Bioprocess Validation Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

Bioprocess Validation Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028


Market Overview:

The global bioprocess validation market size reached US$ 334.6 Million in 2022. Looking forward, IMARC Group expects the market to reach US$ 573.6 Million by 2028, exhibiting a growth rate (CAGR) of 8.78% during 2023-2028.

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 2023-2028. 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:
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
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

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