Industry Insights, Market Size, CAGR, High-Level Analysis: Advanced Therapy Medicinal Products Market
The global advanced therapy medicinal products market size was valued at USD 3.14 billion in 2019 and is projected to expand at a CAGR of 17.4% 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, the 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 is 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 production 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.
Type Insights of Advanced Therapy Medicinal Products Market
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 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 of Advanced Therapy Medicinal Products Market
The presence of a substantial number of approved ATMPs for use in 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 Europes 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.
Market Share Insights of Advanced Therapy Medicinal Products Market
Currently, 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 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.
Segmentations, Sub Segmentations, CAGR, & High-Level Analysis overview of Advanced Therapy Medicinal Products Market Research 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, this market research report has segmented the global advanced therapy medicinal products market report on the basis of therapy type and region:
Therapy Type Outlook (Revenue, USD Million, 2019 - 2030)
- Cell Therapy
- Stem Cell Therapy
- Non-stem Cell Therapy
- CAR-T Therapy
- Gene Therapy
- Tissue Engineered Product
In September 2020, Takeda Pharmaceutical Company Limited announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. The facility provides end-to-end research and development capabilities and will accelerate Takedas efforts to develop next-generation cell therapies, initially focused on oncology with the potential to expand into other therapeutic areas.
The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U., and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world.
The proximity and structure of Takedas cell therapy teams allow them to quickly apply what they learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts, and gamma delta T cells. Insights gained in manufacturing and clinical development can be quickly shared across global research, manufacturing, and quality teams, a critical ability in their effort to deliver potentially transformative treatments to patients as fast as possible.
Takeda and MD Anderson are developing a potential best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD19-targeted chimeric antigen receptor-directed natural killer (CAR-NK) cell therapy with the potential for off-the-shelf use being studied in patients with relapsed or refractory non-Hodgkins lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Two additional Phase 1 studies of Takeda cell therapy programs were also recently initiated: 19(T2)28z1xx CAR T cells (TAK-940), a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed/refractory B-cell cancers, and a cytokine and chemokine armored CAR-T (TAK-102) developed in partnership with Noile-Immune Biotech to treat GPC3-expressing previously treated solid tumors.
Takedas Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development, and commercialization. It provides bioengineering, chemistry, manufacturing, and control (CMC), data management, analytical, and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.
In Aug 2020, European Commission approves BLENREP (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma. GlaxoSmithKline plc today announced the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose disease has progressed despite the current standard of care.
Data demonstrated that treatment with single-agent BLENREP, administered as a 2.5 mg/kg dose every three weeks (Q3W), resulted in an overall response rate of 32%. The median duration of response was 11 months and median overall survival was 13.7 months.
The approval of BLENREP, with its novel mechanism of action, represents a new class of treatment that patients can turn to when their cancer stops responding to other standard of care options.
BLENREP employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells. BLENREP is an antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.
The US Food and Drug Administration approved BLENREP as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent, following a priority review for the companys Biologics License Application.