News | January 10, 2023

Bioprocess Validation Market Worth $842.5M By 2030: Grand View Research, Inc.

San Francisco, CA /PRNewswire/ - The global bioprocess validation market size is projected to reach USD 842.5 million by 2030, at a CAGR of 9.10% from 2023 to 2030, according to a new report by Grand View Research, Inc. Bioprocess validation is the process of documentation of all the stages, activities and procedures of the bioproduct formation. This documentation complied with the EMEA and US FDA guidelines of cGMP. It aims to deliver standard, quality, and safe manufacturing of bioproducts. The process has a wide range of applications in drug discovery, therapeutics development, and biosimilar development. Precise analysis of active pharmaceutical ingredients and the removal of contaminants such as endotoxins and, bacteria during drug development are the most crucial step of bioprocess validations.

Key Industry Insights & Findings from the report:

  • The bioprocess residuals testing segment dominated the market with the largest market share of 28.65% in 2022. The increases in the demand for impurity-free bio-products by pharmaceutical, biopharmaceutical, and biotechnology industries and enhancing drug discovery and therapeutics development process will drive the segment to grow in the upcoming forecast.
  • By stage segment, the continued process verification segment held the largest share of 42.3% in 2022. This is due to the increasing use and availability of automation facilities for continued process verification, which drives the segment to account for the largest share.
  • By mode segment, the outsourced segment dominated the market in 2022. The presence of increased bioprocess validation outsourcing testing services by the majority of the critical players propels the market to account for a large share of this segment.
  • North America held the largest share of 38.93% in 2022, due to the presence of an established healthcare sector and key players such as Thermo Fisher Scientific, Inc.; Danaher Corporation; and others in the region.

Read 150 page full market research report, "Bioprocess Validation Market Size, Share & Trends Analysis Report By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals Testing), By Stage, By Mode (In house, Outsourced) By Region And Segment Forecasts, 2023 - 2030", published by Grand View Research.

Bioprocess Validation Market Growth & Trends
There is a surge in demand for the in-house as well as outsourcing of the validation process, which drives the global market. Trace contaminants are formed during the production and manufacturing process of bio-products. This is due to the presence of extractable and leachables, which can cause potential hazards to consumers. This can be a major restraining factor, which can hamper the market growth. Moreover, biopharmaceutical and biotechnology industries focusing on low manufacturing costs with higher yields of the products create lucrative opportunities for market growth. The major challenge faced by the key players and bio manufacturers is the approval of novel therapies to validate drug and therapeutics development by the government and regulatory agencies.

COVID-19 has had a positive impact on the global market as the R&D sector and the development of vaccines and therapeutics have flourished. Moreover, increasing demand for the safety and quality cGMP-approved vaccines to treat the COVID-19 virus has led to an increase in the mergers and, partnerships among the market key players for enhancing the upstream and downstream process for delivering efficient bioproducts. An effective validation process not just ensures the quality and safety but also the efficacy of the product. Moreover, during the post-COVID era, most of the biopharmaceutical industries, suppliers, and service providers have increased their pandemic-related research, development, and manufacturing of biosimilars, thus propelling the market.

The increasing CDMOs, bioprocess outsourcing services, stringent government regulations, and guidelines for developing safe and quality products propel the global bioprocess validation industry. Moreover, an increase in the number of clinical trials to deliver impurity-free biosimilars and drugs for the treatment of chronic diseases such as cancer, diabetes, and arthritis boosts the market. In addition to these leading advancements in the life sciences tools and automated systems for the bioprocess, methods boost industry growth.

Bioprocess Validation Market Segmentation
Grand View Research has segmented the global bioprocess validation market based on testing type, stage, mode, and region:

Bioprocess Validation Market - Testing Type Outlook (Revenue, USD Million, 2018 - 2030)

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

Bioprocess Validation Market - Stage Outlook (Revenue, USD Million, 2018 - 2030)

  • Process Design
  • Process Qualification
  • Continued Process Verification

Bioprocess Validation Market - Mode Outlook (Revenue, USD Million, 2018 - 2030)

  • In House
  • Outsourced

Bioprocess Validation Market - Regional Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • North America
    • U.S.
    • Canada
  • Europe
    • UK
    • Germany
    • France
    • Italy
    • Spain
    • Denmark
    • Sweden
    • Norway
  • Asia Pacific
    • Japan
    • China
    • India
    • Thailand
    • Australia
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Kuwait

List of Key Players in the Bioprocess Validation Market

  • 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.

Check out more related studies published by Grand View Research:

  • Single-use Bioprocessing Market - The global single-use bioprocessing market size is projected to reach USD 79.47 billion by 2030, registering a compound annual growth rate (CAGR) of 16.6% over the forecast period, according to a new report by Grand View Research, Inc. The demand for single-use bioprocessing offerings is driven by the commercial advantages offered, including a reduction in costs and time required for bioprocessing operations. Originally used for monoclonal antibody production, single-use technologies are also gaining traction for cell and gene therapy manufacturing. As a result, broadening the scope of applications in biomanufacturing operations is likely to drive industry growth.
  • Upstream Bioprocessing Market - The global upstream bioprocessing market size is expected to reach USD 12.60 billion by 2026, expanding at a CAGR of 12.90% during the forecast period, according to a new report by Grand View Research, Inc. Commercial success and wide acceptance of biopharmaceuticals have provided lucrative growth avenues to several in house as well as contract manufacturing biopharmaceutical companies. Furthermore, a confluence of factors, such as high demand for biosimilars and biologics, launch of improved cost-effective technologies, and growing acceptance of single-use systems have driven the revenue performance of the market.
  • Single-use Bioprocessing Probes And Sensors Market - The global single-use bioprocessing probes and sensors market size is expected to reach USD 5.4 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 13.9% from 2021 to 2028. The biopharmaceutical industry is witnessing an increase in the use of single-use technology for the production of biologics, biosimilar, and other biopharmaceutical products. As the need to reduce manufacturing costs is increasing, manufacturers are adopting the implementation of single-use equipment in their production workflow, in turn, boosting revenue growth.

Browse through Grand View Research's Biotechnology Industry Research Reports.

About Grand View Research
Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

Source: Grand View Research, Inc

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