Sanofi, AbbVie, Johnson & Johnson (J&J), and other global pharmaceutical companies are opening their wallets to develop new treatments for autoimmune diseases. Autoimmune diseases occur when immune cells that should protect the body from bacteria and viruses attack the body itself. Depending on the affected area, it manifests in over 100 diseases, including rheumatoid arthritis, type 1 diabetes, lupus, and Crohn's disease, and there is currently no groundbreaking treatment available.
Pharmaceutical companies are now securing pipelines (a group of drug candidates) in a blue ocean where competition is still minimal. According to the U.S. market research firm MarketsandMarkets, the global immune therapy market was valued at $255.9 billion (approximately 375 trillion won) in 2023 and is expected to grow at an average annual rate of 15.3% to reach $580.6 billion (approximately 851 trillion won) by 2029.
◇ Companies with new drug candidates continue to acquire others
French pharmaceutical company Sanofi announced on the 20th (local time) that it has signed a contract to acquire the ‘DR-0201 (development code)’ from U.S. biotech company Dren Bio. The total contract size, including an advance payment of $600 million (approximately 879.7 billion won), is $1.3 billion (approximately 1.906 trillion won).
According to Sanofi and Dren Bio, DR-0201 is a new drug candidate expected to be effective in treating a group of B-cell-mediated autoimmune diseases, including lupus, which causes rashes all over the body. B-cells are immune cells that produce antibodies against antigens that invade from the outside. However, excessive activity of B-cells can lead to autoimmune diseases like lupus.
DR-0201 has shown a strong effect in eliminating B-cells in preclinical and early clinical studies. Dren Bio is currently conducting a phase 1 clinical trial involving patients with autoimmune diseases. Sanofi evaluated DR-0201 as a potential 'first-in-class' treatment that presents new possibilities for the treatment of autoimmune diseases.
U.S. pharmaceutical companies AbbVie and Johnson & Johnson (J&J) have led the market for autoimmune disease treatments. AbbVie's Humira was the top-selling drug for a decade following its launch in 2003, with cumulative sales exceeding 300 trillion won. J&J's Stelara also exceeded 15 trillion won in sales last year.
However, as the patent for the original drug expired, the monopoly in the market faced threats, prompting them to acquire new treatment pipelines one after another. The major U.S. patent for Humira expired in 2016, and biosimilars began to emerge in 2020. The substance patent for Stelara also expired in the U.S. and Europe in 2023 and 2024, respectively.
AbbVie acquired U.S. company Nimble Therapeutics for $200 million (approximately 293.5 billion won) last December. Nimble is a company that spun off from Swiss pharmaceutical company Roche in 2019 and has a pipeline of various autoimmune disease treatments, including an oral interleukin (IL)-23R inhibitor being developed for psoriasis and inflammatory bowel disease.
After the expiration of Humira's major U.S. patent, AbbVie delayed the entry of biosimilars into the market until 2023, leveraging 130 patents. This bought them time, and a year later, they strengthened their new autoimmune disease treatment pipeline. Interleukins are immune signaling substances. Nimble's new drug candidate works by blocking them to inhibit excessive immune responses.
J&J also acquired U.S. biotech company Proteologix, which had similar technology, last year for $850 million (approximately 1.2472 trillion won). The acquisition was completed as Proteologix, which possesses PX128 (development code), a dual-specific antibody targeting interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP), was about to begin phase 1 clinical trials. Proteologix also has dual-specific antibodies targeting interleukin-22 (IL-22).
Swiss Roche, U.S. Merck (MSD), and Japan's Takeda have also strengthened their autoimmune disease treatment pipelines through acquisitions and equity investments. MSD attracted attention by acquiring U.S. biotech company Prometheus Bioscience for $10.8 billion (approximately 15 trillion won) in 2023, securing new treatment pipelines for inflammatory bowel disease.
◇ If successful, several trillion won in annual sales are possible
The reason global pharmaceutical companies are scrambling to invest in autoimmune disease treatment pipelines is that a successful drug development could yield annual sales in the tens of trillions of won. AbbVie's Humira recorded annual sales of $21.2 billion (approximately 31 trillion won) in 2022, before the expiration of its patent.
The market for autoimmune disease treatments is also significant. It is estimated that about 5% of the population in Europe and North America suffers from autoimmune diseases. Academic studies have also found that the number of autoimmune disease patients has increased after the COVID-19 pandemic.
The cause of autoimmune diseases is not fully understood, and there are currently no treatments that can cure them. Even blockbuster drugs have not fundamentally cured autoimmune diseases. Nevertheless, continued medication can manage the diseases by regulating immunity. For pharmaceutical companies, this means a steady revenue stream.
Professor Jeong Jae-hyun of Korea University Ansan Hospital noted, 'Lupus was a very lethal disease, with a five-year survival rate of less than 5% just 20 years ago,' and 'With advancements in medical technology and treatments over the years, it has now become a manageable disease with consistent treatment.'
Especially since the basic immune system is the same even if the affected areas differ in autoimmune diseases, developing a successful treatment can easily lead to expanded indications. Humira expanded its indications to 10 types, including rheumatoid arthritis, psoriasis arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis, after receiving approval initially for rheumatoid arthritis. Stelara has four indications: Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Among domestic companies, HANALL BIOPHARMA is developing ‘batoclimab’ as a treatment for various autoimmune diseases in partnership with U.S. partner Immunovant. The company announced this month that it confirmed the efficacy of batoclimab in phase 3 clinical trials for myasthenia gravis and phase 2b clinical trials for chronic inflammatory demyelinating polyneuropathy. It is also expected to announce phase 3 clinical trial results for thyroid eye disease in the second half of this year. Celltrion, LG CHEM, Dong-A ST, Daewoong Pharmaceutical, and others have developed biosimilars for autoimmune disease treatments such as Humira and Stelara and have entered the global market.