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R&D Trends: Women's Health - Investment needed to address lack of innovation Product Image

R&D Trends: Women's Health - Investment needed to address lack of innovation

  • Published: December 2011
  • 100 pages
  • Datamonitor

Investment into the women’s health sector has suffered in recent years as the pharmaceutical industry moves toward more profitable therapy areas. Nevertheless, the pipeline for new therapeutics remains active in women’s health with developments across a broad range of conditions at both the preclinical and clinical level. This report aims to identify and discuss some of these R&D trends.

Features and benefits

- Understand key dynamics in the R&D pipeline for new women’s health therapies
- Assess to what extent innovation exists in drug R&D for hormonal contraception, menopausal symptoms, uterine fibroids, endometriosis, and infertility.
- Support R&D decision making by evaluating clinical trial designs in key indications
- Access The prediction of how the treatment landscape may change in the next 20 years

Highlights

- There are 136 products in development for women’s health conditions. The highest proportions are for contraceptives and menopausal symptoms, which are the most established women’s health therapy areas, yet present growing barriers to entry.
- Uterine fibroids and endometriosis are attractive READ MORE >

Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Women’s health pipeline trends
Contraception, menopausal symptoms, and infertility are the largest pipelines in women’s health
The highest proportion of products are in Phase II development
Small Pharma companies are the most active in the pipeline
Contraception
Pipeline remains dynamic as companies develop mode of delivery and dosing options
Endometriosis
Candidates continue to aim to manage endometriosis by changing estrogen levels in the body
Menopausal symptoms
At least one third of the pipeline is for high-risk non-hormonals
Female sexual dysfunction
R&D focuses on androgen receptor agonists
Infertility
Uterine fibroids
Likely to be seen as a secondary indication after endometriosis
Other indications in women’s health
Labor and delivery has the greatest number of drug candidates among other women’s health indications
TARGET PRODUCT PROFILES
Overview
Contraception
Comparator – Yasmin/Yaz franchise (drospirenone + ethinylestradiol; Bayer-Schering)
Target product profile versus current level of attainment
Endometriosis
Comparator – Lupron (leuprolide acetate; Abbott)
Target product profile versus current level of attainment
Menopausal symptoms
Comparator – Premarin (conjugated estrogens; Pfizer)
Target product profile versus current level of attainment
Infertility
Comparator – Gonal-F (follitropin alpha; Merck Serono)
Target product profile versus current level of attainment
Female sexual dysfunction
Comparator – Intrinsa (testosterone patch; Warner Chilcott)
Clinical trial data for Intrinsa in treating female sexual dysfunction
Target product profile versus current level of attainment
Uterine fibroids
Comparator – Lupron (leuprolide acetate; Abbott)
Clinical trial data for Lupron in treating uterine fibroids
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN WOMEN’S HEALTH
Contraception
Patient inclusion
Clinical trial size
Placebo versus active control
Trial endpoints in contraception
Endometriosis
Patient inclusion
Clinical trial size
Placebo versus active control
Trial endpoints in endometriosis
Pain
Quality of life
Disease regression and infertility
Menopausal symptoms
Patient inclusion
Trial endpoints in menopausal symptoms
Infertility
Code of best practice in infertility trials
Female sexual dysfunction
Clinical trial endpoints
INNOVATIVE EARLY-STAGE APPROACHES
Lack of understanding of the causes of common women’s health disorders limits innovation
Innovative approaches
Contraception – selective progestogen receptor modulators
Endometriosis – steroid sulfatase inhibitor
Female sexual dysfunction – melanocortin 4 receptor modulators
THE FUTURE OF TREATMENT IN WOMEN’S HEALTH
Overview
Contraception – use will increase as safety, administration, and access improve
Greater access to hormonal contraceptives
Understanding VTE risk will make treatment safer
Menopausal symptoms – HRT to remain the mainstay of treatment until efficacious non-hormonal treatments are developed
New non-hormonal treatments
Endometriosis – better understanding of the disorder is required to develop treatments that will change the treatment paradigm
Non-invasive diagnostic tools, such as biomarkers, will unlock patient potential
Understanding the biology of the disorder will provide new treatment targets
Infertility – focusing on increasing pregnancy rates
Identifying healthy embryos to improve chances of success
In vitro maturation
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX

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