Advanced Therapy Medicinal Products CDMO Market to Grow with a CAGR of 12.15% through 2028
Scalable manufacturing solutions and increased
investment in research and development are expected to drive the Global Advanced
Therapy Medicinal Products CDMO Market growth in the forecast period,
2024-2028.
According to TechSci Research report, “Advanced
Therapy Medicinal Products CDMO Market – Global Industry Size, Share,
Trends, Competition Forecast & Opportunities, 2028”, the Global Advanced
Therapy Medicinal Products CDMO Market stood at USD 4.77 billion in 2022 and is
anticipated to grow with a CAGR of 12.15% in the forecast period, 2024-2028.
This can be attributed to global expansion. The ATMP CDMO market has a global
reach, with key players operating across continents. This global presence
allows CDMOs to serve clients worldwide, tapping into diverse markets and
addressing the global demand for advanced therapies. The international
footprint of CDMOs supports the globalization of ATMP development and
distribution.
Furthermore, CDMOs are increasingly relying on data
analytics and artificial intelligence (AI) to improve decision-making. These
technologies assist in optimizing manufacturing processes, predicting
production issues, and ensuring product quality. Data-driven insights are
invaluable in maintaining operational efficiency.
The expansion of the market can be attributed to
several factors, including the growing demand for advanced therapies. There has
been a notable increase in investments directed towards the research and
development of pharmaceutical products in this category. Additionally, there's
a rising incidence of rare and severe disorders, encompassing conditions like
metabolic and optical diseases. The COVID-19 pandemic has significantly
impacted the advancement and production of advanced therapy medicinal products.
Among the various classes of medicines, cell-based therapy has experienced
rapid growth during the pandemic. Countries such as the USA, Jordan, China, and
Iran, among others, initiated clinical research on cell-based therapies for
treating COVID-19 patients with acute respiratory distress, coinciding with the
global spread of the disease. As of 2022, more than 80 clinical trials related
to "Mesenchymal stem cells and COVID-19" were registered on
ClinicalTrials.gov.
Furthermore, one of the primary catalysts for the
advanced therapy medicinal products (ATMP) Contract Development and
Manufacturing Organization (CDMO) market is the increasing number of clinical
trials focusing on ATMPs. According to a report from the American Society of
Gene and Cell Therapy, as of Q1 2022, there were 3,579 therapies in the
pipeline for gene, cell, and RNA therapies. The gene cell therapy pipeline saw
a 16% increase from Q1 2021, with CAR-T cell therapies dominating the
genetically modified cell therapy segment. Notably, 98% of CAR-T cell therapies
were in the development phase for cancer indications.
Moreover, outsourcing activities are on the rise in
this domain, as companies seek to acquire the specialized expertise necessary
for successful ATMP development and commercialization. Apart from extending
their capabilities and enhancing cash flow management, outsourcing offers
significant manufacturing advantages, including reduced investment risks.
Additionally, the relatively low incidence-to-prevalence ratios for genetic and
rare diseases make outsourcing an attractive option, as constructing an in-house
facility for producing a single gene therapy for these diseases would require a
faster cost recovery within a limited timeframe.
Furthermore, intensifying competition among key
companies striving to gain a substantial market share in the field is expected
to drive increased investment in research and development within the advanced
therapy medicinal products CDMO market. For instance, in January 2022,
Excellos, a cell therapy CDMO, announced the successful launch and closure of a
USD 15 million funding round from Telegraph Hill Partners. The company
specializes in providing cGMP cellular services and products, offering
manufacturing and process development expertise to clinicians and scientists
engaged in cell and gene therapy research and development.
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The Global Advanced Therapy Medicinal Products CDMO Market
is segmented into product, phase, indication, regional distribution, and
company.
Based on its phase, the phase 1 sector accounted for
the largest portion of revenue in 2022, primarily driven by the expansion of
research and development activities and a growing number of human trials for
advanced therapies. Phase 1 plays a crucial role in assessing the safety levels
of a drug when administered at various doses and in different forms to a
limited number of patients. Its primary objective is to determine the highest
dosage that a patient can tolerate without experiencing adverse effects. Remarkably,
approximately 70% of drugs in phase 1 successfully progress to the subsequent
phase.
Meanwhile, the phase 2 category is expected to
experience substantial growth during the forecast period. Phase 2 clinical
studies encompass the largest group of developing Advanced Therapy Medicinal
Products (ATMPs), thanks to the high success rate achieved in phase 1 clinical
trials. According to data released by the Alliance for Regenerative Medicine as
of June 2022, there are over 2,093 ongoing clinical trials worldwide, with
1,117 falling within the scope of phase II clinical trials, constituting 53% of
the total. The segment's growth is being fueled by the increasing number of
products advancing to phase 2.
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.
Major companies operating in Global Advanced
Therapy Medicinal Products CDMO Market are:
- Celonic AG
- Bio Elpida
- Rentschler Biopharma SE
- AGC Biologics GmbH
- Catalent Inc
- Lonza Group AG
- WuXi Advanced Therapies
- Minaris Regenerative Medicine
- Patheon Inc
- Cell and Gene Therapy Catapult
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“The Global Advanced Therapy Medicinal Products CDMO
Market is at the forefront of innovation in the healthcare industry. The key
trends reflect the evolving nature of the market, driven by technological
advancements, regulatory dynamics, and the growing demand for advanced
therapies. CDMOs that proactively embrace the upcoming advancements are poised
to remain competitive and continue shaping the future of ATMP development and
manufacturing. As the ATMP landscape continues to evolve, these trends will play
a crucial role in defining the industry's trajectory and the delivery of
transformative therapies to patients worldwide,” said Mr. Karan Chechi,
Research Director with TechSci Research, a research-based management consulting
firm.
“Advanced Therapy Medicinal Products CDMO Market By
Product (Gene Therapy, Cell Therapy, Tissue
Engineered, Others), By Phase (Phase I, Phase II, Phase III, Phase IV), By
Indication (Oncology, Cardiology, Central Nervous System, Musculoskeletal,
Infectious disease, Immunology & inflammation, Others), By Region, By Competition Forecast &
Opportunities, 2018-2028F”, has evaluated the future growth potential of Global
Advanced Therapy Medicinal Products CDMO Market and provides statistics &
information on market size, structure and future market growth. The report
intends to provide cutting-edge market intelligence and help decision makers
take sound investment decisions. Besides, the report also identifies and
analyzes the emerging trends along with essential drivers, challenges, and
opportunities in Global Advanced Therapy Medicinal Products CDMO Market.
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