PUBLISHER: KBV Research | PRODUCT CODE: 1219626
PUBLISHER: KBV Research | PRODUCT CODE: 1219626
The Global Bioprocess Validation Market size is expected to reach $650.6 Million by 2028, rising at a market growth of 8.5% CAGR during the forecast period.
The documentation of all procedures, evidence, and activities of the process of biological and biopharmaceutical product formation is known as bioprocess validation. The documentation is performed as per the guidelines of various regulatory bodies, for instance, US FDA (Food and Drug Administration).
It ensures the maintenance of compliance in all the stages of the product testing procedures. Assessing Active Pharmaceutical Ingredients (API) and impurities is essential to bioprocess validation. The primary principle of validation is to ensure that every process of the bioproduct processing is evaluated, which provides quality products, maintaining scientifically documented evidence.
Quality, efficacy, and safety are maintained during the bioprocess validation. Validation has become an essential issue in manufacturing biopharmaceuticals or biologies intended for therapeutic usage. In addition to the validation of final product quality, manufacturing process validation is gaining wide attention. Bioprocesses are sensitive and delicate and hence require careful planning and organization for successful process validation. As a result, bioprocess chromatography is the most generally utilized unit operation in biologics manufacturing.
COVID-19 Impact Analysis
The COVID-19 pandemic has adversely impacted the world economy due to the imposed lockdown, business shutdown, and restriction on travel. This critically affected numerous industries' manufacturing plants and factories, affecting the sales and product supply chains negatively. The rising COVID-19 infections have led to the development of precision medicines and biosimilars that raise the demands for outsourcing services and the bioprocess validation process. As a result, major market players have also started to enhance and implement the validation process for the bioprocess of biologics and drug developments. An effective validation ensures the product's safety, quality, and efficiency, which is expected further to surge the market growth of the bioprocess validation.
Market Growth Factors
The rise in the need to outsource bioprocess validation
In the pharmaceutical sector, compliance with the standards of different regulatory bodies is essential, which is why bioprocess validation is an integrated process in pharmaceuticals. Validation verifies that all procedures stick to the stated requirements by the government's regulations. Any validation method requires exhaustive documentation that conforms to standard operating procedures and ongoing activities. Pharmaceutical manufacturing is being outsourced to third-party service providers to raise production yields. The wide usage of disposable technologies in medication development aids in reducing production costs. The increasing outsourcing of bioprocesses validation to third-party service providers will propel the growth of the bioprocess validation market.
Rising usage of single use bioprocessing
The implementation of single-use bioprocessing systems enhances manufacturing processes' productivity by reducing automation's cost and complexity. It also eliminates the requirement for changeover cleaning/validation between consecutive operations. In addition, single-use bioprocessing systems eliminate the need for additional investments by removing the requirement for sterilization. The initial investment costs with single-use bioprocessing systems are lower compared to that of the stainless-steel facility at the same scale, making it suitable for new players with low investments. Thereby boosting the demand for the bioprocess validation market.
Market Restraining Factors
Possible issues with extractables & leachable
The food and pharmaceutical sectors are dealing with difficulties with the trace quantity of contaminants generated by the extraction or leaching process. Even after the strict regulations of many nations' governments, corporations are still disregarding such issues and the risk to the lives of consumers/patients. Pharmaceutical manufacturers and regulatory agencies are concerned with extractable and leachable. Any containers and pharmaceutical packaging system, including plastic bottles, labeling ink, packing materials, glass, and foil pouches, can leach undesired pollutants into the food ingredient or drug products. Oral drugs, parental and ophthalmic products often pose a more eminent danger. Hence, the issues related to extractables and leachable are expected to hamper the growth of the bioprocess validation market.
Testing Type Outlook
Based on testing type, the bioprocess validation market is segmented into extractables & leachables testing, bioprocess residuals testing, viral clearance testing, filtration & fermentation systems testing and others. The extractables & leachables testing segment garnered a significant revenue share in the bioprocess validation market in 2021. The growth is attributed to the presence of good manufacturing practice guidelines and US FDA regulations. Due to this, there is a huge demand for certified quality bioproducts. The biotechnology and biopharmaceutical companies are engaged in manufacturing cGMP-certified bioproducts. The requirement for government-certified products will propel the segment's growth in the forecasted period.
On the basis of stage, the bioprocess validation market is divided into process design, process qualification, and continued process verification. The continued process verification segment witnessed the largest revenue share in the bioprocess validation market in 2021. This is because it collects the processing, data collection analysis, and storage of every batch. The primary reasons for creating a continued process verification plan are to achieve compliance with regulatory bodies, prevent batch discards, and mitigate process vulnerabilities while finding constant enhancement possibilities. These features and the automation in this process will boost the segment's expansion.
By mode, the bioprocess validation market is bifurcated into in house and outsourced. The outsourced segment projected a substantial revenue share in the bioprocess validation market in 2021. This is due to biopharmaceutical and biotechnology companies' high demand for testing services. There is an increase in expenditure for healthcare and the supply of raw materials needed by the market players. In addition, there is also a rising number of CDMOs (Contract Development and Manufacturing Organization) providing drug development and manufacturing services to the pharma and biopharma industries.
Region-wise, the bioprocess validation market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America region dominated the bioprocess validation market with the largest revenue share in 2021. This is because of significant outsourcing services providers in the region, which leads to the rise in life science research and the production of biologics. Also, the region has many FDA-approved biopharmaceuticals and biotechnological industries. The increased government funding for the bioprocess validation process and the conduct of clinical trials, combined with the presence of many key players, will surge the market's growth in the region.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc., Eurofins Scientific SE, Sartorius AG, Merck KGaA, Lonza Group AG, Danaher Corporation, Charles River Laboratories International, Inc., SGS S.A., Labcorp Corporation, and Cobetter Filtration equipment Co., Ltd.
Strategies Deployed in Bioprocess Validation Market
Sep-2022: Lonza collaborated with Touchlight, a biotechnology company. With this collaboration, Lonza would have the capacity to combine a diverse, additional source of DNA in its complete suite for customers developing messenger RNA vaccines and therapeutics and at the same time Touchlight could broaden the channels through which customers can earn access to Lonza's novel doggy bone DNA (dbDNA) technology.
Aug-2022: Thermo Fisher Scientific opened a dry powder media manufacturing facility in Grand Island, New York. The new facility would offer the inessential potential to assist the global supply of media and further broadens the site's abilities to deliver the quality technology and materials required for the commercial manufacturing and development of biological and vaccine therapies.
Jun-2022: Merck collaborated with Agilent Technologies, a leader in life diagnostics, sciences, and applied chemical markets. Under this collaboration, both companies would advance bioprocess offering with Agilent's leading analytical solutions to provide combined abilities for improved downstream process control and monitoring.
Feb-2022-Feb: Sartorius Stedim Biotech, a subgroup of Sartorius, completed the acquisition of the chromatography division of Novasep, a leading supplier of services in the field of purification and molecule production. The acquisition of a chromatography suite consists of chromatography systems suitable for smaller biomolecules and advanced systems for the continuous production of biologics.
May-2021: Eurofins BioPharma Product Testing Columbia signed an agreement with Plus Therapeutics, Inc., a clinical-stage pharmaceutical company. Through this Agreement, Eurofins would develop and validate test methods for the composition, and identity of Re-BMEDA, the active pharmaceutical ingredient (API) in RNL and purity.
Jan-2021: Sartorius collaborated with RoosterBio, Inc., a leading provider of highly engineered media, human mesenchymal stem/stromal cell working cell banks, and hMSC bioprocess systems. Under the collaboration, both companies would aim to advance the development of hMSC manufacturing of regenerative medicine by enhancing the quality solutions of both companies to notably decrease process development efforts, industrialize the supply chain and boost the development and production of better cell-based regenerative cures.
Dec-2020: Sartorius completed the acquisition WaterSep BioSeparations LLC, a U.S.-based purification expert. This acquisition aligns with the company's current suite for cell and gene therapy applications, cell harvesting, and multiple solutions for robust bioprocessing.
Apr-2020: Merck launched BioContinuum™ Platform, the Bio4C™ Software Suite, making a first-of-its-kind ecosystem that integrates process management, plant-level automation, and analytics. The launched product portfolio would enable users to view the complete manufacturing process versus particular operational units, delivering biomanufacturers comprehensive deep insights and process control.
Apr-2020: Sartorius announced the acquisition of selected life science businesses of Danaher Corporation, a globally diversified conglomerate company. This acquisition would help customers completely in the advancement of biotech medicines and vaccines, also in the protected and smooth production of the same pharmaceuticals.
May-2018: Eurofins Scientific acquired PHAST, a leading service provider in the field of pharmaceutical product quality. This acquisition would align with Eurofins' BioPharma Product Testing abilities and broadens its geographical reach in these markets.
Market Segments covered in the Report:
By Testing Type
Unique Offerings from KBV Research
List of Figures