Dermatologic conditions, including hair, skin and nail disorders, are estimated to impact one-third of the global population. Drug developers are taking note; the global commercial dermatology market is estimated to reach $33.7 billion by 2022, rising at a 7.73 percent CAGR from 2015 to 2022.1 Historically, dermatology treatment options could largely be classified as topical, phototherapy, or conventional drugs delivered systemically. More recently, research has led to exploration of another treatment option: biologics.
The emergence of biologic therapies for dermatologic conditions created a paradigm shift for patients, physicians and sponsors. Typically offered as a secondor third-line therapy, biologics offer treatment options for patients often with the most severe or debilitating presentations of dermatologic conditions. These options are increasing; a May 2016 report from GBI estimates 37 percent of the approximately 800 dermatology products in development are biologic agents.
This white paper will explore the evolution of biologics within the dermatology landscape, with an emphasis on clinical trial considerations and best practices for sponsors developing biologic agents.
Biologics, derived from living organisms, have been in use for decades (e.g., insulin or vaccines derived from eggs). Today’s biologics – those developed in the past 15 years – are protein-based drugs created from genetically modified cells. Biologic agents can target more specific areas of the immune system than the “small molecule” systemic drugs that tend to impact the body’s overall immunity.