No other drug category has reached the heady heights of GLP-1s in recent years, but immunology remains a strong contender as one of the fastest-growing areas in pharma’s overall market, according to an Evaluate report.
Immunology treatments are often poised to become blockbusters because they’re used over the long term. They also have the ability to treat a range of diseases caused by a misfiring immune system, which turns on the body’s own tissues and organs, said Betty Pio, a partner at Kearney — and their reach is expected to grow.
“What’s interesting about immunology is that it's multi-specialty,” Pio said, pointing out that the space is expanding from its traditional fields like rheumatology and dermatology into new areas like respiratory. “I think that there will be more because we're learning so much more about other conditions and the way that inflammation affects them.”
The field took a major leap forward more than two decades ago with the advent of tumor necrosis factor inhibitors like AbbVie’s mega blockbuster Humira. But while they were effective, they were often wielded like a big hammer with broad effects — similar to how chemotherapy is used for cancer, Pio said. Also like oncology, the field is now moving toward precision approaches.
“We're learning more about different biologic processes, different types of inflammation, and the different inflammatory cascades or cytokines that are associated with inflammation,” Pio said. “It’s way more specific now.”
Even though researchers are getting more precise, today’s drugs still have range.
“There is a whole portfolio of diseases that could be addressed with a single mechanism,” she said.
For example, AbbVie’s Skyrizi, a targeted injectable IL-23 antagonist, is expected to become the second-best selling drug in 2032, raking in more than $33 billion from multiple indications, including psoriasis, ulcerative colitis and Crohn’s disease, according to Evaluate.
One investigational target in particular, tumor necrosis factor-like ligand 1A (TL1A), has led to dealmaking by companies like Roche and Merck & Co. because of its potential to address both inflammation and fibrosis in inflammatory bowel disease.
Other popular drug targets include signaling proteins that can drive inflammation, like IL-17. Drug developers are also investigating drugs that could do double duty by targeting protein signals called BAFF and APRIL, which could throw a wrench into the system that allows immune cells primed to attack the body’s own tissues to survive. CAR-T cell therapies, which are being tested as a way to rid the body of the rogue immune cells driving these conditions, have also driven numerous acquisitions, including Eli Lilly’s acquisition of Orna Therapeutics earlier this year. But they still need to overcome delivery and safety challenges, Pio said.
When big companies are looking for new immunology assets, they’re typically focused on the drug’s mechanism, a multi-indication opportunity, and best-in-class or first-in-class potential, even if it’s in a small or rare indication, Pio said.
Immunology will likely remain an active investment area because of its commercial appeal and significant unmet need, she said, and several companies, including the three below, could be well positioned as acquisition targets.
Spyre Therapeutics
Spyre Therapeutics, which was spun out from Paragon Therapeutics, has generated buzz for its pipeline of long-acting phase 2 antibodies, including two targeting TL1A. Its other programs target IL-23, α4β7 and IL-17, alone or in combination.
The company recently notched a few clinical wins, including favorable results in phase 2 for its anti-TL1A drug SPY002 in ulcerative colitis, and another in phase 2 for its α4β7-targeting drug, SPY001. If SPY001 stays on track in later-stage trials, it could challenge Takeda Pharmaceutical’s blockbuster drug, Entyvio, which also targets α4β7. The company is also expecting to release readouts for six “proof-of-concept” phase 2 trials in 2026.
“Beyond IBD, we are approaching a pivotal milestone with placebo-controlled phase 2 proof-of-concept data for SPY072, an anti-TL1A monotherapy, in rheumatoid arthritis expected [in September], representing a key opportunity to demonstrate the broader utility of this mechanism,” Spyre CEO Cameron Turtle said in a press release. “If successful, we look forward to initiating pivotal development of SPY072 next year, while also exploring combination approaches outside IBD.”
Abivax
Rumors swirled earlier this year that Lilly was interested in acquiring Abivax, speculation that CEO Marc de Garidel dismissed as “noise,” according to Reuters. Talk came on the heels of successful phase 3 results from its drug obefazimod in ulcerative colitis, an indication that is part of an inflammatory bowel disease market that could reach $25 billion by 2030, Reuters reported.
The potential first-in-class oral therapy targets inflammation that marks autoimmune conditions by exploiting one of the body’s natural anti-inflammatory mechanisms, a regulator called microRNA-124. The drug was designed to boost levels of microRNA-124 when out-of-control inflammation arises in the body in order to bring it back under control.
Most recently, Abivax reported exploratory results from part 2 of its phase 3 maintenance study, which included patients who failed to respond during induction or relapsed during maintenance. Among induction nonresponders who continued on the 50-milligram dose, 37% achieved clinical remission and 48% saw endoscopic improvement at week 44, suggesting some patients may benefit from longer treatment exposure.
The company is testing obefazimod as a monotherapy in UC and Crohn’s disease and is evaluating potential combination strategies in preclinical studies. It expects to release additional trial data in 2027. In July, the company announced the completion of a $920 million public offering, which it said will fund its operations through 2029.
MoonLake Immunotherapeutics
MoonLake Immunotherapeutics has also seen interest from pharma’s bigger players, reportedly rejecting an offer from Merck last year, according to the Financial Times. But it’s also seen ups and downs related to its humanized nanobody drug, sonelokimab, which hits multiple inflammation-driving targets including IL-17A and IL-17F, while also binding to a protein found in plasma called human albumin, to enhance the drug’s effects.
MoonLake posted positive phase 3 results this month from sonelokimab in psoriatic arthritis, following mixed phase 3 results across two trials in its lead indication, the skin disease hidradenitis suppurativa. While the first trial succeeded, the second narrowly missed statistical significance at week 16.
In the psoriatic arthritis trial, the drug met all clinical endpoints for the 60-milligram dose and produced “meaningful and statistically significant improvements,” with no new safety signals, the company said. Some 42% of patients achieved an ACR50 response, a standard measure of clinical improvement in psoriatic arthritis.
The outcome reinforced the drug’s potential to become “a leading treatment option for patients living with psoriatic arthritis,” the company said.
But MoonLake was also criticized for failing to include data on how the drug performed compared with placebo in a STAT opinion piece that argued the company’s lack of transparency could cast doubt on the strength of the results.
MoonLake expects to submit a biologics license application in hidradenitis suppurativa by the end of September and receive a PDUFA date and decision on priority review by the end of November. It’s also continuing trials in psoriatic arthritis and other indications, including palmoplantar pustulosis, a condition that causes blistering on the hands and feet, and Axial Spondyloarthritis, which causes chronic inflammatory back pain
