Global Cold Agglutinin Disease Market Report and Forecast 2023-2031

Global Cold Agglutinin Disease Market Report and Forecast 2023-2031

Global Cold Agglutinin Disease Market Outlook

The global cold agglutinin disease (CAD) treatment market size attained a value of USD 82.194 million in 2022, driven by the increasing prevalence of CAD, the development of novel therapies, and the rise in healthcare expenditure. The market is projected to grow at a CAGR of 24% during the forecast period of 2023-2031.

Cold Agglutinin Disease Market: Introduction

Cold agglutinin disease is a rare autoimmune disorder that occurs when the body's immune system produces cold-reactive antibodies that bind to and destroy red blood cells. The disease can cause anaemia, fatigue, and other symptoms, and can be life-threatening in severe cases. The treatment of CAD typically involves the use of corticosteroids and immunosuppressive agents, although there are currently no FDA-approved therapies for the condition.

The report by Expert Market Research provides a comprehensive analysis of the cold agglutinin disease treatment market, including market size, growth, and trends. The report covers the market for CAD treatment, including drugs and therapies used for the treatment of CAD.

Cold Agglutinin Disease Epidemiology

Cold agglutinin disease is a rare autoimmune disorder that affects approximately 15 per million people worldwide. The disease is more common in women than men and is typically diagnosed in patients aged 50 or older. CAD can occur in isolation or as a complication of other conditions, such as lymphoproliferative disorders, infections, and connective tissue diseases. The disease is typically diagnosed through a combination of clinical and laboratory tests, including the cold agglutinin titer, the direct antiglobulin test, and the Coombs test.

The treatment of CAD typically involves the use of corticosteroids and immunosuppressive agents, although there are currently no FDA-approved therapies for the condition. Other treatment options for CAD include blood transfusions, plasmapheresis, and rituximab therapy.

As the global population continues to age and the prevalence of autoimmune disorders rises, the demand for CAD treatment is expected to grow in the coming years. This is expected to drive the growth of the CAD treatment market, as healthcare providers seek new and innovative therapies to manage this rare and debilitating disease.

Cold Agglutinin Disease Market Segmentations

The market can be categorised into type, treatment type, drug class, therapy type, distribution channel, end user, and major region.

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
Cold Agglutinin Disease 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
Cold Agglutinin Disease Market Scenario

The market is expected to experience moderate growth during the forecast period of 2023-2031. The key drivers of the market include the increasing prevalence of CAD, the development of novel therapies, and the rise in healthcare expenditure. However, the limited awareness of the disease and the lack of approved therapies are likely to hinder the growth of the market.

North America dominates the CAD treatment market, followed by Europe and the Asia Pacific. The high prevalence of CAD in North America, coupled with the favorable reimbursement policies, is driving the growth of the market in the region. Europe is also a significant market for CAD treatment, with the presence of key players and increasing investment in research and development activities. The Asia Pacific region is expected to grow at the highest CAGR during the forecast period, owing to the increasing awareness about the disease and the rising healthcare expenditure in the region.

The market for CAD treatment can be categorized into various segments, including treatment type, distribution channel, and end-user. The most used treatment types for CAD include corticosteroids, immunosuppressive agents, and others. In terms of distribution channel, the market can be segmented into hospital pharmacies, retail pharmacies, and online pharmacies.

Key Players in the Global Cold Agglutinin Disease Market

The report gives an in-depth analysis of the key players involved in the Cold Agglutinin Disease market, sponsors manufacturing the drugs, 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


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 (2016-2022)
8.2.1.2 Global Cold Agglutinin Disease Treatment Market Forecast Value (2023-2031)
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 (2016-2022)
9.2.2 Forecast Trend (2023-2031)
9.3 Canada
9.3.1 Historical Trend (2016-2022)
9.3.2 Forecast Trend (2023-2031)
10 Europe Cold Agglutinin Disease Treatment Market
10.1 Market Share by Country
10.2 United Kingdom
10.2.1 Historical Trend (2016-2022)
10.2.2 Forecast Trend (2023-2031)
10.3 Germany
10.3.1 Historical Trend (2016-2022)
10.3.2 Forecast Trend (2023-2031)
10.4 France
10.4.1 Historical Trend (2016-2022)
10.4.2 Forecast Trend (2023-2031)
10.5 Italy
10.5.1 Historical Trend (2016-2022)
10.5.2 Forecast Trend (2023-2031)
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 (2016-2022)
11.2.2 Forecast Trend (2023-2031)
11.3 Japan
11.3.1 Historical Trend (2016-2022)
11.3.2 Forecast Trend (2023-2031)
11.4 India
11.4.1 Historical Trend (2016-2022)
11.4.2 Forecast Trend (2023-2031)
11.5 ASEAN
11.5.1 Historical Trend (2016-2022)
11.5.2 Forecast Trend (2023-2031)
11.6 Australia
11.6.1 Historical Trend (2016-2022)
11.6.2 Forecast Trend (2023-2031)
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 (2016-2022)
12.2.2 Forecast Trend (2023-2031)
12.3 Argentina
12.3.1 Historical Trend (2016-2022)
12.3.2 Forecast Trend (2023-2031)
12.4 Mexico
12.4.1 Historical Trend (2016-2022)
12.4.2 Forecast Trend (2023-2031)
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 (2016-2022)
13.2.2 Forecast Trend (2023-2031)
13.3 United Arab Emirates
13.3.1 Historical Trend (2016-2022)
13.3.2 Forecast Trend (2023-2031)
13.4 Nigeria
13.4.1 Historical Trend (2016-2022)
13.4.2 Forecast Trend (2023-2031)
13.5 South Africa
13.5.1 Historical Trend (2016-2022)
13.5.2 Forecast Trend (2023-2031)
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

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