Summary
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.
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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%.
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?
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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
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