The Global Advanced Therapy Medicinal Products CDMO Market size is expected to reach $11.9 billion by 2028, rising at a market growth of 16.3% CAGR during the forecast period.
Advanced therapy medical products CDMO are organizations that fall under the category of contract development and manufacturing organizations (CDMO) that offer services for the processing of advanced therapy products. Advanced Therapy Medicinal Products (ATMPs) are advanced therapeutic medications that are focused on gene therapy or cell therapy.
CDMOs primarily support their clientele in the process of drug discovery through the provision of manufacturing capabilities and also help the pharmaceutical industry as a whole. The increase in the number of molecular drug approvals, the growing prevalence of infectious diseases, and the growing favorability for innovative therapeutics demand are inducing a rise in the number of CDMO setups in order to facilitate the quick development and production of therapies.
Because of this, the research, knowledge, and manufacturing capabilities of CDMOs are absolutely essential for moving the drug development process forward. Innovative treatments such as somatic cell therapy, gene therapy, and tissue-engineered products are all included in the category of advanced therapy medical products. It is expected that these therapies would deliver significant health advantages.
Medications derived through gene therapy contain genes that have been shown to have a curative, preventative, or diagnostic function. In most cases, they are used to treat a wide range of ailments, such as genetic disorders, cancer, or diseases that have a protracted course of treatment, and they function by introducing recombinant genes into the body. Additionally, a segment of DNA known as a recombinant gene is one that has been synthesized in the lab by combining strands of DNA derived from a variety of different sources.
Mesenchymal stem cells (MSCs), an ATMP, also offered a cutting-edge approach to treating the COVID-19 virus. Due to the challenging nature of the manufacturing process, the COVID-19 pandemic has had a substantial impact on the cell and gene therapy sector. Tissue engineering has significantly benefited from recent technology advancements. Damaged organs and tissues can be replaced or have their functionality restored with this technique. Similar to this, cell and gene therapy are attracting a lot of interest from patients in order to treat rare diseases, which are growing globally. Therefore, the pandemic affected the advanced therapy medicinal products CDMO market positively.
The growing number of clinical studies for advanced therapy medicinal products is one of the key factors driving the need for CDMOs. There were 3,579 gene, cell, and RNA therapies in development as of Q1 2022, according to a study by the American Society of Gene and Cell Therapy. According to the research, as of Q1 2021, the pipeline for gene cell therapy has grown by 16%. Genetically engineered cell therapies are being outperformed in the pipeline by CAR-T cell therapies. Furthermore, 98% of CAR-T cell treatments are still being developed for cancer-related indications. All these factors influence an increase in the number of CDMO and thus promote the growth of the advanced therapy medicinal products CDMO market.
The effect of rising product demand around the world is a significant market trend that has prompted the development of novel therapeutic solutions. Over the course of the projection period, increasing product demand and significant increase in gene and cell therapies are anticipated to fuel growth opportunities for the market. CDMO assures the complete solution, starting with the planning of clinical trials and concluding with drug production. While CDMOs can prepare the drug, pharmaceutical and biopharmaceutical companies increase their research to develop innovative and efficient medicines. Therefore, each of these reasons contributes to the expansion of the advanced therapy medicinal products CDMO market.
Stem cell therapy's primary limitation is that the cells of a single origin can only make cells of the same origin and type, for example, brain cells can only produce more brain cells. This is one of the procedure's most significant downsides. The utilization of cell therapies would become more constrained as a result of these drawbacks. Since the use of stem cell therapy can result in the destruction of human embryos, one might expect to see a decline in the demand for these therapies. In addition, it is expected that the risk of contamination and the possibility of technological malfunctions may act as a barrier to the expansion of the automated cell therapy processing systems, which would hamper the growth of the advanced therapy medicinal products CDMO market.
Based on product, the advanced therapy medicinal products CDMO market is segmented into gene therapy, cell therapy, tissue engineered and others. The cell therapy segment procured a considerable growth rate in the advanced therapy medicinal products CDMO market in 2021. New cell types are continuously being introduced to the domain of cellular therapies, which presents numerous chances for businesses to strengthen their market positions. The significant unmet need for cell therapy production, the recent approval of sophisticated medicines, and the demonstrated efficacy of these products are also drawing new players to the industry. These factors are therefore, propelling the expansion of the segment.
On the basis of phase, the advanced therapy medicinal products CDMO market is bifurcated into phase I, phase II, phase III, and phase IV. The phase I segment acquired the largest revenue share in the advanced therapy medicinal products CDMO market in 2021. The segment's expansion can be attributed to rising R&D efforts and an increase in the number of advanced therapy human trials. Phase 1 assists in ensuring a drug's safety levels when it is given to a small group of patients in a variety of doses and dosing formats. The major goal of this phase is to ascertain the largest dose a patient may get without experiencing any negative effects.
By indication, the advanced therapy medicinal products CDMO market is fragmented into oncology, cardiology, central nervous system & musculoskeletal, infectious disease, dermatology, endocrine, metabolic, genetic, immunology & inflammation, ophthalmology, hematology, gastroenterology, and others. The oncology segment witnessed the maximum revenue share in the advanced therapy medicinal products CDMO market in 2021. The prevalence of the disease, the strategic actions made by key competitors, and the accessibility of cutting-edge medicines utilized to treat various cancer indications are all contributing factors to the segment's rise. Oncology clinical trials include all phases of the process where Phase I trials determines dose and phase II analyses define efficacy in a single tumor type.
| Report Attribute | Details |
|---|---|
| Market size value in 2021 | USD 4.2 Billion |
| Market size forecast in 2028 | USD 11.9 Billion |
| Base Year | 2021 |
| Historical Period | 2018 to 2020 |
| Forecast Period | 2022 to 2028 |
| Revenue Growth Rate | CAGR of 16.3% from 2022 to 2028 |
| Number of Pages | 282 |
| Number of Tables | 443 |
| Report coverage | Market Trends, Revenue Estimation and Forecast, Segmentation Analysis, Regional and Country Breakdown, Competitive Landscape, Companies Strategic Developments, Company Profiling |
| Segments covered | Indication, Product, Phase, Region |
| Country scope | US, Canada, Mexico, Germany, UK, France, Russia, Spain, Italy, China, Japan, India, South Korea, Singapore, Malaysia, Brazil, Argentina, UAE, Saudi Arabia, South Africa, Nigeria |
| Growth Drivers |
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| Restraints |
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Region wise, the advanced therapy medicinal products CDMO market is analyzed across North America, Europe, Asia Pacific and LAMEA. The North America region recorded the highest revenue share in the advanced therapy medicinal products CDMO market in 2021. This can be due to rising interest in innovative therapies and rising outsourcing activities. The growing burden of diseases like cardiovascular, cancer, and certain rare genetic disorders have raised the levels of research and funding for the development of ATMPs that may serve as treatment methods for these diseases. It is projected that America will maintain its position as a leader in R&D for cutting-edge treatments in the coming years.
Free Valuable Insights: Global Advanced Therapy Medicinal Products CDMO Market size to reach USD 11.9 Billion by 2028
The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; Thermo Fisher Scientific, Inc. (Patheon, Inc.) and Lonza Group AG are the forerunners in the Advanced Therapy Medicinal Products CDMO Market. Companies such as AGC Biologics, Inc., WuXi Advanced Therapies, and Catalent, Inc. are some of the key innovators in Advanced Therapy Medicinal Products CDMO Market.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc. (Patheon, Inc.), AGC Biologics, Inc. (AGC, Inc.), Catalent, Inc., Minaris Regenerative Medicine GmbH (Resonac Holdings Corporation), WuXi AppTec Co., Ltd. (WuXi Advanced Therapies), Lonza Group AG, Celonic AG (JRS PHARMA GmbH & Co. KG), Rentschler Biopharma SE, and Bio Elpida (Polyplus-transfection SA.).
By Indication
By Product
By Phase
By Geography
The global Advanced Therapy Medicinal Products CDMO Market size is expected to reach $11.9 billion by 2028.
Rising Need for CDMOS Due to Increasing Number of ATMP Clinical Trials are driving the market in coming years, however, Specific drawbacks of cell therapy methods of ATMP restraints the growth of the market.
Thermo Fisher Scientific, Inc. (Patheon, Inc.), AGC Biologics, Inc. (AGC, Inc.), Catalent, Inc., Minaris Regenerative Medicine GmbH (Resonac Holdings Corporation), WuXi AppTec Co., Ltd. (WuXi Advanced Therapies), Lonza Group AG, Celonic AG (JRS PHARMA GmbH & Co. KG), Rentschler Biopharma SE, and Bio Elpida (Polyplus-transfection SA.).
The expected CAGR of the Advanced Therapy Medicinal Products CDMO Market is 16.3% from 2022 to 2028.
The Gene Therapy segment acquired maximum revenue share in the Global Advanced Therapy Medicinal Products CDMO Market by Product in 2021 thereby, achieving a market value of $5.8 billion by 2028.
The North America market dominated the Global Advanced Therapy Medicinal Products CDMO Market by Region in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $5.7 billion by 2028.
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