OpportunityAnalyzer: Graft-Versus-Host Disease – Opportunity Analysis and Forecasts to 2018
The main drivers of growth in graft versus host disease over the 2013-2018 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&J’s 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 Roche’s Rituxan that GlobalData estimates will be one of the bestselling biologics in GVHD in the US by 2018.
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 randomised 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 $409.0m in 2018, at a Compound Annual Growth Rate (CAGR) of 6.61%.
Key Questions Answered
– How will the GVHD market landscape change within the 2013-2018 forecast period in the 6MM?
– What are the most promising late-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?
– 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
– 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 2018.
– 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.
– Key markets covered are US, France, Germany, Italy, Spain, UK
Reasons to buy
– 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
1 Table of Contents
1 Table of Contents 12
1.1 List of Tables 18
1.2 List of Figures 22
2 Introduction 23
2.1 Catalyst 23
2.2 Related Reports 24
2.3 Upcoming Related Reports 24
3 Disease Overview 25
3.1 Etiology and Pathophysiology 25
3.1.1 Etiology 25
3.1.2 Pathophysiology 27
3.1.3 Classification and Prognosis 28
3.2 Symptoms 30
4 Epidemiology 32
4.1 Disease Background 32
4.2 Risk Factors and Comorbidities 33
4.3 Global Trends 35
4.4 Forecast Methodology 36
4.4.1 Sources Used 38
4.4.2 Sources Not Used 44
4.4.3 Diagnosed Incident Cases of HSCTs 45
4.4.4 Diagnosed Incident Cases of Autologous HSCTs 47
4.4.5 Diagnosed Incident Cases of Allogeneic HSCTs 48
4.4.6 Diagnosed Incident Cases of aGVHD 49
4.4.7 Four-Year Diagnosed Prevalent Cases of aGVHD 49
4.4.8 Diagnosed Incident Cases of cGVHD 50
4.4.9 Five-Year Diagnosed Prevalent Cases of cGVHD 50
4.5 Epidemiological Forecast for GVHD (2013-2023) 51
4.5.1 Diagnosed Incident Cases of HSCTs 51
4.5.2 Diagnosed Incident Cases of Autologous HSCTs 53
4.5.3 Diagnosed Incident Cases of Allogeneic HSCTs 54
4.5.4 Diagnosed Incident Cases of aGVHD 56
4.5.5 Four-Year Diagnosed Prevalent Cases of aGVHD 58
4.5.6 Diagnosed Incident Cases of cGVHD 60
4.5.7 Five-Year Diagnosed Prevalent Cases of cGVHD 61
4.6 Discussion 63
4.6.1 Epidemiological Forecast Insight 63
4.6.2 Limitations of the Analysis 64
4.6.3 Strengths of the Analysis 65
5 Current Treatment Options 66
5.1 Overview 66
5.2 Product Profiles – Major Therapies 68
5.2.1 Methylprednisolone (numerous brand and generic names) 68
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)α Inhibitors, Interleukin-2 Receptor α (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) 101
6 Unmet Need and Opportunity 116
6.1 Overview 116
6.2 Lack of Randomized Clinical Trials 119
6.2.1 Unmet Need 119
6.2.2 Gap Analysis 119
6.2.3 Opportunity 120
6.3 No Consensus Regarding Clinical Trial Endpoints 120
6.3.1 Unmet Need 120
6.3.2 Gap Analysis 120
6.3.3 Opportunity 121
6.4 Optimization of Prophylactic Measures 121
6.4.1 Unmet Need 121
6.4.2 Gap Analysis 122
6.4.3 Opportunity 122
6.5 Lack of Standardized Protocols for Established and Off-Label Therapies 123
6.5.1 Unmet Need 123
6.5.2 Gap Analysis 123
6.5.3 Opportunity 124
6.6 Improved Treatment Outcomes for Patients Who Develop Toxicities 124
6.6.1 Unmet Need 124
6.6.2 Gap Analysis 125
6.6.3 Opportunity 125
6.7 Desire for Treatments that Exhibit Longer-Lasting Efficacy Profiles 125
6.7.1 Unmet Need 125
6.7.2 Gap Analysis 126
6.7.3 Opportunity 127
6.8 Management of SR-aGVHD Patients 127
6.8.1 Unmet Need 127
6.8.2 Gap Analysis 128
6.8.3 Opportunity 128
6.9 Management of Sclerotic cGVHD Patients 128
6.9.1 Unmet Need 128
6.9.2 Gap Analysis 129
6.9.3 Opportunity 129
6.10 Improved Prognosis for Patients with Lung Involvement 130
6.10.1 Unmet Need 130
6.10.2 Gap Analysis 130
6.10.3 Opportunity 131
7 Research and Development Strategies 132
7.1 Overview 132
7.1.1 Improvement of Prophylactic Regimens 132
7.1.2 Inhibition of T-Cell Proliferation and Activation 133
7.1.3 Adopting Treatments from Hematologic Indications 134
7.1.4 Targeting Niche Subgroups Within GVHD 135
7.2 Current Clinical Trial Design 136
7.2.1 Current Trial Designs are Dependent on the Stage Within the Treatment Algorithm That a Product is Targeting 136
7.2.2 Lack of Consensus on Clinical Endpoints in Current Trial Designs 137
7.2.3 Patient Exclusion Issues in Current Trial Designs 137
7.2.4 Current Trial Design of Key Pipeline Products 137
7.3 Future Clinical Trial Design 139
7.3.1 Future Trial Designs Need to Incorporate Randomization 139
7.3.2 Future Trial Designs Need to Incorporate Conditioning Regimens and Hematological Patients 140
7.3.3 Companies Behind Off-Label Therapies Should Strategize to Conduct Randomized Studies 140
7.3.4 Design of Early-Phase Clinical Trials for Cellular and Gene Therapy Products Accommodates 2014 Guidance from the FDA 140
8 Pipeline Assessment 141
8.1 Overview 141
8.2 Promising Drugs in Clinical Development 142
8.2.1 Leukotac (inolimomab) 142
8.2.2 Begedina (BT 5/9) 147
■ 英文：OpportunityAnalyzer: Graft-Versus-Host Disease - Opportunity Analysis and Forecasts to 2018
|世界の移植片対宿主病治療薬市場 (OpportunityAnalyzer: Graft-Versus-Host Disease - Opportunity Analysis and Forecasts to 2018 / GDHC021POA)|
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