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PUBLISHER: IMARC | PRODUCT CODE: 1540812
PUBLISHER: IMARC | PRODUCT CODE: 1540812
Bioprocess Validation Market Report by Test Type, Process Component, End User, and Region 2024-2032
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PAGES: 137 Pages
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The global bioprocess validation market size reached US$ 363.9 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 721.6 Million by 2032, exhibiting a growth rate (CAGR) of 7.66% during 2024-2032.
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 2024-2032. 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.
Key Questions Answered in This Report
- 1. How big is the global bioprocess validation market?
- 2. What is the expected growth rate of the global bioprocess validation market during 2024-2032?
- 3. What are the key factors driving the global bioprocess validation market?
- 4. What has been the impact of COVID-19 on the global bioprocess validation market?
- 5. What is the breakup of the global bioprocess validation market based on the test type?
- 6. What is the breakup of the global bioprocess validation market based on the process component?
- 7. What is the breakup of the global bioprocess validation market based on the end user?
- 8. What are the key regions in the global bioprocess validation market?
- 9. Who are the key players/companies in the global bioprocess validation market?
Product Code: SR112024A6489
Table of Contents
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
- 9.1.1 United States
- 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
- 9.2.1 China
- 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
- 9.3.1 Germany
- 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
- 9.4.1 Brazil
- 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
- 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
- 14.3.1 Almac Group
Product Code: SR112024A6489
List of Figures
- Figure 1: Global: Bioprocess Validation Market: Major Drivers and Challenges
- Figure 2: Global: Bioprocess Validation Market: Sales Value (in Million US$), 2018-2023
- Figure 3: Global: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 4: Global: Bioprocess Validation Market: Breakup by Test Type (in %), 2023
- Figure 5: Global: Bioprocess Validation Market: Breakup by Process Component (in %), 2023
- Figure 6: Global: Bioprocess Validation Market: Breakup by End User (in %), 2023
- Figure 7: Global: Bioprocess Validation Market: Breakup by Region (in %), 2023
- Figure 8: Global: Bioprocess Validation (Extractables Testing Services) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 9: Global: Bioprocess Validation (Extractables Testing Services) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 10: Global: Bioprocess Validation (Microbiological Testing Services) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 11: Global: Bioprocess Validation (Microbiological Testing Services) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 12: Global: Bioprocess Validation (Physiochemical Testing Services) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 13: Global: Bioprocess Validation (Physiochemical Testing Services) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 14: Global: Bioprocess Validation (Integrity Testing Services) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 15: Global: Bioprocess Validation (Integrity Testing Services) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 16: Global: Bioprocess Validation (Compatibility Testing Services) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 17: Global: Bioprocess Validation (Compatibility Testing Services) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 18: Global: Bioprocess Validation (Other Test Types) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 19: Global: Bioprocess Validation (Other Test Types) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 20: Global: Bioprocess Validation (Filter Elements) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 21: Global: Bioprocess Validation (Filter Elements) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 22: Global: Bioprocess Validation (Media Containers and Bags) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 23: Global: Bioprocess Validation (Media Containers and Bags) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 24: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 25: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 26: Global: Bioprocess Validation (Mixing Systems) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 27: Global: Bioprocess Validation (Mixing Systems) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 28: Global: Bioprocess Validation (Bioreactors) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 29: Global: Bioprocess Validation (Bioreactors) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 30: Global: Bioprocess Validation (Transfer Systems) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 31: Global: Bioprocess Validation (Transfer Systems) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 32: Global: Bioprocess Validation (Other Process Components) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 33: Global: Bioprocess Validation (Other Process Components) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 34: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 35: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 36: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 37: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 38: Global: Bioprocess Validation (Other End Users) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 39: Global: Bioprocess Validation (Other End Users) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 40: North America: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 41: North America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 42: United States: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 43: United States: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 44: Canada: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 45: Canada: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 46: Asia-Pacific: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 47: Asia-Pacific: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 48: China: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 49: China: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 50: Japan: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 51: Japan: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 52: India: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 53: India: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 54: South Korea: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 55: South Korea: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 56: Australia: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 57: Australia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 58: Indonesia: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 59: Indonesia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 60: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 61: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 62: Europe: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 63: Europe: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 64: Germany: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 65: Germany: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 66: France: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 67: France: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 68: United Kingdom: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 69: United Kingdom: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 70: Italy: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 71: Italy: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 72: Spain: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 73: Spain: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 74: Russia: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 75: Russia: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 76: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 77: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 78: Latin America: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 79: Latin America: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 80: Brazil: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 81: Brazil: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 82: Mexico: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 83: Mexico: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 84: Others: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 85: Others: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 86: Middle East and Africa: Bioprocess Validation Market: Sales Value (in Million US$), 2018 & 2023
- Figure 87: Middle East and Africa: Bioprocess Validation Market: Breakup by Country (in %), 2023
- Figure 88: Middle East and Africa: Bioprocess Validation Market Forecast: Sales Value (in Million US$), 2024-2032
- 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, 2023 and 2032
- Table 2: Global: Bioprocess Validation Market Forecast: Breakup by Test Type (in Million US$), 2024-2032
- Table 3: Global: Bioprocess Validation Market Forecast: Breakup by Process Component (in Million US$), 2024-2032
- Table 4: Global: Bioprocess Validation Market Forecast: Breakup by End User (in Million US$), 2024-2032
- Table 5: Global: Bioprocess Validation Market Forecast: Breakup by Region (in Million US$), 2024-2032
- Table 6: Global: Bioprocess Validation Market: Competitive Structure
- Table 7: Global: Bioprocess Validation Market: Key Players
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