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The immunology drug market is a dynamic landscape driven by innovation, expanded indications, and competitive strategies. From biologics to biosimilars, the best-performing drugs in this field not only provide life-changing therapies for patients but also generate billions of dollars in revenue for pharmaceutical companies.
Here, based on 2023 sales data, we introduce the top 10 best-selling immunology drugs to understand how these drugs are shaping the immunology market, achieving clinical breakthroughs, and addressing competitive challenges.
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2023 Sales: $14.404 billion
Company: AbbVie
FDA Approval Date: December 31, 2002
Indications: Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Mechanism of action of Humira
Why it’s a top seller: Humira’s dominance ended with a sharp 32% drop in 2023 sales compared to $21.2 billion in 2022. Biosimilar competition hit hardest in Q4 2023, with global sales plummeting nearly 41% to $3.3 billion. AbbVie is pivoting to newer immunology drugs Rinvoq and Skyrizi, expected to generate $16 billion in revenue in 2024 and surpass $27 billion by 2027.
2023 Sales: $11.588 billion
Company: Regeneron and Sanofi
FDA Approval Date: March 28, 2017
Indications: Eczema, eosinophilic or oral steroid-dependent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis (PN).
Mechanism of action of Dupixent
Why it’s a top seller: Dupixent achieved robust growth in 2023, with global net sales increasing by 33% year-over-year to reach $11.588 billion. Compared to the same period in 2022, Q4 sales alone surged by 31% to $3.22 billion. Since its FDA approval in 2017, Dupixent, developed by Regeneron and Sanofi, has been hailed as an innovative therapy for atopic dermatitis patients. Over the years, Regeneron has consistently expanded Dupixent's indications, driving steady annual sales growth from $2.3 billion in 2019 to $4 billion in 2020, $6.2 billion in 2021, and $9.8 billion in 2022. Looking ahead, Dupixent's sales are expected to continue rising.
Additionally, Regeneron and Sanofi are actively seeking FDA approval for Dupixent to treat chronic obstructive pulmonary disease (COPD), which would make it the first biologic therapy approved for this condition. This indication approval could potentially increase Regeneron's peak U.S. sales by $2.5 billion and boost Sanofi's peak international sales by $1 billion.
2023 Sales: $10.858 billion
Company: Johnson & Johnson
FDA Approval Date: September 25, 2009
Indications: Plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Mechanism of action of Stelara
Why it’s a top seller: Stelara performed strongly in 2023, contributing approximately 12.8% of Johnson & Johnson's total annual revenue. According to Johnson & Johnson's 2023 annual report, Stelara remains its best-selling product. However, with Stelara's patent expiration, Johnson & Johnson is preparing for competition from biosimilars. Under agreements reached with biosimilar manufacturers, the first biosimilars are set to enter the market by January 1, 2025. Despite the anticipated competition, Johnson & Johnson is confident that the decline in its immunology market share will be offset by 25 potential blockbuster products. Meanwhile, biosimilars have already entered the European market, affecting Stelara's sales in the second half of 2024.
2023 Sales: $7.763 billion
Company: AbbVie
FDA Approval Date: April 23, 2019
Indications: Plaque psoriasis, active psoriatic arthritis, and Crohn's disease.
Mechanism of action of Skyrizi
Why it’s a top seller: Skyrizi is an interleukin-23 (IL-23) inhibitor that has demonstrated clinical efficacy in treating moderate to severe plaque psoriasis and active psoriatic arthritis. Its targeted mechanism of action and long-lasting efficacy have made it a preferred modern biologic in dermatology. In 2023, Skyrizi generated global revenue of $7.763 billion, marking a remarkable 50% year-over-year growth and establishing itself as a cornerstone of AbbVie's immunology portfolio.
2023 Sales: $5.28 billion
Company: Takeda
FDA Approval Date: May 20, 2014
Indications: Adult ulcerative colitis and Crohn's disease.
Mechanism of action of Entyvio
Why it’s a top seller: Entyvio was initially approved by the FDA for the treatment and maintenance of ulcerative colitis. Its subcutaneous administration method provides patients with significant flexibility. To date, Entyvio has been used globally for over 1 million patient-years, highlighting its broad application and clinical value.
2023 Sales: $4.98 billion
Company: Novartis
FDA Approval Date: January 21, 2015
Indications: Plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory conditions.
Mechanism of action of Cosentyx
Why it’s a top seller: Since its launch in 2015, Cosentyx has consistently demonstrated long-term efficacy and reliable safety across five systemic inflammatory conditions. With over 1 million patients treated worldwide, its expansion beyond psoriasis into other inflammatory diseases has significantly contributed to its steadily increasing sales.
2023 Sales: $4.527 billion
Company: Amgen
FDA Approval Date: November 2, 1998
Indications: Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
Mechanism of action of Enbrel
Why it’s a top seller: Despite growing biosimilar competition, Enbrel remains a staple in immunology treatments.In the United States, the FDA has already approved biosimilar versions of Enbrel, and an increasing number of companies have announced plans to develop additional biosimilar versions, indicating that competition for Enbrel is becoming increasingly intense.
2023 Sales: $3.987 billion
Company: Genentech and Novartis
FDA Approval Date: June 20, 2003
Indications: Persistent asthma, chronic rhinosinusitis with nasal polyps, food allergies, and urticaria.
Mechanism of action of Xolair
Why it’s a top seller: In 2024, Xolair was approved to reduce allergic reactions in food-allergic patients, significantly enhancing its market appeal.On February 16, 2024, the FDA approved omalizumab (Xolair) for reducing allergic reactions caused by accidental exposure to food in adults and children aged one year and older with food allergies. Clinical trials demonstrated that among patients treated with Xolair for 16 to 20 weeks, 68% could tolerate at least 600 mg of peanut protein without experiencing moderate to severe allergic symptoms, compared to only 5% in the placebo group. Additionally, compared to the placebo group, a significantly higher proportion of patients treated with Xolair could tolerate at least 1,000 mg of protein from milk (66% vs. 11%), eggs (67% vs. 0%), or cashews (42% vs. 3%) without moderate to severe allergic reactions.
2023 Sales: $3.969 billion
Company: AbbVie
FDA Approval Date: August 16, 2019
Indications: Rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, and other conditions.
Structure of Rinvoq
Why it’s a top seller: In 2023, the FDA approved Rinvoq as the first oral treatment for moderate to severe active Crohn's disease. Clinical trials demonstrated that patients receiving 45 mg of Rinvoq had a higher rate of achieving clinical remission compared to those receiving a placebo. Additionally, colonoscopy evaluations showed that patients treated with 45 mg of Rinvoq experienced greater improvement in intestinal inflammation compared to the placebo group. By 2027, Rinvoq's sales are projected to exceed $10 billion, driven by its indications in rheumatology, inflammatory bowel disease (IBD), and atopic dermatitis.
2023 Sales: $3.601 billion
Company: Bristol-Myers Squibb
FDA Approval Date: December 23, 2005
Indications: Rheumatoid arthritis, active psoriatic arthritis, and acute graft-versus-host disease (aGVHD).
Structure of Orencia
Why it’s a top seller: In 2023, Orencia's U.S. revenue grew by 4%, primarily due to increased demand. Driven by the rise in demand, international revenue increased by 3%, but this was partly offset by a 3% negative impact from foreign exchange fluctuations. Excluding the foreign exchange impact, global revenue grew by 6%. Bristol-Myers Squibb reported that there are no biosimilars for Orencia in the U.S., European Union (EU), or Japan, and the formulation and other related patents are expected to expire after 2026.
[1] https://xtalks.com/
[2] https://sites.arizona.edu/njardarson-lab/top200-posters/
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