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The warm autoimmune hemolytic anemia market size is expected to grow at a CAGR of 15.9% during the forecast period of 2024-2032, driven by the heightened awareness surrounding autoimmune diseases along with the growing research initiatives focused on the development of novel therapies across the 8 major markets.
Warm autoimmune hemolytic anemia (wAIHA) is considered the most common type of autoimmune hemolytic anemia, affecting about 1 to 3 adults in every 100,000 individuals . The autoimmune disorder is caused by autoantibodies that react with self-red blood cells (RBCs) and destroy them, resulting in anemia. These antibodies are active at body temperature and are present in 80% of the cases. It particularly targets older red blood cells.
Autoimmune hemolytic anemia usually occurs among older adults, with the majority of the patients aged 40 or above at the time of diagnosis. The rise in the geriatric population size is expected to drive the warm autoimmune hemolytic anemia market demand, as more and more elderly patients will need effective therapeutics to manage the condition. Moreover, the growing awareness among patients as well as healthcare providers is encouraging treatment-seeking behaviour, improving diagnosis rates, and ultimately propelling market growth.
The market is driven by increasing research initiatives to develop and commercialize safer and more effective treatment therapies to manage this autoimmune disorder. In November 2023, a study published in the American Journal of Hematology revealed Phase 3 FORWARD trial results of Fostamatinib (an oral spleen tyrosine kinase inhibitor) for warm autoimmune hemolytic anemia patients. The data suggested clinically significant outcomes for the patients in North America, Australia, and Western Europe, indicating the potential of fostamatinib in inducing durable hemoglobin responses. The increased number of clinical trials will aid in bringing promising treatment solutions to the rising patient population, thereby supporting warm autoimmune hemolytic anemia market growth.
The market is witnessing increased collaboration and partnerships among the key market players as well as research institutes. This accelerates development and innovation in the treatment landscape. The market is also driven by favourable regulatory reforms by the health agencies such as the United States Food and Drug Administration (FDA) which helps in addressing the clinical needs of patients suffering from warm autoimmune hemolytic anemia. Moreover, the rising technological innovation in diagnostics and the increased healthcare expenditure will fuel market growth in the coming years.
Key Trend | Impact |
Advancements in Treatment Options | The development of new therapies and treatment options has elevated the market value. Novel treatments which target specific pathways involved in the autoimmune response are exhibiting positive results in clinical trials, offering promising alternatives to traditional corticosteroids and splenectomy, which are associated with certain side effects and risks. These advancements improve efficacy and patient outcomes and drive market growth by addressing the unmet clinical need for safe and effective treatment options. |
Technological Innovations in Diagnostics | The warm autoimmune hemolytic anemia market share is further propelled by the advent of technological advancements in diagnostic technologies such as next-generation sequencing and advanced immunophenotyping are facilitating quick and accurate identification and classification of the condition. These technologies enable a more precise understanding of the cause of the disease, aiding in personalized treatment approaches. By improving diagnostic accuracy and speed, technological innovations enhance patient care and help in identifying a larger patient population eligible for targeted treatments, thereby driving market demand. |
Rising Patient Awareness and Diagnosis Rates | One of the significant warm autoimmune hemolytic anemia market trends is the heightened awareness among healthcare providers and the public about autoimmune hemolytic anemias, including warm autoimmune hemolytic anemia, which has led to higher diagnosis rates. Early and accurate diagnosis lays the foundation for effective management of the disease, reducing the risk of severe complications. This trend is driving demand for diagnostic and therapeutic options, attracting investment in research and development, and consequently boosting market growth. |
Favourable Regulatory and Reimbursement Frameworks | Changes in regulatory policies and reimbursement frameworks significantly impact the market landscape. Faster regulatory approvals for innovative treatments enhance market access and patient adoption rates. Moreover, favorable reimbursement policies for new and existing therapies ensure that more patients can afford these life-saving treatments, thereby expanding the market size. This regulatory and reimbursement support also encourages pharmaceutical companies to invest in the development of new therapies, ultimately driving growth in the market. |
Market Breakup by Drug Class
The market is segmented by drug class into Fostamatinib, Sutimlimab, Parsaclisib, Rilzabrutinib, and Isatuximab. This segment covers various therapeutic options available in the market for managing warm autoimmune hemolytic anemia.
Market Breakup by Distribution Channel
In terms of distribution channels, the warm autoimmune hemolytic anemia market share comprises hospital pharmacies, online pharmacies, and retail pharmacies. These channels offer a robust network to facilitate access to medications for patients with this autoimmune disorder according to their needs and convenience.
Market Breakup by Region
Based on the region, the market includes the United States, EU-4 (Germany, France, Italy, Spain), the United Kingdom, Japan, and India. The United States leads the market share, owing to the high prevalence of autoimmune diseases in the region including warm autoimmune hemolytic anemia. Further, the presence of an advanced healthcare infrastructure fuels the development of novel therapeutics and diagnostics tools for the treatment of this autoimmune disorder. Other factors that propel the market growth are the increasing investment in the healthcare industry and growing research activities in the regional market.
The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
REPORT FEATURES | DETAILS |
Base Year | 2023 |
Historical Period | 2017-2023 |
Forecast Period | 2024-2032 |
Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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Breakup by Drug Class |
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Breakup by Distribution Channel |
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Breakup by Region |
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Market Dynamics |
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Supplier Landscape |
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Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Warm Autoimmune Hemolytic Anemia Market Overview – 8 Major Markets
3.1 Warm Autoimmune Hemolytic Anemia Market Historical Value (2017-2023)
3.2 Warm Autoimmune Hemolytic Anemia Market Forecast Value (2024-2032)
4 Warm Autoimmune Hemolytic Anemia Overview
4.1 Guidelines and Stages
4.2 Pathophysiology
4.3 Screening and Diagnosis
4.4 Treatment Pathway
5 Patient Profile
5.1 Patient Profile Overview
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
6 Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast – 8 Major Markets
6.1 8MM Epidemiology Scenario Overview (2017-2032)
6.2 United States Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.3 EU-4 and United Kingdom Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.3.1 Germany Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.3.2 France Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.3.3 Italy Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.3.4 Spain Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.3.5 United Kingdom Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.4 Japan Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
6.5 India Warm Autoimmune Hemolytic Anemia Epidemiology Scenario and Forecast (2017-2032)
7 Warm Autoimmune Hemolytic Anemia Market Landscape – 8 Major Markets
7.1 Warm Autoimmune Hemolytic Anemia: Developers Landscape
7.1.1 Analysis by Year of Establishment
7.1.2 Analysis by Company Size
7.1.3 Analysis by Region
7.2 Warm Autoimmune Hemolytic Anemia: Product Landscape
7.2.1 Analysis by Drug Class
7.2.2 Analysis by Distribution Channel
8 Warm Autoimmune Hemolytic Anemia Challenges and Unmet Needs
8.1 Treatment Pathway Challenges
8.2 Compliance and Drop-Out Analysis
8.3 Awareness and Prevention Gaps
9 Cost of Treatment
10 Warm Autoimmune Hemolytic Anemia Market Dynamics
10.1 Market Drivers and Constraints
10.2 SWOT Analysis
10.3 Porter’s Five Forces Model
10.4 Key Demand Indicators
10.5 Key Price Indicators
10.6 Industry Events, Initiatives, and Trends
10.7 Value Chain Analysis
11 Warm Autoimmune Hemolytic Anemia Market Segmentation (2017-2032) - 8 Major Markets
11.1 Warm Autoimmune Hemolytic Anemia Market (2017-2032) by Drug Class
11.1.1 Market Overview
11.1.2 Fostamatinib
11.1.3 Sutimlimab
11.1.4 Parsaclisib
11.1.5 Rilzabrutinib
11.1.6 Isatuximab
11.2 Warm Autoimmune Hemolytic Anemia Market (2017-2032) by Distribution Channel
11.2.1 Market Overview
11.2.2 Hospital Pharmacies
11.2.3 Online Pharmacies
11.2.4 Retail Pharmacies
11.3 Warm Autoimmune Hemolytic Anemia Market (2017-2032) by Region
11.3.1 Market Overview
11.3.2 United States
11.3.3 EU-4 and the United Kingdom
11.3.3.1 Germany
11.3.3.2 France
11.3.3.3 Italy
11.3.3.4 Spain
11.3.3.5 United Kingdom
11.3.4 Japan
11.3.5 India
12 United States Warm Autoimmune Hemolytic Anemia Market (2017-2032)
12.1 United States Warm Autoimmune Hemolytic Anemia Market Historical Value (2017-2023)
12.2 United States Warm Autoimmune Hemolytic Anemia Market Forecast Value (2024-2032)
12.3 United States Warm Autoimmune Hemolytic Anemia Market (2017-2032) by Drug Class
12.3.1 Market Overview
12.3.2 Fostamatinib
12.3.3 Sutimlimab
12.3.4 Parsaclisib
12.3.5 Rilzabrutinib
12.3.6 Isatuximab
13 EU-4 and United Kingdom Warm Autoimmune Hemolytic Anemia Market (2017-2032)
13.1 EU-4 and United Kingdom Warm Autoimmune Hemolytic Anemia Market Historical Value (2017-2023)
13.2 EU-4 and United Kingdom Warm Autoimmune Hemolytic Anemia Market Forecast Value (2024-2032)
13.3 EU-4 and United Kingdom Warm Autoimmune Hemolytic Anemia Market Overview
13.4 EU-4 and United Kingdom Warm Autoimmune Hemolytic Anemia Market (2017-2032) by Drug Class
13.4.1 Market Overview
13.4.2 Fostamatinib
13.4.3 Sutimlimab
13.4.4 Parsaclisib
13.4.5 Rilzabrutinib
13.4.6 Isatuximab
14 Japan Warm Autoimmune Hemolytic Anemia Market
14.1 Japan Warm Autoimmune Hemolytic Anemia Market Historical Value (2017-2023)
14.2 Japan Warm Autoimmune Hemolytic Anemia Market Forecast Value (2024-2032)
14.3 Japan Warm Autoimmune Hemolytic Anemia Market (2017-2032) by Drug Class
14.3.1 Market Overview
14.3.2 Fostamatinib
14.3.3 Sutimlimab
14.3.4 Parsaclisib
14.3.5 Rilzabrutinib
14.3.6 Isatuximab
15 India Warm Autoimmune Hemolytic Anemia Market
15.1 India Warm Autoimmune Hemolytic Anemia Market (2017-2032) Historical Value (2017-2023)
15.2 India Warm Autoimmune Hemolytic Anemia Market (2017-2032) Forecast Value (2024-2032)
15.3 India Warm Autoimmune Hemolytic Anemia Market (2017-2032) by Drug Class
15.3.1 Market Overview
15.3.2 Fostamatinib
15.3.3 Sutimlimab
15.3.4 Parsaclisib
15.3.5 Rilzabrutinib
15.3.6 Isatuximab
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 Japan PMDA
16.1.4 Others
17 Patent Analysis
17.1 Analysis by Type of Patent
17.2 Analysis by Publication Year
17.3 Analysis by Issuing Authority
17.4 Analysis by Patent Age
17.5 Analysis by CPC Analysis
17.6 Analysis by Patent Valuation
17.7 Analysis by Key Players
18 Grants Analysis
18.1 Analysis by Year
18.2 Analysis by Amount Awarded
18.3 Analysis by Issuing Authority
18.4 Analysis by Grant Application
18.5 Analysis by Funding Institute
18.6 Analysis by NIH Departments
18.7 Analysis by Recipient Organization
19 Clinical Trials Analysis
19.1 Analysis by Trial Registration Year
19.2 Analysis by Trial Status
19.3 Analysis by Trial Phase
19.4 Analysis by Therapeutic Area
19.5 Analysis by Geography
20 Funding and Investment Analysis
20.1 Analysis by Funding Instances
20.2 Analysis by Type of Funding
20.3 Analysis by Funding Amount
20.4 Analysis by Leading Players
20.5 Analysis by Leading Investors
20.6 Analysis by Geography
21 Partnership and Collaborations Analysis
21.1 Analysis by Partnership Instances
21.2 Analysis by Type of Partnership
21.3 Analysis by Leading Players
21.4 Analysis by Geography
22 Supplier Landscape
22.1 Rigel Pharmaceuticals
22.1.1 Financial Analysis
22.1.2 Product Portfolio
22.1.3 Demographic Reach and Achievements
22.1.4 Mergers and Acquisitions
22.1.5 Certifications
22.2 Apellis Pharmaceuticals, Inc.
22.2.1 Financial Analysis
22.2.2 Product Portfolio
22.2.3 Demographic Reach and Achievements
22.2.4 Mergers and Acquisitions
22.2.5 Certifications
22.3 Johnson & Johnson
22.3.1 Financial Analysis
22.3.2 Product Portfolio
22.3.3 Demographic Reach and Achievements
22.3.4 Mergers and Acquisitions
22.3.5 Certifications
22.4 Sanofi
22.4.1 Financial Analysis
22.4.2 Product Portfolio
22.4.3 Demographic Reach and Achievements
22.4.4 Mergers and Acquisitions
22.4.5 Certifications
22.5 Incyte Corporation
22.5.1 Financial Analysis
22.5.2 Product Portfolio
22.5.3 Demographic Reach and Achievements
22.5.4 Mergers and Acquisitions
22.5.5 Certifications
22.6 Momenta Pharmaceuticals
22.6.1 Financial Analysis
22.6.2 Product Portfolio
22.6.3 Demographic Reach and Achievements
22.6.4 Mergers and Acquisitions
22.6.5 Certifications
22.7 Teva Pharmaceuticals Ltd.
22.7.1 Financial Analysis
22.7.2 Product Portfolio
22.7.3 Demographic Reach and Achievements
22.7.4 Mergers and Acquisitions
22.7.5 Certifications
22.8 F. Hoffmann La Roche Ltd.
22.8.1 Financial Analysis
22.8.2 Product Portfolio
22.8.3 Demographic Reach and Achievements
22.8.4 Mergers and Acquisitions
22.8.5 Certifications
22.9 Alexion Pharmaceuticals Inc.
22.9.1 Financial Analysis
22.9.2 Product Portfolio
22.9.3 Demographic Reach and Achievements
22.9.4 Mergers and Acquisitions
22.9.5 Certifications
22.10 Immunovant
22.10.1 Financial Analysis
22.10.2 Product Portfolio
22.10.3 Demographic Reach and Achievements
22.10.4 Mergers and Acquisitions
22.10.5 Certifications
23 Warm Autoimmune Hemolytic Anemia Treatment Drugs - Distribution Model (Additional Insight)
23.1 Overview
23.2 Potential Distributors
23.3 Key Parameters for Distribution Partner Assessment
24 Key Opinion Leaders (KOL) Insights (Additional Insight)
25 Company Competitiveness Analysis (Additional Insight)
25.1 Very Small Companies
25.2 Small Companies
25.3 Mid-Sized Companies
25.4 Large Companies
25.5 Very Large Companies
26 Payment Methods (Additional Insight)
26.1 Government Funded
26.2 Private Insurance
26.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
* The coverage of the Market Landscape section depends on the data availability and may cover a minimum of 80% of the total market. The EMR team strives to make this section as comprehensive as possible.
The market is anticipated to grow at a CAGR of 15.9% during the forecast period of 2024-2032, driven by the heightened awareness surrounding autoimmune diseases across the 8 major markets.
The market demand is driven by increased healthcare expenditure and improved access to healthcare products and services.
One of the significant trends in the market is increasing research initiatives to develop and commercialize safer and more effective treatment therapies to manage the condition. In November 2023, Phase 3 FORWARD trial results of Fostamatinib showed promising results for warm autoimmune hemolytic anemia patients.
Based on the drug class, the market is segmented into Fostamatinib, Sutimlimab, Parsaclisib, Rilzabrutinib, and Isatuximab.
Distribution channels in the market include hospital pharmacies, online pharmacies, and retail pharmacies.
The major regions of the market include the United States, EU-4 (Germany, France, Italy, Spain), and the United Kingdom, Japan, and India.
Key players involved in the market are Rigel Pharmaceuticals, Apellis Pharmaceuticals, Inc., Johnson & Johnson, Sanofi, Incyte Corporation, Momenta Pharmaceuticals, Teva Pharmaceuticals Ltd., F. Hoffmann La Roche Ltd., Alexion Pharmaceuticals Inc., and Immunovant.
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