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- 2026-01-14 19:26:05
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- Global pharma R&D direction based on M&A trend
- by Son, Hyung Min Jan 14, 2026 09:32am
- Mergers and acquisitions (M&A) have become a survival strategy in the pharmaceutical industry.Throughout 2025, the M&A trends of global pharmaceutical companies revealed not just simple acquisitions, but the very direction of R&D aimed at securing future growth engines.As pipeline acquisition, platform technology integration, and rapid clinical capability building have become central to M&A strategies, R&D planning is undergoing a structural transformation.As of 2026, these changes have become even more pronounced. In oncology drug development, new mechanisms such as radiopharmaceuticals, antibody-drug conjugates (ADCs), and multispecific antibodies are rapidly emerging and swiftly replacing existing standard treatment areas.Another key growth axis is metabolic disease. GLP-1-based novel drugs, which have led the obesity treatment market, are now evolving beyond simple weight loss into metabolic platform therapies encompassing cardiovascular, renal, and hepatic diseases. This shift in the obesity treatment paradigm is ultimately redefining therapeutic strategies for metabolic diseases overall and rewriting the expansion potential of the global market.In this feature, DailyPharm will examine ▲R&D strategies revealed through 2025 M&A trends ▲the rapid reshaping of the oncology development landscape ▲and the expanding innovation driven by GLP-1–based metabolic therapies, in order to forecast the future direction of global R&D paradigms.The return of major deals…2025 emphasized direction over scaleLooking at major M&A deals closed last year, the largest was Johnson & Johnson's USD 14.6 billion (approximately KRW 21 trillion) acquisition of US biopharmaceutical company Intracellular Therapies.Through this acquisition, J&J added the FDA-approved schizophrenia and bipolar disorder treatment Caplyta (lumateperone) to its pipeline. Caplyta is characterized by high serotonin 5-HT2A receptor occupancy and low dopamine D2 receptor occupancy. These features serve as important benchmarks in selective neurotransmitter targeting and drug development. J&J projected Caplyta to generate annual sales exceeding USD 5 billion.Other mega-deals exceeding USD 10 billion included Novartis’ acquisition of RNA therapeutics company Avidity Biosciences (USD 12 billion) and Pfizer’s acquisition of Metsera (USD 10 billion) to secure GLP-1–based candidates.A common theme across these transactions is their focus on next-generation platforms and pipeline scalability rather than short-term revenue expansion.CNS, RNA therapeutics, GLP-1 class drugs, and metabolic dysfunction-associated steatohepatitis (MASH) are all considered areas with significant potential impact upon clinical success and ease of indication expansion.This signals that Big Pharmas are prioritizing and concentrating on certain future markets amid a global environment of heightened uncertainty.Looking at investment trends by disease area, oncology still holds the largest share, but its growth has slowed.According to data from market research firm EY, the size of oncology-related M&A reached approximately USD 109 billion in 2023 but plummeted to USD 68 billion in 2024. Last year, it increased to USD 95 billion, driven by global pharmaceutical companies introducing new drugs with novel mechanisms of action.This trend reflects not a contraction in oncology R&D, but rather the fact that new mechanisms such as ADCs, radiopharmaceuticals, and multispecific antibodies have already been largely absorbed into the internal pipelines of large companies.In other words, the analysis suggests that in the oncology field, strategic alliances or joint development at the technology platform level are now preferred over acquiring individual candidate compounds.Conversely, the CNS sector showed relatively stable investment flows. This, including Johnson & Johnson's major deal, demonstrates that central nervous system disorders are still recognized as an area with both long-term growth potential and unmet medical needs. Many global pharmaceutical companies are shifting their portfolios to focus on rare immune diseases.The most notable change in 2025 M&A is the resurgence of immunology and metabolic disease sectors. Deal size for immunology rose from USD 46 billion in 2024 to USD 65 billion in 2025, while metabolic disease expanded from USD 31 billion to USD 51 billion over the same period.Notably, Novo Nordisk's acquisition of Akero (USD 5.2 billion) and Roche's acquisition of 89bio (USD 3.5 billion) were both transactions aimed at securing metabolic disease pipelines, including MASH.This clearly demonstrates that GLP-1-based obesity treatments are evolving into a platform therapeutic strategy extending beyond simple weight loss to target cardiovascular, hepatic, and renal diseases. Some analysts suggest the next stage of obesity drug competition will be a battle spanning the entire metabolic disease spectrum.Refined new drug development strategies amid persistent uncertaintyThe global pharmaceutical industry’s M&A activity in 2025 is widely regarded as a year that clearly revealed mid- to long-term R&D strategy direction rather than simple scale expansion.Considering both deal size and target disease portfolios, global pharmaceutical companies embarked on structural reorganization to secure platform technologies and future therapeutic areas, going beyond merely bolstering individual pipelines.However, the most significant characteristic of the M&A deals concluded in 2025 was the shift in focus away from aggressive acquisitions centered on anticancer drugs, as seen in the past, towards areas with relatively assured long-term growth potential, such as metabolic diseases, CNS, and rare diseases.Furthermore, last year's M&A trends show a clearer strategic focus compared to the previous year.The largest deal concluded in the global pharmaceutical industry in 2024 was Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences for USD 4.9 billion (approximately KRW 7.03 trillion). This is a significantly smaller scale compared to the multiple USD 10 billion-plus deals of 2023.The 2024 M&A market is generally assessed as a year dominated by caution toward large acquisitions. Global pharmaceutical companies opted for a strategy of selectively acquiring relatively smaller companies instead of making big bets like in the past, then growing their corporate value through internal capabilities.This is the so-called ‘bolt-on strategy’. This approach involves acquiring small-to-mid-sized biotech companies possessing core platforms or promising pipelines, then combining them with in-house R&D, clinical, and commercialization capabilities. This method disperses risk while incrementally increasing the likelihood of success.Against this backdrop, the resurgence of multiple USD 10 billion-plus deals in 2025 suggests that global pharmaceutical companies are moving from a phase of uncertainty into one of selective conviction.However, unlike in 2023, capital is no longer being deployed indiscriminately. Investment is now concentrated solely in disease areas, mechanisms, and platforms that have been clearly validated, signaling that the nature of M&A itself has become far more sophisticated.
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- ‘MenQuadfi advances meningococcal disease prevention’
- by Son, Hyung Min Jan 14, 2026 09:32am
- “Considering how the global trend is focusing on immunization across a wide range of age groups, including infants, adolescents, and young adults, the arrival of MenQuadfi, which can be administered to a broad population, represents a major advance in meningococcal preventive healthcare.”Professor Jin-soo Lee, Department of Infectious Diseases, Inha University HospitalOn the 13th, Sanofi held a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic launch of the meningococcal vaccine MenQuadfi. At the event, Professor Jin-soo Lee of Inha University Hospital's Department of Infectious Diseases presented clinical data on MenQuadfi and predicted that it would have high practical value in clinical use.”MenQuadfi is a quadrivalent protein-conjugated vaccine that can protect against meningococcal serogroups A, C, W, and Y. It can be administered as a single dose to individuals aged 6 weeks to 55 years. The vaccine was approved in April last year and officially launched in the domestic market this January.This vaccine is the only meningococcal vaccine in Korea approved and demonstrated efficacy and effectiveness against meningococcal serogroup A in infants aged 6 weeks to under 24 months. It features a liquid formulation that can be administered directly without separate dilution or mixing, enhancing convenience for healthcare providers. Its vaccination schedule is as follows: a total of 4 dose series for infants aged 6 weeks to under 6 months; a total of 2 dose series for infants aged 6 months to under 24 months; and a single dose for individuals aged 2 to 55 years.Meningococcal disease has long been recognized as a major global public health concern. This infection is a Class 2 notifiable disease with a fatality rate of approximately 10-14%, affecting 500,000 people worldwide every year.Key symptoms include headache, fever, neck stiffness, vomiting, and decreased consciousness, sometimes accompanied by petechiae or petechial rash. Given that 11–19% of recovered patients may experience sequelae such as hearing impairment, cognitive impairment, or neurological disorders, the importance of prevention for this infection is paramount.Because meningococcal disease spreads through droplets or direct contact, vaccination is recommended for individuals in group settings. Representative examples include new military recruits before training and university freshmen residing in dormitories.Vaccination is also recommended for travelers or residents in high-incidence regions, such as the African meningitis belt, and pilgrims traveling to Mecca in Saudi Arabia. Also, vaccination is recommended for individuals with immune system disorders like complement deficiencies and those with anatomical or functional asplenia.Unlike Sanofi's previous meningococcal vaccine, which utilized diphtheria protein as the carrier, MenQuadfi employs tetanus toxoid protein and features increased antigen content (compared to the previous in-house vaccine containing 4 μg each of the meningococcal serogroup polysaccharide antigens A, C, W, and Y; MenQuadfi contains 10 μg each).In clinical trials, MenQuadfi demonstrated non-inferiority to the existing quadrivalent meningococcal vaccine in terms of immunogenicity across all four serogroups. Indeed, when MenQuadpi was administered to individuals aged 10 to 55 years, the seroprotection rates were 94.7% for serogroup A, 95.7% for serogroup C, 96.2% for serogroup W, and 98.8% for serogroup Y.In studies involving children aged 2–9 years, MenQuadfi also demonstrated non-inferiority compared with existing quadrivalent vaccines, with seroprotection rates ranging from 86% to 99%. When co-administered with other pediatric vaccines, MenQuadfi maintained stable immunogenicity.Professor Lee said, “The World Health Organization (WHO) recommends that each country select an appropriate vaccine and establish an immunization strategy based on the prevalent meningococcal serogroups and disease patterns within their borders. In Korea, meningococcal vaccination is recommended for people living in crowded environments, such as those living in dormitories. As travel and work-related visits to high-incidence regions such as Africa continue to increase, the importance of vaccination for individual safety is becoming even greater.”He added, “Given the risk of rapid disease progression, the arrival of MenQuadfi, which provides broad coverage, represents a major advance in preventive medicine. Although early symptoms are nonspecific, meningococcal disease can progress to sepsis and meningitis within hours, making vaccination paramount.”
- Policy
- 3-month import suspension for PCV 'Prevenar 20'
- by Lee, Tak-Sun Jan 14, 2026 09:32am
- Product photo of 'Prevenar 20 Pre-filled Syringe' The imported pneumococcal vaccine 'Prevenar 20 Pre-filled Syringe' will be subjected to a three-month suspension of import operations starting on the 12th. However, no issues are expected regarding its supply.This is interpreted as having sufficient existing imported inventory. As this vaccine is the most in-demand in the pneumococcal vaccination market, concerns about supply instability arose following the import suspension.The Ministry of Food and Drug Safety (MFDS) announced that the import operations for Prevenar 20 Pre-filled Syringe (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) will be suspended for three months, from the 12th of this month to April 11th.The administrative measure was issued in accordance with relevant laws after it was confirmed in June last year that needles of a different specification than the authorized ones were being used.At that time, the MFDS distributed a safety letter ordering a temporary suspension of use. Pfizer faced significant challenges just as it launched a new product.However, after the issue was resolved, the product was initially supplied to the market through co-promotion with Chong Kun Dang. In October of that year, the supply was expanded as it was selected for the National Immunization Program (NIP) for infants from 2 months to children under 5 years of age. Once chosen for the NIP, eligible recipients can receive the vaccination free of charge.Concerns arose following the news of the sudden import suspension, but it has been confirmed that there are no issues with the supply.The MFDS stated, "Currently, there are no cases reported to the MFDS regarding the supply of this item," and added, "It has been confirmed by the company that there are no supply-related issues."Because this vaccine is used in the NIP and adult vaccinations are increasing, it seems that sufficient inventory was secured before the suspension. However, some question the effectiveness of the administrative measure, noting that if inventory is adequate, a fine should have been imposed rather than an import suspension.Prevenar 20 is the first new pneumococcal vaccine introduced by Pfizer in 14 years, adding seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) to the previously available Prevenar 13.This vaccine is expected to replace the existing Prevenar 13. While competing products include Prodiax 23 and Vaxneuvance, Prevenar 20 is anticipated to take No.1 in the market, given that the previous Prevenar 13 has dominated with an outstanding market share.
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- Keytruda reimb extended… estimated claims of KRW 2 trillion
- by Jung, Heung-Jun Jan 14, 2026 09:31am
- While coverage has been strengthened with the expansion of reimbursement this month of the immuno-oncology drug Keytruda (pembrolizumab), the reimbursement expansion is expected to generate a record-high projected claims amount of KRW 238.4 billion, lighting warning signals for the management of Korea’s National Health Insurance finances.At the end of last year, the Ministry of Health and Welfare announced estimates that approximately KRW 1 trillion would be saved through its drug pricing system reform.However, when viewed in terms of net financial impact, the increase in claims for this single drug now accounts for roughly 20–25% of the savings generated from price cuts on listed generics.This is why calls are growing for stronger post-listing control, as more multi-indication blockbuster drugs enter Korea’s reimbursement system.According to industry sources on the 13th, the estimated reimbursement claims for MSD Korea’s immuno-oncology drug Keytruda represent the largest amount ever recorded, exceeding the KRW 2.2 trillion recorded for Paxlovid.This reflects the significant impact the drug is expected to have on national health insurance finances. Previously, Keytruda had been reimbursed for four cancer types, including non-small cell lung cancer. However, starting this year, reimbursement has been expanded to cover 17 regimens across nine cancer types, including head and neck cancer.The number of patients covered is expected to gradually increase from 3,258 to 6,680. Accordingly, the projected claim amount is expected to rise from KRW 178.8 billion in the first year to KRW 238.4 billion.In 2022, Keytruda successfully expanded coverage for first-line treatment of non-small cell lung cancer, among other indications. At that time, the Ministry of Health and Welfare estimated annual claims of KRW 1.762 trillion.Since then, Keytruda, which already generates annual sales exceeding KRW 400 billion as a single product, has continued to expand its reimbursement coverage, growing its market presence.The fact that coverage, previously concentrated on NSCLC, now extends to various cancer types, including female cancers, is welcome news for patients. However, the burden on health insurance finances is inevitably growing.The NHIS also states it will strengthen post-monitoring in consideration of the financial impact. As similar cases are expected to increase gradually, it is also contemplating enhanced post-approval management measures.An NHIS official said, “For new drugs with expanded reimbursement coverage, post-management is conducted through the price-volume linkage system. While other institutions may also have financial management measures in place, NHIS is considering additional post-management strategies as well.”
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- MFDS approves Servier’s Voranigo Tab in KOR
- by Lee, Tak-Sun Jan 14, 2026 09:31am
- The Ministry of Food and Drug Safety (MFDS, Minister Yu-kyoung Oh) announced on the 13th that it has approved Servier’s imported orphan drug ‘Voranigo Tab (vorasidenib) 10mg·40mg.’This drug is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma that have a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) gene mutation in pediatric and adult patients aged 12 years and older weighing at least 40 kg, following surgery, including biopsy, major resection, or complete resection.A biopsy refers to the procedure in which a portion of tissue or cells is collected and examined under a microscope for diagnostic purposes.IDH (Isocitrate Dehydrogenase) mutations cause the abnormal production of excessive metabolic substances (2-HG), which promote the growth and survival of cancer cells.Astrocytoma and oligodendroglioma are types of gliomas, tumors arising from glial cells in the brain and spinal cord. Gliomas are a major category of brain tumors.Voranigo is an IDH-targeted therapy that inhibits mutated IDH1 and IDH2, thereby reducing the production of the carcinogenic substance 2-hydroxyglutarate (2-HG) and suppressing tumor cell proliferation. The Ministry of Food and Drug Safety expects the new approval to provide a new treatment opportunity for patients with brain tumors that are positive for IDH1 or IDH2 mutations.
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