Market Research Report
The Market for Cell and Gene Therapy Manufacturing - The Rise of CMOs & CDMOs (2021)
|The Market for Cell and Gene Therapy Manufacturing - The Rise of CMOs & CDMOs (2021)|
Published: June 5, 2021
BIOINFORMANT WORLDWIDE, LLC
Content info: 123 Pages
Delivery time: 1-2 business days
A contract manufacturing organization (CMO) is a company that provides manufacturing services to cell and gene therapy companies on a contract basis. Contract development and manufacturing organizations (CDMOs) are similar, in that they offer services that include cell therapy product development, manufacturing, clinical trial support, and commercial supply.
Among cell and gene therapy companies, the pressure for manufacturing innovation and optimization can incentivize them to seek third-party partners who possess technical, manufacturing, and regulatory expertise. Benefits of partnering with a cell or gene therapy therapy CDMO include scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies.
This global strategic report analyzes the scope of the manufacturing services required by the burgeoning global cell and gene therapy (CGT) industry. It explores critical facility shortages impacting the industry, as well as the surge of recent funding flowing into the industry that will propel new growth.
In addition to industry giants that include Lonza, Catalent, WuXi Advanced Therapies, Minaris Regenerative Medicine, and others, there are specialty CDMOs serving the CGT marketplace. For example, FUJIFILM Cellular Dynamics opened a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products.
Anemocyte announced itself as the first BMO (Biotech Manufacturing Organization) in the field of cell and gene therapies. In addition to building 2000 sq. metres of GMP and GMP-compliant facilities for the production of ATMP's, its FLYn'ICE project is using drones equipped with cryogenic pods to achieve temperature controlled transit of cell and gene therapies.
There have also been enormous M&A deals within the cell and gene therapy CDMO sector. For example, industry behemoth Thermo Fisher Scientific snagged Brammer Bio for an astonishing $1.7 billion, while Catalent acquired Paragon Bioservices for an impressive $1.2 billion and MaSTherCell for $315 million.
Similarly, Hitachi Chemical Advanced Therapeutics Solutions (HCATS), apceth Biopharma GmbH, and Hitachi Chemical Co., Ltd. Regenerative Medicine now operate under the joint name of Mineras Regenerative Medicine. Of course, Charles River Laboratories (CRL) acquired Cognate BioServices for a hefty price tag of $875 million.
The rapid ascension of cell and gene therapies (CGT) has created a crucial turning point in the history of modern medicine. Not only have new therapies such as CAR-T produced a shift towards highly individualized medicine and a powerful new front in the war against cancer, but the rapidity of change with the CGT sector has taken the world by storm.
By 2025, the FDA has indicated that it will be reviewing an estimated 10 to 20 of CGTs per year, while the European Medicines Agency (EMA), has estimated that it will soon be approving as many as a dozen such therapies per year.
This global strategic report reveals critical activities within the cell and gene therapy sector, with a focus on three key areas:
With the hard-earned marketing approvals gained by cell and gene therapy companies in recent years, biopharmaceutical companies have substantially increased their interest in the CGT sector. Some biopharma companies are resorting to increasing their manufacturing capacity by investing in expansion and new facilities, while others are partnering with third-party contract manufacturing organizations to outsource this work.
With the future in mind, contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are also investing heavily in expanding their manufacturing capacity to be able to take on new clients and larger, later-stage projects as the market expands.
Currently, the cell and gene therapy field is currently on track for a massive capacity shortage. In particular, there is likely to be a shortage of manufacturing capacity at the commercial scale. Although approximately 90% of cell and gene therapy developers would prefer to use CMOs, related CMO capacity is not available within the industry.
Moreover, the lead time for CMOs to begin cell and gene therapy projects averages over 18 months. Thus, CGT developers are often forced to expand their in-house capacity. Of course, CMOs are also investing heavily into the expansion of their cell and gene therapy manufacturing capabilities, but these large build-outs take time.
This market report will position you to:
This report is tailed to the strategic needs of cell and gene therapy (CGT) companies, as well as the CMOs and CDMOs who are handling third-party manufacturing services for these clients. With the competitive nature of this global market, you don't have the time to do the research. Claim this report to become immediately informed, without sacrificing hours of unnecessary research or missing critical opportunities.
In compiling this report, BioInformant's analysts leveraged nearly a decade historical data on the cell and gene therapy manufacturing industry. In addition to conducting extensive secondary research, our analysts interviewed dozens of highly regarded industry leaders.