世界のオピオイド誘発型便秘治療薬市場...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 14
2 Introduction 16
2.1 Catalyst 16
3 Disease Overview 18
3.1 Etiology and Pathophysiology 18
3.1.1 Etiology 18
3.1.2 Pathophysiology 20
3.1.3 Quality of Life 22
3.2 Symptoms 23
3.2.1 The General Treatment Consensus in the US and EU 24
4 Potential Patient Population 26
4.1 Overview 26
4.2 General Forecast Methodology 27
4.3 Region-Specific Forecast Methodology 29
4.3.1 Opioid Consumption 29
4.3.2 Number of OIC Cases 30
4.4 Country-Level Differences in Opioid Consumption 31
4.4.1 US 31
4.4.2 France 35
4.4.3 Germany 38
4.4.4 Italy 41
4.4.5 Spain 44
4.4.6 UK 47
4.5 Potential Patient Population Forecast 50
4.5.1 Total Number of Cases of Opioid-Induced Constipation 50
5 Current Treatment Options 52
5.1 Overview 52
5.2 Product Profiles – Major Brands 57
5.2.1 Relistor 57
5.2.2 Targin 65
5.2.3 Amitiza 72
6 Unmet Needs Assessment and Opportunity Analysis 81
6.1 Overview 81
6.2 Unmet Needs Analysis 82
6.2.1 Lack of Efficacious, Targeted Treatment Options 82
6.2.2 Reimbursement for Non-Laxative Prescription OIC Therapies 83
6.2.3 Lack of Cost-Effective Treatment Options 84
6.2.4 Defined Treatment Guidelines for OIC 85
6.2.5 Improved Physician Awareness and Diagnosis of OIC 86
6.2.6 Improved Patient and Physician Awareness of Prescription Drugs Available for the Treatment of OIC 88
6.2.7 Clinical Data Assessing Laxative Efficacy 89
6.2.8 Parenteral Formulations of OIC Treatments for Patients in Intensive Care 90
6.3 Opportunity Analysis 91
6.3.1 Development of an Efficacious Drug without Adverse Effects or Compromised Analgesia 91
6.3.2 Label Expansion of Approved Constipation Drugs into OIC 91
6.3.3 Treatments that Target Other OBD Symptoms 92
6.3.4 Launch of an Extensive Physician Education Marketing Campaign 93
7 R&D Strategies 94
7.1 Overview 94
7.1.1 Increased Understanding of Drug Mechanism 94
7.1.2 Reformulation Strategies 95
7.1.3 Secondary Indications 95
7.1.4 Niche Patient Subgroups 96
7.1.5 Licensing and Alliances 96
7.2 Clinical Trial Design 97
7.2.1 Current Clinical Trial Design 97
7.2.2 Selection of Clinically Relevant Trial Endpoints 98
7.2.3 Demonstrating the Long-Term Safety of Mu Receptor Antagonists 99
8 Pipeline Assessment 101
8.1 Overview 101
8.2 Promising Drugs in Clinical Development 102
8.2.1 Naloxegol 103
8.2.2 Bevenopran (CB-5945) 108
8.2.3 Oral Relistor (MOA-728) 111
8.2.4 TD-1211 116
8.2.5 Naldemedine (S-297995) 119
8.2.6 Nalcol (oral naloxone) 121
8.2.7 Linzess (linaclotide) 125
8.2.8 Innovative Early-Stage Approaches 127
9 Pipeline Valuation Analysis 130
9.1 Clinical Benchmark of Key Pipeline Drugs 130
9.2 Commercial Benchmark of Key Pipeline Drugs 132
9.3 Competitive Assessment 133
9.4 Top-Line, Five-Year Forecast 134
9.4.1 US 137
9.4.2 5EU 138
10 Appendix 141
10.1 Bibliography 141
10.2 Abbreviations 146
10.3 Methodology 147
10.4 Forecast Methodology 147
10.4.1 Percent Drug-Treated Patients 148
10.4.2 Drugs Included in Each Therapeutic Class 148
10.4.3 Launch and Patent Expiry Dates 149
10.4.4 General Pricing Assumptions 150
10.4.5 Individual Drug Assumptions 150
10.4.6 Pricing of Pipeline Agents 154
10.5 Physicians and Specialists Included in this Study 155
10.6 About the Authors 157
10.6.1 Analyst, Cardiovascular and Metabolic Disorders 157
10.6.2 Therapy Director – CVMD and Infectious Disease 157
10.6.3 Global Head of Healthcare 158
10.7 About GlobalData 159
10.8 Disclaimer 159