As policy uncertainty in the United States, the world's largest pharmaceutical market, continues alongside the staffing cuts at the Food and Drug Administration (FDA), concerns over delays in the approval process are rising, leading to increased technology transactions. Global major pharmaceutical companies (big pharma) are securing technology by either introducing late-stage clinical trial candidates or acquiring entire corporations.
According to the pharmaceutical industry on the 29th, the disclosed transaction scale of corporations that spent more than $1 billion (1 trillion won) on technology transactions among the top 20 global pharmaceutical companies until May this year reaches 60 trillion won. Last year, the total technology transactions of all global corporations amounted to $150 billion (206 trillion won). While the contract scale over five months appears similar in numbers to last year, it only includes large contracts disclosed among the top 20 companies, suggesting that significantly more transactions likely took place.
◇Starting from 20 trillion won contracts, M&A follows
The technologies introduced by the top 20 companies are mostly focused on rare diseases with no suitable treatments, as well as cancer and central nervous system diseases. There are analyses suggesting that they aimed for benefits such as fast track or orphan drug designation from the FDA to avoid the risk of delayed approvals.
The first large-scale technology transaction of this year began with Johnson & Johnson (J&J), which has maintained the number one position in global sales for several years. During the JP Morgan Healthcare Conference (JPM 2025) held in San Francisco, J&J announced it would acquire Intra-Cellular Therapies' schizophrenia and bipolar depression treatment 'Caplyta (menetrepene)' for $14.6 billion (20.6 trillion won), drawing attention.
J&J lost its market monopoly as the major patent for its flagship autoimmune disease treatment 'Stelara (ustekinumab)' expired last year. In need of a new growth engine, the company opted for a central nervous system (CNS) treatment as its 'next Stelara'.
Caplyta has already received FDA approval and is also awaiting additional approval for use in major depressive disorder combination therapy, indicating a high commercial potential. In fact, Caplyta generated sales of $480 million (66 billion won) last year. J&J expects that once it receives additional FDA approvals, annual sales could exceed $5 billion (6.9 trillion won).
Eli Lilly also announced at JPM that it would acquire a new drug candidate under clinical development for breast cancer and advanced solid tumors by Scorpion Therapeutics for $2.5 billion (3.6 trillion won).
There have also been instances of acquisitions where corporations have purchased promising biotechnology firms. Germany's Merck acquired the U.S. company SpringWorks, which develops treatments for severe rare diseases and cancer, for $3.9 billion (5.6 trillion won). Swiss company Novartis acquired U.S.-based Anthos Therapeutics, which develops cardiovascular treatments, for $3.1 billion (4 trillion won), and Glaxo Smith Kline (GSK) of the U.K. acquired U.S. company IDRx, which develops treatments for gastrointestinal cancer and other rare cancers, for $1.15 billion (1.7 trillion won).
Contracts in the form of joint development also continued. Swiss company Roche entered into a $1.3 billion (1.95 trillion won) contract with Denmark's Zealand Pharma to jointly develop a next-generation obesity treatment. Additionally, U.K. AstraZeneca, French Sanofi, and U.S. Pfizer have shown aggressive investment moves in areas such as rare diseases and immune oncology.
◇Rush of technology introductions amid uncertainty… domestic companies benefit
The technologies targeted by global big pharma are mostly focused on new drug candidates for severe rare diseases and cancer treatments. With increasing uncertainties due to potential drug price reductions in the U.S., the possibility of tariffs on pharmaceuticals, and delays in the approval process due to FDA staff cuts, they have decided to secure new drug candidates externally that present lower risks and higher approval chances.
Receiving orphan drug designation from the FDA provides various benefits such as expedited review, conditional approval after Phase 2, waived fees, support for research and development (R&D) funding, and up to 10 years of market exclusivity. Big pharma appears to be introducing substances with proven efficacy and safety from Phase 1 to leverage their expertise in subsequent clinical trials and approvals. New cancer drugs often lack suitable treatments, thus increasing the likelihood of approval.
Hur Hyemin, a researcher at Kiwoom Securities, noted, "With policy changes leading to increased uncertainty and concerns over FDA approval delays, and with the actual FDA approval numbers this year being poor, big pharma is proactively responding to these risks," and added, "The likelihood of technology transfer contracts and M&A is increasing, presenting clear opportunities for domestic biotechnology companies."
In fact, domestic biotech firms such as Alteogen, ABL Bio, and Algenomics have each entered into large-scale technology export contracts with big pharma this year. Hwang Ju-ri, head of the Korea Biotechnology Industry Association's Department of Exchange and Cooperation, stated, "The current trend where global pharmaceutical companies focus on technology introduction rather than self-development presents a clear opportunity for domestic biotech firms that have few funding options outside of IPOs or capital increases."
Yoon Na-ri, executive director of GI Innovation, said, "Domestic corporations often concentrate on a single core platform or pipeline rather than spreading several technologies widely," and added, "Since big pharma looks for a technology that aligns precisely with their strategy rather than selecting multiple options, this could offer greater opportunities to domestic biotech firms that have properly established their own unique technologies."
In particular, there is an analysis that biotechnology firms can increase the likelihood of success for new drugs through collaboration with big pharma, going beyond simple fundraising. An anonymous representative from a domestic biotech firm stated, "The biggest advantage is that technology transactions or development collaborations with overseas big pharma can secure not only funding but also an international network," adding, "We can also learn from them in terms of difficult clinical trial designs, regulatory responses, and commercialization strategies."