Graft Versus Host Disease (GvHD) – Forecast in Asia-Pacific Markets to 2028

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Steady Growth Expected in the GvHD Marketplace from 2018–2028

2.2 Unmet Needs Remain Largely Unattained in GvHD Management

2.3 Opportunity Remains for GvHD Prophylaxis Candidates

2.4 Jakavi Approval for Both Acute and Chronic GvHD Will Drive Sales

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

4.2 Classification and Prognosis

4.2.1 aGvHD

4.2.2 cGvHD

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 Australia

5.3.2 China

5.3.3 India

5.3.4 Japan

5.3.5 South Korea

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Sources Not Used

5.4.3 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for GvHD (2018–2028)

5.5.1 Incident Cases of First Allogeneic HSCT

5.5.2 Incident Cases of aGvHD in First Allogeneic HSCT

5.5.3 Incident Cases of cGvHD in First Allogeneic HSCT

5.5.4 Age-Specific Incident Cases of aGvHD and cGvHD

5.5.5 Diagnosed Incident Cases of aGvHD by Grade

5.5.6 Diagnosed Incident Cases of cGvHD by Severity

5.5.7 100-Day Mortality in Diagnosed Incident Cases of aGvHD

5.5.8 One-Year Mortality in Diagnosed Incident Cases of cGvHD

5.5.9 Three-Year Diagnosed Prevalent Cases of aGvHD

5.5.10 Three-Year Diagnosed Prevalent Cases of cGvHD

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

6.2 Diagnosis

6.3 Treatment

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Lack of Efficacious Treatment

7.3 Lack of Treatment Options for Steroid-Refractory GvHD

7.4 Identification of Patients with High- or Low-Risk Severe Disease

7.5 Lack of Standardized Protocols for Prophylaxis Regimens and Off-Label Treatments

8 R&D Strategies

8.1 Overview

8.1.1 Targeting Niche Subgroups within GvHD

8.1.2 Adopting Treatments from Hematologic Indications

8.1.3 Development of Kinase Inhibitors

8.2 Clinical Trials Design

8.2.1 Current Clinical Trial Design

8.2.2 Lack of Consensus on Clinical Trial Endpoints in Current Trial Designs

8.2.3 Patient Exclusion Issues in Current Clinical Trial Designs

8.2.4 Limitations and Future Outlook

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Pipeline Approaches

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 Australia

10.4.2 India

10.4.3 China

10.4.4 South Korea

10.4.5 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

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analysts

11.6.2 Reviewer

11.6.3 Therapy Area Director

11.6.4 Epidemiologist

11.6.5 Epidemiology Reviewers

11.6.6 Global Director of Therapy Analysis and Epidemiology

11.6.7 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: GvHD: Key Metrics in the 5GM

Table 2: Grading System of Organ Involvement in aGvHD

Table 3: Global Severity of Chronic GvHD

Table 4: Risk Factors for GvHD

Table 5: Innovative Approaches for GvHD, 2019

Table 6: Clinical Benchmark of Key Pipeline Drugs – GvHD Treatment

Table 7: Clinical Benchmark of Key Pipeline Drugs – GvHD Prophylaxis

Table 8: Commercial Benchmark of Key Pipeline Drugs – GvHD Treatment

Table 9: Commercial Benchmark of Key Pipeline Drugs – GvHD Prophylaxis

Table 10: Key Events Impacting Sales for GvHD, 2018–2028

Table 11: GvHD Market – Global Drivers and Barriers, 5GM, 2018–2028

Table 12: Key Historical and Projected Approval/Launch Dates for GvHD

Table 13: Key Projected Patent Expiry Dates for GvHD

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

Figure 1: Global (5GM) Sales Forecast for GvHD, by Country, 2018 and 2028

Figure 2: Competitive Assessment of the Pipeline GvHD Treatments Benchmarked Against the SOC, Corticosteroids

Figure 3: Pathology of Acute GvHD

Figure 4: 5GM, Diagnosed Incidence of aGvHD per 100 First Allogeneic HSCT Cases, All Ages, Both Sexes, 2018

Figure 5: 5GM, Diagnosed Incidence of cGvHD per 100 First Allogeneic HSCT Cases, All Ages, Both Sexes, 2018

Figure 6: Case Flow Map of aGvHD and cGvHD

Figure 7: Sources Used for First Allogeneic HSCT

Figure 8: Sources Used for aGvHD and cGvHD in First Allogeneic HSCT

Figure 9: Sources Used for aGvHD Grades

Figure 10: Sources Used for cGvHD Severity

Figure 11: Sources Used for 100-Day Mortality of aGvHD and One-Year Mortality of cGvHD

Figure 12: Sources Used for Three-Year Diagnosed Prevalent Cases of aGvHD and cGvHD

Figure 13: 5GM, Diagnosed Incident Cases of First Allogeneic HSCT Cases, Both Sexes, All Ages, 2018

Figure 14: 5GM, Diagnosed Incident Cases of aGvHD in First Allogeneic HSCT Cases, Both Sexes, All Ages, 2018

Figure 15: 5GM, Diagnosed Incident Cases of cGvHD in First Allogeneic HSCT Cases, Both Sexes, All Ages, 2018

Figure 16: 5GM, Age-Specific Diagnosed Incident Cases of aGvHD and cGvHD in First Allogeneic HSCT Cases, Both Sexes, 2018

Figure 17: 5GM, Diagnosed Incident Cases of aGvHD by Grade, Both Sexes, All Ages, 2018

Figure 18: 5GM, Diagnosed Incident Cases of cGvHD by Severity, Both Sexes, All Ages, 2018

Figure 19: 5GM, 100-Day Mortality in Diagnosed Incident Cases of aGvHD, Both Sexes, All Ages, 2018 and 2028

Figure 20: 5GM, One-Year Mortality in Diagnosed Incident Cases of cGvHD, Both Sexes, All Ages, 2018

Figure 21: 5GM, Three-Year Diagnosed Prevalent Cases of aGvHD, Both Sexes, All Ages, 2018

Figure 22: 5GM, Three-Year Diagnosed Prevalent Cases of cGvHD, Both Sexes, All Ages, 2018

Figure 23: Unmet Needs and Opportunities in GvHD

Figure 24: Overview of the Development Pipeline in GvHD

Figure 25: Key Phase II/III Trials for Pipeline Agents Expected to Be Licensed for GvHD in the 5GM During the Forecast Period

Figure 26: Competitive Assessment of the Marketed and Pipeline Drugs for GvHD Treatment Benchmarked Against the SOC, Corticosteroids

Figure 27: Competitive Assessment of the Marketed and Pipeline Drugs for GvHD Prophylaxis Benchmarked Against the SOC, Methotrexate

Figure 28: 5GM Sales Forecast by Country for GvHD in 2018 and 2028

Figure 29: Global (5GM) Sales Forecast by Class for GvHD in 2018 and 2028

Figure 30: 5GM Sales Forecast by Patient Population for GvHD in 2018 and 2028

Figure 31: Sales Forecast by Class for GvHD in Australia in 2018 and 2028

Figure 32: Sales Forecast by Class for GvHD in India in 2018 and 2028

Figure 33: Sales Forecast by Class for GvHD in China in 2018 and 2028

Figure 34: Sales Forecast by Class for GvHD in South Korea in 2018 and 2028

Figure 35: Sales Forecast by Class for GvHD in Japan in 2018 and 2028