GMP PROTEIN (E. COLI) CONTRACT MANUFACTURING MARKET ANALYSIS

Proteins are manufactured under guidelines that allow for their use as ancillary materials in cell therapy or further manufacturing processes. GMP proteins also come with extensive documentation and traceability, as well as additional quality control testing. Global GMP protein (E. coli) contract manufacturing market is estimated to be valued at US$ 685.8 million in 2022 and is expected to exhibit a CAGR of 9.7% during the forecast period (2022-2030).

Figure 1. Global GMP Protein (E. coli) Contract Manufacturing Market Share (%), by Application, 2022

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Global GMP Protein (E. coli) Contract Manufacturing Market- Drivers

Increasing research and development activities by key market players are expected to drive market growth over the forecast period. For instance, according to Alliance for Regenerative Medicine, 2020, approximately US$ 9.8 billion was raised in global financings for the cell and gene therapy sector in 2019. Moreover, according to the same source, in 2020, there were 572 ongoing regenerative medicine clinical trials in U.S. trial sites.

Increasing inorganic growth strategies by the key players to increase GMP grade protein production capacities is expected to drive market growth over the forecast period. For instance, in October 2021, Avid Bioservices, Inc., a dedicated biologics Contract Development and Manufacturing Organization (CDMO), announced that the company is increasing its CDMO service offering in the rapidly growing cell and gene therapy market. As part of this effort, the company is constructing a world-class, purpose-built 53,000 sq. ft. viral vector development and CGMP manufacturing facility in Costa Mesa, CA, approximately five miles from Avid’s existing operations in Tustin, CA.

Figure 2. Global GMP Protein (E. coli) Contract Manufacturing Market Share (%), by Region, 2022

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Global GMP Protein (E. coli) Contract Manufacturing Market – Impact of Coronavirus (COVID-19) Pandemic

Supply chain and manufacturing activities in India, Italy, Spain, the U.K., and the U.S. were disrupted due to lockdowns implemented by governments in the past few months, while countries such as Saudi Arabia, the UAE, Egypt, and others faced problems with the transportation of raw materials. The coronavirus or COVID-19 outbreak that started in Wuhan, China has spread across continents, affecting various industries globally. Supply of key materials had been severely disrupted due to forced quarantine and lack of labor and raw materials. As the link between regional warehouses was not smooth, the transportation of raw materials between regions cannot be carried out successfully. This shortage of raw materials and components has affected the supply chain of the GMP protein (E. coli) contract manufacturing market.

Global GMP Protein (E. coli) Contract Manufacturing Market: Key Developments

In June 2021, Vectron Biosolutions AS, a company developing and marketing vector technologies for the biotechnology and life science industries, announced that it had raised US$ 2.7 million in a Series A financing round led by Dynamk Capital along with the acquisition of a bacterial secretion platform from T3S TECHNOLOGIES, INC., a biotechnology company. The acquisition of T3S Technologies’ secretion platform combined with Vectron’s core expression technology and additional financing will significantly help Vectron to reduce costs associated with the production of recombinant proteins or solutions to advance their challenging proteins to the market.

In November 2019, Abcam plc., a supplier of protein research tools to life scientists, announced a strategic partnership with BrickBio, Inc., a developer of a bioconjugation platform intended for research of site-specific modification of proteins. As a part of the partnership, Abcam plc. will have exclusive rights to the proprietary platform for introducing conjugation-ready sites into antibodies and other proteins in both mammalian and bacterial expression systems for the creation of novel conjugation-ready recombinant products for the research tools market. In addition, it will have the right to commercialize the platform across its recombinant antibody and protein portfolio for diagnostic purposes. BrickBio’s platform can site selectively modify proteins in a broad range of eukaryotic and bacterial cell lines. Using a proprietary engineered tRNA synthetase/tRNA pair, the platform can easily incorporate unnatural amino acids that can then be coupled to a second molecule for labeling or other research applications or to create protein-conjugate therapeutics including Antibody-Drug-Conjugates (ADCs).

Global GMP Protein (E. coli) Contract Manufacturing Market: Restraint

The major factors that hinder the growth of the global GMP protein (E. coli) contract manufacturing market include the high cost of recombinant protein manufacturing. The high cost involved in the production and research and development of recombinant proteins is expected to act as a restraint for the market growth. For instance, according to an article published by MDPI, a publisher of open-access scientific journals, in July 2019, the costs of a single clinical trial can vary from US$ 5 million for small, non-controlled orphan drug trials to US$ 350 million for large controlled studies. The median estimate is US$ 19 million. Moreover, according to an article published by ResearchGate, in July 2019, industrial proteins often have a retail price of tens of dollars per kilogram while recombinant proteins for medical use may cost billions of dollars per kilogram. Thus, the high cost of recombinant protein products and high cost involved in its manufacturing is expected to act as a restraint for the market growth.

Global GMP Protein (E. coli) Contract Manufacturing Market - Key Players

Major players operating in the global GMP protein (E. coli) contract manufacturing market include 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.