Across the seven major markets* (7MM), the diagnosed prevalence of type 1 and 2 diabetes (T1D) was approximately 3.7 million and 49.7 million, respectively, in 2020 – according to data and analytics company GlobalData. This is expected to grow to more than 4.3 million by 2025 for Type 1 and 54.4 million for Type 2 across the 7MM*. Due to the increasing prevalence and progressive nature of this disease, there are considerably high unmet needs within the indication. Several developments this year, such as shakeups in the insulin space,  have occurred over the past year and are reshaping both the market and management of the disease.

Jesse Cuaron, PhD, PPM, Associate Director of CMVD and Gender Health at GlobalData, comments: “The diabetes therapeutics market is crowded, but key opinion leaders interviewed by GlobalData have reiterated the need for additional treatments that provide both glycemic and non-glycemic benefits, especially as the control of diabetes comorbidities is less than optimal in most patients.

“Diabetes drug developers have been successful in bringing pharmaceuticals to market that help to induce weight loss and provide cardiovascular (CV) benefits – particularly those that are glucagon-like peptide-1 receptor agonists and sodium glucose co-transporter inhibitors (SGLTIs). Historically, SGLTIs have been approved and marketed for T2D patients, however, three SGLTIs were approved for T1D patients in Europe or Japan in 2019: AstraZeneca’s Farxiga (dapagliflozin), Astellas Pharma’s Suglat (ipragliflozin), and Lexicon’s Zynquista (sotagliflozin).”

There have also been some shakeups in the insulin arena over the past year. Eli Lilly, Novo Nordisk and Sanofi currently dominate the market, but, at the end of 2019, Sanofi announced its plans to completely pivot away from its struggling diabetes and CV R&D programs to focus on oncology and gene therapies. There were also some US-specific changes relating to the regulatory framework around biologics, with insulin now being classified as a biologic by the FDA. Initially, some early biologics, such as insulin, were approved under the Food, Drug, and Cosmetic (FD&C) Act. In this case, follow-on versions could only receive approval for new drug applications (NDA) under the FD&C Act, which is handled by the Center for Drug Evaluation and Research instead of the Center for Biologics Evaluation and Research.

Cuaron continues: “As a result of the changes in the insulin space, GlobalData anticipates that there will be an increase in the development of more affordable insulin products that fall under the biosimilar and interchangeable insulin category in the US, as well as an overall increase in competition within the insulin market with the exit of Sanofi from the space.”

The past year has also witnessed the arrival of COVID-19, which has negatively impacted the diabetes community, as COVID-19 patients with diabetes are at higher risk of developing more severe symptoms and have a higher fatality rate than patients without comorbidities. COVID-19 has also influenced the diabetes arena in the form of drug repurposing.

According to GlobalData’s Pharma Intelligence Center, diabetes drug trials that are being investigated in COVID-19 studies include AstraZeneca’s DARE-19 trial, the University of Milan’s SIDIACO trial and the University of Miami’s study on the effects of DPP4 inhibition on COVID-19. AstraZeneca’s Farxiga is being investigated for the potential to reduce COVID-19 progression, complications, and all-cause mortality. Merck’s Januvia (sitagliptin) is being investigated to modulate the pulmonary inflammatory response in COVID-19 patients. Boehringer Ingelheim and Eli Lilly’s Tradjenta (linagliptin) is being investigated to reduce the severity of the COVID-19 infection.”

Cuaron continues: “Overall, despite the significant advancements made in the diabetes space, additional clinical needs remain among the diabetes community, including improved durability of treatment, hypoglycemia avoidance, tolerability, and ease of compliance. The most pressing need, as confirmed unanimously by interviewed KOLs, is for the development of breakthrough treatments that address the underlying cause of the disease. In T1D, this would be a treatment that can interfere with either the etiology or the pathogenic processes involved in the eradication of the ß cells. In T2D, the treatment would have to effectively target the root of the disease, insulin resistance.

“Whether or not a truly curative treatment will be discovered and developed is yet to be seen, but there are certainly some promising disease-modifying therapies in the pipeline. For example, earlier this month Provention Bio announced the completion of a rolling Biologic License Application submission to the FDA for teplizumab for the delay or prevention of T1D.”

* The US, France, Germany, Italy, Spain, the UK and Japan