Cell and Gene Therapy CDMO Market | Analysis, Size, Share, Trends, Demand, Overview and Segment Forecast To 2031
Cell and Gene Therapy CDMO Market Overview:
The global Cell
and Gene Therapy CDMO Market is anticipated to witness a CAGR of
27% during the forecast period, driven by the growing burden of cancer and
other targeted diseases, rapidly expanding research on cell and gene therapies
and robust CGT pipeline, substantial funding by venture capitalists, and
technological innovations.
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The development and approval of CAR-T cell therapies, such
as Kymriah and Yescarta and their success in combating hematological
malignancies have boosted investment in CGT. A robust CGT pipeline with a
growing number of product approvals, strong support from large pharma and
biotech, and consistent investor interest is set to boost the demand for CGT
services. Also, a growing pipeline of therapies is nearing regulatory decisions.
Additionally, CGT's reach is expanding across new indications. For instance,
newer CAR-T therapies like Abecma (idecabtagene vicleucel) and Carvykti
(ciltacabtagene autoleucel), which were initially approved for multiple
myeloma, are indeed expanding their indications beyond B-cell cancers.
Growing demand
for full-service/one-stop-shop CDMOs
Full-service
CDMOs that can assist with both development and manufacturing are in high
demand. Much of the gene therapy development has come from smaller biotech
companies or research universities that rely on CDMOs from preclinical
development through packaging. Big pharma and biopharma companies also prefer a
full-service CDMO to speed up the timeline and free up resources to focus on
innovation and marketing.
“There is growing
demand for cell and gene therapy CDMOs who can offer integrated development,
manufacturing, and testing services. For cell and gene therapy companies,
outsourcing manufacturing and testing operations to a capable CDMO can reduce
development timelines, provide supplementary capacity, and ultimately control
costs.”- Senior Director, Tier 1 CGT CDMO, US
Greater focus on
long-term strategic collaborations
The cell and gene
therapy industry has witnessed a multi-fold rise in the number of
collaborations between manufacturers/innovators and CDMOs in the form of joint
ventures, manufacturing agreements, licensing agreements, service alliances,
etc. For instance,
·
In
April 2025, Cell Therapies Pty Ltd and Xellera Therapeutics entered into a strategic
partnership to accelerate the development and accessibility of cell and gene
therapies across the Asia-Pacific region, focusing on expanding CGT access in
Australia and Hong Kong through enhanced GMP manufacturing capabilities and
collaborative innovation
·
In
October 2024, CytoImmune, a Biotechnology Company, established a strategic
partnership with Matica Bio, a CDMO specializing in viral vectors, wherein
Matica Bio will produce viral vectors at its GMP facility, and CytoImmune will
manufacture its cell therapy in Puerto Rico, aiming to advance a clinical cell
therapy program for cancer treatment
Substantial outsourcing in the CGT industry due to lack
of internal capabilities
Cell and gene therapy is a highly specialized area that
requires substantial production investments, advanced infrastructure, and
highly skilled professionals. Many large pharmaceutical companies, despite
their scale, often lack the ready-to-go infrastructure and technical setups
required to manage these therapies internally. As a result, they turn to
specialized CDMOs to assist them in the development and manufacturing of CGT
therapies. Additionally, the surge in the number of small biotech companies
entering the market without having their advanced manufacturing facility and technical
expertise has further amplified the reliance on CDMOs. With only a limited
number of CGT-focused manufacturers in the market, the gap between demand and
supply has created a strong growth opportunity for CDMOs with specialized CGT
capabilities.
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North America is the largest and fastest growing region
North America is the largest and fastest-growing cell &
gene therapy (CGT) CDMO market. It is expected to continue its leadership in
the coming 5 years owing to growing manufacturing capacity for CGTs, favorable
regulatory approval process, growing cell and gene therapy approvals per year,
and strong product pipeline of CGTs in the U.S. The regulatory approval process
in the US is evolving and becoming favorable for innovators for developing cell
and gene therapy products. The US FDA is designating orphan drug status,
breakthrough designation, accelerated approvals, and regenerative medicine
advanced therapy (RMAT) designations for cell and gene therapies to expedite
the approval process.
Competitive Landscape Analysis
The cell & gene therapy (CGT) CDMO market is marked by
the presence of both established players and several small and mid-sized
players. Some of the key players in the market include Lonza, Catalent, Inc.
(acquired by Novo Holdings), Cytiva (Danaher Corporation), Samsung Biologics,
Thermo Fisher Scientific Inc., Novartis AG, Charles River Laboratories, AGC
Biologics, OmniaBio, Rentschler Biopharma SE, and WuXi AppTec, among several
others.
Browse Report: https://meditechinsights.com/cell-and-gene-therapy-cdmo-market/
Global Cell and
Gene Therapy CDMO Market Segmentation
This report by Medi-Tech Insights provides the size
of the global cell and gene therapy CDMO market at the regional- and
country-level from 2023 to 2030. The report further segments the market based
on service type, product type and indication.
Market Size & Forecast (2023-2030), By
Service Type, USD Million
·
Clinical Development
·
Commercial Manufacturing
Market Size & Forecast (2023-2030), By
Product Type, USD Million
·
Gene Therapy
o Ex-vivo
o In-vivo
·
Cell Therapy
·
Gene-Modified Cell Therapy
o CAR T-cell therapies
o CAR-NK cell therapy
o TCR-T cell therapy
o Other
Market Size & Forecast (2023-2030), By
Indication, USD Million
·
Oncology
·
Neurological Disorders
·
Infectious Diseases
·
Rare Diseases
·
Others
Market Size & Forecast (2023-2030), By
Region, USD Million
·
North America
o US
o Canada
·
Europe
o UK
o Germany
o France
o Italy
o Spain
o Rest of Europe
·
Asia Pacific
o China
o India
o Japan
o Rest of Asia Pacific
·
Latin America
·
Middle East & Africa
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& hyper-growth start-ups. We have completed 100+ projects in Digital
Health, Healthcare IT, Medical Technology, Medical Devices & Pharma
Services in the areas of market assessments, due diligence, competitive
intelligence, market sizing and forecasting, pricing analysis & go-to-market
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decision-makers.
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