The global bioprocess validation market size reached US$ 363.9 Million in 2023. Looking forward, the publisher expects the market to reach US$ 721.6 Million by 2032, exhibiting a growth rate (CAGR) of 7.9% during 2023-2032.
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.
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.
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?
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:
The publisher 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?
Table of Contents
1 Preface3 Executive Summary11 Value Chain Analysis13 Price Analysis
2 Scope and Methodology
4 Introduction
5 Global Bioprocess Validation Market
6 Market Breakup by Test Type
7 Market Breakup by Process Component
8 Market Breakup by End User
9 Market Breakup by Region
10 SWOT Analysis
12 Porters Five Forces Analysis
14 Competitive Landscape
List of Figures
List of Tables
Companies Mentioned
- 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
- Thermo Fisher Scientific Inc.
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 137 |
| Published | August 2024 |
| Forecast Period | 2023 - 2032 |
| Estimated Market Value ( USD | $ 363.9 Million |
| Forecasted Market Value ( USD | $ 721.6 Million |
| Compound Annual Growth Rate | 7.9% |
| Regions Covered | Global |
| No. of Companies Mentioned | 12 |
