A contract development and manufacturing organization (CDMO), is a company that serves other companies in the healthcare industry on contract basis to provide comprehensive services from drug development through drug manufacturing. Cell and gene therapy (CGT) companies partner with CGT CDMOs to get support on discovery, preclinical, clinical stages, CGT product development, manufacturing, and commercial manufacturing.
Market - Headwinds & Tailwinds
The global cell and gene therapy CDMO market is mainly driven by the growing prevalence of cancer, favorable research landscape of cell & gene therapy, strong product pipeline, adoption of decentralized manufacturing of cell and gene therapies, favorable funding climate, increasing government initiatives, rising investments, increasing application of AI & data analytics. Furthermore, rising collaborations among CDMOs & biotechnology companies have also played a pivotal role in contributing to the growth of the market globally. However, capacity constraints and lack of skilled professionals are likely to hinder the growth of the market to a certain extent.
Market Segmentation & Insights
The global cell and gene therapy CDMO market has been analyzed from three main perspectives: Type, Development Stage, and Region.
Cell and Gene Therapy CDMO Market, By Type
Based on type, the cell and gene therapy CDMO market has been segmented into cell therapy and gene therapy. The cell therapy holds the largest share in the market. The growth of the market can be attributed to rising approvals, growing adoption of regenerative medicines & personalized medicine, and rising government investments in cell-based research.
Cell and Gene Therapy CDMO Market, By Development Stage
Based on the development stage, the cell and gene therapy CDMO market has been segmented into preclinical, clinical, and commercial. The preclinical & clinical segment holds the largest share in the market owing to a large number of ongoing trials in the preclinical & clinical stage and rising investments by private & public organizations for effective cancer therapies.
Cell and Gene Therapy CDMO Market, By Region
Based on region, the global cell and gene therapy CDMO market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (ROW). North America dominated the cell and gene therapy CDMO market. The large share of North America in the global market can be largely attributed to the growing manufacturing capacity for CGTs, robust product pipeline, favorable regulatory policies, rising adoption of outsourcing as a cost-cutting measure, rising cancer incidence, developed healthcare infrastructure, rising investment in R&D, and presence of prominent players.
The cell and gene therapy CDMO market is marked by the presence of prominent players such as Catalent, Inc, Lonza, Thermo Fisher Scientific/Patheon, WuXi Advanced Therapies (WuXi ATU), and Oxford Biomedica. Other prominent/emerging players operating in the market are Merck KGaA, AGC Biologics, Samsung Biologics, Boehringer Ingelheim International GmbH, BIOCENTRIQ, Minaris Regenerative Medicine, FUJIFILM Diosynth Biotechnologies, Exothera, Merck, VIVEbiotech, Vibalogics, among others.
Snapshot: Industry Developments
• In Oct 2021, MilliporeSigma announced the opening of its second Carlsbad, Calif. facility, which expands its footprint as a contract development and manufacturing organization (CDMO) for viral gene therapy
• In Sept 2021, ViroCell Biologics, a CDMO and Great Ormond Street Hospital for Children (GOSH) announced a new partnership to address the global viral vector manufacturing bottleneck for clinical trials. As part of the partnership with GOSH, ViroCell will more than double the UK’s lentivirus vector manufacturing capacity for clinical trials in 2022
• In Aug 2021, Terumo Blood and Cell Technologies and BioCentriq, CDMO focused exclusively on cell and gene therapy announced the formation of a strategic collaboration designed to accelerate the adoption of automated manufacturing to bring novel cell and gene therapies (CGT) to patients more quickly and cost-effectively
• In July 2021, AGC announced that its biopharmaceutical CDMO subsidiary, AGC Biologics signed an agreement with Novartis Gene Therapies to purchase a cell and gene therapy manufacturing facility located in Longmont, Colorado, U.S.
• In May 2021, Charles River Laboratories signed a definitive agreement to acquire US-based gene therapy CDMO, Vigene Biosciences, for $292.5 million
• In Apr 2021, Gene therapy-focused CDMO Forge Biologics closed a $120 million Series B financing which is expected to accelerate its planned expansion of adeno-associated virus (AAV) manufacturing capabilities
• In Feb 2021, Celonic Group, a CDMO specialized in the development and production of Advanced Therapy Medicinal Products (ATMP) and bio-therapeutics, announced a long-term lease agreement for a new production site and office space spanning 91,500 square feet (8,500 sqm) in the WST-222 building at the Novartis-operated Life Science Park Rheintal
• In July 2020, GenScript announced the integration and upgrading of the original CDMO platform and the release of its latest brand GenScript ProBio, dedicated to proactively providing end-to-end service from discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers
• In Jun 2020, Rigenerand SRL entered into the advanced therapy CDMO space, after its gene therapy facility in Modena, Italy gained approval from the Italian Medicine Authority (AIFA)
• In March 2020, Univercells launched a cell and gene therapy contract development and manufacturing organization (CDMO), Exothera to support the cell and gene therapy sector increase its capacity, and also boost its bioprocessing expertise
• In Jan 2020, The Center for Breakthrough Medicines, a CDMO, formed by The Discovery Labs and Deerfield Management Company, planned to invest $1.1bn for its facility to become the world’s biggest cell and gene therapy service provider
Key Insights Captured in the Report
• Quantitative (market size and forecasts) and qualitative insights of the market across years - historical years, current year, and forecasted years
• Deep-rooted insights on headwinds, tailwinds, and opportunities prevailing in the market
• Quantitative (market size and forecasts) and qualitative insights at a segment and sub-segment level
• Comprehensive quantitative (market size and forecasts) and qualitative insights on geographic, regional, and country-level markets
• Granular insights on the competitive landscape prevailing in the market
• Competitive mapping of strategic developments
Scope of the Cell and Gene Therapy (CGT) CDMO Market Report
|Market Size Period||2018-2031|
|Market Segments||Assessment of Cell and Gene Therapy (CGT) CDMO Market By:
• Development Stage
|Geographic Scope||• North America
• Rest of the World
|Companies Covered||Catalent, Inc, Lonza, Thermo Fisher Scientific/Patheon, WuXi Advanced Therapies (WuXi ATU), Oxford Biomedica, Merck KGaA, AGC Biologics, Samsung Biologics, Boehringer Ingelheim International GmbH, BIOCENTRIQ, Minaris Regenerative Medicine, FUJIFILM Diosynth Biotechnologies, Exothera, Merck, VIVEbiotech, Vibalogics, among others.|
1 RESEARCH ENVELOPE
1.1 Market Classification
1.2 Scope of the Study
1.2.1 Timeline Considered for Market Study
• Historic Years – 2018 & 2019
• Base Year – 2020
• Projected Years – 2021 to 2031
1.3 Currency Used in the Report
2 RESEARCH METHODOLOGY
2.1 Research Approach
2.2 Data Collection Methodology
2.3 Data Sources
2.3.1 Secondary Sources
2.3.2 Primary Sources
2.4 Market Crackdown Methodology
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Data Forecasting Model
2.6 Limitations and Assumptions for Study
3 HEADWINDS & TAILWINDS ASSESSMENT
4 PREMIUM INSIGHTS
4.1 Key Market Trends
4.2 Key Players & Their Competitive Positioning (2021)
4.3 Pipeline Assessment
4.4 Value Chain Analysis
4.5 Key Criteria’s Assessment for Selecting a Cell & Gene Therapy CDMO
4.6 CGT CDMO Market – Key Opinion Leaders (KOLs) & Subject Matter Experts (SMEs) Viewpoint
5 GLOBAL CELL AND GENE THERAPY CDMO MARKET - ANALYSIS & FORECAST, BY TYPE
5.1 Cell Therapy
5.2 Gene Therapy
6 GLOBAL CELL AND GENE THERAPY CDMO MARKET - ANALYSIS & FORECAST, BY DEVELOPMENT STAGE
7 GLOBAL CELL AND GENE THERAPY CDMO MARKET - ANALYSIS & FORECAST, BY REGION
7.1 North America
7.3 Asia Pacific
7.4 Rest of the World (RoW)
8 COMPANY PROFILES
8.1 Catalent, Inc
8.1.1 Business Overview
8.1.2 Financial Metrics*
8.1.3 Services Offered
8.1.4 Key Developments
8.3 Thermo Fisher Scientific/Pantheon
8.4 WuXi Advanced Therapies (WuXi ATU)
8.5 Charles River
8.6 Oxford Biomedica
8.7 Merck KGaA
8.8 AGC Biologics
8.9 Samsung Biologics
8.10 Boehringer Ingelheim International GmbH
8.12 Minaris Regenerative Medicine
8.13 FUJIFILM Diosynth Biotechnologies
8.17 Other Prominent Players
*Insights on financial metrics is subject to availability of information in the public domain
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Cell and gene therapy (CGT) companies partner with CGT CDMOs to get support on discovery, preclinical, clinical stages, CGT product development, manufacturing, and commercial manufacturing.