There are no pharmacological treatments that are indicated for celiac disease and the current standard of care treatment involves a gluten free diet (GFD). Steroids and immuno suppressants are used to reduce symptoms in severe cases, targeting approximately 5% of the celiac disease patient population and there are no preventative medications. The anticipated launch of Alba/Teva’s larazotide acetate in 2018 in the US and 2019 in 5EU, followed by the launch of Alvine/AbbVie’s latiglutenase in 2019 and 2020 in the US and 5EU respectively are set to change the management of the disease and drive growth in the celiac disease market. Both drugs are expected to target patients who undergo gluten exposure while on a GFD equating to approximately 95% of the celiac disease patient population. GlobalData estimates that the uptake of both drugs will be equally high, but latiglutenase will rapidly gain market value and emerge the commercially stronger drug with the backing of Immune-Gastro veteran AbbVie.

Highlights

Key Questions Answered

• How will the celiac disease market landscape change within the 2013-2018 and the 2013-2023 forecast periods in the 6MM?
• What are the most promising late-stage pipeline drugs and how will their launch shape the future treatment landscape in the celiac disease market?
• How do the clinical and commercial attributes of late-stage pipeline drugs compare to one another and against existing treatment options?
• What are the significant unmet needs in the celiac disease market?
• What are the remaining opportunities in the celiac disease market?

Key Findings

• High uptake is expected of pipeline drugs for celiac disease that are anticipated to launch during the 2013-2023 forecast period.
• Celiac disease remains a field of highly unattained unmet need.
• There is no consensus over clinical trial design and endpoints for the development of celiac disease products.
• The clinical stage pipeline is mainly focussed on GFD adjunctive therapies, while the pre-clinical stage pipeline has shifted its focus to disease modifying treatments.
• Significant opportunity exists for products targeting in the non-refractory patient segment of the celiac disease market.
• M&A’s and alliance opportunities will be key factors in driving celiac disease drug development.

Scope

• Overview of celiac disease, including epidemiology, etiology, pathophysiology, symptoms and current treatment options
• Annualized celiac disease therapeutics market revenue, annual cost of therapies and forecasts for five years to 2018 and ten years to 2023.
• Key topics covered include strategic product assessment, market characterization, unmet needs, R&D strategies, clinical trial design and implications for the celiac disease therapeutics market.
• Pipeline analysis: comprehensive data split across different phases, emerging trends and mechanisms of action under development, including zonulin inhibitors, gluten peptide enzymes, gluten specific synthetic polymers and therapeutic vaccines.
• Analysis of the current and future market competition in the US and five major EU celiac disease therapeutics market. Clinical and commercial benchmarking of promising pipeline products versus standard of care treatments and competitive assessment of all therapies. Insightful review of the key industry drivers, restraints and challenges.

Reasons to buy

The report will enable you to –

• Identify the unmet needs and remaining opportunities in the celiac disease therapeutics market.
• Develop business strategies by understanding the trends shaping and driving the US and five major EU celiac disease therapeutics market.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Assess the clinical and commercial viability of promising pipeline products.
• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various emerging therapies.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
• Drive revenues by understanding the key trends, innovative products and technologies, market and segments likely to impact the US and five major EU celiac disease therapeutics market in future.

Table of Contents

1 Table of Contents 10
1.1 List of Tables 14
1.2 List of Figures 16

2 Introduction 17
2.1 Catalyst 17
2.2 Related Reports 18
2.3 Upcoming Related Reports 18

3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.2 Prognosis and Quality of Life 21
3.3 Symptoms 22

4 Epidemiology 24
4.1 Disease Background 24
4.2 Risk Factors and Comorbidities 24
4.3 Global Trends 27
4.3.1 US 30
4.3.2 5EU 30
4.4 Forecast Methodology 31
4.4.1 Sources Used 32
4.4.2 Sources Not Used 35
4.4.3 Forecast Assumptions and Methods – Total Prevalent Cases of Celiac Disease 37
4.4.4 Forecast Assumptions – Diagnosed Prevalent Cases of Celiac Disease 40
4.5 Epidemiological Forecast for Celiac Disease (2013–2023) 41
4.5.1 Total Prevalent Cases of Celiac Disease 41
4.5.2 Age-Specific Total Prevalent Cases of Celiac Disease 43
4.5.3 Sex-Specific Total Prevalent Cases of Celiac Disease 44
4.5.4 Age-Standardized Total Prevalence of Celiac Disease 46
4.5.5 Diagnosed Prevalent Cases of Celiac Disease 47
4.6 Discussion 49
4.6.1 Epidemiological Forecast Insight 49
4.6.2 Limitations of the Analysis 50
4.6.3 Strengths of the Analysis 51

5 Current Treatment Options 52
5.1 Overview 52
5.2 Product Profiles – Major Therapies 57
5.2.1 Steroids (Numerous Brands and Generic Names) 57
5.2.2 Immunosuppressants (Azathioprine) 63

6 Unmet Need and Opportunity 68
6.1 Overview 68
6.2 Reliable Diagnosis 71
6.2.1 Unmet Need 71
6.2.2 Gap Analysis 72
6.2.3 Opportunity 72
6.3 Improved Physician Knowledge of Celiac Disease Diagnosis 73
6.3.1 Unmet Need 73
6.3.2 Gap Analysis 74
6.3.3 Opportunity 75
6.4 Increased Patient Awareness of a Gluten-Free Diet 76
6.4.1 Unmet Need 76
6.4.2 Gap Analysis 77
6.4.3 Opportunity 78
6.5 Lack of Approved Pharmacological Therapies 78
6.5.1 Unmet Need 78
6.5.2 Gap Analysis 80
6.5.3 Opportunity 80
6.6 Improved Compliance to a Gluten-Free Diet 81
6.6.1 Unmet Need 81
6.6.2 Gap Analysis 81
6.6.3 Opportunity 82
6.7 Improved Therapies for Refractory Celiac Disease Type I 82
6.7.1 Unmet Need 82
6.7.2 Gap Analysis 83
6.7.3 Opportunity 83
6.8 Available Therapies for Refractory Celiac Disease Type II 83
6.8.1 Unmet Need 83
6.8.2 Gap Analysis 84
6.8.3 Opportunity 85

7 R&D Strategies 86
7.1 Overview 86
7.1.1 Development of Pharmacological Interventions with Novel MOAs 86
7.1.2 Diverse Preclinical Research 87
7.1.3 Licensing and Alliances 88
7.2 Clinical Trial Design 89
7.2.1 No Standardized Clinical Trial Design Exists in Celiac Disease 89
7.2.2 Trial Outcome Measures are Tailored to the Pipeline Drug Being Investigated 90
7.2.3 Trial Designs for Early-Stage Pipeline Drugs Likely to be Dictated by Their MOA 90

8 Pipeline Assessment 92
8.1 Overview 92
8.2 Promising Drugs in Clinical Development 93
8.2.1 Larazotide Acetate 93
8.2.2 Latiglutenase 101
8.2.3 BL-7010 107
8.2.4 NexVax-2 111
8.3 Innovative Early-Stage Approaches 115

9 Pipeline Valuation Analysis 121
9.1 Clinical Benchmark of Key Pipeline Drugs 121
9.2 Commercial Benchmark of Key Pipeline Drugs 123
9.3 Competitive Assessment 126
9.4 Top-Line Five-Year Forecast 128
9.4.1 US 131
9.4.2 5EU 132
9.5 Case Study: Top-Line-Ten Year Forecast 133
9.5.1 US 137
9.5.2 5EU 138

10 Appendix 140
10.1 Bibliography 140
10.2 Abbreviations 151
10.3 Methodology 154
10.4 Forecasting Methodology 154
10.4.1 Diagnosed Celiac Disease Patients 154
10.4.2 Percent Drug-Treated Patients 155
10.4.3 Drugs Included in Each Therapeutic Class 155
10.4.4 Launch Dates 156
10.4.5 General Pricing Assumptions 156
10.4.6 Individual Drug Assumptions 157
10.4.7 Pricing of Pipeline Agents 159
10.5 Physicians and Specialists Included in This Study 160
10.6 About the Authors 161
10.6.1 Author 161
10.6.2 Reviewers 161
10.6.3 Epidemiologist 162
10.6.4 Global Head of Healthcare 163
10.7 About GlobalData 164
10.8 Disclaimer 164

List of Tables

Table 1: Symptoms of Celiac Disease 23
Table 2: Risk Factors for Celiac Disease 26
Table 3: Studies Reporting Temporal Trends for Celiac Disease and Calculated Rate of Change 29
Table 4: 6MM, Sources of Prevalence and Diagnosis Rates of Celiac Disease 32
Table 5: 6MM, Sources Not Used in Epidemiological Forecast for Celiac Disease 36
Table 6: 6MM, Total Prevalent Cases of Celiac Disease, Both Sexes, All Ages, N, Select Years 2013–2023 42
Table 7: 6MM, Age-Specific Total Prevalent Cases of Celiac Disease, Both Sexes, N (Row %), 2013 43
Table 8: 6MM, Sex-Specific Total Prevalent Cases of Celiac Disease, All Ages, N (Row %), 2013 45
Table 9: 6MM, Diagnosed Prevalent Cases of Celiac Disease, Both Sexes, All Ages, Select Years 2013–2023 48
Table 10: Treatments for Celiac Disease, 2014 57
Table 11: Product Profile – Steroids 60
Table 12: Steroids SWOT Analysis, 2013 63
Table 13: Product Profile – Azathioprine 65
Table 14: Azathioprine SWOT Analysis, 2013 67
Table 15: Unmet Need and Opportunity in Celiac Disease 71
Table 16: Celiac Disease Pipeline, 2014 93
Table 17: Product Profile – Larazotide Acetate 95
Table 18: Summary of Clinical Trials for Larazotide Acetate in Celiac Disease, 2014 97
Table 19: Larazotide Acetate SWOT Analysis, 2014 101
Table 20: Product Profile – Latiglutenase 104
Table 21: Latiglutenase SWOT Analysis, 2014 107
Table 22: Product Profile – BL-7010 109
Table 23: BL-7010 SWOT Analysis, 2014 111
Table 24: Product Profile – NexVax-2 113
Table 25: NexVax-2 SWOT Analysis, 2014 115
Table 26: Preclinical Pipeline Products in Celiac Disease 117
Table 27: Clinical Benchmark of Key Pipeline Drugs for Celiac Disease 123
Table 28: Commercial Benchmark of Key Pipeline Drugs for Celiac Disease 125
Table 29: Top-Line Sales Forecasts ($m) for Celiac Disease, 2013–2018 129
Table 30: Key Event Impacting Sales for Celiac Disease, 2013–2018 131
Table 31: Global Celiac Disease Market – Drivers and Barriers, 2013–2018 131
Table 32: Top-Line Sales Forecasts ($m) for Celiac Disease, 2013–2023 134
Table 33: Key Events Impacting Sales for Celiac Disease, 2013–2023 136
Table 34: Global Celiac Disease Market – Drivers and Barriers, 2013–2023 136
Table 35: Key Launch Dates, Celiac Disease, 2013–2023 156

List of Figures

Figure 1: Pathophysiology of Celiac Disease 21
Figure 2: 6MM, Total Prevalent Cases of Celiac Disease, Both Sexes, All Ages, N, 2013–2023 42
Figure 3: 6MM, Age-Specific Total Prevalent Cases of Celiac Disease, Both Sexes, N (Row %), 2013 44
Figure 4: 6MM, Sex-Specific Total Prevalent Cases of Celiac Disease, All Ages, 2013 46
Figure 5: 6MM, Age-Standardized Total Prevalence (%) of Celiac Disease, All Ages, by Sex, 2013 47
Figure 6: 6MM, Diagnosed Prevalent Cases of Celiac Disease, Both Sexes, All Ages, N, 2013–2023 48
Figure 7: Celiac Disease Diagnosis Pathway 53
Figure 8: Celiac Disease Treatment Pathway Post Diagnosis 56
Figure 9: Competitive Assessment of Celiac Disease Pipeline Therapies, 2013–2023 128
Figure 10: Global Sales for Celiac Disease by Region, 2013–2018 130
Figure 11: Global Sales for Celiac Disease by Region, 2013–2023 135