Cold Agglutinin Disease (CAD) Market: By Drugs (Corticosteroids, Alkylating Agents, Purine Nucleoside Analogs, Biologics, Others), By Route of Administration (Oral, Parenteral, Others), By Dosage Form (Tablets, Injections, Others), By End-Users (Hospitals, Specialty Clinics, Homecare, Others), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy, Others) and Geography

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Cold Agglutinin Disease (CAD) Market was valued at USD 109.3 million in 2023 and is poised to grow at a CAGR of 23.1% over 2024-2030. Cold Agglutinin Disease (CAD) is a rare autoimmune disorder that affects the blood, causing the red blood cells to clump together when exposed to cold temperatures. This leads to hemolysis, where the red blood cells are destroyed, resulting in anemia and various complications. The prevalence of CAD is low, with an estimated incidence of 1-3 individuals per million population, according to data from the National Organization for Rare Disorders (NORD). The CAD market faces unique challenges due to its rarity, and there is a limited number of therapeutic options available. Current treatments often focus on managing symptoms and reducing hemolysis. Corticosteroids are commonly used to suppress the immune response and decrease antibody production, while immunosuppressive agents like rituximab have shown promise in reducing cold agglutinin levels, as reported by the American Society of Hematology (ASH).

However, the need for more targeted and efficient therapies remains significant. To diagnose CAD, specialized tests are conducted to detect cold-reactive antibodies. The diagnosis is crucial for timely intervention and to prevent complications. Laboratories and medical institutions offer specific tests to detect these antibodies and confirm the presence of CAD. Research and development efforts for CAD are relatively limited, given its rarity. However, various stakeholders, including pharmaceutical companies, academic institutions, and nonprofit organizations, are investing in clinical trials and studies to explore novel therapeutic approaches and gain a deeper understanding of the disease's mechanisms. Patient advocacy groups play a vital role in the CAD market by raising awareness, providing support to patients, and driving research initiatives. These organizations collaborate with medical professionals and researchers to improve patient outcomes and foster a sense of community among CAD patients. Moreover, the global CAD market is influenced by factors such as regulatory policies, reimbursement scenarios, and advancements in diagnostic technologies and the understanding of CAD continues to evolve, it is expected that more targeted and effective treatments will be developed in the future forecasted period.

Cold Agglutinin Disease (CAD) Market Key Developments:
  • In Feb 2022, Sanofi conducted a phase 1b clinical trial for safety and tolerability testing of Bioverativ (BIVV020) in patients with cold agglutinin disease.
  • In Feb 2022, the US FDA approved Sanofi’s Enjaymo (Sutimlimab-jome), used in reducing the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease.

Cold Agglutinin Disease Market Summary

Study Period

2024-2030

Base Year

2023

CAGR

23.1%

Largest Market

North America

Fastest Growing Market

North America
Cold Agglutinin Disease (CAD) Market Dynamics

There has been an increase in investment in healthcare infrastructure and the increasing number of drug approvals are the factors that will drive the future growth of the cold agglutinin disease market. For example, in Jun 2022, Sanofi’s Enjaymo was approved by Japan’s MHLW, and in Nov 2022, the European Commission granted the marketing authorization, for the treatment of cold agglutinin disease. Furthermore, there are other emerging therapies such as Aspaveli (Pegcetacoplan), by SOBI and Apellis Pharmaceuticals, and LNP023 (Iptacopan) by Novartis in clinical trial phases for cold agglutinin disease. Thus, the increased research and development for rare disorders will lead to the growth of the market within the forecast period. Whereas, a lack of skilled professionals could have a negative impact on the market.

Key Features of the Reports

  • The cold agglutinin disease market report provides granular level information about the market size, regional market share, historic market (2019-2023) and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Cold Agglutinin Disease Market Segmentation

By Drug Class
  • Corticosteroids
  • Alkylating Agents
  • Purine Nucleoside Analogs
  • Biologics
  • Others
By Dosage Form
  • Tablets
  • Injections
  • Others
By Route of Administration
  • Oral
  • Parenteral
  • Others
By End User
  • Hospitals
  • Specialty Clinics
  • Homecare
  • Others
By Distribution Channel
  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Pharmacy
  • Others

Frequently Asked Questions

The Cold Agglutinin Disease (CAD) market was valued at USD 109.3 million in 2023 and is expected to grow at a 23.1% CAGR over the forecast period 2024 – 2030.

An increasing number of R&D activities by the key market players is the key opportunity for the Cold Agglutinin Disease (CAD) market.

The increasing prevalence of cold agglutinin disease risk factors such as cancer, bacterial infections, parasitic infections, viral diseases, and other autoimmune disorders, and the geriatric population are the growth drivers in the Cold Agglutinin Disease (CAD) market.

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., and Incyte Corporation are a few companies operating in the Cold Agglutinin Disease (CAD) market.

 
1.Executive Summary
2.Global Cold Agglutinin Disease Market Introduction 
2.1.Global Cold Agglutinin Disease Market  - Taxonomy
2.2.Global Cold Agglutinin Disease Market  - Definitions
2.2.1.Drug Class
2.2.2.Dosage Form
2.2.3.Distribution Channels
2.2.4.End User
2.2.5.Region
3.Global Cold Agglutinin Disease Market Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4.Global Cold Agglutinin Disease Market Analysis, 2019 - 2023 and Forecast 2024 - 2030
4.1.  Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5.Global Cold Agglutinin Disease Market  By Drug Class, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
5.1. Corticosteroids
5.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
5.2. Alkylating Agents
5.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.2.3. Market Opportunity Analysis 
5.3. Purine Nucleoside Analogs
5.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.3.3. Market Opportunity Analysis 
5.4. Biologics
5.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.4.3. Market Opportunity Analysis 
5.5. Others
5.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
5.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.5.3. Market Opportunity Analysis 
6.Global Cold Agglutinin Disease Market  By Dosage Form, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
6.1. Tablets
6.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. Injections
6.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
6.3. Others
6.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.3.3. Market Opportunity Analysis 
7.Global Cold Agglutinin Disease Market  By Distribution Channels, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
7.1. Hospital Pharmacy
7.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.1.3. Market Opportunity Analysis 
7.2. Retail Pharmacy
7.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.2.3. Market Opportunity Analysis 
7.3. Online Pharmacy
7.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.3.3. Market Opportunity Analysis 
7.4. Others
7.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
7.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
7.4.3. Market Opportunity Analysis 
8.Global Cold Agglutinin Disease Market  By End User, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
8.1. Hospitals
8.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.1.3. Market Opportunity Analysis 
8.2. Specialty Clinics
8.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.2.3. Market Opportunity Analysis 
8.3. Homecare
8.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.3.3. Market Opportunity Analysis 
8.4. Others
8.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
8.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
8.4.3. Market Opportunity Analysis 
9.Global Cold Agglutinin Disease Market  By Region, 2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
9.1. North America
9.1.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.1.3. Market Opportunity Analysis 
9.2. Europe
9.2.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.2.3. Market Opportunity Analysis 
9.3. Asia Pacific (APAC)
9.3.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.3.3. Market Opportunity Analysis 
9.4. Middle East and Africa (MEA)
9.4.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.4.3. Market Opportunity Analysis 
9.5. Latin America
9.5.1. Market Analysis, 2019 - 2023 and Forecast, 2024 - 2030, (Sales Value USD Million)
9.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
9.5.3. Market Opportunity Analysis 
10.North America Cold Agglutinin Disease Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
10.1. Drug Class Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.Corticosteroids
10.1.2.Alkylating Agents
10.1.3.Purine Nucleoside Analogs
10.1.4.Biologics
10.1.5.Others
10.2.  Dosage Form Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.Tablets
10.2.2.Injections
10.2.3.Others
10.3.  Distribution Channels Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.3.1.Hospital Pharmacy
10.3.2.Retail Pharmacy
10.3.3.Online Pharmacy
10.3.4.Others
10.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.4.1.Hospitals
10.4.2.Specialty Clinics
10.4.3.Homecare
10.4.4.Others
10.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.5.1.United States of America (USA)
10.5.2.Canada
11.Europe Cold Agglutinin Disease Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
11.1. Drug Class Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.Corticosteroids
11.1.2.Alkylating Agents
11.1.3.Purine Nucleoside Analogs
11.1.4.Biologics
11.1.5.Others
11.2.  Dosage Form Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Tablets
11.2.2.Injections
11.2.3.Others
11.3.  Distribution Channels Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.3.1.Hospital Pharmacy
11.3.2.Retail Pharmacy
11.3.3.Online Pharmacy
11.3.4.Others
11.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.4.1.Hospitals
11.4.2.Specialty Clinics
11.4.3.Homecare
11.4.4.Others
11.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.5.1.Germany
11.5.2.France
11.5.3.Italy
11.5.4.United Kingdom (UK)
11.5.5.Spain
12.Asia Pacific (APAC) Cold Agglutinin Disease Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
12.1. Drug Class Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.1.1.Corticosteroids
12.1.2.Alkylating Agents
12.1.3.Purine Nucleoside Analogs
12.1.4.Biologics
12.1.5.Others
12.2.  Dosage Form Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.2.1.Tablets
12.2.2.Injections
12.2.3.Others
12.3.  Distribution Channels Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.3.1.Hospital Pharmacy
12.3.2.Retail Pharmacy
12.3.3.Online Pharmacy
12.3.4.Others
12.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.4.1.Hospitals
12.4.2.Specialty Clinics
12.4.3.Homecare
12.4.4.Others
12.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
12.5.1.China
12.5.2.India
12.5.3.Australia and New Zealand (ANZ)
12.5.4.Japan
12.5.5.Rest of APAC
13.Middle East and Africa (MEA) Cold Agglutinin Disease Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
13.1. Drug Class Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.1.1.Corticosteroids
13.1.2.Alkylating Agents
13.1.3.Purine Nucleoside Analogs
13.1.4.Biologics
13.1.5.Others
13.2.  Dosage Form Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.2.1.Tablets
13.2.2.Injections
13.2.3.Others
13.3.  Distribution Channels Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.3.1.Hospital Pharmacy
13.3.2.Retail Pharmacy
13.3.3.Online Pharmacy
13.3.4.Others
13.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.4.1.Hospitals
13.4.2.Specialty Clinics
13.4.3.Homecare
13.4.4.Others
13.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
13.5.1.GCC Countries
13.5.2.South Africa
13.5.3.Rest of MEA
14.Latin America Cold Agglutinin Disease Market ,2019 - 2023 and Forecast 2024 - 2030 (Sales Value USD Million)
14.1. Drug Class Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.1.1.Corticosteroids
14.1.2.Alkylating Agents
14.1.3.Purine Nucleoside Analogs
14.1.4.Biologics
14.1.5.Others
14.2.  Dosage Form Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.2.1.Tablets
14.2.2.Injections
14.2.3.Others
14.3.  Distribution Channels Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.3.1.Hospital Pharmacy
14.3.2.Retail Pharmacy
14.3.3.Online Pharmacy
14.3.4.Others
14.4.  End User Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.4.1.Hospitals
14.4.2.Specialty Clinics
14.4.3.Homecare
14.4.4.Others
14.5.  Country Analysis 2019 - 2023 and Forecast 2024 - 2030 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
14.5.1.Brazil
14.5.2.Mexico
14.5.3.Rest of LA
15. Competition Landscape
15.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
15.2.1.Hoffmann-La Roche Ltd.
15.2.2. Mylan N.V.
15.2.3. Teva Pharmaceutical Industries Ltd.
15.2.4. Sanofi 
15.2.5. Pfizer Inc.
15.2.6. GlaxoSmithKline plc
15.2.7.Novartis AG 
15.2.8. Zydus Cadila 
15.2.9. AstraZeneca
15.2.10. Johnson & Johnson
15.2.11. Bayer AG
15.2.12. Sun Pharmaceutical Industries Ltd.
15.2.13. Apellis Pharmaceuticals
15.2.14. Incyte Corporation
15.2.15. Fresenius Kabi AG
15.2.16. Amgen Inc.
15.2.17. Bristol-Myers Squibb Company
15.2.18. AbbVie Inc.
15.2.19.Eli Lilly and Company
15.2.20. Merck KGaA
16. Research Methodology 
17. Appendix and Abbreviations 
  • Hoffmann-La Roche Ltd.
  •  Mylan N.V.
  •  Teva Pharmaceutical Industries Ltd.
  •  Sanofi 
  •  Pfizer Inc.
  •  GlaxoSmithKline plc
  •  Novartis AG 
  •  Zydus Cadila 
  •  AstraZeneca
  •  Johnson & Johnson
  •  Bayer AG
  •  Sun Pharmaceutical Industries Ltd.
  •  Apellis Pharmaceuticals
  •  Incyte Corporation
  •  Fresenius Kabi AG
  •  Amgen Inc.
  •  Bristol-Myers Squibb Company
  •  AbbVie Inc.
  •  Eli Lilly and Company
  •  Merck KGaA

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