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市場調查報告書

類鴉片誘發性便秘:機會分析與預測

OpportunityAnalyzer: Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2019

出版商 GlobalData 商品編碼 286300
出版日期 內容資訊 英文 166 Pages
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類鴉片誘發性便秘:機會分析與預測 OpportunityAnalyzer: Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2019
出版日期: 2015年12月01日 內容資訊: 英文 166 Pages
簡介

本報告提供類鴉片誘發性便秘(OIC)市場上機會相關分析、OIC概要、OIC治療藥市場收益、年度治療成本、治療利用模式的資料與預測競爭企業的評估、未滿足需求、臨床實驗趨勢、開發平台分析、及現在、未來的市場競爭情形分析,為您概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理學
    • 病因
    • 病理學
    • 生活品質
  • 症狀

第4章 潛在的患者人口

  • 概要
  • 一般的預測手法
  • 地區特有的預測手法
    • 類鴉片消費
    • OIC案例數
  • 類鴉片消費的各國差異
    • 美國
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
  • 潛在的患者人口的預測
    • 類鴉片誘發性便秘的案例總數

第5章 目前可供選擇的治療方案

  • 概要
  • 產品簡介:領導品牌
    • Relistor
    • Targin
    • Amitiza

第6章 未滿足需求的評估、機會分析

  • 概要
  • 未滿足需求分析
    • 缺乏可供選擇的有效的標靶治療方案
    • 對非瀉藥處方藥OIC治療的醫療費給付
    • 缺乏可供選擇的符合成本效益的治療方案
    • OIC的治療指南定義
    • 醫生的認識、OIC診斷的改善
    • 患者、醫生對OIC的治療可利用的處方藥認識的改善
    • 評估瀉藥功效的臨床資料
    • 集中治療患者的OIC非口服製劑
  • 機會分析
    • 開發沒有副作用以及止痛障礙的有效藥物
    • OIC認證便秘藥的標籤擴大
    • 把其他OBD症狀當做目標的治療
    • 集中性醫生教育行銷宣傳活動的開始

第7章 R&D策略

  • 概要
    • 藥物機制理解的提高
    • 改變品質策略
    • 第二徵兆
    • 利基患者的次級族群
    • 授權、聯盟
  • 臨床實驗設計
    • 目前臨床實驗設計
    • 臨床相關的實驗試驗指標的選擇
    • Mu受體拮抗劑的長期安全性的確證

第8章 開發平台評估

  • 概要
  • 臨床開發有潛力的藥劑

第9章 開發平台評估分析

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業基準
  • 競爭評估
  • 銷售額的5年預測

第10章 附錄

  • 參考文獻
  • 簡稱
  • 調查手法
  • 預測手法
  • 從事了本調查的醫生、專家
  • 關於作者
  • 關於GlobalData
  • 免責聲明

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目錄
Product Code: GDHC007EPOA

The Opioid-Induced Constipation (OIC) is a new and rapidly establishing market currently dominated by OTC laxatives set to undergo substantial growth between 2014 and 2019. The main drivers of growth will be an increase in the diagnosed OIC population. This is fuelled by a relaxation of regulations regarding opioid treatment, particularly in the chronic non-cancer pain population. As a result opioid use has risen sharply in the last 15 years. Concurrently, there has been a rapid increase in patients experiencing OIC, with approximately 40-50% of chronic opioid users reporting symptoms. Traditionally, constipation has been treated with laxatives based on empirical research. However, the efficacy of laxatives to treat OIC is relatively poor and only provides adequate relief for approximately 50% of patients. Prior to 2008, the OIC market was desolate, with no approved pharmaceutical (non-laxative) treatment for this condition. The products that have been approved in the past have come with heavy restrictions limiting their use for the majority of OIC sufferers. However, the OIC therapeutic market is set to enter an explosive period of growth over the five-year forecast period. This advance is catalyzed by a major shift in the OIC treatment algorithm with the entry of several highly- targeted, efficacious, orally-formulated drugs. The competitive landscape will continue to evolve over the forecast period.

Highlights

Key Questions Answered

  • The OIC market is marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the OIC market?
  • The late-stage OIC pipeline is heavily congested with several drugs in the same class, PAMORAs. Will the late-stage drugs make a significant impact on the OIC market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?
  • The current OIC market is dominated by OTC laxatives. How will the advent of highly targeted orally-formulated prescription drugs change the drug treatment landscape for OIC? How will the drug treatment rate change over the next five years? What are the key drivers and barriers to this change?

Key Findings

  • The main driver of the enormous expansion of the OIC market will be the dramatic increase in the number of reported OIC cases, which is attributable to the relaxation of opioid prescribing regulations.
  • The second largest driver will be the launch of several highly anticipated, targeted, efficacious treatment options, with a congested and competitive late stage clinical pipeline.
  • To gain approval it is essential for companies to demonstrate high efficacy while proving no reduction of analgesia or Major Cardiovascular Adverse Effects (MACE), by selecting appropriate clinical trial endpoints.
  • In the future, companies will have to increase physician and patient awareness of non-laxative prescription options to treat constipation through extensive marketing campaigns in order to successfully compete for patient share.
  • The number of pipeline agents being developed by small mid-pharma represents an opportunity for large pharma to enter this highly lucrative market through licensing and marketing partnerships.

Scope

  • Overview of OIC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized OIC therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for seven years to 2019.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the OIC therapeutics market.
  • 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 OIC 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 through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global OIC therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global OIC therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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 OIC therapeutics market from 2014-2019.
  • 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. Table of Contents

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

2. Introduction

  • 2.1. Catalyst

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
    • 3.1.3. Quality of Life
  • 3.2. Symptoms
    • 3.2.1. General Treatment Consensus in the US and EU

4. Potential Patient Population

  • 4.1. Overview
  • 4.2. General Forecasting Methodology
  • 4.3. Region-Specific Forecast Methodology
    • 4.3.1. Opioid Consumption
    • 4.3.2. Number of OIC Cases
  • 4.4. Country-Level Differences in Opioid Consumption
    • 4.4.1. US
    • 4.4.2. France
    • 4.4.3. Germany
    • 4.4.4. Italy
    • 4.4.5. Spain
    • 4.4.6. UK
  • 4.5. Potential OIC Patient Population Forecast
    • 4.5.1. Total Number of Cases of OIC

5. Current Treatment Options

  • 5.1. Overview
  • 5.2. Product Profiles - Major Brands
    • 5.2.1. Relistor
    • 5.2.2. Targin
    • 5.2.3. Amitiza
    • 5.2.4. Movantik

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Reimbursement for Non-Laxative Prescription OIC Therapies in Europe
    • 6.2.2. Defined Treatment Guidelines for OIC
    • 6.2.3. Improved Physician Awareness and Diagnosis of OIC
    • 6.2.4. Improved Patient and Physician Awareness of Prescription Drugs Available for the Treatment of OIC
    • 6.2.5. Clinical Data Assessing Laxative Efficacy
  • 6.3. Opportunity Analysis
    • 6.3.1. Launch of an Extensive Marketing Campaign
    • 6.3.2. Treatments that Target Other OBD Symptoms
    • 6.3.3. Label Expansion of Approved Constipation Drugs into OIC

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Increased Understanding of Drug Mechanism of Action
    • 7.1.2. Reformulation Strategies
    • 7.1.3. Secondary Indications
    • 7.1.4. Licensing Agreements and Alliances
  • 7.2. Clinical Trial Design
    • 7.2.1. Current Clinical Trial Design
    • 7.2.2. Selection of Clinically Relevant Trial Endpoints
    • 7.2.3. Demonstrating the Long-Term Safety of Mu Receptor Antagonists

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Oral Relistor
    • 8.2.2. Naldemedine
    • 8.2.3. Axelopran
    • 8.2.4. Bevenopran
    • 8.2.5. Nalcol
    • 8.2.6. Dolcanatide
    • 8.2.7. Innovative Early-Stage Approaches

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmarking of Key Pipeline OIC Drugs
  • 9.2. Commercial Benchmarking of Key Pipeline OIC Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top-Line, Five-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecast Methodology
    • 10.4.1. Percentage of Drug-Treated Patients
    • 10.4.2. Drugs Included in Each Therapeutic Class
    • 10.4.3. Key Launch Dates
    • 10.4.4. General Pricing Assumptions
    • 10.4.5. Individual Drug Assumptions
    • 10.4.6. Pricing of Pipeline Agents
  • 10.5. Physicians and Specialists Included in This Study
  • 10.6. Primary Research - Prescriber Survey
  • 10.7. About the Authors
    • 10.7.1. Analyst, Cardiovascular and Metabolic Disorders
    • 10.7.2. Therapy Area Director
    • 10.7.3. Global Director of Therapy Analysis and Epidemiology
    • 10.7.4. Global Head of Healthcare
  • 10.8. About GlobalData
  • 10.9. Disclaimer

List of Tables

  • Table 1: Symptoms of OIC
  • Table 2: Potential Number of Cases of OIC in the US, 2014-2019
  • Table 3: Potential Number of Cases of OIC in France, 2014-2019
  • Table 4: Potential Number of Cases of OIC in Germany, 2014-2019
  • Table 5: Potential Number of Cases of OIC in Italy, 2014-2019
  • Table 6: Potential Number of Cases of OIC in Spain, 2014-2019
  • Table 7: Potential Number of Cases of OIC in the UK, 2014-2019
  • Table 8: Total Number of Cases of OIC Among Chronic Opioid Users in the 6MM, 2014-2019
  • Table 9: OTC and Generic Prescription Laxatives Commonly Used To Treat OIC
  • Table 10: Leading Prescription Treatments for OIC
  • Table 11: Product Profile - Relistor
  • Table 12: Relistor SWOT Analysis, 2015
  • Table 13: Product Profile - Targin
  • Table 14: Targin SWOT Analysis, 2015
  • Table 15: Product Profile - Amitiza
  • Table 16: Amitiza SWOT Analysis, 2015
  • Table 17: Product Profile - Movantik
  • Table 18: Naloxegol SWOT Analysis, 2015
  • Table 19: Overall Unmet Needs in OIC - Current Level of Attainment
  • Table 20: OIC - Late-Stage Pipeline, 2015
  • Table 21: Product Profile - Oral Relistor
  • Table 22: Oral Relistor SWOT Analysis, 2015
  • Table 23: Product Profile - Naldemedine
  • Table 24: Naldemedine SWOT Analysis, 2015
  • Table 25: Product Profile - Axelopran
  • Table 26: Clinical Efficacy Data of Axelopran (5mg, 10mg and 15mg) vs. Placebo
  • Table 27: Axelopran SWOT Analysis, 2015
  • Table 28: Product Profile - Bevenopran
  • Table 29: Bevenopran SWOT Analysis, 2015
  • Table 30: Product Profile - Nalcol
  • Table 31: Nalcol SWOT Analysis, 2015
  • Table 32: Product Profile - Dolcanatide
  • Table 33: Efficacy of Dolcanatide
  • Table 34: Safety of Dolcanatide
  • Table 35: Dolcanatide SWOT Analysis, 2015
  • Table 36: Early-Stage Pipeline Products in OIC, 2014
  • Table 37: Clinical Benchmarking of Key Pipeline OIC Drugs
  • Table 38: Commercial Benchmarking of Key Pipeline OIC Drugs
  • Table 39: Top-Line Sales Forecasts ($m) for OIC, 2014-2019
  • Table 40: Key Events Impacting Sales for OIC, 2014-2019
  • Table 41: OIC Market - Drivers and Barriers, 2014-2019
  • Table 42: Abbreviations
  • Table 43: Key Launch Dates
  • Table 44: Number of High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Consumption of Six Commonly Prescribed Opioids in the US, 1995-2010
  • Figure 2: Number of Chronic Opioid Users in the US, 2001-2017
  • Figure 3: Number of Cases of OIC in the US, 2004-2017
  • Figure 4: Consumption of Six Commonly Prescribed Opioids in France, 1995-2010
  • Figure 5: Number of Chronic Opioid Users in France, 2001-2017
  • Figure 6: Number of Cases of OIC in France, 2004-2017
  • Figure 7: Consumption of Six Commonly Prescribed Opioids in Germany, 1995-2010
  • Figure 8: Number of Chronic Opioid Users in Germany, 2001-2017
  • Figure 9: Number of Cases of OIC in Germany, 2004-2017
  • Figure 10: Consumption of Six Commonly Prescribed Opioids in Italy, 1995-2010
  • Figure 11: Number of Chronic Opioid Users in Italy, 2001-2017
  • Figure 12: Number of Cases of OIC in Italy, 2004-2017
  • Figure 13: Consumption of Six Commonly Prescribed Opioids in Spain, 1995-2010
  • Figure 14: Number of Chronic Opioid Users in Spain, 2001-2017
  • Figure 15: Number of Cases of OIC in Spain, 2004-2017
  • Figure 16: Consumption of Six Commonly Prescribed Opioids in the UK, 1995-2010
  • Figure 17: Number of Chronic Opioid Users in the UK, 2001-2017
  • Figure 18: Number of Cases of OIC in the UK, 2004-2017
  • Figure 19: Total Number of Cases of OIC in the 6MM, 2014
  • Figure 20: Competitive Assessment of Late-Stage Pipeline Agents in OIC, 2014-2019
  • Figure 21: Sales for OIC by Region, 2014 and 2019
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