面临严峻专利悬崖的制药公司得出结论：未来利润的关键可能是针对患者基因和生活方式定制的疗法，而不是针对庞大患者群体的重磅炸弹药物。
Pharmaceutical companies facing a steep patent cliff are concluding the key to future profits may be customized treatments tailored to patients' genes and lifestyles — not blockbusters aimed at large patient populations.
为什么这很重要：这一转变可能会影响未来几十年治疗哪些疾病，以及医疗系统需要支付多少费用。
Why it matters: The pivot could influence which diseases get treated in the decades to come, and how much the health system pays.
- 赌注巨大。根据咨询公司 Evaluate 的数据，在2026年至2032年间，超过5000亿美元的品牌药销售额可能面临仿制药竞争的风险。
• The stakes are huge. More than $500 billion in brand-name drug sales is potentially at risk from generic competition between 2026 and 2032, according to the consulting firm Evaluate.
最新动态：艾昆纬研究所（Iqvia Institute）的一份新报告发现，寻找每种疗法都能产生至少24亿美元全球销售额的新药的竞赛已经打响。
The latest: The race is on to find new treatments that each generate at least $2.4 billion in global sales, a new Iqvia Institute report finds.
- 它们日益成为特异性疗法、生物制剂和罕见病药物，一小批旗舰产品占据了行业销售额的极高份额。
• They're increasingly specialty treatments, biologics and rare disease drugs — with a small group of flagship products accounting for an outsized share of industry sales.
- 诺和诺德的 Ozempic 和礼来的 Zepbound 等 GLP-1 药物如今定义了这一精英类别。下一波浪潮可能包括将抗体与化疗相结合以靶向特定癌细胞的“生物导弹”。
• GLP-1 drugs like Novo Nordisk's Ozempic and Eli Lilly's Zepbound now define that elite category. The next wave could include "biological missiles" that combine antibodies with chemotherapy to target specific cancer cells.
- 报告指出：“随着精准医学继续推进，类似的方法可能会从肿瘤学扩展到免疫学、代谢性疾病和神经病学等领域。”
• "As precision medicine continues to advance, similar approaches may extend beyond oncology into areas such as immunology, metabolic disease and neurology," the report states.
现实检验：目前尚不清楚所有这些创新是会治愈更多的人，还是只会让医疗费用变得更加昂贵。
Reality check: It's not clear whether all of the innovation will cure more people, or just make health care more expensive.
- 新型RNA药物以及细胞和基因疗法价格昂贵、制造困难且针对小群体患者。
• Novel RNA drugs and cell and gene therapies are expensive, hard to make and target small groups of patients.
- 识别符合条件的患者以及让保险公司为治疗付费所面临的挑战，已经暴露出有前景的研发与患者受益之间存在脱节。
• Challenges identifying eligible patients and getting insurers to pay for treatments have already revealed a disconnect between promising R&D and patient benefit.
- 报告称，对高药价的普遍担忧将迫使制造商在药物推出后更快地找到更多未被满足的需求并建立销售额。
• Widespread concern over high drug prices will force manufacturers to find more unmet needs and build sales more quickly after a drug's launch, according to the report. Context:
背景：历史上，畅销药的目标是高胆固醇等慢性病的庞大患者群体。溃疡药 Tagamet 在1986年成为第一款销售额超过10亿美元的药物。
Top-selling drugs historically were aimed at large patient populations with chronic conditions like high cholesterol. The ulcer drug Tagamet became the first to exceed $1 billion in sales in 1986.
- 随着时间推移，癌症和免疫学药物成为增长的主要驱动力，随后是 GLP-1，它引发了对肥胖和糖尿病以外病症的巨大需求，但也推高了医疗成本。
• Over time, cancer and immunology drugs became major drivers of growth, followed by GLP-1s, which are sparking huge demand for conditions beyond obesity and diabetes but also driving up health costs.
- 艾昆纬发现，重磅炸弹药物在失去市场独占权之前平均能够保持12.1年的主导市场地位，几乎占其商业寿命的80%。针对罕见病或复杂疾病的特异性疗法持续时间甚至更长。
• Iqvia found that blockbusters on average maintain a dominant market position for 12.1 years before losing market exclusivity, or nearly 80% of their commercial life. Specialty drugs for rare or complex diseases lasted even longer. Yes, but:
然而：相当数量的畅销药将在2028年至2036年间失去专利保护，并面临来自仿制药的潜在竞争。
A substantial number of top-sellers will lose patent protection and face potential competition from generics between 2028 and 2036.
- 百时美施贵宝的血液稀释剂 Eliquis 和默克的癌症重磅炸弹 Keytruda 都预计将在2028年失去市场独占权，这两款药在2024年的全球总销售额达到了650亿美元。
• Bristol Myers Squibb's blood thinner Eliquis and Merck's cancer blockbuster Keytruda, which are both due to lose market exclusivity in 2028, accounted for a combined $65 billion in global sales in 2024.
顺藤摸瓜：寻找新重磅炸弹的过程在一个充满激烈竞争的环境中展开。Evaluate 表示，制药商和生物技术公司不仅必须弄清楚如何在拥挤的类别之外实现增长，还要弄清楚支付方对新类别药物的估价是多少。
- 另一个不确定因素是中国，西方制药巨头已在那里投资数百亿美元以巩固其产品管线。
Follow the money: The search for new blockbusters is playing out in a highly charged environment. Drugmakers and biotechs not only have to figure out how to grow outside of crowded categories but also how much payers value new classes of drugs, Evaluate says • There's also uncertainty over China, where Western drug giants have invested tens of billions of dollars to bolster their product pipelines.
- Evaluate 预测，只有自身免疫性疾病药物的潜力能够与 GLP-1 媲美，因为它们具有治疗数十种疾病的潜力。
• Evaluate predicts that only autoimmune disease drugs will come close to rivaling GLP-1s, because of their potential to treat dozens of conditions.
- 一个例子是艾伯维用于斑块状银屑病、关节炎、克罗恩病和溃疡性结肠炎的可注射药物 Skyrizi，该药可能会找到更多用途，并在2032年产生超过33亿美元的销售额。
• One example is AbbVie's injectable Skyrizi for plaque psoriasis, arthritis, Crohn's disease and ulcerative colitis, which could find more uses and generate more than $33 billion in sales in 2032. Iqvia identifies RNA therapeutics
艾昆纬将RNA疗法确定为传统慢性病“小分子”药物与高度特异性基因疗法之间一个具有潜在重要意义的中庸之道。
as a potentially important middle ground between traditional "small molecule" drugs for chronic diseases and highly specialized genetic treatments.
- 这些药物可以靶向多种基因和疾病中引起疾病的突变，其应用涵盖中枢神经系统、心血管和肾脏疾病以及罕见病。
• These drugs can target disease-causing mutations across many genes and conditions, with applications for central nervous system, cardiovascular and kidney disease, as well as rare conditions.
底线：艾昆纬总结道，在创新同时确保患者能够获得新疗法方面的成功，“最终将决定过去25年观察到的重磅炸弹药物的增长能否以其惊人的速度持续下去”。
The bottom line: The success at innovating while also making sure patients have access to the new treatments "will ultimately determine whether the growth in blockbuster medicines observed over the past 25 years can continue at its extraordinary pace," Iqvia concludes.