Advanced Therapy Medicinal Products CDMO Industry is Rising Rapidly

According to latest study, the global advanced therapy medicinal products CDMO Market size was valued at USD 6.10 billion in 2023 and is projected to reach USD 34.53 billion by 2033, growing at a CAGR of 18.93% from 2024 to 2033.

Key Takeaways:

• North America dominated the overall market share of 49.11% in 2023.
• The U.S. accounted for the largest share of the global market in the North America region in 2023.
• The Asia Pacific region is expected to grow at the fastest CAGR over the forecast period
• The gene therapy segment held the largest share of over 49.11% in 2023.
• The cell therapy segment is expected to show lucrative growth over the forecast period.
• The oncology segment accounted for the largest revenue share in 2023.
• The cardiology segment is estimated to register the fastest CAGR over the forecast period.
• The phase I segment dominated the market in 2023
• The phase II segment has been anticipated to show lucrative growth over the forecast period.

Request PDF Sample Copy of Report: (Including Full TOC, List of Tables & Figures, Chart) @ https://www.novaoneadvisor.com/report/sample/8439

owing to rising clinical trials for advanced therapy medicinal products and the increasing awareness among researchers about the benefits of advanced therapies, driving the advanced therapy medicinal products (ATMP) CDMO market growth. Tissue engineering has greatly benefited in recent years from technological development. The damaged tissues and organ function are replaced or restored using this technique. Similarly, gene and cell therapy are attracting a lot of patients for the treatment of rare diseases, whose incidence is rising globally.

With rising demand for robust disease treatment therapies, key players have focused their efforts to ramp up research and development for effective gene therapies that target the cause of disorder at a genomic level. According to ASGCT, the number of cell and gene therapies in the U.S. pipeline programs (phase I-III trials) increased from 483 in 2021 to 529 in 2022. Furthermore, the FDA delivers constant support for innovations in the gene therapy field via a number of policies with regard to product manufacturing. In January 2020, the agency released six final guidelines on the manufacturing and clinical development of safe & efficient gene therapy products.

Moreover, awareness about ATMP treatment options is being driven by initiatives aimed at informing the public about the benefits of these products, which, in turn, is leading to increased adoption of advanced therapies and fueling market growth for CDMOs. For instance, Alliance for Regenerative Medicine Foundation for Cell and Gene Medicine prioritizes activities for increasing public awareness through educational programs, underlining the clinical & societal benefits of regenerative medicine.

Increasing clinical trial activity along with new product launches generates growth opportunities for the market. As of 2022, there are 1451 ATMPs in preclinical stages and 535 are being studied in Phase 1 to 3 studies. Since August 2020, EMA has approved six of these additional ATMPs, and five more will be approved by 2023. In the UK, there were approximately 168 advanced therapy medicinal product trials underway in 2021, up from the 154 studies reported the year before, which is a 9% increase. 2021 saw a 32% increase in phase 1 trials, indicating a significant shift from experimental medicines to first-in-human studies.

On the other hand, key players are undertaking various strategic initiatives to introduce novel products, which is expected to propel market growth. For instance, in March 2021, CureVac N.V. signed a partnership agreement with Celonic Group, engaged in the manufacture of CVnCoV, CureVac’s mRNA-based COVID-19 vaccine candidate. CureVac’s COVID-19 vaccine candidate is manufactured at Celonic’s commercial manufacturing unit for ATMPs and biologics in Heidelberg, Germany. Under the terms of the commercial supply agreement, the Celonic facility could produce over 100 million doses of CVnCoV.

Immediate Delivery Available, Get Full Access@ https://www.novaoneadvisor.com/report/checkout/8439

Advanced Therapy Medicinal Products CDMO Market Trends

1. Rapid Growth: The market for ATMPs, including gene therapies, cell therapies, and tissue-engineered products, is experiencing rapid growth. This growth is fuelled by advancements in biotechnology, increased investment in research and development, and a growing pipeline of ATMPs in clinical trials.
2. Specialized Expertise: ATMPs are highly complex and require specialized manufacturing expertise. CDMOs with experience and capabilities in ATMP manufacturing are in high demand. These CDMOs offer specialized facilities, equipment, and personnel trained in the unique requirements of manufacturing gene therapies, cell therapies, and tissue-engineered products.
3. Global Expansion: The market for ATMP CDMOs is expanding globally. CDMOs are establishing or expanding their presence in key regions such as North America, Europe, and Asia-Pacific to better serve local markets and meet the growing demand for ATMP manufacturing worldwide. This global expansion enables CDMOs to offer proximity to clients and access to diverse regulatory environments.
4. Partnerships and Collaborations: Collaboration between biopharmaceutical companies and CDMOs is crucial in the ATMP space. Strategic partnerships allow biopharmaceutical companies to leverage the expertise and capabilities of CDMOs in ATMP manufacturing, accelerating the development and commercialization of these therapies. CDMOs, in turn, benefit from long-term contracts and access to innovative ATMP technologies.
5. Regulatory Compliance: Regulatory requirements for ATMPs are stringent and evolving. CDMOs must adhere to complex regulatory standards set forth by agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency). Compliance with these regulations is critical to ensure product safety, efficacy, and quality throughout the manufacturing process.
6. Process Optimization: ATMP manufacturing processes are continually evolving to improve efficiency, scalability, and product quality. CDMOs are investing in process optimization, automation, and advanced analytics to streamline manufacturing operations and reduce production costs. Process optimization efforts focus on increasing yield, minimizing variability, and ensuring consistency in product quality.
7. Scale-Up Challenges: Scaling up ATMP manufacturing from research to commercial-scale production presents significant challenges. CDMOs are investing in scalable manufacturing platforms and flexible facilities that can adapt to varying production scales. Addressing scale-up challenges is essential to meet the increasing demand for ATMPs and ensure timely delivery to patients.
8. Quality Assurance: Quality assurance is paramount in ATMP manufacturing to ensure product safety and efficacy. CDMOs are implementing robust quality management systems and rigorous testing protocols to maintain compliance with regulatory standards. Quality assurance efforts encompass raw material testing, in-process monitoring, and final product release testing to guarantee the quality and consistency of ATMPs.

Segments Insights:

Product Insights

The gene therapy segment held the largest share of over 49.11% in 2023. Increase in financial support and rise in number of clinical trials for gene therapies are driving demand for gene therapy segment. In 2020, in the first three quarters, gene therapies attracted financing of over USD 12 billion globally, with around 370 clinical trials underway. Additionally, in mid-2022, approximately 2,000 gene therapies were in development, targeting several therapeutic areas, such as neurological, cancer, cardiovascular, blood, and infectious diseases.

The cell therapy segment is expected to show lucrative growth over the forecast period. The field of cellular therapeutics is constantly advancing with inclusion of new cell types, which, in turn, provides ample opportunities for companies to enhance their market positions. Furthermore, the market is attracting new entrants due to high unmet demand for cell therapy manufacturing, the recent approval of advanced therapies, and proven effectiveness of these products.

Indication Insights

The oncology segment accounted for the largest revenue share in 2023. The segment’s dominance is attributed to disease burden, strategic initiatives undertaken by key players, and availability of advanced therapies used for treating various cancer indications. In January 2021, around 18,000 to 19,000 patients and 124,000 patients were estimated to be potential patients for treating cancer using cell & gene therapy products Kymriah (Novartis AG) and Yescarta (Gilead Sciences, Inc.), respectively. Furthermore, a publication on PubMed reports that as of the conclusion of the first quarter of 2023, there have been over 100 distinct gene, cell, and RNA therapies approved globally, along with an additional 3,700-plus in various stages of clinical and preclinical development.

The cardiology segment is estimated to register the fastest CAGR over the forecast period. This is attributed to the increasing prevalence of cardiovascular diseases and research collaboration for development of advanced therapies. For instance, in October 2023, Cleveland Clinic administered a novel gene therapy to the first patient globally as part of a clinical trial, aiming to deliver a functional gene to combat the primary cause of hypertrophic cardiomyopathy (HCM). Similarly, in February 2021, Trizell GmbH entered into partnership with Catalent, Inc. for development of phase 1 cell therapy to treat micro- and macroangiopathy. Trizell’s medication is an Advanced Therapy Medicinal Product (ATMP) that employs regulatory macrophages—a platform technology developed in Germany.

Phase Insights

The phase I segment dominated the market in 2023 due to growing R&D activities and increasing number of human trials for advanced therapies. Phase 1 helps ensure the safety levels of a drug at different doses and dosage forms administered to a small number of patients. This phase is mainly conducted to determine the highest dose a patient can take without any adverse effects. Around 70% of drugs in phase 1 move to the next phase.

The phase II segment has been anticipated to show lucrative growth over the forecast period. Phase II clinical studies comprise the largest number of developing ATMPs, due to the high clearance rate of phase I clinical studies. According to data published by Alliance for Regenerative Medicine, as of June 2022, more than 2,093 clinical trials are ongoing globally, out of which 1,117 are under phase II clinical trials accounting for 53%. Thus, the increase in number of products in phase II is driving the segment.

Regional Insights

North America dominated the overall market share of 49.11% in 2023. This can be attributed to increasing outsourcing activities and rising awareness about advanced therapy. North America has consistently been a leader in R&D for advanced treatments, and it is anticipated that it will keep this position during the forecast period. Recent approvals of products such as Kymriah and Yescarta have propelled investments in the regional market. Moreover, in March 2021, the U.S. FDA approved Abecma, the first approval of CAR-T cells to fight against cancer. Similarly, in December 2023, Casgevy and Lyfgenia, the initial cell-based gene therapies for sickle cell disease (SCD) in patients aged 12 and above, received approval from the U.S. Food and Drug Administration, marking a significant milestone.

The U.S. accounted for the largest share of the global market in the North America region in 2023. The U.S. maintains dominance in this sector due to the presence of a robust and highly advanced biopharmaceutical industry with a considerable focus on research and development. Additionally, the continuous presence of numerous pharmaceutical and biotechnology companies, along with academic and research institutions, generates a sustained demand for rigorous safety testing, further reinforcing the country’s leadership in the field.

The Asia Pacific region is expected to grow at the fastest CAGR over the forecast period due to the increasing demand for novel ATMPs and rising R&D activities to develop novel therapies. Moreover, the market growth is driven by continuously expanding CDMO Cell Therapy in the country, a number of domestic players have collaborated with biotech companies from other countries involved in mesenchymal stem cell research and therapy development. In addition, in September 2022 Takara Bio, Inc. launched CDMO Cell Therapy for gene therapy products using siTCR technology for its genetically modified T-cell therapy products.

China accounted for the largest share of the global market in the Asia Pacific region in 2023 due to its strategic focus on advancing research and development capabilities, particularly in the pharmaceutical and biotechnology sectors. Additionally, with a rapidly growing biopharmaceutical industry and supportive government initiatives, China has become a key market for advanced therapy medicinal products (CDMO) market.

Recent Developments

• In October 2023, The US FDA approved the Investigational New Drug (IND) application for NTLA-2001, marking the clearance for the first-ever CRISPR-based gene therapy designed for in vivo treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy.
• In December 2023, the US FDA granted approval for two gene-based treatments for sickle cell disease, marking a significant milestone. Notably, one of these therapies represents the first application of the gene-editing technique CRISPR in the treatment of the disease.
• In February 2022, Recipharm AB completed the acquisition of Vibalogics. With this agreement, Recipharm will obtain expertise in biologics modalities, utilizing Vibalogics’ capability in viral vaccines, oncolytic viruses, and viral vector gene treatments to deliver high level of diversification through several technologies and modalities.
• In April 2022, Pfizer announced the opening of its unit for phase III trial of investigational gene therapy for patients with Duchenne muscular dystrophy.

Key Companies & Market Share Insights

Some of the key players operating in the market include AGC Biologics,WuXi Advanced Therapies and Celonic

• AGC Biologics offers a range of Cell Therapy for advanced therapy medicinal products (ATMPs), including gene and cell therapies.AGC Biologics specializes in the development and manufacturing of protein-based biologics and advanced therapies, including cell therapy, viral vectors, and mammalian and microbial cell therapy.
• WuXi AppTec provides a comprehensive range of analytical testing Cell Therapy to characterize complex biologics, vaccines, and advanced therapies.

Minaris Regenerative Medicine and BlueReg are some of the emerging market players in the global market.

• Minaris Regenerative Medicine offers a wide range of cell types, manufacturing technologies, and procedures, analytical methods, and regulatory expertise.

Key Advanced Therapy Medicinal Products CDMO Companies:

• Celonic
• Bio Elpida
• CGT Catapult
• Rentschler Biopharma SE
• AGC Biologics
• Catalent
• Lonza
• WuXi Advanced Therapies
• BlueReg
• Minaris Regenerative Medicine
• Patheon

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 2033. For this study, Nova one advisor, Inc. has segmented the 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
• Dermatology
• Endocrine, metabolic, genetic
• Immunology & inflammation
• Ophthalmology
• Hematology
• Gastroenterology
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)

Immediate Delivery Available | Buy This Premium Research: https://www.novaoneadvisor.com/report/checkout/8439

You can place an order or ask any questions, please feel free to sales@novaoneadvisor.com| USA - +1 9197 992 333

About US

Nova One Advisor is a worldwide market research and consulting organization. We give unmatched nature of offering to our customers present all around the globe across industry verticals. Nova One Advisor has expertise in giving deep-dive market insight along with market intelligence to our customers spread crosswise over various undertakings.