At a CAGR 12.84% Graft-Versus-Host Disease Market - Opportunity Analysis and Forecast to 2023

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About Graft-Versus-Host Disease Market

The main drivers of growth in graft versus host disease over the 2013-2023 forecast period include the increasing numbers of allogeneic hematopoietic stem cell transplants and the increasing use of biologic off-label and marketed therapies in the 6MM.

Sanofi is a key player in the GVHD market with Thymoglobuline and Lemtrada by infiltrating prophylaxis, aGVHD and cGVHD. J&Js Remicade, has gained a significant patent share of the aGVHD patient group, as it is one of the few drugs that are efficient in GVHD with GI involvement. Gaining more and more ground in the treatment management of cGVHD is Roches Rituxan that GlobalData estimates will be one of the bestselling biologics in GVHD in the US by 2023.

Despite the vast array of available off-label therapies for the treatment and/or prevention of GVHD, very few of these therapies have been tested in large randomized trials. This results in vague treatment recommendations and many patients being enrolled in institutional clinical trials. The only available standard of care is intravenous methylprednisolone that fails to produce a complete response in more than 50% of treated patients. Steroid-refractory subgroups face low prognosis with deteriorating quality of life. Second and third life treatments can vary from country to country but also between different medical institutions in the same country.

The GVHD market was valued at $297.0m across the 6MM in 2013, and is expected to increase to $544.4m in 2023, at a Compound Annual Growth Rate (CAGR) of 12.84%.

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Highlights

Key Questions Answered

- How will the GVHD market landscape change within the 2013-2023 forecast period in the 6MM?
- What are the most promising late-stage pipeline drugs in GVHD?
- How do the clinical and commercial attributes of late-stage pipeline therapies compare to one another and against existing treatment options?
- What are the unmet needs in GVHD treatment management?
- What needs to change in the GVHD R&D and treatment guidelines settings?

Key Findings

- High uptake of off-label biologics (Rituxan, Lemtrada, Remicade and Thymoglobuline)
- No national guidelines are in place
- GVHD remains a field of highly unattained unmet need
- No consensus over clinical trial endpoints
- Regulatory T cells (Tregs) are the focus of the early stage pipeline
- Huge opportunity exists in the chronic patient segment of GVHD
- Institutionally funded studies are the core of GVHD treatment management

Scope

- Overview of GVHD, including epidemiology, etiology, pathophysiology, symptoms and current treatment options
- Annualized GVHD therapeutics market revenue, annual cost of therapies and forecasts for five years to 2023.
- Key topics covered include strategic product assessment, market characterization, unmet needs, R&D strategies, clinical trial design and implications for the GVHD therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging trends and mechanisms of action under development, including TNF blockers, CD25a blockers, GVHD-specific therapies etc.
- Analysis of the current and future market competition in the US and five major EU GVHD therapeutics market. Clinical and commercial benchmarking of promising pipeline products versus standard of care treatments and competitive assessment of all therapies. Insightful review of the key industry drivers, restraints and challenges.

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Reasons to buy

The report will enable you to -
- Identify the unmet needs and remaining opportunities in the GVHD therapeutics market.
- Develop business strategies by understanding the trends shaping and driving the US and five major EU GVHD therapeutics market.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Assess the clinical and commercial viability of promising pipeline products.
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various emerging therapies.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
- Drive revenues by understanding the key trends, innovative products and technologies, market and segments likely to impact the US and five major EU GVHD therapeutics market in future.

Table of Contents

1 Table of Contents 11
1.1 List of Tables 17
1.2 List of Figures 20
2 Introduction 22
2.1 Catalyst 22
2.2 Related Reports 23
2.3 Upcoming Related Reports 23
3 Disease Overview 24
3.1 Etiology and Pathophysiology 24
3.1.1 Etiology 24
3.1.2 Pathophysiology 26
3.1.3 Classification and Prognosis 27
3.2 Symptoms 29

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4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Comorbidities 32
4.3 Global Trends 34
4.4 Forecast Methodology 35
4.4.1 Sources Used 37
4.4.2 Sources Not Used 43
4.4.3 Diagnosed Incident Cases of HSCTs 44
4.4.4 Diagnosed Incident Cases of Autologous HSCTs 45
4.4.5 Diagnosed Incident Cases of Allogeneic HSCTs 46
4.4.6 Diagnosed Incident Cases of aGVHD 48
4.4.7 Four-Year Diagnosed Prevalent Cases of aGVHD 48
4.4.8 Diagnosed Incident Cases of cGVHD 49
4.4.9 Five-Year Diagnosed Prevalent Cases of cGVHD 49
4.5 Epidemiological Forecast for GVHD (2013-2023) 50
4.5.1 Diagnosed Incident Cases of HSCTs 50
4.5.2 Diagnosed Incident Cases of Autologous HSCTs 52
4.5.3 Diagnosed Incident Cases of Allogeneic HSCTs 53
4.5.4 Diagnosed Incident Cases of aGVHD 55
4.5.5 Four-Year Diagnosed Prevalent Cases of aGVHD 57
4.5.6 Diagnosed Incident Cases of cGVHD 58
4.5.7 Five-Year Diagnosed Prevalent Cases of cGVHD 60
4.6 Discussion 62
4.6.1 Epidemiological Forecast Insight 62
4.6.2 Limitations of the Analysis 63
4.6.3 Strengths of the Analysis 64
5 Current Treatment Options 65
5.1 Overview 65
5.2 Product Profiles - Major Therapies 67
5.2.1 Methylprednisolone (numerous brand and generic names) 67
5.2.2 Cyclosporine (numerous brands and generic names) 72
5.2.3 Anti-Thymocyte Globulin (ATG) Therapies 77
5.3 Product Profiles - Off-Label Therapies 82
5.3.1 Biologics (Tumor Necrosis Factor (TNF) Inhibitors, Interleukin-2 Receptor (CD25) Inhibitors, Co-Stimulatory Blockers and Other Biologics) 82
5.3.2 Small Immunosuppressive Molecules (mTOR Inhibitors, Solid Organ Transplant Therapies, and Anti-Neoplastic Therapies) 102
6 Unmet Need and Opportunity 118
6.1 Overview 118
6.2 Lack of Randomized Clinical Trials 121
6.2.1 Unmet Need 121
6.2.2 Gap Analysis 122
6.2.3 Opportunity 122
6.3 No Consensus Regarding Clinical Trial Endpoints 122
6.3.1 Unmet Need 122
6.3.2 Gap Analysis 123
6.3.3 Opportunity 123
6.4 Optimization of Prophylactic Measures 124
6.4.1 Unmet Need 124
6.4.2 Gap Analysis 124
6.4.3 Opportunity 125
6.5 Lack of Standardized Protocols for Established and Off-Label Therapies 125
6.5.1 Unmet Need 125
6.5.2 Gap Analysis 126
6.5.3 Opportunity 126
6.6 Improved Treatment Outcomes for Patients Who Develop Toxicities 127
6.6.1 Unmet Need 127
6.6.2 Gap Analysis 128
6.6.3 Opportunity 128
6.7 Desire for Treatments that Exhibit Longer-Lasting Efficacy Profiles 128
6.7.1 Unmet Need 128
6.7.2 Gap Analysis 129
6.7.3 Opportunity 130
6.8 Management of SR-aGVHD Patients 130
6.8.1 Unmet Need 130
6.8.2 Gap Analysis 131
6.8.3 Opportunity 132
6.9 Management of Sclerotic cGVHD Patients 132
6.9.1 Unmet Need 132
6.9.2 Gap Analysis 133
6.9.3 Opportunity 133
6.10 Improved Prognosis for Patients with Lung Involvement 134
6.10.1 Unmet Need 134
6.10.2 Gap Analysis 134
6.10.3 Opportunity 135

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