![]() |
市場調查報告書
商品編碼
1841984
北美活性藥物成分市場規模、佔有率和趨勢分析報告:按合成類型、製造商、類型、應用、國家和細分市場預測,2025 年至 2033 年North America Active Pharmaceutical Ingredients Market Size, Share & Trends Analysis Report By Type Of Synthesis, By Type Of Manufacturer, By Type, By Application, By Country, And Segment Forecasts, 2025 - 2033 |
||||||
北美活性藥物成分市場規模預計在 2024 年達到 9,664 萬美元,預計到 2033 年將達到 1.4734 億美元,2025 年至 2033 年的複合年成長率為 4.76%。
學名藥需求的不斷成長、生物技術的進步、人口老化以及有利的監管支持正在推動這一成長。
擁有強大製造能力的老牌製藥公司的存在進一步支持了市場擴張。北美 API 市場正在經歷重大變革時期,推動這項轉型的因素包括監管措施、技術進步和旨在加強國內製造能力的策略投資。該市場中最引人注目的新興市場發展之一是美國政府為確保更具彈性的醫藥供應鏈所做的努力。 2025 年 8 月,唐納德·川普總統簽署了一項行政命令,設立戰略活性藥物成分儲備庫 (SAPIR),以儲存國家健康和安全所需的關鍵藥物成分。這項由美國衛生與公眾服務部支持的策略性舉措凸顯了全球 API 供應鏈日益成長的脆弱性,尤其是在 COVID-19 大流行造成中斷之後。此舉旨在減少對海外供應商的依賴,並確保在緊急情況和中斷期間隨時獲得基本藥物。
同時,各大製藥公司紛紛宣布對國內原料藥製造進行大規模投資。 2025 年 2 月,北美最大的製藥公司之一禮來公司宣布計劃投資 270 億美元在美國新建四家製造工廠。此次擴建旨在實現兩個目的:減少對海外原料藥來源的依賴,並減輕潛在藥品進口關稅的影響。這一策略轉變反映了製藥業的一個大趨勢,由於貿易不確定性和海外生產成本上升等因素,越來越多的公司將生產轉移回北美。作為這項舉措的一部分,禮來公司還在 2025 年 8 月確認將出售其新澤西工廠,並專注於根據以美國為中心的生產策略整合製造業務。預計此類大規模投資將對市場產生重大影響,提高本地生產能力並增強供應鏈彈性。
同時,監管變化正在塑造北美原料藥生產的格局。 2024 年 6 月,美國食品藥物管理局(FDA) 修訂了 21 CFR 第 211 部分,以加強藥品(包括原料藥)的現行良好生產規範 (CGMP)。這些修訂旨在改善整個產業的品質保證和生產流程,確保原料藥符合最高的安全性和有效性標準。這些監管更新鼓勵製藥商採用尖端技術和品管措施。此外,2024 年 1 月,FDA 發布了新的指導草案,澄清人用藥物 CGMP 指南 (ICH Q7) 也適用於原料藥的生產。此舉反映了 FDA 致力於加強監管和協調製藥業各個環節實踐的承諾。透過將法律規範擴大到原料藥,FDA 確保用於人類和動物健康的原料藥符契約樣嚴格的標準,從而提高藥品的整體安全性和有效性。
除了監管和投資主導的變化之外,技術進步對於塑造原料藥製造業也至關重要。一個關鍵趨勢是向連續製造轉變,這使得原料藥生產更有效率、可擴展且具有成本效益。 2023 年 5 月, 原料藥製造商 Cambrex 完成了其位於馬薩諸塞州的原料藥製造工廠的大規模擴建,提高了生產能力,以滿足對高品質、高效價原料藥日益成長的需求。此次擴建是該公司更廣泛策略的一部分,該策略旨在投資先進的製造技術,以提高生產效率並更快地響應不斷變化的市場需求。連續製造與自動化即時監控系統相結合,可幫助公司縮短生產前置作業時間、降低營運成本並最大限度地降低人為錯誤的風險。這些技術進步有望成為維持市場成長的關鍵因素,因為它們提高了靈活性和對醫藥需求變化的應對力。
這些發展標誌著北美正在齊心協力加強其國內原料藥)製造業。透過投資製造設施、法規更新和最尖端科技,該地區正致力於在全球市場動盪的背景下,增強自力更生和韌性。隨著學名藥和創新藥需求的不斷成長,北美原料藥市場預計將繼續發展,這些因素將有助於打造更穩健、更具前瞻性的醫藥供應鏈。該行業專注於增強製造能力、提高法規遵從性並採用先進技術,這將有助於北美在全球原料藥市場保持領先地位。
The North America active pharmaceutical ingredients market was estimated at USD 96.64 million in 2024 and is projected to reach USD 147.34 million by 2033, growing at a CAGR of 4.76% from 2025 to 2033. The increasing demand for generic drugs, advancements in biotechnology, a rising aging population, and favorable regulatory support drive this growth.
The presence of established pharmaceutical companies with strong manufacturing capabilities further supports the market's expansion. The North America API market is undergoing a significant transformation, driven by various dynamic factors, including regulatory initiatives, technological advancements, and strategic investments to bolster domestic manufacturing capabilities. One of the most prominent developments in this market is the U.S. government's efforts to ensure a more resilient pharmaceutical supply chain. In August 2025, President Donald Trump signed an executive order to establish the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to stockpile critical drug components necessary for national health and security. This strategic initiative, supported by the U.S. Department of Health and Human Services, highlights the growing recognition of the vulnerabilities in the global API supply chain, especially following the disruptions caused by the COVID-19 pandemic. This move is intended to reduce dependence on foreign suppliers, ensuring that essential medicines are readily available during emergencies and disruptions.
Simultaneously, major pharmaceutical companies have announced significant investments in domestic API manufacturing. In February 2025, Eli Lilly, one of the largest pharmaceutical companies in North America, revealed plans to invest USD 27 billion to construct four new manufacturing facilities in the United States, with three of these facilities dedicated to API production. The purpose of this expansion is twofold: to reduce reliance on foreign sources of APIs and to mitigate the impact of potential pharmaceutical import tariffs. This strategic shift reflects broader trends in the pharmaceutical industry, where companies are increasingly bringing production back to North America, driven by factors such as trade uncertainties and rising costs of overseas manufacturing. As part of this initiative, Eli Lilly also confirmed in August 2025 that it would sell a New Jersey plant, focusing on consolidating its manufacturing operations to align with its U.S.-centric production strategy. Such large-scale investments are expected to impact the market significantly, increasing local production capacity and enhancing supply chain resilience.
Alongside these developments, regulatory changes are shaping the landscape of API manufacturing in North America. In June 2024, the U.S. Food and Drug Administration (FDA) amended 21 CFR Part 211, enhancing Current Good Manufacturing Practices (CGMP) for drug products, including APIs. These revisions aim to improve quality assurance and manufacturing processes across the industry, ensuring that APIs meet the highest safety and efficacy standards. Such regulatory updates push pharmaceutical manufacturers to adopt state-of-the-art technologies and quality control measures. Furthermore, in January 2024, the FDA released new draft guidance clarifying that the human drug CGMP guidelines (ICH Q7) now apply to manufacturing veterinary APIs. This move reflects the FDA's commitment to enhancing oversight and aligning practices across various pharmaceutical industry segments. By expanding regulatory oversight to include veterinary APIs, the FDA ensures that APIs used in human and animal health meet the same rigorous standards, thereby improving the overall safety and effectiveness of medications.
In addition to regulatory and investment-driven changes, technological advancements are pivotal in shaping the API manufacturing sector. A significant trend is the shift toward continuous manufacturing, which allows for more efficient, scalable, and cost-effective production of APIs. In May 2023, Cambrex, an API manufacturer, completed a large-scale expansion of its API production plant in Massachusetts, increasing its capacity to meet the growing demand for high-quality, high-potency APIs. This expansion is part of a broader strategy by companies to invest in advanced manufacturing technologies that enhance production efficiency and enable faster response times to changing market demands. Continuous manufacturing, which involves automated, real-time monitoring systems, helps companies reduce production lead times, lower operational costs, and minimize the risk of human error. These technological innovations are expected to be a key factor in sustaining market growth, as they offer greater flexibility and responsiveness to shifts in the demand for pharmaceutical products.
These developments indicate a concerted effort to strengthen North America's domestic API manufacturing sector. By leveraging investments in manufacturing facilities, regulatory updates, and cutting-edge technologies, the region is positioning itself to become more self-reliant and resilient in the face of global disruptions. With increasing demand for generic and innovative drugs, the North American API market is set to continue evolving, driven by these factors contributing to a more robust and future-proof pharmaceutical supply chain. The industry's focus on enhancing manufacturing capacity, improving regulatory compliance, and adopting advanced technologies will help ensure North America remains at the forefront of the global API market.
North America Active Pharmaceutical Ingredients Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the North America active pharmaceutical ingredients market report based on type of synthesis, type of manufacturer, type, application, and country: