1.      Market Size & Forecast

11.4.2.1.1.           By Value

11.4.2.2.      Market Share & Forecast

11.4.2.2.1.           By Test Type

11.4.2.2.2.           By Process Component

11.4.2.2.3.           By End-User

11.4.3.  UAE Bioprocess Validation Market Outlook

11.4.3.1.      Market Size & Forecast

11.4.3.1.1.           By Value

11.4.3.2.      Market Share & Forecast

11.4.3.2.1.           By Test Type

11.4.3.2.2.           By Process Component

11.4.3.2.3.           By End-User

12.  Market Dynamics

12.1.              Drivers

12.2.              Challenges

13.  Market Trends & Developments

14.  Competitive Landscape

14.1.              Competition Outlook

14.2.              Players Profiled (Leading Companies)

14.2.1.  Sartorius Stedim Biotech S.A.

14.2.2.  Pall Corporation

14.2.3.  Eurofins Scientific

14.2.4.  SGS S.A.

14.2.5.  Cobetter Filtration Equipment Co., Ltd.

14.2.6.  Merck KGaA

14.2.7.  Thermo Fisher Scientific Inc.

14.2.8.  Toxikon Corporation

14.2.9.  Meissner Filtration Products, Inc.

14.2.10.                Doc S.R.L.

14.2.11.                Hangzhou Anow Microfiltration Co., Ltd.

14.2.12.                Almac Group

14.2.13.                Tianshan Precision Filter Material Co., Ltd.

14.2.14.                Porvair Plc

15.  Strategic Recommendations

16. About Us & Disclaimer

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