Over the next 10 years, the hypoglycemia market is expected to almost completely transition from traditional glucagon hypokits to nasal glucagon or liquid-stable formulations of glucagon to treat severe hypoglycemia. According to GlobalData’s recent Hypoglycemia Global Market Forecast and Analysis report, the majority of the innovation regarding severe hypoglycemia therapeutics has occurred in the last five years, with recent and pending approvals of nasal glucagon and liquid-stable glucagon across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) occurring before 2030. As a result of these recent therapeutics, the pipeline for hypoglycemia is limited and there is limited opportunity to enter the severe hypoglycemia space.

GlobalData expects the hypoglycemia market to approximately double over the 2020–2030 period at a compound annual growth Rate (CAGR) of 4.8%. The launches of the novel formulations of glucagon therapeutics will be the main drivers of market growth, with the first liquid-stable glucagons expected to launch during the forecast period in addition to increased uptake of the nasal glucagon Baqsimi. Other major drivers for the hypoglycemia market include the increased prevalence of type 1 diabetes (T1D) diagnoses, and the uptake of novel glucagon formulations will drive therapy usage over hospital treatment.

Hypoglycemia, or low blood sugar, is primarily observed in diabetic patients who are receiving insulin therapy. Hypoglycemia is primarily treated through the consumption of glucose, however in diabetic patients on insulin, hypoglycemia can suddenly become severe with neuroglycopenic symptoms including a loss of consciousness. In these instances, a rescue intervention of glucagon or IV glucose is administered.

Key opinion leaders (KOLs) interviewed by GlobalData noted that the main issue the market must address is that insulins are still causing hypoglycemia. The consensus among KOLs regarding the current treatment landscape of hypoglycemia is that there are sufficient treatments to address severe hypoglycemia, and there are few unmet needs for hypoglycemia that can be addressed therapeutically. KOLs also highlighted the importance of preventing severe hypoglycemia through blood glucose monitoring and insulin management.

The figure below summaries the unmet needs and opportunities in hypoglycemia scored on a 1–5 scale to forecast their level of attainment over the forecast period.

The primary unmet need, and the main opportunity in the space, is that there are no adequate treatments for non-diabetic hypoglycemia. These include, but are not limited to, treatments for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (CHI). Both PBH and CHI patients are rarely treated with glucagon due to the specific etiologies of their disease, and there are currently no targeted therapies approved for either indication. Other unmet needs for diabetic hypoglycemia include the lack of affordable treatments, the lack of convenient treatments, and the prevalence of hypoglycemia unawareness. GlobalData’s research suggests that the future level of attainment of these unmet needs will be medium-high, and there is not much of an of opportunity for drug developers to enter the severe hypoglycemia market, but there is opportunity to address the non-diabetic hypoglycemia market.

While there is a limited market for novel severe hypoglycemia treatments, physicians are primarily concerned with severe hypoglycemia prevention. The increasing trend of glucose monitoring in the treatment and management of insulin-dependent diabetic patients will impact the therapeutics that find success in the market. Increased monitoring will allow patients to catch hypoglycemia before it becomes severe. For T1D, the drive toward closed-loop pump systems, like an artificial pancreas, provides an opportunity for dual-hormonal pumps to use glucagon to actively manage hypoglycemia.