The price of Nemolizumab (Nemluvio)

Research and development (R&D) costs form a foundational expense: developing a biologic drug involves years of preclinical testing, costly clinical trials (Phases I–III), and high failure rates, requiring companies to recoup investments through pricing.

Manufacturing complexity also drives costs. As a biologic, Nemolizumab requires specialized production processes, such as mammalian cell culture and strict quality control, which demand advanced facilities, skilled labor, and rigorous regulatory compliance. These steps ensure purity and efficacy but add significant overhead.

Market dynamics play a role. In regions with limited competition for atopic dermatitis treatments, pricing power may lean toward manufacturers. However, in markets with robust healthcare negotiations (e.g., Europe), governments or insurers may pressure companies to lower prices for broader patient access.

Intellectual property and regulatory hurdles further influence costs. Patents grant exclusivity, allowing higher prices during the protection period, while post-approval surveillance and compliance with agencies like the FDA or EMA incur ongoing expenses.

Finally, healthcare system structures vary globally: in the U.S., private insurance negotiations and formularies affect pricing, whereas countries with public healthcare systems prioritize cost-effectiveness, potentially limiting markups. Balancing innovation with affordability remains a critical challenge in determining Nemolizumab's market price.