米国の原薬（API）市場の評価：合成別、効力別、メーカー別、タイプ別、医薬品別、使用別、用途別、地域別、機会、予測（2017年～2031年）

米国の原薬（API）の市場規模は、2023年に331億9,000万米ドルとなり、2031年に608億9,000万米ドルに達すると予測され、2024年～2031年の予測期間にCAGRで7.88%の成長が見込まれす。市場の成長に影響を与える主な要因は、感染症、遺伝性疾患、慢性疾患の有病率の上昇、生物製剤やバイオシミラーの使用の拡大、製薬企業やバイオ医薬品企業による生産施設の拡張、ジェネリック医薬品の重要性の高まり、原薬（API）製造における技術開発などです。新たな治療クラスの承認の拡大、生物学的製剤やバイオシミラーの開発と臨床試験の増加により、医師や患者による採用が見込まれ、市場の成長が予測されます。その結果、米国における原薬（API）の需要が増加すると予測されます。

慢性疾患の有病率と負担の増大

慢性疾患、感染症、遺伝性疾患の有病率と負担の増大は、有効かつ安全な医薬品への需要に拍車をかけています。その結果、原薬（API）のニーズが高まり、市場拡大の促進要因となることが予測されます。例えば、2022年4月にCDCが発表したデータによると、米国では推定5,850万人の成人が関節炎に罹患しており、約2,570万人の成人が普段の活動に制限を感じています。この数は、2040年までに3,500万人に増加すると予測されています。

さらに、IDFが発表した2022年の統計によると、米国では2021年に約3,200万人が糖尿病を患っており、この数字は2030年までに3,470万人、2045年までに3,620万人に増加すると予測されています。その結果、糖尿病人口の大幅な増加が、大量の原薬（API）を必要とする先進の安全な医薬品の開発活動の増加を促し、市場成長を促進しています。

米国がん協会（American Cancer Society）が発表したデータによると、米国では2022年に190万を超えるがんが新たに診断されると予測されています。さらに、Breastcancer.orgの2022年の統計で報告されているように、同年に米国で新たに診断された浸潤性乳がんの症例は28万7,850例、非浸潤性（in situ）乳がんの症例は5万1,400例と推定されています。がん患者の増加に伴い、がん治療薬に対する需要が高まっており、医薬品製剤用の原薬（API）が必要とされています。

バイオシミラーと生物製剤の臨床試験数の増加

バイオシミラーや生物製剤の開発と臨床試験の増加は、新たな治療クラスに対する承認の増加とともに、医師や患者によるバイオシミラー医薬品の採用を促進すると予測されます。その結果、原薬（API）の需要が高まり、市場の成長が促進されると予測されます。例えば、米国食品医薬品局が2022年10月に発表したデータによると、2022年に承認された生物学的製剤は10品目あります。これらの医薬品には、神経機能障害に対するSkysona、B-サラセミアに対するZynteglo、C型肝炎ウイルスに対するAlintity、麻疹・おたふくかぜ・風疹に対するPriorix、再発または難治性の多発性骨髄腫に対するCarvykti、COVID-19に対するSpikevax、IgGとC3dに対するAnti-C3d製品が含まれます。複数のバイオシミラー利用管理プログラムも開始されており、バイオシミラーの利用と採用を促進しています。例えば、米国の非営利医療システムであるProvidence St. Joseph Healthは、バイオシミラー利用管理プログラムを導入し、高コストのバイオオリジンよりも低コストのバイオシミラーの使用を奨励しています。

製薬企業による取り組み

医薬品を開発する企業の活動が活発化し、市場が拡大しています。例えば、Adamas Pharmaceuticals, Inc.は2021年2月、GOCOVRI（アマンタジン）徐放カプセルに関する新薬追加申請について米国食品医薬品局（FDA）からの販売承認を取得しました。GOCOVRIは、レボドパ/カルビドパと併用することで、不定愁訴を有するパーキンソン病患者に対する補助的治療薬として承認されました。

当レポートでは、米国の原薬（API）市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。

目次

第1章 調査手法

第2章 プロジェクトの範囲と定義

第3章 米国の原薬（API）市場に対するCOVID-19の影響

第4章 エグゼクティブサマリー

第5章 米国の原薬（API）市場の見通し（2017年～2031年）

• 市場規模と予測
  • 金額
  • 数量
• 合成
  • バイオテクノロジー
  • 合成
• 効力
  • 従来式API
  • HPAPI
• メーカー
  • キャプティブAPI
  • マーチャントAPI
• タイプ
  • 汎用API
  • 革新的なAPI
• 医薬品
  • 処方薬
  • OTC医薬品
• 使用
  • 臨床
  • 研究
• 用途
  • 心血管疾患
  • 腫瘍
  • 中枢神経系、神経
  • 整形外科
  • 糖尿病
  • 呼吸器科
  • 消化器内科
  • 腎臓
  • 眼科
  • その他
• 地域別
  • 北東部
  • 南西部
  • 西部
  • 中西部
  • 南東部
• 市場シェア：企業別（2023年）

第6章 市場マッピング（2023年）

• 合成別
• 効力別
• メーカー別
• タイプ別
• 医薬品別
• 使用別
• 用途別
• 地域別

第7章 マクロ環境と産業構造

• 需給分析
• 輸出入の分析 - 数量と金額
• サプライ/バリューチェーン分析
• PESTEL分析
• ポーターのファイブフォース分析

第8章 市場力学

• 成長促進要因
• 成長抑制要因（課題、抑制要因）

第9章 規制枠組みとイノベーション

• 臨床試験
• 特許情勢
• 規制当局の承認
• イノベーション/新技術

第10章 主要企業の情勢

• マーケットリーダー上位5社の競合マトリクス
• マーケットリーダー上位5社の市場収益分析（2023年）
• 合併と買収/合弁事業（該当する場合）
• SWOT分析（市場企業5社）
• 特許分析（該当する場合）

第11章 価格分析

第12章 ケーススタディ

第13章 主要企業の見通し

• 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14章 戦略的推奨

第15章 当社について、免責事項

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

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