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.
Contract Manufacturing for Cell and Gene Therapies
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.
Funding the Cell and Gene Therapy Boom
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:
- Expansions of Manufacturing Capacity
- Mergers & Acquisitions (M&A)
- Financing Events
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 global strategic report reveals:
- All known M&A deals recently executed within the CGT Sector
- All known CMO & CDMO expansions executed within the CGT Sector
- All known financing events executed within the CGT Sector, including:
- Financing rounds
- Venture capital events
- Strategic and corporate partnerships
- Follow-up public offerings
- Profiles of all known competitors specializing in cell and gene therapy CMO and CDMO services
- Market size determinations for the Cell & Gene Therapy (CGT) Manufacturing Industry with forecasts through 2028
This market report will position you to:
- Capitalize on emerging trends
- Improve internal decision-making
- Reduce company risk
- Approach outside partners and investors
- Outcompete your competition
- Implement an informed and advantageous business strategy in 2021
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.
Table of Contents
1. Funding the Cell and Gene Therapy Boom
- 1.1. Recent CMO/CDMO Expansions in Cell and Gene Therapy Sector
- 1.1.1. Expected Capacity Crunch
- 1.1.2. Investments for CGT Capacity Expansion
- 1.1.3. Other CGT Manufacturing Investments
- 1.1.4. Events Driving Expansion for CGT Facilities and Infrastructure
- 188.8.131.52. Lyell Immunopharma
- 184.108.40.206. ElevateBio
- 220.127.116.11. Thermo Fisher Scientific
- 18.104.22.168. Biogen
- 22.214.171.124. Rentschler Biopharma
- 126.96.36.199. FUJIFILM Corporation
- 188.8.131.52. Thermo Fisher Scientific, Inc. and Henogen S.A.
- 184.108.40.206. Genezen Laboratories
- 220.127.116.11. Thermo Fisher Scientific - Global Expansion Across 3 Sites
- 18.104.22.168. Minaris Regenerative Medicine
- 22.214.171.124. AGC Biologics
- 126.96.36.199. Lonza
- 188.8.131.52. Samsung Biologics
- 184.108.40.206. Forge Biologics
- 220.127.116.11. Polpharma Biologics
- 18.104.22.168. Sekisui Diagnostics
- 22.214.171.124. Bionova Scientific
- 126.96.36.199. WuXi Biologics
- 188.8.131.52. Fujifilm Diosynth Biotechnologies
- 184.108.40.206. Merck KGaA
- 220.127.116.11. Exothera
- 18.104.22.168. ChemPartner
- 22.214.171.124. Hitachi Chemical Advanced Therapeutics Solutions
- 126.96.36.199. Krystal Biotech
- 188.8.131.52. Center for Breakthrough Medicines
- 184.108.40.206. The Discovery Labs
- 220.127.116.11. Piramal Pharma Solutions
- 18.104.22.168. Catalent
2. Recent Merger and Acquisition (M&A) Deals within the Cell and Gene Therapy Sector
- 2.1. Charles River Laboratories International/Retrogenix
- 2.2. Charles River Laboratories International/Cognate BioServices
- 2.3. Beam Therapeutics/Guide Therapeutics
- 2.4. Thermo Fisher Scientific/Henogen
- 2.5. Eli Lilly/Prevail Therapeutics
- 2.6. Novartis/Vedere Bio
- 2.7. Bayer/Asklepios
- 2.8. AGC Biologics/MolMed
- 2.9. Sorrento Therapeutics/SmartPharm
- 2.10. Catalent/MaSTherCell
- 2.11. ElevateBio
- 2.12. Ixaka
3. Financing Rounds
- 3.1. Major Private Placements
- 3.1.1. Orchard Therapeutics
- 3.1.2. Amryt
- 3.1.3. BioNTech
- 3.1.4. Kiadis Pharma
- 3.2. Major Venture Capital Financings
- 3.2.1. ElevateBio
- 3.2.2. Century Therapeutics
- 3.2.3. Artiva Biotherapeutics, Inc.
- 3.2.4. Vineti, Inc.
- 3.2.5. Ori Biotech Ltd.
- 3.2.6. Neogene Therapeutics
- 3.2.7. Forge Biologics
- 3.2.8. Sana Biotechnology
- 3.2.9. Orca Bio
- 3.2.10. Freeline Therapeutics
- 3.2.11. Poseida Therapeutics
- 3.2.12. Kriya Therapeutics
- 3.2.13. Legend Biotech Corporation
- 3.2.14. Lyell Immunopharma
- 3.2.15. Mammoth Biosciences
- 3.2.16. Kyverna Therapeutics
- 3.3. Major Corporate Partnerships within the CGT Market
- 3.3.1. Bayer/Atara Biotherapeutics
- 3.3.2. Novartis/Mesoblast
- 3.3.3. Novartis/Sangamo
- 3.3.4. Janssen Biotech/Fate Therapeutics
- 3.3.5. Biogen/Sangamo
- 3.4. Follow-on Public Offerings by CGT Companies
- 3.4.1. Rocket Pharmaceuticals
- 3.4.2. Adaptimmune Therapeutics
- 3.4.3. Allogene Therapeutics
- 3.4.4. Iovance Biotherapeutics, Inc.
- 3.4.5. Bluebird bio
- 3.5. Initial Public Offerings (IPO)
- 3.5.1. Legend Biotech
- 3.5.2. Decibel Therapeutics
- 3.5.3. Sana Biotechnology
- 3.5.4. Rocket Pharmaceuticals
- 3.5.5. JW Therapeutics
- 3.5.6. AlloVir
- 3.5.7. Akouos
- 3.5.8. Generation Bio
- 3.5.9. Passage Bio
- 3.5.10. Beam Therapeutics
4. Market Size for Cell and Gene Therapy CMO/CDMOs
5. Profiles of Cell and Gene Therapy CMOs and CDMOs
- 5.1. 3P Biopharmaceuticals
- 5.2. ABL, Inc.
- 5.2.1. Biomanufacturing Services
- 5.3. AGC Biologics
- 5.4. Advent BioServices Ltd.
- 5.5. Akron Biotech
- 5.6. Aldevron
- 5.6.1. Platforms
- 5.6.2. Services
- 5.7. Anemocyte S.r.l
- 5.8. Applied Viromics
- 5.8.1. AAV Vectors
- 5.8.2. Adenovirus
- 5.9. ATVIO Biotech, Ltd./Orgenesis Biotech Israel, Ltd.
- 5.10. Austrianova
- 5.11. Avid Bioservices, Inc.
- 5.12. Batavia Biosciences B.V.
- 5.13. Bio Elpida
- 5.14. BioCentriq
- 5.14.1. Clinical Manufacturing Services
- 5.14.2. Process Development Services
- 5.15. BioNTech IMFS GmbH
- 5.16. BioReliance Corporation/Merck Millipore
- 5.17. Bio-Techne
- 5.17.1. Bioprocessing Services
- 5.17.2. Cell and Gene Therapy Services
- 5.18. Biovian Oy
- 5.19. Boehringer Ingelheim BioXcellence
- 5.20. Brammer Bio/Thermo Fisher Scientific
- 5.21. C3i
- 5.21.1. Biomarker and Diagnostic Unit
- 5.21.2. GMP Manufacturing Unit
- 5.22. Catalent Biologics
- 5.23. CATAPULT
- 5.23.1. Facility at London
- 5.23.2. Facility at Stevenage
- 5.23.3. Facility at Braintree
- 5.23.4. Catapult's Capabilities
- 5.24. CCRM
- 5.24.1. CDMO Services
- 5.24.2. Process Development Lab
- 5.25. Cell Therapies Pty Ltd.
- 5.26. CELLforCURE (Novartis)
- 5.27. Celonic AG
- 5.28. Cellular Therapeutics Ltd.
- 5.29. Center for Breakthrough Medicines
- 5.29.1. Process Development
- 5.29.2. Analytical Method Development and Testing
- 5.29.3. Plasmid DNA
- 5.29.4. Adeno-Associated Virus
- 5.29.5. Lentivirus
- 5.29.6. Adenovirus
- 5.29.7. Cell Banking
- 5.29.8. Cell Processing
- 5.30. Charles River Laboratories International, Inc.
- 5.30.1. Cell Therapy Services
- 5.30.2. Gene Therapy Services
- 5.31. Cobra Biologics
- 5.31.1. Viral Vector Platform Process Development & Scale up
- 5.31.2. GMP Cell Banking & Viral Seed Stocks
- 5.31.3. GMP Manufacture
- 5.31.4. Viral Vector Analytical Development & Qualification
- 5.32. Cognate BioServices
- 5.33. Delphi Genetics S.A.
- 5.34. ElevateBio
- 5.35. Emergent BioSolutions
- 5.35.1. Contract Development
- 5.36. Eurogentec
- 5.37. Exothera
- 5.38. FinVector
- 5.39. Flash Therapeutics
- 5.39.1. Partnered Clinical Programs
- 5.40. Fraunhofer Institute for Cell Therapy and Immunology
- 5.41. FUJIFILM Cellular Dynamics, Inc.
- 5.41.1. Products
- 5.41.2. The Innovation Facility for Advanced Cell Therapy (iFACT)
- 5.41.3. CDMO Services
- 22.214.171.124. iPSC Technical Expertise
- 126.96.36.199. Advanced Cell Technology and Manufacturing Expertise
- 188.8.131.52. iPSC-derived Cardiomyocytes
- 184.108.40.206. iPSC-derived Neural Cells
- 220.127.116.11. iPSC-derived Immune Cells
- 5.42. FUJIFILM Diosynth Biotechnologies
- 5.43. GenScript Biotech Corporation
- 5.44. KBI Biopharma
- 5.44.1. Capabilities & Services
- 5.45. Lonza Group Ltd.
- 5.45.1. Capabilities & Expertise
- 5.45.2. Services
- 5.46. MaSTherCell
- 5.47. Matica Biotechnology, Inc.
- 5.48. Medinet Co., Ltd.
- 5.49. Minaris Regenerative Medicine, LLC
- 5.49.1. Cell Therapy Expertise
- 5.50. MolMed S.p.A
- 5.51. NECSTGEN
- 5.52. NEOBIOSIS, LLC
- 5.53. NIKON CeLL Innovation Co., Ltd.
- 5.54. Ology Bioservices, Inc.
- 5.55. OrganaBio
- 5.56. Orgenesis
- 5.57. OxfordBiomedica plc
- 5.57.1. Bioprocessing Capability
- 5.58. Patheon/Thermo Fisher Scientific
- 5.58.1. Viral Vector Services
- 5.59. Performance Cell Manufacturing
- 5.60. Q-Gen Cell Therapeutics
- 5.61. RoslinCT
- 5.62. Samsung Biologics
- 5.63. SK biotek
- 5.64. Stanford Laboratory for Cell and Gene Medicine
- 5.64.1. Current Projects
- 5.64.2. Services
- 5.65. Stemmatters, Biotechnologia e Medicina Regenerativa S.A.
- 5.65.1. Capabilities & Facilities
- 5.66. Takara Bio Europe SAS
- 5.67. TUM Cells
- 5.68. Interdisciplinary Stem Cell Institute/Miami University
- 5.69. Upstate Stem Cell cGMP Facility
- 5.70. VGXI, Inc.
- 5.71. Vigene Biosciences, Inc.
- 5.72. Waisman Biomanufacturing
- 5.73. Yposkesi
INDEX OF FIGURES
- FIGURE 1.1: Survey Respondent's Plans for In-House Capacity Expansion
- FIGURE 3.1: Gene Therapy Financings, 2016-2020
- FIGURE 4.1: Global Market for CGT Manufacturing by CMO/CDMOs, 2020-2027
INDEX OF TABLES
- TABLE 1.1: Recent CMO/CDMO Expansions in Cell and Gene Therapy Sector
- TABLE 2.1: Recent Merger and Acquisition (M&A) Deals in Cell and Gene Therapy Sector
- TABLE 3.1: Cell and Gene Therapy Financings, 2016-2020
- TABLE 3.2: Major Private Placement Offerings with the CGT Market
- TABLE 3.3: Major Venture Capital Financings
- TABLE 3.4: Major Corporate Partnerships
- TABLE 3.5: Follow-on Offerings by CGT Companies
- TABLE 3.6: Major CGT Company Initial Public Offerings (IPOs) in 2020 and 2021
- TABLE 4.1: Global Market for CGT Manufacturing by CMO/CDMOs, 2020-2027