Cold Agglutinin Disease market Size, Share,Trends Analysis, Top Manufacturers, Shares, Growth Opportunities, Statistics & Forecast

7 min readJun 23, 2022

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.

Cold Agglutinin Disease Market Dynamics


Increasing prevalence of cold agglutinin disease

The rising prevalence of cold agglutinin disease is estimated to enhance the market’s growth. Certain type of cancer, bacterial infections, parasitic infections, viral diseases and other autoimmune disorders are the risk factors result in the prevalence of secondary cold agglutinin disease.

Increasing investment for healthcare infrastructure

Another significant factor influencing the growth rate of cold agglutinin disease market is the rising healthcare expenditure which helps in improving its infrastructure. Also, various government organizations aims to improve the healthcare infrastructure by increasing funding and this will further influence the market dynamics.

Growing number of geriatric population

The surging geriatric population is estimated to enhance the market’s expansion during the forecast period of 2022–2029. According to the World Health Organization (WHO), the worldwide geriatric population, which was estimated to be over 524 million in 2010, is expected to increase to nearly 2 billion by 2050. Due to their compromised immune systems, geriatrics are more susceptible to get cold agglutinin disease, further estimated to enhance the market’s growth rate.

Furthermore, rising initiatives by public and private organizations to spread awareness will expand the cold agglutinin disease market. Additionally, rise in the level of disposable income and sedentary lifestyle of people will result in the expansion of cold agglutinin disease market.


Increase in the number of research and development activities

Moreover, the market’s growth is fueled by an increase in the number of research and development activities. This will provide beneficial opportunities for the cold agglutinin disease market growth. Along with this, rising drug approvals and launches will further propel the market’s growth rate.

Moreover, rising investment for the development of advanced technologies and increase in the number of emerging markets will further provide beneficial opportunities for the cold agglutinin disease market growth during the forecast period.

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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Cold Agglutinin Disease Market Regional Analysis/Insights

The cold agglutinin disease market is analysed and market size insights and trends are provided by country, drugs, dosage form, route of administration, end-users and distribution channel as referenced above.

The countries covered in the cold agglutinin disease market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America

North America dominates the cold agglutinin disease market because of the rise in adoption of newer technologies in this region. Additionally, rising healthcare expenditure and surging demand for disease specific treatment will further propel the market’s growth rate in this region.

Asia-Pacific are expected to grow during the forecast period due to increasing patient pool in this region. Also, the development of healthcare infrastructure and rising geriatric population will further propel themarket’s growth rate in this region.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter’s five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Competitive Landscape and Cold Agglutinin Disease Market Share Analysis

The cold agglutinin disease market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to cold agglutinin disease market.

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)

Sun Pharmaceutical Industries Ltd. (India)

Apellis Pharmaceuticals (US)

Incyte Corporation (US)

Fresenius Kabi AG (Germany)

Amgen Inc. (US)

Bristol-Myers Squibb Company (US)

AbbVie Inc. (US)

Eli Lilly and Company (US)

Merck KGaA (Germany)

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