Cold Agglutinin Disease Market expected to rise | Companies – Sanofi, Bioverativ, Sobi, Apellis Pharmaceuticals, Novartis, Incyte Corporation, expected to drive market

Cold Agglutinin Disease Market

The Cold Agglutinin Disease market growth is driven by factors like increase in the prevalence of Cold Agglutinin Disease, investments in research and development, entry of emerging therapies during the study period 2019-2032.

The Cold Agglutinin Disease market report also offers comprehensive insights into the Cold Agglutinin Disease market size, share, Cold Agglutinin Disease epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Cold Agglutinin Disease market size growth forward. 

Some of the key highlights from the Cold Agglutinin Disease Market Insights Report:

• Several key pharmaceutical companies, including Sanofi, Bioverativ, Sobi, Apellis Pharmaceuticals, Novartis, Incyte Corporation, and others, are developing novel products to improve the Cold Agglutinin Disease treatment outlook. 
• The total Cold Agglutinin Disease market size will include the market size of the potential upcoming therapies and current treatment regimens in the seven major markets.
• As per DelveInsight analysis, the Cold Agglutinin Disease market is anticipated to witness growth at a considerable CAGR

Strategise your business goals by understanding market dynamics @ Cold Agglutinin Disease Market Landscape

Cold Agglutinin Disease Overview 

Cold Agglutinin Disease (CAD) is a rare autoimmune disorder characterized by prematurely destroying the red blood cells (RBCs) (hemolysis). It is a subtype of autoimmune hemolytic anemia (AIHA). AIHAs are generally classified as warm, cold, or mixed type, depending on the optimum temperature at which the autoantibodies bind with surface antigens. In CAD, the red blood cells are destroyed prematurely, and the production rate of new cells in the bone marrow can no longer compensate for their loss.

Cold Agglutinin Disease Diagnosis

A Cold Agglutinin Disease diagnosis is generally made through physical exams and laboratory tests. Additional tests may be required to identify the underlying cause of the disease in the case of secondary CAD, a form of Cold Agglutinin Disease associated with other illnesses, including infections, cancers, or other autoimmune disorders. Further tests may also be required to differentiate CAD from other diseases that can lead to the premature destruction of red blood cells.

Blood samples taken at a hospital or clinic may be used to diagnose Cold Agglutinin Disease. The blood is analyzed using multiple laboratory tests, including a complete blood count, a blood smear, biochemical tests, the Coombs test, a cold agglutinin titer, or a thermal amplitude test.

Cold Agglutinin Disease TreatmentThe treatment of Cold Agglutinin Disease depends on the severity of the clinical symptoms. Currently, the therapeutic market of CAD is majorly acquired by nonpharmacological (cold avoidance) and pharmacological management, including Rituximab monotherapy and combination therapy, plasmapheresis, and transfusions. The FDA approved ENJAYMO in February 2022 as the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. The Japanese Ministry of Health, Labor, and Welfare approved ENJAYMO in June 2022, and in November 2022, the European Commission (EC) granted marketing authorization for ENJAYMO.

The current therapeutic market for Cold Agglutinin Disease is dominated by nonpharmacological (cold avoidance) and pharmacological management. Corticosteroids, alkylating agents, purine nucleoside analogs, and majorly biologics, such as rituximab monotherapy or combination therapy (fludarabine and rituximab, bendamustine and rituximab) and others are the major therapeutic line of treatment for CAD.

The first treatment shown to be effective in Cold agglutinin disease was rituximab monotherapy, 375 mg/m2 once a week for 4 weeks; rituximab is often used as a first-line therapy. If patients do not respond to rituximab, it can be combined with other drugs, such as bendamustine and fludarabine, administered orally has resulted in higher response rates and sustained remissions. Although rituximab alone or in combination is still the most widely used treatment, it is likely to be replaced with emerging therapies expected to launch in the future.

Over the next few years, the US Cold Agglutinin Disease Market is expected to change and experience growth substantially, as it will be dominated by one already approved product, ENJAYMO (sutimlimab). In contrast, we also anticipate the launch of a second product, Pegcetacoplan, in the US market in the coming 2–3 years. We expect the market to expand, especially as safer and more effective therapies enter the market.

Do you know the treatment paradigms for different countries? Download our Cold Agglutinin Disease Market Sample Report

Recent Breakthroughs in the Cold Agglutinin Disease Market:

FDA Approval Updates Enjaymo Indication for Cold Agglutinin Disease. The Food and Drug Administration (FDA) has expanded the approval of Enjaymo® (sutimlimab-jome) for the treatment of hemolysis in adults with cold agglutinin disease (CAD) to include patients with or without a history of transfusions.

Cold Agglutinin Disease Epidemiology Insights:

• The total number of diagnosed prevalent cases of Cold Agglutinin Disease in the United States was around 4,300 cases in 2022.
• The United States contributed to the largest prevalent population of Cold Agglutinin Disease, acquiring ~43% of the 7MM in 2022. Whereas EU4 and the UK, and Japan accounted for around 42% and 16% of the total population share, respectively, in 2022.
• Among the EU4 countries, Germany accounted for the largest number of diagnosed Cold Agglutinin Disease cases, followed by France, whereas Spain accounted for the lowest number of cases in 2022.
• According to DelveInsight estimates, there were around 4,000 cases of primary and 500 cases of secondary Cold agglutinin disease in the United States in 2022. The prevalence is projected to increase during the forecasted period.
• In 7MM, ~40% of the patient share is attributed to males, whereas only 60% of females have Cold agglutinin disease.

Cold Agglutinin Disease Epidemiology Segmentation 

DelveInsight’s Cold Agglutinin Disease market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Cold Agglutinin Disease historical patient pools and forecasted Cold Agglutinin Disease patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Cold Agglutinin Disease Market report proffers epidemiological analysis for the study period 2019-32 in the 7MM segmented into:

• Cold Agglutinin Disease Prevalence 
• Age-Specific Cold Agglutinin Disease Prevalence 
• Gender-Specific Cold Agglutinin Disease Prevalence 
• Diagnosed and Treatable Cases of Cold Agglutinin Disease

Visit for more @ Cold Agglutinin Disease Epidemiological Insights

Cold Agglutinin Disease Treatment Market 

The Cold Agglutinin Disease market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Cold Agglutinin Disease market trends by analyzing the impact of current Cold Agglutinin Disease therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Cold Agglutinin Disease market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Cold Agglutinin Disease market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the Cold Agglutinin Disease market in 7MM is expected to witness a major change in the study period 2019-2032.

Cold Agglutinin Disease Key Companies

• Sanofi
• Bioverativ
• Sobi
• Apellis Pharmaceuticals
• Novartis
• Incyte Corporation

For more information, visit Cold Agglutinin Disease Market Analysis, Patient Pool, and Emerging Therapies

Scope of the Cold Agglutinin Disease Market Report:

• 11 Years Forecast
• 7MM Coverage 
• Descriptive overview of Cold Agglutinin Disease, causes, signs and symptoms, diagnosis, treatment
• Comprehensive insight into Cold Agglutinin Disease epidemiology in the 7MM
• Cold Agglutinin Disease marketed and emerging therapies 
• Cold Agglutinin Disease companies
• Cold Agglutinin Disease market drivers and barriers 

Key Questions Answered in the Cold Agglutinin Disease Market Report 2032:

• What was the Cold Agglutinin Disease market share distribution in 2019, and how would it appear in 2032?
• What is the total Cold Agglutinin Disease market size and the market size by therapy across the 7MM for the study period (2019-32)?
• What are the important findings from 7MM, and which country will have the greatest Cold Agglutinin Disease market size from 2019-32?
• During the study period (2019-2032), at what CAGR is the Cold Agglutinin Disease market projected to expand at 7MM?

Table of Contents:

1 Cold Agglutinin Disease Market Key Comprehensive Insights 

2 Cold Agglutinin Disease Market Report Introduction

3 Competitive Intelligence Analysis for Cold Agglutinin Disease

4 Cold Agglutinin Disease Market Analysis Overview at a Glance

5 Executive Summary of Cold Agglutinin Disease

6 Cold Agglutinin Disease Epidemiology and Market Methodology

7 Cold Agglutinin Disease Epidemiology and Patient Population

8 Cold Agglutinin Disease Patient Journey

9 Cold Agglutinin Disease Treatment Algorithm, Cold Agglutinin Disease Current Treatment, and Medical Practices

10 Key Endpoints in Cold Agglutinin Disease Clinical Trials

11 Cold Agglutinin Disease Marketed Therapies 

12 Cold Agglutinin Disease Emerging Therapies

13 Cold Agglutinin Disease: 7 Major Market Analysis

14 Attribute analysis

15 Access and Reimbursement Overview of Cold Agglutinin Disease

16 Cold Agglutinin Disease Market Key Opinion Leaders Reviews

18 Cold Agglutinin Disease Market Drivers

19 Cold Agglutinin Disease Market Barriers

20 SWOT Analysis

21 Disclaimer

22 DelveInsight Capabilities

23 About DelveInsight

Related Reports:

Cold Agglutinin Disease Epidemiology 2032

DelveInsight’s “Cold Agglutinin Disease – Epidemiology Forecast to 2032” report delivers an in-depth understanding of the disease, historical and forecasted Cold Agglutinin Disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Cold Agglutinin Disease Pipeline 2023

“Cold Agglutinin Disease Pipeline Insights, 2023” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Cold Agglutinin Disease market. A detailed picture of the Cold Agglutinin Disease pipeline landscape is provided, which includes the disease overview and Cold Agglutinin Disease treatment guidelines. 

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