The immunology therapeutic landscape is undergoing a dramatic transformation, marked by shifting drug preferences, breakthrough research, and increasing biosimilar adoption. This evolution is reshaping one of pharma's most profitable sectors, where several of the world's top-selling medications compete for market share.
Shifting Dynamics in Drug Classes
The market has witnessed a notable transition toward interleukin inhibitors, while TNF inhibitors face declining sales. This shift is primarily attributed to biosimilar competition and the superior safety profiles of newer interleukin-targeting therapies. AbbVie's Humira (adalimumab), despite generating approximately $19 billion in global sales in 2019, is experiencing pressure from biosimilar alternatives, particularly in Europe.
Janssen's Stelara is emerging as a dominant force in the interleukin inhibitor category, projected to rank among the world's top ten best-selling drugs by 2025. JAK inhibitors have also gained prominence, starting with Pfizer's Xeljanz in 2012, followed by Eli Lilly's Olumiant and AbbVie's Rinvoq, though safety concerns have prompted regulatory scrutiny.
Research Breakthroughs in Underserved Areas
The past decade has marked significant progress in addressing previously untreated conditions. Notable achievements include the 2017 approval of Sanofi's Dupixient for atopic dermatitis and the 2011 authorization of Benlysta for systemic lupus erythematosus. The FDA has accelerated development in areas of high unmet need, with multiple breakthrough and fast-track designations, particularly in graft versus host disease (GvHD), atopic dermatitis, and systemic lupus erythematosus.
Biosimilar Market Impact
Biosimilars have emerged as a significant market force, particularly affecting established biologics like Janssen's Remicade and AbbVie's Humira. The European market has seen substantial biosimilar adoption, with the UK's NHS projecting £300 million in savings through Humira biosimilars alone. However, market access remains challenging, especially in the United States, where patent litigation and market entry barriers persist.
Market Access and Future Implications
While biosimilars were introduced to reduce healthcare costs, their impact varies by region. Europe has successfully integrated these alternatives, but the United States faces ongoing challenges in achieving similar cost reductions. Major pharmaceutical companies are adapting by investing in biosimilar pipelines, often through strategic partnerships, to maintain their market position in this evolving landscape.
Patrick Aiyes, senior immunology analyst at GlobalData, notes: "Biosimilars present a significant risk to big pharma. However, many companies have invested in their own biosimilar pipelines to offset risk, typically through partnerships. While this strategy is working in Europe, there is still more to be done to keep healthcare costs low in the US."
