Polycystic Ovary Syndrome is a condition in which the ovaries produce abnormal amount of androgens (males sex hormones), higher than the amount usually present in a woman with normal ovaries. The ovaries develop fluid filled sacs, known as follicles, which contain an immature egg. However, in polycystic ovary syndrome, none of the eggs mature and the female does not ovulate. This lack of ovulation further alters the level of luteinizing hormone (LH), follicle stimulating hormone (FSH), estrogen and progesterone, and disrupts the menstrual cycle. It affects 1 in 10 women of childbearing age. Although women of all races and ethnicities are at almost same risk of developing PCOS, the risk is high if a woman is already obese, or mother is suffering from the same condition.
What are the symptoms and diagnosis criteria of PCOS?
There is no single test that can diagnose polycystic ovary syndrome. Diagnosis involves evaluation of medical history, physical examination, various other tests and experiencing of symptoms. Some of the women experience the associated symptoms during menarche and majorly discover it while gaining weight or facing problems getting pregnant.
What are the treatments available for PCOS?
Currently, there is no cure for the syndrome, however the affiliated symptoms can be treated using a combination of different types of medications. In addition, the treatment involves management of individual concerns, such as infertility, hirsutism, acne, diabetes and obesity.
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Majority of the drugs in the market are designed for the symptomatic treatment of polycystic ovary syndrome whilst a few drugs are being evaluated for curing this clinical condition. Of these, over 50% of the prescribed drugs for the treatment of PCOS are oral contraceptives. Among various symptoms, acne, ovarian cysts and menstrual irregularities are the most common symptoms of polycystic ovary syndrome, for which physicians preferably prescribe oral contraceptives. Further, majority (80%) of the prescribed drugs are designed for administration through oral route.
Which are the leading administering institute centers supporting the research related to this domain?
In the past few years, majority of the funding institutes have helped the research groups by providing funds for the purpose of identifying novel treatments. There has been a continuous increase in the number of grants awarded for research efforts in this domain; NICHD has emerged as the leading funding institute in terms of awarding grants. Majority of the funding institutes have helped the research groups by providing funds for the purpose of identifying novel treatments.
Which geographies are the most active in conducting clinical trials on PCOS?
There has been a steady rise in the number of clinical trials registered in this domain over the past few years; some big pharma players have been engaged in multiple such studies. Close to 700 trials for PCOS related treatments were registered in the last 20 years; ~90% of these studies have either been completed or are currently recruiting patients. Further, 52% of the trials are being conducted in Europe and Asia-Pacific region, however, more than 80% of the patients are enrolled in clinical trials conducted in North America.
How has the intellectual property landscape in this market evolved over the years?
Over time, close to 3800 patents related to polycystic ovary syndrome have been filed / granted, indicating the rising level of R&D activity in this field. In addition to industry players, majority of the academic institutes have also filed multiple patents related to PCOS.
How is the current and future market opportunity likely to be distributed across key market segments?
The current market is estimated to be worth USD 3.4 billion; this value is projected to reach USD 5 billion by 2031, growing at a CAGR of 4% between 2021-2031
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