Global Cold Agglutinin Disease Treatment Market - 2023-2030

Global Cold Agglutinin Disease Treatment Market - 2023-2030


Global cold agglutinin disease treatment market reached US$ YY billion in 2022 and is expected to reach US$ YY billion by 2030, growing with a CAGR of YY% during the forecast period 2023-2030.

The global cold agglutinin disease treatment market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. A uncommon kind of autoimmune hemolytic anemia is known as cold agglutinin disease, which is brought on by autoantibodies that react to cold.

Government investments and research, particularly in developing economies, will continue to drive utilization of advanced treatments and boost the global cold agglutinin disease treatment market. The respective innovative treatments includes the use of monoclonal antibodies for better treatment.

Market Dynamics: Drivers

Growing development of novel therapies or drugs

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by high income levels, investments and infrastructure development. Several countries have experienced substantial demand for cold agglutinin disease treatment owing to its positive outcomes in clinical trials leading to drug approval will be a crucial factor driving the growth of the market.

On July 7, 2023, with less red blood cell damage in a cellular model of CAD, Sanofi's investigational medication SAR445088 successfully inhibits the traditional complement pathway, a component of the immune system linked to cold agglutinin disease (CAD) in a study. Because of its more focused activity, SAR445088 might replace Sanofi's Enjaymo (sutimlimab-jome). Adults with CAD are being investigated with the next-generation treatment in a Phase 1 clinical trial in Europe (NCT04802057). Rising awareness among people and increasing robust pipeline with drugs in phase 3 will be a major factor driving the growth of the cold agglutinin syndrome drugs market.

Market Dynamics: Restraints

Side effects associated with the drugs

Patients having symptomatic anemia or other annoying symptoms should be addressed, while medication is not always necessary. Due to their negative effects, corticosteroids are not recommended to treat CAD. Heart or heart rhythm issues, such as arrhythmia, heart attacks, and cardiogenic shock, could be brought on by this medication. When mAbs are administered, there is a chance of immunological reactions like serum sickness, acute anaphylaxis, and the production of antibodies.

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Segment Analysis

The global cold agglutinin disease treatment market is segmented based on type, drug type, route of administration, distribution channel and region.

Biologics segment holds approximately 37% of market share

The biologics segment from drug type is the largest share holder among all the drug types owing to its high effectiveness and rising researches and product developments. Monoclonal antibodies, immune modulators, growth factors, vaccinations, and items made from human blood and plasma all fall within the broad category of biological medicines.

Rituximab, a monoclonal antibody, is the first- and second-line treatment for cold agglutinin illness as well as the preferred therapy for steroid-refractory warm autoimmune hemolytic anemia (wAIHA).

Geographical Penetration

North America accounted for around 33% of market share in 2022

Due to the rising need for cold agglutinin disease treatment in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for cold agglutinin disease treatment.

Increasing expenditure on healthcare and rising research studies, advancement of technologies and different type of drugs for treatment, and increase in pharmaceutical or biotech business establishment across the region are also contributing to the growth of cold agglutinin disease treatment market share of this region. The market in this area is growing as people become more aware of various novel treatments such as monoclonal antibodies. The aforementioned elements further attest to North America's hegemonic position in the world.

North America continues to be a key player in the global cold agglutinin disease treatment market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising advancements have fueled the demand for cold agglutinin disease treatment in the U.S. United States have been proactive in executing several initiatives or researches, stimulating cold agglutinin disease treatment drugs demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global cold agglutinin disease treatment market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the pharmaceutical sector, with a significant consumer of various types of drugs, was significantly impacted. Several efforts all throughout the world were impacted by the pandemic's broad lockdowns and limitations that started in early 2020.

Major pharmaceutical industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for cold agglutinin disease treatment. Now several research studies have been initiated and companies have again started trial for their respective pipelines. Overall, the impact of the pandemic on the global cold agglutinin disease treatment market is expected to be relatively moderate, with the market continuing to grow steadily due to the ongoing need and research for monoclonal antibodies and other programs to control such kind of disorders.

Key Developments
• On February 4, 2022, Enjaymo (sutimlimab-jome) has received FDA approval to reduce the requirement for red blood cell transfusions in adults having cold agglutinin disease (CAD) related to hemolysis. Enjaymo, the first and only medication for CAD to receive FDA approval, prevents the breakdown of red blood cells (hemolysis).

Competitive Landscape

The major global players in the market include Sanofi, NovelMed Inc., Novartis AG, Swedish Orphan Biovitrum AB, Apellis Pharmaceuticals, Inc., Alpine Immune Sciences, Genentech USA, Inc., Alexion Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. and Viatris Inc. among others.

Why Purchase the Report?
• To visualize the global cold agglutinin disease treatment market segmentation based on type, drug type, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of cold agglutinin disease treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global cold agglutinin disease treatment market report would provide approximately 69 tables, 68 figures and 186 Pages.

Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies


1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Type
3.2. Snippet by Drug Type
3.3. Snippet by Route of Administration
3.4. Snippet by Distribution Channel
3.5. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Growing development of novel therapies or drugs
4.1.1.2. Rising technological advancements and developments
4.1.2. Restraints
4.1.2.1. Side effects associated with the drugs
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Pricing Analysis
5.6. SWOT Analysis
5.7. Patent Analysis
5.8. Russia-Ukraine War Impact Analysis
5.9. DMI Opinion
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID
6.1.2. Scenario During COVID
6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion
7. By Type
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
7.1.2. Market Attractiveness Index, By Type
7.2. Primary Cold Agglutinin Disease*
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Secondary Cold Agglutinin Disease
8. By Drug Type
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
8.1.2. Market Attractiveness Index, By Drug Type
8.2. Biologics*
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.2.3. Sutimlimab (Enjaymo)
8.2.4. Rituximab (Rituxan)
8.2.5. Eculizumab (Soliris)
8.3. Purine Analogue
8.3.1. Fludarabine
8.3.2. Azathioprine
8.4. Corticosteroid
8.4.1. Prednisone
8.5. Alkylating Agents
8.5.1. Chlorambucil
8.5.2. Cyclophosphamide
8.6. Folic Acid Supplements
8.7. Others
9. By Route of Administration
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
9.1.2. Market Attractiveness Index, By Route of Administration
9.2. Oral *
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Parenteral
10. By Distribution Channel
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
10.1.2. Market Attractiveness Index, By Distribution Channel
10.2. Hospital Pharmacies*
10.2.1. Introduction
10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Retail Pharmacies
10.4. Online Pharmacies
11. By Region
11.1. Introduction
11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
11.1.2. Market Attractiveness Index, By Region
11.2. North America
11.2.1. Introduction
11.2.2. Key Region-Specific Dynamics
11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.2.7.1. U.S.
11.2.7.2. Canada
11.2.7.3. Mexico
11.3. Europe
11.3.1. Introduction
11.3.2. Key Region-Specific Dynamics
11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.3.7.1. Germany
11.3.7.2. UK
11.3.7.3. France
11.3.7.4. Italy
11.3.7.5. Spain
11.3.7.6. Rest of Europe
11.4. South America
11.4.1. Introduction
11.4.2. Key Region-Specific Dynamics
11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.4.7.1. Brazil
11.4.7.2. Argentina
11.4.7.3. Rest of South America
11.5. Asia-Pacific
11.5.1. Introduction
11.5.2. Key Region-Specific Dynamics
11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.5.7.1. China
11.5.7.2. India
11.5.7.3. Japan
11.5.7.4. Australia
11.5.7.5. Rest of Asia-Pacific
11.6. Middle East and Africa
11.6.1. Introduction
11.6.2. Key Region-Specific Dynamics
11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
12. Competitive Landscape
12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis
13. Company Profiles
13.1. Sanofi*
13.1.1. Company Overview
13.1.2. Product Portfolio and Description
13.1.3. Financial Overview
13.1.4. Key Developments
13.2. NovelMed Inc.
13.3. Novartis AG
13.4. Swedish Orphan Biovitrum AB
13.5. Apellis Pharmaceuticals, Inc.
13.6. Alpine Immune Sciences
13.7. Genentech USA, Inc.
13.8. Alexion Pharmaceuticals, Inc.
13.9. Teva Pharmaceuticals USA, Inc.
13.10. Viatris Inc.
LIST NOT EXHAUSTIVE
14. Appendix
14.1. About Us and Services
14.2. Contact Us

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