According to Nova One Advisor, the global cell
& gene therapy contract research organizations market size is
calculated at USD 5.35 billion in 2024, grows to USD 5.88 billion in 2025, and
is projected to reach around USD 13.76 billion by 2034, growing at a CAGR of
9.91% from 2025 to 2034.
The cell & gene therapy contract
research organizations market is expanding due to CRO
offering numerous advantages for cell
and gene therapy, such as speed, expertise, and flexibility. CRO is
that it authorizes sponsors to make informed decisions, keep trial quality, use
resources effectively, and reduce interruptions. It offers auditable financials
and improves resource allocation to lower operational expenses of cell and gene
therapies.
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Cell & Gene Therapy Contract
Research Organizations Market Highlights:
• North America dominated the global bone
regeneration material market in 2024.
• Asia Pacific is expected to grow at the
fastest CAGR over the forecast period.
• By type, the clinical segment dominated
the market with the largest share in 2024.
• By type, the preclinical segment is
expected to show the fastest growth over the forecast period.
• By service, the clinical monitoring
segment accounted for the highest market share in 2024.
• By service, the regulatory strategy
segment is expected to expand rapidly during the predicted timeframe.
• By indication, the oncology segment held
the largest market share in 2024.
• By indication, the CNS disorders segment
is expected to register the fastest growth during the forecast period.
• By modality, the cell-based therapies
segment captured the largest market share in 2024.
• By modality, the gene therapies segment
is expected to show the fastest growth during the forecast period.
Market Overview and Industry Potential
The cell and gene therapy contract research
organizations market is expanding due to CROs bringing valuable resources and
abilities to the cell and gene therapies, which accelerates timelines and
efficient processes through government expertise and access to advanced technologies.
CROs have a deep understanding of the governing landscape and can navigate the
complex maze of regulations and guidelines that govern cell and gene
therapy research. They have dedicated teams of specialists who stay up
to date with the modern regulatory changes and ensure that the study remains
compliant throughout its period. This level of government expertise helps avoid
costly delays and ensures that research progresses efficiently.
⬥︎ For Instance, In September 2024, Cryoport, Inc., a global leader in
supply chain solutions for the life sciences industry, and SK pharmteco, a
worldwide contract development and manufacturing organization, announced a
strategic collaboration to provide fully integrated logistics and manufacturing
services to biotechnology and pharmaceutical companies.
Continuous increasing interest in cell and
gene therapy outsourcing provides access to a specialised organization’s
internal resources, including its equipment and in-house specialists. Working
with a proficient CRO, customers usually scale up faster with their services.
CRO continuously examine and progress their portfolios and what they can offer
to their novel cell
and gene therapy customers.
CRO to handle entirely aspects of a clinical
trial or advancement program, fundamentally end-to-end. The CRO is
responsible for the complete study operations, and the sponsor’s contribution
is primarily oversight and decision-making.
What are the Latest Trends of Cell &
Gene Therapy Contract Research Organizations Market?
⬥︎ In July 2025, the Centers for Medicare
& Medicaid Services (CMS) announced that 33 states, plus the District of
Columbia and Puerto Rico, will participate in the Cell and Gene Therapy (CGT)
Access Model, a bold novel strategy to delivering advanced treatments for
people on Medicaid living with sickle cell disease. Participating states
represent approximately 84% of Medicaid beneficiaries with the condition,
significantly expanding access to transformative care.
⬥︎ In April 2025, Charles River Laboratories International, Inc.
announced the initial cohort of its Charles River Incubator Program (CIP). The
program offers early-stage biotechnology pioneers access to extensive scientific
and commercial expertise and a wide ecosystem of discovery, development, and
manufacturing capabilities to expedite the development of technologies and
life-changing therapies for patients in need.
Increasing Demand for Personalized Cell
Therapies: Market’s Largest Potential
Growing demand for personalize cell
therapies as it provides major advantages, ranging from enhancing diagnostic
precision to recognizing the ideal treatment option for a patient based on
their characteristics, to targeted therapy that rises the likelihood of
effective treatments, lowers adverse effects, enables for better disease
prevention, and most significantly, increases patient engagement, lowers
medical care expenses, and promotes research and revolution, so these create strong
demand of scalable, flexible and rapid advancement platforms, CROs are
particularly good at providing.
⬥︎ For Instance, In February 2024,
AstraZeneca expands its US manufacturing footprint to accelerate ambitions in
next-generation cell therapy discovery and development. AstraZeneca is
investing $300 million in an advanced facility in Rockville, MD, to launch its
life-saving cell therapy platforms in the US for critical cancer trials and
future commercial supply.
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Report Scope of Cell & Gene Therapy
Contract Research Organizations Market
Report Coverage
Details
Market Size in 2025
USD 5.88 Billion
Market Size by 2034
USD 13.76 Billion
Growth Rate From 2025
to 2034
CAGR of 9.91%
Base Year
2024
Forecast Period
2025-2034
Segments Covered
Type, Service,
Indication, Modality, Region
Market Analysis
(Terms Used)
Value (US$ Million/Billion)
or (Volume/Units)
Regional scope
North America;
Europe; Asia Pacific; Latin America; MEA
Key Companies
Profiled
Altasciences,
Allucent, ICON plc, Labcorp, Linical, Medpace, Thermo Fisher Scientific Inc.,
Precision Medicine Group, LLC., QPS Holdings, Syneos Health
Cell & Gene Therapy Contract
Research Organizations Market Segmentation Analysis:
By Type Analysis:
The clinical
segment dominates in the cell and gene therapy contract research
organization market, as cell and gene therapy in clinical trials involves a stretch
of DNA
to prevent or manage a genetic condition. It’s presently applied for treating
various types of blood cancers and a small number of rare genetic conditions.
These trials lead to long-lasting or even one-time treatments, potentially
avoiding the requirement for continuing medication.
On the other hand, the preclinical segment
is expected to grow significantly during the forecast period, as CRO conducts
preclinical research and offer data to support drug or device development in
early stages. It conducts preclinical research on behalf of biopharmaceutical
or life science organizations. CROs are often applied for preclinical
studies in fields like cell and gene therapy, immunology, and oncology. This
model removes the requirement for in-house lab space and personnel.
By Service Analysis:
The clinical monitoring segment dominated
the market in 2024, as it ensures trial success with person-centric
specialists, custom site funding, and operative excellence in all phases.
Monitoring in clinical trials supports study sponsors to assess and prove study
data, improve patient safety, and ensure protocol agreement, in real-time and
from a centralized location, and with significantly lower requirements for
in-person site monitoring visits.
On the other hand, the regulatory strategy
segment is expected to grow at the fastest CAGR in the market during the
forecast period, as an efficient regulatory strategy is a game changer for
organizations, improving potential revenue, lowering product failure rates, and
bringing much-needed therapies to patients. A clear regulatory strategy includes
quickening timelines, cost incentives, and the chance to partner with the
government to ensure a smooth advancement programme.
By Therapeutic Area Analysis:
The oncology
segment dominated the market in 2024, as cancer is the most common disease in gene
therapy clinical
trials. Cancer
gene therapy mainly focuses on removing the cancer cells, blocking
tumor vascularization, and improving the immune response to cancer antigens.
Many gene and cell therapy strategies are being discovered for the treatment of
a diversity of acquired diseases.
On the other hand, the CNS disorders
segment is expected to grow at the fastest CAGR in the market during the
forecast period, as gene therapy is significant for central nervous system
(CNS) disorders, opening up a compelling possible for the development of
advanced therapies. It provides the potential of transformative and
disease-modulating management opportunities.
By Modality Analysis:
The cell-based therapies segment dominated
the market in 2024, as cell-based therapy, particularly stem cells, offers a
new hope for patients suffering from irredeemable diseases, where treatment
strategies focus on the treatment of the disease rather than treating it. It
is a significant branch of regenerative medicine with the ultimate aim of
improving the body’s repair machinery through modulation, stimulation, and
regulation of the endogenous stem cell population and replenishing the cell
pool toward tissue regeneration and homeostasis.
On the other hand, the gene therapies
segment is expected to grow at the fastest CAGR in the market during the
forecast period, as gene therapies are applied to avoid, manage, or cure some
inherited disorders, like cystic fibrosis, alpha-1 antitrypsin deficiency, beta
thalassemia, haemophilia, and sickle cell disease. They may also be used to
manage and treat cancers or infections, including HIV. Gene therapy has huge
potential to get rid of a patient’s symptoms for life. Gene
therapy provides many people with an improved quality of life.
By Regional Insights
North America dominated the cell and gene
therapy contract research organization market in 2024, due to it has strong
research ecosystem as well as federal funds that have supported academic
research, which in turn, has boosted private advancement, increasing
discoveries in technology, medicine, and advanced cell and gene therapies,
which drives the growth of the market. Growing investments in health research
and development (R&D), supported by private funding and government grants,
also contribute to the growth of the market.
⬥︎ For Instance, In October 2024, Minaris
Regenerative Medicine, LLC and TFBS Bioscience Inc. are pleased to announce a
strategic partnership in cell and gene therapy (CGT), mainly in North America.
This collaboration is designed to improve their abilities to drive industry
innovation by providing one-stop-shop solutions.
There were 4,321 contract research
organizations in the U.S. businesses as of 2024, a rise of 2.1% from 2023,
which adopt new technology of cell and gene therapies. U.S. leadership in
novel drugs and medical devices is gaining regulatory approval. The country
also ranks at the top in scientific Nobel prizes per capita, scientific impact
in academia, and research and development expenses per capita, which drive the
growth of the market.
Why Asia Pacific is the Fastest Growing
in the Cell & Gene Therapy Contract Research Organizations Market?
Strong presence of leading CROs in Asia
Pacific, such as Novotech, Charles River Laboratories, Labcorp (Covance),
Medpace, and Caidya, drives the growth of the market. Increasing government
support for rare diseases research and gene therapy approvals, increasing
outsourcing, and revolution, which contribute to the growth of the market.
Cell & Gene Therapy Contract
Research Organizations Market Companies:
• Allucent
• ICON plc
• Labcorp
• Linical
• Medpace
• Thermo Fisher Scientific
Inc.
• Precision Medicine Group, LLC.
• QPS Holdings
What is Going Around the Globe?
⬥︎ In April 2025, AGC
Biologics Launched a New Dedicated Cell and Gene Business Division. The
new Cell and Gene Technologies Division will focus on elevating existing AGC
Biologics capabilities and supporting developers in need of capacity,
scientific capabilities, and technically qualified cell and gene CDMO operators
⬥︎ In June 2024, Cryoport, Inc., a global leader in
supply chain solutions for the life sciences, and Minaris Regenerative Medicine
Co., Ltd., a global contract development and manufacturing organization for
cell and gene therapies, announced a collaborative partnership to offer fully
integrated logistics and manufacturing solution to biotechnology and
pharmaceutical companies for regenerative medicine products to helps the
advancement of cell and gene therapies.
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Segments Covered in the Report
This report forecasts revenue growth at
country levels and provides an analysis of the latest industry trends in each
of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc.
has segmented the cell & gene therapy contract research organizations market.
By Type
• Drug Discovery
o
Target Validation
o
Lead Identification
o
Lead Optimization
• Preclinical
• Clinical
o
Phase I
o
Phase II
o
Phase III
o
Phase IV
By Service
• Project & Clinical Trial Management
• Regulatory Strategy
• Data Management & Medical Writing
• Clinical Monitoring
• Quality Management / GMP Compliance
• Biostatistics & Safety Monitoring
• Patient & Site Recruitment
• Technology Transfer
• Others
By Indication
• Oncology
• CNS Disorders
• Infectious Diseases
• Immunological Disorders
• Cardiovascular Diseases
• Respiratory Diseases
• Diabetes
• Ophthalmology
• Pain Management
• Others
By Modality
• Cell-Based Therapies
• Gene Therapies
• Gene-Modified Cell Therapies
By Regional
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)
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About-Us
Nova One Advisor is a global leader
in market intelligence and strategic consulting, committed to delivering deep, data-driven
insights that power innovation and transformation across industries. With a
sharp focus on the evolving landscape of life sciences, we specialize in
navigating the complexities of cell and gene therapy, drug development, and the
oncology market, enabling our clients to lead in some of the most revolutionary
and high-impact areas of healthcare.
Our expertise spans the entire
biotech and pharmaceutical value chain, empowering startups, global
enterprises, investors, and research institutions that are pioneering the next
generation of therapies in regenerative medicine, oncology, and precision
medicine.
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