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915017

女性不孕症:市場機會分析和未來預測 ∼2028年

Female Infertility: Opportunity Analysis and Forecasts to 2028

出版日期: | 出版商: GlobalData | 英文 134 Pages | 訂單完成後即時交付

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  • 簡介
  • 目錄
簡介

全球主要7國 (美國、法國、德國、義大利、西班牙、英國、加拿大) 的女性不孕症治療藥物市場規模,預估將從2017年的18億美元,以3.4%的CAGR (複合年均成長率) 於2028年成長至25億美元規模。

本報告研究女性不孕症治療藥物最新研究和開發動向,分析未來市場趨勢展望、彙整疾病概述、現段階治療方法、未滿足需求和市場機會評估、未來10年病例數和市場規模預測、臨床試驗進展、新治療藥物PIPELINE評估、未來市場和技術動向等情報。

第1章 目錄

第2章 女性不孕症:摘要整理

第3章 前言

第4章 疾病概述

  • 病因
    • 卵巢儲備功能下降和排卵異常
    • 子宮內膜異位
    • 輸卵管異常/骨盆內粘連
    • 子宮因素
    • 原因不明的不孕症
    • 其他因素

第5章 流行病學

  • 疾病背景
  • 風險因素和合併症
  • 全球和歷史趨勢
  • 預測方法
    • 使用來源
    • 預測假設和方法:女性不孕症和生殖力受損病例總數
    • 預測假設和方法:女性不孕症罹病數:按主要病因
    • 預測假設和方法:生殖力受損罹病數:按治療類型
  • 女性不孕症和生殖力受損之流行病學預測 (未來11年)
    • 女性不孕症病例數
    • 生殖力受損病例數
    • 女性不孕症病例數:按年齡
    • 生殖力受損病例數:按年齡
    • 女性不孕症病例數:按主要病因
  • 討論
    • 流行病學預測結果考察
    • 分析侷限
    • 分析優勢

第6章 目前的治療選項

  • 概述
  • 排卵誘導
    • 排卵藥
    • 芬香環轉化□抑制劑
    • 促性腺激素
  • 人工生殖技術 (ART)
    • 促性腺激素
    • GnRH致效劑
    • GnRH拮抗劑

第7章 未滿足需求和市場機會評估

  • 概述
  • 改善體外受精 (IVF) 每週期成功率
  • 透過口服和長效型藥物簡化IVF流程
  • 黃體期支援用之病患友好的黃體素投藥
  • 針對反應較差病患的新療法
  • 子宮肌瘤相關不孕症之非手術療法
  • 降低頻繁接受體外受精治療病患的中斷率
  • 高風險病患的早期發現

第8章 研發策略

  • 概述
    • 長效FSH (濾泡刺激素) Analogue
    • 預填充筆型注射裝置
    • Follitropin Alfa + Lutropin Alfa混合劑
  • 臨床試驗
    • 目前的臨床試驗設計
    • 不完整的病患結果報告

第9章 PIPELINE產品評估

  • 概述
  • 臨床開發中有希望的藥物
    • Nolasiban (OBE001)
    • MVT-602
    • Milprosa (DR-2011、孕酮陰道環)
    • 口服GnRH拮抗劑:藥品仿單標示外使用 (Off Label Use) 的可能性
  • 其他開發中藥物

第10章 PIPELINE評估分析

  • 主要PIPELINE藥物的臨床基準分析
    • Nolasiban
    • MVT-602
    • Milprosa
  • 主要PIPELINE藥物的商業基準分析
  • 競爭評估
  • 主要國家市場預測 (未來10年)
    • 美國
    • 歐洲主要5國 (EU5)
    • 日本

第11章 附錄

目錄
Product Code: GDHC103POA

The report "Female Infertility: Opportunity Analysis and Forecasts to 2028" expects the Female Infertility (FI) drug market to grow from $1.8bn in 2018 to $2.5bn in 2028 across the seven major markets (7MM - US, France, Germany, Italy, Spain, the UK and Japan) at a compound annual growth rate (CAGR) of 3.4%. This growth will be partially attributed to the projected increase in assisted reproductive technology (ART) treatment rates in the seven major markets (7MM - US, France, Germany, Italy, Spain, the UK and Japan) during the forecast period.

Female Infertility (FI) is a complex disorder defined as the inability to conceive after at least one year of timed, unprotected intercourse. The etiology of the condition spans a wide range of disorders that can be broadly classified into the following categories: diminished ovarian reserve & ovulation disorders, endometriosis, fallopian tube abnormalities, uterine factors and unexplained infertility.

The fact that a growing number of women are postponing pregnancy until later in life when fertility has generally decreased, will translate into increased use of ART fertility treatments between 2018 and 2028.

A limited number of established companies compete in this space, and the strategy has mainly been to create improved versions of existing drugs. As such, the drugs used to treat patients have remained largely unchanged. These include, among others, blockbuster drugs such as EMD Serono's Gonal-F (follitropin alfa), Merck & Co's Follistim (follitropin beta) and Ferring Pharmaceuticals' Menopur (menotropins) which collectively claimed over 50% of the total FI market in 2018.

Among the late stage pipeline agents, key opinion leaders (KOLs) interviewed by GlobalData were especially enthusiastic regarding nolasiban, noting a promising future for the drug in the ART treatment setting. In 2028, this drug will be worth $320m in the US and 5EU (France, Germany, Italy, Spain and the UK). Ultimately, nolasiban will be a welcome addition to the therapeutic paradigm that will partially address the unmet need of improving embryo implantation rates during ART cycles.

Of particular note are the unmet needs for treatments that further improve success rate per ART cycle, orally and less frequently administered drugs during in vitro fertilization (IVF) treatment, novel treatments for improving IVF outcomes in reproductively older women and reducing the high IVF treatment dropout rates.

Scope:

  • Overview of Female Infertility including epidemiology, etiology and current treatment options, namely ovulation induction and ART
  • Topline Female Infertility market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting Female Infertility therapeutics sales in the 7MM.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global Female Infertility therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy:

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global Female Infertility therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Female Infertility market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global Female Infertility therapeutics market from 2018-2028.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Female Infertility: Executive Summary

  • 2.1. Moderate Growth in the Female Infertility Market Expected Between 2018. and 2028, Driven by US and EU Sales
  • 2.2. R&D Strategies Focused Largely on Improved Versions of Current Drugs
  • 2.3. Despite Major Progress in Treating Patients, Unmet Needs Exists in the Space
  • 2.4. Sparse Pipeline, But Potential New Addition Highly Intriguing to Physicians
  • 2.5. What Do Physicians Think?

3. Introduction

  • 3.1. Catalyst
  • 3.2. Related Reports

4. Disease Overview

  • 4.1. Etiology
    • 4.1.1. Diminished Ovarian Reserve & Ovulation Disorders
    • 4.1.2. Endometriosis
    • 4.1.3. Fallopian tube abnormalities/pelvic adhesions
    • 4.1.4. Uterine factors
    • 4.1.5. Unexplained infertility
    • 4.1.6. Other factors

5. Epidemiology

  • 5.1. Disease Background
  • 5.2. Risk Factors and Comorbidities
  • 5.3. Global and Historical Trends
  • 5.4. Forecast Methodology
    • 5.4.1. Sources Used
    • 5.4.2. Forecast Assumptions and Methods: Total Prevalent Cases of Female Infertility and Impaired Fecundity
    • 5.4.3. Forecast Assumptions and Methods: Total Prevalence of Female Infertility by Major Etiological Factors
    • 5.4.4. Forecast Assumptions and Methods: Total Prevalence of Impaired Fecundity by Treatment Type
  • 5.5. Epidemiological Forecast for Female Infertility and Impaired Fecundity (2018-2028)
    • 5.5.1. Total Prevalent Cases of Female Infertility
    • 5.5.2. Total Prevalent Cases of Impaired Fecundity
    • 5.5.3. Age-Specific Total Prevalent Cases of Female Infertility
    • 5.5.4. Age-Specific Total Prevalent Cases of Impaired Fecundity
    • 5.5.5. Total Prevalent Cases of Female Infertility by Major Etiological Factors
  • 5.6. Discussion
    • 5.6.1. Epidemiological Forecast Insight
    • 5.6.2. Limitations of the Analysis
    • 5.6.3. Strengths of the Analysis

6. Current Treatment Options

  • 6.1. Overview
  • 6.2. Ovulation Induction
    • 6.2.1. Clomiphene Citrate
    • 6.2.2. Aromatase Inhibitors
    • 6.2.3. Gonadotropins
  • 6.3. Assisted Reproductive Technologies
    • 6.3.1. Gonadotropins
    • 6.3.2. GnRH Agonists
    • 6.3.3. GnRH Antagonists

7. Unmet Needs and Opportunity Assessment

  • 7.1. Overview
  • 7.2. Improved IVF Success Rates Per Cycle
  • 7.3. Oral and Longer-Acting Drugs that Simplify the IVF Process
  • 7.4. Patient-Friendlier Progesterone Administration for Luteal Phase Support
  • 7.5. Novel Treatments for Poor Responders
  • 7.6. Non-Surgical Treatments for Uterine Fibroid-Related Infertility
  • 7.7. Reducing High IVF Treatment Patient Dropout Rates
  • 7.8. Early Detection of High-Risk Patients

8. R&D Strategies

  • 8.1. Overview
    • 8.1.1. Long-Acting FSH Analogue
    • 8.1.2. Pre-Filled Pen Injection Devices
    • 8.1.3. Fixed Combination of Follitropin Alfa + Lutropin Alfa
  • 8.2. Clinical Trials
    • 8.2.1. Current Clinical Trial Design
    • 8.2.2. Incomplete Reporting of Outcomes

9. Pipeline Assessment

  • 9.1. Overview
  • 9.2. Promising Drugs in Clinical Development
    • 9.2.1. Nolasiban (OBE001)
    • 9.2.2. MVT-602
    • 9.2.3. Milprosa (DR-2011, Progesterone Vaginal Ring)
    • 9.2.4. Off-Label Potential for Oral GnRH Antagonists
  • 9.3. Other Drugs in Development

10. Pipeline Valuation Analysis

  • 10.1. Clinical Benchmark of Key Pipeline Drugs
    • 10.1.1. Nolasiban
    • 10.1.2. MVT-602
    • 10.1.3. Milprosa
  • 10.2. Commercial Benchmark of Key Pipeline Drugs
  • 10.3. Competitive Assessment
  • 10.4. Top-Line 10-Year Forecast
    • 10.4.1. US
    • 10.4.2. 5EU
    • 10.4.3. Japan

11. Appendix

  • 11.1. Bibliography
  • 11.2. Abbreviations
  • 11.3. Methodology
    • 11.3.1. Forecasting Methodology
    • 11.3.2. Percent Drug-Treated Patients
    • 11.3.3. Drugs Included in Each Therapeutic Class
    • 11.3.4. Launch and Patent Expiry Dates
    • 11.3.5. General Pricing Assumptions
    • 11.3.6. Individual Drug Assumptions
    • 11.3.7. Generic Erosion
    • 11.3.8. Pricing of Pipeline Agents
  • 11.4. Primary Research - KOLs Interviewed for This Report
    • 11.4.1. KOLs
  • 11.5. Primary Research - Prescriber Survey
  • 11.6. About the Authors
    • 11.6.1. Analyst
    • 11.6.2. Therapy Area Director
    • 11.6.3. Therapy Area Associate Director
    • 11.6.4. Epidemiologists
    • 11.6.5. Epidemiology Reviewers
    • 11.6.6. Global Director of Therapy Analysis and Epidemiology
    • 11.6.7. Global Head and EVP of Healthcare Operations and Strategy
  • 11.7. About GlobalData
  • 11.8. Contact Us
  • 11.9. Disclaimer

List of Tables

  • Table 1: Female Infertility: Key Metrics in the 7MM
  • Table 2: Classification of Female Infertility
  • Table 3: Risk Factors and Comorbid Conditions Associated with Female Infertility
  • Table 4: Treatment Guidelines for Female Infertility
  • Table 5: Common on-label drugs for clinical use as part of female infertility treatments
  • Table 6: Off-Label Treatments for Female Infertility
  • Table 7: Comparison of Therapeutic Classes in Development for Female Infertility, 2018-2028
  • Table 8: Other Drugs in Development for Female Infertility, 2019
  • Table 9: Clinical Benchmark of Nolasiban Against Off-Label Use of Atosiban
  • Table 10: Clinical Benchmark of MVT-602 Against SOC
  • Table 11: Clinical Benchmark of Milprosa Against SOC
  • Table 12: Commercial Benchmark of Nolasiban
  • Table 13: Commercial Benchmark of MVT-602
  • Table 14: Commercial Benchmark of Milprosa
  • Table 15: Key Events Impacting Sales for Female Infertility, 2018-2028
  • Table 16: Female Infertility Market - Global Drivers and Barriers, 2018-2028
  • Table 17: Key Historical and Projected Launch Dates for Female Infertility
  • Table 18: Key Historical and Projected Patent Expiry Dates for Female Infertility
  • Table 19: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Global Sales Forecast by Country for Female Infertility in 2018 and 2028
  • Figure 2: Competitive Assessment of Pipeline Drug Nolasiban Benchmarked Against Off-Label Use of Atosiban During Embryo Transfer
  • Figure 3: Competitive Assessment of the Pipeline Drug MVT-602 Benchmarked Against the Trigger Shot SOC Options hCG and GnRH agonists
  • Figure 4: Competitive Assessment of the Pipeline Drug Milprosa Benchmarked Against the Luteal Phase Support SOC IM and Vaginal Progesterone
  • Figure 5: Major Etiologic Factors of Female Infertility
  • Figure 6: 7MM, Total Prevalence of Female Infertility (%), Ages 15-44 Years, 2018
  • Figure 7: 7MM, Total Prevalence of Impaired Fecundity (%), Ages 15-44 Years, 2018
  • Figure 8: 7MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of Female Infertility
  • Figure 9: 7MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of Impaired Fecundity
  • Figure 10: 7MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of Female Infertility by Major Etiological Factors
  • Figure 11: 7MM, Total Prevalent Cases of Female Infertility, N, Ages 15-44 Years, 2018
  • Figure 12: 7MM, Total Prevalent Cases of Impaired Fecundity, N, Ages 15-44 Years, 2018
  • Figure 13: 7MM, Age-Specific Total Prevalent Cases of Female Infertility, N, Ages 15-44 Years, 2018
  • Figure 14: 7MM, Age-Specific Total Prevalent Cases of Impaired Fecundity, N, Women, Ages 15-44 Years, 2018
  • Figure 15: 7MM, Total Prevalent Cases of Female Infertility by Major Etiological Factors, N, Ages 15-44 Years, 2018
  • Figure 16: Unmet Needs and Opportunities in Female Infertility
  • Figure 17: Overview of the Development Pipeline in Female Infertility
  • Figure 18: Key Phase II/III Trials for the Promising Pipeline Agents
  • Figure 19: Competitive Assessment of the Pipeline Drug Nolasiban Benchmarked Against the Off-Label Use of Atosiban
  • Figure 20: Competitive Assessment of the Pipeline Drug MVT-602 Benchmarked Against the SOC, hCG and GnRH Agonist
  • Figure 21: Competitive Assessment of the Pipeline Drug Milrposa Benchmarked Against the SOC, IM and Vaginal Progesterone
  • Figure 22: Global (7MM) Sales Forecast by Country for Female Infertility, 2018 and 2028
  • Figure 23: Global Sales Forecast by Class for Female Infertility, 2018 and 2028
  • Figure 24: Sales Forecast by Class for Female Infertility in the US, 2018 and 2028
  • Figure 25: Sales Forecast by Class for Female Infertility in the 5EU, 2018 and 2028
  • Figure 26: Sales Forecast by Class for Female Infertility in Japan, 2018 and 2028