表紙
市場調査レポート

肥満治療薬:大きな市場機会にもかかわらず安全性の懸念が薬剤効能を妨げる

Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity

発行 GBI Research 商品コード 281888
出版日 ページ情報 英文 93 Pages
即納可能
価格
本日の銀行送金レート: 1USD=105.42円で換算しております。
Back to Top
肥満治療薬:大きな市場機会にもかかわらず安全性の懸念が薬剤効能を妨げる Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity
出版日: 2013年08月31日 ページ情報: 英文 93 Pages
概要

現在の抗肥満薬市場は、特許期限切れのオルリスタット製品が独占していますが、2012年の約7億5,000万米ドルから2019年の約26億米ドルへ、CAGR20.7%で成長すると予測されています。この成長の大部分は、最近認可されたキューシミア(Qsymia)の実績によるものです。

当レポートでは、世界の肥満治療薬市場について調査し、疾病の概要、主な上市薬、パイプライン薬、主要国の市場予測、および共同開発・ライセンシング契約動向などの分析を提供しており、概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

  • 病因・病態生理学
  • 分類
  • 疫学
  • 併存疾患
  • 経済的負担
  • 現在の治療選択肢
  • 治療用の抗肥満薬を開発する理由?

第3章 上市製品

  • アンフェタミン様薬剤
    • 概要
    • 効能プロファイル
    • 安全性プロファイル
  • キューシミア(Qsymia):Vivus, Inc.
    • 概要
    • 効能プロファイル
    • 安全性プロファイル
    • 議論
  • オルリスタット(Orlistat)
    • 概要
    • 効能プロファイル
    • 安全性プロファイル
    • 議論
  • (Belviq):Arena Pharmaceuticals
    • 概要
    • 効能プロファイル
    • 安全性プロファイル
    • 議論
  • 上市抗肥満薬の低い長期成功率
  • 議論

第4章 パイプライン

  • パイプライン段階、分子タイプおよび分子標的別によるパイプラインの概要
  • 治験期間・規模
  • 治験の失敗、摩耗率および治験失敗の理由
  • 1次・2次エンドポイント
  • 開発パイプラインの後期段階治療薬
  • 議論

第5章 市場予測

  • 世界市場
  • 米国
  • 欧州
  • 日本
  • 議論
  • 抗肥満市場の促進因子・阻害因子
  • 抗肥満市場の促進因子
  • 抗肥満市場の阻害因子

第6章 ライセンシング・共同開発契約

  • ライセンシング契約
  • 共同開発契約

第7章 付録

図表リスト

目次
Product Code: GBIHC302MR

The Obesity Therapeutics Market has Few Candidates in Late-stage Development, Limiting Market Growth

Only 3% of the developmental pipeline is currently in the late stages of development, with only one drug candidate in Pre-registration and two in Phase III. This therefore limits the number of drugs with the potential to be approved during the forecast period and subsequently the potential for market growth. Over two thirds of the pipeline molecules (67%) are in the discovery or Pre-registration Phases of development, suggesting a recent surge in interest in anti-obesity drugs. This may be a reflection of the continued increase in the prevalence of obesity and a need for additional treatment to the currently favored option of lifestyle modification, through dieting and increased exercise.

The Growth of the Anti-obesity Drugs Market is Restricted by High Attrition Rates

The successful transition of anti-obesity drugs from Phase I to market is very difficult. The development of more than 80% of products is terminated before reaching Pre-registration. This may contribute to the low number of drug candidates seen at the later stages of the developmental pipeline. Furthermore, previously approved drugs, including Sanofi-Aventis' Acomplia (rimonabant) and Knoll Pharmaceutical's/Abbott Laboratories' Meridia (sibutramine), were withdrawn from the market in 2008 and 2010 respectively due to the emergence of serious side effects post-marketing, such as severe depression, anxiety, suicidal thoughts, and cardiovascular complications, including heart failure. This has resulted in a stagnant anti-obesity market over the past decade, with only orlistat being proven safe as a long-term treatment for obesity.

Recently Approved Product Expected to Drive Obesity Market

The global prevalence of obesity and overweight (anti-obesity medication is also indicated for patients who are overweight with comorbidities) is very high, with a minimum of 20% of the population falling into this category in the countries covered in this report (US, UK, France, Germany, Italy, Spain and Japan), rising to a maximum of 45%. Despite this, a very small percentage of patients known to healthcare professionals to be obese are treated with pharmacotherapy. This may be a result of several factors, such as the limited efficacy of currently available drugs and the general unfavorable opinion of healthcare professionals and patients of anti-obesity drugs due to side effects and multiple withdrawals following negative post-marketing safety studies.

The current market, which is dominated by off-patent orlistat products, is expected to grow at a modest Compound Annual Growth Rate (CAGR) of 20.7% from approximately $750m in 2012 to approximately $2.6 billion in 2019. This growth is mostly attributed to the performance of the recently approved Qsymia, which is superior in terms of efficacy to the current best option for the long-term treatment of obesity, namely orlistat, and to any of the late-stage pipeline drugs. It is currently undergoing post-marketing studies to determine its long-term cardiovascular safety.

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Obesity Therapeutics to 2019 - Safety Concerns Hinder Drug Performance Despite Large Market Opportunity". Obesity is often described as a global endemic, with incidence dramatically increasing over the past decades, particularly in developed countries. Being overweight or obese is a major risk factor in the development of many chronic diseases, including cardiovascular diseases, cancer, and diabetes, of which treatment incurs extensive economic and healthcare costs. Numerous anti-obesity drugs have been approved in the past decade, including Knoll Pharmaceutical's Meridia (sibutramine) and Acomplia (rimonabant), only for them to be removed from the market due to evidence of suicidal thoughts, depression and cardiovascular problems with their long-term use. As such, healthcare professionals have a negative perception of such drugs and do not widely prescribe them, a major barrier to the growth of the anti-obesity therapeutics market.

Only orlistat is currently deemed safe for the long-term treatment of obesity; being proven to produce a placebo-adjusted weight-loss average of a limited 3kg. Two anti-obesity drugs were approved in June and July 2012, and GBI Research believes that only one, Vivus' Qsymia, has a strong enough safety and efficacy (average placebo-adjusted weight loss of 5kg at the medium dose) profile to make a significant impact on the market, providing it is proven safe in long-term-use studies. If proven safe, GBI Research expects the sales of Qsymia and other drugs expected to be approved over the forecast period to increase the market size to $2.7 billion. Although moderate, this is significantly below the market potential given the size of the prevalence population. Optimally safe and effective anti-obesity drugs which overcome healthcare professionals' negative opinions will have to be developed if the size of the market is ever to reflect the prevalence of obesity.

Scope

  • The report analyzes the incidence of obesity, current treatment options, pipeline and market forecasts, and deals surrounding anti-obesity drugs.
  • A brief introduction to obesity; detailed analysis of recent, current and projected incidence trends; co-morbidities; economic implications of their treatment; and the current treatment options
  • Analysis of the currently marketed anti-obesity drugs, including recent sales figures, safety and efficacy data, and a discussion of each drug's expected performance within the forecast period
  • Comprehensive reviews of the pipeline for anti-obesity drugs, including analysis by molecule type and mechanism of action
  • Statistical analysis of clinical trial duration, size, and failure rate by Phase and molecule type
  • An in-depth forecast model for the anti-obesity drugs market in the US, UK, France, Germany, Italy, Spain and Japan. Each model is based on the anticipated market performance of marketed drugs and those expected to be approved within the forecast period, and takes into account drug cost, efficacy, safety, and likely prescription volumes.
  • A detailed discussion of the drivers and barriers for this immature market.

Reasons to buy

  • The report will enhance your decision-making capability by allowing you to -
  • Understand the large number of potential molecular targets for the development of an anti-obesity drug, as well as the strengths, weaknesses, and risks of each drug type
  • Gain an in-depth view of the current status of the anti-obesity drug pipeline, including the most common molecular targets and molecule types in development
  • Observe the trends in clinical trial duration and size by Phase, molecule type and mechanism of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and future developmental programs
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the anti-obesity drugs market
  • Analyze current and past deals surrounding anti-obesity drugs, including their value, year of deal and in depth details of the highest value deals.

About GBI Research

GBI Research is a leading business information company providing global business information reports and services.

Our highly qualified team of Analysts, Researchers, and Solution Consultants use proprietary data sources and various tools and techniques to gather, analyze and represent the latest and the most reliable information essential for businesses to sustain a competitive edge.

Table of Contents

1. Table of Contents

  • 1.1 List of Tables
  • 1.2 List of Figures

2. Introduction

  • 2.1 Etiology and Pathophysiology
  • 2.2 Classification
  • 2.3 Epidemiology
    • 2.3.1 The US
    • 2.3.2 Obesity in the Top Five European Markets
    • 2.3.3 Japan
  • 2.4 Comorbidities
    • 2.4.1 Type 2 Diabetes
    • 2.4.2 Hypertension
    • 2.4.3 Dyslipidemia
    • 2.4.4 Respiratory Problems
    • 2.4.5 Osteoarthritis
    • 2.4.6 Cancer Risk
  • 2.5 Economic Burden
  • 2.6 Current Therapy Options
    • 2.6.1 Lifestyle and Behavioral Modifications
    • 2.6.2 Bariatric Surgery
    • 2.6.3 Pharmacotherapy
    • 2.6.4 Treatment Algorithms and Prescription Habits
    • 2.6.5 Method of Determining Treatment Effectiveness
  • 2.7 Why Develop Therapeutic Anti-obesity Drugs?

3. Marketed Products

  • 3.1 Amphetamine-like Drugs
    • 3.1.1 Overview
    • 3.1.2 Efficacy Profile
    • 3.1.3 Safety Profile
  • 3.2 Qsymia, Vivus, Inc.
    • 3.2.1 Overview
    • 3.2.2 Efficacy Profile
    • 3.2.3 Safety Profile
    • 3.2.4 Discussion
  • 3.3 Orlistat
    • 3.3.1 Overview
    • 3.3.2 Efficacy Profile
    • 3.3.3 Safety Profile
    • 3.3.4 Discussion
  • 3.4 Belviq, Arena Pharmaceuticals
    • 3.4.1 Introduction
    • 3.4.2 Efficacy Profile
    • 3.4.3 Safety Profile
    • 3.4.4 Discussion
  • 3.5 Low Long-term Success Rate of Marketed Anti-Obesity Drugs
  • 3.6 Discussion

4. Pipeline

  • 4.1 Overview of Pipeline by Phase, Molecule Type and Molecular Target
  • 4.2 Clinical Trial Duration and Size
    • 4.2.1 Clinical Trial Duration
    • 4.2.2 Clinical Trial Size
  • 4.3 Clinical Trial Failure, Attrition Rate and Reasons for Clinical Trial Failure
  • 4.4 Primary and Secondary Endpoints
  • 4.5 Late-stage Drugs of the Developmental Pipeline
    • 4.5.1 Contrave, Orexigen Therapeutics
    • 4.5.2 Cametor, Norgine BV
    • 4.5.3 Victoza, Novo Nordisk
    • 4.5.4 Tesofensine (NeuroSearch)
  • 4.6 Discussion

5. Market Forecasts

  • 5.1 Global Market
  • 5.2 The US
    • 5.2.1 Epidemiology and Treatment Usage Patterns
    • 5.2.2 Annual Cost of Therapy
    • 5.2.3 Market Size
  • 5.3 Europe
    • 5.3.1 Treatment Usage Patterns
    • 5.3.2 Annual Cost of Therapy
    • 5.3.3 Market Size
  • 5.4 Japan
    • 5.4.1 Treatment Usage Patterns
    • 5.4.2 Annual Cost of Therapy
    • 5.4.3 Market Forecast
  • 5.5 Discussion
  • 5.6 Drivers and Barriers of the Anti-obesity Market
  • 5.7 Obesity Market Drivers
    • 5.7.1 Obesity is a Very Prevalent Disease with Large Potential Target Populations Globally
    • 5.7.2 Recent Approval of Qsymia to Drive Market Growth Providing its Long-term Safety is Proved
    • 5.7.3 Diversification of Molecular Targets
  • 5.8 Obesity Market Barriers
    • 5.8.1 Low Treatment Rate
    • 5.8.2 Reimbursement Issues

6. Licensing and Co-Development Deals

  • 6.1 Licensing Deals
    • 6.1.1 EMD Serono Enters into Collaboration and Licensing Agreement with Theratechnologies
    • 6.1.2 Amylin Pharma Enters into Licensing Agreement with Takeda Pharma
    • 6.1.3 Palatin Technologies Extends License Agreement with AstraZeneca
    • 6.1.4 Zealand Pharma Enters into Licensing and Collaboration Agreement with Boehringer Ingelheim
  • 6.2 Co-development Deals
    • 6.2.1 Isis Enters into Collaboration Agreement with Ortho-McNeil
    • 6.2.2 Orexigen Therapeutics Enters into Co-development Agreement with Takeda Pharma for Contrave

7. Appendix

  • 7.1 References
  • 7.2 Abbreviations
  • 7.3 All Pipeline Drugs by Phase
    • 7.3.1 Discovery
    • 7.3.2 Preclinical
    • 7.3.3 Phase I
    • 7.3.4 Phase II
    • 7.3.5 Phase III
    • 7.3.6 Pre-Registration
  • 7.4 Market Forecasts to 2019
    • 7.4.1 Global
    • 7.4.2 The US
    • 7.4.3 UK
    • 7.4.4 France
    • 7.4.5 Germany
    • 7.4.6 Italy
    • 7.4.7 Spain
    • 7.4.8 Japan
  • 7.5 Methodology
  • 7.6 Secondary Research
  • 7.7 Therapeutic Landscape
  • 7.8 Epidemiology-Based Forecasting
  • 7.9 Market Size by Geography
  • 7.10 Pipeline Analysis
  • 7.11 Contact Us
  • 7.12 Disclaimer

List of Tables

  • Table 1: BMI Classifications
  • Table 2: Key Components of Pathways Thought to be Related to Obesity
  • Table 3: Treatment Options Dependent on BMI
  • Table 4: Obesity Therapeutics, Leading Brand Names of Phentermine
  • Table 5: Efficacy Results* for Qsymia at 52 Weeks
  • Table 6: Changes in Key Safety Parameters in Patients Treated with Qsymia
  • Table 7: Sales Data for Xenical ($m), 2008-2011
  • Table 8: Efficacy Results for Orlistat as an Initial and Maintenance Therapy
  • Table 9: Safety Results of Orlistat
  • Table 10: Efficacy Results for Belviq
  • Table 11: Placebo-adjusted Safety Results for Belviq
  • Table 12: Obesity Therapeutics Market, Global, Common Molecular Targets in the Obesity Pipeline
  • Table 13: Obesity Therapeutics Market, Global, Average Clinical Trial Size for the Most Common Modes of Action Amongst Pipeline Drugs, 2006-2013
  • Table 14: Obesity Therapeutics Market, Global, Average Clinical Trial Duration for the Main Modes of Action Amongst Pipeline Drugs, 2013
  • Table 15: Contrave, Phase III Clinical Trial Results
  • Table 16: Contrave, Efficacy Results, Phase III Clinical Trial
  • Table 17: Cametor, Efficacy Results of a Phase II Clinical Trial
  • Table 18: Cametor, Safety and Efficacy Results, Phase III Clinical Trial
  • Table 19: Victoza, Clinical Trial Results, Phase III Clinical Trial, 2009
  • Table 20: Victoza, Clinical Trial Results, Phase III Clinical Trial, 2009
  • Table 21: Victoza ,Safety and Efficacy Results, Phase III Clinical Trial, 2009
  • Table 22: Obesity Therapeutics Market, Europe, Current Prevalence Rate of the Population Which is Obese or Overweight, 2012-2019
  • Table 23: Obesity Therapeutics Market: Global, Developmental Pipeline, Discovery Phase
  • Table 24: Obesity Therapeutics Market: Global, Developmental Pipeline, Preclinical Phase
  • Table 25: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase I
  • Table 26: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase II
  • Table 27: Obesity Therapeutics Market: Global, Developmental Pipeline, Phase III
  • Table 28: Obesity Pharmacotherapy Market: Global, Developmental Pipeline, Pre-Registration
  • Table 29: Obesity Therapeutics Market, Global, Market Forecasts, 2012-2019
  • Table 30: Obesity Therapeutics Market, US, Market Forecasts, 2012-2019
  • Table 31: Obesity Therapeutics Market, UK, Market Forecasts, 2012-2019
  • Table 32: Obesity Therapeutics Market, France, Market Forecasts, 2012-2019
  • Table 33: Obesity Therapeutics Market, Germany, Market Forecasts, 2012-2019
  • Table 34: Obesity Therapeutics Market, Italy, Market Forecasts, 2012-2019
  • Table 35: Obesity Therapeutics Market, Spain, Market Forecasts, 2012-2019
  • Table 36: Obesity Therapeutics Market, Japan, Market Forecasts, 2012-2019

List of Figures

  • Figure 1: Obesity, Global, Prevalence (%), 1990-2010
  • Figure 2: Effects of Topiramate on Food Intake
  • Figure 3: Obesity Therapeutics Market, Obesity Drug Approvals and Market Removals
  • Figure 4: Obesity Therapeutics Market, Heat Map Comparing the Safety and Efficacy of Marketed Drugs
  • Figure 5: Obesity Therapeutics Market, Heat Map Comparing the Performance of Marketed Drugs in Major Safety Parameters
  • Figure 6: Obesity Therapeutics Market, Global, Pipeline by Phase and Molecule Type and Molecular Target
  • Figure 7: Obesity Therapeutics Market, Global, Clinical Trial Duration by Phase and Molecule Type, 2006-2013
  • Figure 8: Obesity Therapeutics Market: Global, Clinical Trial Size by Phase and Molecule Type, 2006-2013
  • Figure 9: Obesity Therapeutics Market, Global, Clinical Trial Failure and Attrition Rates by Phase and Molecule Type, 2006-2013
  • Figure 10: Obesity Therapeutics Market, Global, Clinical Trial Primary and Secondary Endpoints, 2006-2013
  • Figure 11: Heat Map Comparing the Safety and Efficacy of Marketed and Key Pipeline Drugs
  • Figure 12: Heat Map Comparing the Performance of Marketed and Key Pipeline Drugs in Major Safety Parameters
  • Figure 13: Obesity Therapeutics Market, Global, Epidata and Market Forecasts, 2012-2019
  • Figure 14: Obesity Therapeutics Market, US, Epidata and Market Forecasts, 2012-2019
  • Figure 15: Obesity Therapeutics Market, Europe, Treatment Patterns, 2012-2019
  • Figure 16: Obesity Therapeutics Market, Europe, Annual Cost of Therapy, 2012-2019
  • Figure 17: Obesity Therapeutics Market, Europe, Market Forecasts, 2012-2019
  • Figure 18: Obesity Therapeutics Market, Japan, Epidata and Market Forecast, 2012-2019
  • Figure 19: Obesity Therapeutics Market, Global, Status, Value and Number of Licensing Deals, 2006-2013
  • Figure 20: Obesity Therapeutics Market, Global, Licensing Deals by Phase, Molecule Type and Value, 2006-2013
  • Figure 21: Obesity Therapeutics Market, Global, Status, Value and Number of Co-development Deals, 2006-2011
  • Figure 22: Obesity Market, Global, GBI Research Market Sizing Model
Back to Top