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The Market for Cell and Gene Therapy Manufacturing - The Rise of CMOs & CDMOs (2021)

  • ID: 5341631
  • Report
  • June 2021
  • Region: Global
  • 123 Pages
  • BioInformant
CMOs & CDMOs are Investing Heavily in Expanding Their Manufacturing Capacity to Be Able to Take on New Clients and Larger, Later-Stage Projects

FEATURED COMPANIES

  • 3P Biopharmaceuticals
  • Avid Bioservices, Inc.
  • Cell Therapies Pty Ltd.
  • Freeline Therapeutics
  • MolMed
  • Poseida Therapeutics
  • MORE

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
    • IPOs
  • 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, the research analysts leveraged nearly a decade of 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.

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • 3P Biopharmaceuticals
  • Avid Bioservices, Inc.
  • Cell Therapies Pty Ltd.
  • Freeline Therapeutics
  • MolMed
  • Poseida Therapeutics
  • MORE

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
1.1.4.1 Lyell Immunopharma
1.1.4.2 ElevateBio
1.1.4.3 Thermo Fisher Scientific
1.1.4.4 Biogen
1.1.4.5 Rentschler Biopharma
1.1.4.6 FUJIFILM Corporation
1.1.4.7 Thermo Fisher Scientific, Inc. and Henogen S.A.
1.1.4.8 Genezen Laboratories
1.1.4.9 Thermo Fisher Scientific - Global Expansion Across 3 Sites
1.1.4.10 Minaris Regenerative Medicine
1.1.4.11 AGC Biologics
1.1.4.12 Lonza
1.1.4.13 Samsung Biologics
1.1.4.14 Forge Biologics
1.1.4.15 Polpharma Biologics
1.1.4.16 Sekisui Diagnostics
1.1.4.17 Bionova Scientific
1.1.4.18 WuXi Biologics
1.1.4.19 Fujifilm Diosynth Biotechnologies
1.1.4.20 Merck KGaA
1.1.4.21 Exothera
1.1.4.22 ChemPartner
1.1.4.23 Hitachi Chemical Advanced Therapeutics Solutions
1.1.4.24 Krystal Biotech
1.1.4.25 Center for Breakthrough Medicines
1.1.4.26 The Discovery Labs
1.1.4.27 Piramal Pharma Solutions
1.1.4.28 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
5.1.1 Services
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.
5.9.1 Services
5.10 Austrianova
5.10.1 Services
5.11 Avid Bioservices, Inc.
5.11.1 Services
5.12 Batavia Biosciences B.V.
5.13 Bio Elpida
5.13.1 Services
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
5.16.1 Services
5.17 Bio-Techne
5.17.1 Bioprocessing Services
5.17.2 Cell and Gene Therapy Services
5.18 Biovian Oy
5.18.1 Services
5.19 Boehringer Ingelheim BioXcellence
5.19.1 Services
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
5.22.1 Services
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.
5.25.1 Services
5.26 CELLforCURE (Novartis)
5.27 Celonic AG
5.27.1 Capabilities
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.
5.33.1 Services
5.34 ElevateBio
5.35 Emergent BioSolutions
5.35.1 Contract Development
5.36 Eurogentec
5.36.1 Services
5.37 Exothera
5.37.1 Services
5.38 FinVector
5.38.1 Services
5.39 Flash Therapeutics
5.39.1 Partnered Clinical Programs
5.40 Fraunhofer Institute for Cell Therapy and Immunology
5.40.1 Services
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
5.41.3.1 iPSC Technical Expertise
5.41.3.2 Advanced Cell Technology and Manufacturing Expertise
5.41.3.3 iPSC-derived Cardiomyocytes
5.41.3.4 iPSC-derived Neural Cells
5.41.3.5 iPSC-derived Immune Cells
5.42 FUJIFILM Diosynth Biotechnologies
5.42.1 Services
5.43 GenScript Biotech Corporation
5.43.1 Services
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
5.46.1 Services
5.47 Matica Biotechnology, Inc.
5.47.1 Services
5.48 Medinet Co., Ltd.
5.48.1 Services
5.49 Minaris Regenerative Medicine, LLC
5.49.1 Cell Therapy Expertise
5.50 MolMed S.p.A
5.50.1 Capabilities
5.51 NECSTGEN
5.51.1 Services
5.52 NEOBIOSIS, LLC
5.53 NIKON CeLL Innovation Co., Ltd.
5.53.1 Services
5.54 Ology Bioservices, Inc.
5.54.1 CDMO Services
5.55 OrganaBio
5.55.1 Services
5.56 Orgenesis
5.56.1 POCare Therapies
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
5.59.1 Services
5.60 Q-Gen Cell Therapeutics
5.60.1 Services
5.61 RoslinCT
5.61.1 Services
5.62 Samsung Biologics
5.62.1 Services
5.63 SK biotek
5.63.1 Services
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
5.66.1 Services
5.67 TUM Cells
5.68 Interdisciplinary Stem Cell Institute/Miami University
5.69 Upstate Stem Cell cGMP Facility
5.69.1 Capabilities
5.70 VGXI, Inc.
5.70.1 Services
5.71 Vigene Biosciences, Inc.
5.71.1 Services
5.72 Waisman Biomanufacturing
5.72.1 Services
5.73 Yposkesi
5.73.1 Services

List 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

List 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

Note: Product cover images may vary from those shown

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  • 3P Biopharmaceuticals
  • ABL, Inc.
  • Adaptimmune Therapeutics
  • Advent BioServices Ltd.
  • AGC Biologics
  • Akouos
  • Akron Biotech
  • Aldevron
  • Allogene Therapeutics
  • AlloVir
  • Amryt
  • Anemocyte S.r.l
  • Applied Viromics
  • Artiva Biotherapeutics, Inc.
  • Asklepios
  • Atara Biotherapeutics
  • ATVIO Biotech, Ltd./Orgenesis Biotech Israel, Ltd.
  • Austrianova
  • Avid Bioservices, Inc.
  • Batavia Biosciences B.V.
  • Bayer
  • Beam Therapeutics
  • Bio Elpida
  • Bio-Techne
  • BioCentriq
  • Biogen/Sangamo
  • BioNTech
  • BioNTech IMFS GmbH
  • BioReliance Corporation/Merck Millipore
  • Biovian Oy
  • Bluebird bio
  • Boehringer Ingelheim BioXcellence
  • Brammer Bio/Thermo Fisher Scientific
  • C3i
  • Catalent
  • CATAPULT
  • CCRM
  • Cell Therapies Pty Ltd.
  • CELLforCURE (Novartis)
  • Cellular Therapeutics Ltd.
  • Celonic AG
  • Center for Breakthrough Medicines
  • Century Therapeutics
  • Charles River Laboratories International, Inc.
  • Cobra Biologics
  • Cognate BioServices
  • Decibel Therapeutics
  • Delphi Genetics S.A.
  • ElevateBio
  • Eli Lilly
  • Emergent BioSolutions
  • Eurogentec
  • Exothera
  • FinVector
  • Flash Therapeutics
  • Forge Biologics
  • Fraunhofer Institute for Cell Therapy and Immunology
  • Freeline Therapeutics
  • FUJIFILM Cellular Dynamics, Inc.
  • FUJIFILM Diosynth Biotechnologies
  • Generation Bio
  • GenScript Biotech Corporation
  • Guide Therapeutics
  • Henogen
  • Interdisciplinary Stem Cell Institute/Miami University
  • Iovance Biotherapeutics, Inc.
  • Ixaka
  • Janssen Biotech/Fate Therapeutics
  • JW Therapeutics
  • KBI Biopharma
  • Kiadis Pharma
  • Kriya Therapeutics
  • Kyverna Therapeutics
  • Legend Biotech
  • Legend Biotech Corporation
  • Lonza Group Ltd.
  • Lyell Immunopharma
  • Mammoth Biosciences
  • MaSTherCell
  • Matica Biotechnology, Inc.
  • Medinet Co., Ltd.
  • Minaris Regenerative Medicine, LLC
  • MolMed
  • MolMed S.p.A
  • NECSTGEN
  • NEOBIOSIS, LLC
  • Neogene Therapeutics
  • NIKON CeLL Innovation Co., Ltd.
  • Novartis
  • Novartis/Mesoblast
  • Novartis/Sangamo
  • Ology Bioservices, Inc.
  • Orca Bio
  • Orchard Therapeutics
  • OrganaBio
  • Orgenesis
  • Ori Biotech Ltd.
  • OxfordBiomedica plc
  • Passage Bio
  • Patheon/Thermo Fisher Scientific
  • Performance Cell Manufacturing
  • Poseida Therapeutics
  • Prevail Therapeutics
  • Q-Gen Cell Therapeutics
  • Retrogenix
  • Rocket Pharmaceuticals
  • RoslinCT
  • Samsung Biologics
  • Sana Biotechnology
  • SK biotek
  • SmartPharm
  • Sorrento Therapeutics
  • Stanford Laboratory for Cell and Gene Medicine
  • Stemmatters, Biotechnologia e Medicina Regenerativa S.A.
  • Takara Bio Europe SAS
  • Thermo Fisher Scientific
  • TUM Cells
  • Upstate Stem Cell cGMP Facility
  • Vedere Bio
  • VGXI, Inc.
  • Vigene Biosciences, Inc.
  • Vineti, Inc.
  • Waisman Biomanufacturing
  • Yposkesi
Note: Product cover images may vary from those shown

The content and statistics contained within the publisher's reports are compiled using a broad range of sources, as described below.

Input Sources

  • Clinical Trial Databases (ClinicalTrials.gov, International Clinical Trials Registry Platform, European Union Clinical Trials Register, Chinese Clinical Trial Registry, Others)
  • Scientific Publication Databases (PubMed, Highwire Press, Google Scholar)
  • Patent Databases (United States Patent and Trade Office, World Intellectual Property Organization, Google Patent Search)
  • Grant Funding Databases (RePORT Database, CIRM, MRC, Wellcome Trust - UK, Others)
  • Product Launch Announcements (Trade Journals, Google News)
  • Industry Events (Google News, Google Alerts, Press Releases)
  • Company News (SEC Filings, Investor Publications, Historical Performance)
  • Social Analytics (Google Adwords, Google Trends, Twitter, Topsy.com, Hashtagify.me, BuzzSumo.com)
  • Interviews with Stem Cell Industry Leaders

Research & Analysis Methodologies

The publisher employs the following techniques for deriving its market research:

  • Historical Databases: As the first and only market research firm to specialize in the stem cell industry, the publisher has 13+ years of historical data on each segment of the stem cell the industry. This provides an extremely rare and robust database for establishing market size determinations, as well as making future market predictions.
  • Prolific Interviews with Industry Leaders: As the global leader in stem cell industry data, the publisher has interviewed hundreds of leaders from across the stem cell industry, including the CEO of FUJIFILM CDI, FUJIFILM Irvine Scientific, Pluristem Therapies, Celularity, and many others.
  • Industry Relationships: The research team and its President/Founder, Cade Hildreth, Chair and present at a wide range of stem cell industry events, including Phacilitate's Advanced Therapies Week, World Stem Cell Summit (WSCS), Perinatal Stem Cell Society Congress, AABB's International Cord Blood Symposium (ICBS), and other events hosted within the U.S. and worldwide.
  • Global Integrated Feedback: Because the publisher maintains the world's largest stem cell industry news site that is read by nearly a million unique readers per year and the company has large social media audiences (25.7K+ followers on Linked, 21.2K+ followers on Twitter, and 4.3K+ followers on Facebook), the publisher is able to publish content relevant to the industry and receive immediate feedback/input from a global community of readers. In short, the publisher's data is crowd-sourced from market participants worldwide, including those in diverse geographic regions.
  • Preliminary Research: In addition to the interviews described above, the publisher conducts market surveys, executes social media polls, and aggregates market data from stem cell industry announcements, press releases, and corporate filings/presentations.
  • Secondary Research: The publisher summarizes, collects and synthesizes existing market research that is relevant to the market area of interest.
  • Future Projections: Using the resources described above, the publisher is uniquely positioned to make future projections about market size, market growth by segment, market trends, technology evolution, funding activities (financing rounds, M&A, and IPOs), and importantly, market leadership (market share by company).
 

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