Advanced Therapy Medicinal Products (ATMP) CDMO Market Size
| Study Period | 2021 - 2029 |
| Market Size (2024) | USD 6.04 Billion |
| Market Size (2029) | USD 17.98 Billion |
| CAGR (2024 - 2029) | 24.40 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Advanced Therapy Medicinal Products (ATMP) CDMO Market Analysis
The Advanced Therapy Medicinal Products CDMO Market size is estimated at USD 6.04 billion in 2024, and is expected to reach USD 17.98 billion by 2029, growing at a CAGR of 24.40% during the forecast period (2024-2029).
Major factors propelling the growth of the advanced therapy medicinal products (ATMP) market include increasing clinical trials in the ATMP space and growing demand for outsourcing in the pharmaceutical industry.
Advanced therapeutic medicinal products (AMTPs) give patients revolutionary therapy modalities for previously thought to be incurable conditions. While gene therapies like Zolgensma have demonstrated long-term efficacy in treating infants with spinal muscular atrophy (SMA), CAR-T cell therapies have shown significant results in treating some blood malignancies. For instance, in May 2023, REPROCELL expanded its offerings to include contract development and manufacturing organization (CDMO) services, focusing on the production of advanced therapy medicinal products (ATMPs) derived from mesenchymal stem cells (MSCs). This strategic expansion results from a partnership with Histocell, allowing REPROCELL to bolster its capabilities in the field of advanced therapeutic products.
Similarly, in September 2023, Charles River Laboratories International Inc. launched its lentiviral vector (LVV) manufacturing platform, Lentivation. The platform can reduce LVV manufacturing timelines for gene and gene-modified cell therapies by up to 60%, translating to fewer than seven months compared to traditional manufacturing workflows. With such emerging advancements, there is likely to be a growing demand for CDMOs, which is believed to propel market growth in the coming years.
The astonishing speed with which it has responded to difficulties demonstrates the industry's resilience and global nature. Most people in the world have profited from the services these businesses offer. For instance, according to the Contract Pharma Journal data published in February 2022, the biopharmaceutical CDMO companies have seen an average 29% rise in revenue from 2021 to 2022 for advanced therapies such as cell and gene therapy.
However, the high cost associated with CDMO and stringent regulatory policies are some of the factors hindering market growth.
Advanced Therapy Medicinal Products (ATMP) CDMO Market Trends
The Gene Therapy Segment is Expected to Hold a Major Market Share During the Forecast Period
Gene therapy is believed to witness rapid growth in the coming years owing to the increasing demand for gene therapy-based products for treating life-threatening diseases and the active participation of the CDMOs in gene therapy.
The emergence of CDMOs in the gene therapy space is one of the key factors benefitting the segment growth. For instance, to enable the production of several medicines for clinical trials, eXmoor Pharma, the full-service cell and gene therapy (CGT) manufacturing partner, opened its new Cell and Gene Therapy Center good manufacturing practice (GMP) facility in October 2023. The 65,000-square-foot facility was built to enable the subsequent generation of CGTs to participate in human trials and beyond. The transformation of eXmoor into a full-service CGT contract development and manufacturing organization (CDMO) is also completed with this step.
Also, in May 2023, Avirmax CMC Inc. (ACI) inaugurated its new clinical good manufacturing practice (GMP), adeno-associated virus vector (AAV) CDMO facility, attracting various industry leaders, academics, and government officials. The company is involved in AAV vector design, engineering, process development, GMP manufacturing, analytical testing, and characterization that enable clients to obtain full services in AAV product supply from transgene DNA sequences into final AAV products.
Similarly, in June 2023, RoslinCT and Lykan Bioscience announced a collaborative agreement, unifying their operations under the RoslinCT brand. The partnership, orchestrated with the support of GHO Capital, a leading global investment firm, is designed to create a formidable entity in the advanced cell and gene therapy contract development and manufacturing organization (CDMO) market. This strategic integration aims to solidify the newly combined business's position as a key player within this rapidly growing industry. These advancements provide effective, quick, reproducible commercial and clinical GMP manufacturing, vector development, and production for gene therapy projects.
Therefore, increasing focus on gene therapy and company activities is expected to propel the segment growth in the coming years.
North America is Expected to Hold a Significant Share in the Market During the Forecast Period
North American countries have a well-established pharmaceutical industry and a significant presence of CDMOs, which benefits the market.
Increasing activities in the CDMO space in the United States are responsible for the market growth. For instance, in July 2023, Kincell Bio, a CDMO organization active in cell therapies, secured USD 36 million in funding. Kincell emerged as a spinout from Inceptor Bio’s Chemistry, Manufacturing, and Controls (CMC) division, a group designed to expedite groundbreaking research and clinical trials. The company has acquired a facility and a fully staffed team at its Gainesville location. It plans to expand within Gainesville and other key areas, including Research Triangle Park (RTP), Boston, and additional customer sites.
Also, growing product launches are assisting the market growth in the region. For instance, in October 2023, Cleveland Clinic marked a significant milestone by administering a groundbreaking gene therapy to the first patient in a clinical trial designed to address hypertrophic cardiomyopathy (HCM). This innovative approach involves introducing a functional gene to target the underlying cause of HCM, showcasing the clinic's commitment to pioneering advanced treatment options for cardiac disorders.
Additionally, low incidence-to-prevalence ratios for genetic and rare diseases make it hard to justify building in-house facilities for gene therapies, given the need for rapid cost recovery. Outsourcing to contract development and manufacturing organizations (CDMOs) specializing in advanced therapy medicinal products (ATMPs) is an attractive option. For instance, the United States grapples with a substantial burden of rare diseases, such as oncological and neurological disorders, where advanced therapy medicines play a pivotal role. For instance, according to a report published by the Orphanet Journal of Rare Diseases in June 2023, rare diseases affect more than 30 million Americans. Companies can leverage CDMOs' existing infrastructure and expertise to produce medicine for such diseases, allowing them to avoid high upfront costs and lengthy setup times while focusing on therapy development and marketing.
Similarly, according to a report published by the Government of Canada, over 14,000 children under the age of 15 die each year from a rare disease. This creates lucrative opportunities for CDMO companies to produce more advanced treatment methods. This trend fuels the ATMP CDMO market growth as more companies choose flexible and cost-effective production solutions.
Hence, due to new product launches and growing activities by the CDMOs, the market is expected to grow significantly in the coming years.
Advanced Therapy Medicinal Products (ATMP) CDMO Industry Overview
The advanced therapy medicinal products (ATMP) CDMO market is moderately competitive, with several international players. Companies are involved in strategic activities like partnerships and collaboration to sustain the market. Some of the key players in the market include Catalent Inc., Lonza, WuXi Advanced Therapies, AGC Biologics, and CELONIC Group.
Advanced Therapy Medicinal Products (ATMP) CDMO Market Leaders
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Catalent, Inc.
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Lonza
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WuXi Advanced Therapies
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AGC Biologics
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CELONIC Group
*Disclaimer: Major Players sorted in no particular order
Advanced Therapy Medicinal Products (ATMP) CDMO Market News
- January 2024: Pluri, an Israel-based biotech company, introduced its new division named PluriCDMO, which offers cell therapy manufacturing services as a contract development and manufacturing organization (CDMO). The new division includes a 47,000-square-foot good manufacturing practice (GMP) cell therapy production facility.
- January 2024: Charles River Laboratories International Inc. launched its off-the-shelf Rep/Cap plasmid offering, designed to streamline adeno-associated virus (AAV)-based gene therapy programs.
Advanced Therapy Medicinal Products (ATMP) CDMO Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Clinical Trials in ATMP
4.2.2 Growing Demand for Outsourcing in Pharmaceutical Industry
4.3 Market Restraints
4.3.1 High Cost of CDMO
4.3.2 Stringent Regulatory Policies
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Value in USD)
5.1 By Product
5.1.1 Gene Therapy
5.1.2 Cell Therapy
5.1.3 Tissue Engineering
5.1.4 Other Products
5.2 By Phase
5.2.1 Phase I
5.2.2 Phase II
5.2.3 Phase III
5.2.4 Phase IV
5.3 By Indication
5.3.1 Oncology
5.3.2 Cardiology
5.3.3 Neurology
5.3.4 Infectious Disease
5.3.5 Other Indications
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Cell and Gene Therapy Catapult (CGT Catapult)
6.1.2 Patheon Inc.
6.1.3 CELONIC Group
6.1.4 Bio Elpida
6.1.5 AGC Biologics
6.1.6 Rentschler Biopharma SE
6.1.7 WuXi Advanced Therapies
6.1.8 Lonza
6.1.9 Catalent Inc.
6.1.10 Minaris Regenerative Medicine
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Advanced Therapy Medicinal Products (ATMP) CDMO Industry Segmentation
As per the scope of the report, advanced therapy medicinal products (ATMP) are human-use medicines based on genes, tissues, or cells. The advanced therapy medicinal products (ATMP) CDMO market is segmented by product, phase, indication, and geography. The product segment is divided into gene therapy, cell therapy, tissue engineering, and other products. The phase segment is further segmented into phase I, phase II, phase III, and phase IV. The indication segment is bifurcated into oncology, cardiology, neurology, infectious diseases, and other indications. The geography is further divided into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value in USD for the above segments.
| By Product | |
| Gene Therapy | |
| Cell Therapy | |
| Tissue Engineering | |
| Other Products |
| By Phase | |
| Phase I | |
| Phase II | |
| Phase III | |
| Phase IV |
| By Indication | |
| Oncology | |
| Cardiology | |
| Neurology | |
| Infectious Disease | |
| Other Indications |
| Geography | ||||||||
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Advanced Therapy Medicinal Products (ATMP) CDMO Market Research FAQs
How big is the Advanced Therapy Medicinal Products CDMO Market?
The Advanced Therapy Medicinal Products CDMO Market size is expected to reach USD 6.04 billion in 2024 and grow at a CAGR of 24.40% to reach USD 17.98 billion by 2029.
What is the current Advanced Therapy Medicinal Products CDMO Market size?
In 2024, the Advanced Therapy Medicinal Products CDMO Market size is expected to reach USD 6.04 billion.
Who are the key players in Advanced Therapy Medicinal Products CDMO Market?
Catalent, Inc., Lonza, WuXi Advanced Therapies, AGC Biologics and CELONIC Group are the major companies operating in the Advanced Therapy Medicinal Products CDMO Market.
Which is the fastest growing region in Advanced Therapy Medicinal Products CDMO Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Advanced Therapy Medicinal Products CDMO Market?
In 2024, the North America accounts for the largest market share in Advanced Therapy Medicinal Products CDMO Market.
What years does this Advanced Therapy Medicinal Products CDMO Market cover, and what was the market size in 2023?
In 2023, the Advanced Therapy Medicinal Products CDMO Market size was estimated at USD 4.57 billion. The report covers the Advanced Therapy Medicinal Products CDMO Market historical market size for years: 2021, 2022 and 2023. The report also forecasts the Advanced Therapy Medicinal Products CDMO Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Advanced Therapy Medicinal Products (ATMP) CDMO Industry Report
Statistics for the 2024 Advanced Therapy Medicinal Products (ATMP) CDMO market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Advanced Therapy Medicinal Products (ATMP) CDMO analysis includes a market forecast outlook for 2024 to (2024to2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
Advanced Therapy Medicinal Products (ATMP) CDMO Market Report Snapshots
