|
Forecast
Period
|
2026-2030
|
|
Market
Size (2024)
|
USD
5.12 Billion
|
|
Market
Size (2030)
|
USD
8.87 Billion
|
|
CAGR
(2025-2030)
|
9.54%
|
|
Fastest
Growing Segment
|
Oncology
|
|
Largest
Market
|
North
America
|
Market Overview
Global Advanced Therapy Medicinal Products CDMO
Market was
valued at USD 5.12 Billion in 2024 and is expected to reach USD 8.87 Billion by
2030 with a CAGR of 9.54% during the forecast period. The Global
Advanced Therapy Medicinal Products CDMO Market is a dynamic and rapidly evolving sector within the
pharmaceutical and biotechnology industries. This market encompasses
organizations that provide specialized services for the development and
manufacturing of advanced therapy medicinal products (ATMPs), which include
gene therapies, cell therapies, and tissue-engineered products.
Key Market Drivers
Proliferation of Advanced Therapies
The healthcare landscape is witnessing a revolution
as advanced therapies, including gene therapies, cell therapies, and
tissue-engineered products, emerge as groundbreaking treatments for previously
incurable diseases. This paradigm shift in medicine is driving the demand for
specialized services provided by Contract Development and Manufacturing
Organizations (CDMOs).
The advent of advanced therapies has expanded
therapeutic horizons, offering new hope to patients suffering from rare and
debilitating conditions. These therapies target the root causes of diseases at
the genetic and cellular levels, promising higher efficacy and fewer side
effects compared to traditional treatments. As more conditions become treatable
through advanced therapies, the demand for CDMO services to develop and
manufacture these products increases.
Pharmaceutical companies, biotechnology firms, and
academic institutions are investing heavily in advanced therapy research and
development. This surge in investment translates into a growing pipeline of
potential therapies. CDMOs are integral to this process, providing the
expertise and infrastructure needed to advance these therapies from the
laboratory to clinical trials and eventual commercialization.
The development and manufacturing of advanced
therapies come with complex regulatory challenges. Regulatory bodies like the
FDA and EMA have stringent requirements to ensure the safety and efficacy of
these novel treatments. CDMOs specializing in advanced therapies possess the
regulatory expertise to help clients navigate this intricate landscape,
ensuring compliance throughout the product lifecycle. This support streamlines
the regulatory approval process, accelerating market entry.
Scaling up the production of advanced therapies for
clinical trials and commercialization is a significant challenge. CDMOs offer
scalable manufacturing solutions, enabling companies to transition smoothly
from small-scale production for clinical trials to large-scale manufacturing
for broader patient populations. This scalability is essential for meeting the
increasing demand for advanced therapies.
The Global Advanced Therapy Medicinal Products CDMO
Market is characterized by its global reach. Leading CDMOs operate across
regions, making advanced therapies accessible to a wider patient base. Global
presence also allows for diversification into different markets, ensuring a
steady demand for CDMO services.
The healthcare industry is increasingly adopting a
patient-centric approach, focusing on personalized medicine. Advanced therapies
align perfectly with this trend as they can be tailored to individual patients'
genetic and biological profiles. As personalized medicine gains prominence, the
demand for advanced therapies and CDMO services tailored to their development
and manufacturing is poised to soar.
The competitive landscape of the Global Advanced Therapy Medicinal Products CDMO Market fosters innovation and efficiency. Established CDMOs and emerging players
continuously enhance their capabilities, drive down costs, and improve
manufacturing processes. This competitive environment benefits clients by
making advanced therapy development and production more accessible and
cost-effective.
Increased Investment in Research and Development
The world of healthcare is witnessing a profound
transformation, largely driven by the relentless pursuit of innovative
treatments and therapies. Among these, advanced therapy medicinal products
(ATMPs) such as gene therapies, cell therapies, and tissue-engineered products
are emerging as the future of medicine. Fueling this transformation is the
substantial increase in investment in research and development (R&D), which
has a profound impact on the Global Advanced Therapy Medicinal Products CDMO Market.
Increased R&D investment has broadened the
horizons of therapeutic possibilities. It has enabled the discovery and
development of ATMPs for a wide range of diseases, including rare genetic
disorders, cancers, and autoimmune conditions. As more therapeutic targets are
identified and explored, the demand for CDMO services to facilitate their
development and production surges.
The infusion of capital into ATMP R&D programs
has significantly shortened development timelines. As a result, promising
therapies are progressing rapidly through preclinical studies, clinical trials,
and regulatory approvals. CDMOs play a pivotal role in this acceleration,
offering their expertise in process development, manufacturing, and regulatory
compliance to expedite the journey from laboratory discovery to patient
treatment.
Pharmaceutical companies, biotechnology startups,
and academic institutions are actively seeking collaboration with CDMOs to
leverage their specialized capabilities. The increased R&D funding fosters
more partnerships, as organizations pool their resources and expertise to
advance ATMPs. CDMOs, acting as strategic partners, help navigate the
complexities of ATMP development, including manufacturing scale-up and
regulatory hurdles.
Investment in ATMP R&D often involves
significant financial risk. Collaborating with CDMOs can help mitigate some of
this risk. CDMOs offer cost-effective and efficient solutions for process
development and manufacturing, allowing organizations to optimize their R&D
budgets and manage expenditures more effectively.
Developing and manufacturing ATMPs require
specialized expertise, as these therapies are at the cutting edge of science
and technology. CDMOs have honed their capabilities in this niche field,
attracting organizations seeking to tap into their knowledge and experience.
This expertise accelerates the development process and ensures adherence to
regulatory requirements.
Scalable Manufacturing Solutions
The landscape of healthcare is undergoing a
revolutionary transformation with the advent of advanced therapy medicinal
products (ATMPs). These innovative therapies, which include gene therapies,
cell therapies, and tissue-engineered products, have the potential to treat
previously incurable diseases. As the demand for these groundbreaking
treatments continues to surge, scalable manufacturing solutions provided by
Contract Development and Manufacturing Organizations (CDMOs) are playing a
pivotal role in fueling the growth of the Global Advanced Therapy Medicinal
Products CDMO Market.
The rise in the popularity of ATMPs has created a
significant demand for large-scale production. Scalable manufacturing solutions
offered by CDMOs are essential to meet this growing demand. These solutions
enable the transition from small-scale clinical production to large-scale
commercial manufacturing, ensuring a steady and reliable supply of advanced
therapies for patients.
One of the primary advantages of scalable
manufacturing is its ability to reduce time to market. By efficiently scaling
up production processes, CDMOs help pharmaceutical companies and biotech firms
bring their ATMPs to market more quickly. This accelerated timeline is critical
for patients who urgently need these life-saving therapies.
CDMOs specialize in flexible manufacturing
solutions that can adapt to the changing needs of their clients. Scalability
allows for the adjustment of production volumes as clinical trials progress and
the demand for ATMPs increases. This flexibility ensures that clients have the
manufacturing capacity required at every stage of development.
Scalable manufacturing is not solely about
increasing production volumes; it also involves optimizing and fine-tuning
manufacturing processes. CDMOs excel in process development and optimization,
ensuring that the transition from laboratory-scale production to large-scale
manufacturing is smooth and efficient. This expertise streamlines the
manufacturing process, reducing costs and improving product quality.
The Global Advanced Therapy Medicinal Products CDMO
Market operates on a global scale. Leading CDMOs have a presence in various
regions, allowing them to serve clients worldwide. This global reach not only
supports international collaborations but also ensures that ATMPs are
accessible to a diverse patient population across the globe.
Patient-Centric Healthcare
The landscape of healthcare is evolving, with a
growing emphasis on patient-centric approaches that prioritize individualized
care and treatment. This transformation is particularly evident in the realm of
advanced therapy medicinal products (ATMPs), which include gene therapies, cell
therapies, and tissue-engineered products. Patient-centric healthcare is
emerging as a driving force behind the growth of the Global Advanced Therapy
Medicinal Products CDMO Market.
Patient-centric healthcare places the patient at
the center of decision-making and treatment planning. Personalized medicine, a
key component of this approach, tailors medical interventions to the specific
genetic, molecular, and clinical characteristics of each patient. ATMPs align
perfectly with this paradigm, as they can be customized to target the unique
biological factors driving a patient's disease.
The shift toward personalized medicine has led to a
surge in the demand for tailored therapies. Patients with rare genetic
disorders, cancers, and other challenging conditions are seeking treatments
that address the root causes of their diseases. ATMPs, which have the potential
to provide precisely such treatments, are thus gaining popularity and fueling
growth in the Global Advanced Therapy Medicinal Products CDMO Market.
To create truly patient-centric therapies,
collaboration between pharmaceutical companies, biotech startups, academic
institutions, and CDMOs is essential. CDMOs bring specialized expertise in ATMP
development and manufacturing to the table, enabling organizations to navigate
the complexities of personalized therapies more effectively. As collaborations
increase, so does the demand for CDMO services. In April 2022, Pfizer made public its establishment of a division dedicated to conducting a phase III trial for an experimental gene therapy aimed at patients with Duchenne muscular dystrophy.
Patient safety and product quality are paramount in
patient-centric healthcare. ATMPs must meet stringent regulatory standards to
ensure efficacy and safety. CDMOs specializing in advanced therapies have the
expertise to help clients meet these regulatory requirements, ensuring that
patient-centric treatments adhere to the highest standards of quality and
safety.
While patient-centric therapies are tailored to
individual patients, they still need to be scalable to serve broader
populations. CDMOs offer scalable manufacturing solutions that can transition
from small-scale clinical production to large-scale commercial manufacturing.
This scalability ensures that successful therapies can reach a wider patient
base.
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Key Market Challenges
High Costs
The development and manufacturing of
advanced therapies, such as ATMPs (Advanced Therapy Medicinal Products), are
inherently resource-intensive. These therapies require significant investment
in research and development, with cutting-edge technology and highly
specialized expertise necessary for their creation. The costs associated with
preclinical and clinical trials, regulatory approvals, and the production of
these therapies can often be prohibitively high, which poses a challenge for
Contract Development and Manufacturing Organizations (CDMOs) involved in the
production process. Furthermore, the advanced nature of these products demands
high-quality standards, specialized facilities, and skilled personnel to ensure
safety, efficacy, and compliance with stringent regulations. CDMOs must find
innovative ways to streamline production processes, optimize resource
allocation, and implement cost-control strategies without compromising the
quality of the therapies being developed. Balancing cost efficiency while
meeting the demands for high-end manufacturing processes is a critical
challenge in the ATMP sector, and finding sustainable solutions is key to
ensuring the long-term success of these products.
Supply Chain Complexity
The supply chain for ATMPs is
multifaceted and can be significantly more complex than that of traditional
pharmaceutical products. It involves several interconnected stages, including
the sourcing of specialized raw materials, manufacturing, packaging, storage,
and distribution, with each step requiring careful coordination and precision.
Many of the ingredients or biological materials required for ATMPs are highly
sensitive and need to be handled with specialized procedures to maintain their
integrity and effectiveness. This level of complexity increases the risk of
disruptions, which can impact product quality, timelines, and patient safety.
For instance, temperature-sensitive biologics or cell-based therapies require
specialized storage and transportation solutions to avoid degradation.
Moreover, due to the high level of customization in ATMPs, any delay or
inconsistency in the supply chain can have significant consequences. CDMOs must
establish robust, resilient supply chain strategies that can handle potential
bottlenecks and mitigate risks such as shortages of raw materials, regulatory
delays, or logistical challenges. Ensuring a smooth and secure supply chain not
only helps in maintaining product quality and integrity but also ensures timely
delivery to healthcare providers, directly impacting patient outcomes and
treatment efficacy. With a growing emphasis on patient-centric care and the
increasing global demand for ATMPs, developing agile, efficient, and secure
supply chains is more critical than ever for CDMOs in the ATMP sector.
Key Market Trends
Increased Collaboration and Partnerships
Collaboration is increasingly becoming a
critical driver of innovation within the Advanced Therapy Medicinal Product
(ATMP) sector. As the complexity and scope of these therapies continue to grow,
Contract Development and Manufacturing Organizations (CDMOs) are recognizing
the importance of strategic partnerships with pharmaceutical companies, biotech
startups, and academic institutions. These alliances allow stakeholders to pool
resources, share knowledge, and co-develop cutting-edge therapies that may otherwise
be challenging to create independently. In February 2022, Recipharm AB successfully finalized its acquisition of Vibalogics. Through this arrangement, Recipharm is set to gain valuable expertise in biologics, harnessing Vibalogics' capabilities in areas such as viral vaccines, oncolytic viruses, and gene treatments using viral vectors. This strategic move is expected to provide Recipharm with a substantial diversification of its offerings across various technologies and modalities.
By leveraging each partner’s unique
expertise—whether in research, clinical trials, regulatory pathways, or
production capabilities—collaborative efforts are helping to accelerate the
development of novel therapies. Additionally, partnerships can enable faster
problem-solving and troubleshooting during the manufacturing process, which is
essential in an industry where timelines are tight and regulatory hurdles are
high. As the ATMP landscape becomes more competitive, the trend of increased
collaboration is expected to intensify, as companies strive to tap into each
other’s strengths to overcome technical, regulatory, and financial challenges.
These collaborations also foster innovation in production processes and
facilitate the scaling of promising therapies, ultimately benefiting patients
with unmet medical needs.
Shift Towards Allogeneic Therapies
In the ATMP sector, there has been a
notable shift from autologous therapies—where a patient’s own cells are used
for treatment—to allogeneic therapies, which rely on donor cells. This
transition is being driven by several factors that make allogeneic therapies
increasingly attractive for both patients and manufacturers. One of the primary
advantages of allogeneic therapies is their scalability. Unlike autologous
therapies, which require the collection, processing, and re-infusion of a
patient’s cells, allogeneic therapies can be produced in larger batches using
standardized donor cells, making them more suitable for widespread use. This
scalability not only improves access to these therapies for a larger patient
population but also reduces manufacturing costs per dose, improving the overall
cost-effectiveness of treatment. Moreover, the shorter manufacturing timelines
associated with allogeneic therapies can significantly speed up the time from
development to patient treatment, which is a crucial factor for patients with
urgent medical needs.
CDMOs are adapting their capabilities to
meet this demand by developing processes tailored to the production of
off-the-shelf, standardized allogeneic products. This includes optimizing cell
expansion techniques, creating more efficient bioprocessing workflows, and
ensuring that the final product meets rigorous safety and quality standards.
Furthermore, the move towards allogeneic therapies opens new opportunities for
collaboration, particularly in the sourcing of high-quality donor cells and the
establishment of reliable, scalable manufacturing processes. As the market for
allogeneic therapies expands, CDMOs will continue to innovate in areas such as
cell line development, gene editing, and cryopreservation to further reduce
costs and improve the consistency of products. Ultimately, this shift towards
allogeneic therapies is expected to play a key role in addressing the
increasing demand for advanced treatments while making these therapies more
accessible and affordable for a broader range of patients.
Segmental Insights
Product Insights
Based on the category of Product, the gene therapy
sector emerged as the dominant force in the market, boasting the highest
revenue share. This supremacy can be attributed to the surge in
financial backing and the escalating number of clinical trials focused on gene
therapies, both of which are fueling the demand for Contract Development and
Manufacturing Organization (CDMO) services. Conversely, the cell therapy segment is projected
to experience the most rapid growth throughout the forecast period. The field
of cellular therapeutics is in a constant state of evolution, as it integrates
new cell types, thereby presenting abundant opportunities for companies to
bolster their market positions. Moreover, the market is drawing new entrants
due to the substantial unmet demand for cell therapy manufacturing, recent
approvals of advanced therapies, and the proven efficacy of these products.
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Regional Insights
North America seized the largest market. This can be attributed to the growing trend of outsourcing activities and
an increasing awareness of advanced therapy. The United States, in particular,
has consistently held a leading position in the research and development of
advanced treatments, and this dominance is expected to persist throughout the
forecast period. Recent approvals of products like Kymriah and Yescarta have
further catalyzed investments in the regional market for advanced therapy medicinal
products. Furthermore, in March 2021, the U.S. Food and Drug Administration
(FDA) granted approval for Abecma, marking the first approval of CAR-T cell
therapy for combating cancer.
On the other hand, the Asia Pacific region is
projected to be the second dominating region during the forecast period,
primarily due to the surging demand for innovative Advanced Therapy Medicinal
Products (ATMPs) and increased research and development activities aimed at
creating novel therapies. Additionally, the growth of the advanced therapy
medicinal products CDMO market in this region is driven by the continual
expansion of CDMO services. Numerous local players have collaborated with
biotech firms from other countries engaged in mesenchymal stem cell research
and therapy development. Furthermore, in September 2022, Takara Bio, Inc.
introduced CDMO services for gene therapy products utilizing siTCR technology
for its genetically modified T-cell therapy products.
Recent Developments
- In October 2023, the FDA has approved
Intellia Therapeutics’ investigational new drug (IND) application to begin a
phase 3 trial of NTLA-2001 in patients with transthyretin (ATTR) amyloidosis
associated with cardiomyopathy (CM). Scheduled to start by the end of 2023,
this trial will be the first late-stage clinical study to assess an in vivo
CRISPR-based gene editing therapy. The therapy utilizes Intellia’s proprietary
non-viral platform, deploying lipid nanoparticles to deliver guide RNA and
Cas9-encoding mRNA to the liver. This program is a collaboration between
Intellia and Regeneron, with an ongoing phase 1 trial (NCT04601051) currently
evaluating the treatment in patients with hereditary ATTR amyloidosis, either
with polyneuropathy (ATTRv-PN) or CM. ATTR amyloidosis leads to serious
complications due to the accumulation of abnormal transthyretin (TTR) protein,
which can ultimately result in death.
- In December 2023, the U.S. Food and Drug
Administration has approved two groundbreaking treatments, Casgevy and
Lyfgenia, marking the first cell-based gene therapies for sickle cell disease
(SCD) in patients aged 12 and older. Among these, Casgevy stands out as the
first FDA-approved therapy to incorporate a novel genome editing technology,
representing a significant advancement in the field of gene therapy.
- In October 2024, OmniaBio, a Contract
Development and Manufacturing Organization (CDMO) specializing in cell and gene
therapies, has unveiled a new manufacturing facility, which it claims is the
largest of its kind in Canada. The 120,000-square-foot facility, located just
outside Toronto in Hamilton, Ontario, is designed to cater to the unique
demands of cold chain logistics while also supporting the production of cell
and gene therapies with the assistance of artificial intelligence.
- In September 2024, Kincell Bio, a
technology-driven cell therapy cGMP contract development and manufacturing
organization (CDMO), has announced a new partnership for the production of
early-phase clinical material for an allogeneic cell therapy product. This
contract follows the acquisition of a GMP-ready facility in April 2024 and
further expands the manufacturing activities at the site. The agreement marks
the beginning of a multi-year collaboration and serves as a strong validation
of the team’s expertise in allogeneic cell therapy production and release.
Key Market Players
- Celonic
AG
- Rentschler
Biopharma SE
- Catalent,
Inc.
- Lonza
Group AG
- WuXi
Advanced Therapies
- Minaris
Regenerative Medicine, LLC
- Pluri
Biotech Ltd.
- REPROCELL
USA Inc.
- BioPhorum
Operations Group
- Cellares
Corporation
|
By Product
|
By Phase
|
By Indication
|
By Region
|
- Gene Therapy
- Cell Therapy
- Tissue Engineered
- Others
|
- Phase I
- Phase II
- Phase III
- Phase IV
|
- Oncology
- Cardiology
- Central Nervous System
- Musculoskeletal
- Infectious disease
- Immunology & inflammation
- Others
|
- North America
- Europe
- Asia-Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global Advanced Therapy
Medicinal Products CDMO Market has been segmented into the following
categories, in addition to the industry trends which have also been detailed
below:
- Advanced Therapy Medicinal Products CDMO
Market, By Product:
o Gene Therapy
o Cell Therapy
o Tissue Engineered
o Others
- Advanced Therapy Medicinal Products CDMO
Market, By Phase:
o Phase I
o Phase II
o Phase III
o Phase IV
- Advanced Therapy Medicinal Products CDMO
Market, By Indication:
o Oncology
o Cardiology
o Central Nervous System
o Musculoskeletal
o Infectious disease
o Immunology & inflammation
o Others
- Advanced Therapy Medicinal Products CDMO
Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ Germany
§ United Kingdom
§ France
§ Italy
§ Spain
o Asia-Pacific
§ China
§ Japan
§ India
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Advanced
Therapy Medicinal Products CDMO Market.
Available Customizations:
Global Advanced Therapy Medicinal Products CDMO
market report with the given market data, TechSci Research offers
customizations according to a company's specific needs. The following
customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
Global Advanced Therapy Medicinal Products CDMO
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