Graft vs Host Disease (GVHD) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032

Graft vs Host Disease (GVHD) Market Outlook

Thelansis’s “Graft vs Host Disease (GVHD) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Graft vs Host Disease treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Graft vs Host Disease (GVHD) Overview

Graft vs Host Disease (GVHD) is a condition in transplant rejection where the immune cells from the donor launch an immune attack against the recipient's tissues, perceiving them as foreign. This immune reaction primarily involves the donor's T cells (the graft) targeting and damaging the recipient's healthy cells (the host). GVHD has traditionally been categorized based on the onset time, with a cutoff point of 100 days following the transplant. The National Institutes of Health (NIH) has further classified GVHD based on recognized clinical manifestations into the following subtypes:

1. Acute classic GVHD: This form appears within the first 100 days after transplantation and displays the typical clinical features of acute GVHD.
2. Persistent, recurrent, or late-onset acute GVHD: This variation presents with the classic features of acute GVHD but occurs more than 100 days after the transplant.
3. Classic chronic GVHD: Manifesting after the 100-day mark post-transplant, this type exhibits the characteristic clinical features of chronic GVHD.
4. Overlap syndrome: This syndrome can emerge any time following the transplant and combines features of acute and chronic GVHD.

GVHD can develop under various circumstances, including after allogeneic bone transplantation (most commonly), after the transplantation of solid organs rich in lymphoid cells (e.g., liver), and following the transfusion of non-irradiated blood. GVHD's occurrence requires the transplantation of immunologically competent cells into immunodeficient recipients, and these transferred cells must recognize alloantigens within the recipient's body. Several crucial factors influence the occurrence and severity of GVHD, including donor-host factors, stem-cell source factors, immune modulation factors, and the use of chemotherapy and radiation therapy. The standard initial systemic treatment for acute GVHD typically involves corticosteroids, usually administered at a dose of 1-2 mg/kg/day of prednisone or its equivalent. However, around 50% of patients do not respond to steroids or become refractory to them (SR), leading to a poor long-term prognosis, with an estimated 40% nonrelapse mortality (NRM) rate within 12 months. Since 2017, the US Food and Drug Administration (FDA) has approved four treatments for GVHD: ruxolitinib (for both acute and chronic GVHD), ibrutinib (for chronic GVHD), and belumosudil (for chronic GVHD).

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2021-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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