Bioprocess Validation Market Size (2024 - 2029)

Bioprocess Validation Market Analysis

The bioprocess validation market is expected to witness a healthy 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 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.