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.
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.
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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.
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.
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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
- Ex-vivo
- In-vivo
- Cell
Therapy
- Gene-Modified
Cell Therapy
- CAR
T-cell therapies
- CAR-NK
cell therapy
- TCR-T
cell therapy
- 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
- US
- Canada
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Rest
of Europe
- Asia
Pacific
- China
- India
- Japan
- Rest
of Asia Pacific
- Latin
America
- Middle
East & Africa
About Medi-Tech Insights
Medi-Tech Insights is a healthcare-focused business research
& insights firm. Our clients include Fortune 500 companies, blue-chip
investors & 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 strategy. Our methodology includes rigorous secondary research combined
with deep-dive interviews with industry-leading CXO, VPs, and key demand/supply
side decision-makers.
Contact:
Ruta Halde
Associate, Medi-Tech Insights
+32 498 86 80 79
info@meditechinsights.com

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