Global Advanced Therapy Medicinal Products CDMO Market Size, Share & Industry Trends Analysis Report By Indication, By Product (Gene Therapy, Cell Therapy, and Tissue Engineered & Others), By Phase (Phase I, Phase II, Phase III, and Phase IV), By Regional

Global Advanced Therapy Medicinal Products CDMO Market Size, Share & Industry Trends Analysis Report By Indication, By Product (Gene Therapy, Cell Therapy, and Tissue Engineered & Others), By Phase (Phase I, Phase II, Phase III, and Phase IV), By Regional Outlook and Forecast, 2022 - 2028

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.

COVID-19 Impact Analysis

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.

Market Growth Factors

Rising Need for CDMOS Due to Increasing Number of ATMP Clinical Trials

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.

Increasing efforts to develop novel therapies for various diseases

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.

Market Restraining Factors

Specific drawbacks of cell therapy methods of ATMP

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.

Product Outlook

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.

Phase Outlook

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.

Indication Outlook

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.

Regional Outlook

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.

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.)

Recent Strategies Deployed in Advanced Therapy Medicinal Products CDMO Market

Acquisitions and Mergers:

Aug-2022: Catalent acquired Metrics Contract Services (Metrics), a US-based organization, primarily into providing contract development and manufacturing services for the medical sector. The acquisition advances Catalent's ability to better serve its clients, particularly those clients with R & D pipelines having rare, orphan, diseases for oncology and other therapeutic areas.

Apr-2022: Catalent took over Erytech's cell Therapy Development and Manufacturing Facility in Princeton, New Jersey. The 30,900-square-foot manufacturing plant's acquisition reflects Catalent's devotion to fulfilling the growing demand for cell therapies.

Aug-2021: AGC Biologics acquired a commercial facility in Longmont, Colorado, USA from Novartis Gene Therapies. The acquisition expands AGC's manufacturing capacity supporting its global end-to-end Cell and Gene Therapy (C>) offerings and further expanding cell and gene therapy presence in the US.

Mar-2021: WuXi AppTec acquired OXGENE, a pioneering United Kingdom-based contract research, and development organization. Through this acquisition, the company aims to provide its customers with end-to-end aid in the development and creation of advanced cell and gene therapies.

Jul-2020: AGC took over MolMed, an Italy-based biotechnology company. The acquisition brings in MolMed's expertise and competence in development and GMP manufacturing services to AGC Biologics' global CDMO service offerings.

Partnerships, Collaborations and Agreements:

Jan-2023: Catalent came into agreement with Sarepta Therapeutics, a US-based provider of precision genetic medicines. The commercial supply agreement involves Catalent manufacturing Sarepta’s gene therapy delandistrogene moxeparvovec (SRP-9001) meant for the treatment of Duchenne muscular dystrophy (DMD).

Aug-2022: AGC Biologics partnered with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs). The partnership involves cashing on RoosterBio’s media and cell products and AGC's gene and cell therapy manufacturing abilities, to develop an end-to-end solution for the production and expansion of exosome and hMSC therapeutics that help media and cell growth services.

Apr-2022: WuXi Advanced Therapies partnered with Bioprocessing Technology Institute, a Singapore-based research institute. The partnership involves accelerating cell and gene therapy products in the APAC region, and focuses on WuXi ATU’s Tetracycline-Enabled Self-Silencing Adenovirus (TESSA) technology that enhances adeno-associated virus (AAV) yields and particle quality.

Feb-2021: Rentschler Biopharma SE signed an agreement with Cell and Gene Therapy Catapult (CGT Catapult), an independent center of excellence in innovation advancing the UK's cell and gene therapy industry. The agreement involves leveraging Catapult's expertise to set up a manufacturing capability in advanced therapy medicinal products intended for clinical trial supply at Catapult's manufacturing facility in Stevenage, England.

Nov-2020: Lonza came into partnership with Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies. Through this partnership, the company aims to offer end-to-end solutions that advance the growth of cell and gene therapies throughout the CGT supply chain.

Feb-2020: Catalent signed a contract with Zumutor Biologics, a US-based biotechnology company, primarily into providing NK cell therapeutics. The agreement involves manufacturing Zumutor’s ZM008 meant for solid tumor treatment.

Product Launches and Expansions:

May-2020: WuXi Advanced Therapies launched the CAR-T Cell Therapy Platform. A platform intended for advanced therapy companies providing them with various capabilities including, regulatory and technical expertise, full in-process and release testing, robust quality control, etc. The new platform advances the time taken for cell and gene therapy development, at the same time offering greater definiteness.

Jan-2020: WuXi Advanced Therapies unveiled the associated virus (AAV) Vector Suspension Platform. The platform supports advancing the timeline for cell and gene therapy development, at the same time offering greater predictability.

Geographical Expansions:

Oct-2022: Lonza expanded its laboratory space at its facilities in Houston (US) and Geleen (NL). The capacity expansion is intended to expand the CGT process and analytical development. Moreover, the expansion reinforces Lonza's global process development service offerings.

May-2022: AGC Biologics expanded its production capacity at its plant in Colorado, US to cater to the strong demand for cell and gene therapy.

Mar-2021: AGC expanded its geographical footprint by installing new viral vector production equipment at its facility in Milan, Italy. The new equipment would allow AGC to implement a platform best suited for the large-scale manufacturing of viral vectors.

Scope of the Study

Market Segments covered in the Report:

By Indication

• Oncology
• Cardiology
• Central Nervous System & Musculoskeletal
• Infectious Disease
• Dermatology
• Endocrine, Metabolic, Genetic
• Immunology & Inflammation
• Ophthalmology
• Hematology
• Gastroenterology
• Others

• Gene Therapy
• Cell Therapy
• Tissue Engineered & Others

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

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
• Germany
• UK
• France
• Russia
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• South Korea
• Singapore
• Malaysia
• Rest of Asia Pacific
• LAMEA
• Brazil
• Argentina
• UAE
• Saudi Arabia
• South Africa
• Nigeria
• Rest of LAMEA

• 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
• Bio Elpida (Polyplus-transfection SA.)

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