Market Trends of Advanced Therapy Medicinal Products (ATMP) CDMO Industry
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.
