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医薬品原薬（API）市場レポート：医薬品タイプ、メーカータイプ、合成タイプ、治療用途、地域別、2024-2032

Active Pharmaceutical Ingredients Market Report by Drug Type, Type of Manufacturer, Type of Synthesis, Therapeutic Application, and Region 2024-2032

出版日
発行
IMARC
ページ情報
英文 135 Pages
納期
2～3営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.99円
医薬品原薬（API）市場レポート：医薬品タイプ、メーカータイプ、合成タイプ、治療用途、地域別、2024-2032
出版日: 2024年03月02日
発行: IMARC
ページ情報: 英文 135 Pages
納期: 2～3営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の医薬品原薬（API）市場規模は2023年に2,347億米ドルに達しました。今後、IMARC Groupは、2024年から2032年にかけて4.6%の成長率（CAGR）を示し、2032年までに3,570億米ドルに達すると予測しています。がん、糖尿病、心血管疾患、神経疾患などの慢性疾患の蔓延、バイオシミラー医薬品やジェネリック医薬品に対する需要の高まり、医薬品研究開発（R&D）活動への投資の増加などが市場を牽引する主な要因となっています。

医薬品原薬（API）は、意図した治療効果をもたらすために医薬品に使用されます。APIは生物学的に活性な物質で、疾患の病態に直接対処し、様々な病状の症状を管理します。原薬は通常、様々な複雑な化学的・生物学的過程を経て合成され、その純度、力価、安定性は治療効果にとって最も重要です。医薬品は多様な病態の標的治療を容易にし、医薬品メーカーが疾患や患者群に特化した医薬品を開発することを可能にします。医薬品は錠剤、カプセル剤、軟膏剤、注射剤など様々な形態で利用され、それぞれに異なる製造要件があります。これに加えて、ドラッグデリバリーシステムの進歩を促進し、より効果的で安全な薬剤の体内分布を可能にします。

いくつかの医薬品の特許切れや、費用対効果の高い治療法への注目の高まりに後押しされたジェネリック医薬品市場の台頭は、原薬需要を刺激する重要な要因のひとつです。さらに、さまざまな大手製薬企業が革新的な医薬品や治療法を発見・開発するために研究開発（R&D）活動に投資しており、これが市場の成長を後押ししています。さらに、原薬製造には高いコストと複雑な工程が伴うため、多くの製薬企業が原薬製造を第三者メーカーに委託しており、これが市場の成長を強化しています。さらに、医薬品開発・製造に対する支援的な規制政策が実施されていることも、良好な市場見通しをもたらしています。

医薬品原薬（API）市場の動向と促進要因：

慢性疾患の増加

心臓病、がん、糖尿病、呼吸器疾患などの慢性疾患は、現在世界人口のかなりの割合を占めています。世界保健機関（WHO）によると、慢性疾患は世界の死因の71％を占めると推定されています。これらの疾病に罹患する人々の数が増加の一途をたどる中、効果的な医薬品治療に対する需要が高まっています。治療効果を原薬に依存する新薬と改良された既存薬の両方が求められています。したがって、慢性疾患の高い有病率によって特徴付けられる現在の世界の健康状況は、高品質の原薬の需要を絶えず促進し、市場の成長を刺激しています。

バイオテクノロジーとバイオ医薬品の進歩

バイオテクノロジー分野は現在大きな進歩を遂げており、医薬品業界に大きな変革をもたらしつつあります。生物に由来することが多いバイオ医薬品は現在、従来の化学医薬品よりも効果的かつ安全にさまざまな病気を治療しています。バイオ原薬として知られる、バイオテクノロジーを駆使して合成された原薬は、こうしたバイオ医薬品に不可欠なものです。技術の進歩が続き、バイオ医薬品の採用が増えるにつれて、バイオ原薬の需要も同時に急増しています。

個別化医療と標的ドラッグデリバリーシステムへの注目

個別化医療とは、個人の遺伝的体質、ライフスタイル、環境に合わせた治療計画を含むもので、現在重視されています。このアプローチは、より患者に特化した治療法へとパラダイムシフトしつつあります。同様に、標的ドラッグデリバリーシステムの進歩は、薬効を向上させ、副作用を減らし、患者のコンプライアンスを高めることを目的としています。原薬はこの両分野で重要な役割を果たし、望ましい治療効果を達成するために様々な組み合わせや処方の可能性を提供しています。これらの分野が進化を続け、牽引力を増すにつれて、API市場の成長を常に後押ししています。

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査目的
  • 利害関係者
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

  • 概要
  • 主要産業動向

第5章 世界の原薬市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場内訳：医薬品タイプ別
  • 市場内訳：メーカー別
  • 市場内訳：合成タイプ別
  • 市場内訳：治療用途別
  • 市場内訳：地域別
  • 市場予測
  • SWOT分析
    • 概要
    • 強み
    • 弱み
    • 機会
    • 脅威
  • バリューチェーン分析
  • ポーターのファイブフォース分析
    • 概要
    • 買い手の交渉力
    • 供給企業の交渉力
    • 競合の程度
    • 新規参入業者の脅威
    • 代替品の脅威
  • 価格分析
    • 価格指標
    • 価格構造

第6章 市場内訳：医薬品タイプ別

  • 革新的医薬品原薬
  • ジェネリック医薬品原薬

第7章 医薬品タイプ別市場内訳：メーカー別

  • キャプティブメーカー
  • マーチャント原薬メーカー
    • 革新的なマーチャント原薬メーカー
    • ジェネリックマーチャント原薬メーカー

第8章 市場内訳：合成タイプ別

  • 合成医薬品原薬
    • 市場内訳：タイプ別
      • 革新的合成原薬
      • ジェネリック合成原薬
  • バイオ医薬品原薬
    • 市場内訳：タイプ別
      • 革新的バイオ医薬品原薬
      • バイオシミラー
    • 市場内訳：製品別
      • モノクローナル抗体
      • ワクチン
      • サイトカイン
      • 融合タンパク質
      • 治療用酵素
      • 血液因子
    • 市場内訳：発現システム別
      • 哺乳類発現システム
      • 微生物発現系
      • 酵母発現系
      • トランスジェニック動物発現系
      • その他

第9章 市場内訳：治療用途別

  • がん領域
  • 循環器・呼吸器
  • 糖尿病
  • 中枢神経系疾患
  • 神経疾患
  • その他

第10章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • アジア太平洋
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • ラテンアメリカ
  • 中東・アフリカ

第11章 原薬製造プロセス

  • 製品の概要
  • 原料の要件
  • 製造プロセス
  • 主な成功要因とリスク要因

第12章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Pfizer, Inc.
    • Novartis International AG
    • Sanofi
    • Boehringer Ingelheim
    • Bristol-Myers Squibb
    • Teva Pharmaceutical Industries Ltd.
    • ELI Lilly and Company
    • GlaxoSmithKline
    • Merck & Co., Inc.
    • Abbvie Inc
図表

List of Figures

  • Figure 1: Global: Active Pharmaceutical Ingredients (API) Market: Major Drivers and Challenges
  • Figure 2: Global: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Billion US$), 2018-2023
  • Figure 3: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Drug Type (in %), 2023
  • Figure 4: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Type of Manufacturer (in %), 2023
  • Figure 5: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Type of Synthesis (in %), 2023
  • Figure 6: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Therapeutic Application (in %), 2023
  • Figure 7: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Region (in %), 2023
  • Figure 8: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 9: Global: Active Pharmaceutical Ingredients (API) Industry: SWOT Analysis
  • Figure 10: Global: Active Pharmaceutical Ingredients (API) Industry: Value Chain Analysis
  • Figure 11: Global: Active Pharmaceutical Ingredients (API) Industry: Porter's Five Forces Analysis
  • Figure 12: Active Pharmaceutical Ingredients (API) Manufacturing: Price Structure (in %)
  • Figure 13: Global: Innovative Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 14: Global: Innovative Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 15: Global: Generic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 16: Global: Generic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 17: Global: Active Pharmaceutical Ingredients (Captive Manufacturers) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 18: Global: Active Pharmaceutical Ingredients (Captive Manufacturers) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 19: Global: Active Pharmaceutical Ingredients (Merchant API Manufacturers) Market: Sales Value (in Billion US$), 2018-2023
  • Figure 20: Global: Active Pharmaceutical Ingredients (Merchant API Manufacturers) Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 21: Global: Merchant API Manufacturers Market: Breakup by Type (in %), 2023
  • Figure 22: Global: Merchant Generic API Manufacturers Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 23: Global: Merchant Generic API Manufacturers Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 24: Global: Merchant Innovative API Manufacturers Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 25: Global: Merchant Innovative API Manufacturers Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 26: Global: Synthetic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 27: Global: Synthetic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 28: Global: Synthetic Active Pharmaceutical Ingredients (API) Market: Breakup by Type (in %), 2023
  • Figure 29: Global: Innovative Synthetic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 30: Global: Innovative Synthetic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 31: Global: Generic Synthetic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 32: Global: Generic Synthetic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 33: Global: Biotech Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 34: Global: Biotech Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 35: Global: Biotech Active Pharmaceutical Ingredients (API) Market: Breakup by Type (in %), 2023
  • Figure 36: Global: Innovative Biotech Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 37: Global: Innovative Biotech Active Pharmaceutical Ingredients (API) Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 38: Global: Biotech Active Pharmaceutical Ingredients (Biosimilars) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 39: Global: Biotech Active Pharmaceutical Ingredients (Biosimilars) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 40: Global: Biotech Active Pharmaceutical Ingredients (API) Market: Breakup by Product Type (in %), 2023
  • Figure 41: Global: Biotech Active Pharmaceutical Ingredients (Monoclonal Antibodies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 42: Global: Biotech Active Pharmaceutical Ingredients (Monoclonal Antibodies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 43: Global: Biotech Active Pharmaceutical Ingredients (Vaccines) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 44: Global: Biotech Active Pharmaceutical Ingredients (Vaccines) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 45: Global: Biotech Active Pharmaceutical Ingredients (Cytokines) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 46: Global: Biotech Active Pharmaceutical Ingredients (Cytokines) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 47: Global: Biotech Active Pharmaceutical Ingredients (Fusion Proteins) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 48: Global: Biotech Active Pharmaceutical Ingredients (Fusion Proteins) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 49: Global: Biotech Active Pharmaceutical Ingredients (Therapeutic Enzymes) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 50: Global: Biotech Active Pharmaceutical Ingredients (Therapeutic Enzymes) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 51: Global: Biotech Active Pharmaceutical Ingredients (Blood Factors) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 52: Global: Biotech Active Pharmaceutical Ingredients (Blood Factors) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 53: Global: Biotech Active Pharmaceutical Ingredients Market: Breakup by Expression System (in %), 2023
  • Figure 54: Global: Biotech Active Pharmaceutical Ingredients (Mammalian Expression Systems) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 55: Global: Biotech Active Pharmaceutical Ingredients (Mammalian Expression Systems) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 56: Global: Biotech Active Pharmaceutical Ingredients (Microbial Expression Systems) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 57: Global: Biotech Active Pharmaceutical Ingredients (Microbial Expression Systems) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: Global: Biotech Active Pharmaceutical Ingredients (Yeast Expression Systems) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 59: Global: Biotech Active Pharmaceutical Ingredients (Yeast Expression Systems) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: Global: Biotech Active Pharmaceutical Ingredients (Transgenic Animal Systems) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 61: Global: Biotech Active Pharmaceutical Ingredients (Transgenic Animal Systems) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: Global: Biotech Active Pharmaceutical Ingredients (Others) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 63: Global: Biotech Active Pharmaceutical Ingredients (Others) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: Global: Active Pharmaceutical Ingredients (Oncology) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 65: Global: Active Pharmaceutical Ingredients (Oncology) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: Global: Active Pharmaceutical Ingredients (Cardiovascular and Respiratory Disease) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 67: Global: Active Pharmaceutical Ingredients (Cardiovascular and Respiratory Disease) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Global: Active Pharmaceutical Ingredients (Diabetes) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 69: Global: Active Pharmaceutical Ingredients (Diabetes) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: Global: Active Pharmaceutical Ingredients (Central Nervous System Disorders) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 71: Global: Active Pharmaceutical Ingredients (Central Nervous System Disorders) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 72: Global: Active Pharmaceutical Ingredients (Neurological Disorders) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 73: Global: Active Pharmaceutical Ingredients (Neurological Disorders) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 74: Global: Active Pharmaceutical Ingredients (Other Applications) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 75: Global: Active Pharmaceutical Ingredients (Other Applications) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 76: North America: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 77: North America: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 78: United States: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 79: United States: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 80: Canada: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 81: Canada: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 82: Europe: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 83: Europe: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 84: Germany: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 85: Germany: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 86: France: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 87: France: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 88: United Kingdom: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 89: United Kingdom: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 90: Italy: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 91: Italy: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 92: Spain: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 93: Spain: Active Pharmaceutical Ingredients Market (API) Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 94: Russia: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 95: Russia: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 96: Others: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 97: Others: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 98: Asia Pacific: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 99: Asia Pacific: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 100: China: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 101: China: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 102: Japan: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 103: Japan: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 104: India: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 105: India: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 106: South Korea: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 107: South Korea: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 108: Australia: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 109: Australia: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 110: Indonesia: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 111: Indonesia: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 112: Others: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 113: Others: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 114: Middle East and Africa: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 115: Middle East and Africa: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 116: Latin America: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 117: Latin America: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 118: API Manufacturing (Chemical Synthesis): Process Flow

List of Tables

  • Table 1: Global: Active Pharmaceutical Ingredients (API) Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Drug Type (in Million US$), 2024-2032
  • Table 3: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Type of Manufacturer (in Million US$), 2024-2032
  • Table 4: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Type of Synthesis (in Million US$), 2024-2032
  • Table 5: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Therapeutic Application (in Million US$), 2024-2032
  • Table 6: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 7: Active Pharmaceutical Ingredients (API): Raw Material Requirements
  • Table 8: Active Pharmaceutical Ingredients (API): Equipment Requirements
  • Table 9: Global: Active Pharmaceutical Ingredients (API) Market: Competitive Structure
  • Table 10: Global: Active Pharmaceutical Ingredients (API) Market: Key Players
目次
Product Code: SR112024A1142

The global active pharmaceutical ingredients (API) market size reached US$ 234.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 357.0 Billion by 2032, exhibiting a growth rate (CAGR) of 4.6% during 2024-2032. The growing prevalence of chronic diseases, such as cancer, diabetes, cardiovascular and neurological disorders, rising demand for biosimilars and generic drugs, and increasing investments in pharmaceutical research and development (R&D) activities represent some of the key factors driving the market.

Active pharmaceutical ingredients (APIs) are used in medications to produce the intended therapeutic effects. They are biologically active substances that directly address disease pathology and manage the symptoms of various medical conditions. They are typically synthesized through a range of complex chemical and biological processes, and their purity, potency, and stability are paramount to their therapeutic effectiveness. They facilitate targeted treatment of diverse medical conditions, enabling drug manufacturers to develop medication specific to diseases and patient groups. They are utilized in various forms like tablets, capsules, ointments, or injectables, each having distinct production requirements. Besides this, they facilitate advancements in drug delivery systems, allowing for more effective and safe distribution of medications in the body.

The rise of the generics market, driven by patent expiries of several drugs and the rising focus on cost-effective treatment options, represents one of the key factors catalyzing the demand for APIs. Moreover, various leading pharmaceutical companies are investing in research and development (R&D) activities to discover and develop innovative drugs and therapeutic methods, which is favoring market growth. Furthermore, due to the high costs and complex processes involved in API production, many pharmaceutical companies are outsourcing their API manufacturing to third-party manufacturers, which is strengthening the market growth. Additionally, the implementation of supportive regulatory policies for drug development and manufacturing is offering a favorable market outlook.

Active Pharmaceutical Ingredients (API) Market Trends/Drivers:

Rising prevalence of chronic diseases

Chronic diseases like heart disease, cancer, diabetes, and respiratory disorders are currently affecting a significant percentage of the global population. According to the World Health Organization, chronic diseases are responsible for an estimated 71% of all global deaths. As the number of people affected by these diseases continues to rise, there is an increasing demand for effective pharmaceutical treatments. Both new and improved existing medications, which depend on APIs for their therapeutic effects, are being sought after. Hence, the current global health landscape marked by a high prevalence of chronic diseases is continually driving the demand for high-quality APIs and is stimulating the market growth.

Advancements in biotechnology and biopharmaceuticals

The biotechnology sector is currently making significant strides, resulting in major transformations within the pharmaceutical industry. Biopharmaceuticals, often derived from living organisms, are now treating a wide array of diseases more effectively and safely than traditional chemical drugs. APIs synthesized through biotechnological processes, known as biotech APIs, are integral to these biopharmaceuticals. As technological advancements continue to unfold and the adoption of biopharmaceuticals increases, the demand for biotech APIs is concurrently experiencing a surge.

Focus on personalized medicine and targeted drug delivery systems

Personalized medicine, which includes tailoring treatment plans to the genetic makeup of an individual, lifestyle, and environment, is currently being emphasized. This approach is shifting the paradigm towards more patient-specific therapies. Similarly, advancements in targeted drug delivery systems aim to improve drug efficacy, reduce side effects, and enhance patient compliance. APIs play a crucial role in both these areas, offering possibilities for various combinations and formulations to achieve the desired therapeutic effects. As these areas continue to evolve and gain traction, they are constantly fueling the growth of the API market.

Active Pharmaceutical Ingredients (API) Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global active pharmaceutical ingredients (API) market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on drug type, type of manufacturer, type of synthesis and therapeutic application.

Breakup by Drug Type:

Innovative Active Pharmaceutical Ingredients (API)

Generic Active Pharmaceutical Ingredients (API)

Innovative active pharmaceutical ingredients (API) dominate the market

The report has provided a detailed breakup and analysis of the market based on the drug type. This includes innovative active pharmaceutical ingredients (API) and generic active pharmaceutical ingredients (API). According to the report, innovative active pharmaceutical ingredients (API) represented the largest segment.

With the constant pursuit of advancements in healthcare, there is a continuous demand for new and improved treatment options. Additionally, innovative APIs play a crucial role in the development of these cutting-edge drugs that target specific diseases and offer enhanced therapeutic benefits. Apart from this, innovative APIs are often protected by patents, providing exclusivity to pharmaceutical companies and enabling them to capitalize on their investments in research and development (R&D). This exclusivity creates a competitive advantage and drives growth of this segment. Furthermore, the increasing focus on personalized medicine and precision therapies further fuels the demand for innovative APIs as they are tailored to specific patient needs.

Breakup by Type of Manufacturer:

Captive Manufacturers

Merchant API Manufacturers

Innovative Merchant API Manufacturers

Generic Merchant API Manufacturers

Captive manufacturers hold the largest share in the market

A detailed breakup and analysis of the market based on the type of manufacturer has also been provided in the report. This includes captive manufacturers and merchant API manufacturers (innovative merchant API manufacturers and generic merchant API manufacturers). According to the report, captive manufacturers accounted for the largest market share.

Captive manufacturers produce APIs exclusively for their own internal use in the production of branded medications. They can ensure a secure and reliable supply chain, which is essential for the consistent manufacturing of their branded pharmaceutical products. Additionally, this approach provides them with greater flexibility in terms of developing and optimizing APIs to suit their specific product portfolio, resulting in enhanced therapeutic outcomes. Apart from this, captive manufacturers often have robust research and development (R&D) capabilities, allowing them to innovate and create new APIs that align with their strategic objectives.

Breakup by Type of Synthesis:

Synthetic Active Pharmaceutical Ingredients (API)

Market Breakup by Type

Innovative Synthetic APIs

Generic Synthetic APIs

Biotech Active Pharmaceutical Ingredients (API)

Market Breakup by Type

Innovative Biotech APIs

Biosimilars

Market Breakup By Product

Monoclonal Antibodies

Vaccines

Cytokines

Fusion Proteins

Therapeutic Enzymes

Blood Factors

Market Breakup By Expression System

Mammalian Expression Systems

Microbial Expression Systems

Yeast Expression Systems

Transgenic Animal Systems

Others

Synthetic API accounted for the largest market share

A detailed breakup and analysis of the market based on the type of synthesis has also been provided in the report. This includes Synthetic Active Pharmaceutical Ingredients (API) [Market Breakup By Type {Innovative Synthetic APIs and Generic Synthetic APIs}]; and Biotech Active Pharmaceutical Ingredients (API) [Market Breakup By Type {Innovative Biotech APIs and Biosimilars}, Market Breakup By Product {Monoclonal Antibodies, Vaccines, Cytokines, Fusion Proteins, Therapeutic Enzymes, and Blood Factors}, and Market Breakup By Expression System {Mammalian Expression Systems, Microbial Expression Systems, Yeast Expression Systems, Transgenic Animal Systems and Others}]. According to the report, synthetic active pharmaceutical ingredients (API) accounted for the largest market share.

Synthetic APIs are those that are produced through chemical synthesis in the laboratory. The synthetic synthesis process allows for precise control over the molecular structure and composition of the API, ensuring consistency and purity of the final product. This reliability is essential for the development of safe and effective medications. Additionally, synthetic APIs offer a wide range of options in terms of chemical modifications and derivatizations, enabling pharmaceutical companies to optimize the therapeutic properties of the drug. Furthermore, synthetic synthesis methods often offer scalability, allowing for large-scale production to meet the market demand efficiently. Moreover, the scalability of synthetic synthesis methods is another advantage driving the demand for synthetic APIs. Chemical synthesis can often be easily scaled up to meet large-scale production requirements, ensuring a steady and reliable supply of APIs to meet market demands. This scalability is particularly important for medications with high demand or for treating widespread conditions.

Breakup by Therapeutic Application:

Oncology

Cardiovascular and Respiratory

Diabetes

Central Nervous System Disorders

Neurological Disorders

Others

Oncology holds the largest market share

Based on the therapeutic application, the market has been segmented as oncology, cardiovascular & respiratory, diabetes, central nervous system disorders, neurological disorders, and others. According to the report, oncology accounted for the largest market share.

The rising incidence of cancer globally is catalyzing the demand for APIs in the oncology segment. This growing prevalence necessitates the development and availability of effective cancer therapies, which heavily rely on APIs for their therapeutic effects. Additionally, the evolving understanding of cancer biology and the emergence of targeted therapies is revolutionizing cancer treatment. Targeted therapies focus on specific molecular targets involved in cancer development and progression. Apart from this, the substantial investment in oncology research and development (R&D) by pharmaceutical companies and the healthcare industry is propelling market growth. Furthermore, the regulatory environment and drug approval processes are becoming more streamlined and expedited for oncology therapies. This is encouraging pharmaceutical companies to invest in the development of oncology APIs and bring new cancer treatments to the market more efficiently.

Breakup by Region:

North America

United States

Canada

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Asia Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Latin America

Middle East and Africa

North America exhibits a clear dominance, accounting for the largest active pharmaceutical ingredients (API) market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America; and the Middle East and Africa. According to the report, North America accounted for the largest market share.

North America has a well-established and advanced pharmaceutical industry with significant investments in research and development (R&D). This enables the region to lead in the development and production of high-quality APIs. Additionally, North America possesses a robust regulatory framework that ensures adherence to stringent quality standards and safety regulations. This encourages domestic and international buyers regarding the reliability and credibility of APIs originating from the region. Furthermore, the presence of major pharmaceutical companies and API manufacturers in North America is creating a positive market outlook. These companies have extensive capabilities in API production, supply chain management, and distribution networks, solidifying their market position.

Competitive Landscape:

Leading companies are currently prioritizing various strategies to strengthen their market presence. They are actively investing in R&D to explore innovative APIs, particularly in the field of biotechnology and precision medicine. To meet the increasing demand, these companies are continuously expanding their production capacities and adopting advanced manufacturing processes. They are also entering strategic collaborations and partnerships to optimize their supply chain and enhance their global footprint. Furthermore, they are progressively addressing environmental concerns by promoting sustainable practices in their operations. In the face of evolving health challenges, these companies are persistently adapting to cater to the changing needs of the global patient population, making a significant impact on the health sector.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Pfizer, Inc.

Novartis International AG

Sanofi

Boehringer Ingelheim

Bristol-Myers Squibb

Teva Pharmaceutical Industries Ltd.

ELI Lilly and Company

GlaxoSmithKline

Merck & Co., Inc.

Abbvie Inc

Recent Developments:

In June 2023, Pfizer Inc. invested $25 million in a biopharma company Caribou Biosciences to support the development of an immune-cloaked allogeneic CAR-T cell therapy.

In May 2023, Novartis International AG purchased cystinosis gene therapy from AVROBIO Novartis and has acquired an investigational gene therapy program for the treatment of cystinosis, a rare genetic disease, from AVROBIO for $87.5 million. The purchase is aimed at extending Novartis' cash runway and aligns with their platform strategy in Gene & Cell Therapy.

In December 2022, Merck & Co., Inc. collaborated with Antengene to test Keytruda, ATG-037 Combo for solid tumors in phase 1 trial. This collaboration aims to explore the potential benefits of combining targeted therapies and immune-oncology drugs to improve treatment outcomes.

Key Questions Answered in This Report

  • 1. How big is the active pharmaceutical ingredient market?
  • 2. What is the expected growth rate of the global Active Pharmaceutical Ingredients (API) market during 2024-2032?
  • 3. What are active ingredients in pharmaceutical industry?
  • 4. What are the key factors driving the global Active Pharmaceutical Ingredients (API) market?
  • 5. What has been the impact of COVID-19 on the global Active Pharmaceutical Ingredients (API) market?
  • 6. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the drug type?
  • 7. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the type of manufacturer?
  • 8. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the type of synthesis?
  • 9. What is the breakup of the global Active Pharmaceutical Ingredients (API) market based on the therapeutic application?
  • 10. What are the key regions in the global Active Pharmaceutical Ingredients (API) market?
  • 11. Who is the biggest API manufacturer?
  • 12. Who are the key players/companies in the global Active Pharmaceutical Ingredients (API) market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Active Pharmaceutical Ingredients (API) Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Breakup by Drug Type
  • 5.5 Market Breakup by Type of Manufacturer
  • 5.6 Market Breakup by Type of Synthesis
  • 5.7 Market Breakup by Therapeutic Application
  • 5.8 Market Breakup by Region
  • 5.9 Market Forecast
  • 5.10 SWOT Analysis
    • 5.10.1 Overview
    • 5.10.2 Strengths
    • 5.10.3 Weaknesses
    • 5.10.4 Opportunities
    • 5.10.5 Threats
  • 5.11 Value Chain Analysis
  • 5.12 Porters Five Forces Analysis
    • 5.12.1 Overview
    • 5.12.2 Bargaining Power of Buyers
    • 5.12.3 Bargaining Power of Suppliers
    • 5.12.4 Degree of Competition
    • 5.12.5 Threat of New Entrants
    • 5.12.6 Threat of Substitutes
  • 5.13 Price Analysis
    • 5.13.1 Price Indicators
    • 5.13.2 Price Structure

6 Market Breakup by Drug Type

  • 6.1 Innovative Active Pharmaceutical Ingredients (API)
  • 6.2 Generic Active Pharmaceutical Ingredients (API)

7 Market Breakup by Type of Manufacturer

  • 7.1 Captive Manufacturers
  • 7.2 Merchant API Manufacturers
    • 7.2.1 Innovative Merchant API Manufacturers
    • 7.2.2 Generic Merchant API Manufacturers

8 Market Breakup by Type of Synthesis

  • 8.1 Synthetic Active Pharmaceutical Ingredients (API)
    • 8.1.1 Market Breakup by Type
      • 8.1.1.1 Innovative Synthetic APIs
      • 8.1.1.2 Generic Synthetic APIs
  • 8.2 Biotech Active Pharmaceutical Ingredients (API)
    • 8.2.1 Market Breakup by Type
      • 8.2.1.1 Innovative Biotech APIs
      • 8.2.1.2 Biosimilars
    • 8.2.2 Market Breakup by Product
      • 8.2.2.1 Monoclonal Antibodies
      • 8.2.2.2 Vaccines
      • 8.2.2.3 Cytokines
      • 8.2.2.4 Fusion Proteins
      • 8.2.2.5 Therapeutic Enzymes
      • 8.2.2.6 Blood Factors
    • 8.2.3 Market Breakup by Expression System
      • 8.2.3.1 Mammalian Expression Systems
      • 8.2.3.2 Microbial Expression Systems
      • 8.2.3.3 Yeast Expression Systems
      • 8.2.3.4 Transgenic Animal Systems
      • 8.2.3.5 Others

9 Market Breakup by Therapeutic Application

  • 9.1 Oncology
  • 9.2 Cardiovascular and Respiratory
  • 9.3 Diabetes
  • 9.4 Central Nervous System Disorders
  • 9.5 Neurological Disorders
  • 9.6 Others

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 United States
    • 10.1.2 Canada
  • 10.2 Europe
    • 10.2.1 Germany
    • 10.2.2 France
    • 10.2.3 United Kingdom
    • 10.2.4 Italy
    • 10.2.5 Spain
    • 10.2.6 Russia
    • 10.2.7 Others
  • 10.3 Asia Pacific
    • 10.3.1 China
    • 10.3.2 Japan
    • 10.3.3 India
    • 10.3.4 South Korea
    • 10.3.5 Australia
    • 10.3.6 Indonesia
    • 10.3.7 Others
  • 10.4 Latin America
  • 10.5 Middle East and Africa

11 API Manufacturing Process

  • 11.1 Product Overview
  • 11.2 Raw Material Requirements
  • 11.3 Manufacturing Process
  • 11.4 Key Success and Risk Factors

12 Competitive Landscape

  • 12.1 Market Structure
  • 12.2 Key Players
  • 12.3 Profiles of Key Players
    • 12.3.1 Pfizer, Inc.
    • 12.3.2 Novartis International AG
    • 12.3.3 Sanofi
    • 12.3.4 Boehringer Ingelheim
    • 12.3.5 Bristol-Myers Squibb
    • 12.3.6 Teva Pharmaceutical Industries Ltd.
    • 12.3.7 ELI Lilly and Company
    • 12.3.8 GlaxoSmithKline
    • 12.3.9 Merck & Co., Inc.
    • 12.3.10 Abbvie Inc