Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Definition And Segments
An advanced therapy medicinal product contract development and manufacturing organization (CDMO) is a specialized service provider that assists in the development and manufacturing of advanced therapy medicinal products. The objective of an advanced therapy medicinal product CDMO is to provide the expertise, infrastructure, and resources required for advanced therapy medicinal product development and manufacturing.
The main types of products of advanced therapy medicinal products contract development and manufacturing organization (CDMO) include gene therapy, cell therapy, and tissue engineered. Gene therapy involves the introduction, removal, or alteration of genetic material within a patient's cells to treat or prevent disease. This can be done using viral or non-viral vectors to deliver therapeutic genes to target cells in several phases, such as phase I, phase II, phase III, and phase IV for the treatment of various indications, including oncology, cardiology, central nervous system and musculoskeletal, infectious disease, dermatology, endocrine, metabolic, genetic, immunology and inflammation, ophthalmology, and hematology.
The advanced therapy medicinal products contract development and manufacturing organization (CDMO) market covered in this report is segmented –
1) By Product: Gene Therapy, Cell Therapy, Tissue Engineered
2) By Phase: Phase I, Phase II, Phase III, Phase IV
3) By Indication: Oncology, Cardiology, Central Nervous System And Musculoskeletal, Infectious Disease, Dermatology, Endocrine, Metabolic, Genetic, Immunology And Inflammation, Ophthalmology, Hematology
The advanced therapy medicinal product contract development and manufacturing organization (CDMO) market size has grown rapidly in recent years. It will grow from $4.55 billion in 2023 to $5.30 billion in 2024 at a compound annual growth rate (CAGR) of 16.7%. The growth in the historic period can be attributed to the increasing number of ATMP clinical trials, rising awareness and belief among researchers regarding the benefits of advanced therapy, the presence of several ATMP CDMOs, increasing efforts to develop novel therapies for various diseases, and supportive government initiatives.
The advanced therapy medicinal product contract development and manufacturing organization (CDMO) market size is expected to see rapid growth in the next few years. It will grow to $9.85 billion in 2028 at a compound annual growth rate (CAGR) of 16.8%. The growth in the forecast period can be attributed to the high investment of CDMOs, a growing number of emerging players in the cell and gene therapy (CGT) sector, increasing grants and investments for the development of cell and gene therapies, increasing pharmaceutical R&D spending, increasing number of clinical trials for ATMPs. Major trends in the forecast period include advancements in AAV biomanufacturing facilities, expansion of cell and gene therapy manufacturing, technological advancements in cell and gene therapy, increasing need for access to advanced platforms and technologies, and incorporating advanced technologies such as CRISPR and next-generation sequencing for heightened accuracy.
Rising Clinical Trial Numbers Fuel Growth In The ATMP CDMO Market
The increasing number of clinical trials is expected to propel the growth of the advanced therapy medicinal products CDMO market going forward. Clinical trials are research studies conducted in humans to evaluate the safety and efficacy of medical interventions such as drugs, treatments, devices, or preventive measures. Clinical trial numbers are rising to meet the increasing demand for innovative treatments and to address a growing global disease burden. With the use of advanced therapy medicinal products, the demand for CDMO manufacturing services rises, leveraging specialized expertise and infrastructure. Clinical trial data aids in optimizing manufacturing, ensuring scalability, and quality maintenance to meet larger clinical and commercial needs. For instance, in November 2023, according to the Association of the British Pharmaceutical Industry, a UK-based trade association, the overall number of industry clinical trials initiated in the UK per year increased marginally by 4.3%, from 394 in 2021 to 411 in 2022. Therefore, the increasing number of clinical trials is driving the growth of the advanced therapy medicinal products CDMO market.
Major companies operating in the advanced therapy medicinal products contract development and manufacturing organization (CDMO) market are Thermo Fisher Scientific Inc., Merck KGaA, Resonac Corporation, Lonza Group AG, Catalent Inc., Charles River Laboratories International Inc., Recipharm AB, KBI Biopharma, Takara Bio Inc., Rentschler Biopharma SE, Ajinomoto Co. Inc., ElevateBio LLC, Fujifilm Diosynth Biotechnologies, Axplora Group GmbH, WuXi Advanced Therapies Inc., Celonic Group, Batavia Biosciences B.V., BioCentriq, Cytovance Biologics, Andelyn Biosciences, Genezen, AGC Biologics, ABL Manufacturing, Minaris Regenerative Medicine, Porton Advanced Solutions
Transforming Cell Therapy Manufacturing With Innovations In Advanced Therapy Medicinal Products
Major companies operating in the advanced therapy medicinal products CDMO market are developing advanced cell therapy manufacturing services to overcome critical issues in cell therapy manufacturing and speed the development activities of their partners. Cell therapy manufacturing services are contract development and manufacturing organization services that offer services which vary from early preclinical development to late-stage clinical trials and commercialization. For instance, in January 2024, Pluristem Therapeutics Inc., an Israel-based biotech company that transforms cells into solutions, launched PluriCDMO, a new business division offering cell therapy manufacturing. It utilizes a patented bioreactor system that allows for 3D cell multiplication, facilitating the production of a variety of cell types such as stem cells, induced pluripotent stem cells, exosomes, and immune therapies. PluriCDMO desires to provide high-quality, vital medicines to patients while maintaining unique batch-to-batch consistency in a scalable and cost-effective manner in good manufacturing practice settings.
Recipharm AB Expands Biologic Capabilities With Acquisition Of Vibalogics
In February 2022, Recipharm AB, a Sweden-based contract development and manufacturing organization (CDMO), acquired Vibalogics for an undisclosed amount. The acquisition aims to strengthen Recipharm's position in advanced therapy medicinal products and allow it to grow into additional biologic modalities such as viral vectors. The deal will enable Recipharm to broaden its technologies and modalities, allowing it to better service the rapidly growing biopharmaceutical industry demand for specialist CDMO capabilities in viral manufacturing. Vibalogics is a Germany-based virotherapy CDMO manufacturer of oncolytic viruses, viral vaccines, and gene therapies
North America was the largest region in the advanced therapy medicinal product contract development and manufacturing organization (CDMO) market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the advanced therapy medicinal products contract development and manufacturing organization (CDMO) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the advanced therapy medicinal products contract development and manufacturing organization (CDMO) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain
The advanced therapy medicinal product contract development and manufacturing organization (CDMO) market includes revenues earned by entities by providing services such as process development, analytical method development, good manufacturing practice manufacturing, and quality control testing. The market value includes the value of related goods sold by the service provider or included within the service offering. The advanced therapy medicinal products CDMO market also includes sales of bioreactors and fermenters, cryopreservation equipment, and laboratory instruments. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
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