4 min readJan 11, 2023


Cold Agglutinin Disease market Application,Trends, Demand, Growth, Challenges and Competitive Outlook

Data Bridge Market Research analyses that the cold agglutinin disease market was valued at USD 72 million in 2021 and is expected to reach USD 293.46 million by 2029, registering a CAGR of 19.20% during the forecast period of 2022 to 2029. The market report curated by the Data Bridge Market Research team includes in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

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In recent years, the cold agglutinin disease market is anticipated to grow rapidly during the forecast period. Cold agglutinin disease (CAD) is an uncommon subset of autoimmune haemolytic anaemia that affects clonal B-cell lymphoproliferative cells (AIHA). CAD occurs for 15–25 percent of AIHA and primarily affects middle-aged and elderly people. When bone marrow-derived clonal B lymphocytes are exposed to freezing temperatures (0–4°C), they produce autoantibodies that attach to erythrocytes, producing agglutination and eventually immune-mediated haemolysis.

Cold agglutinin disease is a rare type of acquired autoimmune haemolytic anaemia in which the body’s immune system attacks and destroys its own red blood cells due to exposure to cold temperatures. Cold temperatures or viral infections can trigger or worsen symptoms of cold agglutinin disease (CAD), and most people with the disease experience haemolytic anaemia symptoms such as fatigue, cold hands and feet, dizziness, headaches, pale skin, dark urine, jaundice, chest pain, back pain, leg pain, diarrhoea, heart problems and vomiting.

Patient Epidemiology Analysis

People between the ages of 40 and 80 are most likely to get cold agglutinin disease (CAD). The median age for symptom start is roughly 65 years old, which means that half of those affected develop symptoms before this age and the other half after. The disease affects roughly 16 individuals per million (prevalence), and one person per million develops the disease each year (incidence). In comparison to men, women are nearly twice as likely to develop the condition.

Cold agglutinin disease market also provides you with detailed market analysis for patient analysis, prognosis and cures. Prevalence, incidence, mortality, adherence rates are some of the data variables that are available in the report. Direct or indirect impact analyses of epidemiology to market growth are analysed to create a more robust and cohort multivariate statistical model for forecasting the market in the growth period.

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COVID-19 Impact on Cold Agglutinin Disease Market

Over the projected period, the cold agglutinin disease market was expected to be constrained by the COVID-19 outbreak. Since its emergence in December 2019, the COVID-19 virus has spread to nearly every country on the planet, prompting the World Health Organization (WHO) to declare it a public health emergency. COVID-19, a new coronavirus, was identified as the causal agent in the pneumonia cases. This virus spread quickly over the world, killing a large number of people. COVID-19 was labelled a global pandemic by the World Health Organization (WHO) in March 2020, and rigorous measures to prevent the disease’s spread were recommended. Since then, the pandemic has delayed the expansion of the healthcare sector and disrupted the supply chain. Furthermore, governments in many nations had imposed nationwide lockdowns to halt the spread of COVID-19. Similarly, healthcare organizations in numerous nations throughout the world were having difficulty continuing their supply chain activities. The supply chain slowness hampered the cold agglutinin disease market.

Recent Development

In February 2022, the U.S. Food and Drug Administration (FDA) had approved Enjaymo (sutimlimab-jome) with the objective of reducing the need for red blood cell transfusion due to haemolysis in adults with cold agglutinin disease (CAD). It is the first as well as only approved treatment for people suffering from CAD. This medication functions by inhibiting the destruction of red blood cells (haemolysis).

Global Cold Agglutinin Disease Market Scope

The cold agglutinin disease market is segmented on the basis of drugs, dosage form, route of administration, end-users and distribution channel. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.



Alkylating Agents

Purine Nucleoside Analogs



Dosage form




Route of Administration






Specialty Clinics



Distribution Channel

Hospital Pharmacy

Retail Pharmacy

Online Pharmacy


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Some of the major players operating in the cold agglutinin disease market are:

F. Hoffmann-La Roche Ltd. (Switzerland)

Mylan N.V. (US)

Teva Pharmaceutical Industries Ltd.(Israel)

Sanofi (France)

Pfizer Inc. (US)

GlaxoSmithKline plc (UK)

Novartis AG (Switzerland)

Zydus Cadila (India)

AstraZeneca (UK)

Johnson & Johnson (US)

Bayer AG (Germany)

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