研發趨勢：婦科醫療 -必須要有充裕投資， 解決技術創新之不足

研發趨勢：婦科醫療 -必須要有充裕投資， 解決技術創新之不足 是由出版商Datamonitor在2011年12月所出版的。 這份英文市場調查報告書包含Pages: 100 價格從美金3800起跳。

簡介

隨醫療藥物產業逐漸轉移至收益較高之領域，近年來婦科醫療正苦於其投資之減少。但即使同領域，也分為臨床前及臨床層級，在網羅各種條件之研發下，新藥產品線仍算活絡。

本報告為，關注婦科領域之新藥開發情形，並匯整其動態最新資訊，以下列摘要形式闡述。

實施概要

• 策略性範圍設定及觀點
• Datamonitor重要看法
• 相關報告

概要

• 驅力
• 摘要

臨床產品線概況

• 婦科醫療產品線趨勢
  • 婦科醫療藥物開發最大產品線為避孕、更年期、不孕治療
  • 第二開發階段之產品比率最高
  • 產品線中小型醫療藥物企業最為活躍
• 避孕
  • 各公司於開發分娩方式及給藥選項同時，仍維持產品線之動態
• 子宮內膜異位症
  • 對候補藥劑之企圖不變，依體內雌激素數值調整進行病症管理
• 更年期症狀
  • 產品線中最低三分之一為高風險之非激素類藥物
• 女性性功能障礙
  • 研發重點轉向雄激素受體激動劑
• 不孕
• 子宮肌瘤
  • 被視為是子宮內膜異位症之次發症狀
• 其他婦科疾病
  • 「其他婦科疾病」中，具有最多候補藥物之分娩領域

對象產品簡介

• 概要
• 避孕
  • 比較 - Yasmin/Yaz 專利（屈螺酮+炔雌醇：Bayer-Schering）
  • 目標產品簡介及目前達成率
• 子宮內膜異位症
  • 比較 - Lupron（亮丙瑞林醋酸：Abbott）
  • 目標產品簡介及目前達成率
• 更年期症狀
  • 比較 - Premarin（共軛雌激素：Pfizer）
  • 目標產品簡介及目前達成率
• 不孕
  • 比較 - Gonal-F（卵泡刺激素：Merck Serono）
  • 目標產品簡介及目前達成率
• 女性性功能障礙
  • 比較 - Intrinsa（睾酮貼片：Warner Chilcott）
  • 治療女性性功能障礙Intrinsa之i治臨床實驗數據
  • 目標產品簡介及目前達成率
• 子宮肌瘤
  • 比較 - Lupron（亮丙瑞林醋酸：Abbott）
  • 目標產品簡介及目前達成率

婦科試驗設計

• 避孕
• 子宮內膜異位症
• 更年期症狀
• 不孕
• 女性性功能障礙

創新早期階段之方式

• 對婦科疾病認識不足，限制技術創新
• 創新方式
  • 避孕 - 選擇性孕激素受體調節劑
  • 子宮內膜異位症 - 類固醇硫酸酯酶抑製劑
  • 女性性功能障礙 - 4型黑皮素受體調節劑

婦科治療展望

• 概要
• 避孕 - 提升安全性、管理方式、容易獲得等，將可增加使用量
  • 荷爾蒙避孕藥極為容易獲得
  • 更年期症狀 - 在有效的非激素療法開發之前，以HRT（激素替代療法）為主
    • 新的非激素療法
  • 子宮內膜異位症
  • 更年期症狀 - 轉換治療模式之治療開發上，必須對疾病有更多之認識
    • 與病患潛能發揮息息相關之生物標誌物等非侵入式診斷工具
    • 疾病生物學認識將提供新治療目標
  • 不孕 - 懷孕率上升受到關注
    • 健康胎兒之檢測成功率增加
    • 體外成熟

  參考文獻

  • 論文
  • 網站
  • Datamonitor報告

  附錄

目錄

Description

Introduction

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 Datamonitor's 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 markets, yet there is limited investment and innovation. In the short term, the most eagerly awaited candidates are oral gonadotropin releasing hormone antagonists, while long term innovation is shown in diagnostic and biomarker research.
• Drug discovery investment is lacking in women's health because of the lower perceived return. As such, patient access, not drug advances, will drive long term growth in the market. A continuous increase in the treatable population will be driven by raising demand for treatments, particularly for infertility and contraceptives.

Your key questions answered

• Which are the most targeted women's health disorders by drug developers and why?
• What modes of action and administration are being targeted and by which companies im each of the core women's health conditions?
• What is the most appropriate comparator therapy and what are the target product profiles for key women's health indications?
• What are the requirements of European and US regulatory bodies to ensure approval of a novel candidate?
• How will the management of women's health develop over the next 20 years?

TOC

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

APPENDI

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