Previously, Sanofi and Regeneron announced that the FDA has approved a new indication for Dupilumab for the treatment of chronic spontaneous urticaria (CSU) in children and adults aged 12 years and older that is not well controlled with H1 antihistamines. It is worth mentioning that Dupilumab is the first targeted treatment for CSU in the United States in more than a decade.

This progress not only consolidates the core position of Dupilumab in the field of autoimmune therapy, but also brings the competition for the "king of autoimmunity" into a white-hot stage. This battle between dragons and tigers for the "autoimmune overlord" has just begun.

1. Self-immunity pioneer

The autoimmune field has always been a battleground for pharmaceutical companies, and AbbVie was once the undisputed king of this field.

According to Frost & Sullivan data, from the perspective of the global autoimmune market, autoimmune diseases are the second largest drug market after tumors. In 2024, the total size of the global autoimmune disease drug market is expected to be US$136.8 billion, with biological drugs accounting for 75% of it. Considering the huge patient base and long-term high-frequency medication methods, it is estimated that by 2030, the global market size will reach US$163.8 billion, with a CAGR of 3% from 2024 to 2030. The proportion of biological drugs is expected to continue to increase to 81%.
Between 2012 and 2022, AbbVie's autoimmune drug market share ranked among the top. Looking back at its development history, Humira, the king of medicine that has accompanied AbbVie all the way, is its well-deserved loyal minister.

The sales of the autoimmune drug Humira soared after its launch. It not only won the title of the king of autoimmune drugs and even the world's king of drugs, but also almost single-handedly supported AbbVie to become one of the top 10 pharmaceutical companies in the world. The company's sales accounted for a peak of 65% (in 2017), bringing AbbVie a total revenue of more than US$200 billion.
But no big drug can escape the fate of facing the patent cliff. As early as 2016, the patents of Humira expired. But in order to "extend the life" of Humira, AbbVie submitted about 250 patent applications for multiple indications, pushing the launch of Humira generic drugs to 2023. But with the advent of generic drugs, Humira's sales fell sharply, and the era of the king of medicine will eventually come to an end.

In addition to internal troubles, there are external threats. As the sales of Humira fell sharply, Sanofi's Dupilumab surpassed Humira in sales in 2024 and won the title of the king of autoimmune drugs.
Although AbbVie's sales in the autoimmune field are still greater than Sanofi's at this time, people can't help but wonder whether AbbVie can really withstand the impact of the up-and-coming immune companies?

2. Rising Star

Sanofi, which has the best-selling product of the year (duplimab), deserves greater expectations.
From the perspective of the competitive landscape of the TOP10 MNC autoimmune market, although AbbVie has firmly maintained its TOP1 position in the autoimmune market, as other MNC companies' blockbuster autoimmune products have been launched one after another, AbbVie's share of the total sales of the TOP10 autoimmune products has shown a downward trend, and its sales share CAGR from 2021 to 2024 is -4%.

Among the TOP10 MNCs, Sanofi's sales share CAGR from 2021 to 2024 is 27%, and the sales share of its autoimmune products shows a rapid growth trend, mainly due to the rapid growth in sales of its flagship product Dupilumab (sales CAGR of 36% from 2021 to 2024); Sanofi's autoimmune drug revenue will rise from sixth in 2021 to third in 2024 among global multinational pharmaceutical companies, approaching Johnson & Johnson and AbbVie.

It is worth noting that Sanofi's sales in 2024 will be only $3.6 billion less than the second-ranked Johnson & Johnson.

Dupilumab is now in a period of strong strength and has great development potential. In addition to being in the patent protection period in major global markets, it is also actively expanding more indications, such as chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria (CSU), bullous pemphigoid (BP) and other fields.

Recently, Sanofi and Regeneron announced that the FDA has approved a new indication for dupilumab for the treatment of chronic spontaneous urticaria (CSU) in children and adults aged 12 years and older who are not well controlled with H1 antihistamines. Dupilumab is the first targeted treatment for CSU in the United States in more than a decade.

In addition to Dupilumab, Sanofi has also built a rich autoimmune pipeline matrix. For example, Tolebrutinib for the treatment of multiple sclerosis is currently applying for registration and marketing. Rilzabrutinib has been granted orphan drug designation in the U.S. for the treatment of immune thrombocytopenia and is also applying for registration and marketing approval. Frexalimab is already in Phase III clinical trials for multiple sclerosis. Amlitelimab has a unique mechanism of action and significant long-term advantage (administered once every 12 weeks). It is currently undergoing Phase II/III trials for the treatment of atopic dermatitis and is expected to be approved for marketing as early as 2026.

It can be seen that in the next few years, Sanofi's autoimmune products will gradually achieve results and enter a stage of intensive harvest. This development trend has added many advantages to Sanofi, greatly increasing its bargaining chips in its journey to catch up with AbbVie and compete for the position of "self-immunity king".

3. Back to the top

In the face of the attacks from up-and-coming companies, AbbVie has already made preparations. Although Humira has fallen, its successors Skyrizi and Rinvoq have entered a period of strong growth.

Skyrizi is an IL-23 inhibitor developed by AbbVie. It was initially approved for the treatment of psoriatic arthritis and plaque psoriasis and was first approved by the US FDA in April 2019. Since then, Skyrizi's indications have gradually expanded to include ulcerative colitis and Crohn's disease.

Rinvoq Upadacitinib was approved by the FDA for marketing in the United States on August 16, 2019. Rinvoq is a selective JAK inhibitor, mainly used to treat patients with moderate to severe rheumatoid arthritis who have insufficient response or intolerance to methotrexate.

With the valuable experience accumulated from Humira, AbbVie has built a mature strategic system in the field of autoimmune diseases. AbbVie is well aware of the key significance of expanding indications for drug development. Based on the deep foundation accumulated from years of deep cultivation in the field of autoimmune diseases, it has quickly developed an indication expansion plan for the two drugs Skyrizi and Rinvoq. Take upadacitinib as an example. In just five years since its launch, the number of indications has expanded to 12, covering a variety of autoimmune diseases.

Behind the soaring sales of these two products is AbbVie's successful experience in marketing Humira. According to public reports, in order to help Rinvoq and Skyrizi's sales increase rapidly, AbbVie gradually transferred the marketing expenses that it had invested in Humira in the past to these two products. In 2022, the two companies spent as much as $650 million on advertising on US TV alone. At the same time, AbbVie also proposed to sell Humira in a bundle with Skyrizi and Rinvoq, such as providing PBMs with price discounts on Humira in exchange for Skyrizi and Rinvoq's favorable position in the prescription set.

In addition to business expansion, AbbVie even chooses to compete directly with its rivals for the market.

For example: Upadacitinib was successful in a head-to-head clinical trial with the 2024 self-immune best-selling drug, Sanofi's dupilumab.

The head-to-head trial of the two is a 24-week, head-to-head, multicenter, randomized, double-blind, double-dummy, active-controlled Phase IIIb clinical trial jointly conducted in 129 medical centers in 22 countries or regions, and included a total of 692 adult patients with moderate to severe AD who were to receive systemic treatment; patients were randomly divided into the upadacitinib treatment group (oral, 30 mg/d) or the dupilumab treatment group (injection of 300 mg every other week) at a 1:1 ratio. The results are obvious, upadacitinib won.

The rapid expansion of indications and commercialization has brought about explosive sales growth. Skyrizi's revenue surged 51% to $11.7 billion, while Rinvoq grew 53% to $6 billion. The combined sales of the two will account for 30% of AbbVie's overall revenue in 2024.

If we look at the year-on-year growth, AbbVie's autoimmune product Risenqizhumab is very likely to surpass Dupilumab in 2025 and regain the title of the king of single-product drugs, returning to the position of the king of single-product autoimmune drugs and continuing to dominate the autoimmune field, defending the title of the double king of autoimmune drugs.

It is undeniable that with the development of the market, the era of "one drug in hand, the world is mine" has gradually passed. Therefore, in addition to the two major drugs mentioned above, AbbVie is continuing to build more autoimmune pipelines.

Data shows that AbbVie's innovative drug layout in the field of autoimmune disease includes 26 products on the market, including 2 innovative drugs in Phase III, 10 innovative drugs in Phase II, and 6 innovative drugs in Phase I.

From the transaction point of view, the introduction of Mingji Biopharma's TL1A-targeted monoclonal antibody for US$1.71 billion will enhance AbbVie's research and development capabilities in the treatment of autoimmune diseases such as inflammatory bowel disease. This introduction brings new therapeutic targets and potential drugs to AbbVie, and is expected to develop more effective drugs for the treatment of autoimmune diseases. In addition, the acquisition of Nimble will obtain its core asset, oral peptide IL-23 inhibitors, and further improve the autoimmune disease product line. This acquisition enables AbbVie to occupy a more advantageous competitive position in the field of IL-23 inhibitors and provides the possibility for the development of new autoimmune disease drugs.

4. Conclusion

The competition among kings is always cruel. Although AbbVie has almost covered all the major indications in the autoimmune field, and is well-deserved to be the king of autoimmune diseases, as multinational pharmaceutical giants have entered the market, competition in the autoimmune field will continue to intensify.

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