Warm Autoimmune Hemolytic Anemia (WAIHA) Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034

Warm Autoimmune Hemolytic Anemia (WAIHA) Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034


The 7 major warm autoimmune hemolytic anemia (WAIHA) markets reached a value of US$ 730.8 Million in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 3,486.9 Million by 2034, exhibiting a growth rate (CAGR) of 15.26% during 2024-2034.

The warm autoimmune hemolytic anemia (WAIHA) market has been comprehensively analyzed in IMARC's new report titled "Warm Autoimmune Hemolytic Anemia (WAIHA) Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Warm autoimmune hemolytic anemia (WAIHA) is a rare autoimmune disorder characterized by the destruction of red blood cells by the body's immune system. The symptoms of the ailment can vary depending on the severity of the condition but typically include fatigue, weakness, shortness of breath, etc. Various other indications are pallor, jaundice, rapid heartbeat, dark urine, an enlarged spleen, etc. In severe cases, WAIHA can lead to acute hemolytic crisis, characterized by the sudden onset of anemia, and can be life-threatening. The diagnosis of WAIHA usually begins with a physical exam and medical history evaluation. A complete blood count (CBC) is the first step, which can reveal a low red blood cell count (anemia) and a high number of reticulocytes (young red blood cells). Various additional blood tests may be ordered to look for antibodies that attack red blood cells and rule out other causes of anemia. Besides this, a bone marrow biopsy is also performed to help confirm the diagnosis. Numerous imaging tests, such as ultrasound and CT scan, are done to check for an enlarged spleen, which is a common complication of WAIHA.

The rising cases of variations in genes that regulate immune system function are primarily driving the warm autoimmune hemolytic anemia (WAIHA) market. In addition to this, the increasing prevalence of several triggering factors, such as viral and bacterial infections, autoimmune diseases like lupus and rheumatoid arthritis, fluctuations in hormones, etc., is also bolstering the market growth. Moreover, the escalating utilization of intravenous immunoglobulin (IVIG) treatment, which involves infusing high levels of immunoglobulin into the bloodstream to control the autoimmune response and reduce the destruction of red blood cells, is acting as another significant growth-inducing factor. Apart from this, the widespread adoption of supportive therapies, such as iron supplementation, folic acid supplementation, erythropoietin, etc., to manage the symptoms of anemia and improve the quality of life in patients is further propelling the market growth. Additionally, numerous key players are making extensive investments in R&D activities to identify several potential pathways and molecules, including the B-cell receptor (BCR) signaling pathway and complement system proteins like C1s and C5, that could be targeted to treat WAIHA. This, in turn, is also creating a positive outlook for the market. Furthermore, the emerging popularity of rituximab for targeting and eliminating B cells in patients who do not respond to or cannot tolerate corticosteroids or immunosuppressants is expected to drive the warm autoimmune hemolytic anemia (WAIHA) market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the warm autoimmune hemolytic anemia (WAIHA) market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for warm autoimmune hemolytic anemia (WAIHA) and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the warm autoimmune hemolytic anemia (WAIHA) market in any manner.

Recent Developments:
In March 2024, HUTCHMED Limited announced that it had launched the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients suffering from WAIHA in China. Sovleplenib is a novel, experimental, and selective small molecule inhibitor for oral administration that targets the spleen tyrosine kinase, or Syk.

Key Highlights:
WAIHA is the most common form (60-70%) of autoimmune hemolytic anemia (AIHA).
WAIHA is a rare condition affecting around 45,000 persons in the United States.
WAIHA can affect people of any age, including children, but it is more common in adults, with a peak prevalence between 50 and 70 years.
Depending on its causative factors, WAIHA can be classified as primary and secondary.
Primary WAIHA is considered to be significantly less frequent than secondary WAIHA, with an estimated distribution of 35-50% of all WAIHA being primary instances.

Drugs:
Ianalumab is a fully human monoclonal antibody that targets BAFF-R. It possesses a new dual mechanism of action: it inhibits BAFF-R-mediated signaling while also effectively depleting B cells through antibody-dependent cellular cytotoxicity.

Rilzabrutinib is an oral, reversible, and covalent BTK inhibitor that can be a first- or best-in-class treatment for a variety of immune-mediated illnesses, including WAIHA. BTK, which is expressed in B and mast cells, plays a significant role in multiple immune-mediated disease processes.

Fostamatinib is an under-development potent, orally administered spleen tyrosine kinase inhibitor designed for the treatment of WAIHA. This therapeutic candidate has the potential to trigger a long-lasting increase in hemoglobin levels for some patients.


Time Period of the Study

Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2034

Countries Covered

United States
Germany
France
United Kingdom
Italy
Spain
Japan

Analysis Covered Across Each Country

Historical, current, and future epidemiology scenario
Historical, current, and future performance of the warm autoimmune hemolytic anemia (WAIHA) market
Historical, current, and future performance of various therapeutic categories in the market
Sales of various drugs across the warm autoimmune hemolytic anemia (WAIHA) market
Reimbursement scenario in the market
In-market and pipeline drugs

Competitive Landscape:
This report also provides a detailed analysis of the current warm autoimmune hemolytic anemia (WAIHA) marketed drugs and late-stage pipeline drugs.

In-Market Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

Drug Overview
Mechanism of Action
Regulatory Status
Clinical Trial Results
Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.


Key Questions Answered in this Report:
Market Insights

How has the warm autoimmune hemolytic anemia (WAIHA) market performed so far and how will it perform in the coming years?
What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
What was the country-wise size of the warm autoimmune hemolytic anemia (WAIHA) market across the seven major markets in 2023 and what will it look like in 2034?
What is the growth rate of the warm autoimmune hemolytic anemia (WAIHA) market across the seven major markets and what will be the expected growth over the next ten years?
What are the key unmet needs in the market?

Epidemiology Insights

What is the number of prevalent cases (2018-2034) of warm autoimmune hemolytic anemia (WAIHA) across the seven major markets?
What is the number of prevalent cases (2018-2034) of warm autoimmune hemolytic anemia (WAIHA) by age across the seven major markets?
What is the number of prevalent cases (2018-2034) of warm autoimmune hemolytic anemia (WAIHA) by gender across the seven major markets?
How many patients are diagnosed (2018-2034) with warm autoimmune hemolytic anemia (WAIHA) across the seven major markets?
What is the size of the warm autoimmune hemolytic anemia (WAIHA) patient pool (2018-2023) across the seven major markets?
What would be the forecasted patient pool (2024-2034) across the seven major markets?
What are the key factors driving the epidemiological trend of warm autoimmune hemolytic anemia (WAIHA)?
What will be the growth rate of patients across the seven major markets?

Warm Autoimmune Hemolytic Anemia (WAIHA): Current Treatment Scenario, Marketed Drugs and Emerging Therapies

What are the current marketed drugs and what are their market performance?
What are the key pipeline drugs and how are they expected to perform in the coming years?
How safe are the current marketed drugs and what are their efficacies?
How safe are the late-stage pipeline drugs and what are their efficacies?
What are the current treatment guidelines for warm autoimmune hemolytic anemia (WAIHA) drugs across the seven major markets?
Who are the key companies in the market and what are their market shares?
What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the warm autoimmune hemolytic anemia (WAIHA) market?
What are the key regulatory events related to the warm autoimmune hemolytic anemia (WAIHA) market?
What is the structure of clinical trial landscape by status related to the warm autoimmune hemolytic anemia (WAIHA) market?
What is the structure of clinical trial landscape by phase related to the warm autoimmune hemolytic anemia (WAIHA) market?
What is the structure of clinical trial landscape by route of administration related to the warm autoimmune hemolytic anemia (WAIHA) market?


1 Preface
2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology
3 Executive Summary
4 Warm Autoimmune Hemolytic Anemia (WAIHA) - Introduction
4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2018-2023) and Forecast (2024-2034)
4.4 Market Overview (2018-2023) and Forecast (2024-2034)
4.5 Competitive Intelligence
5 Warm Autoimmune Hemolytic Anemia (WAIHA) - Disease Overview
5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment
6 Patient Journey
7 Warm Autoimmune Hemolytic Anemia (WAIHA) - Epidemiology and Patient Population
7.1 Epidemiology - Key Insights
7.2 Epidemiology Scenario - Top 7 Markets
7.2.1 Epidemiology Scenario (2018-2023)
7.2.2 Epidemiology Forecast (2024-2034)
7.2.3 Epidemiology by Age (2018-2034)
7.2.4 Epidemiology by Gender (2018-2034)
7.2.5 Diagnosed Cases (2018-2034)
7.2.6 Patient Pool/Treated Cases (2018-2034)
7.3 Epidemiology Scenario - United States
7.3.1 Epidemiology Scenario (2018-2023)
7.3.2 Epidemiology Forecast (2024-2034)
7.3.3 Epidemiology by Age (2018-2034)
7.3.4 Epidemiology by Gender (2018-2034)
7.3.5 Diagnosed Cases (2018-2034)
7.3.6 Patient Pool/Treated Cases (2018-2034)
7.4 Epidemiology Scenario - Germany
7.4.1 Epidemiology Scenario (2018-2023)
7.4.2 Epidemiology Forecast (2024-2034)
7.4.3 Epidemiology by Age (2018-2034)
7.4.4 Epidemiology by Gender (2018-2034)
7.4.5 Diagnosed Cases (2018-2034)
7.4.6 Patient Pool/Treated Cases (2018-2034)
7.5 Epidemiology Scenario - France
7.5.1 Epidemiology Scenario (2018-2023)
7.5.2 Epidemiology Forecast (2024-2034)
7.5.3 Epidemiology by Age (2018-2034)
7.5.4 Epidemiology by Gender (2018-2034)
7.5.5 Diagnosed Cases (2018-2034)
7.5.6 Patient Pool/Treated Cases (2018-2034)
7.6 Epidemiology Scenario - United Kingdom
7.6.1 Epidemiology Scenario (2018-2023)
7.6.2 Epidemiology Forecast (2024-2034)
7.6.3 Epidemiology by Age (2018-2034)
7.6.4 Epidemiology by Gender (2018-2034)
7.6.5 Diagnosed Cases (2018-2034)
7.6.6 Patient Pool/Treated Cases (2018-2034)
7.7 Epidemiology Scenario - Italy
7.7.1 Epidemiology Scenario (2018-2023)
7.7.2 Epidemiology Forecast (2024-2034)
7.7.3 Epidemiology by Age (2018-2034)
7.7.4 Epidemiology by Gender (2018-2034)
7.7.5 Diagnosed Cases (2018-2034)
7.7.6 Patient Pool/Treated Cases (2018-2034)
7.8 Epidemiology Scenario - Spain
7.8.1 Epidemiology Scenario (2018-2023)
7.8.2 Epidemiology Forecast (2024-2034)
7.8.3 Epidemiology by Age (2018-2034)
7.8.4 Epidemiology by Gender (2018-2034)
7.8.5 Diagnosed Cases (2018-2034)
7.8.6 Patient Pool/Treated Cases (2018-2034)
7.9 Epidemiology Scenario - Japan
7.9.1 Epidemiology Scenario (2018-2023)
7.9.2 Epidemiology Forecast (2024-2034)
7.9.3 Epidemiology by Age (2018-2034)
7.9.4 Epidemiology by Gender (2018-2034)
7.9.5 Diagnosed Cases (2018-2034)
7.9.6 Patient Pool/Treated Cases (2018-2034)
8 Warm Autoimmune Hemolytic Anemia (WAIHA) - Treatment Algorithm, Guidelines, and Medical Practices
8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm
9 Warm Autoimmune Hemolytic Anemia (WAIHA) - Unmet Needs
10 Warm Autoimmune Hemolytic Anemia (WAIHA) - Key Endpoints of Treatment
11 Warm Autoimmune Hemolytic Anemia (WAIHA) - Marketed Products
11.1 List of Warm Autoimmune Hemolytic Anemia (WAIHA) Marketed Drugs Across the Top 7 Markets
11.1.1 Drug Name – Company Name
11.1.1.1 Drug Overview
11.1.1.2 Mechanism of Action
11.1.1.3 Regulatory Status
11.1.1.4 Clinical Trial Results
11.1.1.5 Sales Across Major Markets
Kindly note that the complete list of marketed drugs has been provided in the report.
12 Warm Autoimmune Hemolytic Anemia (WAIHA) - Pipeline Drugs
12.1 List of Warm Autoimmune Hemolytic Anemia (WAIHA) Pipeline Drugs Across the Top 7 Markets
12.1.1 M281 - Janssen Research & Development
12.1.1.1 Drug Overview
12.1.1.2 Mechanism of Action
12.1.1.3 Clinical Trial Results
12.1.1.4 Safety and Efficacy
12.1.1.5 Regulatory Status
12.1.2 Isatuximab - ImmunoGen/Sanofi
12.1.2.1 Drug Overview
12.1.2.2 Mechanism of Action
12.1.2.3 Clinical Trial Results
12.1.2.4 Safety and Efficacy
12.1.2.5 Regulatory Status
12.1.3 Ianalumab - MorphoSys/Novartis
12.1.3.1 Drug Overview
12.1.3.2 Mechanism of Action
12.1.3.3 Clinical Trial Results
12.1.3.4 Safety and Efficacy
12.1.3.5 Regulatory Status
12.1.4 Rilzabrutinib - Sanofi
12.1.4.1 Drug Overview
12.1.4.2 Mechanism of Action
12.1.4.3 Clinical Trial Results
12.1.4.4 Safety and Efficacy
12.1.4.5 Regulatory Status
12.1.5 Fostamatinib - Rigel Pharmaceuticals
12.1.5.1 Drug Overview
12.1.5.2 Mechanism of Action
12.1.5.3 Clinical Trial Results
12.1.5.4 Safety and Efficacy
12.1.5.5 Regulatory Status
Kindly note that the above only represents a partial list of pipeline drugs, and the complete list has been provided in the report.
13. Warm Autoimmune Hemolytic Anemia (WAIHA) - Attribute Analysis of Key Marketed and Pipeline Drugs
14. Warm Autoimmune Hemolytic Anemia (WAIHA) – Clinical Trial Landscape
14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events
15 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Scenario
15.1 Market Scenario - Key Insights
15.2 Market Scenario - Top 7 Markets
15.2.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.2.1.1 Market Size (2018-2023)
15.2.1.2 Market Forecast (2024-2034)
15.2.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.2.2.1 Market Size by Therapies (2018-2023)
15.2.2.2 Market Forecast by Therapies (2024-2034)
15.3 Market Scenario - United States
15.3.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.3.1.1 Market Size (2018-2023)
15.3.1.2 Market Forecast (2024-2034)
15.3.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.3.2.1 Market Size by Therapies (2018-2023)
15.3.2.2 Market Forecast by Therapies (2024-2034)
15.3.3 Warm Autoimmune Hemolytic Anemia (WAIHA) - Access and Reimbursement Overview
15.4 Market Scenario - Germany
15.4.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.4.1.1 Market Size (2018-2023)
15.4.1.2 Market Forecast (2024-2034)
15.4.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.4.2.1 Market Size by Therapies (2018-2023)
15.4.2.2 Market Forecast by Therapies (2024-2034)
15.4.3 Warm Autoimmune Hemolytic Anemia (WAIHA) - Access and Reimbursement Overview
15.5 Market Scenario - France
15.5.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.5.1.1 Market Size (2018-2023)
15.5.1.2 Market Forecast (2024-2034)
15.5.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.5.2.1 Market Size by Therapies (2018-2023)
15.5.2.2 Market Forecast by Therapies (2024-2034)
15.5.3 Warm Autoimmune Hemolytic Anemia (WAIHA) - Access and Reimbursement Overview
15.6 Market Scenario - United Kingdom
15.6.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.6.1.1 Market Size (2018-2023)
15.6.1.2 Market Forecast (2024-2034)
15.6.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.6.2.1 Market Size by Therapies (2018-2023)
15.6.2.2 Market Forecast by Therapies (2024-2034)
15.6.3 Warm Autoimmune Hemolytic Anemia (WAIHA) - Access and Reimbursement Overview
15.7 Market Scenario - Italy
15.7.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.7.1.1 Market Size (2018-2023)
15.7.1.2 Market Forecast (2024-2034)
15.7.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.7.2.1 Market Size by Therapies (2018-2023)
15.7.2.2 Market Forecast by Therapies (2024-2034)
15.7.3 Warm Autoimmune Hemolytic Anemia (WAIHA) - Access and Reimbursement Overview
15.8 Market Scenario - Spain
15.8.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.8.1.1 Market Size (2018-2023)
15.8.1.2 Market Forecast (2024-2034)
15.8.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.8.2.1 Market Size by Therapies (2018-2023)
15.8.2.2 Market Forecast by Therapies (2024-2034)
15.8.3 Warm Autoimmune Hemolytic Anemia (WAIHA) - Access and Reimbursement Overview
15.9 Market Scenario - Japan
15.9.1 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size
15.9.1.1 Market Size (2018-2023)
15.9.1.2 Market Forecast (2024-2034)
15.9.2 Warm Autoimmune Hemolytic Anemia (WAIHA) - Market Size by Therapies
15.9.2.1 Market Size by Therapies (2018-2023)
15.9.2.2 Market Forecast by Therapies (2024-2034)
15.9.3 Warm Autoimmune Hemolytic Anemia (WAIHA) - Access and Reimbursement Overview
16 Warm Autoimmune Hemolytic Anemia (WAIHA) - Recent Events and Inputs From Key Opinion Leaders
17 Warm Autoimmune Hemolytic Anemia (WAIHA) Market - SWOT Analysis
17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats
18 Warm Autoimmune Hemolytic Anemia (WAIHA) Market – Strategic Recommendations
19 Appendix

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