Graft Versus Host Disease Treatment Market Size, Share, Industry, Forecast and outlook (2024-2031)

Market Overview

Global graft versus host disease drugs market reached US$ million in 2022 and is expected to reach US$ XX million by 2030, growing with a CAGR of  during the forecast period 2024-2031.

Graft-versus-host disease (GVHD) is a potentially serious complication of allogeneic stem cell transplantation and reduced-intensity allogeneic stem cell transplantation. In this treatment, a patient’s own damaged or diseased blood-forming stem cells are destroyed. Then they are replaced with healthy stem cells from a donor. GVHD occurs when the donor stem cells (the graft) attack healthy cells in the patient (the host), causing the condition “graft-versus-host disease” or GVHD.

Moreover, they are acute and chronic types. The most common symptom of skin acute GvHD is a rash or reddened area on the skin which is similar to a sunburn. The skin may feel painful or itchy and chronic GvHD most commonly affects the skin, liver, GI tract and lungs, but it can affect any body part. The most important risk factor is donor/recipient HLA match.

Market Scope

Market Dynamics: Drivers

Increasing demand for innovative drugs 

There is an increasing demand for innovative drugs, which is expected to drive the global market over the forecast period. Novel drugs aim to address the unmet needs associated with the treatment of graft versus host disease by providing alternative or complementary drug options. The regulatory approvals increase the trust in innovative drugs.

For instance, on March 25, 2022, Incyte received approval for ruxolitinib (Jakavi) for the treatment of patients aged 12 years and older with acute graft-versus-host disease or chronic graft-versus-host disease (GVHD) and who have inadequate response to corticosteroids or other systemic therapies.

Moreover, many clinical trials are going on for the development of innovative drugs that show better results in the treatment. For instance, on July 24, 2023, Syndax Pharmaceuticals and Incyte stated the positive topline data from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with chronic graft-versus-host disease (GVHD).

Additionally, on August 7, 2023, Humanigen, Inc., a clinical-stage biopharmaceutical company, released the successful dosing of the first participant in the RATinG trial of lenzilumab for the early treatment of acute Graft versus Host Disease (aGvHD)

Further, the increasing prevalence of graft versus host disease, rising FDA approvals, increasing clinical trials, increasing awareness and advancements in the development of new drugs are also factors expected to drive the market over the forecast period.

Restraints

Factors such as complications and risks associated with corticosteroids and other drugs and the high cost of the drugs are expected to hamper the market. For instance, according to the National Institute of Health (NIH), the cost of ruxolitinib, which is used in graft versus host disease is US$ 1,187,657.

Segment Analysis

The global graft versus host disease drugs market is segmented based on disease type, drug class, distribution channel and region.

The corticosteroids segment accounted for approximately 47.2% of the graft versus host disease drugs market share

The corticosteroids segment is expected to hold the largest market share over the forecast period. The corticosteroids are considered as first-line treatment for the graft versus host disease. Corticosteroids such as prednisone, methylprednisone, and others are most commonly used in the treatment. Additionally, corticosteroids are also mostly preferred with the combination of other drugs to enhance their effectiveness.

For instance, on January 2, 2020, Incyte Corporation cleared the pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in patients with treatment of acute graft-versus-host disease (GVHD). Itacitinib added to corticosteroids improved the overall response rate in patients with treatment of acute GVHD.

Moreover, their wide availability, acceptability, and, ease of application helps to hold the largest market share. These combining drugs are considered especially in cases where a single drug modality may not be sufficient. In addition, their wide adoption also increases the demand for the corticosteroids. For instance, according to the National Institute of Health (NIH), 2021, the standard treatment for chronic GVHD high doses of a steroid such as prednisone works for about half of patients.

Geographical Analysis

North America accounted for approximately 38.8% of the market share 

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and rising FDA approvals. North America especially the United States is home to many pharmaceutical companies. The presence of major players actively performing in clinical trials and research activities leads to the launch of novel drugs.

For instance, on July 12, 2021, Equillium, Inc., a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, declared the completion of an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for itolizumab in first-line treatment of patients with acute graft-versus-host disease (aGVHD). 

Furthermore, regulatory approvals like FDA approvals are increasing in the region, which is expected to drive the market. For instance, on August 24, 2022, the Janssen Pharmaceutical Companies of Johnson & Johnson declared that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft-versus-host disease (cGVHD) after the failure of one or more lines of systemic therapy.

Competitive Landscape

The major global players in the graft versus host disease drugs market include Kadmon Pharmaceuticals, LLC., Novartis AG, Astellas Pharma Inc., Neovii Pharmaceuticals AG, Mesoblast Ltd, Johnson & Johnson, INCYTE CORPORATION, Janssen Biotech, Inc., Bristol-Myers Squibb Company, MaaT Pharma and among others. 

Key Developments

• On March 25, 2022, Novartis released a positive opinion recommending approval of Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease (GvHD) who have inadequate response to corticosteroids or other systemic therapies.
• On June 28, 2022, Veloxis Pharmaceuticals, an Ashai Kasei company, cleared the dosing of the first patient by its partner, Xenikos, in a global pivotal Phase 3 clinical study [NCT04934670] designed to evaluate T-Guard versus ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT).
• On December 15, 2021, Bristol Myers Squibb, received approval for Orencia (abatacept) from the U.S. Food and Drug Administration (FDA) for the prophylaxis, or prevention, of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor (URD).

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global graft versus host disease drugs market. The pandemic created unprecedented challenges for pharmaceutical industries worldwide, including the global drugs market by temporarily disrupting many clinical trials, research activities, and regulatory approvals due to the redirected focus on the COVID-19 pandemic and its related restrictions. The pandemic also disrupted the supply chain of these treatment drugs globally.

Why Purchase the Report?

• To visualize the global graft versus host disease drugs market segmentation based on disease type, drug class, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of graft versus host disease drugs market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global graft versus host disease drugs market report would provide approximately 61 tables, 59 figures, and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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