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 the NDA/BLA phase.
• Therapies in development for hypogonadism focus on targets such as androgen receptors, estrogen receptor alpha, estrogen receptor beta, gonadotropin-releasing hormone, and aromatase. The majority of the pipeline drugs are administered via the oral route, with the remainder being subcutaneous and transdermal formulations.
• An expected PDUFA date for Tlando is the only high-impact upcoming event in the hypogonadism space. The overall likelihood of approval of a Phase I endocrine-other asset is 23.6%, and the average probability a drug advances from Phase III is 77.4%. Drugs, on average, take 9.2 years from Phase I to approval, compared to 9.1 years in the overall endocrine space.
• There have been 16 licensing and asset acquisition deals involving hypogonadism drugs during 2014–19. The $317.5m exclusive license agreement signed in 2014 between Apricus and Forendo for fispemifene, an investigational treatment for urological conditions in men, was the largest deal.
• The distribution of clinical trials across Phase I–IV indicates that trials for hypogonadism have been evenly split between the early and late phases of development, with 51% of trials 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 EU 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