What unmet needs remain for women suffering from infertility and how will pipeline agents help remedy these struggles?

Female Infertility – SWOT analysis

Key findings: A variety of medications, surgical procedures, and assisted reproductive technologies are employed to treat female infertility, often determined by the underlying driver of the condition, which may include ovulatory dysfunction, uterine fibroids, endometriosis, or others. Clomiphene and injectable gonadotropins (e.g., Gonal F, Follistim/Puregon) have long been mainstays of therapy to promote ovulation and they serve a key role in in vitro fertilization (IVF), an approach that revolutionized the field of infertility.

Despite the transformative benefits of IVF, the success rate with the procedure is typically below 40%, leaving considerable room for improvement. In particular, advanced age and implantation issues are considered contributors to the failure of IVF. Although there are few validated drug targets, ObsEva’s nolasiban, an oral oxytocin receptor antagonist designed to facilitate implantation, has shown promise in a sizable Phase III study.

The “so what” for decision makers: Nolasiban relies on a mechanism already established for the prevention of pre-term labor; it is designed to prevent uterine contractions that may, in turn, prevent implantation. The drug showed an absolute increase in ongoing pregnancy rate at 10 weeks of 7.1% (placebo 28.5% and nolasiban 35.6%, p = 0.031) in the Phase III IMPLANT2 study in Europe. Interviewed experts who are familiar with the data, released in February 2018, consider it an exciting program—and one that validates a novel pathway for drug developers. ObsEva intends to begin a U.S. pivotal study by the end of 2018.

Beyond nolasiban, the small pipeline for female infertility comprises mostly early-phase programs and emerging biosimilars.  This observation underscores the unmet need to identify and validate additional drug targets to maximize pregnancy outcomes for these motivated patients.

Key questions answered in the analysis:

  • How large is the prevalent population of female patients suffering from infertility?
  • What are the most common causes of female infertility? Is this expected to change in the next 10 years? How are they expected to change?
  • What are current treatment options for female infertility? How do reproductive endocrinologists approach different underlying causes of female infertility?
  • What unmet needs remain for the treatment of different drivers of infertility?
  • What are the most promising pipeline agents? How do experts believe these will fit into future treatment paradigms?

Markets covered: United States, France, Germany, Italy, Spain, and United Kingdom.

Methodology: Six country-specific interviews with thought-leading reproductive endocrinologists supported by survey data from fifty female infertility-treating physicians.

Key drugs covered: Nolasiban, Gonal F (follitropin alfa), Puregon/Follistim (follitropin beta), Rekovelle (follitropin delta) Ovaleap (follitropin alfa biosimilar), Bemfola (follitropin alfa biosimilar), Pergoveris (follitropin alfa/lutropin alfa), Menopur (menotropin), Pregnyl (chorionic gonadotropin), Ovidrel (choriogonadotropin alfa), Clomid (clomiphene).

Key companies mentioned:  Merck KGaA, Merck, Ferring Pharmaceuticals, ObsEva.

For more information about our market assessment for female infertility, please follow this link.

 

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