Advanced Therapy Medicinal Products Market Size, Share & Trends Analysis Report By Therapy Type (CAR-T, Gene, Cell, Stem Cell Therapy), By Region (North America, Europe, APAC, ROW), And Segment Forecasts, 2021 - 2028

Report Overview

The global advanced therapy medicinal products market size was valued at USD 7.9 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 13.2% from 2021 to 2028. The emergence of Advanced Therapy Medicinal Products (ATMPs) has transformed the pharmaceutical industry and disease treatment landscape. It has opened new routes for the treatment of incurable diseases and several cancer types. The success of products such as Kymriah, Zolgensma, and others is the key factor driving the market.

The COVID-19 pandemic has triggered the application of advanced therapies in virology research to a major extent. A study was issued in December 2020 which stated the potential of T-cell therapy for the treatment of high-risk COVID-19 infected individuals. Prior to this, in September 2020, the U.S. FDA has approved the ALVR109 (an allogeneic T-cell therapy IND application) designed for the treatment of COVID-19 patients.

This is anticipated to drive investment in R&D of advanced therapy for SARS-CoV2 infections. Furthermore, a growing number of Mesenchymal Stromal/Stem Cells (MSCs) based clinical trials have been registered recently as a new treatment paradigm for SARS-CoV-2 infection. These therapies have shown promising results as the treatment modality in research programs, further supplementing the marketspace's organic revenue generation.

Although the market for advanced therapy medicinal products is currently in its nascent stage, it is continuously growing. Conventional drug manufacturers striving to gain a competitive edge are considering ATMPs as a lucrative source of revenue in future healthcare systems. Currently, this arena is very active and companies are investing significantly in clinical trials of ATMPs post success of approved products.

Over the past years, several proteins and small molecule-based developing companies have begun focusing on the development of adoptive cell T therapies. For instance, in March 2021, Bristol Myers Squibb in collaboration with bluebird bio secured approval for its Abecma (idecabtagene vicleucel) - a cell-based gene therapy medicinal product developed for the treatment of patients with multiple myeloma, from the U.S. FDA.

Therapy Type Insights

The tissue-engineered product segment dominated the market with the largest revenue share of 39.0% in 2020. This dominance can be attributed to the incorporation of tissue-engineered products or procedures as an integral part of medicine and treatment procedures, particularly in treatments that require functional restoration of any diseased or injured part of the body.

This segment has witnessed significant traction over the past years, as evidenced by the remarkable increase in the number of publications, research studies, clinical trials, and translational products. Furthermore, continuous advancements in technologies and products to advance the tissue engineering process aids in the segment growth. For instance, in February 2021, a team of researchers at the University of Illinois Chicago has introduced a novel hydrogel- shape-changing 4D materials which can change shape in response to physiological stimuli.

On the other hand, the CAR-T therapy segment is gaining significant momentum in the space and is expected to register the fastest CAGR over the forecast period. Key players such as Novartis AG, Gilead Sciences, Inc., and Bristol Myers Squibb are focused on expanding the reach of their CAR-T products across the globe. For instance, Novartis AG announced the approval of its Kymriah by the Health Sciences Authority as Singapore’s first commercially approved CAR-T therapy.

Kymriah is a CAR-T product designed for the treatment of patients with B-cell acute lymphoblastic leukemia and relapsed or refractory (r/r) diffuse large B-cell lymphoma. Similarly, Bristol Myers Squibb’s Breyanzi - a new CAR-T cell therapy for R/R B-Cell Lymphoma secured approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) in March 2021. This has resulted in the shift in the investment flow toward the development of CAR-T products, leading to significant segment growth.

Regional Insights

North America dominated the advanced therapy medicinal products market and accounted for the largest revenue share of 47.0% in 2020. A favorable regulatory environment, successful product launches, and sizable investments in research and development are the major factors contributing to the dominance of the region in the market for advanced therapy medicinal products. Also, the rapidly increasing number of clinical trials in this new treatment modality in the U.S. supplements regional growth.

As of March 2021, the U.S. accounts for around 57.0% of total clinical trials ongoing for gene therapy across the world. This high share indicates the increasing investment flow in this market thereby propelling the revenue generation. Europe held the second-largest share in the market in 2020 due to a strong research base for advanced therapies.

In recent years, China has emerged as a potential market for advanced therapies ranking second in the world in the cell and gene therapy market. Focused efforts including government investment and reforms in China have led to considerable growth, consequently exhibiting the fastest CAGR for the Asia Pacific region.

Key Companies & Market Share Insights

The market for advanced therapy medicinal products has witnessed tremendous growth in the past few years. The increasing number of companies emerging in this arena is anticipated to intensify the competition in the market. Besides, recent approvals of ATMPs have accelerated the expansion in this area. The market players are undertaking various strategies to sustain their market position. Collaborations with contract manufacturing organizations are the current trend observed in this space. The CDMO/CMOs are witnessing high demand for their services owing to increasing R& D activity in this market. Some of the prominent players in the advanced therapy medicinal products (ATMPs) market include:

• Spark Therapeutics, Inc.

• Bluebird Bio, Inc.

• Novartis AG

• UniQure N.V.

• Celgene Corporation

• Gilead Lifesciences, Inc.

• Kolon TissueGene, Inc.

• JCR Pharmaceuticals Co., Ltd.

• MEDIPOST;

• Vericel Corporation;

• PHARMICELL Co., Ltd

• Organogenesis Inc.

Advanced Therapy Medicinal Products Market Report Scope

Segments Covered in the Report

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 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global advanced therapy medicinal products market report on the basis of therapy type and region:

• Therapy Type Outlook (Revenue, USD Million, 2017 - 2028)

  • Cell Therapy

    • Stem Cell Therapy

    • Non-stem Cell Therapy

  • CAR-T Therapy

  • Gene Therapy

  • Tissue Engineered Product

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

  • Asia Pacific

    • China

    • Japan

    • Russia

    • Australia

    • India

  • Rest of World