This Market Spotlight report covers the Polycystic Ovary Syndrome market, comprising key pipeline and marketed drugs, clinical trials, patent information, and a 10-year disease prevalence forecast, as well as licensing and acquisition deals.

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 commonly administered via the oral, subcutaneous, or intramuscular routes.
• Therapies in the pipeline for PCOS focus on targets such as AMP-activated protein kinase and gonadotropin-releasing hormone receptor. These therapies are administered orally.
• The overall likelihood of approval of a Phase I endocrine asset is 11.1%, and the average probability a drug advances from Phase III is 69.7%. Drugs, on average, take 9.4 years from Phase I to approval 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.