Bioprocess Validation Market Size
| Study Period | 2019 - 2030 |
| Base Year For Estimation | 2024 |
| Forecast Data Period | 2025 - 2030 |
| CAGR | 9.50% |
| Fastest Growing Market | North America |
| Largest Market | Asia-Pacific |
| Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Bioprocess Validation Market Analysis
The Bioprocess Validation Market is expected to register a CAGR of 9.5% during the forecast period.
The COVID-19 pandemic has significantly impacted the bioprocess validation market. This can be attributed to significant disruptions in their respective manufacturing and supply-chain operations as a result of various precautionary lockdowns and other restrictions imposed by governments all over the world. The demand for bioprocess validation increased during the pandemic because validation is required at all phases of drug development to monitor accuracy, efficiency, and safety. Due to the uncontrolled and sudden increase in COVID-19 cases, the development of biosimilars, combination molecules, and other innovative vaccines and medicines has grown, which has resulted in an increased demand for significant bioprocess validation. Currently, as the pandemic has subsided, the market has lost some traction. Hence, the market is expected to experience stable growth during the forecast period of the study.
The market's growth is being driven by the high demand for bioprocess validation services, as well as stringent safety and quality regulations governing product certifications and testing beyond the biopharmaceutical and pharmaceutical industries, and increasing demand for outsourcing bioprocess validation coupled with rising R&D expenditure.
According to the US FDA's Drug Recall Statistics published in July 2021, approximately 1,279 drugs are recalled each year globally, with 94% of FDA drug recalls occurring in the United States and 4% in Canada. The FDA issued 12,028 drug recalls in the United States between 2012 and 2021. This necessitates the validation of products and the assurance of public safety before they are marketed. Medicines are designed to improve outcomes in humans and animals, as low-quality medicines have a negative impact on patient health and funding systems. As a result, bioprocess validation is critical in ensuring the safety and efficacy data of drugs.
For instance, in December 2021, Sartorius and HOF Sonderanlagenbau formed a partnership to integrate two HOF horizontal plate freeze-thaw units into Sartorius' portfolio, providing customers with a complete freeze-thaw solution. Through improved validation and purchase support from a single supplier, this partnership enables faster and easier implementation of robust frozen drug-substance management platforms. Thereby, such developments are elevating the growth of the bioprocess validation market.
The increased need for specific types of tests in R&D activities, as well as the growing trend of outsourcing laboratory testing services, are two major factors driving the market's growth. Companies are expanding their market share by offering a variety of services and solutions in response to the growing trend of outsourcing laboratory testing services. Major players are also concentrating on various strategies such as mergers, acquisitions, and other developments. For example, in August 2021, Eurofins Scientific agreed to buy GeneTech Inc., a leading Japanese player in genetic analysis, from Noritsu Koki Co. Ltd, to expand Eurofins' testing portfolio in Japan. Because bioprocess validation plays such an important role, the market is expected to expand significantly.
Furthermore, increase in research and development expenditure in pharmaceutical research the market is expected to see a surge over the forecast period. For instance, according to the Pharmaceutical Research and Manufacturers of America data updates from September 2021, since 2000, PhRMA member companies have invested more than USD 1.1 trillion in the search for new treatments and cures, including USD 102.3 billion in 2021 alone. Furthermore, these are expected to increase further over the forecast period. Thus, the rising research and development expenditure is expected to boost the bioprocess validation market.
However, the issues related to extractables and leachables is expected to hinder market growth.
Bioprocess Validation Market Trends
Bioreactor Expected to Hold Significant Market Share
The pharmaceutical sector uses bioreactors for the manufacture of medicines, vaccines, and other components. Bioreactors are also used for the production of monoclonal antibodies for the treatment of cancer, rheumatoid arthritis, and other diseases. Bioreactors have been utilized in many different areas of industry and research and for the progression of in vitro models of 2D cultures and suspensions to 3D constructs, mimicking the natural physiological state in situ.
In the pharmaceutical sector, bioreactors are used to hold organisms for the purpose of harnessing their natural biochemical processes. Bioreactors are designed to allow microorganisms to thrive, causing the contents of the tank to ferment and creating a usable end product. In a batch bioreactor, everything is added at once to a controlled and sealed environment, and the biochemical reactions are allowed to run their course before the reactor is opened so that the contents can be extracted and utilized, disposed of, or further processed. Others operate on a continuous flow method, in which materials constantly flow through the bioreactor.
According to the OECD, 2021, the gross domestic expenditure towards R&D was 12.5% in Germany, 12.4% in France, 11.5% in Austria, 11.4% in Sweden, and 11.3% in Norway. Hence, the increasing research and development activities is driving the usage of various bioprocess valadation devices such as bioreactors, thus elevating the segment growth.
For instance, in April 2020, researchers from Ology Bioservices and Univercells SA announced that they had developed a high-yield live-virus vaccine production platform by using a novel fixed-bed bioreactor in a paper published in the 'Vaccine' magazine. The scientists from these companies further stated that their bioreactor platform allows for a cost-effective and scalable process for viral vaccine production. Initiatives such as these are expected to boost segment growth.
In addition, as per the article published by researchers from Denmark in June 2021 under the title 'SARS-CoV-2 Production in a Scalable High Cell Density Bioreactor', researchers have established a process for COVID-19 vaccine manufacturing in Vero cells cultivated in a single-use tide-motion bioreactor (CelCradle 500-AP), one of the few scalable packed-bed bioreactors available and an attractive option for large-scale cost-effective production.
Therefore, the rising demand and use of bioreactors for applications in the pharmaceutical sector are expected to boost the innovation and usage of bioreactors, thus propelling the segment growth.
North America to Hold a Significant Market Share
North America holds a significant share in the bioprocess validation market owing to the increasing number of R&D activities and investments as well as rising demand for biopharmaceuticals and increasing demand for outsourcing bioprocess validation.
According to a report published in September 2021 by the Pharmaceutical Research and Manufacturers of America (PhRMA), in the last decade, biopharmaceutical companies invested more than USD 1 trillion in research and development, including a record-breaking year in 2020, where PhRMA member companies invested about USD 91 billion in research and development. Outsourcing drug development helps biotechnology firms properly utilization of their resources and limit financial risks. As a result, the bioprocess validation market is anticipated to grow over the forecast period.
In September 2022, The US government invested over USD 2 billion to launch its biomanufacturing initiative, which aims to expand manufacturing capacity in the country and ensure pandemic preparedness. Around USD 20.6 million from the initiative will be distributed to the independent, nonprofit Manufacturing Innovation Institute BioMADE to support nine tech and innovation projects. Thus, such funding is expected to increase the growth of clinical research institutes in the country which is expected to increase segmental growth.
Thus, owing to the abovementioned factors, the market is expected to show growth over the forecast period.
Bioprocess Validation Industry Overview
The bioprocess validation market is fragmented in nature due to the presence of a number of companies globally. The studied market consists of several international and local companies that hold the majority of the market shares and are well known, including Eurofins Scientific, SGS SA, Labcorp (Toxikon Corporation), Sartorius AG, Pall Corporation, Cobetter Filtration Equipments Co., Ltd, and DOC S.r.l.
Bioprocess Validation Market Leaders
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Merck KGaA
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Eurofins Scientific
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SGS S.A.
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Sartorius AG
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Pall Corporation
- *Disclaimer: Major Players sorted in no particular order
Bioprocess Validation Market News
- May 2022: Qosina launched its new Bioprocess Resource Center, an information source for the bioprocess industry.
- September 2022: Eppendorf SE expanded its bioprocess site in Jülich, Germany, with the construction of a new state-of-the-art multifunctional building.
Bioprocess Validation Industry Segmentation
Bioprocess validation is the process of documenting all the procedures, activities, and evidence of the process of biological and biopharmaceutical product formation. Precisely, data are collected, evaluated, and documented from every stage of a specific project at all desired levels. In this way, bioprocess validation establishes the scientific evidence that a process is capable of consistently delivering quality products.
The Bioprocess Validation Market is Segmented by Test Type (Extractables Testing Services, Microbiological Testing Services, Physiochemical Testing Services, Integrity Testing Services, Compatibility Testing Services, and Other Testing Services), Process Component (Filter Elements, Media containers and bags, Freezing And Thawing Process Bags, Mixing Systems, Bioreactors, Transfer Systems, and Other Process Components), End-User (Pharmaceutical & Biotechnology Companies, Contract Development & Manufacturing Organizations, Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments. The report offers the value (in USD million) for the above segments.
| By Test Type | Extractables Testing Services | ||
| Microbiological Testing Services | |||
| Physiochemical Testing Services | |||
| Integrity Testing Services | |||
| Compatibility Testing Services | |||
| Other Testing Services | |||
| By Process Component | Filter Elements | ||
| Media containers and bags | |||
| Freezing And Thawing Process Bags | |||
| Mixing Systems | |||
| Bioreactors | |||
| Transfer Systems | |||
| Others | |||
| By End User | Pharmaceutical & Biotechnology Companies | ||
| Contract Development & Manufacturing Organizations | |||
| Other End Users | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
Biprocess Validation Market Research FAQs
What is the current Bioprocess Validation Market size?
The Bioprocess Validation Market is projected to register a CAGR of 9.5% during the forecast period (2025-2030)
Who are the key players in Bioprocess Validation Market?
Merck KGaA, Eurofins Scientific, SGS S.A., Sartorius AG and Pall Corporation are the major companies operating in the Bioprocess Validation Market.
Which is the fastest growing region in Bioprocess Validation Market?
North America is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Bioprocess Validation Market?
In 2025, the Asia-Pacific accounts for the largest market share in Bioprocess Validation Market.
What years does this Bioprocess Validation Market cover?
The report covers the Bioprocess Validation Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Bioprocess Validation Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Bioprocess Validation Industry Report
Statistics for the 2025 Bioprocess Validation market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Bioprocess Validation analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
