Bioprocess Validation Market

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.

Report Coverage:

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?