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 immunosuppressants 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.
Key Questions Answered
- (Q.) How will the celiac disease market landscape change within the 2013-2018 and the 2013-2023 forecast periods in the 6MM?
- (Q.) What are the most promising late-stage pipeline drugs and how will their launch shape the future treatment landscape in the celiac disease market?
- (Q.) How do the clinical and commercial attributes of late-stage pipeline drugs compare to one another and against existing treatment options?
- (Q.) What are the significant unmet needs in the celiac disease market?
- (Q.) What are the remaining opportunities in the celiac disease market?
- 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.
- 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
- 1.1. List of Tables
- 1.2. List of Figures
- 2.1. Catalyst
- 2.2. Related Reports
- 2.3. Upcoming Related Reports
3. Disease Overview
- 3.1. Etiology and Pathophysiology
- 3.2. Prognosis and Quality of Life
- 3.3. Symptoms
- 4.1. Disease Background
- 4.2. Risk Factors and Comorbidities
- 4.3. Global Trends
- 4.4. Forecast Methodology
- 4.4.1. Sources Used
- 4.4.2. Sources Not Used
- 4.4.3. Forecast Assumptions and Methods - Total Prevalent Cases of Celiac Disease
- 4.4.4. Forecast Assumptions - Diagnosed Prevalent Cases of Celiac Disease
- 4.5. Epidemiological Forecast for Celiac Disease (2013-2023)
- 4.5.1. Total Prevalent Cases of Celiac Disease
- 4.5.2. Age-Specific Total Prevalent Cases of Celiac Disease
- 4.5.3. Sex-Specific Total Prevalent Cases of Celiac Disease
- 4.5.4. Age-Standardized Total Prevalence of Celiac Disease
- 4.5.5. Diagnosed Prevalent Cases of Celiac Disease
- 4.6. Discussion
- 4.6.1. Epidemiological Forecast Insight
- 4.6.2. Limitations of the Analysis
- 4.6.3. Strengths of the Analysis
5. Current Treatment Options
- 5.1. Overview
- 5.2. Product Profiles - Major Therapies
- 5.2.1. Steroids (Numerous Brands and Generic Names)
- 5.2.2. Immunosuppressants (Azathioprine)
6. Unmet Need and Opportunity
- 6.1. Overview
- 6.2. Reliable Diagnosis
- 6.2.1. Unmet Need
- 6.2.2. Gap Analysis
- 6.2.3. Opportunity
- 6.3. Improved Physician Knowledge of Celiac Disease Diagnosis
- 6.3.1. Unmet Need
- 6.3.2. Gap Analysis
- 6.3.3. Opportunity
- 6.4. Increased Patient Awareness of a Gluten-Free Diet
- 6.4.1. Unmet Need
- 6.4.2. Gap Analysis
- 6.4.3. Opportunity
- 6.5. Lack of Approved Pharmacological Therapies
- 6.5.1. Unmet Need
- 6.5.2. Gap Analysis
- 6.5.3. Opportunity
- 6.6. Improved Compliance to a Gluten-Free Diet
- 6.6.1. Unmet Need
- 6.6.2. Gap Analysis
- 6.6.3. Opportunity
- 6.7. Improved Therapies for Refractory Celiac Disease Type I
- 6.7.1. Unmet Need
- 6.7.2. Gap Analysis
- 6.7.3. Opportunity
- 6.8. Available Therapies for Refractory Celiac Disease Type II
- 6.8.1. Unmet Need
- 6.8.2. Gap Analysis
- 6.8.3. Opportunity
7. R&D Strategies
- 7.1. Overview
- 7.1.1. Development of Pharmacological Interventions with Novel MOAs
- 7.1.2. Diverse Preclinical Research
- 7.1.3. Licensing and Alliances
- 7.2. Clinical Trial Design
- 7.2.1. No Standardized Clinical Trial Design Exists in Celiac Disease
- 7.2.2. Trial Outcome Measures are Tailored to the Pipeline Drug Being Investigated
- 7.2.3. Trial Designs for Early-Stage Pipeline Drugs Likely to be Dictated by Their MOA
8. Pipeline Assessment
- 8.1. Overview
- 8.2. Promising Drugs in Clinical Development
- 8.2.1. Larazotide Acetate
- 8.2.2. Latiglutenase
- 8.2.3. BL-7010
- 8.2.4. NexVax-2
- 8.3. Innovative Early-Stage Approaches
9. Pipeline Valuation Analysis
- 9.1. Clinical Benchmark of Key Pipeline Drugs
- 9.2. Commercial Benchmark of Key Pipeline Drugs
- 9.3. Competitive Assessment
- 9.4. Top-Line Five-Year Forecast
- 9.5. Case Study: Top-Line-Ten Year Forecast
- 10.1. Bibliography
- 10.2. Abbreviations
- 10.3. Methodology
- 10.4. Forecasting Methodology
- 10.4.1. Diagnosed Celiac Disease Patients
- 10.4.2. Percent Drug-Treated Patients
- 10.4.3. Drugs Included in Each Therapeutic Class
- 10.4.4. Launch Dates
- 10.4.5. General Pricing Assumptions
- 10.4.6. Individual Drug Assumptions
- 10.4.7. Pricing of Pipeline Agents
- 10.5. Physicians and Specialists Included in This Study
- 10.6. About the Authors
- 10.6.1. Author
- 10.6.2. Reviewers
- 10.6.3. Epidemiologist
- 10.6.4. Global Head of Healthcare
- 10.7. About GlobalData
- 10.8. Disclaimer
List of Tables
- Table 1: Symptoms of Celiac Disease
- Table 2: Risk Factors for Celiac Disease
- Table 3: Studies Reporting Temporal Trends for Celiac Disease and Calculated Rate of Change
- Table 4: 6MM, Sources of Prevalence and Diagnosis Rates of Celiac Disease
- Table 5: 6MM, Sources Not Used in Epidemiological Forecast for Celiac Disease
- Table 6: 6MM, Total Prevalent Cases of Celiac Disease, Both Sexes, All Ages, N, Select Years 2013-2023
- Table 7: 6MM, Age-Specific Total Prevalent Cases of Celiac Disease, Both Sexes, N (Row %), 2013
- Table 8: 6MM, Sex-Specific Total Prevalent Cases of Celiac Disease, All Ages, N (Row %), 2013
- Table 9: 6MM, Diagnosed Prevalent Cases of Celiac Disease, Both Sexes, All Ages, Select Years 2013-2023
- Table 10: Treatments for Celiac Disease, 2014
- Table 11: Product Profile - Steroids
- Table 12: Steroids SWOT Analysis, 2013
- Table 13: Product Profile - Azathioprine
- Table 14: Azathioprine SWOT Analysis, 2013
- Table 15: Unmet Need and Opportunity in Celiac Disease
- Table 16: Celiac Disease Pipeline, 2014
- Table 17: Product Profile - Larazotide Acetate
- Table 18: Summary of Clinical Trials for Larazotide Acetate in Celiac Disease, 2014
- Table 19: Larazotide Acetate SWOT Analysis, 2014
- Table 20: Product Profile - Latiglutenase
- Table 21: Latiglutenase SWOT Analysis, 2014
- Table 22: Product Profile - BL-7010
- Table 23: BL-7010 SWOT Analysis, 2014
- Table 24: Product Profile - NexVax-2
- Table 25: NexVax-2 SWOT Analysis, 2014
- Table 26: Preclinical Pipeline Products in Celiac Disease
- Table 27: Clinical Benchmark of Key Pipeline Drugs for Celiac Disease
- Table 28: Commercial Benchmark of Key Pipeline Drugs for Celiac Disease
- Table 29: Top-Line Sales Forecasts ($m) for Celiac Disease, 2013-2018
- Table 30: Key Event Impacting Sales for Celiac Disease, 2013-2018
- Table 31: Global Celiac Disease Market - Drivers and Barriers, 2013-2018
- Table 32: Top-Line Sales Forecasts ($m) for Celiac Disease, 2013-2023
- Table 33: Key Events Impacting Sales for Celiac Disease, 2013-2023
- Table 34: Global Celiac Disease Market - Drivers and Barriers, 2013-2023
- Table 35: Key Launch Dates, Celiac Disease, 2013-2023
List of Figures
- Figure 1: Pathophysiology of Celiac Disease
- Figure 2: 6MM, Total Prevalent Cases of Celiac Disease, Both Sexes, All Ages, N, 2013-2023
- Figure 3: 6MM, Age-Specific Total Prevalent Cases of Celiac Disease, Both Sexes, N (Row %), 2013
- Figure 4: 6MM, Sex-Specific Total Prevalent Cases of Celiac Disease, All Ages, 2013
- Figure 5: 6MM, Age-Standardized Total Prevalence (%) of Celiac Disease, All Ages, by Sex, 2013
- Figure 6: 6MM, Diagnosed Prevalent Cases of Celiac Disease, Both Sexes, All Ages, N, 2013-2023
- Figure 7: Celiac Disease Diagnosis Pathway
- Figure 8: Celiac Disease Treatment Pathway Post Diagnosis
- Figure 9: Competitive Assessment of Celiac Disease Pipeline Therapies, 2013-2023
- Figure 10: Global Sales for Celiac Disease by Region, 2013-2018
- Figure 11: Global Sales for Celiac Disease by Region, 2013-2023