DelveInsight’s ‘Hemophagocytic Lymphohistiocytosis Market Insights, Epidemiology, and Market Forecast – 2034’ report deliver an in-depth understanding of the disease, historical & forecasted epidemiology as well as the market trends of Hemophagocytic Lymphohistiocytosis (HLH) in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Hemophagocytic lymphohistiocytosis is a life-threatening disorder characterized by unbridled activation of cytotoxic T lymphocytes, natural killer (NK) cells, and macrophages resulting in hypercytokinemia and immune-mediated injury of multiple organ systems.
Key highlights from the Hemophagocytic lymphohistiocytosis Market Report:
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Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening hyperinflammatory syndrome caused by uncontrolled activation of the immune system. It is classified into two types: primary (familial) HLH, resulting from genetic mutations that impair immune regulation, and secondary (acquired) HLH, triggered by infections, cancers, or autoimmune disorders.
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In November 2024, Electra Therapeutics Receives FDA Fast Track Designation for ELA026 in Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
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In 2023, the 7MM reported approximately 4,500 new cases of HLH. Current treatment mainly includes therapies such as dexamethasone, etoposide, cyclosporine, intrathecal hydrocortisone, methylprednisolone, and rituximab.
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The HLH market was valued at around USD 140 million in 2023, with expectations for significant growth due to increasing drug adoption, the potential launch of new therapies, and heightened awareness of the condition. The United States holds the largest share of the HLH market, surpassing the combined market size of the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
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Although the HLH pipeline is limited, a promising drug, ELA026, is in development. In June 2024, Electra Therapeutics presented clinical data for ELA026 in secondary HLH at the European Hematology Association (EHA) Congress in Madrid, with the results featured as one of six late-breaking oral presentations.
Hemophagocytic lymphohistiocytosis (HLH) is a rare and potentially fatal hyperinflammatory syndrome caused by uncontrolled activation of the immune system. It is categorized into two types: primary (familial) HLH, which results from genetic mutations disrupting immune regulation, and secondary (acquired) HLH, which can be triggered by infections, malignancies, or autoimmune diseases. Common symptoms include fever, hepatosplenomegaly, pancytopenia, lymphadenopathy, and rash. The condition occurs due to the dysregulated activation of natural killer (NK) cells, cytotoxic T cells, and macrophages, leading to excessive inflammation and multi-organ damage.
Diagnosing HLH can be challenging because its symptoms are nonspecific, requiring a high level of suspicion. The Histiocyte Society’s diagnostic criteria are based on at least 5 out of 8 key findings: fever, splenomegaly, cytopenias in two or more lineages, hypertriglyceridemia or hypofibrinogenemia, hemophagocytosis in bone marrow/spleen/lymph nodes, hyperferritinemia, impaired NK cell function, and elevated soluble CD25 levels. Additional signs may include liver dysfunction (transaminitis), coagulopathy, hyponatremia, and neurological symptoms. Molecular testing can also aid in confirming the diagnosis. Early detection is critical, as HLH can be fatal without prompt intervention.
As per the John Hopkins Medicine, there are 2 types of HLH: familial and acquired. Familial HLH accounts for about 25% of cases and families pass down the condition.
The best treatment options for hemophagocytic lymphohistiocytosis (HLH) are determined by a number of factors, including the severity of symptoms, the age of onset, and the underlying cause of the condition.
Hemophagocytic lymphohistiocytosis Epidemiology Insights:
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In 2023, there were approximately 100 incident cases of familial hemophagocytic lymphohistiocytosis (HLH) in the United States. According to DelveInsight’s analysis, the distribution of genetic mutations associated with HLH included around 50 cases of PRF1 mutations, 35 cases involving STX11/STXBP2/UNC13D mutations, 10 cases of XIAP mutations, and 10 cases of NLRC4 or other mutations.
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Additionally, in 2023, the United States saw approximately 130 cases of HLH related to malignancies, 135 cases linked to infections, 35 cases associated with autoimmune conditions, and 30 cases with unknown causes.
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In the EU4 region and the UK, Germany recorded the highest number of incident HLH cases, while Spain reported the fewest.
Hemophagocytic lymphohistiocytosis Key pharma players involved:
1. A2B Bio Ltd
2. Bellicum Pharmaceuticals
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Hemophagocytic Lymphohistiocytosis Market Insights:
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In 2023, the market size for hemophagocytic lymphohistiocytosis (HLH) in the United States was approximately USD 20 million.
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Among the EU4 countries and the UK, France led the market with a size of around USD 30 million, followed by the UK at approximately USD 25 million.
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The HLH market is expected to experience positive growth in the coming years, driven by the anticipated launch of emerging therapies such as ELA026.
Table of contents:
1 Key Insight
2 Executive Summary of Hemophagocytic Lymphohistiocytosis
3 Hemophagocytic Lymphohistiocytosis Market Overview at a Glance
4 Disease Background and Overview: Hemophagocytic Lymphohistiocytosis
5 Case Reports
6 Hemophagocytic Lymphohistiocytosis Epidemiology and Patient Population
7 United States Epidemiology
8 EU5 Epidemiology
9 Japan Epidemiology
10 Current Hemophagocytic Lymphohistiocytosis Treatment and Medical Practices
11 Unmet needs
12 Hemophagocytic Lymphohistiocytosis Marketed Drugs
13 Hemophagocytic Lymphohistiocytosis Emerging Drugs
14 Hemophagocytic Lymphohistiocytosis 7MM Market Analysis
15 United States
16 EU-5 countries: Market Outlook
17 Japan Market Outlook
18 Hemophagocytic Lymphohistiocytosis Market Drivers
19 Hemophagocytic Lymphohistiocytosis Market Barriers
20 SWOT Analysis
21 Reimbursement and market access
22 Appendix
23 DelveInsight Capabilities
24 Disclaimer
25 About DelveInsight
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