OpportunityAnalyzer: Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2017

Summary

The Opioid-Induced Constipation (OIC) is a new and rapidly establishing market currently dominated by OTC laxatives set to undergo substantial growth between 2012 and 2017. 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. There is currently a paucity of approved products, 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.

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 2012 and forecast to 2017
- 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

- 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 2012-2017.
- 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

Table of Contents

1 Table of Contents 7
1.1 List of Tables 11
1.2 List of Figures 13
2 Introduction 14
2.1 Catalyst 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 16
3.1.3 Quality of Life 17
3.2 Symptoms 18
3.2.1 The General Treatment Consensus in the US and EU 19
4 Potential Patient Population 21
4.1 Overview 21
4.2 General Forecast Methodology 22
4.3 Region-Specific Forecast Methodology 23
4.3.1 Opioid Consumption 23
4.3.2 Number of OIC Cases 24
4.4 Country-Level Differences in Opioid Consumption 25
4.4.1 US 25
4.4.2 France 28
4.4.3 Germany 31
4.4.4 Italy 33
4.4.5 Spain 36
4.4.6 UK 39
4.5 Potential Patient Population Forecast 42
4.5.1 Total Number of Cases of Opioid-Induced Constipation 42
5 Current Treatment Options 44
5.1 Overview 44
5.2 Product Profiles - Major Brands 49
5.2.1 Relistor 49
5.2.2 Targin 55
5.2.3 Amitiza 60
6 Unmet Needs Assessment and Opportunity Analysis 68
6.1 Overview 68
6.2 Unmet Needs Analysis 69
6.2.1 Lack of Efficacious, Targeted Treatment Options 69
6.2.2 Reimbursement for Non-Laxative Prescription OIC Therapies 69
6.2.3 Lack of Cost-Effective Treatment Options 71
6.2.4 Defined Treatment Guidelines for OIC 71
6.2.5 Improved Physician Awareness and Diagnosis of OIC 72
6.2.6 Improved Patient and Physician Awareness of Prescription Drugs Available for the Treatment of OIC 73
6.2.7 Clinical Data Assessing Laxative Efficacy 74
6.2.8 Parenteral Formulations of OIC Treatments for Patients in Intensive Care 75
6.3 Opportunity Analysis 75
6.3.1 Development of an Efficacious Drug without Adverse Effects or Compromised Analgesia 75
6.3.2 Label Expansion of Approved Constipation Drugs into OIC 76
6.3.3 Treatments that Target Other OBD Symptoms 76
6.3.4 Launch of an Extensive Physician Education Marketing Campaign 77
7 RandD Strategies 78
7.1 Overview 78
7.1.1 Increased Understanding of Drug Mechanism 78
7.1.2 Reformulation Strategies 78
7.1.3 Secondary Indications 79
7.1.4 Niche Patient Subgroups 79
7.1.5 Licensing and Alliances 79
7.2 Clinical Trial Design 80
7.2.1 Current Clinical Trial Design 80
7.2.2 Selection of Clinically Relevant Trial Endpoints 81
7.2.3 Demonstrating the Long-Term Safety of Mu Receptor Antagonists 81
8 Pipeline Assessment 83
8.1 Overview 83
8.2 Promising Drugs in Clinical Development 84
8.2.1 Naloxegol 85
8.2.2 Bevenopran (CB-5945) 89
8.2.3 Oral Relistor (MOA-728) 93
8.2.4 TD-1211 96
8.2.5 Naldemedine (S-297995) 98
8.2.6 Nalcol (oral naloxone) 100
8.2.7 Linzess (linaclotide) 103
8.2.8 Innovative Early-Stage Approaches 105
9 Pipeline Valuation Analysis 108
9.1 Clinical Benchmark of Key Pipeline Drugs 108
9.2 Commercial Benchmark of Key Pipeline Drugs 110
9.3 Competitive Assessment 111
9.4 Top-Line, Five-Year Forecast 112
9.4.1 US 115
9.4.2 5EU 116
10 Appendix 118
10.1 Bibliography 118
10.2 Abbreviations 122
10.3 Methodology 123
10.4 Forecast Methodology 123
10.4.1 Percent Drug-Treated Patients 124
10.4.2 Drugs Included in Each Therapeutic Class 124
10.4.3 Launch and Patent Expiry Dates 125
10.4.4 General Pricing Assumptions 126
10.4.5 Individual Drug Assumptions 126
10.4.6 Pricing of Pipeline Agents 129
10.5 Physicians and Specialists Included in this Study 129
10.6 About the Authors 131
10.6.1 Analyst, Cardiovascular and Metabolic Disorders 131
10.6.2 Therapy Director - CVMD and Infectious Disease 131
10.6.3 Global Head of Healthcare 131
10.7 About GlobalData 132
10.8 Disclaimer 132




List of Tables

Table 1: Symptoms of Opioid-Induced Constipation 19
Table 2: Number of Cases of Opioid-Induced Constipation in the US, 2012-2017 28
Table 3: Number of Cases of Opioid-Induced Constipation in France, 2012-2017 30
Table 4: Number of Cases of Opioid-Induced Constipation in Germany, 2012-2017 33
Table 5: Number of Cases of Opioid-Induced Constipation in Italy, 2012-2017 36
Table 6: Number of Cases of Opioid-Induced Constipation in Spain, 2012-2017 39
Table 7: Number of Cases of Opioid-Induced Constipation in the UK, 2012-2017 42
Table 8: Total Number of Cases of Opioid-Induced Constipation Among Chronic Opioid Users in the 6MM, 2012-2017 43
Table 9: Commonly Prescribed and OTC Laxatives Used To Treat Opioid-Induced Constipation 45
Table 10: Leading Treatments for Opioid-Induced Constipation 48
Table 11: Product Profile - Relistor 50
Table 12: Relistor SWOT Analysis 54
Table 13: Product Profile - Targin 55
Table 14: Targin SWOT Analysis 59
Table 15: Product Profile - Amitiza 61
Table 16: Amitiza SWOT Analysis 66
Table 17: Overall Unmet Needs - Current Level of Attainment 68
Table 18: Opioid-Induced Constipation - Late-Stage Pipeline, 2013 84
Table 19: Product Profile - Naloxegol 86
Table 20: Naloxegol SWOT Analysis, 2013 88
Table 21: Product Profile - Bevenopran 90
Table 22: Bevenopran SWOT Analysis, 2013 92
Table 23: Product Profile - Oral Relistor 94
Table 24: Oral Relistor SWOT Analysis, 2013 95
Table 25: Product Profile - TD-1211 96
Table 26: TD-1211 SWOT Analysis, 2013 98
Table 27: Product Profile - Naldemedine (S-297995) 99
Table 28: Naldemedine SWOT Analysis, 2013 100
Table 29: Product Profile - Nalcol (Oral Naloxone) 101
Table 30: Nalcol SWOT Analysis, 2013 102
Table 31: Product Profile - Linzess 104
Table 32: Linzess SWOT Analysis, 2013 105
Table 33: Early-Stage Pipeline Products in Opioid-Induced Constipation 106
Table 34: Clinical Benchmark of Key Pipeline Drugs 108
Table 35: Commercial Benchmark of Key Pipeline Drugs 110
Table 36: Top-Line Sales Forecasts ($m) for Opioid-Induced Constipation, 2012-2017 113
Table 37: Key Events Impacting Sales for Opioid-Induced Constipation, 2012-2017 115
Table 38: Opioid-Induced Constipation Market - Drivers and Barriers, 2012-2017 117
Table 39: Abbreviations 122
Table 40: Key Launch Dates 125
Table 41: Number of High-Prescribing Physicians Surveyed 130




List of Figures

Figure 1: Consumption of Six Commonly Prescribed Opioids in the US, 1995-2010 26
Figure 2: Annual Number of Opioid Users in the US, 2001-2017 26
Figure 3: Annual Number of Cases of Opioid-Induced Constipation in the US, 2004-2017 27
Figure 4: Consumption of Six Commonly Prescribed Opioids in France, 1995-2010 29
Figure 5: Annual Number of Opioid Users in France, 2001-2017 29
Figure 6: Annual Number of Cases of Opioid-Induced Constipation in France, 2004-2017 30
Figure 7: Consumption of Six Commonly Prescribed Opioids in Germany, 1995-2010 31
Figure 8: Annual Number of Opioid Users in Germany, 2001-2017 32
Figure 9: Annual Number of Cases of Opioid-Induced Constipation in Germany, 2004-2017 32
Figure 10: Consumption of Six Commonly Prescribed Opioids in Italy, 1995-2010 34
Figure 11: Annual Number of Opioid Users in Italy, 2001-2017 35
Figure 12: Annual Number of Cases of Opioid-Induced Constipation in Italy, 2004-2017 35
Figure 13: Consumption of Six Commonly Prescribed Opioids in Spain, 1995-2010 37
Figure 14: Annual Number of Opioid Users in Spain, 2001-2017 38
Figure 15: Annual Number of Cases of Opioid-Induced Constipation in Spain, 2004-2017 38
Figure 16: Consumption of Six Commonly Prescribed Opioids in the UK, 1995-2010 40
Figure 17: Annual Number of Opioid Users in the UK, 2001-2017 40
Figure 18: Annual Number of Cases of Opioid-Induced Constipation in the UK, 2004-2017 41
Figure 19: Graphical Comparison of the Total Number of Cases of Opioid-Induced Constipation in the 6MM, 2012 43
Figure 20: Competitive Assessment of Late-Stage Pipeline Agents in Opioid-Induced Constipation, 2012-2017 112
Figure 21: Sales for Opioid-Induced Constipation by Region, 2012 and 2017 114

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