Immunological Rare Disease Market Size, Share, Growth, Trends, and Global Industry Analysis: By Drug Class (Monoclonal Antibody (mAb), Fusion Proteins, Immunosuppressants, and Others), By Disease Indication (Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Disease, Prophylaxis of Organ Rejection, and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) and Region Forecast 2020-2031

Immunological Rare Disease Market size was valued at US$ 3.1 billion in 2024 and is expected to reach US$ 9.6 billion by 2031, growing at a significant CAGR of 17.36% from 2025-2031. The immune system is delegated to defend the body from attacks from outside or inside. Many diseases can affect the immune system reducing its ability to defend itself or inducing an abnormal response against external or internal antigens. Immunological Rare diseases, often known as orphan diseases, afflict a small percentage of the population at any given time. Orphan medications are those that are suggested for the treatment of rare disorders. An orphan immunological disease affects less than 200,000 persons in the United States, according to the Food and Drug Administration (FDA).

Furthermore, Several diseases can affect the immune system. Disorders associated with a reduced response against no self-antigens are called immunodeficiencies. On the other hand, primary immunodeficiencies (PIDs) are in most cases rare diseases associated with specific, genetic mutations. Immunology medications or substances modify immune responses by enhancing or inhibiting the immune system. They are used to fight infections as well as to prevent or cure autoimmune or immunological illnesses such as rheumatoid arthritis, psoriatic arthritis, type 1 diabetes, and others.    Rising awareness about rare immunological diseases such as Hypoalbuminemia and Hypovolemia, and Severe Congenital Protein C Deficiency in both developing and developed nations and the rising occurrence of immunological disorders due to environmental factors are critical reasons for increasing the demand for rear immunological drugs in the market. 

Key Developments

• In May 2022, Pfizer Inc. strengthened its product portfolio by acquiring Arena Pharmaceuticals, a business that discovers revolutionary potential treatments for the treatment of many immuno-inflammatory diseases.