Cold Agglutinin Disease Market Size is Set for Rapid Growth as Innovative Treatments and Rising Awareness Drive Demand by 2034

The Cold Agglutinin Disease market size is expected to increase during the forecast period with the increasing prevalence, disease awareness, and promising emerging treatment options by leading companies such as Sanofi/Bioverativ, Novartis, Incyte Corporation, Swedish Orphan Biovitrum, Sanofi, Bioverativ, a Sanofi company, Apellis Pharmaceuticals, Inc., Alpine Immune Sciences, Inc.

[Nevada, United States] - DelveInsight's "Cold Agglutinin Disease Market Insights, Epidemiology, and Market Forecast 2034." report offers a detailed examination of Cold Agglutinin Disease, covering historical and predicted epidemiology, market trends, and treatment scenarios in the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

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Key Findings from the Cold Agglutinin Disease Market Report:
• The Cold Agglutinin Disease market size is poised for significant growth, with an anticipated Compound Annual Growth Rate (CAGR) during the study period (2020-2034).
• In September, 2024: Swedish Orphan Biovitrum announced that the purpose of their study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin disease (CAD).
• In July, 2024: Alpine Immune Sciences, Inc. announced that the goal of their study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.
• As per DelveInsight's analysis, in 2022, the total prevalent cases of CAD were around 12,900 in the 7MM, which are expected to rise during the forecasted period 2023-2032.
• According to DelveInsight's analysis, in 2022, the total diagnosed cases of CAD were around 4,400 in the US, which are expected to rise during the forecasted period 2023- 2032.
• In the year 2022, the total type-specific cases of CAD were approximately 9,300 and about 1000 cases for primary and secondary CAD, respectively, in the 7MM, which are expected to rise during the forecast period 2023-2032.
• Key Cold Agglutinin Disease Companies are as follows: Sanofi/Bioverativ, Novartis, Incyte Corporation, Swedish Orphan Biovitrum, Sanofi, Bioverativ, a Sanofi company, Apellis Pharmaceuticals, Inc., Alpine Immune Sciences, Inc.
• Key Cold Agglutinin Disease Therapies are as follow: ENJAYMO (sutimlimab), LNP023 (iptacopan), INCB050465 (parsaclisib), Pegcetacoplan, sutimlimab, sutimlimab (BIVV009), APL-2, povetacicept
• Launching multiple stage Cold Agglutinin Disease pipeline products is expected to revolutionize market dynamics, further propelling market growth.

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Cold Agglutinin Disease Overview:
Cold agglutinin disease (CAD), is a rare autoimmune disorder characterized by the premature destruction of red blood cells (hemolysis). In CAD, the red blood cells are detroyed prematurely and the rate of production of new cells in the bone marrow can no longer compensate for their loss.

Cold Agglutinin Disease Epidemiology Segmentation:
The Cold Agglutinin Disease market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Cold Agglutinin Disease Total Prevalent Cases
• Cold Agglutinin Disease Total Diagnosed Cases
• Cold Agglutinin Disease Total Gender-specific Cases
• Cold Agglutinin Disease Total Type-specific Cases

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Cold Agglutinin Disease Market Insights
• Increasing Awareness and Diagnosis Awareness of CAD among healthcare professionals has been increasing in recent years, leading to better diagnosis and more consistent treatment approaches.
• Emergence of Novel Therapies Historically, the treatment of CAD was limited to managing symptoms with supportive care, such as avoiding cold environments and using blood transfusions.
• Unmet Needs and Opportunity for Growth Despite the approval of newer therapies, there remain unmet needs in CAD treatment, particularly in patients with severe disease or those who do not respond to existing therapies.

Cold Agglutinin Disease Drugs Uptake
• Sutimlimab (Enjaymo) Sutimlimab, developed by Sanofi, is the first and only FDA-approved treatment specifically for CAD. It is a monoclonal antibody that inhibits the C1s protein in the classical complement pathway, preventing the destruction of red blood cells.
• Rituximab, a monoclonal antibody targeting CD20 on B-cells, has been used off-label for treating CAD, especially in cases associated with lymphoproliferative disorders. While not specifically approved for CAD, rituximab has been a mainstay of treatment due to its ability to deplete B-cells that produce cold agglutinins, thereby reducing hemolysis.
• Several other therapies are in development for CAD, focusing on the complement system and other pathways involved in hemolysis. Companies are conducting clinical trials to test new complement inhibitors and other targeted therapies that can provide additional options for CAD management.

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Cold Agglutinin Disease Therapies and Key Companies:
• ENJAYMO (sutimlimab): Sanofi/Bioverativ
• LNP023 (iptacopan): Novartis
• INCB050465 (parsaclisib): Incyte Corporation
• Pegcetacoplan: Swedish Orphan Biovitrum
• sutimlimab: Sanofi
• sutimlimab (BIVV009): Bioverativ, a Sanofi company
• APL-2: Apellis Pharmaceuticals, Inc.
• povetacicept: Alpine Immune Sciences, Inc.

Cold Agglutinin Disease Epidemiology:
Cold Agglutinin Disease is considered a rare disease with an estimated prevalence of 1-1.9 per million people annually. CAD primarily affects older adults, typically those over 50 years of age, with an increased incidence observed in the elderly population. The condition is more common in women than in men. In the United States, it is estimated that there are around 10,000-16,000 people living with CAD. In Europe, the prevalence is similar, with data suggesting that CAD affects approximately 1 in 100,000 individuals. Despite being a rare disease, CAD contributes to significant healthcare costs due to the chronic nature of the disease and its complications.

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Cold Agglutinin Disease Market Drivers:
• Growing Awareness and Improved Diagnosis
• Launch of Targeted Therapies
• Orphan Drug Incentives
• Improving Healthcare Infrastructure

Cold Agglutinin Disease Market Barriers:
• Limited Awareness Among General Practitioners
• Availability of Treatment in Emerging Markets
• Side Effects and Risks of Long-Term Therapy

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Scope of the Cold Agglutinin Disease Market Report:
• Study Period: 2020-2034
• Coverage: 7MM (The United States, EU5, and Japan)
• Key Cold Agglutinin Disease Companies: Sanofi/Bioverativ, Novartis, Incyte Corporation, Swedish Orphan Biovitrum, Sanofi, Bioverativ, a Sanofi company, Apellis Pharmaceuticals, Inc., Alpine Immune Sciences, Inc.
• Key Cold Agglutinin Disease Therapies: ENJAYMO (sutimlimab), LNP023 (iptacopan), INCB050465 (parsaclisib), Pegcetacoplan, sutimlimab, sutimlimab (BIVV009), APL-2, povetacicept
• Cold Agglutinin Disease Therapeutic Assessment: Current marketed and emerging therapies
• Cold Agglutinin Disease Market Dynamics: Cold Agglutinin Disease Market drivers and Cold Agglutinin Disease barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Cold Agglutinin Disease Unmet Needs: Insights into unmet needs, KOL's views, Analyst's views, Market Access, and Reimbursement.

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Table of Content:

1 Key Insights
2 Report Introduction
3 CAD Market Overview at a Glance
4 Executive Summary of Cold Agglutinin Disease (CAD)
5 Epidemiology and Market Methodology
6 Disease Background and Overview
7 Diagnosis of CAD
8 Diagnostic Guidelines
9 Treatment of CAD
10 Treatment Guidelines
11 Epidemiology and Patient Population
12 Patient Journey
13 Key Endpoints in Cold Agglutinin Disease Clinical Trials
14 Marketed Therapies
15 Emerging Therapies
16 CAD: The 7MM Analysis
17 Market Access and Reimbursement
18 KOL Views
19 SWOT Analysis
20 Unmet Needs
21 Appendix
22 DelveInsight Capabilities
23 Disclaimer
24 About DelveInsight

About DelveInsight:
DelveInsight is a leading market research firm providing insightful solutions and services to pharmaceutical and life sciences companies. With a commitment to delivering accurate and comprehensive reports, DelveInsight empowers businesses to make informed decisions and navigate the complexities of the healthcare industry.

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