After 10 years of consecutive dominance of Humira (Humira and adalimumab), the medicine king may usher in a transposition in 2023.
The industry speculates that Merck's Keytruda (commonly known as "K drug") is a certainty that it will become a new generation of drug king, but the recent revival of related controversies in the market, mainly because Novo Nordisk recently released its 2023 Q1 financial report, and its GLP-1 blockbuster product Semeglutide sales reached $4.2 billion in 2023Q1, refreshing the industry's awareness with a nearly doubling growth rate.
At the same time, according to the latest quarterly financial report, with the expiration of adalimumab's patent this year, its Q1 sales in 2023 will be $3.541 billion, down nearly 1/4 compared with the same period last year. K continued its rapid growth, increasing from US$4.809 billion in Q1 2022 to US$5.8 billion.
(in US$ billion)
According to the statistics of the reporter of the New Media Center of "Medical Economic News", the cumulative sales of Humira exceeded 10 billion US dollars in the 11th year after listing; The K drug and semeglutide were used for only 5 years. At the same time, K Medicine reached 20 billion sales in only 8 years, only half of Humira's time; On the other hand, compared to K drugs, semeglutide shows more amazing potential and a faster growth rate.
(Unit: US$ billion, gray data curve for semeglutide)
At the same time, due to the rapid increase in GLP-1 related products in the related field market, the two giants of the sugar reduction + weight reduction track, the market value of Eli Lilly Pure Medicine exceeded 400 billion US dollars, followed by Novo Nordisk with 380 billion US dollars. In addition, in a study published in the journal Obesity by Maynooth University in Ireland, GLP-1 products have further aroused the imagination of the industry because of their ability to restore the function of natural killer cells (NK cells) in the body, including the ability to kill cancer cells.
Just two days ago, on May 22, Novo Nordisk and Eli Lilly announced the latest progress of related products. Novo Nordisk publishes data from the weight loss phase IIIa OASIS 1 study of semeglutide 50 mg tablets, which showed a 17.4% weight loss in the 50 mg group and 1.8% weight loss in the placebo group! Meanwhile, Eli Lilly registered the first Phase III Weight Loss Clinical Trial (ATTAIN-1) on the clinicaltrials.gov website to evaluate the efficacy of Orforglipron (LY3502970) orally once daily.
The industry predicts that K drugs will increase sales by nearly $3 billion in 2023, with total sales of nearly $25 billion; Semeglutide's full-year sales are expected to exceed $20 billion. Market participants said that the performance of semeglutide continues to refresh the industry's cognition, and it is not surprising that any changes occur before the next generation of "medicine kings" is truly revealed.
The "legendary" Humira ended the curtain, and who did the new "medicine king" flower?
In January 2023, Humira's first biosimilar was launched in the United States, marking the end of Humira's 20-year market patent period. Approved for marketing on the last day of 2002, Humira is an anti-TNFα fully human IgG1κ monoclonal antibody for autoimmune diseases such as rheumatoid arthritis. At the beginning of the listing, Humira was not optimistic by everyone, and no one expected that it would burst into huge market potential after listing, and the road of medicine king was overwhelming.
As of today, Humira's cumulative global sales have exceeded 210 billion US dollars, and its sales in the 7th year after approval are 5 billion US dollars (2009), the sales in the 11th year are 10 billion US dollars (2013), and the sales in the 16th year are 20 billion US dollars (2018).
According to the 2022 financial report, Humira earned $21.237 billion that year, holding the throne of "medicine king" for ten consecutive years (excluding the new crown vaccine). However, "it is not easy to fight the rivers and mountains, and it is even more difficult to defend the rivers and mountains." "As Humira's new drug patent expires in 2023, not only are many generic drugs "looking around" and want to share the cake from the huge market, but there are also new competitors such as K drugs and semeglutide competing for the throne.
The success of Humira, in addition to the expansion of indications, more importantly, AbbVie has put a lot of effort into "patents". AbbVie filed approximately 250 patent applications for Humira in the United States, 90 percent of which were filed after the drug was approved in 2002, of which 130 have been patented. This enhanced patent protection extends Humira's legal monopoly in the United States for 6 years since the expiration of Humira's main patent in 2016.
However, how beautiful the company is when it monopolizes the market, how lonely it is in the face of the "patent cliff", and if there is no new generation of replacement products, the situation faced by the big manufacturers will be more embarrassing. Market analysis, it is expected that more than 10 Humira biosimilars will be launched in the United States from 2023, which has brought great competitive pressure to AbbVie.
According to AbbVie's Q1 2023 financial report, its first-quarter revenue was $12.225 billion, a year-on-year decrease of 9.70%. Among them, the core product Humira was affected by the expiration of patents, and the global net revenue was US$3.541 billion, down 25.2% year-on-year.
In the face of the patent crisis, it is clear that AbbVie has long planned for a long time. AbbVie bought Allergan for $63 billion to acquire its blockbuster product, Botox (botulinum toxin type A for injection), which generated sales of nearly $5 billion in 2021. AbbVie is also accelerating the expansion of two autoimmune drug indications, Skyrizi (Risankizumab) and Rinvoq/Rinvoq (upatinib). However, ABBV-154, a self-exempt ADC drug that was once seen as a potential successor to Humira, was terminated due to insufficient efficacy signals.
In any case, AbbVie's reliance on Humira has gradually diminished over the past few years, with Humira accounting for more than half of the company's revenue in 2019 and 36% in the first half of 2022. Industry insiders believe that with the end of the world's best-selling drug Humira, not only AbbVie has been affected, but the global pharmaceutical pattern has also undergone drastic changes, and the new generation of "medicine king" dispute has begun!
GLP-1 accelerated the rewriting of history, and international and domestic "disputes" intensified
Merck's anti-PD-1 humanized IgG4κ monoclonal antibody Keytruda (commonly known as K drug) was approved for marketing in September 2014 for malignant tumors such as melanoma. Last year, thanks to strong global demand in the cancer field and the continuous expansion of K drug indications, K drugs approached Humira with sales of $20.9 billion; In the first quarter of this year, it rose 24% year-over-year, achieving sales of $5.8 billion. Industry forecasts that there is no suspense that total sales will surpass Humira in 2023.
Specifically, sales of K drugs exceeded US$10 billion in the fifth year after approval (2019) and reached US$20.937 billion in the eighth year (2020), compared to 11 and 16 years for Humira respectively. K drug has almost halved its time, and the corresponding results have been achieved, which shows that its sales have grown rapidly.
At the same time, Novo Nordisk's semeglutide is also like K drugs, constantly breaking records, and even showing the possibility of creating history. Semeglutide is a novel long-acting glucagon-like peptide-1 (GLP-1) analogue. In December 2017, the US FDA approved the marketing of semeglutide injection for blood glucose control in adult patients with type 2 diabetes. In June 2021, the indication of semeglutide injection for weight loss was approved by the US FDA.
This new drug for diabetes and obesity has shown amazing commercialization capabilities at the beginning of its launch. The sales of semeglutide in the calendar year from 2018 to 2022 overlapped with the sales of K drugs in the first five years, and showed an accelerated growth trend. In the performance of semeglutide in Q1 2023, the initial slight acceleration trend was amplified, from $2.245 billion to $4.2 billion. The market believes that if semeglutide continues to grow at this rate, it will bring more variables to the drug king battle in 2023.
(in US$ billion)
As another strong player in this field, Eli Lilly not only has dulaglutide, a competitive weapon with a revenue of $7.44 billion in 2022, but also its other product, Tirzepatide, which has shown good potential. The drug was first approved by the FDA for type 2 diabetes in May last year and generated $483 million in sales in less than nine months on the market. In the 2023Q1 financial report, telpotide first-quarter sales of 568 million US dollars, far more than the sum of the three quarters of last year, more than the original semeglutide showed momentum.
At the same time, as a blockbuster product in the GLP-1 field, telpotide has too much expectation and investment from Lilly. This is evident from the fact that Lilly has just registered a Phase 3 clinical trial (SURMOUNT-5) on the clinicaltrials.gov website, because the core of this clinical trial is a head-to-head trial with semeglutide in the field of weight loss.
Industry insiders say that from insulin to GLP-1, from diabetes to obesity, Eli Lilly and Novo Nordisk are all-round competitors. At present, the competition between the two powers is becoming more and more fierce, and the "battle of kings" of GLP-1 is not only staged on the international stage, but also blows the clarion call to seize the market in the domestic market:
In January this year, Novo Nordisk submitted a clinical trial application for semeglutide injection for new indications related to obesity or overweight;
Eli Lilly also announced positive results in February of a phase III clinical trial of Tirzepatide in China for obese or overweight adult patients. This means that Tirzepatide's future registration in China will enter a new stage.
In fact, in China, diabetes and obesity have always had a huge potential market. At present, the total population of the mainland has exceeded 1.4 billion, and the huge population base has not only brought economies of scale to the mainland, but also inevitably brought more sick people, of which chronic diseases account for the largest proportion, and diabetes and obesity are important components.
In the past, insulin has dominated the domestic market for diabetes treatment, but due to the limitations of the mode of administration, patients and the market are expecting the emergence of new dosage forms or new products; In terms of obesity, there is currently only one orlistat capsule in China, which cannot meet the vast market demand. Therefore, when GLP-1 products that can act on both glucose and weight reduction appear, a stone stirs up a thousand waves, bringing new choices to more than 130 million diabetic patients and many obese patients in mainland China.
Not only MNC such as Eli Lilly and Novo Nordisk has targeted the domestic market, but domestic innovative pharmaceutical companies are also not far behind. As early as 2017, Huadong Medicine, which is a leader in China, began to develop liraglutide injection for obesity or overweight indications, and at the same time, it also began to lay out generic drugs of semeglutide. In addition to Huadong Pharmaceutical, many enterprises such as Renhui Biotechnology, Hengrui Pharmaceutical, Dongguang Technology and Hongyun Huaning have successively entered the market and joined the GLP-1 innovative drug research and development army.
GLP-1 sprang up and emerged in the pharmaceutical market in less than ten years, and semeglutide only took five years to hand over a "potential drug king" report card, and telpotide also achieved outstanding results. Market participants pointed out that GLP-1 is rewriting the market pattern, with intensified competition from global pharmaceutical giants and domestic rookies after the remark, and it will be interesting to see what the future market will be.