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.
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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