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美國活性藥物成分 (API) 市場評估：依合成、依效力、依製造商、依類型、依藥物、依用途、依應用、依地區、機會、預測 (2017-2031)
市場調查報告書
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1417597

美國活性藥物成分 (API) 市場評估：依合成、依效力、依製造商、依類型、依藥物、依用途、依應用、依地區、機會、預測 (2017-2031)

United States Active Pharmaceutical Ingredient Market Assessment, By Synthesis, By Potency, By Manufacturer, By Type, By Drug, By Usage, By Application, By Region, Opportunities and Forecast, 2017-2031F
出版日期: | 出版商: Market Xcel - Markets and Data | 英文 153 Pages | 商品交期: 3-5個工作天內

價格

2023年美國活性藥物成分（API）市場規模為331.9億美元，預計到2031年將達到608.9億美元，預計2024-2031年期間複合年增長率為7.88%。影響市場成長的主要因素是傳染病、遺傳性疾病和慢性病盛行率的上升、生物製劑和生物相似藥的使用不斷增加、製藥和生物製藥公司生產設施的擴張、仿製藥的重要性日益增加以及活躍的技術發展。擴大新治療類別的批准、增加生物製劑和生物相似藥的開發和臨床試驗預計將增加醫生和患者的採用，並預測市場成長。因此，美國對活性藥物成分（API）的需求預計將會增加。

慢性病的盛行率和負擔不斷增加

慢性病、傳染性疾病和遺傳性疾病的盛行率和負擔日益增加，刺激了對有效和安全藥物的需求。因此，對活性藥物成分（API）的需求預計將增加，並成為市場擴張的驅動因素。例如，根據 CDC 2022 年 4 月發佈的數據，美國估計有 5,850 萬成年人患有關節炎，約 2,570 萬成年人的正常活動受到限制。預計到 2040 年，這一數字將增至 3,500 萬。

此外，根據IDF發佈的2022年統計數據，2021年美國約有3,200萬人患有糖尿病，預計到2030年將增加至3,470萬，到2045年將增至3,620萬。因此，糖尿病人口的顯著增加正在推動需要大量活性藥物成分 (API) 的先進、安全藥物的開發活動的增加，從而推動市場成長。

根據美國癌症協會（American Cancer Society）發佈的數據，預計 2022 年美國將診斷出超過 190 萬例新癌症病例。此外，根據Breastcancer.org 2022年統計顯示，當年美國診斷出287,850例新發生侵襲性乳癌病例，5例新發生原位乳癌病例估計為1,400例。隨著癌症患者數量的增加，對癌症治療藥物的需求不斷增加，並且需要用於藥物製劑的活性藥物成分（API）。

生物相似藥和生物製劑的臨床試驗數量增加

生物相似藥和生物製劑的開發和臨床試驗的增加，以及新治療類別的批准增加，預計將推動醫生和患者採用生物相似藥。因此，對活性藥物成分（API）的需求預計將增加，推動市場成長。例如，根據美國食品藥物管理局2022年10月發佈的數據，2022年核准的生物製劑有10種。這些藥物包括治療神經功能障礙的Skysona、治療B 地中海貧血的Zynteglo、治療丙型肝炎病毒的Alintity、治療麻疹、腮腺炎和風疹的Priorix、治療復發或難治性多發性骨髓瘤的Carvykti 以及治療COVID -19 的Spikevax，包括針對C3d 的產品。也啟動了多個生物相似藥利用管理計劃，以促進生物相似藥的利用和採用。例如，美國非營利衛生系統Providence St. Joseph Health實施了一項生物仿製藥利用管理計劃，以鼓勵使用成本較低的生物仿製藥而不是成本較高的生物原料藥。

製藥公司的舉措

開發藥品的公司變得更加活躍，市場也在擴大。例如，2021 年 2 月，Adamas Pharmaceuticals, Inc. 的 GOCOVRI（金剛烷胺）緩釋膠囊的另一項新藥申請獲得了美國食品藥物管理局 (FDA) 的上市批准。GOCOVRI 與左旋多巴/卡比多巴聯合使用，已被批准作為症狀不確定的帕金森氏症患者的輔助治療。

本報告研究和分析了美國活性藥物成分 (API) 市場，提供市場規模和預測、市場動態以及主要參與者的現狀和前景。

目錄

第一章研究方法論

第二章 專案範圍與定義

第 3 章 COVID-19 對美國活性藥物成分 (API) 市場的影響

第 4 章執行摘要

第五章 美國活性藥物成分（API）市場展望（2017-2031）

  • 市場規模及預測
    • 金錢金額
    • 數量
  • 合成
    • 生物技術
    • 合成
  • 功效
    • 傳統API
    • 高壓API
  • 製造商
    • 專屬API
    • 商家API
  • 類型
    • 一般API
    • 創新的API
  • 藥品
    • 處方藥
    • 非處方藥
  • 使用
    • 臨床
    • 研究
  • 用法
    • 心血管疾病
    • 腫瘤
    • 中樞神經、神經
    • 骨科
    • 糖尿病
    • 呼吸科
    • 胃腸病學
    • 腎
    • 眼科
    • 其他
  • 依地區
    • 東北
    • 西南
    • 西
    • 中西部
    • 東南
  • 市場佔有率：依公司劃分（2023 年）

第六章 市場測繪（2023）

  • 依成分分類
  • 依效力
  • 依製造商
  • 依類型
  • 透過藥物
  • 依用途
  • 依用途
  • 依地區

第七章 宏觀環境與產業結構

  • 供需分析
  • 進出口分析 - 數量和價值
  • 供應/價值鏈分析
  • PESTEL 分析
  • 波特五力分析

第八章市場動態

  • 增長動力
  • 成長限制因素（問題、限制因素）

第九章 監理架構與創新

  • 臨床試驗
  • 專利情況
  • 監管審批
  • 創新/新技術

第十章 主要公司情況

  • 前 5 名市場領導者的競爭矩陣
  • 前 5 名市場領導者的市場收入分析（2023 年）
  • 併購/合資（如適用）
  • SWOT 分析（5 家市場公司）
  • 專利分析（如果適用）

第11章價格分析

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 戰略建議

第十五章 關於我們公司、免責聲明

Product Code: MX10891

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