Graft Versus Host Disease – Opportunity Analysis and Forecasts to 2028

Graft versus host disease (GvHD) is a morbid disease and accounts for the highest cause of non-relapse mortality following allogeneic hematopoietic stem cell transplant (HSCT). Mortality is caused by either extensive tissue damage or uncontrolled opportunistic infection due to the immunosuppressive properties of the current GvHD treatment. Drug-related toxicity issues also contribute significantly to morbidity and mortality in GvHD. The GvHD market is expected to undergo significant change and growth over the next 10 years across the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, and Japan) covered in this report. In this report, GlobalData analyses the current GvHD treatment and prophylaxis landscape and provides detailed insights into the market dynamics of this newly recognized disorder. This analysis also includes the evaluation of the commercial and clinical profiles of drugs in development for GvHD, and their sales projections within GvHD over the 2018–2028 forecast period.

Key Questions Answered

How will the GvHD prophylaxis and treatment landscape in the 7MM (US, France, Germany, Italy, Spain, UK, Japan) change from 2018–2028?

What GvHD prophylaxis agents and treatments are in clinical development?

How do the clinical and commercial attributes of GvHD prophylaxis and treatment candidates in development compare with one another, and against treatment options?

What are the remaining unmet needs in GvHD prevention and treatment?

What drivers and barriers will affect GvHD sales in the 7MM over the forecast period?

Scope

Overview of therapies used in GvHD prophylaxis in patients receiving allogenic hematopoietic stem cell transplants, and treatments for acute, chronic and steroid-refractory GvHD.

Topline GvHD prophylaxis and treatment market revenue from 2018-2028. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

Key topics covered include currently available treatments and prophylaxis products, unmet needs and opportunities, and the drivers and barriers affecting GvHD sales in the 7MM.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of pipeline products.

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

Key Highlights

The GvHD market is expected to undergo significant change and growth over the next 10 years across the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, and Japan) covered in this report. In this report, GlobalData analyzes the current GvHD treatment and prophylaxis landscape and provides detailed insights into the market dynamics of this newly recognized disorder. This analysis also includes the evaluation of the commercial and clinical profiles of drugs in development for GvHD, and their sales projections within GvHD over the 2018–2028 forecast period.

Currently, the GvHD prophylaxis and treatment algorithm varies significantly among physicians and institutions, largely due to the current treatment options consisting of mostly off-label therapies. Over the forecast period GlobalData expects that treatment options for GvHD patients will become more consistent as pipeline products with significant clinical evidence are approved and launched for GvHD prophylaxis and treatment. The launches of products with demonstrated efficacy will be a major driver of growth over the next 10 years, other drivers of growth during this period will include:

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global GvHD prophylaxis and treatment market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the GvHD market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Companies mentioned

Janssen

AbbVie

Incyte

Novartis

Takeda

BMS

Kadmon

Xenikos

CSL Behring

Mesoblast

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

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

2.2 Lack of Consensus on Clinical Trial Endpoints

2.3 GvHD Unmet Needs Expected to Be Partially Addressed

2.4 Opportunity Remains for GvHD Prophylaxis Candidates

2.5 Jakafi Approval for Both Acute and Chronic GvHD Will Drive Sales

2.6 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 Acute GvHD

4.2.2 Chronic GvHD

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

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

8 R&D Strategies

8.1 Overview

8.1.1 Targeting Niche Subgroups within GvHD

8.1.2 Adopting Treatments from Hematologic Indications

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 Early-Stage 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 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 Analysts

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Epidemiology Reviewers

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

Table 1: GvHD Key Metrics in the 7MM

Table 2: Grading System of Organ Involvement in aGvHD

Table 3: Global Severity of Chronic GvHD

Table 4: Risk Factors for GvHD

Table 5: Treatment Guidelines for GvHD

Table 6: Innovative Approaches for GvHD, 2019

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

Table 8: Clinical Benchmark of Key Pipeline Drugs – GvHD Prophylaxis

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

Table 10: Commercial Benchmark of Key Pipeline Drugs – GvHD Prophylaxis

Table 11: Key Events Impacting Sales for GvHD, 2018–2028

Table 12: GvHD Market – Global Drivers and Barriers, 7MM, 2018–2028

Table 13: Key Historical and Projected Approval/Launch Dates for GvHD

Table 14: Key Historical and Projected Patent Expiry Dates for GvHD

Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for GvHD in 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: 7MM, Diagnosed Incidence of aGvHD per 100 Diagnosed Incident First Allogeneic HSCT Cases, All Ages, Both Sexes, 2018

Figure 5: 7MM, Diagnosed Incidence of cGvHD per 100 Diagnosed Incident First Allogeneic HSCT Cases, All Ages, Both Sexes, 2018

Figure 6: Sources Used for First Allogeneic HSCT

Figure 7: Sources Used for aGvHD and cGvHD in First Allogeneic HSCT

Figure 8: Sources Used for aGvHD Grades

Figure 9: Sources Used for cGvHD Severity

Figure 10: Sources Used for 100-Day Mortality of aGvHD and One-Year Mortality of cGvHD

Figure 11: Sources Used for Three-Year Diagnosed Prevalent Cases of aGvHD and cGvHD

Figure 12: 7MM, Diagnosed Incident Cases of First Allogeneic HSCT Cases, Men and Women, All Ages, 2018

Figure 13: 7MM, Diagnosed Incident Cases of aGvHD in First Allogeneic HSCT Cases, Men and Women, All Ages, 2018

Figure 14: 7MM, Diagnosed Incident Cases of cGvHD in First Allogeneic HSCT Cases, Men and Women, All Ages, 2018

Figure 15: 7MM, Age-Specific Diagnosed Incident Cases of aGvHD and cGvHD in First Allogeneic HSCT Cases, Men and Women, 2018

Figure 16: 7MM, Diagnosed Incident Cases of aGvHD by Grade, Men and Women, All Ages, 2018

Figure 17: 7MM, Diagnosed Incident Cases of cGvHD by Severity, Men and Women, All Ages, 2018

Figure 18: 7MM, 100-Day Mortality in Diagnosed Incident Cases of aGvHD, Men and Women, All Ages, 2018 and 2028

Figure 19: 7MM, One-Year Mortality in Diagnosed Incident Cases of cGvHD, Men and Women, All Ages, 2018

Figure 20: 7MM, Three-Year Diagnosed Prevalent Cases of aGvHD, Men and Women, All Ages, 2018

Figure 21: 7MM, Three-Year Diagnosed Prevalent Cases of cGvHD, Men and Women, All Ages, 2018

Figure 22: Unmet Needs and Opportunities in GvHD

Figure 23: Overview of the Development Pipeline in GvHD

Figure 24: Key Phase II/III Trials for Pipeline Agents Expected to Be Licensed for GvHD in the 7MM During the Forecast Period

Figure 25: Competitive Assessment of the Marketed and Pipeline Drugs for GvHD Treatment Benchmarked Against the SOC, corticosteroids

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

Figure 27: 7MM Sales Forecast by Country for GvHD in 2018 and 2028

Figure 28: 7MM Sales Forecast by Class for GvHD in 2018 and 2028

Figure 29: 7MM Sales Forecast by Patient Population for GvHD in 2018 and 2028

Figure 30: Sales Forecast by Class for GvHD in the US in 2018 and 2028

Figure 31: Sales Forecast by Class for GvHD in the 5EU in 2018 and 2028

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

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