PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1464654
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1464654
Bioprocess validation Market size was valued at USD 420.91 Million in 2023, expanding at a CAGR of 9.83% from 2024 to 2032.
Bioprocess validation plays a vital role in guaranteeing the safety, quality, and effectiveness of bioproducts, including vaccines, antibodies, enzymes, and biosensors. Its purpose is to demonstrate that a bioprocess can consistently generate the desired bioproduct according to predetermined specifications and conditions. In the pharmaceutical industry, bioprocess validation is a mandatory regulatory requirement that ensures the uniformity and excellence of biopharmaceutical products throughout their entire lifespan.
Bioprocess validation Market- Market Dynamics
Surge in demand for outsourcing bioprocess validation and increase in life science R&D expenditure are expected to drive the market growth.
Numerous pharmaceutical and biotechnology companies are increasingly delegating various aspects of their operations, such as bioprocess validation. With the expansion of R&D activities in the life sciences sector, there is a rising demand for services related to bioprocess validation to facilitate the development and production of new biopharmaceutical products. Global expenditure on R&D has surged to nearly US$ 1.7 trillion, with approximately 10 countries contributing to 80% of the spending. As part of the Sustainable Development Goals (SDGs), nations have committed to significantly boosting public and private R&D expenditure, as well as the number of researchers, by 2030, as per the UNESCO Institute for Statistics (UIS). Additionally, advancements in bioprocessing technologies and regulatory compliance requirements may present growth opportunities for the market. Nonetheless, the high cost of validation could impede market growth.
Bioprocess validation Market- Key Insights
As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 9.83% over the forecast period (2024-2032)
Based on Test Type segmentation, Extractables & Leachables Testing was predicted to show maximum market share in the year 2023
Based on Process Component segmentation, Filter Elements was the leading type in 2023
Based on End-User segmentation, Pharmaceutical & Biotechnology Companies was the leading type in 2023
On the basis of region, North America was the leading revenue generator in 2023
The Global Bioprocess validation Market is segmented on the basis of Test Type, Process Component, End-User, and Region.
The market is categorized into four groups according to the Test Type: Extractables & Leachables Testing, Bioprocess Residuals Testing, Viral Clearance Testing, Filtration & Fermentation Systems Testing, and Others. The dominant category in the market is Extractables & Leachables Testing. This type of testing plays a crucial role in the development and manufacturing of pharmaceutical products, especially when it comes to packaging materials, containers, and processing equipment used in biopharmaceutical production.
The market is segmented into five categories according to Process Component: Filter Elements, Media containers and bags, Freezing And Thawing Process Bags, Mixing Systems, Bioreactors, Transfer Systems and Others. Filter Elements are the leading category in the market. They play a vital role in biopharmaceutical manufacturing processes, especially in downstream processing.
The market is segmented into three groups according to the end-users: Pharmaceutical & Biotechnology Companies, Contract Development & Manufacturing Organizations, and Other. The dominant force in the market is the Pharmaceutical & Biotechnology Companies. These companies play a significant role in driving the demand for bioprocess validation services. Given their involvement in the development and production of biopharmaceutical products, it is crucial for them to maintain consistent quality and adhere to regulatory standards in their manufacturing processes.
Bioprocess validation Market- Geographical Insights
Geographically, this market spans across North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. These regions are further segmented by countries contributing to business activities. The market is anticipated to be primarily driven by North America, particularly the United States, owing to the rising demand for Biopharmaceuticals. The United States boasts a strong and well-established biopharmaceutical industry. Validation of bioprocesses plays a critical role in ensuring the quality, safety, and effectiveness of biopharmaceutical products, leading to an increased demand for validation services and products. As per Pharmaceutical Statistics, the U.S. pharmaceutical industry recorded a revenue of $550 billion in 2021, while Americans spent USD 576.9 billion on medications. Europe stands as the second-largest region for market growth.
The bioprocess validation market is experiencing substantial growth as a result of the rising need for biopharmaceuticals, advancements in bioprocess technology, and strict regulatory standards. Manufactures in this market are constantly striving to innovate and create cutting-edge technologies and methodologies for validating bioprocesses. By staying at the forefront of innovation, these companies gain a competitive advantage by providing validation solutions that are more efficient, accurate, and cost-effective. Additionally, companies that prioritize customer satisfaction and establish strong consumer relationships often benefit from repeat business and transfers, further enhancing their competitive position.
Eurofins BioPharma Product Testing Columbia part of the biggest network of harmonized bio/pharmaceutical GMP product testing facilities globally, announced a collaboration agreement with Plus Therapeutics, Inc. ("Plus Therapeutics"), a clinical stage pharmaceutical company developing novel, targeted therapies for rare and difficult cancers.
April 30, 2020, Merck, a leading science and technology company, today unveiled the next component of its BioContinuum Platform, the Bio4C Software Suite, generating a first-of-its-kind ecosystem that syndicates process control, analytics as well as plant-level automation.
GLOBAL BIOPROCESS VALIDATION MARKET KEY PLAYERS- DETAILED COMPETITIVE INSIGHTS
Eurofins Scientific, Inc.
Sartorius AG
Merck KGaA
Thermo Fisher Scientific Inc.
Lonza
Danaher Corporation
Charles River Laboratories
SGS S.A.
Toxikon Corporation
Cobetter Filtration Equipment Co., Ltd.
Others