Bioprocess Validation Market Size Worth $993.22 Million in 2032| CAGR: 9.40%

The global bioprocess validation market size was valued at USD 993.22 million in 2032, according to a new study by Polaris Market Research. The report “Bioprocess Validation Market Size, Share & Trends Analysis Report, By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals Testing), By Stage, By Mode, By Region and Segment Forecasts, 2024-2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.

A rise in the demand for outsourcing bioprocess validation, an increase in biologics-focused life science research, and a spike in investments by pharmaceutical and biotechnology firms are the major factors driving the market of bioprocess validation. In addition, there is an increase in government measures that support the development of the pharmaceutical and biotechnology sectors in several nations, as well as in the number of CROs and Contract Development & Manufacturing Organizations.

The market is expanding due to significant technical developments in biomanufacturing infrastructure and continuous bioprocess validation of bioreactors to enable the affordable and scalable manufacture of pharmaceuticals. In addition, the market is expected to grow thanks to the developing trend of outsourcing laboratory testing services, the rising demand for individualized medications, and ongoing research and development (R&D) operations to guarantee the highest possible quality of pharmaceuticals.

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Precision medicine and biosimilars have been developed in response to the rise of COVID-19 infections worldwide, which has boosted the demand for outsourcing services and the bioprocess validation process. Key competitors in the market have also started to implement and improve the validation procedure for the bioprocess of developing biologics and drugs. For instance, SGS invested in the Biosafety Centre of Excellence in Glasgow in November 2020 and has increased its vaccine manufacturing, medicinal, and R&D portfolio.

Bioprocess Validation Market Report Highlights

• The bioprocess residuals testing category dominated the market in 2022. This is primarily due high demand for safe, high-quality, safe drugs, vaccines, and therapeutics developed by the biotechnological and pharmaceutical companies.
• Extractables and leachables registered the highest growth rate over the study period. This is because the US FDA standards and current good manufacturing practice recommendations are in force.
• Process Verification segment accounted for the largest revenue share. It encompasses acquiring data and storing, processing, and analyzing each batch. Automation in this procedure also fosters sector growth.
• Continued Process Verification accounted for a significant market share owing to its increasing prevalence and increasing process automation support expansion of the market.
• North America witnessed a dominating share in the global market, which is mainly due to a growing number of R&D initiatives and investments, expanding demand for biopharmaceuticals, and rising need for outsourced bioprocess validation.
• Asia-Pacific region has shown enormous development potential, due to favorable government backing, expanding private investment, a rising senior population, and a growing tendency of outsourcing to developing Asian nations.
• Global players include Eurofins Scientific, Sartorius, Merck, Thermo Fisher Scientific, Lonza, Danaher Corporation, Charles River Laboratories, SGS, Toxikon Corporation, and Co better Filtration Equipment.

Polaris Market Research has segmented the bioprocess validation market report based on testing type, stage, mode, and region:

Bioprocess Validation Market, Testing Type Outlook (Revenue - USD Million, 2019 - 2032)

• Extractable & Leachables Testing
• Bioprocess Residuals Testing
• Viral Clearance Testing
• Filtration & Fermentation Systems Testing
• Others

Bioprocess Validation Market, Stage Outlook (Revenue - USD Million, 2019 - 2032)

• Process Design
• Process Qualification
• Continued Process Verification

Bioprocess Validation Market, Mode Outlook (Revenue - USD Million, 2019 - 2032)

• In House
• Outsourced

Bioprocess Validation Market, Region Outlook (Revenue - USD Million, 2019 - 2032)

• North America

• U.S.
• Canada

• Europe

• Germany
• UK
• France
• Italy
• Spain
• Russia
• Netherlands

• Asia Pacific

• China
• India
• Japan
• South Korea
• Indonesia
• Malaysia

• Latin America

• Argentina
• Brazil
• Mexico

• Middle East & Africa

• UAE
• Saudi Arabia
• Israel
• South Africa