美国活性药物成分 (API) 市场评估：依合成、依效力、依製造商、依类型、依药物、依用途、依应用、依地区、机会、预测 (2017-2031)

2023年美国活性药物成分（API）市场规模为331.9亿美元，预计到2031年将达到608.9亿美元，预计2024-2031年期间复合年增长率为7.88%。影响市场成长的主要因素是传染病、遗传性疾病和慢性病盛行率的上升、生物製剂和生物相似药的使用不断增加、製药和生物製药公司生产设施的扩张、仿製药的重要性日益增加以及活跃的技术发展。扩大新治疗类别的批准、增加生物製剂和生物相似药的开发和临床试验预计将增加医生和患者的采用，并预测市场成长。因此，美国对活性药物成分（API）的需求预计将会增加。

慢性病的盛行率和负担不断增加

慢性病、传染性疾病和遗传性疾病的盛行率和负担日益增加，刺激了对有效和安全药物的需求。因此，对活性药物成分（API）的需求预计将增加，并成为市场扩张的驱动因素。例如，根据 CDC 2022 年 4 月发布的数据，美国估计有 5,850 万成年人患有关节炎，约 2,570 万成年人的正常活动受到限制。预计到 2040 年，这一数字将增至 3,500 万。

此外，根据IDF发布的2022年统计数据，2021年美国约有3,200万人患有糖尿病，预计到2030年将增加至3,470万，到2045年将增至3,620万。因此，糖尿病人口的显着增加正在推动需要大量活性药物成分 (API) 的先进、安全药物的开发活动的增加，从而推动市场成长。

根据美国癌症协会（American Cancer Society）发布的数据，预计 2022 年美国将诊断出超过 190 万例新癌症病例。此外，根据Breastcancer.org 2022年统计显示，当年美国诊断出287,850例新发生侵袭性乳癌病例，5例新发生原位乳癌病例估计为1,400例。随着癌症患者数量的增加，对癌症治疗药物的需求不断增加，并且需要用于药物製剂的活性药物成分（API）。

生物相似药和生物製剂的临床试验数量增加

生物相似药和生物製剂的开发和临床试验的增加，以及新治疗类别的批准增加，预计将推动医生和患者采用生物相似药。因此，对活性药物成分（API）的需求预计将增加，推动市场成长。例如，根据美国食品药物管理局2022年10月发布的数据，2022年核准的生物製剂有10种。这些药物包括治疗神经功能障碍的Skysona、治疗B 地中海贫血的Zynteglo、治疗丙型肝炎病毒的Alintity、治疗麻疹、腮腺炎和风疹的Priorix、治疗復发或难治性多发性骨髓瘤的Carvykti 以及治疗COVID -19 的Spikevax，包括针对C3d 的产品。也启动了多个生物相似药利用管理计划，以促进生物相似药的利用和采用。例如，美国非营利卫生系统Providence St. Joseph Health实施了一项生物仿製药利用管理计划，以鼓励使用成本较低的生物仿製药而不是成本较高的生物原料药。

製药公司的举措

开发药品的公司变得更加活跃，市场也在扩大。例如，2021 年 2 月，Adamas Pharmaceuticals, Inc. 的 GOCOVRI（金刚烷胺）缓释胶囊的另一项新药申请获得了美国食品药物管理局 (FDA) 的上市批准。GOCOVRI 与左旋多巴/卡比多巴联合使用，已被批准作为症状不确定的帕金森氏症患者的辅助治疗。

本报告研究和分析了美国活性药物成分 (API) 市场，提供市场规模和预测、市场动态以及主要参与者的现状和前景。

目录

第一章研究方法论

第二章 专案范围与定义

第 3 章 COVID-19 对美国活性药物成分 (API) 市场的影响

第 4 章执行摘要

第五章 美国活性药物成分（API）市场展望（2017-2031）

• 市场规模及预测
  • 金钱金额
  • 数量
• 合成
  • 生物技术
  • 合成
• 功效
  • 传统API
  • 高压API
• 製造商
  • 专属API
  • 商家API
• 类型
  • 一般API
  • 创新的API
• 药品
  • 处方药
  • 非处方药
• 使用
  • 临床
  • 研究
• 用法
  • 心血管疾病
  • 肿瘤
  • 中枢神经、神经
  • 骨科
  • 糖尿病
  • 呼吸科
  • 胃肠病学
  • 肾
  • 眼科
  • 其他
• 依地区
  • 东北
  • 西南
  • 西
  • 中西部
  • 东南
• 市场占有率：依公司划分（2023 年）

第六章 市场测绘（2023）

• 依成分分类
• 依效力
• 依製造商
• 依类型
• 透过药物
• 依用途
• 依用途
• 依地区

第七章 宏观环境与产业结构

• 供需分析
• 进出口分析 - 数量和价值
• 供应/价值链分析
• PESTEL 分析
• 波特五力分析

第八章市场动态

• 增长动力
• 成长限制因素（问题、限制因素）

第九章 监理架构与创新

• 临床试验
• 专利情况
• 监管审批
• 创新/新技术

第十章 主要公司情况

• 前 5 名市场领导者的竞争矩阵
• 前 5 名市场领导者的市场收入分析（2023 年）
• 併购/合资（如适用）
• SWOT 分析（5 家市场公司）
• 专利分析（如果适用）

第11章价格分析

第十二章案例研究

第十三章 主要公司展望

• Pfizer, Inc.
• Merck & Co., Inc.
• AbbVie, Inc.
• Teva Pharmaceutical Industries Ltd.
• Pfizer, Inc.
• Novartis AG
• Sanofi
• Eli Lilly and Company
• GlaxoSmithKline plc
• F. Hoffmann-La Roche Ltd.
• AstraZeneca plc

第十四章 战略建议

第十五章 关于我们公司、免责声明

United States active pharmaceutical ingredient market size was valued at USD 33.19 billion in 2023, and is expected to reach USD 60.89 billion in 2031, with a CAGR of 7.88% for the forecast period between 2024 and 2031. Some of the key factors influencing the growth of the market include the rising prevalence of infectious, genetic, and chronic disorders, growing use of biologics and biosimilars, expansion of production facilities by pharmaceutical and biopharmaceutical companies, the growing significance of generic drugs, and technological developments in API manufacturing. The market is expected to grow due to the growing approvals for new therapeutic classes and the increased development and clinical trials of biologics and biosimilars, which are expected to be adopted by physicians and patients. It in turn, is expected to increase the demand for APIs in the United States.

Increase Prevalence and Burden of Chronic Diseases

The increasing prevalence and burden of chronic diseases, infectious diseases, and genetic disorders are spurring the demand for drugs that are both effective and safe. It in turn, is leading to a growing need for active pharmaceutical ingredients (APIs), expected to drive market expansion. For instance, according to data released by the CDC in April 2022, an estimated 58.5 million adults in the United States are affected by arthritis, with around 25.7 million adults experiencing limitations in their usual activities. The number is projected to rise to 35 million by the year 2040.

Additionally, as per the 2022 statistics published by the IDF, approximately 32 million people had diabetes in the United States in 2021, and the figure is anticipated to increase to 34.7 million by 2030 and 36.2 million by 2045. Consequently, the substantial diabetic population in the country is prompting increased efforts to develop advanced and safe drugs, requiring a significant quantity of APIs, thereby propelling the market growth.

According to data released by the American Cancer Society, it was anticipated that there would be more than 1.9 million new cancer diagnoses in the United States in 2022. Furthermore, as reported in the 2022 statistics from Breastcancer.org, an estimated 287,850 new cases of invasive breast cancer and 51,400 new cases of non-invasive (in situ) breast cancer were diagnosed in the United States in the same year. With the increasing prevalence of cancer cases, there is a growing demand for oncology drugs, necessitating the availability of active pharmaceutical ingredients (APIs) for drug formulation.

Growing Volume of Clinical Trials of Biosimilar and Biologics

The increasing development and clinical trials of biosimilar and biologics drugs, along with the growing approvals for new therapeutic classes, are expected to drive their adoption by physicians and patients. It in turn, is projected to boost the demand for APIs, thereby stimulating market growth. For instance, according to data released by the United States Food and Drug Administration in October 2022, there were 10 biologic drugs approved in 2022. These drugs include Skysona for neurologic dysfunction, Zynteglo for B-thalassemia, Alintity for Hepatitis C Virus, Priorix for measles, mumps, and rubella, Carvykti for relapsed or refractory multiple myeloma, Spikevax for COVID-19, and Anti-C3d for IgG and C3d products. Several biosimilar utilization management programs have been initiated to promote the utilization and adoption of biosimilars, with the aim of meeting the increased demand for these products. For instance, Providence St. Joseph Health, a nonprofit healthcare system in the United States, introduced a biosimilar utilization management program that encouraged the use of lower-cost biosimilars over higher-cost bio-originators.

Initiatives by the Pharmaceutical Companies

The market is experiencing growth due to the increasing activities of companies that are developing drugs. For instance, in February 2021, Adamas Pharmaceuticals, Inc. obtained marketing authorization from the United States Food and Drug Administration (FDA) for a supplemental New Drug Application concerning GOCOVRI (amantadine) extended-release capsules. GOCOVRI is authorized for use as an adjunctive treatment alongside levodopa/carbidopa in patients with Parkinson's disease who are experiencing OFF episodes.

During July 2021, AbbVie extended its worldwide operations to facilitate comprehensive drug substance and product supply services for its Contract Manufacturing Organization (CMO) partners. The expanded AbbVie contract manufacturing services now encompass various offerings, including biologics fill-finish, topical creams and ointments, sterile ophthalmic ointments, and customized Active Pharmaceutical Ingredient (API) solutions. Additionally, the acquisition of Allergan and increased capital expenditure have empowered AbbVie CMO to offer enhanced capabilities to clients across multiple manufacturing sectors in the United States.

Technological Advancements

The United States Active Pharmaceutical Ingredient (API) market has recently witnessed significant technological advancements. One of the most notable developments is the adoption of advanced manufacturing techniques, including continuous manufacturing and process automation. Continuous manufacturing enables pharmaceutical companies to produce APIs more efficiently and with better quality control, reducing production costs and time to market. In addition, there has been a growing emphasis on personalized medicine, which relies on advanced diagnostic tools and genetic profiling to tailor API formulations to individual patients' needs. The approach enhances the efficacy and safety of pharmaceutical products. In October of 2021, Merck's Life Science division introduced innovative technology and increased its capabilities to enhance the development of antibody-drug-conjugate (ADC) therapies.

Impact of COVID-19

The COVID-19 pandemic impacted the whole pharmaceutical supply chain, including the supply of APIs from the United States. According to the FDA, the United States had less than 5% API sites in August 2021. Over 80% of APIs were employed in key therapeutic areas, and vital pharmaceuticals were supplied from China and India. The United States, was experiencing a severe shortage of active pharmaceuticals after the Government of India temporarily prohibited the export of 26 drugs, including acetaminophen and various antibiotics. More than 40 Chinese manufacturers were subjected to national restrictions. It influenced market growth in the United States during the pandemic. However, the government developed policies to establish API production facilities in the country, which took time.

Key Players Landscape and Outlook

The active pharmaceutical ingredients market in the United States exhibits considerable fragmentation. Numerous API manufacturers are actively pursuing expanding their presence through diverse business strategies, including partnerships, facility expansion, and obtaining drug approvals.

In June 2022, Merck enhanced its capacity to produce high-potent active pharmaceutical ingredients (HPAPI) by doubling its facility in Wisconsin. 50 new jobs in Wisconsin were created due to this production facility spanning an area of 70,000 square feet.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Impact of COVID-19 on United States Active Pharmaceutical Ingredient Market

4. Executive Summary

5. United States Active Pharmaceutical Ingredient Market Outlook, 2017-2031F

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
  • 5.1.2. By Volume
• 5.2. Synthesis
  • 5.2.1. Biotech
  • 5.2.2. Synthetic
• 5.3. Potency
  • 5.3.1. Traditional API
  • 5.3.2. HPAPI
• 5.4. Manufacturer
  • 5.4.1. Captive APIs
  • 5.4.2. Merchant APIs
• 5.5. Type
  • 5.5.1. Generic APIs
  • 5.5.2. Innovative APIs
• 5.6. Drug
  • 5.6.1. Prescription Drugs
  • 5.6.2. Over-the-counter Drugs
• 5.7. Usage
  • 5.7.1. Clinical
  • 5.7.2. Research
• 5.8. Application
  • 5.8.1. Cardiovascular Diseases
  • 5.8.2. Oncology
  • 5.8.3. CNS and Neurology
  • 5.8.4. Orthopedic
  • 5.8.5. Diabetes
  • 5.8.6. Pulmonology
  • 5.8.7. Gastroenterology
  • 5.8.8. Nephrology
  • 5.8.9. Ophthalmology
  • 5.8.10. Others
• 5.9. By Region
  • 5.9.1. Northeast
  • 5.9.2. Southwest
  • 5.9.3. West
  • 5.9.4. Midwest
  • 5.9.5. Southeast
• 5.10. By Company Market Share (%), 2023

6. Market Mapping, 2023

• 6.1. By Synthesis
• 6.2. By Potency
• 6.3. By Manufacturer
• 6.4. By Type
• 6.5. By Drug
• 6.6. By Usage
• 6.7. By Application
• 6.8. By Region

7. Macro Environment and Industry Structure

• 7.1. Supply Demand Analysis
• 7.2. Import Export Analysis - Volume and Value
• 7.3. Supply/Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.5.1. Supplier Power
  • 7.5.2. Buyer Power
  • 7.5.3. Substitution Threat
  • 7.5.4. Threat from New Entrant
  • 7.5.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges, Restraints)

9. Regulatory Framework and Innovation

• 9.1. Clinical Trials
• 9.2. Patent Landscape
• 9.3. Regulatory Approvals
• 9.4. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)
• 10.5. Patent Analysis (If Applicable)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

• 13.1. Pfizer, Inc.
  • 13.1.1. Company Details
  • 13.1.2. Key Management Personnel
  • 13.1.3. Products & Services
  • 13.1.4. Financials (As reported)
  • 13.1.5. Key Market Focus & Geographical Presence
  • 13.1.6. Recent Developments
• 13.2. Merck & Co., Inc.
• 13.3. AbbVie, Inc.
• 13.4. Teva Pharmaceutical Industries Ltd.
• 13.5. Pfizer, Inc.
• 13.6. Novartis AG
• 13.7. Sanofi
• 13.8. Eli Lilly and Company
• 13.9. GlaxoSmithKline plc
• 13.10. F. Hoffmann-La Roche Ltd.
• 13.11. AstraZeneca plc

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

14. Strategic Recommendations

15. About Us & Disclaimer

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. United States Active Pharmaceutical Ingredient Market, By Value, In USD Billion, 2017-2031F
• Figure 2. United States Active Pharmaceutical Ingredient Market, By Volume, In Thousand Units, 2017-2031F
• Figure 3. United States Active Pharmaceutical Ingredient Market Share (%), By Synthesis, 2017-2031F
• Figure 4. United States Active Pharmaceutical Ingredient Market Share (%), By Potency, 2017-2031F
• Figure 5. United States Active Pharmaceutical Ingredient Market Share (%), By Manufacturer, 2017-2031F
• Figure 6. United States Active Pharmaceutical Ingredient Market Share (%), By Type, 2017-2031F
• Figure 7. United States Active Pharmaceutical Ingredient Market Share (%), By Drug, 2017-2031F
• Figure 8. United States Active Pharmaceutical Ingredient Market Share (%), By Usage, 2017-2031F
• Figure 9. United States Active Pharmaceutical Ingredient Market Share (%), By Application, 2017-2031F
• Figure 10. United States Active Pharmaceutical Ingredient Market Share (%), By Region, 2017-2031F
• Figure 11. By Synthesis Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 12. By Potency Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 13. By Manufacturer Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 14. By Type Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 15. By Drug Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 16. By Usage Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 17. By Application Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 18. By Region Map-Market Size (USD Billion) & Growth Rate (%), FY2023