On 16 December, Novo Nordisk announced that it will investigate its type 2 diabetes (T2D) drug Rybelsus (semaglutide) in a pivotal Phase IIIa study of patients with early Alzheimer’s disease. Rybelsus, the first and only oral glucagon-like peptide-1 receptor agonist (GLP1-RA), first launched in the US in Q4 2019 and has achieved significant sales in 2020 despite the ongoing Covid-19 pandemic. Novo Nordisk’s decision to pursue a new indication was based on preclinical models, real-world evidence studies, and a post-hoc analysis of data from cardiovascular (CV) outcomes trials in which semaglutide appeared to reduce neuroinflammation, which impacts cognition and improves memory function. GlobalData believes that due to the growing unmet needs in the Alzheimer’s space, which has not seen any major medical breakthroughs over the past decade, and the increasing evidence of a potential therapeutic role for GLP-1, oral semaglutide may be able to secure its position in a yet another lucrative market if found to be efficacious in clinical trials in this space. However, the drug may face fierce competition from a number of novel therapies entering the Alzheimer’s market over the next several years.

Rybelsus has been approved to treat T2D as an adjunct to diet and exercise in the US, Europe, and Japan. The drug is a game-changer in the T2D space, as it is the first-to-market oral GLP-1RA, as opposed to all other marketed GLP-1RAs that are administered via injection. Rybelsus gained $173M during the Q1–3 2020, accounting for 16% of Novo Nordisk’s overall growth, despite the Covid-19 pandemic setbacks that affected most of the T2D drugs. GlobalData’s Type 2 Diabetes: Global Drug Forecast and Market Analysis to 2029 report forecasts that the drug will reach over $7B in T2D sales in nine major markets by 2029. Rybelsus will capture a great deal of the market share from the existing subcutaneously administered GLP-1RAs, such as Eli Lilly’s Bydureon (exenatide extended-release) and Trulicity (dulaglutide), and it will cannibalise the sales of Novo Nordisk’s Victoza (liraglutide) and Ozempic (injectable semaglutide).

According to GlobalData’s Alzheimer’s Disease: Global Drug Forecast and Market Analysis to 2028 report, sales in the Alzheimer’s market will reach $12.9B in 2028, growing from $2.2B in 2018 at a Compound Annual Growth Rate (CAGR) of 19.3% over the 10-year period. This growth will be driven not only by the increase in the diagnosed prevalence of the disease but also by the launch of 18 new therapies, including several drug candidates that have the potential to modify the underlying cause of the disease.

Novo Nordisk will face a tough battle when entering into the Alzheimer’s space, not only because of the myriad of competitors that are lined up to enter the market but also because getting successfully through the clinical trials for this disease may prove to be a difficult task. Given a large number of failures in Alzheimer’s trials seen in 2019, and more recently the failure of Eli Lilly’s solanezumab and Roche’s gantenerumab in the DIAN-TU trials, key opinion leaders interviewed by GlobalData showed a high degree of pessimism with regards to having a product that can cure Alzheimer’s disease any time soon.”