Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report By Product (Gene Therapy, Cell Therapy, Tissue Engineered), By Phase, By Indication, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global advanced therapy medicinal products CDMO market size was valued at USD 4.81 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 18.8% from 2023 to 2030. The growth of the market is attributed to factors such as the rising demand for advanced therapy. There has been an increased investment in the research and development of advanced therapy pharmaceutical products, as well as an increase in the prevalence of rare and severe disorders, including metabolic and optical diseases. The COVID-19 pandemic has had a massive impact on the development and manufacturing of advanced therapy medicinal products. Cell-based therapy is one of the fastest-growing classes of medicines during the COVID-19 pandemic. The USA, Jordan, China, Iran, and several other nations started cell-based therapy clinical research to treat COVID-19 individuals with acute respiratory distress at the same time that the disease was spreading over the world. For instance, more than 80 clinical trials had been registered as of 2022, according to a search on ClinicalTrials.gov for "Mesenchymal stem cells and COVID-19".

One of the major drivers of the advanced therapy medicinal products (ATMP) CDMO market is the increasing number of clinical trials for ATMPs. According to the American Society of Gene and Cell Therapy report, as of Q1 2022, there are 3,579 therapies in the pipeline for gene, cell, and RNA therapies. As per the report, the gene cell therapy pipeline has increased by 16% as of Q1 2021. In the pipeline, CAR-T cell therapies are dominating genetically modified cell therapies. Moreover, 98% of CAR-T cell therapies are in the development phase for cancer indication.

Furthermore, outsourcing activities in this domain are rising, as this strategy enables companies to acquire additional competencies required for the successful development and commercialization of ATMPs. Apart from offering extended expertise and aiding in better management of cash flows, outsourcing provides significant manufacturing advantages, such as a reduction in investment risks. In addition, low incidence-to-prevalence ratios for genetic and rare diseases make outsourcing an attractive option, as the construction of an in-house facility for producing a single gene therapy for these diseases requires a faster cost recovery in a short time frame.

Moreover, increasing competition among the key companies to gain considerable market share in the field is expected to boost R&D investment flow in the advanced therapy medicinal products CDMO market. For instance, in January 2022, Excellos, a cell therapy CDMO, announced the launch and closing of USD 15 million in funding from Telegraph Hill Partners. The company is engaged in supplying cGMP cellular services and products, with manufacturing and process development expertise to clinicians and scientists working with cell and gene therapies.

Product Insights

The gene therapy segment dominated the market with the largest revenue share of 49.6% in 2022. An increase in financial support and a rise in the number of clinical trials for gene therapies are driving the demand for Contract Development and Manufacturing Organization (CDMO) services. In 2020, in the first three quarters, gene therapies attracted financing of over USD 12 billion globally, with around 370 clinical trials underway. Additionally, in mid-2022, approximately 2,000 gene therapies were in development, targeting several therapeutic areas such as neurological, cancer, cardiovascular, blood, and infectious diseases.

The cell therapy segment is expected to expand at the fastest growth rate over the forecast period. The field of cellular therapeutics is constantly advancing with the inclusion of new cell types, which, in turn, provides ample opportunities for companies to enhance their market positions. Furthermore, the market is attracting new entrants due to the high unmet demand for cell therapy manufacturing, the recent approval of advanced therapies, and the proven effectiveness of these products.

Indication Insights

The oncology segment dominated the market and accounted for a revenue share of 46.1%; it is anticipated to witness significant growth over the forecast period due to disease burden, strategic initiatives undertaken by key players, and availability of advanced therapies used for treating various cancer indications. In January 2021, around 18,000 to 19,000 patients and 124,000 patients were estimated to be potential patients for treating cancer, using cell & gene therapy products Kymriah (Novartis AG) and Yescarta (Gilead Sciences, Inc.), respectively.

The cardiology segment is expected to show significant growth over the forecast period. This is attributed to the increasing prevalence of cardiovascular diseases and research collaboration for the development of advanced therapies. For instance, in February 2021, Trizell GmbH entered into a partnership with Catalent, Inc. for the development of phase 1 cell therapy to treat micro- and macroangiopathy. Trizell's medication is an Advanced Therapy Medicinal Product (ATMP) that employs regulatory macrophages, a platform technology developed in Germany.

Phase Insights

The phase 1 segment held the largest revenue share of 50.3% in 2022 due to growing R&D activities and the increasing number of human trials for advanced therapies. Phase 1 helps ensure the safety levels of a drug at different doses and dosage forms administered to a small number of patients. This phase is mainly conducted to determine the highest dose a patient can take without any adverse effects. Around 70% of drugs in phase 1 move to the next phase.

The phase 2 segment is anticipated to grow at a significant rate over the forecast period. Phase 2 of clinical studies comprise the largest number of developing ATMPs, due to the high clearance rate of phase 1 clinical studies. According to data published by Alliance for Regenerative Medicine, as of June 2022, more than 2,093 clinical trials are ongoing globally, out of which 1,117 are under phase II clinical trials, translating to 53%. An increase in the number of products in phase 2 is driving the segment.

Regional Insights

North America accounted for the largest market share of 49.3% in 2022. This can be attributed to increasing outsourcing activities and rising awareness about advanced therapy. America has consistently been a leader in R&D for advanced treatments, and it is anticipated that it will keep this position during the forecast period. Recent approvals of products such as Kymriah and Yescarta have propelled investments in the regional advanced therapy medicinal products CDMO market. Moreover, in March 2021, the U.S. FDA approved Abecma, the first approval of CAR-T cells to fight against cancer.

Asia Pacific is estimated to be the fastest-growing regional segment over the forecast period due to the increasing demand for novel ATMPs and rising R&D activities to develop novel therapies. Moreover, the advanced therapy medicinal products CDMO market growth is driven by the continuously expanding CDMO services in the country. A number of domestic players have collaborated with biotech companies from other countries involved in mesenchymal stem cell research and therapy development. In addition, in September 2022, Takara Bio, Inc. launched CDMO services for gene therapy products using siTCR technology for its genetically modified T-cell therapy products.

Key Companies & Market Share Insights

Key companies operating in the advanced therapy medicinal products CDMO market are focusing on collaborations, merger and acquisition partnerships, and regional expansions to strengthen their market position. To take advantage of this expanding industry, the key market players primarily concentrate on service quality and product development, and manufacturing competence. . In April 2022, Pfizer announced the opening of its unit for a phase III trial of investigational gene therapy for patients with Duchenne muscular dystrophy. In addition, in February 2022, Recipharm AB completed the acquisition of Vibalogics. With this agreement, Recipharm will obtain expertise in biologics modalities, utilizing Vibalogics' capability in viral vaccines, oncolytic viruses, and viral vector gene treatments to deliver a high level of diversification through several technologies and modalities. Some prominent players in the global advanced therapy medicinal products CDMO market include:

• Celonic

• Bio Elpida

• CGT Catapult

• Rentschler Biopharma SE

• AGC Biologics

• Catalent

• Lonza

• WuXi Advanced Therapies

• BlueReg

• Minaris Regenerative Medicine

• Patheon

Advanced Therapy Medicinal Products CDMO Market Report Scope

Global Advanced Therapy Medicinal Products CDMO Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global advanced therapy medicinal products CDMO market report on the basis of product, phase, indication, and region:

• Product Outlook (Revenue, USD Billion, 2018 - 2030)

  • Gene Therapy

  • Cell Therapy

  • Tissue Engineered

  • Others

• Phase Outlook (Revenue, USD Billion, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Indication Outlook (Revenue, USD Billion, 2018 - 2030)

  • Oncology

  • Cardiology

  • Central Nervous System

  • Musculoskeletal

  • Infectious Disease

  • Dermatology

  • Endocrine, Metabolic, Genetic

  • Immunology & Inflammation

  • Ophthalmology

  • Hematology

  • Gastroenterology

  • Others

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • India

    • Japan

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Chile

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Israel

    • Egypt

    • Kuwait