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, as well as licensing and acquisition deals.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
Published: 30 September 2021
Number of pages:28
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.
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.
22 CLINICAL TRIAL LANDSCAPE
24 Sponsors by status
25 Sponsors by phase
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of PCOS (Rotterdam Criteria), 2019–28
14 Figure 2: Trends in prevalent cases of PCOS (NIH Criteria), 2019–28
17 Figure 3: Overview of pipeline drugs for PCOS in the US
17 Figure 4: Pipeline drugs for PCOS, by company
17 Figure 5: Pipeline drugs for PCOS, by drug type
18 Figure 6: Pipeline drugs for PCOS, by classification
21 Figure 7: Probability of success in the endocrine-other pipeline
22 Figure 8: Clinical trials in PCOS
23 Figure 9: Top 10 drugs for clinical trials in PCOS
23 Figure 10: Top 10 companies for clinical trials in PCOS
24 Figure 11: Trial locations in PCOS
25 Figure 12: PCOS trials status
25 Figure 13: PCOS trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of PCOS (Rotterdam Criteria), 2019–28
13 Table 2: Prevalent cases of PCOS (NIH Criteria), 2019–28
16 Table 3: Marketed drugs for PCOS
19 Table 4: Pipeline drugs for PCOS in the US
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