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 2017, there were approximately 113.2 million (NIH criteria) to 188.7 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 119.5 million (NIH criteria) and 199.1 million (Rotterdam criteria) by 2026.
• 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 or subcutaneous routes, with one product also being available in an intramuscular formulation.
• Therapies in the pipeline for PCOS focus on targets such as AMP-activated protein kinase, neurokinin receptor, and sodiumglucose cotransporter (SGLT). These therapies are administered orally.
• The overall likelihood of approval of a Phase I endocrine asset is 13.2%, and the average probability a drug advances from Phase III is 68.9%. Drugs, on average, take 8.9 years from Phase I to approval in the overall endocrine space.
• There has been only one licensing agreement involving PCOS drugs during 2013–18. The deal was an exclusive licensing agreement signed in 2016 between Millendo and AstraZeneca for the worldwide development and commercialization rights to MLE4901. The deal value was not disclosed.
• The clinical trials distribution across Phase I–IV indicates that the majority of trials for PCOS have been in the late phases of development, with approximately 83% of trials in Phase III–IV, and only 17% in Phase I–II.
• The US has a substantial lead in the number of PCOS clinical trials globally. Germany and the UK lead the major EU markets, while 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 number of clinical trials for PCOS, followed by AstraZeneca and Merck & Co.