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Bioprocess Validation Market Report by Test Type (Extractables Testing Services, Microbiological Testing Services, Physiochemical Testing Services, Integrity Testing Services, Compatibility Testing Services, and Others), Process Component (Filter Elements, Media Containers and Bags, Freezing And Thawing Process Bags, Mixing Systems, Bioreactors, Transfer Systems, and Others), End User (Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Organizations, and Others), and Region 2024-2032
Report Format: PDF+Excel | Report ID: SR112024A6489
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Market Overview:
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.
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Report Attribute
|
Key Statistics
|
|---|---|
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Base Year
|
2023
|
|
Forecast Years
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2024-2032
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Historical Years
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2018-2023
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Market Size in 2023
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US$ 363.9 Million |
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Market Forecast in 2032
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US$ 721.6 Million |
| Market Growth Rate 2024-2032 | 7.66% |
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.
Report Coverage:
| Report Features | Details |
|---|---|
| Base Year of the Analysis | 2023 |
| Historical Period | 2018-2023 |
| Forecast Period | 2024-2032 |
| 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, Thermo Fisher Scientific Inc. |
| Customization Scope | 10% Free Customization |
| Report Price and Purchase Option | Single User License: US$ 3899 Five User License: US$ 4899 Corporate License: US$ 5899 |
| 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) |
The global bioprocess validation market was valued at US$ 363.9 Million in 2023.
We expect the global bioprocess validation market to exhibit a CAGR of 7.66% during 2024-2032.
The emerging trend of outsourcing laboratory testing services, the escalating need for personalized medicines, and the continuous R&D activities to ensure the optimal quality of drugs, are primarily driving the global bioprocess validation market.
The sudden outbreak of the COVID-19 pandemic has led to the rising utilization of bioprocess validation by pharmaceutical companies to monitor the accuracy, purity, efficiency, and safety of the drugs, while manufacturing novel vaccines of the coronavirus-infection.
Based on the test type, the global bioprocess validation market can be segmented into extractables testing services, microbiological testing services, physiochemical testing services, integrity testing services, compatibility testing services, and others. Currently, extractables testing services hold largest market share.
Based on the process component, the global bioprocess validation market has been divided into filter elements, media containers and bags, freezing and thawing process bags, mixing systems, bioreactors, transfer systems, and others. Among these, filter elements currently exhibit a clear dominance in the market.
Based on the end user, the global bioprocess validation market can be bifurcated into pharmaceutical and biotechnology companies, contract development and manufacturing organizations, and others. Currently, pharmaceutical and biotechnology companies account for the majority of the global market share.
On a regional level, the market has been classified into North America, Asia-Pacific, Europe, Latin America, and Middle East and Africa, where North America currently dominates the global market.
Some of the major players in the global bioprocess validation market include 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.
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