How can drugmakers stand out in a crowded immunology market?

Launching the next autoimmune therapy blockbuster is becoming harder.

Immunology therapies are becoming harder to stand out as treatment outcomes level off, forcing drugmakers to rethink how they compete in one of pharma’s most crowded markets.

As existing medicines deliver similar clinical results, differentiation based on efficacy alone is fading. That has raised the bar for companies developing the next wave of immunology treatments, according to a November 2025 report by global consultancy Kearney.

Breakthrough approaches such as antibody-drug conjugates, combination regimens, and potentially curative therapies could still reshape patient care, Kearney said.

Much of the near-term pipeline focuses on small improvements, such as better dosing, longer-lasting effects, and simpler ways to deliver treatments.

The commercial outlook is also shifting. A separate November 2025 report by IQVIA Holdings, Inc. expects immunology’s five-year growth outlook to lag the wider pharmaceutical market for the first time. The slowdown reflects mounting pressure on auto immune therapies, which were once the sector’s main growth engine.

Biosimilar competition is intensifying, with several top-selling immunology drugs nearing patent expiry in the early to mid-2030s.

As lower-cost alternatives enter the market, pricing power is expected to weaken across major drug classes.

Competition is intensifying within each disease area. In ulcerative colitis alone, as many as 24 drugs using 10 different mechanisms could compete over the next three to five years, IQVIA said. Similar crowding is emerging across other immunology conditions.

This saturation complicates treatment decisions, makes it harder for companies to show clear advantages, and expands choices for payors.

It also forces developers to show that their drugs work in real-world settings, not just in trials.

Developers are exploring new biological targets and innovative approaches like cell therapies, bispecific antibodies, T-cell engagers, and nanobodies, whilst also focusing on oral drugs, combination treatments, and more specific patient groups.

Still, access remains a challenge. Patient access is limited by step therapy, strict formularies, and inconsistent prescribing, Kearney said.

This creates a tougher commercial environment as returns on research and development come under pressure from smaller patient pools and eroding value, the consultancy said.

“The chances of launching the next immunology blockbuster become lower, whilst commercial efforts increase,” it added.

Kearney said success is no longer defined by product launch alone. Companies must sustain value over time, adjust portfolios as evidence evolves, and use clinical and real-world data to refine positioning.

Key priorities are tracking policy and competitors, running disciplined launches, engaging regulators, payors, doctors, and patients, and coordinating pricing, access, manufacturing, and supply chains.

Kearney said future winners would pair strong science with smart strategy and effective execution across the patient journey.

Questions to ponder: