PUBLISHER: The Business Research Company | PRODUCT CODE: 1826934
PUBLISHER: The Business Research Company | PRODUCT CODE: 1826934
Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening disorder caused by excessive immune activation, resulting in severe inflammation and multi-organ failure. The primary goal of HLH management is to regulate the overactive immune response and prevent organ damage, with timely diagnosis and intervention being crucial for improving survival outcomes.
The primary types of HLH are familial and acquired. Familial HLH is an inherited condition caused by genetic mutations that disrupt immune system regulation, emphasizing the need for genetic insights in developing targeted treatments. Diagnosis involves various methods, including blood tests, bone marrow biopsy, genetic testing, and blood cultures, while treatment options include steroids, chemotherapy, antibiotics, antiviral drugs, and others. These treatments are distributed through multiple channels such as hospital pharmacies, retail pharmacies, and online pharmacies, serving various end-users, including hospitals, home care settings, and specialty clinics.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.
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The hemophagocytic lymphohistiocytosis market size has grown strongly in recent years. It will grow from $2.3 billion in 2024 to $2.44 billion in 2025 at a compound annual growth rate (CAGR) of 6.0%. The growth in the historic period can be attributed to an increase in the investment in research and development activities, increasing prevalence of musculoskeletal disorders, increasing awareness of rare diseases, increasing awareness among healthcare professionals, and rising prevalence of chronic disorders.
The hemophagocytic lymphohistiocytosis market size is expected to see strong growth in the next few years. It will grow to $3.07 billion in 2029 at a compound annual growth rate (CAGR) of 5.9%. The growth in the forecast period can be attributed to the increasing prevalence of immuno-oncology diseases, rising healthcare expenditure, rising prevalence of infectious diseases, rising prevalence of autoimmune diseases, and increasing prevalence of HIV cases. Major trends in the forecast period include advancements in hematopoietic stem cell transplants, ongoing research targeted therapies, development of monoclonal antibody therapies, innovative gene therapy approaches, and adoption of personalized medicine and precision therapies.
The forecast of 5.9% growth over the next five years reflects a slight reduction of 0.1% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff escalations are likely to burden U.S. hospitals by driving up the cost of immunosuppressants and cytokine testing panels sourced from Austria and Denmark, exacerbating this life-threatening condition and elevating pediatric hematology costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The increasing prevalence of autoimmune diseases is expected to drive the growth of the hemophagocytic lymphohistiocytosis (HLH) market in the coming years. Autoimmune diseases occur when the immune system mistakenly attacks the body's healthy cells and tissues. This rising prevalence is influenced by factors such as genetic predisposition, environmental triggers, infections, hormonal changes, and improved early diagnosis and awareness. HLH treatments assist autoimmune patients by suppressing excessive immune activation, reducing inflammation, and restoring immune system balance, which helps alleviate severe immune-mediated complications and improves disease management. For instance, in June 2024, the Australian Institute of Health and Welfare reported that rheumatoid arthritis, a systemic autoimmune disorder, affected approximately 514,000 people (2.0%) in Australia in 2022, with 2.5% of females and 1.6% of males diagnosed with the condition. As a result, the increasing prevalence of autoimmune diseases is fueling the growth of the HLH market.
The rising healthcare expenditure is also expected to boost the growth of the HLH market. Healthcare expenditure refers to the total amount spent on medical goods, services, and public health programs within a country or region. Factors such as an aging population, the growing burden of chronic diseases, medical advancements, rising service costs, and increased demand for improved healthcare are driving healthcare spending. Increased healthcare expenditure enhances HLH treatments by funding advanced diagnostics, therapies, and research, improving access to specialized care, and supporting the development of new treatments and early detection methods. For example, in December 2023, the Centers for Medicare & Medicaid Services reported that U.S. healthcare spending increased by 4.1% in 2022, reaching $4.5 trillion, marking an acceleration compared to the 3.2% growth observed in 2021. Consequently, rising healthcare expenditure is contributing to the expansion of the HLH market.
Leading companies in the HLH market are focusing on developing innovative solutions, such as monoclonal antibody therapies, to selectively target and deplete pathogenic immune cells. Monoclonal antibody therapy involves lab-engineered antibodies that specifically target antigens on cells, helping modulate immune responses and treat diseases. For example, in October 2024, Electra Therapeutics, Inc., a US-based biotechnology company, launched ELA026, which received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration for treating HLH. ELA026 is a first-in-class antibody therapy that targets signal regulatory proteins (SIRP), offering a novel approach for secondary HLH (sHLH), a rare and life-threatening condition with no approved treatments.
Major players in the hemophagocytic lymphohistiocytosis market are Labcorp, Quest Diagnostics Incorporated, Electra Therapeutics Inc., Swedish Orphan Biovitrum AB (Sobi), ARUP Laboratories, Invitae Corp., Mayo Clinic Laboratories, Metropolis Healthcare, Centogene NV, Fulgent Genetics, Atara Biotherapeutics Inc., Innate Pharma S.A., Blueprint Genetics, Novimmune SA, Machaon Diagnostics Inc., SeaStar Medical Inc., AB2 Bio Ltd., Elixiron Immunotherapeutics Inc., Bellicum Pharmaceuticals Inc., Eurofins Biomnis.
North America was the largest region in the hemophagocytic lymphohistiocytosis market in 2024. The regions covered in hemophagocytic lymphohistiocytosis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the hemophagocytic lymphohistiocytosis market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The hemophagocytic lymphohistiocytosis market consists of revenues earned by entities by providing services such as stem cell transplantation, supportive care, and follow-up care. The market value includes the value of related goods sold by the service provider or included within the service offering. The hemophagocytic lymphohistiocytosis market includes sales of immunosuppressive drugs, intravenous immunoglobulin, and plasmapheresis equipment. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Hemophagocytic Lymphohistiocytosis Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on hemophagocytic lymphohistiocytosis market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for hemophagocytic lymphohistiocytosis ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The hemophagocytic lymphohistiocytosis market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.