Big Pharma Expected to Lose $220 Billion Over the Next Five Years
Opportunities Emerge for Domestic Bio Companies Amid Accelerated Development
The so-called "Big Pharma," referring to major global pharmaceutical companies, is expected to incur losses of approximately $220 billion (about 306 trillion KRW) over the next five years due to the expiration of original drug patents. In addition, the competitive landscape of the pharmaceutical market is projected to change rapidly.
On July 20, Yonhap News cited forecasts from the pharmaceutical market research firm IQVIA, reporting that Big Pharma is expected to lose exclusive rights in the pharmaceutical markets of ten major countries, including the United States and Europe, due to patent expirations between 2024 and 2029, resulting in revenue losses totaling $220 billion. This figure is more than three times higher than the estimated losses from 2020 to 2024.
The drugs anticipated to be most affected include: the autoimmune disease treatment Humira (adalimumab); the anticoagulant Xarelto (rivaroxaban); the diabetes treatment Forxiga (dapagliflozin); the immunology drug Stelara (ustekinumab); the thrombosis prevention drug Eliquis (apixaban); and the immuno-oncology drug Keytruda (pembrolizumab).
IQVIA stated, "Patent expirations over the next five years will provide new revenue opportunities for generic and biosimilar manufacturers," and projected that more than half of the immunology sector will face biosimilar and generic competition due to patent expirations within the next five years.
IQVIA further explained, "With the introduction of major biosimilars such as adalimumab, ustekinumab, and tocilizumab, the average daily treatment cost is expected to decrease to approximately $29.66."
Domestic bio companies are also accelerating the development of biosimilars to coincide with the expiration of original drug patents.
Celltrion, Dong-A ST, and Samsung Bioepis have each developed Stelara biosimilars: Stekima, Imuldosa, and Fyzchiva, respectively. For Humira biosimilars, Celltrion's Yuflyma and Samsung Bioepis's Hadlima are available, and Aprogen is developing AP096.
As of 2023, development of biosimilars for Keytruda, the world's top-selling drug, is also underway. Samsung Bioepis launched a global Phase 3 clinical trial for its Keytruda biosimilar candidate SB27 last year. Celltrion has received approval from the U.S. FDA for a Phase 3 clinical trial plan for its Keytruda biosimilar CT-P51 and has submitted the same plan to the European Medicines Agency (EMA).
However, in order for biosimilars to enter the market, they must overcome the patent defense strategies of original pharmaceutical companies. For example, Merck, the holder of Keytruda in the United States, is pursuing a strategy of switching from the existing intravenous (IV) formulation to a subcutaneous (SC) formulation to fend off competition from biosimilars.
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