Table of Content

1 Key Insights

2 Executive Summary of HCL

3 Hairy Cell Leukemia Market Overview at a Glance
3.1 Market Share (%) Distribution of Hairy Cell Leukemia in 2017
3.2 Market Share (%) Distribution of Hairy Cell Leukemia in 2030

4 Disease Background and Overview
4.1 Introduction
4.2 Symptoms
4.3 Risk Factor
4.4 Staging and Risk Stratification
4.5 Genetics
4.6 Morphologic and Immunophenotypic Features
4.7 Biology of HCL
4.8 Pathogenesis
4.9 Diagnosis
4.9.1 Differential Diagnosis
4.1 Diagnostic Guidelines
4.10.1 NCCN Clinical Practice Guidelines in Oncology - Hairy Cell Leukemia, Version 2.2018
4.10.2 European Society for Medical Oncology (ESMO): Clinical Practice Guidelines - Hairy Cell Leukemia
4.10.3 Consensus guidelines for the diagnosis Classic Hairy Cell Leukemia

5 Epidemiology and Patient Population
5.1 Key Findings

6 7MM Epidemiology
6.1 Assumptions and rationale
6.2 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in 7MM
6.3 The United States
6.3.1 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in the United States
6.3.2 Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the United States
6.3.3 Age-specific Diagnosed Incident of Hairy Cell Leukemia in the United States
6.3.4 Gender-Specific cases of Hairy Cell Leukemia (HCL) in the United States
6.4 EU5 Countries
6.4.1 Germany
6.4.1.1 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Germany
6.4.1.2 Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Germany
6.4.1.3 Age-specific Diagnosed Incident of Hairy Cell Leukemia in Germany
6.4.1.4 Gender-specific cases of Hairy Cell Leukemia (HCL) in Germany
6.4.2 France
6.4.2.1 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in France
6.4.2.2 Diagnosed Incident of Hairy Cell Leukemia by Symptoms in France
6.4.2.3 Age-specific Diagnosed Incident of Hairy Cell Leukemia in France
6.4.2.1 Gender-specific cases of Hairy Cell Leukemia (HCL) in France
6.4.3 Italy
6.4.3.1 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Italy
6.4.3.2 Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Italy
6.4.3.3 Age-specific Diagnosed Incident of Hairy Cell Leukemia in Italy
6.4.3.4 Gender-specific cases of Hairy Cell Leukemia (HCL) in Italy
6.4.4 Spain
6.4.4.1 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Spain
6.4.4.2 Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Spain
6.4.4.3 Age-specific Diagnosed Incident of Hairy Cell Leukemia in Spain
6.4.4.4 Gender-specific cases of Hairy Cell Leukemia (HCL) in Spain
6.4.5 United Kingdom
6.4.5.1 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in the United Kingdom
6.4.5.2 Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the United Kingdom
6.4.5.3 Age-specific Diagnosed Incident of Hairy Cell Leukemia in the United Kingdom
6.4.5.4 Gender-specific cases of Hairy Cell Leukemia (HCL) in the United Kingdom
6.4.6 Japan
6.4.6.1 Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Japan
6.4.6.2 Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Japan
6.4.6.3 Age-specific Diagnosed Incident of Hairy Cell Leukemia in Japan
6.4.6.4 Gender-specific cases of Hairy Cell Leukemia (HCL) in Japan

7 Treatment and Management
7.1 ESMO (European Society for Medical Oncology) Clinical Practice Guidelines for Treatment
7.2 Consensus Guidelines for the management of patients with classic Hairy Cell Leukemia
7.3 NCCN Clinical Practice Guidelines Hairy Cell Leukemia, Version 1.2021
7.3.1 Treatment Options
7.3.2 Treatment Guidelines

8 Unmet Needs

9 Organizations contributing toward HCL

10 Case studies
10.1 A Case Report of Hairy Cell Leukemia Presenting Concomitantly with Sweet Syndrome
10.2 Skin Metastasis in Patient with Hairy Cell Leukemia: Case Report
10.3 Tuberculous Meningoencephalitis in a Patient with Hairy Cell Leukemia in Complete Remission
10.4 A Case Report of CD27-positive hairy cell leukemia-Japanese variant

11 KOL Views

12 Patient Journey

13 Marketed Therapies
13.1 Leustatin: Janssen
13.1.1 Drug Description
13.1.2 Other Developmental Activities
13.1.3 Safety and Efficacy
13.2 Nipent: Pfizer
13.2.1 Product Description
13.2.2 Other Developmental Activities
13.2.3 Safety and Efficacy
13.3 Intron A: Merck
13.3.1 Product Description
13.3.2 Other Development Activities
13.3.3 Safety and Efficacy
13.4 Roferon-A: Roche
13.4.1 Product Description
13.4.2 Other Development Activities
13.4.3 Safety and Efficacy

14 Emerging Therapies
14.1 Key cross competition – Emerging Therapies
14.2 Lumoxiti: Innate Pharma/AstraZeneca
14.2.1 Drug Description
14.2.2 Other Developmental Activities
14.2.3 Clinical Development
14.2.3.1 Clinical Trial Description
14.3 Obinutuzumab: Roche
14.3.1 Product Description
14.3.2 Clinical Development
14.3.2.1 Clinical Trials Information
14.3.3 Safety and Efficacy

15 Other Promising Therapies
15.1 Ibrutinib: Johnson and Johnson/Pharmacyclics
15.1.1 Product Description
15.1.2 Other Development Activities
15.1.3 Clinical Development
15.1.3.1 Clinical Trials Information
15.1.4 Safety and Efficacy
15.2 Vemurafenib: Roche
15.2.1 Product Description
15.2.2 Other Development Activities
15.2.3 Clinical Development
15.2.3.1 Clinical Trials Information
15.2.4 Safety and Efficacy

16 Hairy Cell Leukemia (HCL): Seven Major Market Analysis
16.1 Key Findings
16.2 Market Size of Hairy Cell Leukemia (HCL) in 7MM

17 Seven Major Market Outlook
17.1 The United States Market Size
17.1.1 Total Market Size of Hairy Cell Leukemia (HCL) in the United States
17.1.2 Total Market Size of Hairy Cell Leukemia (HCL) by Therapies in the United States
17.2 Germany
17.2.1 The total market size of Hairy Cell Leukemia (HCL) in Germany
17.2.2 Market size of Hairy Cell Leukemia (HCL) by Therapies in Germany
17.3 France
17.3.1 The total market size of Hairy Cell Leukemia (HCL) in France
17.3.2 Market size of Hairy Cell Leukemia (HCL) by Therapies in France
17.4 Italy
17.4.1 Market size of Hairy Cell Leukemia (HCL) by Therapies in Italy
17.4.2 The total market size of Hairy Cell Leukemia (HCL) in Italy
17.5 Spain
17.5.1 Total Market Size of Hairy Cell Leukemia (HCL) in Spain
17.5.2 Market size of Hairy Cell Leukemia (HCL) by Therapies in Spain
17.6 United Kingdom
17.6.1 The total market size of Hairy Cell Leukemia (HCL) in the United Kingdom
17.6.2 Market size of Hairy Cell Leukemia (HCL) by Therapies in the UK
17.7 Japan
17.7.1 The total market size of Hairy Cell Leukemia (HCL) in Japan
17.7.2 Market size of Hairy Cell Leukemia (HCL) by Therapies in Japan
18 Market Drivers
19 Market Barriers
20 SWOT Analysis for HCL
21 Reimbursement
22 Appendix
22.1 Report Methodology
22.2 References
23 DelveInsight Capabilities
24 Disclaimer
25 About DelveInsight



List of Figures


Figure 1: RAF-MEK-ERK signaling pathway in hairy cell leukemia
Figure 2: B-cell development in peripheral lymphoid organs: the germinal center reaction
Figure 3: Signaling pathways involved in hairy-cell leukemia (HCL) growth
Figure 4: Hairy-cell leukemia (HCL) homing and dissemination properties
Figure 5: Bone-marrow fibrosis in hairy-cell leukemia (HCL)
Figure 6: ?Hairy’ morphology: molecular mediators and their relationship with hairy-cell survival
Figure 7: Histologic image of a hairy cell
Figure 8: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in 7MM (2017–2030)
Figure 9: Total Diagnosed Incident Cases of HCL in the United States (2017–2030)
Figure 10: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the US (2017–2030)
Figure 11: Age-specific Diagnosed Incident of Hairy Cell Leukemia in the US (2017–2030)
Figure 12: Gender-Specific cases of Hairy Cell Leukemia (HCL) in the US (2017–2030)
Figure 13: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Germany (2017–2030)
Figure 14: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Germany (2017–2030)
Figure 15: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Germany (2017–2030)
Figure 16: Gender-specific cases of Hairy Cell Leukemia (HCL) in Germany (2017–2030)
Figure 17: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in France (2017–2030)
Figure 18: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in France (2017–2030)
Figure 19: Age-specific Diagnosed Incident of Hairy Cell Leukemia in France (2017–2030)
Figure 20: Gender-specific cases of Hairy Cell Leukemia (HCL) in France (2017–2030)
Figure 21: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Italy (2017–2030)
Figure 22: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Italy (2017–2030)
Figure 23: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Italy (2017–2030)
Figure 24: Gender-specific cases of Hairy Cell Leukemia (HCL) in Italy (2017–2030)
Figure 25: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Spain (2017–2030)
Figure 26: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Spain (2017–2030)
Figure 27: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Spain (2017–2030)
Figure 28: Gender-specific cases of Hairy Cell Leukemia (HCL) in Spain (2017–2030)
Figure 29: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in the UK (2017–2030)
Figure 30: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the UK (2017–2030)
Figure 31: Age-specific Diagnosed Incident of Hairy Cell Leukemia in the UK (2017–2030)
Figure 32: Gender-specific cases of Hairy Cell Leukemia (HCL) in the UK (2017–2030)
Figure 33: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Japan (2017–2030)
Figure 34: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Japan (2017–2030)
Figure 35: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Japan (2017–2030)
Figure 36: Gender-specific cases of Hairy Cell Leukemia (HCL) in Japan (2017–2030)
Figure 37: Treatment Algorithm
Figure 38: Treatment algorithm for relapsed and refractory classical HCL according to ESMO guidelines
Figure 39: Treatment algorithm according to ESMO guidelines
Figure 40: Treatment algorithm according to ESMO guidelines
Figure 41: NCCN Treatment Guidelines
Figure 42: Unmet Needs
Figure 43: Market Size of Hairy Cell Leukemia (HCL) in USD Million (2017–2030)
Figure 44: Market Size of Hairy Cell Leukemia (HCL) in the US, USD Millions (2017–2030)
Figure 45: Market Size of Hairy Cell Leukemia (HCL) in the US by therapies, USD Millions (2017–2030)
Figure 46: Market Size of Hairy Cell Leukemia (HCL) in Germany, USD Millions (2017–2030)
Figure 47: Market Size of Hairy Cell Leukemia (HCL) in Germany by therapies, USD Millions (2017–2030)
Figure 48: Market Size of Hairy Cell Leukemia (HCL) in France, USD Millions (2017–2030)
Figure 49: Market Size of Hairy Cell Leukemia (HCL) in France by therapies, USD Millions (2017–2030)
Figure 50: Market Size of Hairy Cell Leukemia (HCL) in Italy by therapies, USD Millions (2017–2030)
Figure 51: Market Size of Hairy Cell Leukemia (HCL) in Italy, USD Millions (2017–2030)
Figure 52: Market Size of Hairy Cell Leukemia (HCL) in Spain, USD Millions (2017–2030)
Figure 53: Market Size of Hairy Cell Leukemia (HCL) in Spain by therapies, USD Millions (2017–2030)
Figure 54: Market Size of Hairy Cell Leukemia (HCL) in the UK, USD Millions (2017–2030)
Figure 55: Market Size of Hairy Cell Leukemia (HCL) in the UK by therapies, USD Millions (2017–2030)
Figure 56: Market Size of Hairy Cell Leukemia (HCL) in Japan, USD Millions (2017–2030)
Figure 57: Market Size of Hairy Cell Leukemia (HCL) in Japan by therapies, USD Millions (2017–2030)
Figure 58: Market Drivers
Figure 59: Market Barriers


List of Tables


Table 1: Summary of Hairy Cell Leukemia Market, Epidemiology, and Key Events (2017–2030)
Table 2: Genomic alterations in hairy cell leukemia (HCL), hairy cell leukemia?variant (HCL?V), splenic diffuse red pulp lymphoma (SDRPL) and splenic marginal zone lymphoma (SMZL)
Table 3: NCCN Categories of Evidence and Consensus
Table 4: Diagnosis and workup for HCL by NCCN
Table 5: Diagnostic workup of classical HCL
Table 6: Diagnostic criteria for HCL and HCL-V
Table 7: Initial workup for a patient suspected of hairy cell leukemia
Table 8: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in 7MM (2017–2030)
Table 9: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in the United States (2017–2030)
Table 10: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the US (2017–2030)
Table 11: Age-specific Diagnosed Incident of Hairy Cell Leukemia in the US (2017–2030)
Table 12: Gender-specific cases of Hairy Cell Leukemia (HCL) in the US (2017–2030)
Table 13: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Germany (2017–2030)
Table 14: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Germany (2017–2030)
Table 15: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Germany (2017–2030)
Table 16: Gender-specific cases of Hairy Cell Leukemia (HCL) in Germany (2017–2030)
Table 17: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in France (2017–2030)
Table 18: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in France (2017–2030)
Table 19: Age-specific Diagnosed Incident of Hairy Cell Leukemia in France (2017–2030)
Table 20: Gender-specific cases of Hairy Cell Leukemia (HCL) in France (2017–2030)
Table 21: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Italy (2017–2030)
Table 22: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in Italy (2017–2030)
Table 23: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Italy (2017–2030)
Table 24: Gender-specific cases of Hairy Cell Leukemia (HCL) in Italy (2017–2030)
Table 25: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Spain (2017–2030)
Table 26: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the US (2017–2030)
Table 27: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Spain (2017–2030)
Table 28: Gender-specific cases of Hairy Cell Leukemia (HCL) in Spain (2017–2030)
Table 29: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in the United Kingdom (2017–2030)
Table 30: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the UK (2017–2030)
Table 31: Age-specific Diagnosed Incident of Hairy Cell Leukemia in the UK (2017–2030)
Table 32: Gender-specific cases of Hairy Cell Leukemia (HCL) in the UK (2017–2030)
Table 33: Total Diagnosed Incident Cases of Hairy Cell Leukemia (HCL) in Japan (2017–2030)
Table 34: Diagnosed Incident of Hairy Cell Leukemia by Symptoms in the UK (2017–2030)
Table 35: Age-specific Diagnosed Incident of Hairy Cell Leukemia in Japan (2017–2030)
Table 36: Gender-specific cases of Hairy Cell Leukemia (HCL) in Japan (2017–2030)
Table 37: Definition of response categories
Table 38: Initial workup for a patient suspected of hairy cell leukemia
Table 39: Implications for Recommendations
Table 40: Assessment of response in HCL
Table 41: Assessment of response in HCL
Table 42: Supportive Care
Table 43: Key cross competition - Emerging Therapies
Table 44: Lumoxiti, Clinical Trial Description, 2020
Table 45: obinutuzumab, Clinical Trial Description, 2020
Table 46: Ibrutinib, Clinical Trial Description, 2020
Table 47: Vemurafenib, Clinical Trial Description, 2020
Table 48: Market Size of Hairy Cell Leukemia (HCL) in 7MM in USD Million (2017–2030)
Table 49: The US Market Size of Hairy Cell Leukemia (HCL) in USD Million (2017–2030)
Table 50: US Market Size of Hairy Cell Leukemia (HCL) in USD Million (2017–2030)
Table 51: Market Size of Hairy Cell Leukemia (HCL) in Germany, USD Millions (2017–2030)
Table 52: Germany Market Size of Hairy Cell Leukemia (HCL) by Therapies in USD Million (2017–2030)
Table 53: Market Size of Hairy Cell Leukemia (HCL) associated in France, USD Millions (2017–2030)
Table 54: France Market Size of Hairy Cell Leukemia (HCL) by Therapies in USD Million (2017–2030)
Table 55: Italy Market Size of Hairy Cell Leukemia (HCL) by Therapies in USD Million (2017–2030)
Table 56: Market Size of Hairy Cell Leukemia (HCL) in Italy, USD Millions (2017–2030)
Table 57: Market Size of Hairy Cell Leukemia (HCL) in Spain, USD Millions (2017–2030)
Table 58: Spain Market Size of Hairy Cell Leukemia (HCL) by Therapies in USD Million (2017–2030)
Table 59: Market Size of Hairy Cell Leukemia (HCL) in the UK, USD Millions (2017–2030)
Table 60: UK Market Size of Hairy Cell Leukemia (HCL) by Therapies in USD Million (2017–2030)
Table 61: Market Size of Hairy Cell Leukemia (HCL) in Japan, USD Millions (2017–2030)
Table 62: Japan Market Size of Hairy Cell Leukemia (HCL) by Therapies in USD Million (2017–2030)