Advanced Therapy Medicinal Products CDMO Market to Achieve a Remarkable 18.8% CAGR, Crossing USD 26.27 Billion By 2032

Report Overview

Advanced Therapy Medicinal Products (ATMPs) are a class of innovative therapies that encompass gene therapies, cell therapies, and tissue-engineered products. They hold tremendous promise for treating a wide range of diseases, including genetic disorders, cancer, and degenerative conditions. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in the ATMP market by providing specialized services for the development, manufacturing, and commercialization of these therapies.

Global Advanced Therapy Medicinal Products CDMO Market size and share is currently valued at USD 6.63 billion in 2024 and is anticipated to generate an estimated revenue of USD 26.27 billion by 2032, according to the latest study by Polaris Market Research. Besides, the report notes that the market exhibits a robust 18.8% Compound Annual Growth Rate (CAGR) over the forecasted timeframe, 2024 - 2032

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The evolution of numerous diseases among the population and the ability to cure chronic health issues with the prevailing medicines is compelling researchers and government institutions to invest in genetic medicine and cell and tissue therapies. This ongoing trend is facilitating a compatible environment for pharmaceutical companies to innovate new therapies, driving the need for organizations that have the required infrastructure for the development, testing, and manufacturing of new therapies, necessitating the assistance of contract development and manufacturing organizations (CDMO).

The rising government initiatives to regulate the pharmaceutical industry are showing a positive impact on the advanced therapy medicinal products CDMO market growth opportunities. In September 2023, UK CDMO Rentschler Biopharma SE received approval to develop and supply adeno-associated virus vectors (AAV) for gene therapy, including bioprocessing and cGMP production, from the Medicines & Healthcare Products Regulatory Agency.

The growing strategic collaborations and partnerships to expand the research and development activities towards treating health problems are positively influencing the ATMP CDMO market. With the Histocell partnership, Reprocell will produce advanced therapies and medicinal products generated from mesenchymal stem cells.

Cell and gene therapy production is showing a positive outlook in the market. According to the Gene, Cell, & RNA Therapy Landscape Report, in Q3 2023, 27 gene therapies, 26 RNA therapies, and 65 non-genetically modified cell therapies, received approval for clinical use. The total number of gene therapies in phase 1 Q3 registered growth by 7% compared to Q1. This trend is demonstrating the potential demand to produce advanced therapeutic medicinal products, boosting the need for CDMO in the coming years.

The tissue engineering industry is gaining momentum in the marketplace, driven by its profound scope in the replacement, repair, and regeneration of tissues, which are used to cure skin, heart, liver, and lung tissue-related health problems. The rising research activities on the development of tissue engineering therapies are expected to drive the advanced therapy medicinal products CDMO market.

Some of the major players operating in the global market include:

• AGC Biologics (Switzerland)
• Bio Elpida (France)
• BlueReg (France)
• Catalent (US)
• Celonic (Switzerland)
• CGT Catapult (UK)
• Lonza (Switzerland)
• Medicine Patheon (US)
• Minaris Regenerative (US)
• Rentschler Biopharma SE (US)
• WuXi Advanced Therapies (US)

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Growth Drivers:

Increasing Investment in ATMPs: Growing investment and funding in research and development activities for ATMPs by pharmaceutical companies, biotech firms, and government institutions are driving the demand for CDMO services.

Expanding Pipeline of ATMPs: The expanding pipeline of ATMPs, including gene therapies, CAR-T cell therapies, and tissue-engineered products, is creating opportunities for CDMOs to offer their expertise in development and manufacturing.

Regulatory Support: Regulatory agencies such as the FDA and EMA have established frameworks to support the development and approval of ATMPs, providing a clear pathway for companies to bring these therapies to market. This regulatory support encourages collaboration with CDMOs possessing the necessary expertise in navigating regulatory requirements.

Applications

Gene Therapies: Gene therapies involve the delivery of genetic material to target cells to correct genetic defects or modulate cellular functions. CDMOs specializing in gene therapy production offer services such as viral vector production, cell line development, and process optimization.

Cell Therapies: Cell therapies utilize living cells, such as stem cells or immune cells, to treat diseases or repair damaged tissues. CDMOs provide expertise in cell culture, cell expansion, cell banking, and cryopreservation to support the development and manufacturing of cell-based therapies.

Tissue-Engineered Products: Tissue engineering involves the creation of biological substitutes to restore, maintain, or improve tissue function. CDMOs with expertise in tissue engineering offer services for scaffold fabrication, cell seeding, bioreactor culture, and tissue maturation to produce tissue-engineered products for various applications, including regenerative medicine and organ transplantation.

Advanced Therapy Medicinal Products CDMO Market Report Highlights

• Gene therapy segment is anticipated to witness the highest growth in the coming years due to the increasing clinical trials on gene therapies.
• Phase I segment accounted for the largest revenue share, owing to the rise in number of therapeutic developments.
• Oncology segment held the largest share, due to the rising number of cancer patients and its varied forms
• Asia pacific is projected to register the fastest growth during the forecast period, attributable to the growing investments in cell and gene therapies.

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Polaris Market Research has segmented the advanced therapy medicinal products CDMO market report based on product, phase, indication and region:

Advanced Therapy Medicinal Products CDMO, Product Outlook (Revenue - USD Billion, 2019 - 2032)

• Cell Therapy
• Gene Therapy

Advanced Therapy Medicinal Products CDMO, Phase Outlook (Revenue - USD Billion, 2019 - 2032)

• Phase I
• Phase II
• Phase III
• Phase IV

Advanced Therapy Medicinal Products CDMO, Indication Outlook (Revenue - USD Billion, 2019 - 2032)

• Oncology
• Cardiology
• Central nervous system
• Musculoskeletal
• Infectious disease
• Dermatology
• Endocrine, metabolic, genetic
• Immunology & inflammation
• Ophthalmology
• Hematology
• Gastroenterology
• Others

Advanced Therapy Medicinal Products CDMO, Regional Outlook (Revenue - USD Billion, 2019 - 2032)

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

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