Entry of New Therapies Will Drive Growth in Cushing Syndrome Market
Cushing’s syndrome (CS) is a serious and debilitating endocrine disorder caused by prolonged exposure to excessive levels of cortisol (hydrocortisone) or other glucocorticoids of endogenous or exogenous origin. Endogenous CS fall into two groups: those due to excess adrenocorticotropic hormone (ACTH), also called ACTH-dependent, and ACTH-independent. A pituitary adenoma, also known as Cushing’s disease (CD), is the most common form of endogenous CS. CD produces excess ACTH which stimulates the adrenal cortex to produce excess glucocorticoid hormones. Other forms of endogenous CS include ACTH-independent ectopic tumors of the adrenal gland (adrenocortical adenomas) and adrenocortical carcinomas.
Exogenous CS is primarily caused by iatrogenic administration of glucocorticoids, such as administration of prednisolone over a long period of time. Current treatment for CS involves the use of glucocorticoid receptor (GR) antagonists such as Korlym from Corcept (mifepristone), steroidogenesis inhibitors such as Isturisa from Recordati Rare Diseases (osilodrostat), ketoconazole, Lysodren from HRA Pharma Rare Diseases (mitotane) and Metopirone (metyrapone) and the somatostatin analogue Recordati Rare Diseases’ Signifor (pasireotide) / Signifor LAR. These therapies tend to treat the overproduction of cortisol, but are unable to address the underlying pathophysiology of CS, leaving a significant unmet need that biopharmaceutical companies have yet to fully address.
There are several therapies in development for SC in the two main markets (2MM), namely the United States and Germany, with a high likelihood of approval. Key Opinion Leaders (KOLs) surveyed by GlobalData expressed their enthusiasm for this development. These therapies are the novel relacorilant GR-II antagonist from Corcept Therapeutics (Phase III in EU and US), steroidogenesis inhibitor from Strongbridge Biopharma Recorlev (levoketoconazole) (US pre-registration and Phase III in the EU), and Sparrow Pharmaceuticals’ the first hydroxysteroid dehydrogenase-1 (HSD-1) inhibitor SPI-62 (phase II in the US).
The KOLs reported, however, that they were unimpressed with the efficacy and safety data for these therapies, as well as the primary endpoints of their trials. Although the new therapies offer improved efficacy over currently marketed therapies, the improvement is not considered significant, and it is expected that they will be less adopted compared to their cheaper counterparts such as ketoconazole and generic therapies that are expected to be started during the forecast period, such as mifepristone, osilodrostat phosphate (generic from Isturisa) and pasireotide (generic from Signifor).
GlobalData expects the CS market to experience significant growth from last year to 2030. The market size of 2MM will increase from total sales of $ 121.35 million last year to $ 448.73 million. dollars in 2030, at a compound annual growth rate (CAGR) of 14.0%. This sales growth will be in line with the steady increase in the prevalence of the disease in the US market and the arrival of new agents in 2MM.
The figure below shows the sales forecast for the CS market.
In 2MM, there have been consistent improvements in the treatment of CS, with significant improvement in diagnostic rates as doctors have developed a better understanding of the symptoms of CS. This has improved the accuracy of the diagnosis of CS in patients with early symptoms of CS, such as weight gain and more upper body fat in the upper trunk, as well as depression, bruising, and depression. round, reddened face. This will increase the number of prescriptions for the three main therapeutic classes, but in particular for steroidogenesis inhibitors.
Recorlev will likely launch in the second half of 2021 in the United States, and several generics will be launched during the forecast period, with the patents for the brand-name therapies Isturisa and Recorlev expiring in 2026 and 2030 respectively. Additionally, if SPI-62 produces successful advanced-stage clinical data and obtains US Food and Drug Administration (FDA) approval, it is likely to be significantly adopted by physicians and gain significant market share in the US CS market, with sales of approximately $ 118.3 million, due to its new mechanism of action and promising early clinical data. KOLs expressed positive interest when asked about the SPI-62.