Sjogren’s Syndrome (SS) – Opportunity Analysis and Forecasts to 2029

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Sjögren’s Syndrome: Executive Summary

2.1 Growth in the Sjögren’s Syndrome Market Is Expected from 2019 to 2029

2.2 R&D Strategies for the Sjögren’s Syndrome Market

2.3 High Level of Unmet Need Persists in the Sjögren’s Syndrome Marketplace

2.4 The Arrival of Novel Biologics Will Transform the Sjögren’s Syndrome Treatment Paradigm

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.1.3 Symptoms

4.1.4 Prognosis

4.2 Classification or Staging Systems

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 Diagnosed Prevalence of SS (%)

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Sources Not Used

5.4.3 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for SS (2019–2029)

5.5.1 Diagnosed Prevalent Cases of pSS

5.5.2 Diagnosed Prevalent Cases of sSS

5.5.3 Age-Specific Diagnosed Prevalent Cases of pSS

5.5.4 Sex-Specific Diagnosed Prevalent Cases of pSS

5.5.5 Diagnosed Prevalent Cases of pSS by ESSDAI

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Approval of Treatments for Glandular and Extraglandular Manifestations

7.3 Earlier Sjögren’s Syndrome Diagnosis

7.4 Improved Public and Patient Awareness of Sjögren’s Syndrome

7.5 Better Clinical Trial Endpoints

8 R&D Strategies

8.1 Overview

8.1.1 Evaluation of Biologic Therapies Marketed for Other Autoimmune Diseases

8.1.2 Increasing Efficiency of Clinical Trials

8.2 Clinical Trials Design

8.2.1 Endpoint Selection

8.2.2 Inclusion Criteria

8.2.3 Patient Recruitment

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Early-Stage Approaches

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Reviewers

11.6.3 Therapy Area Director

11.6.4 Epidemiologist

11.6.5 Reviewers

11.6.6 Director of Epidemiology

11.6.7 Global Director of Therapy Analysis and Epidemiology

11.6.8 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: Sjögren’s Syndrome: Key Metrics in the 7MM

Table 2: Classification Criteria for Sjögren’s Syndrome

Table 3: The EULAR Sjögren's syndrome disease activity index (ESSDAI)

Table 4: Risk Factors and Comorbidities for SS

Table 5: Key Marketed and Off-Label Products for Sjögren’s Syndrome, 7MM

Table 6: Innovative Early-Stage Approaches for Sjögren’s Syndrome, 2021

Table 7: Drugs in Development for Sjögren’s Syndrome, 2021

Table 8: Clinical Benchmark of Key Pipeline Drugs – SS

Table 9: Commercial Benchmark of Key Pipeline Drugs – SS

Table 10: Key Events Impacting Sales for Primary Sjögren’s Syndrome, 2019–2029

Table 11: Primary Sjögren’s Syndrome Market – Global Drivers and Barriers, 2019–2029

Table 12: Key Historical and Projected Launch Dates for Sjögren’s Syndrome

Table 13: Key Historical and Projected Patent Expiry Dates for Sjögren’s Syndrome

Table 14: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country for Sjögren’s Syndrome in 2019 and 2029

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs for Sjögren’s Syndrome Benchmarked Against Off-Label Orencia

Figure 3: Pathophysiology of Sjögren’s Syndrome

Figure 4: 7MM, Diagnosed Prevalence of SS (%), Men and Women, ≥18 Years, 2019

Figure 5: 7MM, Sources Used and Not Used for the Diagnosed Prevalence of pSS

Figure 6: 7MM, Sources Used for the Diagnosed Prevalence of sSS

Figure 7: 7MM, Sources Used for the Diagnosed Prevalence of pSS by ESSDAI

Figure 8: 7MM, Diagnosed Prevalent Cases of pSS, Men and Women, Ages ≥18 Years, 2019

Figure 9: 7MM, Diagnosed Prevalent Cases of sSS, Men and Women, Ages ≥18 Years, 2019

Figure 10: 7MM, Age-Specific Diagnosed Prevalent Cases of pSS, Men and Women, Ages ≥18 Years, 2019

Figure 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of pSS, Men and Women, Ages ≥18 Years, 2019

Figure 12: 7MM, Diagnosed Prevalent Cases of pSS by ESSDAI, Men and Women, Ages ≥18 Years, 2019

Figure 13: Unmet Needs and Opportunities in Sjögren’s Syndrome

Figure 14: Overview of the Development Pipeline in Sjögren’s Syndrome

Figure 15: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for Sjögren’s Syndrome in the 7MM During the Forecast Period

Figure 16: Competitive Assessment of Pipeline Drugs Benchmarked Against Off-Label Therapy, Orencia

Figure 17: Global (7MM) Sales Forecast by Country for Primary Sjögren’s Syndrome in 2019 and 2029

Figure 18: Global Sales Forecast by Class for Primary Sjögren’s Syndrome in 2019 and 2029

Figure 19: Sales Forecast by Class for Primary Sjögren’s Syndrome in the US in 2019 and 2029

Figure 20: Sales Forecast by Class for Primary Sjögren’s Syndrome in the 5EU in 2019 and 2029

Figure 21: Sales Forecast by Class for Primary Sjögren’s Syndrome in Japan in 2019 and 2029