Cold Agglutinin Disease Market: Current Analysis and Forecast (2023-2030)

Cold agglutinin disease (CAD) is a rare autoimmune disorder that can cause the human body to produce antibodies that attack and destroy red blood cells, leading to anemia and other symptoms. It is associated with clonal B-cell lymphoproliferative cells (AIHA). It can be caused by a variety of factors, including genetics, infections, and certain medications. Some common symptoms of CAD include fatigue, weakness, pale skin, shortness of breath, and fever. Symptoms of CAD tend to be exacerbated during cold weather. The cold agglutinin disease market is growing at a tremendous rate owing to a surge in the number of disease cases, increased focus on early detection and prevention, advances in treatment options, and a rise in the geriatric population. For instance, according to the American Society of Hematology in December 2021, the estimated incidence rate of cold agglutinin disease is between 5 and 20 per million individuals and between 0.5 and 1.9 per million individuals per year.

The Cold Agglutinin Disease Market is expected to grow at a strong CAGR of 18% during the forecast period owing to the rising research and developments for finding a potential cure for cold agglutinin disease. For instance, Enjaymo was granted marketing authorization in the U.S. by the FDA in February 2022, with the purpose of reducing the requirement for red blood cell transfusions in adults with chronic obstructive diseases of the central nervous system. This is the first and only FDA-approved treatment for people with cold agglutinin disease. It works by blocking the destruction of red blood cells. Several other factors such as increased number of clinical trials, investment in research, and improved patient outcomes are also leading to the surge in the market. For instance, in February 2022, a Phase 1b clinical study was conducted by Sanofi to evaluate the safety, tolerability, and pharmacokinetics of Bioverativ (BIVV020) in patients with cold agglutin diseases.

Based on drugs, the market is segmented into corticosteroids, alkylating agents, purine nucleoside analogs, biologics, and others. The corticosteroids segment held the highest share in the market in the year 2022 owing to technological progress, and increased awareness of the condition. Other factors such as the rise in the geriatric population are also strengthening grounds for the corticosteroids segment in the cold agglutinin disease market as the older generation is more prone to getting affected by the disease. For instance, the World Health Organization (WHO) reported in October 2022 that between 2015 to 2050, the segment of the world's population over 60 years will nearly double from 12% to 22%, which will propel the cold agglutinin disease market at a steady rate. Hence, the corticosteroids segment held a significant share of the market in the year 2022.

Based on the route of administration, the market is bifurcated into oral, parenteral, and others. The oral segment is expected to grow with the highest CAGR during the forecast period owing to the ease of consumption, growing awareness of chronic conditions like cold agglutinin disease, the increased need for minimally invasive treatments, and the growing acceptance of such treatment procedures by healthcare professionals. For instance, according to Frontiers article, Advances in Oral Drug Delivery in February 2021, the most widely used method of drug administration is through the oral route, with approximately 60% of commercially available small molecule drug products being administered this way. Thus, the oral segment is expected to gain prominence in the market in the forecast period.

Based on end-users, the market is segmented into hospitals, specialty clinics, and others. The hospitals category held the highest share in the market in 2022 attributed to the ease of access to healthcare provided by hospitals, the availability of highly qualified healthcare personnel, the utilization of advanced medical technology, and a diverse number of units all over the globe. For instance, according to the American Hospital Association in 2023, there are in total of 6,129 hospitals in the U.S with 919,649 staffed beds and 34,011,386 hospital admissions in the year 2022. The market for the hospital segment is highly competitive and is projected to remain so in the foreseeable future. Thus, the hospital segment held dominance in the market in the year 2022.

For a better understanding of the market adoption of the cold agglutinin disease industry, the market is analyzed based on its worldwide presence in countries such as North America (U.S., Canada, and Rest of North America), Europe (Germany, U.K., France, Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. APAC is expected to grow with the highest CAGR during the forecast period. This is due to the presence of major players in the market, the increasing incidence of cold agglutinin disorder, and the presence of well-established academic and research institutes. For example, in September 2021, Aleph Pharmaceuticals, Inc., announced that it would launch Ultomiris in Japan for the treatment of cold agglutinin disorder. Countries such as India and China offer attractive investment opportunities for clinical research and are anticipated to positively drive research and development prospects for cold agglutinin disease. Hence, given the large population size of APAC, it is expected to grow with a high CAGR during the forecast period.

Some of the major players operating in the market include: Johnson & Johnson Services, Inc., Novartis AG; Bayer AG; Pfizer Inc.; Sanofi; AstraZeneca; Bristol-Myers Squibb Company; Mylan N.V.; Teva Pharmaceutical Industries Ltd.; GSK plc.