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Report Overview: Advanced Therapy Medicinal Products MarketThe global advanced therapy medicinal products market size was valued at USD 2.03 billion in 2020 and is projected to expand at a CAGR of 16.3% during the forecast period. Recent advancements in biological therapies have resulted in a gradual shift toward personalized medicine from the conventional one-size-fits-all approach. The advanced therapy medicinal product (ATMP) landscape is one of the active spaces in this new trend. These products offer solutions for conditions with negligible therapeutic alternatives as well, which is one of the major growth drivers for the market. Although the regulation for ATMPs is currently in its nascent stage, it is a constantly developing area. The number of Investigational New Drug (IND) applications for these therapies continues to increase. Post-approval of Yescarta, Center for Biologics Evaluation and Research has received around 150 INDs in the fiscal year 2018. According to the Alliance for Regenerative Medicine (ARM), more than 1,000 clinical trials were carried out for the ATMP designation to the products, by January 2019, globally. With the approval of Luxturna, Yescarta, and Kymriah, this market has witnessed several acquisitions intended for market entry or expansion in the sector. For example, acquisition of Kite Pharma by Gilead Life Science, Juno Therapeutics by Celgene, and AveXis by Novartis are some of the notable acquisitions that took place in recent times. These acquisitions indicate the rising interest of major pharma companies in advanced therapy medicinal products. Although the companies have successfully secured product approvals in the past years, the high cost of therapies and challenges with respect to financial sustainability are anticipated to slow down product adoption. Several products have been pulled off from the market as they were not considered financially viable for the developers as well as the payers. Moreover, some companies like Fibrocell have also witnessed the wind-down of their product operations. Despite the above-articulated challenges, this field is constantly expanding owing to the health benefits offered by these new classes of therapies, along with benefitting society and the healthcare system in context to healthcare outcome and resource availability. Considering the efficiency and clinical benefits of advanced therapy medicinal products, various stakeholders of the market are constantly designing strategies to overcome the existing challenges and spur advanced therapy medicinal product usage. Therapy Type Insights Over the past few years, there has been a notable increase in the clinical development of advanced therapies, including gene therapies, cell therapies, and tissue engineering products. Several products have already secured approval in the U.S., China, Europe, South Korea, Japan, Australia, Canada, India, and New Zealand. As a result, a substantial number of well-established as well as start-up pharma companies, universities, and hospitals are shifting their focus from conventional therapies to advanced therapies. Cell therapies held the largest revenue share of the advanced therapy medicinal products market in 2019. Increased funding from governments as well as private organizations to support cell therapy clinical trials, improving the legal framework for cell therapy manufacturing and implementation, and proven efficacy of products are some of the key drivers for the growth of the segment. Based on cell types, stem cell therapies held the dominant revenue share in 2019 owing to the presence of a substantial number of approved therapies. The entry of new players such as Celularity, Rubius Therapeutics, Century Therapeutics, Fate Therapeutics, ViaCyte, Magenta Therapeutics, ReNeuron, Promethera Biosciences, Frequency Therapeutics, and Cellular Dynamics in the recent years reflects the expanding stem cells business operations. Currently, the number of approved gene therapy is limited, however, a substantial number of products is anticipated to receive regulatory approvals in the forthcoming years. Growing R&D activities in gene therapy trials have resulted in an increase in market activities by the key stakeholders operating in the ATMP market. For instance, in April 2019, Catalent announced to acquire Paragon Bioservices to expand its business footprint in the gene therapy arena.
Regional Insights: Advanced Therapy Medicinal Products MarketThe presence of a substantial number of approved ATMPs for use in the U.S. has contributed to the large revenue share of this region. The recent approval of products like Kymriah, Yescarta, and Zolgensma has propelled the investment in the U.S. ATMP market. Furthermore, the U.S. FDA has announced that it has over 800 active Investigational New Drug applications on file by 2020 and the agency showed interest to receive more than 200 applications per year. In 2017, an estimated 391 gene therapy companies were operating in the U.S. market. In September 2019, around a hundred more companies including Big Pharma companies had entered the market. These factors are anticipated to accelerate the North America market at a lucrative CAGR in the forthcoming years. Europe is the second-largest pharmaceutical market globally, with Western Europe accounting for the large proportion of drug revenue. In the forthcoming years, cell therapy developers are anticipated to account for a major share of Europe’s drug revenues. In addition, the presence of a substantial number of academic institutes engaged in conducting early-stage cell therapy research is anticipated to boost regional revenue growth. Furthermore, global companies are expanding their cell therapy manufacturing capabilities across Europe, thereby driving the regional market growth.
Key Companies & Market Share Insights: Advanced Therapy Medicinal Products MarketCurrently, this market is a very active space. Recent approvals of ATMPs have prompted an unprecedented expansion in this area. Conventional drug makers are striving to gain a competitive advantage, considering ATMP as a lucrative source of revenue in the future healthcare systems. Companies are investing enormously in clinical trials of ATMP post the success of approved products. Some major players are 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; and Organogenesis Inc. The companies are adopting various operating models to accelerate the product manufacturing process. While some companies undertake in-house production of therapies, a substantial number of players are preferring third-party service providers, including Contract Manufacturing Organizations (CMOs). The gene therapy contract development market space is driven by the surging demand that stems from the expansion of the drug development pipeline and the rise in the number of start-ups that embrace human-testing but lack production capacities. On the other hand, several companies have marked their presence in the space by acquiring small and emerging CAR T-cell therapy developers. Advanced Therapy Medicinal Products Market Report Scope
Key companies Profiled: Advanced Therapy Medicinal Products Market 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 2015 to 2026. For the purpose of this study, Trusted Business Insights has segmented the global advanced therapy medicinal products market report on the basis of therapy type and region:
- Spark Therapeutics, Inc.
- Bluebird Bio, Inc.
- Novartis AG
- UniQure N.V.
- Celgene Corporation
- Gilead Lifesciences, Inc.
- Kolon TissueGene, Inc.
- JCR Pharmaceuticals Co., Ltd.
- Vericel Corporation
- PHARMICELL Co., Ltd
- Organogenesis Inc.
Therapy Type Outlook (Revenue, USD Million, 2015 - 2026)
- Cell Therapy
- Stem Cell Therapy
- Non-stem Cell Therapy
- CAR-T Therapy
- Gene Therapy
- Tissue Engineered Product
Table of content Chapter 1 Executive Summary 1.1 Market Outlook 1.2 Competitive Environment 1.3 Segment Outlook 1.4 Market SnapshotChapter 2 Research Methodology 2.1 Information Procurement 2.2 Information or Data Analysis 2.3 Market Formulation & Validation 2.4 Market Scope & Definition 2.4.1 ATMP’s definition as per the EU regulatory body: 2.4.2 ATMP’s definiti | read more...