Graft Versus Host Disease (GvHD) Epidemiology

Key Highlights

• DelveInsight’s analysis projects that in 2024, there were approximately 53,000 cases of GvHD in the 7MM. This number is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 2%, reaching approximately 63,000 cases by 2034.
• The rise in GVHD cases is linked to HLA mismatch, donor and recipient age, sex mismatches, and the use of peripheral blood stem cells, which carry a higher risk than bone marrow stem cells.
• In 2024, the US had around 24,000 cases of GVHD, with cases projected to grow at a 2% CAGR by 2034.
• In 2024, Germany reported approximately 1,250 cases of acute GvHD and 7,000 five-year prevalent cases of chronic GvHD.
• In 2024, the UK reported the following distribution of acute GvHD (aGvHD) cases by grading: approximately 300 cases of Grade B[II] aGvHD, 150 cases of Grade C[III] aGvHD, and 110 cases of Grade D[IV] aGvHD.
• In 2024, Japan reported approximately 2,100 mild, 3,000 moderate, and 1,800 severe cases of chronic GvHD by grading.

DelveInsight’s “GvHD Epidemiology Forecast – 2034” report delivers an in-depth understanding of GvHD, historical and forecasted epidemiology of GvHD in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2021-2034

GvHD Understanding

GvHD Overview

GvHD is an immune response that occurs when donor immune cells, typically T cells, attack the recipient’s tissues after a transplant, particularly following an allogeneic bone marrow or stem cell transplant. There are two main forms of GvHD: acute GvHD (aGvHD) and chronic GvHD (cGvHD). GvHD can be further classified into grades: Grade I (mild), Grade II (moderate), Grade III (severe), and Grade IV (life-threatening). Approximately 50% of patients with acute GvHD develop cGvHD.

Acute GvHD typically manifests within 3 months after transplant and is commonly observed in patients who undergo unrelated transplants or those with an HLA mismatch. The condition primarily affects the skin, liver, and gastrointestinal tract. It is staged and graded based on the extent of organ involvement (Grade 0–IV), with higher-grade GvHD (Grade III–IV) generally associated with worse outcomes. Symptoms of acute GvHD may include skin rashes, jaundice, nausea, vomiting, diarrhea, and abdominal cramps. Risk factors for aGvHD include HLA mismatches, female donors who have given birth, advanced age, and donor-recipient sex differences.

Chronic GvHD typically develops >100 days post-transplant and can affect multiple organs, including the skin, liver, mouth, lungs, gastrointestinal tract, neuromuscular system, and genitourinary tract. It is a major cause of late non-relapse mortality after hematopoietic cell transplantation. Symptoms of chronic GvHD can vary widely across different organs, including skin rash, tightening or thickening of the skin, jaundice, abdominal swelling, dry eyes or mouth, pain when swallowing, shortness of breath, joint stiffness, and fatigue.

Diagnosis of cGvHD relies on clinical manifestations, with additional tests such as biopsies, endoscopy, imaging, lung function tests, and blood work used to confirm the diagnosis.

Patients at higher risk of developing cGvHD include those who received stem cells or bone marrow from an HLA-mismatched related or HLA-matched unrelated donor, those who have had aGvHD, older transplant recipients, and those who have undergone certain conditioning regimens.

The diagnosis of aGvHD is based on clinical evaluation and biopsies of affected organs. In contrast, cGvHD diagnosis may require the exclusion of other conditions and the use of multiple diagnostic tests.

Further details related to diagnosis are provided in the report...

GvHD Epidemiology

For the purpose of designing the patient-based model for GvHD, the report provides historical as well as forecasted epidemiology segmented by total allogenic transplant cases, total cases of GvHD, type-specific cases of GvHD, aGvHD cases by grading, aGvHD cases by organ involvement, cGvHD cases by grading, and cGvHD cases by organ involvement in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2021 to 2034.

• DelveInsight’s epidemiology model estimates that in 2024, there were approximately 58,000 allogenic transplant cases and nearly 53,000 cases of GvHD across the 7MM which are expected to increase by 2034.
• In 2024, the US reported the highest number of GvHD cases among the 7MM, with approximately 24,000, a figure expected to rise by 2034.
• In 2024, Germany reported the highest number of GvHD cases among EU4 and the UK, with approximately 8,200 cases, followed by Italy, with around 3,400 cases. Spain had the lowest number, with approximately 2,750 cases.
• In 2024, Japan reported approximately 8,200 GvHD cases, a number projected to increase by 2034.
• In 2024, the US reported around 5,300 cases of aGvHD and 18,700 prevalent cases of cGvHD over five years.
• In 2024, EU4 and the UK reported the following distribution of aGvHD cases by grading: 2,300 cases of Grade B[II] aGvHD, 1,050 cases of Grade C[III] aGvHD, and 850 cases of Grade D[IV] aGvHD.
• In 2024, Germany reported approximately 900 aGvHD cases involving the skin, 400 cases involving the liver, and 800 cases involving the gastrointestinal tract.
• The UK reported approximately 650 mild, 1,000 moderate, and 770 severe cases of cGvHD by grading in 2024.
• In 2024, Japan reported the following cGvHD cases: 1,100 cases involving the skin, 3,150 cases affecting the oral mucosa, 1,900 cases impacting the eyes, 300 cases involving the liver, 770 cases in the gastrointestinal tract, 2,400 cases affecting the lungs, 320 cases involving the genitals, and 430 cases related to the joints and fascia.

KOL Views

To gaze into the epidemiology insights of the real world, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research on disease prevalence.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Medicine Department of Ohio State University, US; University of Minnesota, US; Universite de Bordeaux, France; University of Glasgow, UK; and the Department of Hematology and Oncology, Japan, among others, were contacted. Their opinion helps understand and validate current disease prevalence, gender involved with the disease, diagnosis rate, and diagnostic criteria.

As per the KOLs from the US, aGvHD typically affects only three organs: the epidermis, digestive system, and liver. It develops rapidly following transplantation and is primarily triggered by a T-cell-mediated response.

As per the KOLs from the UK, GvHD occurs when donor immune cells attack host tissues, primarily driven by donor T cells activated by MHC differences. The pathophysiology involves tissue damage from conditioning regimens, T-cell activation, and effector responses leading to organ injury, particularly in the skin, liver, and gastrointestinal tract.

As per the KOLs from Japan, GvHD diagnosis combines clinical evaluation and lab tests, identifying donor cell presence and tissue damage. Key lab markers, such as autoimmune cytopenias and elevated liver enzymes, help differentiate it from similar conditions. Severity classification based on organ involvement is critical for tailoring effective treatment strategies.

Scope of the Graft versus Host Disease Epidemiology Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of GvHD, explaining its causes, signs and symptoms, and currently available diagnostic algorithms and guidelines.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and diagnosis guidelines.
• The report provides an edge for understanding trends, expert insights/KOL views, and patient journeys in the 7MM.
• A detailed review of current challenges in establishing the diagnosis.

GvHD Report Insights

• Graft versus Host Disease Patient Population
• Country-wise Epidemiology Distribution
• Total Allogenic Transplant Cases                            
• Total Cases of GvHD
• Type-specific Cases of GvHD
• Acute GvHD Cases by Grading
• Acute GvHD Cases by Organ Involvement
• Chronic GvHD Cases by Grading
• Chronic GvHD Cases by Organ Involvement

Graft versus Host Disease Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• GvHD Epidemiology Segmentation

Graft versus Host Disease Report Assessment

• Current GVHD Diagnostic Practices
• Graft versus Host Disease Patient Segmentation

Graft versus Host Disease Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of GvHD? What will be the growth opportunities across the 7MM concerning the patient population of GvHD?
• What is the historical and forecasted GvHD patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Why are the total cases of GvHD in Japan lower than in the US?
• Which country has a high patient share for GvHD?

Reasons to Buy Graft versus Host Disease Epidemiology Report

• Insights on patient burden/disease, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the GvHD cases in varying geographies over the coming years.
• To understand the perspective of key opinion leaders around the current challenges with establishing the diagnosis options.
• Detailed insights on various factors hampering disease diagnosis and other existing diagnostic challenges.

Frequently Asked Questions

1.           What is the forecast period covered in the report?

The GvHD Epidemiology report for the 7MM covers the forecast period from 2025 to 2034, providing a projection of epidemiology dynamics and trends during this timeframe.

2.           Out of all EU4 countries and the UK, which country had the highest population of GvHD cases in 2024?

The highest cases of GvHD were found in Germany among EU4 and the UK in 2024.

3.           How is epidemiological data collected and analyzed for forecasting purposes?

Epidemiological data is collected through surveys, clinical studies, health records, and other sources. It is then analyzed to calculate disease rates, identify trends, and project future disease burdens using mathematical models.

4.           Out of all 7MM countries, which country had the highest population of GvHD cases in 2024?

The highest cases of GvHD were found in the US among the 7MM in 2024.