Global Advanced Therapy Medicinal Products CDMO
Market has valued at USD 4.77 billion in 2022 and is anticipated to project impressive
growth in the forecast period with a CAGR of 18.05% through 2028. The Global
Advanced Therapy Medicinal Products Contract Development and Manufacturing
Organization (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
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 ATMP 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
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 Contract
Development and Manufacturing Organization (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
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
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
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.
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 Contract Development and Manufacturing Organization (CDMO)
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 ATMP 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.
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
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
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Key Market Challenges
The development and manufacturing of advanced
therapies are resource-intensive endeavors. The costs associated with research,
development, and manufacturing can be prohibitively high. CDMOs must find ways
to manage costs effectively while maintaining the high-quality standards
required for ATMPs.
Talent and Expertise
The specialized nature of ATMPs demands a skilled
workforce with expertise in various fields, including molecular biology,
bioprocessing, and regulatory affairs. Attracting and retaining top talent can
be a challenge, especially when competing with other sectors of the
Supply Chain Complexity
The supply chain for ATMPs can be complex,
involving the sourcing of raw materials, manufacturing, storage, and
distribution. Ensuring a secure and efficient supply chain is essential for
maintaining product integrity and patient safety. CDMOs must establish robust
supply chain strategies to mitigate potential disruptions.
Key Market Trends
Increased Collaboration and Partnerships
Collaboration is a cornerstone of innovation in the
ATMP sector. CDMOs are forming strategic partnerships with pharmaceutical
companies, biotech startups, and academic institutions. These collaborations
facilitate knowledge sharing, resource pooling, and the co-development of
cutting-edge therapies. The trend of collaborative ventures is expected to
accelerate as stakeholders seek to leverage collective expertise and resources.
Shift Towards Allogeneic Therapies
While autologous therapies, which use a patient's
own cells, have been prevalent, there is a growing shift towards allogeneic
therapies, which use donor cells. Allogeneic therapies offer advantages in
terms of scalability, cost-effectiveness, and shorter manufacturing timelines.
CDMOs are adapting their capabilities to accommodate this shift, including the
development of standardized, off-the-shelf allogeneic products.
Automation and Process Optimization
Automation and process optimization are becoming
increasingly crucial in ATMP manufacturing. CDMOs are investing in
state-of-the-art automation technology to enhance process efficiency, reduce
variability, and ensure product quality. These advancements not only reduce
production costs but also accelerate the time to market for advanced therapies.
Based on the category of Product, the gene therapy
sector emerged as the dominant force in the market, boasting the highest
revenue share in 2022. 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. In the initial three quarters of
2020, gene therapies globally secured over USD 12 billion in funding,
concurrently with the commencement of approximately 370 clinical trials.
Additionally, as of mid-2022, around 2,000 gene therapies were in the
developmental pipeline, targeting various therapeutic areas such as
neurological, cancer, cardiovascular, blood, and infectious diseases.
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.
Based on Indication, the oncology sector has taken
a commanding position in the market and is poised for substantial growth in the
coming forecast period. This projected growth is primarily driven by the heavy
burden of disease, strategic initiatives implemented by key industry players,
and the availability of advanced therapies for treating various forms of
cancer. As of January 2021, it was estimated that there were approximately
18,000 to 19,000 potential patients for the treatment of cancer using cell and
gene therapy products like Kymriah (manufactured by Novartis AG) and Yescarta
(developed by Gilead Sciences, Inc.), with an even larger pool of around
124,000 patients for potential treatment.
Conversely, the cardiology segment is expected to
exhibit significant expansion during the forecast period. This growth can be
attributed to the escalating prevalence of cardiovascular diseases and
collaborative research efforts aimed at advancing therapies. For example, in
February 2021, Trizell GmbH partnered with Catalent, Inc. to develop phase 1
cell therapy for the treatment of micro- and macroangiopathy. Trizell's
medication falls under the category of Advanced Therapy Medicinal Products
(ATMPs) and employs regulatory macrophages, which are a platform technology
originating from Germany.