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Cold Agglutinin Disease Market Size, Growth, Forecast | 2032
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Cold Agglutinin Disease Market Size, Growth, Forecast | 2032

Segments - Cold Agglutinin Disease Market by Drug (Corticosteroids, Alkylating Agents, Purine Nucleoside Analogs, Biologics, and Others) Dosage Form (Tablets, Injections, and Other) End-user (Hospitals, Specialty Clinics, Homecare Settings, and Other), and Region (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2024 – 2032

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Author : Raksha Sharma
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Fact-checked by : V. Chandola
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Editor : Vishal Golekar

Upcoming | Report ID :HC-6475 | 4.5 Rating | 87 Reviews | 287 Pages | Format : PDF Excel PPT

Report Description


The global cold agglutinin disease market size was USD 124.3 Million in 2023 and is likely to reach USD 733.3 Million by 2032, expanding at a CAGR of 21.8% during 2024–2032. The market growth is attributed to the ­­increasing prevalence of cold agglutinin and growing awareness of diseases.

Cold agglutinin disease is a rare autoimmune disorder characterized by the production of abnormal antibodies that react with the red blood cells, leading to their destruction. The disease is known as cold hemagglutinin disease or cold hemolytic anemia.

  • In March 2024, WebMD reports that approximately 1 person in 300,000 is affected by CAD. American Society of Hematology mentions that CAD has a prevalence of 5 to 20 cases per million and an incidence of 0.5 to 1.9 cases per million per year, with variations based on climate.

Cold Agglutinin Disease Market Outlook

Corticosteroids is used to reduce inflammation and immunoglobulin therapy to reduce antibody production. Other treatment techniques such as plasmapheresis and blood transfusion techniques are used to remove abnormal antibodies and replace destroyed RBCs.

Impact of Artificial Intelligence (AI) in Cold Agglutinin Disease Market

Rapid improvements in diagnostics in reducing time and cost associated is expected to propel the market during the forecast period. Moreover, the personalized treatment and healthcare predictive analytics is propelling the market. AI is enabling personalized treatment plans for patients with cold agglutinin disease, taking into account individual factors such as age, health status, and medical history.

Predictive analytics and remote patient monitoring reduce the need for hospitalizations and improving patient outcomes, thus driving the market. The optimization of clinical trail is reducing the time and cost associated with trail design and execution is fueling the market.

Cold Agglutinin Disease Market Dynamics

Cold Agglutinin Disease Market Dynamics

Major Drivers

Increasing prevalence of cold agglutinin disease is driving the global market. The prevalence of cold agglutinin disease is increasing due to various such as aging population, lifestyle changes, and environmental factors. Furthermore, growing awareness of disease and advancements in diagnostic technologies is expected to fuel the market during the forecast period.

Existing Restraints

Limited awareness and high cost of treatment are expected to restrain the market during the forecast period. Lack of awareness about cold agglutinin disease among the general public and healthcare professionals, leading to delayed diagnosis and treatment.

Emerging Opportunities

Immunotherapy is an emerging area of research in the treatment of cold agglutinins disease, and several immunotherapy agents are currently in clinical trials. Stem cell therapy is an emerging area of research in the treatment of cold agglutinins disease, and several stem cell therapy agents are currently in clinical trials. Additionally, the increasing trend toward personalized medicine is expected to drive the development of targeted therapies for cold agglutinins disease.

Scope of the Cold Agglutinin Disease Market Report

The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Attributes

Details

Report Title

Cold Agglutinin Disease Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast

Base Year

2023

Historic Data

2017–2022

Forecast Period

2024–2032

Segmentation

Drug (Corticosteroids, Alkylating Agents, Purine Nucleoside Analogs, Biologics, and Others) Dosage Form (Tablets, Injections, and Other) and End-user (Hospitals, Specialty Clinics, Homecare Settings, and Other)

Regional Scope

Asia Pacific, North America, Latin America, Europe, and Middle East & Africa

Report Coverage

Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast

Key Players Covered in the Report

Pfizer; Roche; Novartis; Johnson & Johnson; Merck & Co.; GSK; Sanofi; Bristol-Myers Squibb; Celgene; and Biogen


Market Segment Insights

Regional Analysis

In terms of region, the global cold agglutinin disease market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America dominated the global market in 2023 owing to the high prevalence of cold agglutinin disease. The prevalence of cold agglutinin disease is higher in North America as compared to other regions, which drives the demand for treatments and therapies. Furthermore, advanced healthcare infrastructure of North America is expected to fuel the regional market.

The market in Europe is projected to grow at a significant pace in the coming years owing to the strong pharmaceutical industry. Additionally, high awareness of cold agglutinin disease in Europe among healthcare professionals and patients is fueling the demand for therapies and treatments. 

Cold Agglutinin Disease Market Region

Segment Analysis

Drug Segment Analysis

Based on drug, the cold agglutinin disease market is divided into corticosteroids, alkylating agents, purine nucleoside analogs, biologics, and others. The corticosteroids segment held the largest share of the global market in 2023.

Corticosteroids, such as prednisone, are commonly used to treat cold agglutinin disease due to their anti-inflammatory and immunosuppressive properties. Corticosteroids are often the first-line treatment for cold agglutinin disease, as they help reduce inflammation and alleviate symptoms such as fever, chills, and joint pain. It helps in reducing the production of cold agglutinin antibodies, which are the primary cause of the disease. Increasing number of clinical trails for the drug approvals is boosting the segment.

  • In October 2023, Novartis announced the phase III trial of iptacopan study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN).

The alkylating agents segment is anticipated to expand at a substantial CAGR during the forecast period due to its high efficacy. Alkylating agents are proven to be effective in reducing and symptoms and improving quality of life of patients with cold agglutinin disease. Moreover, the combination therapy of alkylating agents with corticosteroids, enhances its efficacy and reduce the risk of side effects.

Cold Agglutinin Disease Market Drug

Dosage Form Segment Analysis

On the basis of dosage form, the global market is segregated into tablets, injections, and other. the injections segment is anticipated to register a considerable CAGR during the forecast period owing to its rapid onset of action and high efficacy. Injections delivers high doses of medication directly to the site of action, which are more effective than oral medications. Moreover, high flexibility and increasing patient preferences over oral medications is expected to boost the segment during the forecast period.

The oral segment is projected to register a robust growth during the assessment years due to its ease of administration. Moreover, increasing patient preferences and rising adoption of biologics are propelling the segment. Advances in pharmaceutical research have led to the development of oral medications that are more effective and better tolerated than their injectable counterparts.

Cold Agglutinin Disease Market Dosage Form

End-user Segment Analysis

In terms of end-user, the cold agglutinin disease market is segmented into hospitals, specialty clinics, homecare settings, and other. The hospitals segment registered robust growth in 2023 due to high volume of patients. Furthermore, the comprehensive care and availability of specialized care is driving the segment. Hospitals with its specialized departments and teams providing specialized care for patients with cold agglutinin disease, including rheumatology, hematology, and immunology, thus boosting the segment.

The specialty clinic segment is expected to expand at a significant growth over the projection period owing to the specialized care and expertise. The convenient location and patient centric care are expected to drive the segment significantly during the forecast period.

Segments

The cold agglutinin disease market has been segmented on the basis of

Drug

  • Corticosteroids
  • Alkylating Agents
  • Purine Nucleoside Analogs
  • Biologics
  • Others

Dosage Form

  • Tablets
  • Injections
  • Other

End-user

  • Hospitals
  • Specialty Clinics
  • Homecare Settings
  • Other

Region

  • Asia Pacific
  • North America
  • Latin America
  • Europe
  • Middle East & Africa

Key Players

  • Biogen
  • Bristol-Myers Squibb
  • Celgene
  • GSK
  • Johnson & Johnson
  • Merck & Co.
  • Novartis
  • Pfizer
  • Roche
  • Sanofi

Competitive Landscape

Key players competing in the global cold agglutinin disease market are Pfizer; Roche; Novartis; Johnson & Johnson; Merck & Co.; GSK; Sanofi; Bristol-Myers Squibb; Celgene; and Biogen.

  • In February 2022, Enjaymo (sutimlimab-jome) was approved by the US Food and Drug Administration (FDA) with the aim of reducing the need for red blood cell transfusion due to haemolysis in adults with cold agglutinin disease (CAD). It is the first and only approved treatment for people suffering from CAD. This medication functions by inhibiting the destruction of red blood cells (haemolysis).

    Cold Agglutinin Disease Market Key Players

Table Of Content

1. Executive Summary
2. Assumptions and Acronyms Used
3. Research Methodology
4. Cold Agglutinin Disease Market Overview
  4.1. Introduction
     4.1.1. Market Taxonomy
     4.1.2. Market Definition
  4.2. Macro-Economic Factors
     4.2.1. Industry Outlook
  4.3. Cold Agglutinin Disease Market Dynamics
     4.3.1. Market Drivers
     4.3.2. Market Restraints
     4.3.3. Opportunity
     4.3.4. Market Trends
  4.4. Cold Agglutinin Disease Market - Supply Chain
  4.5. Global Cold Agglutinin Disease Market Forecast
     4.5.1. Cold Agglutinin Disease Market Size (US$ Mn) and Y-o-Y Growth
     4.5.2. Cold Agglutinin Disease Market Size (000’ Units) and Y-o-Y Growth
     4.5.3. Cold Agglutinin Disease Market Absolute $ Opportunity
5. Global Cold Agglutinin Disease Market Analysis and Forecast by End Users
  5.1. Market Trends
  5.2. Introduction
     5.2.1. Basis Point Share (BPS) Analysis by End Users
     5.2.2. Y-o-Y Growth Projections by End Users
  5.3. Cold Agglutinin Disease Market Size and Volume Forecast by End Users
     5.3.1. Hospitals
     5.3.2. Specialty Clinics
     5.3.3. Homecare Settings
     5.3.4. Other
  5.4. Absolute $ Opportunity Assessment by End Users
  5.5. Market Attractiveness/Growth Potential Analysis by End Users
6. Global Cold Agglutinin Disease Market Analysis and Forecast by Region
  6.1. Market Trends
  6.2. Introduction
     6.2.1. Basis Point Share (BPS) Analysis by Region
     6.2.2. Y-o-Y Growth Projections by Region
  6.3. Cold Agglutinin Disease Market Size and Volume Forecast by Region
     6.3.1. North America
     6.3.2. Latin America
     6.3.3. Europe
     6.3.4. Asia Pacific
     6.3.5. Middle East and Africa (MEA)
  6.4. Absolute $ Opportunity Assessment by Region
  6.5. Market Attractiveness/Growth Potential Analysis by Region
  6.6. Global Cold Agglutinin Disease Demand Share Forecast, 2019-2026
7. North America Cold Agglutinin Disease Market Analysis and Forecast
  7.1. Introduction
     7.1.1. Basis Point Share (BPS) Analysis by Country
     7.1.2. Y-o-Y Growth Projections by Country
  7.2. North America Cold Agglutinin Disease Market Size and Volume Forecast by Country
     7.2.1. U.S.
     7.2.2. Canada
  7.3. Absolute $ Opportunity Assessment by Country
  7.4. North America Cold Agglutinin Disease Market Size and Volume Forecast by End Users
     7.4.1. Hospitals
     7.4.2. Specialty Clinics
     7.4.3. Homecare Settings
     7.4.4. Other
  7.5. Basis Point Share (BPS) Analysis by End Users
  7.6. Y-o-Y Growth Projections by End Users
  7.7. Market Attractiveness/Growth Potential Analysis
     7.7.1. By Country
     7.7.2. By Product Type
     7.7.3. By Application
  7.8. North America Cold Agglutinin Disease Demand Share Forecast, 2019-2026
8. Latin America Cold Agglutinin Disease Market Analysis and Forecast
  8.1. Introduction
     8.1.1. Basis Point Share (BPS) Analysis by Country
     8.1.2. Y-o-Y Growth Projections by Country
     8.1.3. Latin America Average Pricing Analysis
  8.2. Latin America Cold Agglutinin Disease Market Size and Volume Forecast by Country
      8.2.1. Brazil
      8.2.2. Mexico
      8.2.3. Rest of Latin America
   8.3. Absolute $ Opportunity Assessment by Country
  8.4. Latin America Cold Agglutinin Disease Market Size and Volume Forecast by End Users
     8.4.1. Hospitals
     8.4.2. Specialty Clinics
     8.4.3. Homecare Settings
     8.4.4. Other
  8.5. Basis Point Share (BPS) Analysis by End Users
  8.6. Y-o-Y Growth Projections by End Users
  8.7. Market Attractiveness/Growth Potential Analysis
     8.7.1. By Country
     8.7.2. By Product Type
     8.7.3. By Application
  8.8. Latin America Cold Agglutinin Disease Demand Share Forecast, 2019-2026
9. Europe Cold Agglutinin Disease Market Analysis and Forecast
  9.1. Introduction
     9.1.1. Basis Point Share (BPS) Analysis by Country
     9.1.2. Y-o-Y Growth Projections by Country
     9.1.3. Europe Average Pricing Analysis
  9.2. Europe Cold Agglutinin Disease Market Size and Volume Forecast by Country
     9.2.1. Germany
     9.2.2. France
     9.2.3. Italy
     9.2.4. U.K.
     9.2.5. Spain
     9.2.6. Russia
     9.2.7. Rest of Europe
  9.3. Absolute $ Opportunity Assessment by Country
  9.4. Europe Cold Agglutinin Disease Market Size and Volume Forecast by End Users
     9.4.1. Hospitals
     9.4.2. Specialty Clinics
     9.4.3. Homecare Settings
     9.4.4. Other
  9.5. Basis Point Share (BPS) Analysis by End Users
  9.6. Y-o-Y Growth Projections by End Users
  9.7. Market Attractiveness/Growth Potential Analysis
     9.7.1. By Country
     9.7.2. By Product Type
     9.7.3. By Application
  9.8. Europe Cold Agglutinin Disease Demand Share Forecast, 2019-2026
10. Asia Pacific Cold Agglutinin Disease Market Analysis and Forecast
  10.1. Introduction
     10.1.1. Basis Point Share (BPS) Analysis by Country
     10.1.2. Y-o-Y Growth Projections by Country
     10.1.3. Asia Pacific Average Pricing Analysis
  10.2. Asia Pacific Cold Agglutinin Disease Market Size and Volume Forecast by Country
     10.2.1. China
     10.2.2. Japan
     10.2.3. South Korea
     10.2.4. India
     10.2.5. Australia
     10.2.6. Rest of Asia Pacific (APAC)
  10.3. Absolute $ Opportunity Assessment by Country
  10.4. Asia Pacific Cold Agglutinin Disease Market Size and Volume Forecast by End Users
     10.4.1. Hospitals
     10.4.2. Specialty Clinics
     10.4.3. Homecare Settings
     10.4.4. Other
  10.5. Basis Point Share (BPS) Analysis by End Users
  10.6. Y-o-Y Growth Projections by End Users
  10.7. Market Attractiveness/Growth Potential Analysis
     10.7.1. By Country
     10.7.2. By Product Type
     10.7.3. By Application
  10.8. Asia Pacific Cold Agglutinin Disease Demand Share Forecast, 2019-2026
11. Middle East & Africa Cold Agglutinin Disease Market Analysis and Forecast
  11.1. Introduction
     11.1.1. Basis Point Share (BPS) Analysis by Country
     11.1.2. Y-o-Y Growth Projections by Country
     11.1.3. Middle East & Africa Average Pricing Analysis
  11.2. Middle East & Africa Cold Agglutinin Disease Market Size and Volume Forecast by Country
     11.2.1. Saudi Arabia
     11.2.2. South Africa
     11.2.3. UAE
     11.2.4. Rest of Middle East & Africa (MEA)
  11.3. Absolute $ Opportunity Assessment by Country
  11.4. Middle East & Africa Cold Agglutinin Disease Market Size and Volume Forecast by End Users
     11.4.1. Hospitals
     11.4.2. Specialty Clinics
     11.4.3. Homecare Settings
     11.4.4. Other
  11.5. Basis Point Share (BPS) Analysis by End Users
  11.6. Y-o-Y Growth Projections by End Users
  11.7. Market Attractiveness/Growth Potential Analysis
     11.7.1. By Country
     11.7.2. By Product Type
     11.7.3. By Application
  11.8. Middle East & Africa Cold Agglutinin Disease Demand Share Forecast, 2019-2026
12. Competition Landscape
  12.1. Global Cold Agglutinin Disease Market: Market Share Analysis
  12.2. Cold Agglutinin Disease Distributors and Customers
  12.3. Cold Agglutinin Disease Market: Competitive Dashboard
  12.4. Company Profiles (Details: Overview, Financials, Developments, Strategy)
     12.4.1. Biogen
     12.4.2. Bristol-Myers Squibb
     12.4.3. Celgene
     12.4.4. GSK
     12.4.5. Johnson & Johnson
     12.4.6. Merck & Co.
     12.4.7. Novartis
     12.4.8. Pfizer
     12.4.9. Roche
     12.4.10. Sanofi

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