Change Language

Select Language

COVID-19
The pandemic continues to cause unprecedented disruption across industries worldwide.
Get detailed insights regarding the impact of COVID-19 on the market.

Bioprocess Validation Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027

Market Overview:

The global bioprocess validation market size reached US$ 303.32 Million in 2021. Looking forward, IMARC Group expects the market to reach US$ 529.2 Million by 2027, exhibiting a growth rate (CAGR) of 9.10% during 2022-2027.

Bioprocess validation refers to an approach of acquiring documentary evidence by demonstrating various procedures, processes, and activities that are conducted during the production and testing of the product to maintain the desired level of compliance at all phases. It involves extractable, microbiological, compatibility, integrity, and physiochemical testing services as standard methods. These techniques help evaluate multiple active pharmaceutical ingredients (APIs) and possible contaminants, including endotoxin, mycoplasma, and bacteria, during the development of biological products and animal drugs. Apart from this, bioprocess validation is cost-effective and monitors practices and medication manufacturing procedures. As a result, it is used by pharmaceutical, biopharmaceutical, and contract development and manufacturing organization (CMO) to assure drug quality, safety, efficacy, and predetermined attributes.

Bioprocess Validation Market Trends:

The increasing need for outsourcing bioprocess validation services in hospitals and clinics to maintain compliance with good manufacturing practices (GMP) is majorly driving the market growth. This is further supported by the execution of stringent quality and product safety regulations by governments. Additionally, the rising prevalence of various chronic ailments and the escalating demand for biopharmaceuticals are supplementing the widespread adoption of bioprocess validation across the healthcare sector, thus favoring the market growth. Moreover, the extensive usage of bioprocess validation by pharmaceutical and CMO companies to monitor the accuracy, purity, efficiency, and safety of drugs while manufacturing novel vaccines and biosimilars, especially during COVID-19, is acting as another growth-inducing factor. In line with this, significant technological advancements in bio-manufacturing infrastructure and the ongoing bioprocess validation of bioreactors to ensure the cost-effective and scalable production of medications are propelling the market growth. Apart from this, the emerging trend of outsourcing laboratory testing services, the escalating need for personalized medicines, and continuous research and development (R&D) activities to ensure the optimal quality of drugs are creating a positive outlook for the market. 

Key Market Segmentation:

IMARC Group provides an analysis of the key trends in each sub-segment of the global bioprocess validation market report, along with forecasts at the global, regional and country level from 2022-2027. Our report has categorized the market based on test type, process component and end user.

Breakup by Test Type:

  • Extractables Testing Services
  • Microbiological Testing Services
  • Physiochemical Testing Services
  • Integrity Testing Services
  • Compatibility Testing Services
  • Others
     

Breakup by Process Component:

  • Filter Elements
  • Media Containers and Bags
  • Freezing And Thawing Process Bags
  • Mixing Systems
  • Bioreactors
  • Transfer Systems
  • Others
     

Breakup by End User:

  • Pharmaceutical and Biotechnology Companies
  • Contract Development and Manufacturing Organizations
  • Others
     

Breakup by Region:

  • North America
    • United States
    • Canada
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa
     

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players being Almac Group, Biozeen, Doc S.R.L., Eurofins Scientific, Hangzhou Anow Microfiltration Co. Ltd., Hangzhou Cobetter Filtration Equipment Co. Ltd., Hangzhou Tianshan Precision Filter Material Co. Ltd., Meissner Filtration Products, Inc., Merck KGaA, Sartorius AG, SGS SA and Thermo Fisher Scientific Inc.

Report Coverage:

Report Features Details
Base Year of the Analysis 2021
    Historical Period 2016-2021
Forecast Period 2022-2027
Units US$ Million
Segment Coverage Test Type, Process Component, End User, Region
Region Covered  Asia Pacific, Europe, North America, Latin America, Middle East and Africa
Countries Covered United States, Canada, Germany, France, United Kingdom, Italy, Spain, Russia, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico
Companies Covered Almac Group, Biozeen, Doc S.R.L., Eurofins Scientific, Hangzhou Anow Microfiltration Co. Ltd., Hangzhou Cobetter Filtration Equipment Co. Ltd., Hangzhou Tianshan Precision Filter Material Co. Ltd., Meissner Filtration Products, Inc., Merck KGaA, Sartorius AG, SGS SA and Thermo Fisher Scientific Inc.
Customization Scope 10% Free Customization
Report Price and Purchase Option Single User License: US$ 2499
Five User License: US$ 3499
Corporate License: US$ 4499
Post-Sale Analyst Support 10-12 Weeks
Delivery Format PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request)

 

Key Questions Answered in This Report:

  • How has the global bioprocess validation market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global bioprocess validation market?
  • What are the key regional markets?
  • What is the breakup of the market based on the test type?
  • What is the breakup of the market based on the process component?
  • What is the breakup of the market based on the end user?
  • What are the various stages in the value chain of the industry?
  • What are the key driving factors and challenges in the industry?
  • What is the structure of the global bioprocess validation market and who are the key players?
  • What is the degree of competition in the industry?

1    Preface
2    Scope and Methodology

    2.1    Objectives of the Study
    2.2    Stakeholders
    2.3    Data Sources
        2.3.1    Primary Sources
        2.3.2    Secondary Sources
    2.4    Market Estimation
        2.4.1    Bottom-Up Approach
        2.4.2    Top-Down Approach
    2.5    Forecasting Methodology
3    Executive Summary
4    Introduction

    4.1    Overview
    4.2    Key Industry Trends
5    Global Bioprocess Validation Market
    5.1    Market Overview
    5.2    Market Performance
    5.3    Impact of COVID-19
    5.4    Market Forecast
6    Market Breakup by Test Type
    6.1    Extractables Testing Services
        6.1.1 Market Trends
        6.1.2 Market Forecast
    6.2    Microbiological Testing Services
        6.2.1 Market Trends
        6.2.2 Market Forecast
    6.3    Physiochemical Testing Services
        6.3.1 Market Trends
        6.3.2 Market Forecast
    6.4    Integrity Testing Services
        6.4.1 Market Trends
        6.4.2 Market Forecast
    6.5    Compatibility Testing Services
        6.5.1 Market Trends
        6.5.2 Market Forecast
    6.6    Others
        6.6.1 Market Trends
        6.6.2 Market Forecast
7    Market Breakup by Process Component
    7.1    Filter Elements
        7.1.1 Market Trends
        7.1.2 Market Forecast
    7.2    Media Containers and Bags
        7.2.1 Market Trends
        7.2.2 Market Forecast
    7.3    Freezing And Thawing Process Bags
        7.3.1 Market Trends
        7.3.2 Market Forecast
    7.4    Mixing Systems
        7.4.1 Market Trends
        7.4.2 Market Forecast
    7.5    Bioreactors
        7.5.1 Market Trends
        7.5.2 Market Forecast
    7.6    Transfer Systems
        7.6.1 Market Trends
        7.6.2 Market Forecast
    7.7    Others
        7.7.1 Market Trends
        7.7.2 Market Forecast
8    Market Breakup by End User
    8.1    Pharmaceutical and Biotechnology Companies
        8.1.1 Market Trends
        8.1.2 Market Forecast
    8.2    Contract Development and Manufacturing Organizations
        8.2.1 Market Trends
        8.2.2 Market Forecast
    8.3    Others
        8.3.1 Market Trends
        8.3.2 Market Forecast
9    Market Breakup by Region
    9.1    North America
        9.1.1 United States
           9.1.1.1 Market Trends
           9.1.1.2 Market Forecast
        9.1.2 Canada
           9.1.2.1 Market Trends
           9.1.2.2 Market Forecast
    9.2    Asia-Pacific
        9.2.1 China
           9.2.1.1 Market Trends
           9.2.1.2 Market Forecast
        9.2.2 Japan
           9.2.2.1 Market Trends
           9.2.2.2 Market Forecast
        9.2.3 India
           9.2.3.1 Market Trends
           9.2.3.2 Market Forecast
        9.2.4 South Korea
           9.2.4.1 Market Trends
           9.2.4.2 Market Forecast
        9.2.5 Australia
           9.2.5.1 Market Trends
           9.2.5.2 Market Forecast
        9.2.6 Indonesia
           9.2.6.1 Market Trends
           9.2.6.2 Market Forecast
        9.2.7 Others
           9.2.7.1 Market Trends
           9.2.7.2 Market Forecast
    9.3    Europe
        9.3.1 Germany
           9.3.1.1 Market Trends
           9.3.1.2 Market Forecast
        9.3.2 France
           9.3.2.1 Market Trends
           9.3.2.2 Market Forecast
        9.3.3 United Kingdom
           9.3.3.1 Market Trends
           9.3.3.2 Market Forecast
        9.3.4 Italy
           9.3.4.1 Market Trends
           9.3.4.2 Market Forecast
        9.3.5 Spain
           9.3.5.1 Market Trends
           9.3.5.2 Market Forecast
        9.3.6 Russia
           9.3.6.1 Market Trends
           9.3.6.2 Market Forecast
        9.3.7 Others
           9.3.7.1 Market Trends
           9.3.7.2 Market Forecast
    9.4    Latin America
        9.4.1 Brazil
           9.4.1.1 Market Trends
           9.4.1.2 Market Forecast
        9.4.2 Mexico
           9.4.2.1 Market Trends
           9.4.2.2 Market Forecast
        9.4.3 Others
           9.4.3.1 Market Trends
           9.4.3.2 Market Forecast
    9.5    Middle East and Africa
        9.5.1 Market Trends
        9.5.2 Market Breakup by Country
        9.5.3 Market Forecast
10    SWOT Analysis
    10.1    Overview
    10.2    Strengths
    10.3    Weaknesses
    10.4    Opportunities
    10.5    Threats
11    Value Chain Analysis
12    Porters Five Forces Analysis

    12.1    Overview
    12.2    Bargaining Power of Buyers
    12.3    Bargaining Power of Suppliers
    12.4    Degree of Competition
    12.5    Threat of New Entrants
    12.6    Threat of Substitutes
13    Price Analysis
14    Competitive Landscape

    14.1    Market Structure
    14.2    Key Players
    14.3    Profiles of Key Players
        14.3.1    Almac Group
           14.3.1.1 Company Overview
           14.3.1.2 Product Portfolio
           14.3.1.3 SWOT Analysis
        14.3.2    Biozeen
           14.3.2.1 Company Overview
           14.3.2.2 Product Portfolio
        14.3.3    Doc S.R.L.
           14.3.3.1 Company Overview
           14.3.3.2 Product Portfolio
        14.3.4    Eurofins Scientific SE
           14.3.4.1 Company Overview
           14.3.4.2 Product Portfolio
           14.3.4.3 Financials
           14.3.4.4 SWOT Analysis
        14.3.5    Hangzhou Anow Microfiltration Co. Ltd.
           14.3.5.1 Company Overview
           14.3.5.2 Product Portfolio
        14.3.6    Hangzhou Cobetter Filtration Equipment Co. Ltd.
           14.3.6.1 Company Overview
           14.3.6.2 Product Portfolio
        14.3.7    Hangzhou Tianshan Precision Filter Material Co. Ltd.
           14.3.7.1 Company Overview
           14.3.7.2 Product Portfolio
        14.3.8    Meissner Filtration Products, Inc.
           14.3.8.1 Company Overview
           14.3.8.2 Product Portfolio
        14.3.9    Merck KGaA
           14.3.9.1 Company Overview
           14.3.9.2 Product Portfolio
           14.3.9.3 Financials
           14.3.9.4 SWOT Analysis
        14.3.10    Sartorius AG
           14.3.10.1 Company Overview
           14.3.10.2 Product Portfolio
           14.3.10.3 Financials
           14.3.10.4 SWOT Analysis
        14.3.11    SGS SA
           14.3.11.1 Company Overview
           14.3.11.2 Product Portfolio
           14.3.11.3 Financials
        14.3.12    Thermo Fisher Scientific Inc.
           14.3.12.1 Company Overview
           14.3.12.2 Product Portfolio
           14.3.12.3 Financials
           14.3.12.4 SWOT Analysis

List of Figures

Figure 1: Global: Bioprocess Validation Market: Major Drivers and Challenges
Figure 2: Global: Bioprocess Validation Market: Sales Value (in Million US$), 2016-2021
Figure 3: Global: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 4: Global: Bioprocess Validation Market: Breakup by Test Type (in %), 2021
Figure 5: Global: Bioprocess Validation Market: Breakup by Process Component (in %), 2021
Figure 6: Global: Bioprocess Validation Market: Breakup by End User (in %), 2021
Figure 7: Global: Bioprocess Validation Market: Breakup by Region (in %), 2021
Figure 8: Global: Bioprocess Validation (Extractables Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 9: Global: Bioprocess Validation (Extractables Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 10: Global: Bioprocess Validation (Microbiological Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 11: Global: Bioprocess Validation (Microbiological Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 12: Global: Bioprocess Validation (Physiochemical Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 13: Global: Bioprocess Validation (Physiochemical Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 14: Global: Bioprocess Validation (Integrity Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 15: Global: Bioprocess Validation (Integrity Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 16: Global: Bioprocess Validation (Compatibility Testing Services) Market: Sales Value (in Million US$), 2016 & 2021
Figure 17: Global: Bioprocess Validation (Compatibility Testing Services) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 18: Global: Bioprocess Validation (Other Test Types) Market: Sales Value (in Million US$), 2016 & 2021
Figure 19: Global: Bioprocess Validation (Other Test Types) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 20: Global: Bioprocess Validation (Filter Elements) Market: Sales Value (in Million US$), 2016 & 2021
Figure 21: Global: Bioprocess Validation (Filter Elements) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 22: Global: Bioprocess Validation (Media Containers and Bags) Market: Sales Value (in Million US$), 2016 & 2021
Figure 23: Global: Bioprocess Validation (Media Containers and Bags) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 24: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market: Sales Value (in Million US$), 2016 & 2021
Figure 25: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 26: Global: Bioprocess Validation (Mixing Systems) Market: Sales Value (in Million US$), 2016 & 2021
Figure 27: Global: Bioprocess Validation (Mixing Systems) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 28: Global: Bioprocess Validation (Bioreactors) Market: Sales Value (in Million US$), 2016 & 2021
Figure 29: Global: Bioprocess Validation (Bioreactors) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 30: Global: Bioprocess Validation (Transfer Systems) Market: Sales Value (in Million US$), 2016 & 2021
Figure 31: Global: Bioprocess Validation (Transfer Systems) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 32: Global: Bioprocess Validation (Other Process Components) Market: Sales Value (in Million US$), 2016 & 2021
Figure 33: Global: Bioprocess Validation (Other Process Components) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 34: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million US$), 2016 & 2021
Figure 35: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 36: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market: Sales Value (in Million US$), 2016 & 2021
Figure 37: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 38: Global: Bioprocess Validation (Other End Users) Market: Sales Value (in Million US$), 2016 & 2021
Figure 39: Global: Bioprocess Validation (Other End Users) Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 40: North America: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 41: North America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 42: United States: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 43: United States: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 44: Canada: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 45: Canada: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 46: Asia-Pacific: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 47: Asia-Pacific: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 48: China: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 49: China: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 50: Japan: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 51: Japan: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 52: India: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 53: India: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 54: South Korea: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 55: South Korea: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 56: Australia: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 57: Australia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 58: Indonesia: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 59: Indonesia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 60: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 61: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 62: Europe: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 63: Europe: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 64: Germany: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 65: Germany: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 66: France: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 67: France: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 68: United Kingdom: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 69: United Kingdom: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 70: Italy: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 71: Italy: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 72: Spain: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 73: Spain: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 74: Russia: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 75: Russia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 76: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 77: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 78: Latin America: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 79: Latin America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 80: Brazil: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 81: Brazil: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 82: Mexico: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 83: Mexico: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 84: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 85: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 86: Middle East and Africa: Bioprocess Validation Market: Sales Value (in Million US$), 2016 & 2021
Figure 87: Middle East and Africa: Bioprocess Validation Market: Breakup by Country (in %), 2021
Figure 88: Middle East and Africa: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2022-2027
Figure 89: Global: Bioprocess Validation Industry: SWOT Analysis
Figure 90: Global: Bioprocess Validation Industry: Value Chain Analysis
Figure 91: Global: Bioprocess Validation Industry: Porter's Five Forces Analysis

List of Tables

Table 1: Global: Bioprocess Validation Market: Key Industry Highlights, 2021 and 2027
Table 2: Global: Bioprocess Validation Market Forecast: Breakup by Test Type (in Million US$), 2022-2027
Table 3: Global: Bioprocess Validation Market Forecast: Breakup by Process Component (in Million US$), 2022-2027
Table 4: Global: Bioprocess Validation Market Forecast: Breakup by End User (in Million US$), 2022-2027
Table 5: Global: Bioprocess Validation Market Forecast: Breakup by Region (in Million US$), 2022-2027
Table 6: Global: Bioprocess Validation Market: Competitive Structure
Table 7: Global: Bioprocess Validation Market: Key Players


Note: We value your privacy and will never rent or sell your email address. Privacy policy

Need more help?

  •   Speak to our experienced analysts for insights on the current market scenarios.
  •   Include additional segments and countries to customize the report as per your requirement.
  •   Gain an unparalleled competitive advantage in your domain by understanding how to utilize the report and positively impacting your operations and revenue.
  •   For further assistance, please connect with our analysts.

Purchase Options




$ 2499

REACH OUT TO US

Call us on

( US: +1-631-791-1145 )
( UK: +44-753-713-2163 )
( India: +91 120 433 0800 )


Drop us an email at

sales@imarcgroup.com

Social Links

4