OpportunityAnalyzer: Vasculitis – Opportunity Analysis and Forecast to 2024

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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.


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?

Boehringer Ingelheim
Zydus Cadila
Mitsubishi Tanabe
Eli Lilly

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 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

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