Global Advanced Therapy Medicinal Products (ATMP) Market Grows Steadily at a CAGR of 10.5%

Introduction

Advanced therapy medicinal products (ATMPs) are a novel class of heterogeneous, research-driven biopharmaceuticals. They are being created with assistance from the European Union (EU) and the United States. ATMPs are regulated as biological products in both zones, establishing the legal basis for their production. The European Union has four main categories of advanced therapies: gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies. However, the subcategorization of these therapies varies by region.

Market Dynamics

Benefits Over Conventional Therapies Drive the Global Market

ATMPs, over the long term, can substantially improve the health and quality of life of patients with life-threatening diseases. They are utilized specifically for disorders with few or no alternative treatments. Patients who undertake invasive procedures frequently for symptom relief have also benefited from ATMPs. Therefore, using ATMPs can enhance patient health and quality of life, benefiting caregivers, families, and society by alleviating physical, emotional, and monetary burdens.

Additionally, ATMPs can prevent the need for costly procedures such as blood transfusion and enzyme replacement therapy, thereby reducing expenditures on apparatus and training for medical personnel and nursing staff who perform these complex procedures. Moreover, patients treated with ATMPs tend to experience fewer co-morbidities that necessitate costly therapies and support. Therefore, these benefits provided by ATMPs are anticipated to promote market expansion.

Increased Financing for Gene and Cell Therapy Creates Tremendous Opportunities

Numerous opportunities for market expansion are anticipated to result from an increase in financing and investments in ATMPs. For example, in July 2019, Bayer provided USD 215 million to the U.S. biotechnology startup Century Therapeutics to develop therapies for solid tumors and blood cancer. Versant Ventures and Fujifilm Cellular Dynamics each contributed USD 35 million, bringing the total amount of funding to USD 250 billion. Similarly, Allogene Therapeutics, a biotechnology company based in California, raised over USD 300 million in 2018 for its allogeneic product pipeline. The company develops CAR T-cell therapeutics for solid tumors and cancers of the blood.

Regional Analysis

North America is the most significant global advanced therapy medicinal products (ATMP) market shareholder and is anticipated to exhibit a CAGR of 12.6% during the forecast period. North America's leading revenue share is due to factors such as a robust regulatory framework for promoting cellular therapy development, the high cost of therapies in the United States, and many regional companies. Federal investments in expanding advanced therapy research in the region are anticipated to contribute to expanding the North American stem cell therapy market. In addition, the market is anticipated to be driven by organizations such as the International Society for Cellular Therapy, a global society of technologists, regulators, clinicians, and industry partners whose mission is to improve the safety and efficacy of cellular therapies to enhance patient outcomes.

Asia-Pacific is estimated to exhibit a CAGR of 8.2% over the forecast period. Asia-Pacific's ATMP market, led by Japan, China, and South Korea, has gained momentum internationally in recent years. Biotech companies from other regions concentrate on creating novel therapies by increasing their technologies and presence in the Asia-Pacific region. For instance, Merck and GenScript formed a strategic alliance in March 2019 to manufacture gene and cell therapies. Under the terms of this partnership, Merck would provide manufacturing services to GenScript. In addition, global companies are forming partnerships with domestic firms. For instance, Pluristem Therapeutics Inc. partnered with CHA Bio of South Korea. According to the terms of the collaboration, CHA would conduct and fund multiple PLacental eXpanded (PLX) cell-based clinical trials for the latter. Such collaborations drive market growth.

Key Highlights

• The global advanced therapy medicinal products (ATMP) market size was valued at USD 9.28 billion in 2023. It is projected to reach from USD 10.26 billion in 2024 to USD 22.80 billion by 2032, growing at a CAGR of 10.50% during the forecast period (2024–2032).
• Based on therapy type, the global advanced therapy medicinal products (ATMP) market is segmented into cell therapy, gene therapy, CAR-T therapy, and tissue-engineered product. The tissue-engineered product segment owns the highest market share and is predicted to exhibit a CAGR of 6.5% during the forecast period.
• North America is the most significant global advanced therapy medicinal products (ATMP) market shareholder and is anticipated to exhibit a CAGR of 12.6% during the forecast period.

Competitive Players

1. Spark Therapeutics, Inc.
2. Organogenesis Inc.
3. Bluebird Bio, Inc.
4. Novartis AG
5. Bristol-Myers Squibb
6. Gilead Lifesciences, Inc.
7. Kolon TissueGene, Inc.
8. MEDIPOST
9. JCR Pharmaceuticals Co., Ltd.
10. Vericel Corporation
11. UniQure N.V.
12. Celgene Corporation
13. Corning Incorporated
14. Cytiva
15. Astellas Pharma Inc.
16. PHARMICELL Co., Ltd
17. Orchard Therapeutics

Recent Developments

Recent Developments

• In September 2022, Myrtelle Inc., a clinical-stage gene therapy company focused on neurodegenerative diseases, announced that the European Medicines Agency (EMA) had categorized the company's lead gene therapy product candidate, for treating Canavan disease, as an Advanced Therapy Medicinal Product (ATMP) and specifically as a Gene Therapy Medicinal Product (GTMP).
• In February 2021, the U.S. FDA approved Bristol Myers Squibb's CAR-T therapy, Breyanzi, for the treatment of adults with relapsed or refractory large B-cell lymphoma.

Analyst Opinion

The Advanced Therapy Medicinal Products (ATMP) market is poised for substantial growth, driven by ongoing advancements in gene, cell, and tissue therapies that offer transformative treatment options for various rare conditions. The market benefits from increasing investment in research and development, coupled with supportive regulatory frameworks that facilitate faster approvals. As technology advances and manufacturing processes become more streamlined, we can expect broader adoption and reduced costs, making these therapies more accessible. Moreover, the market's expansion is supported by the promising clinical outcomes and innovative approaches emerging from leading biopharmaceutical companies and research institutions.

Segmentation

1. By Therapy Type
   1. Cell Therapy
   2. Gene Therapy
   3. CAR-T Therapy
   4. Tissue Engineered Products
2. By Manufacturer
   1. Biopharmaceutical Companies
   2. Contract Development and Manufacturing Organizations (CDMOs)
   3. Others