The Rising Wave of Cell Therapies for Diabetes: Promising Developments and Market Dynamics

Cell therapies for diabetes have gained significant momentum in recent years, as demonstrated by promising developments and regulatory milestones. The FDA approval of Lantidra and Lilly's acquisition of Sigilon Therapeutics exemplifies the growing interest and investment in this field. These advancements offer hope for improved treatment options and potentially even a cure for diabetes. As research continues, addressing scalability, cost-effectiveness, and long-term safety will be crucial to harnessing the full potential of cell therapies for diabetes and transforming the lives of millions affected by this chronic condition.

According to the International Diabetes Federation (IDF), diabetes remains a significant global health concern, affecting approximately 537 million individuals worldwide in 2021. This number is projected to increase by 2040. In 2019, diabetes was accountable for 1.5 million fatalities, with nearly half of those deaths occurring before the age of 70. According to BioIntel360, the global diabetes devices and therapeutics market size is expected to record a CAGR of 13.0% during 2023-2027 to reach US$188 billion by 2027, increasing from US$115 billion in 2023. Over the last five years, the sector has recorded a CAGR of 12.7% to reach US$102 billion in 2022.

Moreover, diabetes contributed to an additional 460,000 deaths related to kidney disease and approximately 20% of all cardiovascular fatalities. From 2000 to 2019, there was a 3% rise in age-adjusted mortality rates attributed to diabetes, particularly with a 13% increase in lower-middle-income countries. However, during the same period, there was a notable 22% decrease in the likelihood of dying from any of the four primary non-communicable diseases, including diabetes, globally between the ages of 30 and 70 years. Cell therapies for diabetes have recently garnered significant attention, with notable advancements and regulatory milestones. At the ADA meeting, Vertex and Sernova presented encouraging data from their research programs, and the FDA approved the first-ever cell therapy medication for a rare form of diabetes.

Additionally, Eli Lilly made headlines with its acquisition of Sigilon Therapeutics, emphasizing the growing interest in this field.
The recent FDA approval of Celltrans's Lantidra, a donor-derived pancreatic islet cell therapy, marks a significant milestone for cell therapies in diabetes. While Lantidra addresses a rare form of the condition, this approval could have positive implications for other investigational projects in the field. The regulatory green light establishes a precedent and potentially paves the way for future approvals of similar therapies targeting more prevalent types of diabetes.
Eli Lilly's acquisition of Sigilon Therapeutics further underscores the growing interest in cell therapies for diabetes. Five years ago, Lilly and Sigilon began working together on the development of encapsulated cell treatments, including SIG-002, to treat type 1 diabetes.
Sigilon had previously concentrated on haemophilia A, but a program halt and eventual termination led to the refocusing of its pipeline.
SIG-002 uses Sigilon's technology to enclose insulin-producing islet cells to suppress the patient's immune response and do away with the necessity for systemic immunosuppression necessary for other therapies.
Sigilon's journey from IPO to acquisition by Lilly illustrates the challenges and fluctuations inherent in the biotech market. The acquisition highlights Lilly's commitment to expanding its presence in the cell therapy space and diabetes treatment. The addition of Sigilon's pipeline, especially the advanced SIG-002 program, positions Lilly to potentially tap into the growing market for cell therapies for diabetes. The technology developed by Sigilon, with its potential to address immune response challenges, could offer a competitive advantage over existing therapies.

BioIntel360 suggests that cell therapies for diabetes hold tremendous promise, particularly in personalized medicine approaches. The ability to transplant functional islet cells or employ encapsulated cell therapies opens up new avenues for treating and potentially curing diabetes. By reducing the need for systemic immunosuppression, cell therapies like SIG-002 could minimize complications and improve patient outcomes.

However, several challenges remain on the path to widespread adoption and commercial success. Scalability and cost-effectiveness are crucial factors to consider. The development of large-scale manufacturing processes and ensuring affordability for patients are critical for the widespread availability of cell therapies. Additionally, long-term safety and efficacy data must be carefully monitored and evaluated to gain regulatory approvals and instill confidence in these novel treatment approaches.