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: 24 August 2022
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 2021, there were approximately 114.9 million (NIH criteria) to 189.8 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.
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 13.8%, and the average probability a drug advances from Phase III is 68.2%. Drugs, on average, take 10.4 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 77% of trials in Phase III–IV, and only 20% 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
22 CLINICAL TRIAL LANDSCAPE
23 Sponsors by status
24 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
22 Figure 9: Top 10 drugs for clinical trials in PCOS
23 Figure 10: Top 10 companies for clinical trials in PCOS
23 Figure 11: Trial locations in PCOS
24 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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