Hemophagocytic Lymphohistiocytosis Market Poised for Phenomenal Expansion in the US at a CAGR of 24.5% During the Forecast Period (2025-2034)

The hemophagocytic lymphohistiocytosis market is expected to increase due to the launch of emerging therapies, such as plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), tadekinig alfa (r-hIL-18BP) (AB2 Bio), and others, as well as label expansions of current therapies. This is because of the higher patient burden, approval of newer therapies with high cost, and broader acceptance and availability of newly approved therapies.

LAS VEGAS, Jan. 15, 2026 /PRNewswire/ — DelveInsight’s Hemophagocytic Lymphohistiocytosis Market Insights report includes a comprehensive understanding of current treatment practices, hemophagocytic lymphohistiocytosis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Hemophagocytic Lymphohistiocytosis Market Summary

The market size for hemophagocytic lymphohistiocytosis was found to be USD 140 million in the United States in 2024.
The HLH market remains highly unmet, with conventional therapies leading to high mortality (20–30% before HSCT) and only about 60% long-term survival due to toxicity, treatment failure, and relapse risk.
Among the 7MM countries, there were 5,100 incident cases of HLH in the US in 2024.
Leading hemophagocytic lymphohistiocytosis companies, such as TJ Biopharma, AB2 Bio, Electra Therapeutics, Novartis, and others, are developing new hemophagocytic lymphohistiocytosis treatment drugs that can be available in the hemophagocytic lymphohistiocytosis market in the coming years.
The promising hemophagocytic lymphohistiocytosis therapies in clinical trials include Plonmarlimab (TJM2/TJ003234), Tadekinig alfa (r-hIL-18BP), ELA026, MAS 825, and others.

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Key Factors Driving the Growth of the Hemophagocytic Lymphohistiocytosis Market

Rising HLH Incidence: The increasing incidence of HLH, often triggered by underlying infections, autoimmune diseases, malignancies, or immuno-oncology treatments, has expanded the pool of patients needing diagnosis and therapy.
Advances in Diagnostics and Early Detection: Improvements in diagnostic technologies, including genetic testing, immunologic profiling, and next-generation sequencing, enable earlier and more accurate detection of HLH. This allows timely intervention, which is critical given the rapid, life-threatening course of HLH.
GAMIFANT Maintains First-in-Class Position in HLH: GAMIFANT (Sobi) remains the only approved therapy for primary HLH (since 2018) and has recently expanded its label, gaining US FDA approval in June 2025 for MAS associated with Still’s disease. Following this approval, GAMIFANT has demonstrated stronger-than-projected market uptake, with double-digit growth in Constant Exchange Rates (CER). The company plans to pursue EU regulatory submission in 2026, indicating continued strategic expansion of its HLH and MAS portfolio.
Launch of Emerging HLH Drugs: The dynamics of the HLH market are expected to change in the coming years due to the launch of emerging therapies such as plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), tadekinig alfa (r-hIL-18BP) (AB2 Bio), and others.

Hemophagocytic Lymphohistiocytosis Market Analysis

Management of HLH necessitates a comprehensive, multimodal strategy that integrates immunosuppressive, cytotoxic, and targeted therapies to control hyperinflammation, limit pathological immune activation, and restore immune homeostasis.
Therapeutic decisions are guided by disease severity and the underlying trigger, with early, aggressive intervention essential to prevent irreversible organ damage.
High-dose corticosteroids, particularly dexamethasone, constitute a foundational component of HLH treatment due to their potent anti-inflammatory effects and ability to suppress cytokine-mediated tissue injury.
Etoposide-based regimens remain a cornerstone of first-line therapy, as they effectively eradicate cytotoxic lymphocytes and macrophages that are excessively activated and drive disease pathology.
Immunosuppressive agents such as cyclosporine are commonly employed to suppress T-cell activation and reduce cytokine release, thereby dampening immune overactivation.
Targeted biologic therapies, including rituximab for EBV-associated HLH and monoclonal antibodies such as alemtuzumab or antithymocyte globulin in refractory disease, enable more selective immune modulation.
When infections serve as triggering factors, concurrent antimicrobial therapy, including antivirals and antibiotics, is critical to address both the precipitating cause and the downstream inflammatory cascade.
Collectively, these treatment approaches aim to achieve disease stabilization and control, allowing eligible patients to proceed to definitive curative options such as hematopoietic stem cell transplantation (HSCT).
GAMIFANT demonstrated strong commercial momentum in Q3 2025, generating USD 66.6 million in revenue, a 98% year-over-year increase.
Revenue growth was driven by rising patient adoption, a favorable product mix, and the successful U.S. launch for macrophage activation syndrome (MAS) in Still’s disease, making GAMIFANT the first approved therapy for both pediatric and adult patients.
This milestone highlights GAMIFANT’s broader applicability across the HLH–MAS disease spectrum and reinforces its long-term growth potential.
Regulatory momentum remains positive, while active compassionate-use programs in Europe continue to reflect sustained clinician demand.
Looking ahead, GAMIFANT revenues are expected to grow at a low double-digit CAGR at constant exchange rates, supported by global market expansion, improved patient access, and continued uptake across both MAS and HLH indications.

Hemophagocytic Lymphohistiocytosis Competitive Landscape

The pipeline of HLH is very scarce, with only three emerging therapies: plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), and tadekinig alfa (r-hIL-18BP) (AB2 Bio). Despite all being in late-stage development, this underscores the scarcity of therapeutic innovation in this space.

AB2 Bio’s Tadekinig alfa is an innovative recombinant human IL-18 binding protein (IL-18BP) that neutralizes IL-18, a key pro-inflammatory cytokine. Under normal physiological conditions, endogenous IL-18BP is present in excess, maintaining circulating free IL-18 at undetectable levels. In certain autoinflammatory disorders, this regulatory balance is disrupted, leading to elevated systemic free IL-18 and severe pathological hyperinflammation. Tadekinig alfa re-establishes this balance by sequestering excess free IL-18, thereby attenuating inflammatory responses. This mechanism represents a novel and promising therapeutic strategy for autoimmune and inflammatory diseases characterized by elevated systemic IL-18 levels. The therapy is currently being evaluated in a Phase III clinical trial.

Electra Therapeutics’ ELA026 is a monoclonal antibody developed to treat severe inflammatory diseases driven by dysregulated myeloid cells and T-lymphocytes. It selectively and rapidly depletes the circulating inflammatory myeloid cells and T cells responsible for disease pathology, while preserving the CD47/SIRPα immune checkpoint pathway. ELA026 is presently in Phase II/III clinical development.

The anticipated launch of these emerging therapies are poised to transform the hemophagocytic lymphohistiocytosis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the hemophagocytic lymphohistiocytosis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

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Recent Developments in the Hemophagocytic Lymphohistiocytosis Market

In October 2025, Electra Therapeutics announced that the first patients had been dosed in the SURPASS study, a pivotal Phase II/III clinical trial evaluating ELA026, the first investigational therapy designed to broadly treat secondary HLH.
In June 2025, Sobi announced that the US FDA approved emapalumab for the treatment of adult and pediatric (newborn and older) patients with HLH/MAS in known or suspected Still’s disease, including sJIA, with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.

What is Hemophagocytic Lymphohistiocytosis?

Hemophagocytic lymphohistiocytosis is a rare, life-threatening immune system disorder characterized by extreme and uncontrolled immune activation. In HLH, immune cells, particularly macrophages and lymphocytes, become overactive and release excessive amounts of inflammatory cytokines, leading to a “cytokine storm” that causes widespread tissue damage and organ failure. The condition can be inherited (primary HLH) due to genetic defects affecting immune regulation, or acquired (secondary HLH) and triggered by infections, malignancies, autoimmune diseases, or other immune challenges. Clinically, HLH often presents with persistent high fever, enlarged liver and spleen, cytopenias, liver dysfunction, and markedly elevated inflammatory markers. Without prompt diagnosis and treatment, HLH can rapidly progress and is frequently fatal.

Hemophagocytic Lymphohistiocytosis Epidemiology Segmentation

The hemophagocytic lymphohistiocytosis epidemiology section provides insights into the historical and current hemophagocytic lymphohistiocytosis patient pool and forecasted trends for the leading markets. The commonest single disease entities were lymphoma, SLE, and sJIA. There has been evidence of clinically diagnosed HIV, EBV, or CMV infection either in the health record or on the death certificate in 2.3%, 8.9%, and 3.3%, respectively.

The hemophagocytic lymphohistiocytosis treatment market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:

Total Incident Cases of HLH
Total Incident Cases of HLH by Type
Incident Cases of HLH by Gender
Incident Cases of Familial HLH by Mutation
Incident Cases of Acquired HLH by Etiology
Total Treated Cases of HLH

Hemophagocytic Lymphohistiocytosis Market Report Metrics	Details
Study Period	2020–2034
Coverage	7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Hemophagocytic Lymphohistiocytosis Market CAGR (US)	24.5 %
Hemophagocytic Lymphohistiocytosis Market Size in 2024 (US)	USD 140 Million
Key Hemophagocytic Lymphohistiocytosis Companies	TJ Biopharma, AB2 Bio, Electra Therapeutics, Novartis, Swedish Orphan Biovitrum AB (Sobi), and others
Key Hemophagocytic Lymphohistiocytosis Therapies	Plonmarlimab (TJM2/TJ003234), Tadekinig alfa (r-hIL-18BP), ELA026, MAS 825, GAMIFANT, and others

Scope of the Hemophagocytic Lymphohistiocytosis Market Report

Therapeutic Assessment: Hemophagocytic Lymphohistiocytosis current marketed and emerging therapies
Hemophagocytic Lymphohistiocytosis Market Dynamics: Key Market Forecast Assumptions of Emerging Hemophagocytic Lymphohistiocytosis Drugs and Market Outlook
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL’s views, Analyst’s views, Hemophagocytic Lymphohistiocytosis Market Access and Reimbursement

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Table of Contents

1	Hemophagocytic Lymphohistiocytosis Market Key Insights
2	Hemophagocytic Lymphohistiocytosis Market Report Introduction
3	Executive Summary
4	Key Events
5	Epidemiology and Market Forecast Methodology
6	HLH Market Overview at a Glance
6.1	Clinical Landscape Analysis (By Phase, RoA, and Molecule Type)
6.2	Market Share of HLH by Therapies (%) in the 7MM in 2024
6.3	Market Share of HLH by Therapies (%) in the 7MM in 2034
7	Disease Background and Overview
7.1	Introduction
7.2	Hemophagocytic Lymphohistiocytosis Causes
7.3	Hemophagocytic Lymphohistiocytosis Symptoms
7.4	Hemophagocytic Lymphohistiocytosis Diagnosis
7.5	Differential Diagnosis
7.6	Diagnostic Algorithm
7.7	Diagnosis Guidelines
8	Hemophagocytic Lymphohistiocytosis Treatment
9	Epidemiology and Patient Population
9.1	Key Findings
9.1.1	Current Challenges, Evolving Paradigms, and Epidemiology Insights
9.2	Assumptions and Rationale
9.3	Total Incident Cases of HLH in the 6MM
9.4	Total Incident Cases of HLH by Type in the 6MM
9.5	United States
9.5.1	Total Incident Cases of HLH in the US
9.5.2	Total Incident Cases of HLH by Type in the US
9.5.3	Incident Cases of HLH by Gender in the US
9.5.4	Incident Cases of Familial HLH by Mutation in the US
9.5.5	Incident Cases of Acquired HLH by Etiology in the United States
9.5.6	Total Treated Cases of HLH in the US
9.6	EU4 and the UK
9.7	Japan
10	Hemophagocytic Lymphohistiocytosis Patient journey
10.1	Patient Journey Description
11	Marketed Hemophagocytic Lymphohistiocytosis Therapies
11.1	Emapalumab-lzsg (GAMIFANT): Swedish Orphan Biovitrum AB (Sobi)
11.1.1	Product Description
11.1.2	Regulatory Milestones
11.1.3	Other Developmental Activities
11.1.4	Summary of Pivotal Trials
11.1.5	Analyst View
12	Emerging Hemophagocytic Lymphohistiocytosis Therapies
12.1	Key Cross Competition
12.2	ELA026: Electra Therapeutics
12.2.1	Product Description
12.2.2	Other Developmental Activities
12.2.3	Clinical Development
12.2.3.1	Clinical Trials Information
12.2.4	Safety and Efficacy
12.2.5	Analyst View
12.2.6	ELA026-specific response
12.3	Tadekinig Alfa (r-hIL-18BP): AB2 Bio
12.4	Plonmarlimab (TJM2/TJ003234): TJ Biopharma
12.5	MAS825: Novartis
13	HLH Market: 7MM Market Analysis
13.1	Key Findings
13.1.1	Current Challenges, Evolving Paradigms, and Emerging Insights in MAS/sHLH
13.2	Hemophagocytic Lymphohistiocytosis Market Outlook
13.4	Conjoint Analysis
13.5	Key Hemophagocytic Lymphohistiocytosis Market Forecast Assumptions
13.6	Total Market Size of HLH in the 6MM
13.7	Total Market Size of HLH by Therapies in the 6MM
13.8	The United States Hemophagocytic Lymphohistiocytosis Market Size
13.8.1	Total Market Size of HLH in the US
13.8.2	Total Market Size of HLH by Therapies in the US
13.9	EU4 and the UK Hemophagocytic Lymphohistiocytosis Market Size
13.10	Japan Hemophagocytic Lymphohistiocytosis Market Size
14	Hemophagocytic Lymphohistiocytosis Market Unmet Needs
15	Hemophagocytic Lymphohistiocytosis Market SWOT Analysis
16	KOL Views on Hemophagocytic Lymphohistiocytosis
17	Hemophagocytic Lymphohistiocytosis Market Access and Reimbursement
17.1.1	The United States
17.2	EU4 and the UK
17.3	Market Access and Reimbursement of HLH
18	Bibliography
19	Hemophagocytic Lymphohistiocytosis Market Report Methodology

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