Bioprocess Validation Market is segmented By Test Type (Extractables/Leachables Testing Services, Microbiological Testing Services, Integrity Testing Services, Physiochemical Testing Services, Compatibility Testing Services, and Others), By Process (Media containers and bags, Freezing and thawing process bags, Filter elements, Others), By End-User (Pharmaceutical Companies, Biotechnology Companies, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031
Market Overview
The bioprocess validation market report provides an analysis of the market shares, size, recent trends, future market outlook, and competitive intelligence. The demand for bioprocess validation is increasing due to the growth of the biopharmaceutical industry and increasing government regulations. The market is witnessing a surge in demand from the American region. The competitive rivalry is intensifying with major players such as Merck KGaA, Thermo Fisher Scientific, and others actively operating in the market.
The Bioprocess Validation Market size was valued at USD 224,687.30 million in 2021 and is estimated to reach a compound annual growth rate (CAGR) of 11.20% over the forecast period 2024 to 2031.
Bioprocess Validation is a process that involves collecting documentary evidence to ensure that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. An important part of bioprocess validation requires evaluating Active Pharmaceutical Ingredients (APIs) and possible contaminants, such as mycoplasma, bacteria, endotoxin, and others, during the development and manufacturing processes of animal disinfectants or other biological products.
As per DataM Intelligence, Bioprocess Validation Market study analysis offers an in-depth outlook on the market containing quantitative and qualitative data. It gives an outlook and forecast of the global market based on market segmentation. It also provides global Bioprocess Validation Market size, and growth, along with the latest trends, opportunities, and forecast till 2029 for the global market with esteem to major countries such as the United States, Canada, Brazil, Germany, Italy, Spain, United Kingdom, Russia, European countries, United Arab Emirates, Saudi Arabia, South Africa, Japan, China, India, South Korea, Australia, and rest of the countries over the globe.
Among all regions, the North American region is expected to hold the largest share of the global market over the forecast period. Bioprocess Validation Market in the United States and Canada produces the utmost share. Whereas the European Bioprocess Validation Market is projected to continue its presence globally from 2023 to 2030.
Market Scope and Summary
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Metrics |
Details |
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Market CAGR |
11.20% |
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Segments Covered |
By Test Type, By Process, By End User, and By Region |
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Report Insights Covered |
Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights. |
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Fastest Growing Region |
Asia Pacific |
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Largest Market Share |
North America |
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Market Dynamics and Trends
Increasing global demand for biopharmaceuticals is expected to boost the demand for the bioprocess validation market
The huge demand for biopharmaceuticals is facilitated by an accelerating focus on research and development-related investments. High demand for outsourcing bioprocess validation services, stringent safety and quality regulations governing product certifications and testing beyond the biopharmaceutical and pharmaceutical industries in the healthcare industry to maintain the agreement with good manufacturing practices are the important factors propelling the growth of the global bioprocess validation industry.
Issues related to extractable and leachable are expected to restrain the global bioprocess validation market
Single-use technology has been adopted widely in bioprocess development and biopharmaceutical manufacturing in recent years. While the benefits of such technologies are well recognized, there are significant concerns regarding extractable and leachable from the components of single-use systems owing to their potential effect on product quality and patient health. A risk assessment is normally required to assess the probability of extractable and leachable migrating into the product stream and their potential risk to the patient. During the forecast period, the issues related to extractable and leachable are expected to restrain the growth of the global market for bioprocess validation.
Expansion into emerging markets is expected to generate new opportunities for the global bioprocess validation market
In the Asian region, China is a high-potential market for bioprocess validation, followed by India. The growth in this market can be attributed to favorable government support, rising private investments, a growing geriatric population, and a rising trend of outsourcing to emerging Asian countries. India, Japan, and Brazil are expected to be the new revenue pockets for market players. Also, the high investment in bio-manufacturing infrastructure is a key factor responsible for the high-growth potential of these markets. The new opportunities offered by emerging markets are expected to boost the growth of the global market.
Stringent government regulations on bioprocess validation are expected to present challenges for the global market for bioprocess validation
Validation is a regulatory requirement for pharmaceutical and biotechnology companies to confirm that they consistently manufacture safe medicines for the public. Companies must be able to provide proof of validation activities when requested, such as during an audit by regulatory agencies. The complexity of government regulations for bioprocess validation prevents its adoption for a wider range of applications and presents a challenge to the growth of the global bioprocess validation market.
Market Segmentation and Shares
The scope of the report covers segmentation based on test type, process component, end-user, and region. The global bioprocess validation market is segmented by test type into extractable/leachable testing services, microbiological testing services, integrity testing services, physiochemical testing services, compatibility testing services, and others. The global market is segmented by process components into media containers and bags, freezing and thawing process bags, filter elements, bioreactors, and others. The global market is segmented by end-user into pharmaceutical companies, biotechnology companies, contract development and manufacturing organizations, and others. The global market is segmented by region into North America, South America, Europe, Asia-Pacific, the Middle East, and Africa.
Pharmaceutical Companies: Pharmaceutical companies have a large share of the end-user segment, which can majorly be attributed to the increasing production of biopharmaceuticals and the corresponding increase in the number of impurities to be checked for, the stringency of standards and regulations regarding the quality and validity of bioprocesses involved in the production
Biotechnology Companies: The biotechnology sector is experiencing rapid growth due to favorable governmental policies. Government initiatives are oriented towards modernizing the drug regulatory pathway, standardizing clinical studies, improving reimbursement policies, and speeding up the product approval process, thereby offering lucrative growth opportunities to the market.
Contract Development & Manufacturing Organizations: With developments in the pharmaceutical industry, leading contract development and manufacturing organizations (CDMOs) aim to seek and bridge capability gaps. CDMOs offering multiple services increase convenience, save time, and enhance cost efficiency as pharmaceutical companies have to only deal with a single entity. The relationship also creates opportunities for the CDMOs to sell more services to the same customer and lock in products at earlier stages of their life cycles
Others: The segment mainly includes laboratories and research institutes. Process-related cell-derived impurities such as buffer components, antibiotics, surfactants, anti-foaming agents, process-enhancing agents, catalysts, or compounds that leach from contact materials can impede research projects. Therefore, process validation studies require a broad set of testing capabilities and expertise.
Geographical Analysis
According to the DataM Intelligence market research report, the global bioprocess validation market is divided into;
North America - United States, and Canada
South America - Brazil, Argentina, Peru, Chile, and the Rest of the South American countries
Europe - UK, Germany, Italy, France, Spain, Russia, and the rest of the European countries
Asia-Pacific - China, India, Japan, South Korea, Singapore, Australia, Malaysia, and the Rest of the Asia-Pacific countries
Middle East and Africa - UAE, KSA, Qatar, South African Countries, and the Rest of the Middle East countries
Competitive Landscape:
The global bioprocess validation market is moderately competitive with several international and regional players. The major players adopt several growth strategies such as licensing activities, collaborations, mergers and acquisitions, government tie-ups, and joint ventures, thereby contributing to the growth of the global bioprocess validation market.
Major Companies:
Some key companies contributing to the growth of the global bioprocess validation market include Cobetter Filtration Equipments Co., Ltd., SGS S.A., DOC S.r.l., Thermo Fisher Scientific, Sartorius Stedim Biotech, Merck KGaA, Meissner Filtration Products, Inc., Eurofins Scientific, Boston Analytical and Danaher Corporation (Pall Corporation), among others.
Recent Developments in the Industry:
In July 2022, Vaccizone, a vaccine manufacturer, announced a partnership with Exothera, a biotechnology research company, to use Exothera's scale-X technology to develop Vaccizone's COVID-19 vaccine with expedited bioprocess validation.
In June 2022, Alder Therapeutics announced a deal to help with the bioprocess validation for NorthX Biologics, a Swedish biotech company. The deal will enable NorthX Biologics to expand into pluripotent stem cell research.
In June 2022, the Jefferson Institute for Bioprocessing (JIB) announced the commencement of its bio technician training and validation program at the Budd Bioworks research space in Philadelphia, U.S.
COVID-19 Impact on Bioprocess Validation Market Growth
COVID-19 had a significant impact on the market. The pandemic caused significant manufacturing and supply-chain operations disruptions due to various precautionary lockdowns and other governmental restrictions globally. Because validation is required at all stages of drug development to monitor accuracy, efficiency, and safety, demand for bioprocess validation increased during the pandemic. The pandemic has increased the demand for bioprocess validation and is expected to positively impact the bioprocess validation market growth.
