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 2019, there were approximately 113.5 million (NIH criteria) to 187.8 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, and follicle-stimulating hormone receptor. These drugs are administered via the oral, subcutaneous, or intramuscular routes.
• The only industry-sponsored drug in active clinical development for PCOS in the US is in Phase II.
• The only therapy available in the pipeline for PCOS targets gonadotropin-releasing hormone receptor. It is administered orally. The overall likelihood of approval of a Phase I endocrine-other asset is 16.6%, and the average probability a drug advances from Phase III is 67.4%. Drugs, on average, take 10.2 years from Phase I to approval, compared to 9.8 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 81% of trials in Phase III–IV, and only 19% in Phase I–II.
• The US has the highest number of PCOS clinical trials globally. Germany and the UK lead the major European markets, while China, Indonesia, and South Korea share 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 five trials.
• Merck KGaA leads industry sponsors with the highest overall number of clinical trials for PCOS, followed by AstraZeneca and Merck & Co.