As the cell and gene therapy market continues to emerge from relative infancy, the innovative products entering the pipeline today offer promise and hope for diseases with high unmet medical needs—from various forms of cancer to central nervous system disorders and cardiovascular diseases.
Little known outside the scientific and biomedical realm just a decade ago, the number of cell and gene therapy products in development has surged in recent years, prompting the U.S. Food and Drug Administration (FDA) in 2019 to predict the agency would be approving 10 to 20 CGT products a year by 2025. While experts now believe the number of annual approvals will likely be on the lower end of that projection, there remains significant momentum. In fact, the FDA has approved three new CAR-T products (Abecma, Breyanzi and Carvykti) over the last 16 months, and existing products have expanded their indications to include additional patient populations in earlier lines of treatment.
And the pipeline continues to expand. Today, there are more than 1,000 cell and gene therapy clinical trials underway globally, with the vast majority of studies in Phase 1 or Phase 2.
“Over the last five years, in particular, we’ve seen tremendous innovation and scientific achievements that have resulted in new therapies for diseases with high unmet medical needs,” said Lung-I Cheng, AmerisourceBergen’s new Vice President of Cell and Gene Therapy – a new role for the organization.
Preparing for the Next Wave of CGT
As more CGT products move through the early development stages, global healthcare services company AmerisourceBergen continues to make strategic investments to strengthen the value it can offer innovators across the commercialization journey and help address the needs of providers, payers and patients, said Willis Chandler, President of Biopharma Services, Strategic Global Sourcing and Commercial Solutions at AmerisourceBergen. Through its network of businesses, the company offers a wide range of commercialization solutions to support CGT innovators, including clinical trial and commercial logistics and market access and reimbursement support.
Earlier this year AmerisourceBergen completed the integration capabilities of TrakCel’s advanced therapy orchestration platform OCELLOS and Fusion, a customer relationship management and patient support ecosystem powered by AmerisourceBergen’s Lash Group. The platform streamlines the exchange of benefits and eligibility information between physicians and hub services, helping to expedite patient enrollment and support.
More recently, AmerisourceBergen formally established a new cell and gene therapy service line – led by Cheng – which will help advance the company’s CGT strategy and support its effort to deliver enhanced value to innovators, Chandler said. Cheng, who joined AmerisourceBergen in April, comes from Takeda, where he most recently served as the head of Global Value & Access for Cell Therapies, Pipeline and Business Development.
“We know cell and gene therapy innovators have different needs based, in part, on their size, the unique requirements of their product and where it is in the product lifecycle. We’re focused on building a robust CGT solution that can be tailored to meet the specific needs of biopharma companies as well as providers, such as health systems and community-based specialty practices,” Chandler said.
Expanded Cryogenic Capacity
Given the nature of these products, cell and gene therapies present unique logistics challenges—particularly when they need to be shipped over long distances. Most autologous products have an extremely limited shelf life—often 24 to 48 hours—requiring supply chain partners to deliver products around the world within a narrow timeframe. Meanwhile, allogenic therapies—which can be manufactured on a much larger scale and be stored ahead of time—need to be cryogenically frozen below -150 degrees Celsius to remain viable over an extended period of time.
These factors have led to a significant increase in the use and demand for cryogenic storage solutions. AmerisourceBergen’s World Courier, a global specialty logistics provider, and ICS, a third-party logistics provider, have made significant investments to build out its cryogenic storage capabilities, including expanding its storage capacity in strategic markets worldwide and increasing its network of qualified cryogenic charging stations and centers, said Doug Cook, EVP and President, Business Group—Global, at AmerisourceBergen. For example, World Courier in 2021 doubled its cryogenic storage capacity across its global network of 18 drug depots.
“CGT innovators developing allogenic therapies are looking to qualify cryopreserved transport and storage from a single source. Through World Courier and ICS, we’re able to deliver a complete cryogenic supply chain,” said Cook.
Realizing the Potential
According to industry estimates, the global cell therapy manufacturing market, which was valued at $3.1 billion in 2020, is forecast to grow with a CAGR value of 12% and hit a market value of about $6 billion by 2026.
As advances in science continue to power medical breakthroughs, it’s increasingly important to establish solutions and processes that help developers navigate challenges and reduce physician and patient-related barriers that affect access, Cheng said.
“As the pipeline of cell and gene therapy products continues to expand, it’s critically important that we, as a healthcare ecosystem, continue to evolve to meet the needs of biopharma companies, healthcare providers, payers and patients, so we can enable access to these innovations,” Cheng said.
To learn more about how AmerisourceBergen’s services support cell and gene therapy innovators, visit: https://www.amerisourcebergen.com/manufacturer-solutions/cell-and-gene-therapy