Authored By: Sarah
11 Jul 2024

 Bioprocess Validation Market Size to grow by USD 364 million between 2024-2028

According to a research report “ Bioprocess Validation Market” by End-user (Pharmaceutical companies, Contract development and manufacturing organizations, Others) Type (In-house, Outsourced) Geography (North America, Europe, Asia, Rest of World (ROW))- Global Forecast to 2028 published by Technavio, the market size is estimated to grow by USD 364 million, at a CAGR of  12.88% during the forecast period. In the dynamic healthcare landscape, biopharmaceuticals have emerged as a critical segment, driving innovation and improvement in patient care. The production of these advanced therapeutics necessitates rigorous bioprocess validation, ensuring consistent and high-quality output. This validation process plays a crucial role during drug development, guaranteeing efficacy and safety for patients. Monoclonal antibodies, essential components in cancer and inflammatory disease treatments, are a prime example. The biological systems employed in their manufacturing can significantly impact product quality and consistency. Consequently, a meticulously planned bioprocess validation strategy is indispensable to meet regulatory standards and specifications, ultimately ensuring the delivery of reliable and effective therapeutic solutions.

Browse market data tables, figures, and in-depth TOC on “Bioprocess Validation Market” by End-user (Pharmaceutical companies, Contract development and manufacturing organizations, Others) Type (In-house, Outsourced) Geography (North America, Europe, Asia, Rest of World (ROW)) Global Forecast to 2028. Download Free Sample

 

By End-user, the Pharmaceutical companies segment is projected to dominate the market size in 2024

The Bioprocess Validation Market is a significant business domain, underpinned by the increasing demand for ensuring product quality and regulatory compliance in the biopharmaceutical industry. Bioprocess validation is a critical step in bringing biologics to market, and market growth is driven by factors such as rising healthcare expenditures, increasing prevalence of chronic diseases, and stringent regulatory requirements. Companies are investing in advanced technologies and strategies to streamline validation processes and reduce costs, making this a dynamic and competitive market.

By Type, In-house  segment is expected to hold the largest market size for the year 2024

The Bioprocess Validation Market is a significant business domain, underpinned by the increasing demand for ensuring the consistency, safety, and efficacy of biopharmaceutical manufacturing processes. This market caters to the validation requirements of bioreactors, downstream processes, and analytical methods, leveraging advanced technologies such as automation, real-time monitoring, and data analytics to streamline validation processes and enhance product quality. Market growth is driven by stringent regulatory compliance, rising demand for complex biologics, and the continuous evolution of validation methodologies.

North America is forecasted to hold the largest market size by region in 2024

The Bioprocess Validation Market is experiencing significant growth due to the increasing demand for biopharmaceuticals and regulatory compliance. Bioprocess validation is a critical step in ensuring the production of high-quality therapeutic proteins and monoclonal antibodies. This process verifies the consistency, reproducibility, and reliability of manufacturing processes, ultimately ensuring product safety and efficacy. Market players are investing in advanced technologies, such as single-use systems and automated processes, to streamline validation and improve efficiency. The market is expected to continue its upward trajectory, driven by these trends and the growing demand for biologics in various therapeutic areas.

The Bioprocess Validation Market growth and forecasting report also includes detailed analyses of the competitive landscape of the market growth and forecasting and information about 20 market companies, including:

  • Agilent Technologies Inc.
  • Asahi Kasei Corp.
  • Avantor Inc.
  • Bangalore Biotech labs Pvt. Ltd.
  • Charles River Laboratories International Inc.
  • Corning Inc.
  • Danaher Corp.
  • Eurofins Scientific SE
  • GEA Group AG
  • Hangzhou Cobetter Filtration Equipment Co. Ltd.
  • Laboratory Corp. of America Holdings
  • Lonza Group Ltd.
  • Meissner Filtration Products Inc.
  • Merck KGaA
  • Porvair Plc
  • ProPharma Group Holdings LLC
  • Sartorius AG
  • SGS SA
  • Thermo Fisher Scientific Inc.
  • W. L. Gore and Associates Inc.
.

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Research Analysis Overview

The Bioprocess Validation Market is witnessing significant growth due to the increasing demand for biologic drugs, particularly in the areas of chronic diseases, recombinant proteins, monoclonal antibodies, biosimilars, precision medicines, and vaccines for conditions like cancer, diabetes, and COVID-19. The market is driven by socioeconomic factors, including the aging population and rising healthcare expenditures. Key components of bioprocess validation include mixing systems, filter elements, compatibility testing services, physiochemical testing services, and integrity testing services. Leading biopharmaceutical companies are increasingly outsourcing these validation services to specialized providers to ensure the quality and efficiency of their bioproduction activities. Bioprocess validation plays a critical role in ensuring the quality and safety of drug products and vaccines, particularly in the biopharmaceutical manufacturing sector. It involves testing for impurities, residuals, and microbiological contamination, among other parameters. The market for bioprocess validation is expected to grow significantly in the coming years, driven by the increasing bioproduction volumes and the development of new technologies for the production of complex biologics. Some of the key trends in the bioprocess validation market include the increasing use of automation and digital technologies, the growing demand for compatibility testing services, and the emergence of new players in the market. The market is highly competitive, with leading biopharmaceutical companies and outsourcing service providers vying for market share. The residuals testing segment is expected to grow significantly due to the increasing focus on ensuring the purity and safety of biologics. The market is also expected to be impacted by the ongoing COVID-19 pandemic, with an increased demand for vaccines and therapeutics.

Market Research Overview

The Bioprocess Validation Market is a significant segment of the biotechnology industry, encompassing mixing systems, filter elements, compatibility testing services, physiochemical testing services, and integrity testing services for bioprocessing facilities. Socioeconomic factors, such as the increasing prevalence of chronic diseases, biologic drugs, and bioproduction volumes, drive market growth. Compatibility with degradation products, high-resolution mass spectrometry, in silico modeling, single-use systems, robotics, and automation technologies are essential considerations. Leading biopharmaceutical companies invest heavily in biopharmaceutical RD expenditure, utilizing advanced analytics, real-time release testing, continuous process monitoring, and digital tools. Contract service providers offer validation protocols and procedures for biologics, biosimilars, and precision medicines, including gene therapy and cell therapy. Validation services encompass chromatography systems, bioreactors, bioprocess instruments, and extractable testing services for drug products, vaccines, and impurities. The market is influenced by regulatory requirements, cleaning procedures, analytical testing methods, and the biopharmaceutical manufacturing process. The market includes the in-house segment and the outsourcing services segment. The Bioprocess Validation Market caters to the needs of the biopharmaceutical manufacturing sector, life science research, and bioproduction activities, including recombinant proteins, monoclonal antibodies, and SARS-CoV-2 virus research.

Contacts

Technavio Research
Jesse Maida
Media & Marketing Executive
US: +1 844 364 1100
UK: +44 203 893 3200
Email: media@technavio.com
Website: www.technavio.com/

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