The bioprocess validation market size is expected to advance at a CAGR of 9.60% during 2022–2030, to reach USD 835 million by 2030. This is ascribed to the rising usage of these services by pharmaceutical and CDMO companies to monitor the purity, accuracy, safety, and efficiency of the drugs during the manufacturing process.
Along with this, the market is driven by the growing pace of technological advancements in the bio-manufacturing industry and the rising usage of bioreactors to ensure the scalable and cost-effective production of medications. Besides, the rising requirement for personalized medicines, the emerging trend of outsourcing laboratory testing services, and the continuous R&D activities to ensure drugs are of the desired quality fuel the demand for bioprocess validation services.
The COVID-19 pandemic has also significantly impacted the market. During the pandemic, the demand for such services increased due to the necessity of validation at all phases of drug development, to monitor efficiency, accuracy, and safety. The testing and manufacturing of vaccines were performed extensively, which drove the requirement for the validation of the processes followed.
The growing prevalence of several chronic diseases is enhancing the demand for biopharmaceuticals, which, in turn, aids in the fast adoption of bioprocess validation services across the healthcare sector. The prevalence of infectious diseases is increasing along with that of cancer and neurological disorders, due to which biopharmaceuticals are becoming really important.
Many of the biopharmaceuticals used for the treatment of neurodegenerative disorders are administered directly into the brain, which is not feasible with traditional, synthetic agents. Moreover, bio-based drugs are advancing technologically and leading to higher survival rates for cancer patients, curing hepatitis, aiding in better management of arthritis, and transforming the treatment options for many other diseases. Due to the rising incidence of such diseases, the use of biopharmaceuticals is growing, which will, in turn, boost the market development.
APAC is expected to witness the fastest growth, at a CAGR of more than 10%, attributed to the rising government support for pharmaceutical R&D, the growing trend of outsourcing, and the ballooning geriatric population. Moreover, the investment in bio-manufacturing infrastructure in the region is high, which is responsible for the advancements in the validation processes.
Essentially, the rising overall healthcare expenditure and the enhancing funding for R&D setups by government agencies are propelling the demand for bioprocess validation services. Furthermore, the growing awareness of the advantages of vaccines and their use in treating several chronic diseases is driving the government to take initiatives for the development, implementation, and progress of these processes in the region.
The European market is also showing significant growth, because of the launch of novel testing services and the rapid development of the healthcare infrastructure in the region. In addition to this, the regulatory approvals for new products and services, as well as the availability of government financing for the critical areas of the healthcare sector, are increasing.
The most-significant bioprocess validation market players are Eurofin Scientific SE, Sartorius AG, SGS, Cytiva, Lonza Group Ltd., Charles River Laboratories International Inc., Thermo Fisher Scientific Inc., Merck KGaA, and Hangzhou Cobetter Filtration Equipment Co. Ltd.