OpportunityAnalyzer: Vasculitis – Opportunity Analysis and Forecast to 2024

Vasculitis is a family of rare autoimmune diseases, causing inflammation of the blood vessels, arteries, veins or capillaries. The different forms of vasculitis are classified by the size and location of the affected blood vessels . This report specifically covers large vessel vasculitis (LLV), Kawasaki disease (KD), antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), and Behçet's disease (BD). In 2014, there were 137,603 and 82,501 diagnosed prevalent and incident cases in the 7MM (US, France, Germany, Spain, Italy, UK, and Japan), respectively. Untreated, the organs and tissues affected by the damaged blood vessels do not get enough blood, which can lead to organ or tissue damage, or even death. J&J's Remicade was the first biologic in the vasculitis market, approved for BD in Japan in 2007. Other biologics approved for vasculitis include AbbVie's Humira for BD in Japan and Biogen/Roche's Rituxan for GPA/MPA in the 7MM. Several unmet needs still remain such as the development of drugs with improved safety and efficacy for use in both the induction and maintenance treatment settings . GlobalData expects the launch of six drugs during the 2014 to 2024 forecast period along with increased diagnosed patient numbers will drive the vasculitis market.

Scope

Overview of vasculitis, including etiology, pathophysiology, and country-specific diagnosis and treatment recommendations.

Annualized vasculitis market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the vasculitis market.

Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically BMS’s Orencia, GSK’s Benlysta and Nucala, Genentech/Roche’s Actemra, Celgene’s Otezla, J&J’s Remicade, and biosimilars (such as Celltrion/Hospira/Alvogen’s Inflectra/Remsima).

Analysis of the current and future market competition in the global vasculitis market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

How large an impact will biosimilars have on the vasculitis market? What do vasculitis specialists and key opinion leaders across the 7MM think about the evolving treatment landscape?

What opportunities remain in the market for new product entrants?

With six drug launches, five of which are biologics, which products are forecast to generate the highest sales over 2014-2024? How are product launches expected to affect the sales of induction and maintenance therapies?

According to KOLs, what are the most important unmet needs in vasculitis? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2024?

What industry developments are likely to affect sales of the top-selling vasculitis drugs in the markets researched? Which is the largest growth market globally?

Companies mentioned

AbbVie, J&J, BMS, Roche, Merck, GSK, Biogen, Genentech, Boehringer Ingelheim, Celltrion, Pfizer, Celgene, Sanofi, Eisai, Zydus Cadila, Mitsubishi Tanabe, Alvogen, Hospira, Mundipharma, Novartis, Baxter, UCB ...

AbbVie, J&J, BMS, Roche, Merck, GSK, Biogen, Genentech, Boehringer Ingelheim, Celltrion, Pfizer, Celgene, Sanofi, Eisai, Zydus Cadila, Mitsubishi Tanabe, Alvogen, Hospira, Mundipharma, Novartis, Baxter, UCB, Prometheus, Aspen, Ono, Eli Lilly, Chugaii, AstraZeneca, ChemoCentryx, Delenex, Sobi, Amgen

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 Upcoming Related Reports

3 Disease Overview

3.1 Types of Vasculitis

3.2 Etiology and Pathophysiology

3.2.1 Large Vessel Vasculitis

3.2.2 Kawasaki Disease

3.2.3 ANCA-Associated Small Vessel Vasculitis

3.2.4 Behҫet’s Disease

3.3 Symptoms

3.4 Disease Management

3.4.1 Classification Criteria

3.4.2 Disease Management Guidelines

4 Epidemiology

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

4.5 Epidemiological Forecast for Vasculitis, 2014–2024

4.5.1 Diagnosed Incident Cases of AAV

4.5.2 Diagnosed Prevalent Cases of AAV

4.5.3 Age-Standardized Incidence of AAV

4.5.4 Diagnosed Incident Cases of LVV – TA and GCA

4.5.5 Diagnosed Prevalent Cases of TA

4.5.6 Age-Standardized Incidence of LVV

4.5.7 Diagnosed Incident Cases of BD

4.5.8 Diagnosed Prevalent Cases of BD

4.5.9 Age-Standardized Incidence of BD

4.5.10 Diagnosed Incident Cases of KD

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

5.2.1 Rituxan (Rituximab)

5.2.2 Humira (Adalimumab)

5.2.3 Remicade (Infliximab)

5.2.4 Mycophenolate Mofetil

5.2.5 Cyclophosphamide

5.2.6 Azathioprine

5.2.7 Methotrexate

5.2.8 Glucocorticoids

5.2.9 Intravenous Immunoglobulin

6 Unmet Needs Assessment and Opportunity Analysis

6.1 Overview

6.2 Improved Drug Efficacy and Safety in the Induction Therapy Setting

6.2.1 Unmet Need

6.2.2 Gap Analysis

6.2.3 Opportunity

6.3 Improved Drug Efficacy and Safety in the Maintenance Therapy Setting

6.3.1 Unmet Need

6.3.2 Gap Analysis

6.3.3 Opportunity

6.4 Biomarkers to Predict Responsiveness to Therapy

6.4.1 Unmet Need

6.4.2 Gap Analysis

6.4.3 Opportunity

6.5 Biomarkers to Predict Disease Relapse

6.5.1 Unmet Need

6.5.2 Gap Analysis

6.5.3 Opportunity

6.6 Early and Non-invasive Diagnosis of Vasculitis

6.6.1 Unmet Need

6.6.2 Gap Analysis

6.6.3 Opportunity

6.7 Adjunctive Therapy for the Treatment of KD

6.7.1 Unmet Need

6.7.2 Gap Analysis

6.7.3 Opportunity

7 R&D Strategies

7.1 Overview

7.2 Expansion for Key Autoimmune Drugs

7.3 Shift Towards Vasculitis as a Primary Indication

7.4 Clinical Trial Design

7.4.1 Current Clinical Trial Design

7.4.2 Challenges in Vasculitis Clinical Trial Design

8 Pipeline Assessment

8.1 Overview

8.2 Promising Drugs in Clinical Development

8.2.1 Orencia (Abatacept)

8.2.2 Benlysta (Belimumab)

8.2.3 Actemra (Tocilizumab)

8.2.4 Otezla (Apremilast)

8.2.5 Nucala (Mepolizumab)

8.3 Additional Drugs in Development for Vasculitis

9 Pipeline Valuation Analysis

9.1 Clinical Benchmark of Key Pipeline Drugs

9.1.1 AAV

9.1.2 LVV

9.1.3 KD

9.1.4 BD

9.2 Commercial Benchmark of Key Pipeline Drugs

9.2.1 AAV

9.2.2 LVV

9.2.3 KD

9.2.4 BD

9.3 Competitive Assessment

9.3.1 AAV

9.3.2 LVV

9.3.3 KD

9.3.4 BD

9.4 Top Line Ten Year Forecast

9.4.1 US

9.4.2 5EU

9.4.3 Japan

10 Appendix

10.1 Bibliography

10.2 Abbreviations

10.3 Methodology

10.4 Forecasting Methodology

10.4.1 Percent Drug-treated Patients

10.4.2 Drugs Included in Each Therapeutic Class

10.4.3 Launch and Patent Expiry Dates

10.4.4 General Pricing Assumptions

10.4.5 Individual Drug Assumptions

10.4.6 Generic Erosion

10.4.7 Pricing of Pipeline Agents

10.5 Primary Research

10.5.1 Physicians and Specialists Included in this Study

10.5.2 Online Survey of High Prescribing Physicians

10.6 About the Authors

10.6.1 Author

10.6.2 Reviewer

10.6.3 Epidemiologist

10.6.4 Global Director of Therapy Analysis and Epidemiology

10.6.5 Global Head of Healthcare

10.7 About GlobalData

10.8 Disclaimer

List of Tables

Table 1: Symptoms of Selected Types of Vasculitis

Table 2: Nine Recommendations for the Management of BD

Table 3: Clinical and Laboratory Features of KD ...

Table 1: Symptoms of Selected Types of Vasculitis

Table 2: Nine Recommendations for the Management of BD

Table 3: Clinical and Laboratory Features of KD

Table 4: Risk Factors and Comorbidities for Vasculitis

Table 5: 2012 Revised CHCC Definitions of Vasculitides

Table 6: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of MPA

Table 7: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of MPA

Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of GPA

Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of GPA

Table 10: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of eGPA

Table 11: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of eGPA

Table 12: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of GCA

Table 13: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of TA

Table 14: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of TA

Table 15: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of BD

Table 16: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of BD

Table 17: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of KD

Table 18: 7MM, Sources Not Used in Epidemiological Analysis of AAV, LVV, BD, and KD

Table 19: 7MM, Diagnosed Incident Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014–2024

Table 20: 7MM, Diagnosed Prevalent Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014–2024

Table 21: 7MM, Diagnosed Incident Cases of LVV, Ages ≥15 Years, Both Sexes, N, 2014–2024

Table 22: 7MM, Diagnosed Prevalent Cases of TA, Ages ≥15 Years, Both Sexes, N, 2014–2024

Table 23: 7MM, Diagnosed Incident Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014–2024

Table 24: 7MM, Diagnosed Prevalent Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014–2024

Table 25: 7MM, Diagnosed Incident Cases of KD, Ages ≤5 Years, Both Sexes, N, 2014–2024

Table 26: Leading Treatments for Vasculitis, 2015

Table 27: Current Treatment Options for Vasculitis Across the 7MM, November 2015

Table 28: Product Profile — Rituxan

Table 29: Rituxan SWOT Analysis, 2015

Table 30: Product Profile — Humira

Table 31: Humira SWOT Analysis, 2015

Table 32: Product Profile — Remicade

Table 33: Completed trials demonstrating Remicade as a potential treatment for vasculitis

Table 34: Remicade SWOT Analysis, 2015

Table 35: Product Profile — Mycophenolate Mofetil

Table 36: Evidence for Mycophenolate Mofetil Treatment Therapy in Vasculitis

Table 37: MMF SWOT Analysis, 2015

Table 38: Product Profile – CYC

Table 39: Evidence for cyclophosphamide treatment therapy in vasculitis

Table 40: CYC SWOT Analysis, 2014

Table 41: Product Profile — Azathioprine

Table 42: Evidence for azathioprine treatment therapy in vasculitis

Table 43: Azathioprine SWOT Analysis, 2015

Table 44: Product Profile — Methotrexate

Table 45: Evidence for Methotrexate treatment therapy in vasculitis

Table 46: Methotrexate SWOT Analysis, 2015

Table 47: Product Profile — Glucocorticoids

Table 48: Evidence for Glucocorticoid Treatment Therapy in Vasculitis

Table 49: GC SWOT Analysis, 2015

Table 50: Product Profile — Intravenous Immunoglobulin

Table 51: Evidence for Intravenous Immunoglobulin Therapy in Vasculitis

Table 52: GC SWOT Analysis, 2015

Table 53: Unmet Need and Opportunity in Vasculitis, 2015

Table 54: Vasculitis — Late Stage Pipeline, December 2015

Table 55: Product Profile — Orencia

Table 56: Orencia SWOT Analysis, 2015

Table 57: Product Profile — Benlysta

Table 58: Benlysta SWOT Analysis, 2015

Table 59: Product Profile — Actemra

Table 60: Clinical Trials Demonstrating Actemra as a Potential Treatment for Vasculitis

Table 61: Actemra SWOT Analysis, 2015

Table 62: Product Profile — Otezla

Table 63: Otezla SWOT Analysis, 2015

Table 64: Product Profile — Nucala

Table 65: Completed Trials Demonstrating Nucala as a Potential Treatment for eGPA

Table 66: Nucala SWOT Analysis, 2015

Table 67: Early-Stage Pipeline Products in Vasculitis, November 2015

Table 68: Clinical Benchmark of Key Pipeline Drugs for AAV

Table 69: Clinical Benchmark of Key Pipeline Drugs for LVV, KD, and BD

Table 70: Commercial Benchmark of Key Pipeline Drugs for AAV

Table 71: Commercial Benchmark of Key Pipeline Drugs for LVV, KD, and BD

Table 72: Top-Line Sales Forecasts ($m) for Vasculitis, 2014–2024

Table 73: Key Events Impacting Sales for Vasculitis, 2014–2024

Table 74: Global Vasculitis Disease Market — Drivers and Barriers, 2014–2024

Table 75: Key Launch Dates

Table 76: Key Patent Expiries

Table 77: Average Body Weight and Surface Area Across the 7MM

Table 78: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Classification of Systemic Vasculitides as Defined by CHCC 2012

Figure 2: 7MM, Diagnosed Incident Cases of AAV, Ages ≥15 Years, Both Sexes, N ...

Figure 1: Classification of Systemic Vasculitides as Defined by CHCC 2012

Figure 2: 7MM, Diagnosed Incident Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014–2024

Figure 3: 7MM, Diagnosed Prevalent Cases of AAV, Ages ≥15 Years, Both Sexes, N, 2014–2024

Figure 4: 7MM, Age-Standardized Diagnosed Incidence of MPA, Ages ≥15 Years, Both Sexes, N, 2014

Figure 5: 7MM, Age-Standardized Diagnosed Incidence of GPA, Ages ≥15 Years, Both Sexes, N, 2014

Figure 6: 7MM, Age-Standardized Incidence of eGPA, Ages ≥15 Years, Both Sexes, N, 2014

Figure 7: 7MM, Diagnosed Incident Cases of LVV, Ages ≥15 Years, Both Sexes, N, 2014–2024

Figure 8: 7MM, Diagnosed Prevalent Cases of TA, Ages ≥15 Years, Both Sexes, N, 2014–2024

Figure 9: 7MM, Age-Standardized Diagnosed Incidence of GCA, Ages ≥15 Years, Both Sexes, N, 2014

Figure 10: 7MM, Age-Standardized Diagnosed Incidence of TA, Ages ≥15 Years, Both Sexes, N, 2014

Figure 11: 7MM, Diagnosed Incident Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014–2024

Figure 12: 7MM, Diagnosed Prevalent Cases of BD, Ages ≥15 Years, Both Sexes, N, 2014–2024

Figure 13: 7MM, Age-Standardized Incidence of BD, Ages ≥15 Years, Both Sexes, N, 2014

Figure 14: 7MM, Diagnosed Incident Cases of KD, Ages ≤5 Years, Both Sexes, N, 2014–2024

Figure 15: Competitive Assessment of AAV Pipeline Therapies, 2014–2024

Figure 16: Competitive Assessment of LVV, KD, and BD Pipeline Therapies, 2014–2024

Figure 17: Global Sales for Vasculitis by Region, 2014–2024

Figure 18: Global Sales for Vasculitis by Indication, 2014–2024

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