This Market Spotlight report covers the Hypogonadism market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, key upcoming and regulatory events, probability of success, patent information, epidemiology, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• The approved drugs in the hypogonadism space target androgen receptors, estrogen receptor alpha, and estrogen receptor beta. These are commonly administered via the transdermal route, with a smaller number of products being available in oral, intramuscular, intranasal, sublingual/oral transmucosal, subcutaneous, and topical formulations.
• The largest proportion of industry-sponsored drugs in active clinical development for hypogonadism are in Phase II, with only one drug in Phase III and one in the NDA/BLA phase.
• Therapies in development for hypogonadism focus on targets such as androgen receptors, estrogen receptor alpha, estrogen receptor beta, and aromatase. These pipeline drugs are administered via the oral route.
• Expected PDUFA dates for Tlando and Kyzatrex are the only high-impact upcoming events for drugs in hypogonadism space. The overall likelihood of approval of a Phase I endocrine-other asset is 16.4%, and the average probability a drug advances from Phase III is 65.9%. Drugs, on average, take 10.0 years from Phase I to approval, compared to 9.6 years in the overall endocrine space.
• There are almost equal proportions of clinical trials for hypogonadism across Phase I–IV, with 51% in Phase I–II, and 49% in Phase III–IV.
• The US has a substantial lead in the number of hypogonadism clinical trials globally. The UK leads the major European markets, while India has the top spot in Asia.
• Clinical trial activity in the hypogonadism space is dominated by completed trials. AbbVie has the highest number of completed clinical trials for hypogonadism, with eight trials.
• AbbVie leads industry sponsors with the highest overall number of clinical trials for hypogonadism, followed by GlaxoSmithKline.