New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19

Cell, Gene & Tissue-Based Therapy Developers Poised to Break Year-Over-Year Global Financing Records

WASHINGTON, D.C. – August 6, 2020 – The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today announces the publication of its H1 2020 Global Sector Report, “Innovation in the Time of COVID-19.” The report provides an in-depth look at trends and metrics in the gene, cell, and tissue-based therapeutic sector in the midst of the pandemic.

As the voice of the sector globally, ARM regularly publishes sector data reports to showcase clinical and scientific progress, as well as advancements and remaining challenges in the policy environment surrounding cell, gene and tissue-based therapies. The report also includes updated metrics on fundraising and clinical trials from more than 1,000 therapeutic developers worldwide.

Highlights from the H1 2020 Global Sector Report include:

• The sector is poised to break records for public and private financings. Globally, regenerative medicine and advanced therapy developers raised $10.7 billion in the first half of 2020 – a 120% increase over the first half of 2019.
• Developers are advancing a robust pipeline of therapies targeting indications from cancer to infectious disease to inherited disorders. There are currently 1,078 ongoing regenerative medicine clinical trials worldwide, including 97 in Phase 3.
• Cell therapy developers are investigating mesenchymal stem cells (MSCs) to treat patients with severe complications of COVID-19, with 11 ongoing trials targeting the disease.
• Cutting edge therapies celebrated new milestones, including initial clinical data in gene editing, with several therapies poised for approval in the coming months.
• ARM advanced market access initiatives for cell and gene therapies, with two landmark proposals from the Centers for Medicare and Medicaid Services (CMS) positioned to improve patient access for Medicare and Medicaid patients.
• Global regulators stood firm in their commitment to advancing the sector in spite of COVID-19 – though the continued impact of the pandemic could result in future delays. ­
• Europe remains competitive globally, and a new proposal from the European Commission intended to streamline the development of therapies using genetically modified organisms (GMOs) to treat COVID-19 could be a positive first step towards mitigating burdensome requirements for gene therapy clinical trials.

Janet Lambert, CEO of ARM, commented: “The regenerative medicine and advanced therapy sector has shown remarkable resilience in the face of many new challenges posed by COVID-19. Most importantly, we’re continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. ARM will continue to work with our membership and with policymakers in the second half of 2020 to further advance these transformative technologies. We are committed to bringing these life-changing therapies to patients in need.”

This report is the latest in ARM’s series of global regenerative medicine sector reports, providing up-to-date metrics on financings and the clinical landscape, as well as expert commentary on key trends and progress in the field. The full report is available online here, with key sector metrics and infographics available here. For more information, please visit www.alliancerm.org or contact Kaitlyn (Donaldson) Dupont at kdonaldson@alliancerm.org.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the voice of the sector, representing the interests of 360+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.