This Market Spotlight report covers the Polycystic Ovary Syndrome (PCOS) market, comprising key marketed and pipeline drugs, clinical trials, probability of success, and a 10-year disease prevalence forecast.

Key Takeaways

• Datamonitor Healthcare estimates that in 2022, there were approximately 115.6 million (NIH criteria) to 190.8 million (Rotterdam criteria) prevalent cases of polycystic ovary syndrome (PCOS) in females aged 15–49 years worldwide, and expects that number to increase to between 120.2 million (NIH criteria) and 197.8 million (Rotterdam criteria) by 2028.
• The approved drugs in the PCOS space target estrogen receptor 1, androgen receptor, aromatase, follicle-stimulating hormone receptor, and AMP-activated protein kinase. These drugs are administered via the oral, subcutaneous, or intramuscular routes.
• There are only two industry-sponsored drugs in active clinical development for PCOS, which are both in Phase II. Therapies in development for PCOS target gonadotropin-releasing hormone receptor and corticotropin-releasing factor receptor 1. These therapies are administered via the oral route.
• The overall likelihood of approval of a Phase I endocrine-other asset is 12.6%, and the average probability a drug advances from Phase III is 63.3%. Drugs, on average, take 10.6 years from Phase I to approval, compared to 10.0 years in the overall endocrine space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for PCOS have been in the late phases of development, with 79% of trials in Phase III–IV, and only 21% in Phase I–II.
• The US has the highest number of PCOS clinical trials globally. The UK leads the major European markets, while China has the top spot in Asia.
• Clinical trial activity in the PCOS space is dominated by completed trials. Merck KGaA has the highest number of completed clinical trials for PCOS, with six trials.
• Merck KGaA leads industry sponsors with the highest overall number of clinical trials for PCOS, followed by Merck & Co.