Enjaymo Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

This Enjaymo market report delivers an in-depth analysis of the market’s key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market.

Market growth during the historical period can be attributed to the rising popularity of Iptacopan, increasing demand for cold agglutinin disease treatments, higher lactate dehydrogenase (LDH) levels in the blood, a growing need for disease-specific therapies, and heightened awareness.

The anticipated growth during the forecast period can be attributed to expanding research and development efforts, the rising prevalence of cold agglutinin disease, growing awareness about the condition, a larger patient population, and increased R&D activities. Key trends during the forecast period include the development of innovative treatment options, advancements in diagnostic technologies, a rise in research and development activities, and the continued progress of advanced technologies.

The growing prevalence of autoimmune disorders is expected to drive the expansion of the enjaymo market in the coming years. Autoimmune disorders are a group of conditions in which the immune system, which usually protects the body against harmful invaders such as bacteria and viruses, mistakenly attacks healthy tissues and organs. The rise in autoimmune disorders is linked to improved diagnostic capabilities, environmental changes, dietary habits, sedentary lifestyles, chronic stress, and the hygiene hypothesis, all of which impact immune system regulation. Enjaymo, a monoclonal antibody therapy, targets and inhibits the complement system, specifically the C1s protein, thereby preventing the immune response that leads to red blood cell destruction. This provides significant relief from hemolytic anemia associated with cold agglutinin disease and other autoimmune hemolytic conditions. For example, in June 2024, the Australian Institute of Health and Welfare reported that in 2021-22, there were 10,000 hospitalizations for rheumatoid arthritis, a 25% increase from the previous year's 8,000, translating to a rate of 39 hospitalizations per 100,000 population. Thus, the increasing prevalence of autoimmune disorders is fueling the growth of the enjaymo market.

The rising number of clinical trial approvals is anticipated to drive the growth of the enjaymo market moving forward. Clinical trial approvals refer to the process by which regulatory agencies review and grant permission to begin clinical trials. The increase in clinical trial approvals is driven by advancements in biotechnology, the rise of biologics, greater participation from smaller companies, and more streamlined regulatory processes aimed at addressing rare diseases and unmet medical needs. Clinical trials for treatments such as Enjaymo undergo rigorous regulatory review to ensure safety and efficacy, with expedited pathways for rare diseases followed by post-market monitoring. For instance, in November 2023, the Association of the British Pharmaceutical Industry reported that the number of industry-sponsored clinical trials initiated in the UK rose by 4.3%, from 394 trials in 2021 to 411 in 2022. Therefore, the growing number of clinical trial approvals is expected to contribute to the growth of the enjaymo market.

A key trend in the enjaymo market is the attainment of regulatory approvals for drugs, which enhances treatment accessibility and ensures adherence to global healthcare standards. Regulatory approvals are official authorizations granted by agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), permitting a drug to be marketed and sold. For example, in January 2023, Sanofi S.A. received FDA approval for Enjaymo (sutimlimab-jome), allowing its use in adults with cold agglutinin disease (CAD) regardless of transfusion history. Enjaymo works by targeting the classical complement pathway to prevent the immune system from attacking red blood cells. The updated formulation also provides a more convenient administration method, reducing infusion time to one hour every two weeks. This approval marks a significant advancement in treatment options for CAD patients, greatly improving their quality of life.

The key company operating in the enjaymo market is Recordati Industria Chimica e Farmaceutica S.p.A.

North America was the largest region in the enjaymo market in 2024. Europe is expected to be the fastest-growing region in the forecast period. The regions covered in enjaymo report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the enjaymo market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Enjaymo (sutimlimab) is a complement inhibitor approved for the treatment of cold agglutinin disease (CAD) in adults, a rare autoimmune hemolytic anemia where the immune system attacks red blood cells in cold temperatures. It functions by inhibiting the C1s protein in the classical complement pathway, preventing the destruction of red blood cells and reducing the need for blood transfusions.

The primary clinical indications for enjaymo include cold agglutinin disease (CAD), autoimmune hemolytic anemia (AIHA), complement-mediated hemolytic disorders, and emerging off-label uses. Cold agglutinin disease is a rare form of autoimmune hemolytic anemia, where the immune system produces cold-reactive autoantibodies known as cold agglutinins. Enjaymo is classified under various drug categories, including monoclonal antibodies, corticosteroids, immunosuppressants, and other biological therapies, and is distributed through hospital pharmacies, retail pharmacies, and online pharmacies.

The enjaymo market research report is one of a series of new reports that provides enjaymo market statistics, including enjaymo industry global market size, regional shares, competitors with an enjaymo market share, detailed enjaymo market segments, market trends and opportunities, and any further data you may need to thrive in the enjaymo industry. This enjaymo market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The enjaymo market consists of sales of products including injection, and drug. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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