Market insights predict, the cell and gene therapy (CGT) pharmaceuticals market is expected to grow from USD 16.75 billion in 2024 to USD 91.56
billion by 2034, driven by a CAGR of 18.93%. The growing demand for
personalized medicine, driving patient-specific therapies, is estimated to
drive the growth of the market. North America led the global market owing to a
strong clinical trial landscape, as the U.S. hosts the majority of global
trials in cell and gene therapy.
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Key Takeaways
➜ Cell
and gene therapy (CGT) pharmaceuticals market to crossed USD 16.75 billion by
2024.
➜ Market
projected at USD 91.56 billion by 2034.
➜ CAGR
of 18.93% expected in between 2025 to 2034.
➜ North
America held a major revenue share of approximately 45% in the market in 2024.
➜ Asia-Pacific
is expected to witness the fastest growth during the predicted timeframe.
➜ By
therapy type, the cell therapies segment registered its dominance over the
global market with a share of approximately 45% in 2024.
➜ By
therapy type, the gene editing & gene modulation segment is expected to
grow with the highest CAGR in the market during the studied years.
➜ By
modality/vector & delivery platform, the viral vectors segment held a dominant
presence in the cell and gene therapy (CGT) pharmaceuticals market with a share
of approximately 52% in 2024.
➜ By
modality/vector & delivery platform, the non-viral delivery segment is
expected to witness the fastest growth in the market over the forecast period.
➜ By
route of administration, the intravenous/systemic infusion segment contributed
the biggest revenue share of approximately 50% in the market in 2024.
➜ By
route of administration, the intrathecal/intracerebral/CNS direct delivery
segment is expected to grow at the fastest CAGR in the market during the
forecast period.
➜ By
manufacturing & supply model, the in-house manufacturing by sponsors
segment accounted for a maximum revenue share of approximately 55% in the
market in 2024.
➜ By
manufacturing & supply model, the outsourced & CDMO manufacturing
segment is expected to expand rapidly in the cell and gene therapy (CGT)
pharmaceuticals market in the coming years.
➜ By
end user /customer, the hospitals & specialized infusion centers segment
contributed the biggest revenue share of approximately 60% in the market in
2024.
➜ By
end user/customer, the CDMOs & contract labs segment is expected to grow at
the fastest CAGR in the market during the forecast period.
What is Cell and Gene Therapy (CGT)
Pharmaceuticals Market?
The pharmaceuticals market for gene therapies and cell
therapies is currently experiencing the start of a huge industry overhaul. Recent
advances in gene therapy and cell therapy have moved it away from the
research and development stage towards the treatment stage. The healthcare
community is increasingly embracing gene therapies that have the
potential to cure disease at their genetic roots instead of just managing the
symptoms associated with them. There is an intense race between the companies
to increase the volume of products they can produce and manufacture, to make the
regulatory processes to receive approval from organizations such as the FDA
faster and easier, and to establish as many new potential therapies in the
clinical pipeline as possible.
Investors are currently pouring money into this area because
of the new and incredible opportunity these types of therapies provide as the
potential to provide long-term cures and personalized
medicine. As new delivery systems, vector engineering and off-the-shelf
therapies continue to evolve and develop, the industry is continuing to change,
with a significant amount of innovation continuing to be introduced. The
industry is on the cusp of becoming a major segment of advanced medicine,
potentially permanently changing the way some of the most complex diseases in
the world are treated.
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What Forces Are Powering the Cell and Gene Therapy
Pharmaceuticals Market?
Consistent with our previous paragraphs analyzing market
drivers, we note that support for development and use of next-generation
therapeutic solutions by regulatory agencies and the continued increase in
prevalence of rare genetic disorders and complex chronic diseases will create
an environment conducive to rapid growth and innovation in the industry. As a
result, the combination of these positive market dynamics resulting from the
increased use of these types of therapies, the proliferation and enhancement of
technology being developed, and the greater support from government to get
treatments to market has created momentum for us to see unprecedented growth
and innovation in our industry over the next few years.
How Can AI Improve the Cell and Gene
Therapy (CGT) Pharmaceuticals Market?
AI integration can significantly enhance
the market by accelerating research, development, and commercialization
processes. In drug discovery, AI algorithms can analyze massive datasets to
identify novel therapeutic targets and optimize gene-editing techniques with
higher precision. During clinical trials, AI can streamline patient
recruitment, predict treatment responses, and monitor safety outcomes in real
time, reducing costs and timelines. In manufacturing, AI-driven automation
ensures consistency, scalability, and quality control of complex cell-based
products.
Moreover, AI supports personalized medicine
by analyzing genomic and patient data to tailor therapies for maximum efficacy.
It also improves regulatory compliance through predictive analytics and
documentation automation. By enabling faster innovation, cost efficiency, and
precision, AI integration addresses key challenges such as high development
costs, long approval cycles, and scalability issues, thereby driving broader
accessibility and adoption of cell and gene therapies in the global
pharmaceuticals market.
What Problems Are Remaining to Be Resolved for the Gene
and Cell Therapies Drug Industry?
The gene and cell therapies industry is growing but, has
significant challenges due to the complexity of the production process. The
slow and expensive nature of cell and gene therapies is causing most therapies
to face significant logistical issues, such as cold-chain requirements, limited
vector production capacity, and highly specialised production processes. The
regulatory landscape continues to evolve and introduce uncertainty for
manufacturers who want to innovate while complying with regulations. In
addition, there is a lack of access for patients with limited financial
resources, and the cost of treatment is creating a financial burden on
healthcare providers in their reimbursement processes.
Manufacturers must also work to increase safety and efficacy
by conducting studies to learn more about the long-term impact of their
cellular and gene therapy products on patients, including immunological
responses, long-term side effects and potentially unintended genetic changes.
Given the complexity of the relationship between science, economics and
operations, therefore, the growth of the gene and cell
therapies market will not increase until these scientific, economic and
operational challenges are adequately addressed.
Regional Insight
Why Does North America Dominates the Cell and Gene
Therapy (CGT) Pharmaceuticals Market?
North America dominates the cell and gene therapy
pharmaceutical market share by 45%, due to several components that create a
strong environment for innovation in biotechnology: an extensive amount of
research and development (R&D) funding; an extensive number of nonprofit
incubators, world-renowned centers of excellence their associated capabilities;
The cell therapy and gene therapy pharmaceutical
market in North America leads the rest of the world due to several
components that create a strong environment for innovation in biotechnology: an
extensive amount of Research and Development (R&D) funding; an extensive
number of nonprofit incubators, world-renowned centers of excellence and their
associated capabilities; extensive manufacturing capabilities; and supportive
Regulatory Agencies who provide clear pathways for companies to confidently
take their innovative therapies to market.
Country Level Analysis
The U.S. has many of the major
pharmaceutical companies are located within the region, and they
continue to work with biotechnology
innovators to commercialize their products and accelerate the growth of
innovative curative therapies. These factors combine to create a unique and
unmatched environment for the development of next-generation medical products
in North America.
Why Asia Pacific is Fastest Growing in the Cell and Gene
Therapy (CGT) Pharmaceuticals Market?
The Asia Pacific is the fastest-growing cell and gene
therapy pharmaceutical market, because of increased investment by healthcare,
proliferation of biotech ecosystems and substantial government support for
advanced therapies; all of which support the rapid adoption of new technologies
driven by demand for personalized medicine in major population centers. Local
biotech companies are actively advancing their production capabilities and clinical
trials within the cell therapy sector to establish themselves within
this competitive landscape, thereby reducing the gap between themselves and
their competitors in the West. In addition, regional governments are building
the necessary supporting infrastructures, particularly Good Manufacturing
Practice (GMP) compliant facilities, to support their self-sufficiency in
advanced therapies.
Country Level Analysis
The rapid growth of China is empowered by a supportive
government, an abundance of patients and a streamlined commercialization path.
Japan remains a strong source of innovation
in regenerative medicine and other areas that benefit from a flexible
regulatory system that allows faster approvals.
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Segment Insights
Therapy Type Segment
Why are cell Therapies dominating the Cell and Gene
Therapy (CGT) Pharmaceuticals Market?
The cell therapies are dominating the cell and gene therapy
pharmaceuticals market, a transformative intervention for cancers, immune
disorders, and regenerative needs. Their ability to modify or replace
dysfunctional cells makes them a powerful therapeutic foundation. Hospitals and
research centers have gained significant experience with cell handling, pushing
adoption even further. Manufacturing networks for autologous and allogeneic
platforms are expanding, supporting higher treatment volumes. Clinical success
stories continue to boost trust among clinicians and investors. As a result,
cell therapies maintain their stronghold as the most established segment in the
advanced therapy landscape.
Gene editing and modulation technologies are growing at a
breathtaking pace as developers pursue more precise and durable corrections at
the DNA and RNA level. The promise of one-time cures for rare genetic diseases
is accelerating R&D across multiple pipelines. Toolkits like gene
silencers, editors, and modulators are becoming more refined and safer in
clinical settings. As delivery methods improve, these therapies are expanding
into broader indications beyond rare disorders. Investor enthusiasm is
extremely high due to the long-term therapeutic potential. Consequently, gene
editing is rapidly becoming the fastest-rising star in the segment.
Modality Segment
Why are Viral Vectors dominating the Cell and Gene
Therapy (CGT) Pharmaceuticals Market?
The viral vectors are dominating the cell and gene therapy
(CGT) pharmaceuticals market, because of their unparalleled effectiveness in
transporting therapeutic genes to the target cells that viral vectors are still
the main method. The developers keep using AAV, lentiviral, and other vector
types because of their familiar and stable nature, and their good clinical
results. The production skills for viral vectors have been greatly elevated,
thus making clinical development more efficient. Also, the fact that they can
be used in both in vivo and ex vivo therapies, makes them increasingly
important. They are still the gold standard for the delivery of genetic
payloads, even though they are costly and complicated. Their firm position in
the market is what makes viral vectors the main force behind the current
success of gene therapy.
Non-viral delivery methods are growing quickly as
firms look for less risky, more easily scalable options to viral vectors. Lipid
nanoparticles, polymers, and physical delivery devices are becoming more
popular because they are more adaptable and less likely to cause immune
responses. These carriers make production easier and less dependent on
complicated viral supply chains. The possibility of using them for larger or
multiple doses is arousing extensive clinical interest. The breakthrough of RNA
vaccines has been the main driver of this change. Consequently, non-viral
delivery is becoming the leading rapid-growth sector in advanced therapies.
Route of Administration
Why are Intravenous dominating the Cell and Gene
Therapy (CGT) Pharmaceuticals Market?
Intravenous administration remains the leading
method of treatment because it is the most known, straightforward, and can
easily distribute drugs throughout the body. Generally, cellular and animal
model gene therapies use IV infusion as a method of delivery. Healthcare
providers are highly skilled in IV management; thus the procedure is less
complicated. Besides, IV procedures offer the possibility of controlled dosing
and monitoring which ensure patient safety. The resources needed for IV therapy
are already available in most big hospitals. These points are the reasons why
intravenous delivery is the most natural first option for most advanced therapy
programs.
Intrathecal administration is rapidly expanding because the
developers are focusing on neurological and spinal diseases that need direct
access to the central nervous system. This method gets around the blood brain
barrier, which makes it perfect for diseases that cannot be treated by systemic
methods. Scientists are widely opening trials in rare neuromuscular and
neurodegenerative disorders, which is resulting in the rapid development of
this field. The clinicians’ proficiency is getting higher with the help of
specialized techniques as well as better safety protocols. Along with the
increase of gene therapies for CNS disorders, intrathecal administration is
becoming a strategic priority. Therefore, it is one of the fastest-growing
administration routes in the market.
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Manufacturing & Supply Model
Why are n-House Manufacturing by Sponsors dominating
the Cell and Gene Therapy (CGT) Pharmaceuticals Market?
In-house production is still the major player because enterprises
want to have more control over the quality, timeframes, and the processes that
are their proprietary. Precision is what advanced therapies require, and that
is what internal facilities can guarantee. Most of the innovators choose to
protect the confidentiality of vectors, cell lines, and the tools used in
editing. Vertical integration is also a way to lower production costs in the
long run, particularly when therapies are scaled. Clinical teams are
experiencing an advantage through closer cooperation with the manufacturing
units. The combination of control and dependability is the reason why in-house
manufacturing is still the prevailing model.
The trend of outsourcing production is picking up speed
significantly as the internal capacity cannot meet the demand. CDMOs provide a
company with the necessary know-how, offer a flexible work capacity, and can be
quickly operational for a company which does not have its own infrastructure.
The increase in clinical programs has been a factor that urged developers to
seek the help of external partners for viral vector, plasmid, and
cell-processing needs. To embrace more talent, CDMOs nowadays are investing
more in the construction of modular and multi-modal facilities that are
tailored for advanced therapies. Besides, their ability to provide end-to-end
solutions, starting from the development phase to fill–finish, is welcoming
more customers. Hence, outsourcing the manufacturing process is gradually
becoming the dominant model in the ecosystem.
End User Segment
Why are Hospitals & Specialized Infusion Centres by
Sponsors dominating the Cell and Gene Therapy (CGT) Pharmaceuticals
Market?
Hospitals and specially equipped treatment centers are still
the major end users of advanced therapies which mostly demand acute clinical
supervision. These centers have the necessary equipment for cell processing,
skilled staff, and the ability to monitor. The management of patients
undergoing cell and gene therapies is a complicated one, so the dependence on
high-tier institutions is increased. Most therapies are given only at certified
treatment sites, which thus, fortifies their position. Moreover, their
engagement in managing the severest cases further elevates them to be primary
users. Such a concentration of experience keeps hospitals at the core of
therapy delivery.
As the production is getting decentralized and the
development of therapies is becoming increasingly specialized, CDMOs, and
contract providers are the group of users whose number is increasing most
rapidly. These partners usually take the responsibility for managing analytical
testing, process development, and clinical trial supply, if only partly.
Relatively to smaller biotechs entering the market, the need for contract
partners is growing significantly. Also, through logistics and handling
capabilities, CDMOs are broadening their offering of treatment support
services. Their participation is instrumental in alleviating bottlenecks and
speeding up commercialization timelines. The scope of their involvement is expanding;
thus, they are a rapidly rising user segment.
Recent News of Cell and Gene Therapy (CGT)
Pharmaceuticals Market:
➜
In August 2025the U.S. Food and Drug Administration (FDA)
granted full approval to PAPZIMEOS (zopapogene imadenovec-drba) for
treatment of adults with Recurrent Respiratory Papillomatosis (RRP), a rare
disease caused by persistent infection with HPV types 6 or 11.
➜
PAPZIMEOS is the first and only approved therapy for RRP, representing a
major milestone for the CGT field because it offers a non-surgical,
immunotherapy-based option (four subcutaneous injections over 12 weeks)
targeting the root cause (HPV-infected cells) rather than just repeated
surgeries.
Value Chain Analysis for Cell and Gene
Therapy (CGT) Pharmaceuticals Market
Research & Development (R&D)
Steps:
● Target
identification and validation
● Preclinical
studies (in vitro and in vivo)
● Development of
vectors, gene-editing tools, or cell therapy products
● Process
optimization for manufacturing
Key Organizations/Companies:
Novartis, Gilead/Kite Pharma, CRISPR
Therapeutics, Sangamon Therapeutics – Gene therapy development, Cellectis,
Academic & research institutions:
Harvard Medical School, Stanford University, University of Pennsylvania
Clinical Trials & Regulatory
Approvals
Steps:
● Phase I–III
clinical trials (safety, efficacy, dose optimization)
● Regulatory
submissions to FDA, EMA, PMDA, or other national authorities
● Fast-track or
breakthrough designations for accelerated approval
● Post-approval
monitoring
Key Organizations/Companies:
Novartis, Bluebird Bio, Sarepta
Therapeutics, etc., FDA (USA) – Regulatory oversight, EMA (Europe) – Approval
and regulation, PMDA (Japan) – Regulatory review, Contract research
organizations (CROs): IQVIA, Parexel, Charles River Labs
Manufacturing & Distribution
(optional step for completeness)
Steps:
● In-house or
outsourced production (CDMOs)
● Quality control
and batch release
● Cold-chain
distribution to hospitals and infusion centers
Key Organizations/Companies:
Lonza, WuXi AppTec, Samsung Biologics,
Catalent – Contract manufacturing
Patient Support & Services
Steps:
● Patient
education and counseling
● Therapy
administration support
● Monitoring and
follow-up care
● Insurance, reimbursement,
and financial assistance programs
Key Organizations/Companies: Novartis Patient Support Programs, Gilead’s KiteCare, Bluebird Bio
Patient Services, Hospitals & specialized infusion centers (e.g., Mayo
Clinic, MD Anderson Cancer Center)
Top Companies in the Cell and Gene Therapy (CGT)
Pharmaceuticals Market
➣ Novartis
➣ Gilead
Sciences / Kite Pharma
➣ Bristol
Myers Squibb (BMS) / Juno Therapeutics
➣ Roche
/ Spark Therapeutics
➣ bluebird bio
➣ Sarepta
Therapeutics
➣ REGENXBIO
➣uniQure
➣ Orchard Therapeutics
➣ Sangamo
Therapeutics
➣ CRISPR
Therapeutics
➣ Intellia
Therapeutics
➣ Published by Medicine
➣ Beam
Therapeutics
➣ Allogene Therapeutics
➣ Fate
Therapeutics
➣ Catalent
(Cell & Gene Services)
➣ Lonza
(Cell & Gene Solutions)
➣ Thermo
Fisher Scientific (including Patheon services)
➣ WuXi
AppTec / WuXi Advanced Therapies
Segment Covered
By Therapy Type
● Cell Therapies
○ Autologous Cell
Therapies (patient-derived CAR-T, TCR-T, autologous NK)
○ Allogeneic Cell
Therapies (off-the-shelf CAR-T, iPSC-derived NK, universal cells)
○ Stem-cell
Therapeutics (MSC, iPSC-derived products)
● Gene Therapies
○ In-vivo Gene
Therapy (AAV, adenoviral, non-viral delivery)
○ Ex-vivo Gene
Therapy (cells modified outside the body then re-infused)
● Gene Editing
& Gene Modulation
○ CRISPR/Cas,
base editors, prime editors (in-vivo and ex-vivo)
○ Epigenetic
regulators, RNA-based modulation (CRISPRa/CRISPRi, antisense oligos)
● RNA &
Oligonucleotide-based Therapies
○ mRNA
therapeutics for cell engineering or in-vivo expression
○ siRNA / ASO
adjuncts to CGT programs
By Modality / Vector & Delivery
Platform
● Viral Vectors
○ AAV
(Adeno-Associated Virus)
○ Lentivirus /
Retrovirus
○ Adenovirus
& HSV
● Non-Viral
Delivery
○ Lipid
nanoparticles (LNPs), polymers, electroporation, nanoparticle platforms for
in-vivo and ex-vivo delivery
○ Novel physical
delivery (e.g., focused ultrasound, electroporation devices)
● Gene Editing
Tools & Platforms
○ CRISPR/Cas
families, base/prime editors, meganucleases (often sold as platform tech or
licensed)
By Route of Administration
● Intravenous /
Systemic Infusion
● Intrathecal /
Intracerebral / CNS Direct Delivery (Fastest Growing for CNS programs)
● Intramuscular /
Intravitreal / Intratumoral / Localized catheters and implants
By Manufacturing & Supply Model
● In-House
Manufacturing by Sponsors
○ Pharma/biotech
builds its own suites for the chain-of-identity and control
● Outsourced
& CDMO Manufacturing
○ Viral vector
CDMOs, cell therapy CDMOs, fill/finish partners, analytical service providers
● Hybrid /
Strategic Partnerships
By End User / Customer
● Hospitals &
Specialized Infusion Centers
● CDMOs &
Contract Labs
● Academic
Medical Centers & Clinical Trial Sites
● Specialty
Pharmacies & Treatment Networks
By Region
● North America
○ U.S.
○ Canada
● Asia Pacific
○ China
○ Japan
○ India
○ South Korea
○ Thailand
● Europe
○ Germany
○ UK
○ France
○ Italy
○ Spain
○ Sweden
○ Denmark
○ Norway
● Latin America
○ Brazil
○ Mexico
○ Argentina
● Middle East and
Africa (MEA)
○ South Africa
○ UAE
○ Saudi Arabia
○ Kuwait
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