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

Summary

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

Opportunity Analyzer: Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2019
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 11
1.2 List of Figures 13
2 Introduction 15
2.1 Catalyst 15
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 19
3.1.3 Quality of Life 20
3.2 Symptoms 22
3.2.1 General Treatment Consensus in the US and EU 23
4 Potential Patient Population 25
4.1 Overview 25
4.2 General Forecasting Methodology 26
4.3 Region-Specific Forecast Methodology 28
4.3.1 Opioid Consumption 28
4.3.2 Number of OIC Cases 29
4.4 Country-Level Differences in Opioid Consumption 30
4.4.1 US 30
4.4.2 France 34
4.4.3 Germany 37
4.4.4 Italy 40
4.4.5 Spain 43
4.4.6 UK 46
4.5 Potential OIC Patient Population Forecast 49
4.5.1 Total Number of Cases of OIC 49
5 Current Treatment Options 51
5.1 Overview 51
5.2 Product Profiles - Major Brands 56
5.2.1 Relistor 56
5.2.2 Targin 64
5.2.3 Amitiza 70
5.2.4 Movantik 78
6 Unmet Needs Assessment and Opportunity Analysis 84
6.1 Overview 84
6.2 Unmet Needs Analysis 85
6.2.1 Reimbursement for Non-Laxative Prescription OIC Therapies in Europe 85
6.2.2 Defined Treatment Guidelines for OIC 87
6.2.3 Improved Physician Awareness and Diagnosis of OIC 88
6.2.4 Improved Patient and Physician Awareness of Prescription Drugs Available for the Treatment of OIC 90
6.2.5 Clinical Data Assessing Laxative Efficacy 91
6.3 Opportunity Analysis 93
6.3.1 Launch of an Extensive Marketing Campaign 93
6.3.2 Treatments that Target Other OBD Symptoms 94
6.3.3 Label Expansion of Approved Constipation Drugs into OIC 95
7 RandD Strategies 97
7.1 Overview 97
7.1.1 Increased Understanding of Drug Mechanism of Action 97
7.1.2 Reformulation Strategies 98
7.1.3 Secondary Indications 98
7.1.4 Licensing Agreements and Alliances 99
7.2 Clinical Trial Design 100
7.2.1 Current Clinical Trial Design 100
7.2.2 Selection of Clinically Relevant Trial Endpoints 101
7.2.3 Demonstrating the Long-Term Safety of Mu Receptor Antagonists 102
8 Pipeline Assessment 103
8.1 Overview 103
8.2 Promising Drugs in Clinical Development 104
8.2.1 Oral Relistor 105
8.2.2 Naldemedine 109
8.2.3 Axelopran 113
8.2.4 Bevenopran 118
8.2.5 Nalcol 122
8.2.6 Dolcanatide 126
8.2.7 Innovative Early-Stage Approaches 130
9 Pipeline Valuation Analysis 133
9.1 Clinical Benchmarking of Key Pipeline OIC Drugs 134
9.2 Commercial Benchmarking of Key Pipeline OIC Drugs 135
9.3 Competitive Assessment 137
9.4 Top-Line, Five-Year Forecast 138
9.4.1 US 141
9.4.2 5EU 142
10 Appendix 144
10.1 Bibliography 144
10.2 Abbreviations 151
10.3 Methodology 153
10.4 Forecast Methodology 153
10.4.1 Percentage of Drug-Treated Patients 153
10.4.2 Drugs Included in Each Therapeutic Class 154
10.4.3 Key Launch Dates 155
10.4.4 General Pricing Assumptions 155
10.4.5 Individual Drug Assumptions 156
10.4.6 Pricing of Pipeline Agents 159
10.5 Physicians and Specialists Included in This Study 160
10.6 Primary Research - Prescriber Survey 162
10.7 About the Authors 163
10.7.1 Analyst, Cardiovascular and Metabolic Disorders 163
10.7.2 Therapy Area Director 163
10.7.3 Global Director of Therapy Analysis and Epidemiology 164
10.7.4 Global Head of Healthcare 164
10.8 About GlobalData 165
10.9 Disclaimer 165

1.1 List of Tables
Table 1: Symptoms of OIC 22
Table 2: Potential Number of Cases of OIC in the US, 2014-2019 34
Table 3: Potential Number of Cases of OIC in France, 2014-2019 37
Table 4: Potential Number of Cases of OIC in Germany, 2014-2019 40
Table 5: Potential Number of Cases of OIC in Italy, 2014-2019 43
Table 6: Potential Number of Cases of OIC in Spain, 2014-2019 46
Table 7: Potential Number of Cases of OIC in the UK, 2014-2019 49
Table 8: Total Number of Cases of OIC Among Chronic Opioid Users in the 6MM, 2014-2019 50
Table 9: OTC and Generic Prescription Laxatives Commonly Used To Treat OIC 52
Table 10: Leading Prescription Treatments for OIC 56
Table 11: Product Profile - Relistor 60
Table 12: Relistor SWOT Analysis, 2015 62
Table 13: Product Profile - Targin 65
Table 14: Targin SWOT Analysis, 2015 69
Table 15: Product Profile - Amitiza 73
Table 16: Amitiza SWOT Analysis, 2015 76
Table 17: Product Profile - Movantik 80
Table 18: Naloxegol SWOT Analysis, 2015 83
Table 19: Overall Unmet Needs in OIC - Current Level of Attainment 85
Table 20: OIC - Late-Stage Pipeline, 2015 104
Table 21: Product Profile - Oral Relistor 107
Table 22: Oral Relistor SWOT Analysis, 2015 109
Table 23: Product Profile - Naldemedine 111
Table 24: Naldemedine SWOT Analysis, 2015 113
Table 25: Product Profile - Axelopran 115
Table 26: Clinical Efficacy Data of Axelopran (5mg, 10mg and 15mg) vs. Placebo 116
Table 27: Axelopran SWOT Analysis, 2015 118
Table 28: Product Profile - Bevenopran 120
Table 29: Bevenopran SWOT Analysis, 2015 122
Table 30: Product Profile - Nalcol 124
Table 31: Nalcol SWOT Analysis, 2015 126
Table 32: Product Profile - Dolcanatide 128
Table 33: Efficacy of Dolcanatide 129
Table 34: Safety of Dolcanatide 129
Table 35: Dolcanatide SWOT Analysis, 2015 130
Table 36: Early-Stage Pipeline Products in OIC, 2014 130
Table 37: Clinical Benchmarking of Key Pipeline OIC Drugs 134
Table 38: Commercial Benchmarking of Key Pipeline OIC Drugs 135
Table 39: Top-Line Sales Forecasts ($m) for OIC, 2014-2019 139
Table 40: Key Events Impacting Sales for OIC, 2014-2019 141
Table 41: OIC Market - Drivers and Barriers, 2014-2019 143
Table 42: Abbreviations 151
Table 43: Key Launch Dates 155
Table 44: Number of High-Prescribing Physicians (non-KOLs) Surveyed, By Country 162

1.2 List of Figures
Figure 1: Consumption of Six Commonly Prescribed Opioids in the US, 1995-2010 32
Figure 2: Number of Chronic Opioid Users in the US, 2001-2017 33
Figure 3: Number of Cases of OIC in the US, 2004-2017 33
Figure 4: Consumption of Six Commonly Prescribed Opioids in France, 1995-2010 35
Figure 5: Number of Chronic Opioid Users in France, 2001-2017 36
Figure 6: Number of Cases of OIC in France, 2004-2017 36
Figure 7: Consumption of Six Commonly Prescribed Opioids in Germany, 1995-2010 38
Figure 8: Number of Chronic Opioid Users in Germany, 2001-2017 39
Figure 9: Number of Cases of OIC in Germany, 2004-2017 39
Figure 10: Consumption of Six Commonly Prescribed Opioids in Italy, 1995-2010 41
Figure 11: Number of Chronic Opioid Users in Italy, 2001-2017 42
Figure 12: Number of Cases of OIC in Italy, 2004-2017 42
Figure 13: Consumption of Six Commonly Prescribed Opioids in Spain, 1995-2010 44
Figure 14: Number of Chronic Opioid Users in Spain, 2001-2017 45
Figure 15: Number of Cases of OIC in Spain, 2004-2017 45
Figure 16: Consumption of Six Commonly Prescribed Opioids in the UK, 1995-2010 47
Figure 17: Number of Chronic Opioid Users in the UK, 2001-2017 48
Figure 18: Number of Cases of OIC in the UK, 2004-2017 48
Figure 19: Total Number of Cases of OIC in the 6MM, 2014 50
Figure 20: Competitive Assessment of Late-Stage Pipeline Agents in OIC, 2014-2019 138
Figure 21: Sales for OIC by Region, 2014 and 2019 140

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