Disease severity

Disease severity refers to the extent or intensity of a condition’s impact on a patient’s health, functioning, and quality of life.

What is disease severity?

Disease severity is a classification of how seriously a health condition affects an individual. It can be defined by clinical indicators such as biomarker levels, organ involvement, symptom burden, progression rate, or the degree of disability. Disease severity may be categorized as mild, moderate, or severe, and is often used to guide treatment decisions and trial inclusion criteria.

Why is disease severity important in pharmaceutical strategy?

Understanding disease severity informs clinical trial design, subgroup analyses, and market segmentation. It also helps identify high-need populations, support value differentiation, and tailor payer and provider messaging. Many Market Access and Regulatory decisions depend on clear evidence of benefit in patients with more severe or refractory disease.

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