The downstream processing market involves the separation, purification, and recovery of biopharmaceutical products from the harvested cell culture medium or fermentation broth. Downstream processing plays an integral role in the biopharmaceutical manufacturing process as it helps isolate the desired therapeutic protein from unwanted contaminants. These downstream purification systems consists of various steps such as centrifugation, chromatography, ultrafiltration, precipitation, nanofiltration, and formulation. The rising demand for monoclonal antibodies, gene therapies, and vaccines have prompted biopharmaceutical companies to invest significantly in developing automated and continuous downstream purification platforms to reduce production costs and improve yields.
The global downstream processing market is estimated to be valued at US$ 246.2 Mn in 2024 and is expected to exhibit a CAGR of 2.6% over the forecast period 2024 to 2031.
Key Takeaways
Key players operating in the downstream processing market are Merck KGaA, Thermo Fisher Scientific Inc., GE Healthcare, Sartorius Stedim Biotech S.A., Repligen Corporation, Pall Corporation, M Company, Eppendorf AG, Agilent Technologies, Inc., Waters Corporation, Shimadzu Corporation, Bio-Rad Laboratories, Inc., Avantor Performance Materials, LLC, Tosoh Corporation, Column Technology Inc., Purolite, W.R. Grace & Co., Asahi Kasei Corporation, Novasep Holding S.A.S, and Boehringer Ingelheim.
The key opportunities in the downstream processing market include increasing demand for single-use technologies from contract manufacturing organizations and biopharmaceutical companies to reduce capital costs. Implementation of continuous manufacturing and multi-use products are also attracting significant interest from industry stakeholders.
Technological advancements such as pre-packed and fixed bed chromatography columns, membrane adsorbers, and modular/ready-to-use downstream solutions are supporting automated downstream processes. Continuous downstream processes are witnessing increased adoption to enhance process efficiency and flexibility.
Market drivers
The major drivers fueling the growth of Downstream Processing Market Size are rapid expansion of biopharmaceutical industry, growing importance of monoclonal antibodies and recombinant proteins, rising R&D investments by biotech companies for new product development, and increasing government support in the form of funding. In addition, increasing preference for automated single-use technologies by biopharma players to reduce production costs is expected to boost market revenues.
The Downstream Processing market is facing several challenges which can hamper its growth over the forecast period. The extensive initial capital investments required for setting up downstream processing facilities pose a major challenge. Downstream processing facilities need large investments for installing purification equipment, filters, chromatography columns, centrifuges and various media which increases the initial setup costs. Another challenge is the complex and dynamic regulatory requirements for the approval of biopharmaceutical products. Regulatory changes by authorities like FDA adds to compliance burden of companies.
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