市場調查報告書

市場聚光燈:子宮肌瘤

Market Spotlight: Uterine Fibroids

出版商 Datamonitor Healthcare 商品編碼 951555
出版日期 內容資訊 英文 38 Pages
商品交期: 最快1-2個工作天內
價格
市場聚光燈:子宮肌瘤 Market Spotlight: Uterine Fibroids
出版日期: 2020年07月16日內容資訊: 英文 38 Pages
簡介

全球15歲以上的女性的子宮肌瘤的患病人數,預計從2019年的約9,490萬人,到2028年增加到1億500萬人。美國,子宮肌瘤的臨床試驗數,在世界領先。英國,在歐洲的主要市場領先。日本,在亞洲佔首位。

本報告提供全球子宮肌瘤治療藥市場相關調查分析,主要的上市藥、開發平台藥物,臨床試驗,最近的趨勢,未來趨勢,成功概率,專利資訊,10年預測等相關的系統性資訊。

目錄

概要

要點

疾病的背景

  • 亞型

治療

  • 手術
  • 醫藥品

流行病學

上市藥

開發平台藥物

最近的趨勢和分析師的見解

不久將來的趨勢

主要的法規趨勢

成功概率

許可證與資產收購交易

本源專利

商機

臨床試驗形勢

  • 贊助商:各狀態
  • 贊助商:各階段

參考文件

  • 處方資訊

附錄

目錄
Product Code: DMKC0183230

This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming events, probability of success, regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals.

Key Takeaways

Datamonitor Healthcare estimates that in 2019, there were approximately 94.9 million prevalent cases of uterine fibroids worldwide in females aged 15 years and over, and forecasts that number to increase to 105.0 million prevalent cases by 2028.

Lupron, relugolix, and ORIAHNN, which target gonadotropin-releasing hormone receptor, and ulipristal acetate, which targets progesterone receptor, are the only approved drugs for uterine fibroids. These drugs are administered via the oral and subcutaneous routes.

The largest proportion of industry-sponsored drugs in active clinical development for uterine fibroids are in Phase III, with one drug in the NDA/BLA phase.

Therapies in development for uterine fibroids focus on targets such as progesterone receptor, gonadotropin-releasing hormone receptor, and collagen. The majority of pipeline drugs are administered via the oral route, with one product being available in a subcutaneous formulation.

High-impact upcoming events for drugs in the uterine fibroids space comprise topline Phase III trial results and an expected meeting with the FDA for linzagolix; and an estimated PDUFA date as well as an expected CHMP opinion for relugolix.

The overall likelihood of approval of a Phase I gynecology asset is 14.5%, and the average probability a drug advances from Phase III is 63.6%. Drugs, on average, take 11.8 years from Phase I to approval, compared to 13.0 years in the overall obstetrics/gynecology space.

The distribution of clinical trials across Phase I-IV indicates that the majority of trials for uterine fibroids have been in the early and mid-phases of development, with 59% of trials in Phase I-II, and 41% in Phase III-IV.

The US has a substantial lead in the number of uterine fibroids clinical trials globally. The UK leads the major European markets, while Japan has the top spot in Asia.

Clinical trial activity in the uterine fibroids space is dominated by completed trials. Repros Therapeutics has the highest number of completed clinical trials for uterine fibroids, with 17 trials.

Repros Therapeutics leads industry sponsors with the highest number of clinical trials for uterine fibroids, followed by Takeda

TABLE OF CONTENTS

CONTENTS

OVERVIEW

KEY TAKEAWAYS

DISEASE BACKGROUND

  • Subtypes

TREATMENT

  • Surgery
  • Medical agents

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

  • Linzagolix for Uterine Fibroids (December 9, 2019)
  • Relugolix for Uterine Fibroids (July 23, 2019)
  • Multiple Drugs for Uterine Fibroids (June 25, 2019)
  • Relugolix for Uterine Fibroids (May 14, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

  • Myovant's Relugolix Chases AbbVie's Elagolix In Women's Health Market
  • FDA Approves First Medical Treatment For Fibroid-Related Heavy Menstrual Bleeding
  • Myovant Sciences' Relugolix Among 14 New Hopefuls At EMA
  • Ulipristal Suspended In EU Pending Further Review
  • FDA Recommends Further Limiting Use Of Laparoscopic Power Morcellation
  • AbbVie Revs Up The Race To Market In Uterine Fibroids
  • Myovant Plans Q4 Uterine Fibroid Drug Filing In A Showdown With AbbVie

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Myovant Licenses Ex-US Relugolix Rights To Gedeon Richter
  • Deals Shaping The Medical Industry, August 2019
  • QXMedical Gets Exclusive Rights To University of Minnesota Bioresorbable Technology

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of uterine fibroids, 2019-28
  • Figure 2: Overview of pipeline drugs for uterine fibroids in the US
  • Figure 3: Pipeline drugs for uterine fibroids, by company
  • Figure 4: Pipeline drugs for uterine fibroids, by drug type
  • Figure 5: Pipeline drugs for uterine fibroids, by classification
  • Figure 6: Linzagolix for Uterine Fibroids (December 9, 2019): Phase III - PRIMROSE 2
  • Figure 7: Relugolix for Uterine Fibroids (July 23, 2019): Phase III - LIBERTY 2
  • Figure 8: Relugolix for Uterine Fibroids (May 14, 2019): Phase III - LIBERTY 1
  • Figure 9: Key upcoming events in uterine fibroids
  • Figure 10: Probability of success in the uterine fibroids pipeline
  • Figure 11: Clinical trials in uterine fibroids
  • Figure 12: Top 10 drugs for clinical trials in uterine fibroids
  • Figure 13: Top 10 companies for clinical trials in uterine fibroids
  • Figure 14: Trial locations in uterine fibroids
  • Figure 15: Uterine fibroids trials status
  • Figure 16: Uterine fibroids trials sponsors, by phase

LIST OF TABLES

  • Table 1: Prevalent cases of uterine fibroids, 2019-28
  • Table 2: Marketed drugs for uterine fibroids
  • Table 3: Pipeline drugs for uterine fibroids in the US
  • Table 4: Linzagolix for Uterine Fibroids (December 9, 2019)
  • Table 5: Relugolix for Uterine Fibroids (July 23, 2019)
  • Table 6: Multiple Drugs for Uterine Fibroids (June 25, 2019)
  • Table 7: Relugolix for Uterine Fibroids (May 14, 2019)
  • Table 8: Historical global sales, by drug ($m), 2015-19
  • Table 9: Forecasted global sales, by drug ($m), 2020-24