Through continuous exploration and practice, the value of autoimmune subfields such as inflammatory bowel disease and IgA nephropathy is gradually gaining attention within the industry. At the same time, cutting-edge technologies like CAR-T and TCE are being innovatively introduced to the autoimmune field. Furthermore, the development of drugs targeting classic autoimmune targets has entered new phases, with PD-1, BTK, and other targets, originally prominent in oncology, showing great autoimmune potential.
Today, the autoimmune field is thriving with unprecedented vitality, further activating its market potential. This fertile ground not only gives birth to a new generation of blockbuster products but also shapes the great ambitions of major pharmaceutical giants in the autoimmune sector. Let’s now reveal the Top 10 autoimmune business revenue rankings for 2024 and analyze the product layouts and pipeline evolution strategies of these autoimmune giants, exploring the future development trends in the autoimmune field.
Although Pfizer’s autoimmune business still ranks in the Top 10, it seems to be showing a trend of shrinking year by year. The JAK inhibitor Xeljanz (Tofacitinib) is unable to escape the impact of patent expiration, with 2024 sales reaching $1.168 billion, a 31% year-on-year decline. Enbrel (Etanercept), co-developed with Amgen, saw Pfizer’s share of revenue drop 17% to $690 million in 2024.
The JAK1 inhibitor Cibinqo (Abrocitinib), an iteration of Tofacitinib, has higher target selectivity. Abrocitinib is also showing a strong growth momentum, with a 69% year-on-year increase in 2024 to $215 million, though it has yet to reach the sales scale of Upadacitinib, a competitor targeting the same pathway.
Fortunately, Pfizer still has some hidden assets. The IFNβ monoclonal antibody dazukibart has reached Phase III, while the IL-4/IL-13/TSLP tri-antibody PF-07275315 and the IL-4/IL-13/IL-33 tri-antibody PF-07264660 are in Phase II trials.
Eli Lilly’s Taltz (Ixekizumab), the second approved IL-17A monoclonal antibody, performed well, achieving $3.26 billion in sales with an 18% growth rate in 2024. Eli Lilly is heavily investing in oral IL-17 small molecule inhibitors, having acquired two IL-17 inhibitors, DC-806 and DC-853, from DICE Therapeutics for $2.4 billion in 2023. However, DC-806 failed in development.
The company’s Q4 2024 earnings report did not disclose the specific sales of the JAK inhibitor Olumiant (Baricitinib), but based on data from the first three quarters ($696 million), it is estimated that 2024 sales will be around $950 million, roughly in line with the previous year.
Omvoh (Mirikizumab), which entered the market in 2023, is an important strategic move for Eli Lilly in the inflammatory bowel disease (IBD) field. It is the first IL-23 antibody approved for ulcerative colitis and recently gained approval for Crohn’s disease.
In 2024, Eli Lilly made a significant move by acquiring Morphic Therapeutic for $3.2 billion, strengthening its IBD portfolio. This acquisition provided Eli Lilly with a Phase II oral small molecule α4β7 inhibitor, MORF-057, and expanded its preclinical pipeline with next-generation α4β7 inhibitors, αvβ8 inhibitors, α5β1 inhibitors, and TL1A/IL-23-targeting drugs.
BMS’s best-selling autoimmune product is the CTLA4-Fc fusion protein Orencia (Abatacept), which achieved $3.682 billion in sales in 2024 after nearly 20 years on the market. The oral selective S1PR modulator Zeposia (Ozanimod) was launched in 2020 and has been approved for multiple sclerosis and ulcerative colitis, with revenue growing to $566 million.
The first TYK2 allosteric inhibitor, Sotyktu (Deucravacitinib), has completed its second full year of sales, reaching $246 million, below market expectations. Currently, Deucravacitinib has only one approved indication for plaque psoriasis, but two Phase III studies for psoriatic arthritis have been successful, suggesting potential for further market expansion.
Notably, BMS has excluded the IL-13 monoclonal antibody cendakimab, which was in Phase III, from its pipeline following its Q4 2024 earnings update. This move reflects BMS’s decision to prioritize more competitive investment opportunities. Similarly, the development of the second-generation TYK2 inhibitor BMS-986322 has been slowed down.
BMS’s current focus in autoimmune investment is on controlling inflammation, resetting immune memory, and promoting balance. In line with these priorities, the LPAR1 antagonist admilparant and CD19 monoclonal antibody Obexelimab have both advanced to Phase III clinical trials.
Takeda’s successful strategy in the autoimmune field lies in finding differentiated breakthrough points. Unlike most autoimmune products that focus on diseases like atopic dermatitis and plaque psoriasis, Takeda’s α4β7 monoclonal antibody Entyvio (Vedolizumab) early on bet on inflammatory bowel disease (IBD). Now, 10 years after its launch, Entyvio is the best-selling biologic in the IBD field, with 2024 sales reaching ￥880.7 billion (approximately $5.841 billion).
However, with increasing competition in the IBD space, many emerging competitors are poised to enter, and biosimilar competition must be considered. In the face of dual pressures, it may be difficult for Entyvio to maintain long-term growth.
Next-generation autoimmune products are already in development. Takeda’s TYK2 inhibitor zasocitinib (TAK-279), acquired for $6 billion, has entered Phase III clinical trials. This drug has the potential to treat large autoimmune indications like IBD and plaque psoriasis. Takeda has set a peak sales potential of $3-6 billion for zasocitinib and believes it has significant market potential.
The CD38 monoclonal antibody mezagitamab, currently in Phase III for immune thrombocytopenia, is another area of exploration. The two currently marketed CD38 monoclonal antibodies, daratumumab and isatuximab, are approved for multiple myeloma indications, but Takeda hopes that mezagitamab can bring innovation and fundamentally address autoimmune diseases.
Amgen has a solid foundation in the autoimmune field, with products like the TNFR2-Fc fusion protein Enbrel (Etanercept), PDE4 inhibitor Otezla (Apremilast), TSLP monoclonal antibody Tezspire (Tezepelumab), and the adalimumab biosimilar Amgevita maintaining Amgen’s autoimmune performance around $7 billion.
However, signs of risk are emerging. Both Enbrel and Otezla have seen declining sales, with Enbrel’s 2024 revenue falling 10%, which may lead to a widening gap in autoimmune business revenue in the future.
The new incremental growth is driven by Tezspire, the only approved TSLP-targeting drug in the world. With just one indication for severe asthma, Tezspire generated nearly $1 billion ($972 million, +71%) in revenue in its third full year on the market.
In November 2024, Tezspire showed positive results in its Phase III WAYPOINT trial for chronic rhinosinusitis with nasal polyps. Amgen plans to submit a new indication application for Tezspire in the first half of this year. At the same time, Amgen will initiate a Phase III study of Tezspire for chronic obstructive pulmonary disease.
Amgen’s next-generation autoimmune product, the OX40 monoclonal antibody rocatinlimab, is under development for atopic dermatitis, with eight Phase III ROCKET studies in progress. Several key milestones are expected this year.
After two consecutive years of declining revenue, Roche's immunology business rebounded in 2024, moving up one position compared to 2023. This is primarily supported by two long-standing immunology products, IL-6R monoclonal antibody Actemra (tocilizumab) and IgE monoclonal antibody Xolair (omalizumab), which together brought in approximately $3 billion in revenue each.
Roche is also looking for new business growth, such as exploring the potential of other products in treating autoimmune diseases. According to the 2024 financial report, Roche submitted a new indication application to the FDA in December 2024 for Ocrevus (ocrelizumab) to treat lupus nephritis. Ocrevus was approved in the U.S. in 2013, and its previous three indications were all for hematologic cancers. This new submission could make Ocrevus the first FDA-approved CD20-targeted therapy for lupus nephritis. Additionally, Roche is advancing several Phase III clinical trials for Ocrevus in systemic lupus erythematosus, membranous nephropathy, and idiopathic nephrotic syndrome.
These research plans reflect Roche's future focus in immunology—autoimmune kidney diseases. The antisense therapy sefaxersen, born from Roche's collaboration with Ionis Pharmaceuticals, targets IgA nephropathy and fits into this strategic direction.
Novartis's immunology business is aiming for $10 billion in revenue, with a 21% growth in 2024, reaching $9.293 billion. This high growth is driven by IL-17A monoclonal antibody Cosentyx (secukinumab), which achieved $6.141 billion in sales in 2024, a 25% year-on-year increase. The growth of secukinumab is mainly attributed to its new indication for hidradenitis suppurativa and the launch of intravenous formulations. Secukinumab also remains highly competitive in key indications such as psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.
Secukinumab's expansion continues, with ongoing Phase III clinical trials for giant cell arteritis (GCA) and polymyalgia rheumatica (PMR), with results expected in 2025. There are hopes for a new indication application for GCA in the second half of 2025, which will bring further growth opportunities.
Two other immunology products, Xolair (omalizumab) and Ilaris (canakinumab), are also steadily growing, with revenues of $1.643 billion (+15%) and $1.509 billion (+14%) respectively.
In immunology, Novartis is advancing 15 Phase I/II clinical projects and 8 Phase III projects. Over the next five years, Novartis expects 6 Phase III and more than 10 Phase II results to be reported.
BTK inhibitor remibrutinib has won a differentiated victory in Phase III trials for chronic spontaneous urticaria (CSU) and is expected to be submitted for approval this year. BAFF-R monoclonal antibody ianalumab has Phase III results expected for Sj?gren's syndrome in the same timeframe, although the CD40 antibody iscalimab's Phase II program for Sj?gren's syndrome has been terminated by Novartis.
The blockbuster IL-4Rα monoclonal antibody Dupixent (dupilumab) has propelled Sanofi's immunology business to a top-three ranking. In 2024, Dupixent's sales reached €13.072 billion (approximately $14.179 billion, +23.1%), making it the best-selling immunology product. A key factor driving Dupixent's rapid uptake is its approval for chronic obstructive pulmonary disease (COPD) in the U.S. and Europe, marking it as the first biologic targeted therapy in this field.
After securing the COPD milestone, Sanofi submitted new indications for Dupixent for chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP) to the FDA. Currently, only Xolair (omalizumab) is approved for CSU, and there are no targeted therapies available for BP. If these new indications are approved, they will further boost Dupixent's sales.
While Dupixent continues to thrive, Sanofi faces the approaching patent cliff of 2028, which underscores the need for new pipeline products. The IL-6R monoclonal antibody Kevzara (sarilumab), which was launched alongside Dupixent, has seen good growth, but with smaller sales. In 2024, Kevzara generated €424 million (approximately $460 million, +21.0%).
Sanofi also has several potential products on the horizon. BTK inhibitor rilzabrutinib has been submitted for approval in the U.S., Europe, and China for immune thrombocytopenic purpura. Another BTK inhibitor, tolebrutinib, is undergoing multiple Phase III studies for multiple sclerosis, with its HERCULES trial for non-relapsing secondary progressive multiple sclerosis (nrSPMS) achieving its primary endpoint. IL-33 monoclonal antibody itekepkimab's Phase III trial for COPD is expected to report key results this year.
In 2024, Johnson & Johnson's immunology business showed a slight decline, primarily due to biosimilar competition against its major product, the 12p40 monoclonal antibody Stelara (ustekinumab), which experienced a 4.6% drop in sales, reaching $10.361 billion. Nearly 10 biosimilars of ustekinumab have already been approved globally.
The IL-23p19 monoclonal antibody Tremfya (guselkumab) continued double-digit growth, with sales in 2024 reaching $3.670 billion (+16.6%). Last year, Johnson & Johnson focused on expanding Tremfya's footprint, including approvals for a new indication for ulcerative colitis and filings for Crohn's disease and juvenile psoriatic arthritis.
Looking ahead, Johnson & Johnson still has significant opportunities to reverse the decline in its immunology business. The FcRn monoclonal antibody nipocalimab, acquired for $6.5 billion, has entered the submission phase for approval for the treatment of generalized myasthenia gravis. Previously, two other FcRn monoclonal antibodies, Argenx’s Efgartigimod and UCB's rozanolixizumab, were approved by the FDA. Efgartigimod generated $1.449 billion in sales in the first three quarters of 2024. With its deep expertise in immunology and strong sales capabilities, Johnson & Johnson believes nipocalimab has the potential to capture a larger market.
In addition, the oral IL-23R antagonist icotrokinra for plaque psoriasis had two successful Phase III trials in 2024. Based on this, Johnson & Johnson plans to submit a new drug application for icotrokinra, which will help transform psoriasis treatment from injectable monoclonal antibodies to oral drugs.
AbbVie's immunology business has grown steadily thanks to Humira (adalimumab), which has generated over $230 billion in revenue during its 22 years on the market. As the former "king of drugs," Humira still contributes, generating $8.993 billion in sales in 2024.
As market conditions change, Humira’s influence is gradually waning, while AbbVie's immunology stars, IL-23 monoclonal antibody Skyrizi (risankizumab) and JAK1 inhibitor Rinvoq (upadacitinib), are rapidly rising, with 2024 sales reaching $11.718 billion (+50.9%) and $5.971 billion (+50.4%) respectively. In June 2024, Skyrizi was approved by the FDA for the treatment of moderate-to-severe active ulcerative colitis in adults, bringing the total number of indications to seven, including plaque psoriasis, psoriatic arthritis, and Crohn's disease. Due to its extensive application in inflammatory bowel disease and dermatology, Nature predicts Skyrizi will enter the top 5 global best-sellers list in 2025, reaching around $13.7 billion.
Although AbbVie holds a strong lead in the immunology field, it is not slowing down. Instead, it is aggressively embracing external innovation to expand its immunology portfolio. According to the pharmaceutical database, AbbVie completed 7 immunology-related acquisitions and business development deals in 2024, including the purchase of Nimble for its oral peptide IL-23 inhibitors, the licensing of a TL1A-targeting monoclonal antibody from Mingji Biopharma, and the acquisition of Landos Biopharma for innovative projects targeting the NLRX1 and PLXDC2 pathways.
