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Global Cold Agglutinin Disease Treatment Market Growth, Size, Demand, Analysis: By Diagnosis Method: Complete Blood Count (CBC) Test, Reticulocyte Count, Serum Level Test, Direct Coombs Test (DAT), Cold Agglutinin Titer Test, Others; By Drug Class; By Route of Administration; By End Users; Regional Analysis; Supplier Landscape; 2024-2032
Global Cold Agglutinin Disease Treatment Market Outlook
The global cold agglutinin disease treatment market size was around USD 95.94 million in 2023. The market is likely to grow at a rate of 23.60% during the forecast period of 2024-2032. Driven by the increasing prevalence of cold agglutinin disease and growing healthcare infrastructure, the market is anticipated to be worth USD 645.89 million by 2032.
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Cold Agglutinin Disease Insights: Pathophysiology, Symptoms, Diagnosis, and Treatment
Cold agglutinin disease is a rare autoimmune disorder attacking the body’s immune system and its red blood cells. The severity of the disease increases with low temperatures, ranging from dizziness to chronic heart failure.
The common signs and symptoms of cold agglutinin disease include headaches, dizziness, vomiting, nausea, behavioural changes, ringing in the ears, cold hands or feet and irregular beating of the heart.
The cold agglutinin disease is idiopathic in nature, the exact cause of the disease is unknown. However, in some cases, this disease is caused by lymphoma, one of the common types of cancer. Other conditions that can trigger cold agglutinin are bacterial infections (E. coli), viral infections (hepatitis C), and parasitic infections (malaria).
The early and accurate diagnosis of cold agglutinin disease is important for its management and treatment. Complete blood tests are done to count the quality and quantity of red blood cells. Coombs test or direct antiglobulin test is used to examine the increased number of cold agglutinins, antibodies that attack the red blood cells.
The treatment strategies depend on the severity and the clinical manifestations of cold agglutinin disease. Immune system-modulating drugs, such as rituximab and blood transfusion, are the standard therapeutic options for disease management.
The cold agglutinin disease treatment market can be categorised into the following segments:
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Market Breakup by Diagnosis Method
- Complete Blood Count (CBC) Test
- Reticulocyte Count
- Serum Level Test
- Direct Coombs Test (DAT)
- Cold Agglutinin Titer Test
- Others
Market Breakup by Drug Class
- Corticosteroids
- Alkylating Agents
- Purine Nucleoside Analogs
- Biologics
- Others
Market Breakup by Route of Administration
- Oral
- Tablets
- Parenteral
- Injections
- Others
Market Breakup by End Users
- Hospitals
- Speciality Clinics
- Homecare
- Others
Market Breakup by Region
- North America
- United States of America
- Canada
- Europe
- United Kingdom
- Germany
- France
- Italy
- Others
- Asia Pacific
- China
- Japan
- India
- ASEAN
- Australia
- Others
- Latin America
- Brazil
- Argentina
- Mexico
- Others
- Middle East and Africa
- Saudi Arabia
- United Arab Emirates
- Nigeria
- South Africa
- Others
Market Scenario
The cold agglutinin disease treatment market is primarily driven by the rising incidence and prevalence of cold agglutinin disease. Other associated conditions such as bacterial infections, viral infections, parasitic infections, and certain types of cancer are attributed to the increased prevalence of secondary cold agglutinin disease.
According to the World Health Organisation, the elderly population is estimated to reach nearly 2 billion by 2050. The surging geriatric population is expected to accelerate the market growth owing to the weakened immune systems with increasing age.
The market growth is further driven by the growing investments in healthcare infrastructure by the public and private sectors. The expanding research and development activities, increasing levels of disposable income and novel product launches and approvals are aiding the cold agglutinin disease treatment market growth.
Regional Outlook
North America is anticipated to hold a significant share of the market owing to the increasing disease prevalence, growing adoption of novel technologies, and greater awareness among the population.
The Asia Pacific region is expected to exhibit significant growth during the forecast period due to the surging elderly population, increasing patient pool, and developing healthcare infrastructure.
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Therapeutic Landscape
The treatment of cold agglutinin disease depends on the cause of the disease and the severity of the symptoms. The management strategies aim to minimise the disease symptoms to provide relief and stabilising effects. The treatment regimen incorporates medications for mild to moderate symptoms and surgical interventions for severe symptomatic cases.
Standard Therapies: Medications and Blood Transfusion
Rituximab is the first-line treatment for the treatment of cold agglutinin disease. It acts by adhering the immune system from producing antibodies that attack the red blood cells. Sutimlimab, another immune-acting drug functions by blocking the immune system from damaging its erythrocytes.
Plasma exchange or blood transfusions are used to treat acute to chronic cold agglutinin disease and provides immediate relief. Plasmapheresis is a filtration procedure applied to get rid of the immune-attacking antibodies and to reduce the number of autoantibodies in the blood circulation.
Tremendous efforts of scientists, researchers, and healthcare professionals will lead to the discovery of novel therapeutic medications and procedures that will help improve healthcare and the global economy. These new treatment strategies will drive the growth of the cold agglutinin disease treatment market.
Clinical Trials Landscape
At present, there are no approved therapeutic agents for cold agglutinin disease. However, with extensive research and clinical studies, many novel drugs are expected to enter the cold agglutinin disease treatment market. Many of the candidate drugs are under the pipeline for approval by the regulatory authorities. AstraZeneca, a key market player, discovered a potent RSV shot and is waiting for EMA approval, once approved can be helpful in the management of cold agglutinin disease.
Novel Product Approvals and Emerging Drugs
Enjaymo, a sutimlimab-jome drug is recently approved by Food and Drug Administration for the treatment of cold agglutinin disease. This drug acts as a monoclonal antibody that inhibits haemolysis and abnormal damage to red blood cells.
Clinical trials are under process for the novel drug Pegcetacoplan to check and assess its efficacy in increasing the haemoglobin levels in patients suffering from primary cold agglutinin disease.
Another drug, known as APL 2 is under Phase II clinical evaluation for exploring and confirming its efficacy, tolerability, safety, and pharmacokinetics in cold agglutinin subjects.
The combination therapy of the two potent drugs has successfully passed the multiple phases of clinical trials, thus being a novel effective therapy for cold agglutinin disease. Helse Fonna discovered the rituximab and bendamustine combination therapy for treating moderate to severe cold agglutinin disease.
With tremendous efforts and vigorous research, there has been an increase in novel product launches and approvals, which is attributed to the expansion and growth of the cold agglutinin disease treatment market.
Competitive Landscape
The report gives an in-depth analysis of the key players involved in the cold agglutinin disease treatment market, sponsors manufacturing the therapies, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
- Roche Holding AG
- Viatris Inc.
- Teva Pharmaceutical Industries Ltd.
- Sanofi S.A.
- Pfizer Inc.
- GSK plc
- Novartis AG
- Zydus Lifesciences Limited
- AstraZeneca plc
- Johnson & Johnson
- Bayer AG
- Apellis Pharmaceuticals, Inc.
- Incyte Corporation
Key Highlights of 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 Diagnosis Method |
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| Breakup by Drug Class |
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| Breakup by Route of Administration |
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| Breakup by End Users |
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| Breakup by Region |
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| Competitive 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
2 Research Methodology
3 Executive Summary
4 Cold Agglutinin Disease 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 Challenges and Unmet Needs
6.1 Treatment Pathway Challenges
6.2 Compliance and Drop-Out Analysis
6.3 Awareness and Prevention Gaps
7 Global Cold Agglutinin Disease Treatment Market Dynamics
7.1 Market Drivers and Constraints
7.2 SWOT Analysis
7.3 Porter’s Five Forces Model
7.4 Key Demand Indicators
7.5 Key Price Indicators
7.6 Industry Events, Initiatives, and Trends
7.7 Value Chain Analysis
8 Global Cold Agglutinin Disease Treatment Market
8.1 Global Cold Agglutinin Disease Treatment Market Overview
8.2 Global Cold Agglutinin Disease Treatment Market Analysis
8.2.1 Market Overview
8.2.1.1 Global Cold Agglutinin Disease Treatment Market Historical Value (2017-2023)
8.2.1.2 Global Cold Agglutinin Disease Treatment Market Forecast Value (2024-2032)
8.2.2 Global Cold Agglutinin Disease Treatment Market by Diagnosis Method
8.2.2.1 Market Overview
8.2.2.1.1 Complete Blood Count (CBC) Test
8.2.2.1.2 Reticulocyte Count
8.2.2.1.3 Serum Level Test
8.2.2.1.4 Direct Coombs Test (DAT)
8.2.2.1.5 Cold Agglutinin Titer Test
8.2.2.1.6 Others
8.2.3 Global Cold Agglutinin Disease Treatment Market by Drug Class
8.2.3.1 Market Overview
8.2.3.1.1 Corticosteroids
8.2.3.1.2 Alkylating Agents
8.2.3.1.3 Purine Nucleoside Analogs
8.2.3.1.4 Biologics
8.2.3.1.5 Others
8.2.4 Global Cold Agglutinin Disease Treatment Market by Route of Administration
8.2.4.1 Market Overview
8.2.4.1.1 Oral
8.2.4.1.1.1 Tablets
8.2.4.1.2 Parenteral
8.2.4.1.2.1 Injections
8.2.4.1.3 Others
8.2.5 Global Cold Agglutinin Disease Treatment Market by End Users
8.2.5.1 Market Overview
8.2.5.1.1 Hospitals
8.2.5.1.2 Specialty Clinics
8.2.5.1.3 Homecare
8.2.5.1.4 Others
8.2.6 Global Cold Agglutinin Disease Treatment Market by Region
8.2.6.1 Market Overview
8.2.6.1.1 North America
8.2.6.1.2 Europe
8.2.6.1.3 Asia Pacific
8.2.6.1.4 Middle East and Africa
8.2.6.1.5 Latin America
9 North America Cold Agglutinin Disease Treatment Market
9.1 Market Share by Country
9.2 United States of America
9.2.1 Historical Trend (2017-2023)
9.2.2 Forecast Trend (2024-2032)
9.3 Canada
9.3.1 Historical Trend (2017-2023)
9.3.2 Forecast Trend (2024-2032)
10 Europe Cold Agglutinin Disease Treatment Market
10.1 Market Share by Country
10.2 United Kingdom
10.2.1 Historical Trend (2017-2023)
10.2.2 Forecast Trend (2024-2032)
10.3 Germany
10.3.1 Historical Trend (2017-2023)
10.3.2 Forecast Trend (2024-2032)
10.4 France
10.4.1 Historical Trend (2017-2023)
10.4.2 Forecast Trend (2024-2032)
10.5 Italy
10.5.1 Historical Trend (2017-2023)
10.5.2 Forecast Trend (2024-2032)
10.6 Others
11 Asia Pacific Cold Agglutinin Disease Treatment Market
11.1 Market Share by Country
11.2 China
11.2.1 Historical Trend (2017-2023)
11.2.2 Forecast Trend (2024-2032)
11.3 Japan
11.3.1 Historical Trend (2017-2023)
11.3.2 Forecast Trend (2024-2032)
11.4 India
11.4.1 Historical Trend (2017-2023)
11.4.2 Forecast Trend (2024-2032)
11.5 ASEAN
11.5.1 Historical Trend (2017-2023)
11.5.2 Forecast Trend (2024-2032)
11.6 Australia
11.6.1 Historical Trend (2017-2023)
11.6.2 Forecast Trend (2024-2032)
11.7 Others
12 Latin America Cold Agglutinin Disease Treatment Market
12.1 Market Share by Country
12.2 Brazil
12.2.1 Historical Trend (2017-2023)
12.2.2 Forecast Trend (2024-2032)
12.3 Argentina
12.3.1 Historical Trend (2017-2023)
12.3.2 Forecast Trend (2024-2032)
12.4 Mexico
12.4.1 Historical Trend (2017-2023)
12.4.2 Forecast Trend (2024-2032)
12.5 Others
13 Middle East and Africa Cold Agglutinin Disease Treatment Market
13.1 Market Share by Country
13.2 Saudi Arabia
13.2.1 Historical Trend (2017-2023)
13.2.2 Forecast Trend (2024-2032)
13.3 United Arab Emirates
13.3.1 Historical Trend (2017-2023)
13.3.2 Forecast Trend (2024-2032)
13.4 Nigeria
13.4.1 Historical Trend (2017-2023)
13.4.2 Forecast Trend (2024-2032)
13.5 South Africa
13.5.1 Historical Trend (2017-2023)
13.5.2 Forecast Trend (2024-2032)
13.6 Others
14 Current Scenario Evaluation and Regulatory Framework
14.1 Emerging Therapies and Clinical Trials
14.2 Patent Landscape
14.2.1 Patent Overview
14.2.1.1 Patent Status and Expiry
14.2.1.2 Timelines from Drug Development to Commercial Launch
14.2.1.3 New Drug Application
14.2.1.3.1 Documentation and Approval Process
14.3 Cost of Treatment
14.4 Regulatory Framework
14.4.1 Regulatory Overview
14.4.1.1 US FDA
14.4.1.2 EU EMA
14.4.1.3 INDIA CDSCO
14.4.1.4 JAPAN PMDA
14.4.1.5 Others
15 Supplier Landscape
15.1 Roche Holding AG
15.1.1 Company Overview
15.1.2 Product Portfolio
15.1.3 Demographic Reach and Achievements
15.1.4 Mergers and Acquisitions
15.1.5 Certifications
15.2 Viatris Inc.
15.2.1 Company Overview
15.2.2 Product Portfolio
15.2.3 Demographic Reach and Achievements
15.2.4 Mergers and Acquisitions
15.2.5 Certifications
15.3 Teva Pharmaceutical Industries Ltd.
15.3.1 Company Overview
15.3.2 Product Portfolio
15.3.3 Demographic Reach and Achievements
15.3.4 Mergers and Acquisitions
15.3.5 Certifications
15.4 Sanofi S.A.
15.4.1 Company Overview
15.4.2 Product Portfolio
15.4.3 Demographic Reach and Achievements
15.4.4 Mergers and Acquisitions
15.4.5 Certifications
15.5 Pfizer Inc.
15.5.1 Company Overview
15.5.2 Product Portfolio
15.5.3 Demographic Reach and Achievements
15.5.4 Mergers and Acquisitions
15.5.5 Certifications
15.6 GSK plc
15.6.1 Company Overview
15.6.2 Product Portfolio
15.6.3 Demographic Reach and Achievements
15.6.4 Mergers and Acquisitions
15.6.5 Certifications
15.7 Novartis AG
15.7.1 Company Overview
15.7.2 Product Portfolio
15.7.3 Demographic Reach and Achievements
15.7.4 Mergers and Acquisitions
15.7.5 Certifications
15.8 Zydus Lifesciences Limited
15.8.1 Company Overview
15.8.2 Product Portfolio
15.8.3 Demographic Reach and Achievements
15.8.4 Mergers and Acquisitions
15.8.5 Certifications
15.9 AstraZeneca plc
15.9.1 Company Overview
15.9.2 Product Portfolio
15.9.3 Demographic Reach and Achievements
15.9.4 Mergers and Acquisitions
15.9.5 Certifications
15.10 Johnson & Johnson
15.10.1 Company Overview
15.10.2 Product Portfolio
15.10.3 Demographic Reach and Achievements
15.10.4 Mergers and Acquisitions
15.10.5 Certifications
15.11 Bayer AG
15.11.1 Company Overview
15.11.2 Product Portfolio
15.11.3 Demographic Reach and Achievements
15.11.4 Mergers and Acquisitions
15.11.5 Certifications
15.12 Apellis Pharmaceuticals, Inc.
15.12.1 Company Overview
15.12.2 Product Portfolio
15.12.3 Demographic Reach and Achievements
15.12.4 Mergers and Acquisitions
15.12.5 Certifications
15.13 Incyte Corporation
15.13.1 Company Overview
15.13.2 Product Portfolio
15.13.3 Demographic Reach and Achievements
15.13.4 Mergers and Acquisitions
15.13.5 Certifications
16 Global Cold Agglutinin Disease Treatment Market- Drug Distribution Model (Additional Insight)
16.1 Overview
16.2 Potential Distributors
16.3 Key Parameters for Distribution Partner Assessment
17 Payment Methods (Additional Insight)
17.1 Government Funded
17.2 Private Insurance
17.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
Key Questions Answered in the Report
The market is primarily driven by the rising cases of cold agglutinin disease, the growing geriatric population, increasing research and developmental activities and novel product launches and approvals.
North America is anticipated to hold a maximum share in the market during the forecast period.
Based on the diagnosis type, the market is segmented into Complete Blood Count (CBC) test, reticulocyte count, serum level test, Direct Coombs Test (DAT), cold agglutinin titer test and others.
Based on the drug class, the market is bifurcated into corticosteroids, alkylating agents, purine nucleoside analogues, biologics, and others.
Based on the end users, the market is divided into hospitals, speciality clinics, home care, and others.
The different regions in the market are North America, Europe, Asia Pacific, Latin America and the Middle East and Africa.
The key companies involved in the market are Roche Holding AG, Viatris Inc., Teva Pharmaceutical Industries Ltd., Sanofi S.A., Pfizer Inc., GSK plc, Novartis AG, Zydus Lifesciences Limited, AstraZeneca plc, Johnson & Johnson, Bayer AG, Apellis Pharmaceuticals, Inc., Incyte Corporation, among others.
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