July 7, 2024

GMP Protein (E. coli) Contract Manufacturing Market Perspectives: Shaping Bioproduction Strategies

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Market Overiew:
GMP protein (E. coli) contract manufacturing involves the production of therapeutic proteins such as monoclonal antibodies, cytokines, blood factors, fusion proteins, enzymes, and other recombinant proteins using E. coli expression systems under strict GMP guidelines. The process involves fermentation, purification, analytical testing, and formulation of the final drug product. It is essential for biopharmaceutical companies to outsource protein production to dedicated contract manufacturers owing to the capital-intensive nature and specialized expertise required for GMP-compliant production. The market players provide services from pre-clinical stages to commercial manufacturing and supply of proteins to meet the increasing demand for affordable biologics.

The GMP Protein (E. coli) Contract Manufacturing Market is estimated to be valued at US$ 685.8 Mn in 2023 and is expected to exhibit a CAGR of 9.7% over the forecast period of 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Dynamics:
The growth of the global GMP protein (E. coli) contract manufacturing market is driven by the rising prevalence of chronic diseases and the expansion of the biologicspipeline. Biologics have revolutionized the treatment of various diseases. However, biologics manufacturing is a complex and capital-intensive process. This has prompted drug developers to rely on specialized contract manufacturers for their protein production needs. Another key driver is the patent cliffs of major biologics which is offering lucrative opportunities for biosimilars. Contract manufacturers are poised to benefit from this by providing development and manufacturing support. Furthermore, contracting out non-core functions helps companies optimize capital and focus resources on drug development. This favorable outsourcing trend and increasing R&D investment in biologics are expected to propel the market growth over the forecast period.

Segment Analysis
The GMP protein market can be segmented into E. coli expression systems and mammalian expression systems. The E. coli expression system is currently dominating the market due to its ease of use, low cost, and ability to produce high yields of recombinant therapeutic proteins. E. coli remains the most widely used expression system in the industry because it allows for rapid production of large amounts of protein and is well-understood genetically.

PEST Analysis
Political: drug regulations around the world require GMP certified manufacturing of therapeutic proteins, driving demand.

Economic: the biologics market is growing at a high single-digit rate annually, increasing the need for large-scale GMP manufacturing capabilities.

Social: the aging population has led to greater demand for biologics to treat chronic diseases.

Technological: advances in cell culture and purification technologies have improved manufacturing efficiency.

Key Takeaways
The global GMP protein contract manufacturing market is expected to witness high growth, exhibiting a CAGR of 9.7% over the forecast period of 2023 to 2030, driven by the expanding biologics pipeline and growing demand for biologics to treat various diseases.

Regionally, North America is projected to dominate the market during the forecast period due to presence of major players and strong biologics R&D ecosystem in the region. However, Asia Pacific is likely to be the fastest growing market, supported by rising biopharma research, low manufacturing costs, and government initiatives to promote the life sciences industry.

Key players operating in the GMP protein contract manufacturing market include Merck & Co., Inc., Thermo Fisher Scientific Inc., Abcam plc, and GenScript. These players are focusing on capacity expansions to meet the growing demand. For instance, in 2021, Abcam acquired BioVision, Inc. to strengthen its position in proteomics. Other prominent players include Biomay AG, SOL GROUP, Proteintech Group, Inc., and Nordmark Pharma GmbH.

*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it