DelveInsight's “Hairy Cell Leukemia Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of historical and forecasted epidemiology as well as the hairy cell leukemia market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
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Key Takeaways from the Hairy Cell Leukemia Market Report
- In November 2024:- Acerta Pharma BV- This is a Phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. In the first stage, Part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of B-cell malignancies. In the second stage, Part 2 allows for possible expansion cohorts into a wider range of B-cell malignancies, and Part 3 will evaluate the combination in subjects with myelofibrosis (MF).
- The incidence of hairy cell leukemia is very low in Asia, including Japan, and Africa, but is relatively high in Europe and the United States, where it accounts for 2-3% of all leukemia cases, with 3.5 cases per million per year.
- Hairy cell leukemia is very rare, around 230 people are diagnosed with hairy cell leukemia each year in the United Kingdom.
- Hairy cell leukemia is four to five times more common in men than women.
- The median age of patients at diagnosis is 63 years in men and 59 years in women. Although it may occur in younger individuals, it is almost never seen in children.
- The leading Hairy Cell Leukemia Companies such as Roche, Innate Pharma, Johnson & Johnson, Amega Biotech, LAVA Therapeutics, and others.
- Promising Hairy Cell Leukemia Therapies such as Lenalidomide, Obinutuzumab, Oral Azacitidine, Acalabrutinib, Pembrolizumab, and others.
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Hairy Cell Leukemia Epidemiology Segmentation in the 7MM
- Total Incident Cases of Hairy Cell Leukemia
- Incident Cases of Hairy Cell Leukemia by Symptoms
- Age-specific Cases Hairy Cell Leukemia
- Gender-specific Cases of Hairy Cell Leukemia
- Line-wise Treatment Eligible Cases of Hairy Cell Leukemia
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Hairy Cell Leukemia Emerging Drugs
- TECARTUS (brexucabtagene autoleucel): Gilead Sciences
TECARTUS is a CD19-directed genetically modified autologous T-cell immunotherapy that binds to CD19-expressing cancer cells and normal B-cells. It was already approved in mantle cell lymphoma and acute lymphoblastic leukemia. Now the company is conducting Phase II trial for relapsed/refractory hairy cell leukemia. The goal of these trials is to see if CARs can help T cells identify and attack HCL cells, and if increasing the doses of CAR T cells is safe.
- MGD024: MacroGenics
MGD024 is an investigational, second-generation CD123 × CD3 DART molecule that can simultaneously bind CD123 on malignant cells and CD3 on T cells, targeting CD123+ leukemic cells for recognition and elimination by CD3+ T lymphocytes as effector cells. In October 2022, MacroGenics announced that it had entered into an exclusive option and collaboration agreement with Gilead to develop MGD024 and two additional bispecific research programs. MacroGenics is responsible for the ongoing Phase I study for MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points.
- LP-168: Newave Pharmaceutical
LP-168 is a selective next generation inhibitor of BTK that can bind wild-type and C481-mutated BTK covalently and non-covalently, respectively, with preclinical activity in resistant CLL models. This dual activity is hypothesized to allow efficacy against cells with wild-type BTK through covalent activity while preventing expansion of the most common resistance mechanisms through non-covalent activity. Currently Newave Pharmaceutical is running a Phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies including hairy cell leukemia.
Hairy Cell Leukemia Drugs Market Landscape
Systemic therapy of hairy cell leukemia has changed rapidly in the past 10 years because of new biologic agents (eg, interferons) and new purine analogues. Also, the availability of recombinant human hematopoietic growth factors has improved supportive care during life-threatening infections in these patients. Currently CD-19 CAR-T cell therapy and BTK inhibitors are being explored for the treatment of hairy cell leukemia. Purine Analogues: Purine analogues are a standard treatment for hairy cell leukemia. These drugs include cladribine and pentostatin. Both drugs are equally effective at inducing and maintaining remission. In most patients, purine analogues can induce long-term remission. Purine analogues have been one of the biggest successes in cancer treatment history. Before the early 1980s, the median overall survival for HCL patients was around four years. However, patients who are diagnosed at a median age of around 55 years still have a significant risk of relapse later in life.
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Hairy Cell Leukemia Market Outlook
Advances in the understanding of hairy cell leukemia have led to new approaches in management and improved outcomes; nonetheless, there is room for improvement. Over the past decade, there has been enormous progress in the understanding of the biology of hairy cell leukemia which has led to the development of novel therapeutic strategies. The maturation of data regarding existing management strategies has also lent considerable insight into therapeutic outcomes and prognosis of patients treated with chemo- or chemoimmunotherapy. Purine nucleoside analogs remain the cornerstone of treatment, and the addition of rituximab has deepened and prolonged responses in the upfront and relapsed setting. Targeted therapies now have a more defined role in the management of hairy cell leukemia, with BRAF inhibitors now having a potential in the first-line setting in selected cases as well as in relapse. Next-generation sequencing for the identification of targetable mutations, evaluation of measurable residual disease, and risk stratification continue to be areas of active investigation
Hairy Cell Leukemia Treatment Market
Hairy cell leukemia is usually slow growing, and not all newly diagnosed patients with hairy cell leukemia require immediate treatment. For approximately 10% of patients, if they have stable blood counts and no symptoms at the time of diagnosis, the treatment may be the “watch-and-wait” approach. Watch and-wait is an appropriate medical approach that means treatment is delayed until signs and symptoms of the disease appear or progress. Some patients with hairy cell leukemia live for many years without any symptoms and without receiving any treatment. Frequent monitoring, including blood testing, is necessary so that treatment can be started if the disease begins to advance.
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Scope of the Hairy Cell Leukemia Market Report
- Coverage- 7MM
- Hairy Cell Leukemia Companies- Roche, Innate Pharma, Johnson & Johnson, Amega Biotech, LAVA Therapeutics, and others.
- Hairy Cell Leukemia Therapies- Lenalidomide, Obinutuzumab, Oral Azacitidine, Acalabrutinib, Pembrolizumab, and others.
- Hairy Cell Leukemia Therapeutic Assessment: Hairy Cell Leukemia Current marketed and Hairy Cell Leukemia Emerging Therapies
- Hairy Cell Leukemia Market Dynamics: Hairy Cell Leukemia Market drivers and Hairy Cell Leukemia Market Barriers
Table of Content
1 Key Insights
2 Report Introduction
3 Executive Summary of Hairy Cell Leukemia
4 Hairy Cell Leukemia Market Overview at a Glance
5 Key Events
6 Epidemiology and Market Forecast Methodology
7 Hairy Cell Leukemia: Disease Background and Overview
8 Treatment of Hairy Cell Leukemia
9 Epidemiology and Patient Population
10 Hairy Cell Leukemia Patient Journey
11 Hairy Cell Leukemia Marketed Drugs
12 Hairy Cell Leukemia Emerging Drugs
13 Hairy Cell Leukemia: Market Analysis
14 Hairy Cell Leukemia UNMET NEEDS
15 SWOT ANALYSIS
16 KOL VIEWS
17 MARKET ACCESS AND REIMBURSEMENT
18 APPENDIX
19 DELVEINSIGHT CAPABILITIES
20 DISCLAIMER
21 ABOUT DELVEINSIGHT
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