Gene editing, CAR-T, and cell-based regenerative medicine are moving from the lab into commercial reality. Many developers cannot build the specialized manufacturing capacity these products need on their own, so they are turning to contract development and manufacturing organizations (CDMOs). According to Grand View Research, the global advanced therapy medicinal products CDMO market was valued at USD 5.6 billion in 2023. It is expected to reach USD 6.6 billion in 2024 and USD 18.8 billion by 2030, growing at a CAGR of 18.9% from 2024 to 2030.

Key Market Dynamics & Drivers

1. A growing clinical pipeline.
   The pipeline of gene, cell, and RNA therapies is large and expanding. The American Society of Gene and Cell Therapy counted 3,579 therapies in the pipeline as of Q1 2022. CAR-T therapies lead among genetically modified cell therapies, and nearly all of them are being developed for cancer. Policy support is also increasing. In August 2023, the European Commission announced dedicated funding for combined ATMPs, covering Phase 2 trials and later stages.
2. Outsourcing as a strategic choice.
   Outsourcing gives developers access to specialized expertise, better cash-flow management, and lower investment risk. This matters most for rare and genetic diseases. Because the patient populations are small, building an in-house facility for a single therapy can take a long time to pay back.
3. Rising prevalence of rare and severe disorders.
   More diagnoses of rare, metabolic, and optical diseases are increasing demand for targeted advanced therapies, and with it demand for the manufacturing partners behind them.
4. Investment and competition.
   Competition among key players is pulling more R&D capital into the space. One example is Excellos, a cell therapy CDMO, which closed USD 15 million in funding from Telegraph Hill Partners in January 2022.

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Segment Breakdown

By Product

• Gene therapy led in 2023 with a share of over 49.2%. Growth is supported by strong financing and a large development pipeline, with roughly 2,000 gene therapies in development in mid-2022 across neurological, cancer, cardiovascular, blood, and infectious diseases.
• Cell therapy is expected to show lucrative growth. New cell types, recent approvals, and unmet demand for cell therapy manufacturing are attracting new entrants.
• Tissue-engineered products and others make up the remaining segments.

By Indication

• Oncology held the largest revenue share in 2023, driven by disease burden, strategic initiatives from key players, and the availability of advanced cancer therapies.
• Cardiology is projected to grow at the fastest CAGR, supported by the rising prevalence of cardiovascular disease and growing research collaboration. In October 2023, for example, Cleveland Clinic treated the first patient worldwide in a gene therapy trial for hypertrophic cardiomyopathy.

By Phase

• Phase I dominated in 2023 because of growing R&D activity and a rising number of early human trials.
• Phase II is expected to grow strongly. As of June 2022, more than 2,093 trials were ongoing globally, and 1,117 of them (about 53%) were in Phase II.

By Region

• North America led with a 49.0% share in 2023, helped by outsourcing activity, awareness of advanced therapies, and FDA approvals such as Abecma and, in December 2023, Casgevy and Lyfgenia for sickle cell disease. The U.S. is the largest market in the region.
• Asia Pacific is expected to grow at the fastest CAGR, with China the largest market in the region.

Prominent Industry Trends

• Innovation in enabling technologies. CRISPR and next-generation sequencing are improving the precision of advanced therapy development.
• Consolidation through M&A. Players such as AGC Biologics, WuXi Advanced Therapies, and Lonza are using acquisitions to expand their geographic reach and capabilities. Recipharm’s acquisition of Vibalogics in February 2022, which added viral vector and oncolytic virus expertise, is one example.
• Quality and safety compliance. Strict regulatory expectations are driving adoption of advanced testing methods across the manufacturing process.
• Regional capacity expansion. Companies are building facilities and partnerships close to patient populations to meet local regulatory requirements. Takara Bio’s CDMO launch for gene-modified T-cell therapy in Asia Pacific is one example.
• Regulatory milestones. In July 2023, the FDA cleared the IND for NTLA-2001, the first CRISPR-based in vivo gene therapy for ATTR amyloidosis with cardiomyopathy. Approvals like this signal a maturing field.

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Prominent Competitors

The market includes both established CDMOs and emerging specialists. Key companies profiled in the report:

• Celonic
• Bio Elpida
• CGT Catapult
• Rentschler Biopharma SE
• AGC Biologics
• Catalent
• Lonza
• WuXi Advanced Therapies
• BlueReg
• Minaris Regenerative Medicine
• Patheon

AGC Biologics, WuXi Advanced Therapies, and Celonic are named as key players. Minaris Regenerative Medicine and BlueReg are highlighted as emerging participants.

Looking Ahead

Growth in this market comes from three sources: a deepening clinical pipeline, developers’ preference for outsourcing, and steady regulatory progress. Gene therapy and oncology lead today, while cell therapy, cardiology, Phase II programs, and Asia Pacific point to where growth may accelerate.

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