GMP protein contract manufacturing refers to the production of biologics under Good Manufacturing Practices guidelines to ensure safety, efficacy and consistency. E. coli is commonly used as an expression system for biosimilar development and production due to its ease of use, scalability and cost-effectiveness.
The global GMP Protein (E. coli) Contract Manufacturing Market is estimated to be valued at US$ 685.8 Million in 2023 and is expected to exhibit a CAGR of 9.7% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market key trends:
The GMP Protein (E. coli) Contract Manufacturing Market is expected to witness significant growth due to rising demand for biosimilars and biologics. Growing prevalence of chronic diseases is propelling drug development activities globally. Furthermore, increasing R&D investments by biotech companies and academia is fueling outsourcing of biologics manufacturing. Rising focus on healthcare cost containment is boosting adoption of biosimilars which is driving the need for their large scale commercial manufacturing through contract service providers. Additionally, advances in E. coli expression platforms are improving yields and enabling production of complex proteins, thereby supporting market growth over the forecast period.
Strength: The GMP Protein (E. coli) Contract Manufacturing Market is witnessing high growth due to increasing demand for generic medicines and biosimilars by biopharmaceutical companies. E. coli is a well-established platform for recombinant protein manufacturing due to its low cost and ease of scale-up.
Weakness: Reliance on a limited number of vendors makes supply susceptible to disruptions. Require further validation for adherence to stringent quality standards set by regulatory agencies.
Opportunity: Growing need for next-generation biological therapies such as antibodies, enzymes, and vaccines is expected to drive the demand. Emerging economies provide untapped opportunities due to rising chronic disease prevalence.
Threats: Stringent regulations and high capital investment required to set up in-house GMP facilities pose threats to outsourcing trend. Intensity of competition threatens profit margins of players.
The global GMP Protein (E. coli) Contract Manufacturing Market is expected to witness high growth, exhibiting CAGR of 9.7% over the forecast period, due to increasing demand for affordable biologics and biosimilars in healthcare.
Regional analysis: North America dominates the market currently due to presence of majority global players and strong biopharmaceutical industry in the US. Asia Pacific is expected to grow at the fastest pace owing to rising pharmaceutical outsourcing to China and India offering low-cost alternatives.
Key players operating in the GMP Protein (E. coli) Contract Manufacturing Market are Merck & Co., Inc., Thermo Fisher Scientific Inc., Abcam plc, GenScript, Biomay AG, SOL GROUP, Proteintech Group, Inc., Nordmark Pharma GmbH, Sino Biological, Inc., Abnova Corporation, Eurofins Scientific, Arcline Investment Management LP, Abgenex, Xpress Biologics, Avid Bioservices Inc, Bio-Techne, Northway Biotech, Aldevron, Institut Mérieux, PerkinElmer Inc., Creative BioMart, Profacgen, ProBioGen AG, 53Biologics, Leadgene Biomedical, Inc., Ajinomoto Bio-Pharma, FUJIFILM Diosynth Biotechnologies, Avioq, Inc, Biovian Oy, KBI Biopharma, GTP Bioways, QIAGEN, Suzhou Novoprotein Technology Co., Ltd., ACROBiosystems, Kactus, F. Hoffmann-La Roche Ltd., and Enzo Life Sciences, Inc.
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it