Bioprocess Validation Market - By Testing Type, By Stage, By Mode, By Application, By End Use - Global Forecast, 2024 – 2032

Bioprocess Validation Market Size

The global bioprocess validation market size was valued at around USD 416.5 million in 2023 and is estimated to grow at 10.7% CAGR from 2024 to 2032. Bioprocess validation is a systematic approach in biopharmaceutical manufacturing that ensures processes consistently produce products meeting quality and regulatory standards. It involves documented tests and analyses to confirm that each step of the bioprocess, from raw materials to final products, operates within specified parameters. This validation process aims to guarantee the production of safe and effective therapeutic products.
 

The bioprocess validation market is driven by regulatory requirements, increasing demand for biologics, and technological advancements. As biopharmaceutical production and outsourcing expand, the need for robust validation processes to ensure regulatory compliance and product quality remains a significant market driver. The growing demand for biopharmaceutical products, including monoclonal antibodies, vaccines, and gene therapies, is a key factor. These products require extensive validation to meet stringent regulatory standards for quality, safety, and efficacy, increasing the demand for validation services. The World Health Organization (WHO) reports that as of 2021, there were over 320 vaccine candidates in development for COVID-19 alone, demonstrating the surge in biopharmaceutical research and development activities that require rigorous validation processes.
 

Regulatory bodies, such as the FDA and European Medicines Agency (EMA), require thorough validation and process documentation to ensure biopharmaceutical product quality and safety. Compliance with current Good Manufacturing Practices (cGMP) and other regulations necessitates detailed validation processes and continuous monitoring. The FDA's Center for Biologics Evaluation and Research (CBER) approved 56 therapeutic drugs in 2020, emphasizing the ongoing need for robust validation procedures in the biopharmaceutical industry.
 

Bioprocess Validation Market Trends

• The increasing use of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) by biopharmaceutical companies to optimize production and reduce costs is driving the need for outsourced bioprocess validation services.
   
• This trend allows companies to ensure compliance without expanding their in-house capabilities. The National Institutes of Health (NIH) reports a growing number of partnerships between biopharmaceutical companies and CMOs/CDMOs, indicating a rising demand for external validation expertise and services.
   
• Emerging bioprocessing technologies, including single-use systems, continuous biomanufacturing, and automation, necessitate adapted validation processes. The increasing complexity and diversity of bioprocessing methods make validation crucial for maintaining consistent product quality and manufacturing efficiency.
   
• In 2021, the FDA released guidance on the use of digital health technologies for remote data acquisition in clinical investigations, emphasizing the importance of validating these new technologies in bioprocessing. As bioprocessing technologies continue to evolve, validation processes will play an increasingly vital role in ensuring the safety and efficacy of biopharmaceutical products, ultimately benefiting patients worldwide.
   

Bioprocess Validation Market Analysis

The market is segmented by testing type, including extractables/leachables testing, microbiological testing, integrity testing, viral clearance testing, adventitious agent testing, mycoplasma testing, physiochemical testing, compatibility testing, and other testing types. In 2023, the microbiological testing segment led the market, generating a revenue of USD 126.2 million.
 

• Regulatory bodies, including the FDA, EMA, and WHO, impose stringent standards for microbiological testing in biopharmaceuticals. The FDA's Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing emphasizes that environmental monitoring should routinely assess air, surfaces, and personnel in classified areas. Furthermore, Good Manufacturing Practices (GMP) mandate regular microbiological testing at various bioproduction stages to uphold safety and efficacy. Such rigorous standards highlight the paramount importance of microbiological testing in ensuring product quality and safeguarding patient health.
   
• The rise of biologics, biosimilars, and gene therapies has amplified the need for comprehensive microbiological testing. For example, the FDA's approval of thirty biosimilars from 2016 to 2021 underscores the escalating significance of stringent testing protocols. Moreover, personalized medicines, typically produced in smaller batches, demand heightened contamination controls to ensure patient safety and prevent batch cross-contamination. This shift towards personalized therapies amplifies the need for rigorous microbiological testing to uphold product integrity.
   
• Innovations in microbiological testing, such as rapid microbiological methods (RMM), polymerase chain reaction (PCR)-based assays, and automated platforms, have markedly improved the speed, accuracy, and efficiency of contamination detection. These advancements streamline quality control, allowing for quicker release of safe biopharmaceuticals to patients.
   
• Consequently, these factors are poised to sustain the demand for standard formulas in the foreseeable future.

Based on stage, the bioprocess validation market is segmented into process design, process qualification, and continued process verification. In 2023, the process qualification segment led the market, capturing a dominant revenue share of 46.8%.
 

• Process qualification (PQ) is a pivotal phase in bioprocess validation. Its primary goal is to ensure that a biomanufacturing process consistently produces products that meet established quality standards. Typically, PQ follows process design and comes before continued process verification in the validation lifecycle. This stage tests the process under real operating conditions, confirming its robustness and reproducibility.
   
• As the bioprocessing industry shifts towards single-use technologies and continuous manufacturing, it faces new challenges in process qualification. Validating these systems for scalability, sterility, and contamination control becomes paramount, leading to a heightened demand for qualification services.
   
• Given these dynamics, the process qualification segment is poised for significant growth in the coming years.
   

The bioprocess validation market is bifurcated into in-house and outsourced based on mode. The in-house segment is projected to reach USD 702 million by 2032.
 

• In-house bioprocess validation means pharmaceutical and biotechnology firms conduct validation processes within their own facilities, rather than outsourcing. This strategy provides enhanced control over product quality, compliance, and safeguarding of intellectual property. Companies often opt for in-house validation to oversee sensitive processes and strictly adhere to regulatory requirements, especially for specialized or intricate biologics.
   
• With many biopharmaceutical firms adopting continuous manufacturing and Quality by Design (QbD) frameworks, there's a pronounced need for ongoing, in-house validation and process monitoring. This alignment facilitates continuous process enhancements, minimizes variability, and guarantees consistent quality.
   
• Given these considerations, the in-house segment is set for robust growth in the foreseeable future.
   

The bioprocess validation market is segmented by application into biopharmaceuticals, gene and cell therapy, vaccines, and other applications. In 2023, the biopharmaceuticals segment was valued at USD 215.9 million.
 

• Biopharmaceutical manufacturing is inherently complex, with processes being more sensitive than traditional pharmaceutical production. Variations in raw materials, cell cultures, and environmental conditions can profoundly impact product quality.
   
• To navigate these challenges and ensure consistent product quality across batches, bioprocess validation becomes indispensable. Given the intricacies of biopharmaceutical manufacturing and the surging demand for biologics, the significance of bioprocess validation in ensuring product quality, safety, and efficacy is underscored.
   
• The rising prevalence of chronic diseases and intricate health conditions has spurred a heightened demand for biologics, encompassing monoclonal antibodies, vaccines, and gene therapies.
   
• Highlighting this demand, the World Health Organization (WHO) notes that chronic diseases account for 71% of global deaths, underscoring the urgency for advanced biopharmaceutical interventions. Furthermore, biosimilars—generic counterparts of biologics—demand meticulous validation to ensure parity in safety and efficacy with their reference products. The FDA's approval of 29 biosimilars by 2021 further accentuates the burgeoning market for these products and the indispensable role of bioprocess validation in their journey from development to approval.
   

The bioprocess validation market is segmented by end use into pharmaceutical companies, biotechnology companies, CROs and CDMOs, and academic and research institutes. In 2023, the pharmaceutical companies’ segment was valued at USD 187.9 million.
 

• The pharmaceutical landscape is witnessing a swift ascent in biologics, biosimilars, and avant-garde therapies, notably cell and gene therapies. These offerings, being more intricate, are also more susceptible to manufacturing nuances than their traditional counterparts.
   
• Data from the U.S. Food and Drug Administration (FDA) highlights the trend: over 400 cell and gene therapy products were actively under development as of 2020. Given this backdrop, robust bioprocess validation emerges as a linchpin, ensuring consistency and controlling variability, thus steering production success. This trajectory amplifies the significance of bioprocess validation within the pharmaceutical realm.
   
• Innovations like continuous biomanufacturing and single-use systems are reshaping pharmaceutical production, enhancing flexibility and curtailing costs. However, these advancements necessitate revamped bioprocess validation protocols to uphold compliance.
   
• The FDA's endorsement of continuous manufacturing, citing its potential to elevate product quality and mitigate drug shortages, further validates this shift. As firms gravitate towards automated and scalable processes, the appetite for validation services is bound to swell. This momentum towards pioneering manufacturing methodologies heralds a pronounced growth trajectory for the market.

In 2023, the U.S. bioprocess validation market was valued at USD 174.5 million, with projections indicating a growth rate of 10.8% CAGR over the forecast period.
 

• Regulatory bodies, including the U.S. FDA, impose stringent guidelines on biopharmaceutical manufacturing. These guidelines mandate comprehensive bioprocess validation to uphold safety, efficacy, and quality standards. Companies are required to adhere to Good Manufacturing Practice (GMP) standards, validating every facet of their manufacturing processes to ensure compliance. Such regulatory imperatives drive investments in advanced validation methods, underscoring their significance in the market.
   
• The U.S. has a pronounced demand for biologics, spanning monoclonal antibodies, gene therapies, and CAR T-cell therapies. This demand is bolstered by a robust healthcare infrastructure and significant investments in pioneering treatments. Producing these intricate products mandates stringent bioprocess validation to uphold quality standards across batches.
   
• Moreover, the rise of personalized medicine in the U.S. amplifies the need for tailored bioprocesses and, consequently, meticulous validation procedures. Given these dynamics, the U.S. market is poised for growth in the coming years.
   

From 2024 to 2032, the UK bioprocess validation market is set for notable expansion.
 

• The UK is a leading hub for biotechnology and biopharmaceutical advancements, home to numerous firms specializing in biologics, cell and gene therapies, and advanced therapeutic medicinal products (ATMPs). This diverse landscape demands sophisticated bioprocess validation, especially for novel therapies entering clinical trials or the commercial arena.
   
• Recognizing the life sciences sector as pivotal for economic growth and innovation, the UK government actively champions it. Initiatives like the Life Sciences Industrial Strategy and backing from UK Research and Innovation (UKRI) aim to bolster biopharmaceutical manufacturing.
   
• As companies expand to cater to both domestic and international markets, these initiatives amplify validation activities. Given the sector's growth, validation becomes paramount to ensure the quality and reliability of new facilities and production processes.
   
• With heightened awareness and government backing, the region's market growth is set to surge in the coming years.
   

Japan's bioprocess validation market is on track for significant growth between 2024 and 2032.
 

• Japan boasts one of the world's highest life expectancies, with women averaging 87.14 years and men 81.09 years in 2023, as per the World Health Organization (WHO). This longevity trend has birthed a swiftly aging populace, with 29.1% of citizens aged 65 or older in 2023, according to BBC reports.
   
• This demographic shift fuels a heightened demand for advanced therapies, notably biologics and biosimilars, targeting age-related ailments like cancer and neurodegenerative disorders. Such demand underscores the necessity for stringent validation in biomanufacturing.
   
• Moreover, the Japanese government is a staunch advocate for biopharmaceutical innovation, offering incentives and policy support to bolster domestic R&D and manufacturing. Initiatives like "Society 5.0" and healthcare-centric economic strategies further stimulate investment in biologics and biosimilars, amplifying the need for rigorous bioprocess validation.
   
• Given these dynamics, the region's market growth is anticipated to be robust over the forecast period.
   

Saudi Arabia's bioprocess validation market is poised for significant growth from 2024 to 2032.
 

• Saudi Arabia's Vision 2030 is a strategic blueprint aimed at reducing the nation's oil dependency, with a pronounced focus on bolstering the healthcare and biotechnology sectors. Central to this vision are substantial investments in biopharmaceutical R&D and manufacturing, underscoring the need for stringent bioprocess validation.
   
• In a bid to curtail import reliance and achieve self-sufficiency, the government is championing local pharmaceutical manufacturing. This push not only encourages the establishment of domestic manufacturing facilities but also amplifies investments in bioprocess validation, ensuring compliance with regulatory and quality benchmarks.
   
• Given these concerted efforts, the region's market growth trajectory appears promising in the coming years.
   

Bioprocess Validation Market Share

The market is characterized by intense competition, featuring a blend of major global players and smaller to medium-sized firms vying for market dominance. A pivotal strategy in this arena is the consistent rollout of innovative products, harnessing a spectrum of technologies. Industry stalwarts, wielding significant influence, often spearhead advancements, buoyed by hefty investments in research and development. Furthermore, maneuvers like strategic alliances, acquisitions, and mergers play a crucial role in solidifying market positions and broadening global reach, especially in the face of shifting regulatory landscapes.
 

Bioprocess Validation Market Companies

Some of the eminent market participants operating in the bioprocess validation industry include:

• Asahi Kasei Corporation
• Bio-Rad Laboratories
• Charles River Laboratories
• Danaher Corporation
• Eurofins Scientific
• Lonza Group
• Meissner Filtration Products
• Merck KGaA
• Pace Analytical Services
• Repligen Corporation
• Sartorius AG
• SGS S.A.
• Thermo Fisher Scientific
• Tosoh Corporation
• WuXi AppTec
   

Bioprocess Validation Market Industry News:

• In July 2024, BioProcess360 Partners announced the launch of an investment fund aimed at supporting businesses involved in the development of emerging tools and technologies for the bioprocessing of traditional monoclonal antibodies (mAbs) and newer drug modalities. The fund is designed to assist companies in overcoming challenges related to research and development (R&D) and commercialization by providing investment capital, expert industry support, and connections to leading global biopharmaceutical companies.
   
• In October 2024, Thermo Fisher Scientific signed a Memorandum of Understanding (MoU) with the Government of Telangana to establish a bioprocess design center (BDC) in Genome Valley, Hyderabad. Covering a total area of 10,000 square feet, the bioprocess design center is set to become operational in early 2025. It is intended to serve as a benchmark for accelerating the development and manufacturing of innovative biotherapeutics in India and the Asia-Pacific region. The center will feature state-of-the-art laboratories and training hubs to promote scientific research.
   

The bioprocess validation market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Testing Type

• Extractables/leachables testing
• Microbiological testing
• Integrity testing
• Viral clearance testing
• Adventitious agent testing
• Mycoplasma testing
• Physiochemical testing
• Compatibility testing
• Other testing types

Market, By Stage

• Process design
• Process qualification
• Continued process verification

Market, By Mode

• In-house
• Outsourced

Market, By Application

• Biopharmaceuticals
• Gene and cell therapy
• Vaccines
• Other applications

Market, By End Use          

• Pharmaceutical companies
• Biotechnology companies
• CROs and CDMOs
• Academic and research institutes

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE