Market

Celiac Disease

• Celiac disease is an autoimmune disease that is triggered by consuming gluten and results in damage to the small intestine
• Symptoms include diarrhea, fatigue, headaches, anemia, nausea, dermatitis herpetiformis (itchy skin rash)
• Significant patient population does not respond to gluten free diets
• Health consequences for not treating include malnourishment, cancer and other autoimmune conditions
• Estimated prevalence is 1:133 (2.5 million people) with celiac disease in the US (Fasano, Arch Intern Med. 2003 PMID: 12578508)
• 0.3% to 0.5% of celiac disease patients are non-responsive (Malamut Gastroenterology. 2024 38556189)
• There are no approved treatment options for celiac disease

Vitiligo

• Vitiligo is an autoimmune disease of the skin mediated primarily by NK and CD8+ T cells that attack melanocytes leading to patchy depigmentation of the skin
• It is estimated that vitiligo affects 2 million people in the U.S (NIH)
• The global vitiligo treatment market size was estimated at $1.2 billion in 2018 and is projected to reach $1.9 billion by 2026 (Fortune Business Insights)

Type 1 Diabetes

• Type 1 diabetes (T1D) is classified by three stages of progression
• Stage 1: At least one diabetes-related autoantibody but has normal blood sugar and no symptoms
• Stage 2: At least two diabetes-related autoantibodies and abnormal blood sugar levels but otherwise symptom free
• Stage 3: Significant beta cell loss has occurred; abnormal blood sugar levels; hemoglobin A1C >6.4%; excessive thirst and urination; blurry vision; fatigue; requires insulin for disease management
• 64,000 people diagnosed with Type 1 diabetes annually (https://beyondtype1.org/type-1-diabetes-statistics/)
• 2 approved treatment options to delay the onset of Type 1 diabetes

Alopecia Areata (AA)

• AA is an autoimmune disease in which immune cells attack and damage hair follicles and is mediated primarily by CD8+ T cells and NK cells
• The global alopecia treatment market was valued at $2.7 billion in 2018, and is projected to reach $3.9 billion by 2026, registering a CAGR of 4.6% from 2019 to 2026 (Allied Mkt Research)