- Corticosteroids
- Alkylating Agents
- Purine Nucleoside Analogs
- Biologics
- Others
Cold Agglutinin Disease (CAD) Market was valued at USD 86 million in 2022 and is poised to grow at a CAGR of 19.6% over 2023-2029. Cold agglutinin disease (CAD) is a rare autoimmune disorder characterized by the presence of high concentrations of circulating cold-sensitive antibodies, directed against red blood cells, only at low body temperature (28-31?), causing them to agglutinate and undergo lysis. According to the American Society of Hematology, cold agglutinin disease has a prevalence of 5 to 20 cases per million and an incidence of 0.5 to 1.9 cases per million per year. 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 will act as the cold agglutinin disease market growth drivers. However, the high cost of treatment and lack of awareness could be the restraining factor for the market. An increasing number of R&D activities by the key market players will be an opportunity for expansion of the market.
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
2023-29
Base Year
2022
CAGR
19.6%
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.
North-America Got Significant Share of
Cold Agglutinin Disease (CAD) Market Regional Analysis
Cold Agglutinin Disease (CAD) market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. According to the American Society of Hematology, Cold Agglutinin disease accounts for about 15% to 30% of autoimmune hemolytic anaemia, whose annual incidence is estimated to be 1:35,000 to 1:80,000 in North America and Western Europe. The total prevalent cases of CAD was found to be 29,077, in 2017, and the highest prevalence was in China. Additionally, as per the World Health Organization, the global geriatric population, which is more susceptible to autoimmune disorders, is expected to reach 2 billion by 2050. The North America Cold Agglutinin Disease (CAD) market is expected to dominate the market owing to the increasing healthcare expenditure, and demand for disease-specific treatment in the region. For the Asia Pacific region, the growth drivers would be the development of healthcare infrastructure and the rising patient population in certain countries.
Latin America
Europe
Asia Pacific
Middle East
North America
Key Features of the Reports
- The cold agglutinin disease market report provides granular level information about the market size, regional market share, historic market (2018-2022) and forecast (2023-2029)
- 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
By Diagnosis Method
- Complete Blood Count Test
- Reticulocyte Count
- Serum Level Test
- Cold Agglutinin Titer Test
- Others
By Route of Administration
- Oral
- Parenteral
- Others
By End User
- Hospitals
- Specialty Clinics
- Homecare
- Others
Frequently Asked Questions
The Cold Agglutinin Disease (CAD) market was valued at USD 86 million in 2022 and is expected to grow at a 19.6% CAGR over the forecast period 2023 – 2029.
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.
- 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