医薬品有効成分（API）の市場規模、シェア、動向、予測：薬剤タイプ別、メーカー別、合成タイプ別、治療用途別、地域別、2025～2033年

世界の医薬品有効成分（API）の市場規模は、2024年に2,455億9,000万米ドルとなりました。今後、IMARC Groupは、同市場が2033年までに3,689億8,000万米ドルに達し、2025～2033年にかけて4.40%のCAGRを示すと予測しています。現在、北米が市場を独占しており、2024年の市場シェアは38.0%を超えます。同市場は、強力な医薬品研究開発、高度な製造能力、生物製剤や専門治療薬に対する需要の高まり、慢性疾患の有病率の増加、医薬品開発・製造を奨励する規制当局の支援政策によって牽引されています。

米国では、革新的なジェネリック医薬品に対するニーズの高まりが医薬品有効成分（API）市場の成長を刺激し、90.8%のシェアを占めています。強力なヘルスケアインフラと医薬品研究開発への多額の投資がAPI市場成長の主な要因です。医薬品の承認手続きの迅速化や希少疾病用医薬品の開発奨励金などの規制上の取り組みが、新しい治療法の発売を促進しています。情報筋によると、2024年3月、Catalyst Pharmaceuticalsは、2歳以上のデュシェンヌ型筋ジストロフィー患者の治療薬として、米国でAGAMREE（R）（バモロロン）経口懸濁液を商業的に発売しました。さらに、慢性疾患、特に心血管疾患、糖尿病、がんの罹患率の増加は、APIによる有効な治療に対する需要を高めています。生物製剤や特殊医薬品への動向の高まりも原薬生産を促進しています。外国製薬メーカーへの依存を最小限に抑えるため、米国政府が国内製薬業の強化に取り組んでいることも、原薬製造工場への投資に拍車をかけています。加えて、連続製造やグリーンケミストリーの実践といった高度な製造技術により、生産効率が向上し、環境フットプリントも削減されています。医薬品パイプラインの成長と医療費の増加は、米国のAPI市場をさらに押し上げます。

医薬品有効成分（API）市場の動向

慢性疾患の増加

がん、心血管疾患、糖尿病などの慢性疾患の増加は市場発展にプラスに寄与しています。例えば、国際糖尿病連合（IDF）が発表した2022年のデータによると、糖尿病患者は2030年には6億4,300万米ドル、2045年には7億8,400万米ドルに増加すると予測されています。これとともに、オーストラリア統計局は2023年12月に、2022年に糖尿病を患ったオーストラリア人は約130万人で、オーストラリアの人口の5.3％を占めたと報告しています。そのほか、新規かつ革新的な医薬品の開発におけるAPIの広範な応用も世界市場を後押ししています。例えば、2023年3月にIndian Journal of Medical Researchに掲載された別の調査では、インドにおけるがんの有病率は2022年の146万人から2025年には157万人に増加するとされています。これらのデータはすべて、がん患者数が国内でいかに急速に増加しているかを示しています。

バイオテクノロジーとバイオ医薬品の進歩

製品の製法を追跡し、効率を最大化し、製品の品質を向上させるために、原薬の生産工程にデジタル技術とデータ分析を取り入れることが、原薬市場シェアの主な促進要因となっています。バイオテクノロジー業界の強力な投資シナリオもこの動向を支えています。2024年5月までに1億米ドル以上の資金を調達した新興企業は100社を超え、2023年の数字を上回ったと報告されています。興味深いことに、これらの高額案件のほぼ半数がバイオテクノロジー業界に属しており、投資家の楽観的な見方を反映しています。さらに、ワクチン、モノクローナル抗体、組換えタンパク質などのバイオ医薬品の進歩も市場の成長を後押ししています。例えば、2022年9月、生物製剤評価研究センター（CBER）は、Bluebird Bio, Inc.のSKYSONA（elivaldogene autotemcel）を認可しました。SKYSONAは、早期活動性脳性副腎白質ジストロフィー（CALD）の4～17歳の男児の神経機能障害の進行を遅らせる薬として承認されています。同様に2022年6月、CBERはGlaxoSmithKlineの麻疹・流行性耳下腺炎・風疹の生ワクチンであるPRIORIXを認可しました。したがって、これらの製品承認は新薬市場の存在感を高め、予測期間中に検討中の市場を成長させると予想されます。

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

患者に優しい治療に対する市場リーダーのニーズの高まりが、原薬ビジネスの成長を促進しています。さらに、薬の効果を高め、副作用を低減し、患者のコンプライアンスを向上させるための標的ドラッグデリバリーシステムの継続的な技術革新も、市場成長に有益であることが証明されています。米国食品医薬品局（FDA）は、2024年に医薬品評価研究センター（CDER）が50の新薬を承認したと発表し、新薬承認におけるマイルストーンとなりました。例えば、2022年4月、学術誌Nature Medicineの報告書は、多くの種類の腫瘍における診断と治療選択のためのゲノムプロファイリングの適用拡大が、がん患者における精密医療の使用を増大させたと宣言しました。さらに、BioRay Biopharmaceutical Co., Ltd.のズベリタマブ（Zuberitamab）は、がん患者における精密医療の利用を拡大しています。さらに、世界初のTYK2のアロステリック阻害剤であるSotyktu（deucravacitinib）が乾癬治療薬として承認され、AstraZenecaとMerck Sharp & Dohme (MSD)が共同開発したMEK阻害剤であるSelumetinibは、神経線維腫症i型（NF1）治療薬として中国で初めて承認されました。

目次

第1章 序文

第2章 調査範囲と調査手法

• 調査の目的
• ステークホルダー
• 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
• 主要業界動向

第5章 世界の医薬品有効成分（API）市場

• 市場概要
• 市場実績
• COVID-19の影響
• 市場内訳：薬剤タイプ別
• 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
• 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
• 価格分析

第6章 市場内訳：薬剤タイプ別

• 革新的医薬品有効成分（API）
• ジェネリック医薬品有効成分（API）

第7章 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APIメーカー
  • 革新的マーチャントAPIメーカー
  • ジェネリックマーチャントAPIメーカー

第8章 市場内訳：合成タイプ別

• 合成医薬品有効成分（API）
  • 市場内訳：タイプ別
    • 革新的合成API
    • ジェネリック合成API
• バイオテクノロジー医薬品有効成分
  • 市場内訳：タイプ別
    • 革新的バイオテクノロジーAPI
    • 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
    • 微生物
    • 酵母
    • 遺伝子組み換え動物
    • その他

第9章 市場内訳：治療用途別

• 腫瘍
• 心臓血管および呼吸器
• 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
• アジア太平洋地域
  • 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 API製造プロセス

• 製品概要
• 原材料の要件
• 製造プロセス
• 主要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

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 USD), 2019-2024
• Figure 3: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Drug Type (in %), 2024
• Figure 4: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Type of Manufacturer (in %), 2024
• Figure 5: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Type of Synthesis (in %), 2024
• Figure 6: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Therapeutic Application (in %), 2024
• Figure 7: Global: Active Pharmaceutical Ingredients (API) Market: Breakup by Region (in %), 2024
• Figure 8: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Billion USD), 2025-2033
• 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 USD), 2019 & 2024
• Figure 14: Global: Innovative Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 15: Global: Generic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 16: Global: Generic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 17: Global: Active Pharmaceutical Ingredients (Captive Manufacturers) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 18: Global: Active Pharmaceutical Ingredients (Captive Manufacturers) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 19: Global: Active Pharmaceutical Ingredients (Merchant API Manufacturers) Market: Sales Value (in Billion USD), 2019-2024
• Figure 20: Global: Active Pharmaceutical Ingredients (Merchant API Manufacturers) Market Forecast: Sales Value (in Billion USD), 2025-2033
• Figure 21: Global: Merchant API Manufacturers Market: Breakup by Type (in %), 2024
• Figure 22: Global: Merchant Generic API Manufacturers Market: Sales Value (in Million USD), 2019 & 2024
• Figure 23: Global: Merchant Generic API Manufacturers Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 24: Global: Merchant Innovative API Manufacturers Market: Sales Value (in Million USD), 2019 & 2024
• Figure 25: Global: Merchant Innovative API Manufacturers Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 26: Global: Synthetic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 27: Global: Synthetic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 28: Global: Synthetic Active Pharmaceutical Ingredients (API) Market: Breakup by Type (in %), 2024
• Figure 29: Global: Innovative Synthetic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 30: Global: Innovative Synthetic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 31: Global: Generic Synthetic Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 32: Global: Generic Synthetic Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 33: Global: Biotech Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 34: Global: Biotech Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 35: Global: Biotech Active Pharmaceutical Ingredients (API) Market: Breakup by Type (in %), 2024
• Figure 36: Global: Innovative Biotech Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 37: Global: Innovative Biotech Active Pharmaceutical Ingredients (API) Forecast: Sales Value (in Million USD), 2025-2033
• Figure 38: Global: Biotech Active Pharmaceutical Ingredients (Biosimilars) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 39: Global: Biotech Active Pharmaceutical Ingredients (Biosimilars) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 40: Global: Biotech Active Pharmaceutical Ingredients (API) Market: Breakup by Product Type (in %), 2024
• Figure 41: Global: Biotech Active Pharmaceutical Ingredients (Monoclonal Antibodies) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 42: Global: Biotech Active Pharmaceutical Ingredients (Monoclonal Antibodies) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 43: Global: Biotech Active Pharmaceutical Ingredients (Vaccines) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 44: Global: Biotech Active Pharmaceutical Ingredients (Vaccines) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 45: Global: Biotech Active Pharmaceutical Ingredients (Cytokines) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 46: Global: Biotech Active Pharmaceutical Ingredients (Cytokines) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 47: Global: Biotech Active Pharmaceutical Ingredients (Fusion Proteins) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 48: Global: Biotech Active Pharmaceutical Ingredients (Fusion Proteins) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 49: Global: Biotech Active Pharmaceutical Ingredients (Therapeutic Enzymes) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 50: Global: Biotech Active Pharmaceutical Ingredients (Therapeutic Enzymes) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 51: Global: Biotech Active Pharmaceutical Ingredients (Blood Factors) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 52: Global: Biotech Active Pharmaceutical Ingredients (Blood Factors) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 53: Global: Biotech Active Pharmaceutical Ingredients Market: Breakup by Expression System (in %), 2024
• Figure 54: Global: Biotech Active Pharmaceutical Ingredients (Mammalian Expression Systems) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 55: Global: Biotech Active Pharmaceutical Ingredients (Mammalian Expression Systems) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 56: Global: Biotech Active Pharmaceutical Ingredients (Microbial Expression Systems) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 57: Global: Biotech Active Pharmaceutical Ingredients (Microbial Expression Systems) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 58: Global: Biotech Active Pharmaceutical Ingredients (Yeast Expression Systems) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 59: Global: Biotech Active Pharmaceutical Ingredients (Yeast Expression Systems) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 60: Global: Biotech Active Pharmaceutical Ingredients (Transgenic Animal Systems) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 61: Global: Biotech Active Pharmaceutical Ingredients (Transgenic Animal Systems) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 62: Global: Biotech Active Pharmaceutical Ingredients (Others) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 63: Global: Biotech Active Pharmaceutical Ingredients (Others) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 64: Global: Active Pharmaceutical Ingredients (Oncology) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 65: Global: Active Pharmaceutical Ingredients (Oncology) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 66: Global: Active Pharmaceutical Ingredients (Cardiovascular and Respiratory Disease) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 67: Global: Active Pharmaceutical Ingredients (Cardiovascular and Respiratory Disease) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 68: Global: Active Pharmaceutical Ingredients (Diabetes) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 69: Global: Active Pharmaceutical Ingredients (Diabetes) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 70: Global: Active Pharmaceutical Ingredients (Central Nervous System Disorders) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 71: Global: Active Pharmaceutical Ingredients (Central Nervous System Disorders) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 72: Global: Active Pharmaceutical Ingredients (Neurological Disorders) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 73: Global: Active Pharmaceutical Ingredients (Neurological Disorders) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 74: Global: Active Pharmaceutical Ingredients (Other Applications) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 75: Global: Active Pharmaceutical Ingredients (Other Applications) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 76: North America: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 77: North America: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 78: United States: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 79: United States: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 80: Canada: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 81: Canada: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 82: Europe: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 83: Europe: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 84: Germany: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 85: Germany: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 86: France: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 87: France: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 88: United Kingdom: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 89: United Kingdom: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 90: Italy: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 91: Italy: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 92: Spain: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 93: Spain: Active Pharmaceutical Ingredients Market (API) Forecast: Sales Value (in Million USD), 2025-2033
• Figure 94: Russia: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 95: Russia: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 96: Others: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 97: Others: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 98: Asia Pacific: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 99: Asia Pacific: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 100: China: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 101: China: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 102: Japan: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 103: Japan: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 104: India: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 105: India: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 106: South Korea: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 107: South Korea: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 108: Australia: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 109: Australia: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 110: Indonesia: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 111: Indonesia: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 112: Others: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 113: Others: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 114: Middle East and Africa: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 115: Middle East and Africa: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 116: Latin America: Active Pharmaceutical Ingredients (API) Market: Sales Value (in Million USD), 2019 & 2024
• Figure 117: Latin America: Active Pharmaceutical Ingredients (API) Market Forecast: Sales Value (in Million USD), 2025-2033
• Figure 118: API Manufacturing (Chemical Synthesis): Process Flow

List of Tables

• Table 1: Global: Active Pharmaceutical Ingredients (API) Market: Key Industry Highlights, 2024 and 2033
• Table 2: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Drug Type (in Million USD), 2025-2033
• Table 3: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Type of Manufacturer (in Million USD), 2025-2033
• Table 4: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Type of Synthesis (in Million USD), 2025-2033
• Table 5: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Therapeutic Application (in Million USD), 2025-2033
• Table 6: Global: Active Pharmaceutical Ingredients (API) Market Forecast: Breakup by Region (in Million USD), 2025-2033
• 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

The global active pharmaceutical ingredients (API) market size was valued at USD 245.59 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 368.98 Billion by 2033, exhibiting a CAGR of 4.40% from 2025-2033. North America currently dominates the market, holding a market share of over 38.0% in 2024. The market is led by strong pharmaceutical R&D, advanced manufacturing capacity, rising demand for biologics and specialty therapies, increasing prevalence of chronic diseases, and supportive regulatory policies encouraging drug development and manufacture.

In the USA, the active pharmaceutical ingredients (API) market growth is stimulated by the mounting need for innovative and generic drugs with the share of 90.8%. Its strong healthcare infrastructure and heavy investments in pharmaceutical research and development are major drivers for the growth in API markets. Regulatory efforts, such as speeded-up drug approval procedures and orphan drug development incentives, have facilitated the launch of new treatments. According to the sources, in March 2024, Catalyst Pharmaceuticals commercially launched AGAMREE(R) (vamorolone) oral suspension in the U.S. for treating Duchenne muscular dystrophy in patients aged two years and older. Moreover, the heightening incidence of chronic diseases, especially cardiovascular conditions, diabetes, and cancer, fuels API demand for efficacious treatments. The growing trend toward biologics and specialty pharmaceuticals also fuels API production. The effort of the U.S. government to enhance domestic pharma manufacturing to minimize dependence on foreign drug makers has spurred investments in API manufacturing plants. In addition, advanced manufacturing technologies, such as continuous manufacturing and practices of green chemistry, have increased production efficiency as well as cut down on the environmental footprint. The growing pharma pipeline along with higher health expenditure further propel the U.S. API market.

Active Pharmaceutical Ingredients (API) Market Trends:

Rising Prevalence of Chronic Diseases

The increasing number of chronic diseases, such as cancer, cardiovascular diseases, and diabetes, are contributing positively towards the development of the market. For instance, according to 2022 data published by the International Diabetes Federation (IDF), diabetic instances are anticipated to increase to USD 643 Million and USD 784 Million by 2030 and 2045, respectively. Along with this, the Australian Bureau of Statistics reported in December 2023 that there were approximately 1.3 million Australians who had diabetes in 2022 and it made up 5.3% of Australia's population. Besides, the extensive application of APIs in the development of novel and innovative drugs is also fueling the global market. For instance, in March 2023, yet another study in Indian Journal of Medical Research, the prevalence of cancer in India is set to rise from 1.46 million in 2022 to 1.57 million in 2025. All this data indicates how quickly the number of cancer cases is increasing in the country.

Advancements in Biotechnology and Biopharmaceuticals

The incorporation of digital technologies and data analytics in API production processes to track product methods, maximize efficiency, and enhance the product quality is the key driver for the active pharmaceutical ingredient market share. The biotech industry's strong investment scenario also supports the trend. It has been reported that more than 100 startups raised USD 100 Million or more in funding rounds through May 2024, beating 2023's figure. Interestingly, almost half of these high-value deals belonged to the biotech industry, reflecting robust investor optimism. In addition, progress in biopharmaceuticals, such as vaccines, monoclonal antibodies, and recombinant proteins, is also driving the growth of the market. For example, in September 2022, the Center for Biologics Evaluation and Research (CBER) licensed Bluebird Bio, Inc.'s SKYSONA (elivaldogene autotemcel), which is approved to delay the progression of neurologic dysfunction in boys 4-17 years old with early, active cerebral adrenoleukodystrophy (CALD). Likewise, in June 2022, CBER licensed GlaxoSmithKline's PRIORIX, a live vaccine for measles, mumps, and rubella. Therefore, these product approvals enhance the market presence of new drugs, which is anticipated to grow the market under consideration during the forecast period.

Focus on Personalized Medicine and Targeted Drug Delivery Systems

The evolving need of the market leaders towards patient-friendlier therapies is fueling the growth of the active pharmaceutical ingredient business. Moreover, the continuous innovation in targeted drug delivery systems to improve the effectiveness of medicine, lower side effects, and increase patient compliance is also proving to be beneficial to the market growth. The U.S. Food and Drug Administration (FDA) announced that in 2024, the Center for Drug Evaluation and Research (CDER) approved 50 new drugs, representing a milestone in the new therapy approval. For instance, in April 2022, a report in the journal Nature Medicine declared that the expanding application of genomic profiling for diagnosis and treatment choice in many types of tumors has augmented the use of precision medicine in cancer patients. Further, Zuberitamab of BioRay Biopharmaceutical Co., Ltd. In addition, the world's first allosteric inhibitor of TYK2, Sotyktu (deucravacitinib), was approved for the treatment of psoriasis and Selumetinib, a MEK inhibitor co-developed by AstraZeneca and Merck Sharp & Dohme (MSD), was the first drug approved in China for neurofibromatosis type I (NF1) treatment.

Active Pharmaceutical Ingredients (API) Industry Segmentation:

Analysis by Drug Type:

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

Innovative active pharmaceutical ingredients (APIs) are expected to capture a 63.2% market share in 2024 due to innovations in drug discovery and the personalized medicine movement. The increased emphasis on targeted therapies for rare and chronic diseases has improved demand for innovative APIs. Drug companies are investing significantly in research and development to design new drugs with increased efficacy and improved safety. Regulatory bodies are also extending their support through accelerated approval programs for breakthrough therapies, boosting innovation further. Moreover, growth in the number of biologics and gene therapies has initiated the creation of niche APIs. The growth of biopharmaceutical research and growing usage of precision medicine are also boosting the market. Improvements in technology for synthetic biology and drug development are backing productive production processes. As patients highly demand advanced treatment, the innovative APIs market is likely to continue its strong growth in the future.

Analysis by Type of Manufacturer:

• Captive Manufacturers
• Merchant API Manufacturers
  • Innovative Merchant API Manufacturers
  • Generic Merchant API Manufacturers

Captive manufacturers are projected to hold 50.6% of the active pharmaceutical ingredients (API) market share in 2024, driven by the increasing focus on supply chain security and quality control. In-house API production is becoming a major reliance for pharmaceutical companies as it helps them ensure consistency, stay compliant with regulations, and protect proprietary formulas. This mode of manufacturing provides increased flexibility in production processes, simplified operations, and less reliance on third-party suppliers. Captive manufacturing also enables pharmaceutical firms to scale up production effectively in reaction to market needs. In addition, the emphasis on biologics and personalized medicine has propelled the demand for customized API manufacturing capabilities within owned facilities. Sustained investment in cutting-edge manufacturing technologies and process optimization has further entrenched the position of captive manufacturers. As regulatory oversight grows and high-quality APIs are demanded, pharmaceutical companies are likely to continue relying on captive manufacturing for more control and reliability over operations.

Analysis 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 active pharmaceutical ingredients (APIs) are estimated to hold market share of 71.8% in the year 2024 due to their extensive use in the development of small molecule drugs. Synthetic APIs are better due to their cost-sensitivity, scalability, and streamlined production methods. Improved chemical synthesis methodologies, such as green chemistry and continuous manufacturing, have made production more efficient with less wastage. Moreover, synthetic APIs are found to be applied widely in treating chronic diseases including cardiovascular diseases, diabetes, and infectious diseases. Synthetic route optimization is also invested in by pharma companies in order to drive yield and costs of production downward. As markets for generic and specialty drugs rise, demand for synthetic APIs stays robust. Innovation in the development of synthetic APIs is supported continuously by regulatory authorities, promoting low-cost, quality medicines. The increasing incidence of chronic diseases as well as augmenting pharmaceutical R&D expenditure is also likely to propel the market for synthetic API.

• Oncology
• Cardiovascular and Respiratory
• Diabetes
• Central Nervous System Disorders
• Neurological Disorders
• Others

The oncology segment is expected to account for a market share of 21.2% in 2024 in the active pharmaceutical ingredients (API) market, underpinned by the increasing incidence of cancer across the globe. The growing need for targeted therapy, immunotherapy, and personalized medicine has highly increased the requirement for quality APIs in oncology drug development. Ongoing research and development as well as clinical trials for emerging cancer therapies further propel market growth. Moreover, regulatory bodies are providing expedited approval pathways for breakthrough cancer medicines, prompting drug manufacturers to accelerate production of APIs. Increasing usage of combination therapy and biologics' development is also broadening the scope of cancer treatment using APIs. Advances in technology for API synthesis and formulation are improving drug effectiveness and patient outcomes. With growing cancer incidence and broadening oncology drug pipelines, demand for APIs in this therapeutic area is likely to continue strong.

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa

North America is expected to have a market share of 38.0% in 2024 in the active pharmaceutical ingredients (API) market, led by a matured pharmaceutical industry and high spending on drug research and development. The robust regulatory environment in the region guarantees the production of high-quality APIs, promoting ongoing innovation and technological upgradation. Growing incidence of chronic diseases such as cancer, cardiovascular diseases, and diabetes has created a high demand for APIs in North America. Furthermore, the increased emphasis on biologics, specialty pharmaceuticals, and targeted therapies has also fueled the demand for advanced APIs. The presence of large pharmaceutical companies and state-of-the-art production units strengthens local market growth. Government programs to increase domestic API production and lower dependence on imports have also favored market growth. With rising healthcare expenditure and the ongoing launch of new therapies, North America continues to be a leader in the worldwide API market.

Key Regional Takeaways:

United States Active Pharmaceutical Ingredients (API) Market Analysis

The API market in the United States is growing strongly due to rising pharma production, growing demand for specialty medicines, and advances in biotechnology. A robust healthcare infrastructure and good R&D investment are driving API innovation. Increased incidence of chronic diseases and the aging population are also propelling demand for high-quality APIs. 42% of Americans have two or more chronic conditions, and 12% have five or more, as stated by the CDC, emphasizing the growing demand for efficient pharmaceutical drugs. The implementation of new manufacturing methods, including continuous manufacturing and green chemistry, is enhancing efficiency and sustainability in production. Regulation and high quality standards are dictating the market, promoting the manufacture of high-purity APIs. Growing use of biologics and biosimilars is also largely driving the growth of the market. Growing associations between drug makers and API manufacturers are also augmenting the supply chain's efficiency and rising capacities. Based on strong technological support and top-grade API manufacturing, the market will see constant growth, augmenting the changing requirements of the pharmaceutical industry.

Europe Active Pharmaceutical Ingredients (API) Market Analysis

The European API market is experiencing steady growth as a result of the growing pharmaceutical industry, improved drug formulations, and robust regulatory mechanisms guaranteeing quality production. Growing demand for novel medicines, in addition to a concentration on individualized healthcare, is stimulating API development. The market is boosted by large research investments, which allow new therapies to be introduced. The use of cutting-edge pharma manufacturing technology, such as automation and green chemistry, is further increasing efficiency. The increasing trend of biologics and biosimilars is driving the API scenario, with a focus on high-value API manufacture by manufacturers. Significantly, the Europe biosimilar market had reached USD 13,864 Million in 2024 and is expected to grow at a CAGR of 17.1% for 2025-2033, reaching USD 59,733.3 Million by 2033, as per IMARC Group. This fast growth is propelling demand for premium APIs, most notably in the biologics space.

Asia Pacific Active Pharmaceutical Ingredients (API) Market Analysis

The Asia Pacific API market is growing at a fast pace based on growing pharma production, rising generic medicine demand, and advances in pharmaceutical manufacturing technology. The region has the advantage of an expanding health sector and improving R&D investment in high-quality API manufacturing. The use of innovative manufacturing practices, including automation and continuous processing, is enhancing efficiency and value for money. The market for biologics and biosimilars is on the rise, and hence production of APIs in this category is increasing. Also, the region's robust export performance in the pharmaceutical sector is driving growth in the market. Pharmaceutical and drug exports at USD 2.13 Billion during July 2023 rose by 8.36% to USD 2.31 Billion during July 2024, as per the Press Information Bureau. This points to the region's increasing production capacity and increasing global footprint in the supply of APIs. The emphasis on sustainability and adherence to international quality standards is also redefining market dynamics, leading to innovation and growth.

Latin America Active Pharmaceutical Ingredients (API) Market Analysis

The Latin America API market is increasing consistently with the growth of the pharmaceutical industry and growing demand for cheap drugs. The increased production of generic medicines and the increasing emphasis on new drug formulations are driving market growth. Significantly, the generic drug market in Brazil amounted to USD 22.4 Billion in 2024 and is expected to grow at a CAGR of 6.43% during 2025-2033, reaching USD 39.3 Billion by 2033, as per IMARC Group. This growing demand for generics is fueling the demand for affordable and quality APIs in the region. Investment in pharmaceutical R&D, new processes of manufacturing, and transition to high-value APIs are enhancing the production capability and global competitiveness and making Latin America a strong player.

Middle East and Africa Active Pharmaceutical Ingredients (API) Market Analysis

The Middle East and Africa API market is expanding based on pharmaceutical sector growth, increasing demand for crucial medicines, new manufacturing methods, and joint ventures between drug makers and pharma companies, boosting production and supply chain efficiency. Industrial Center forecasts that the KSA pharmaceutical sector will grow at a 4.1% rate until 2024 and reach about USD 9.6 Billion. This expansion indicates the growing needs for pharmaceuticals within the region, which fuels the growing requirement for quality APIs. The development of the healthcare sector and targeted investment in drug production is strengthening the API market further, with the region positioning itself as an emerging force within the global supply chain of pharmaceuticals.

Competitive Landscape:

The API market is dominated by a large number of manufacturers, varying from large pharmaceutical corporations to specialized API manufacturers. Businesses are increasing their production levels in order to accommodate the increased demand for new as well as generic APIs. Research and development investments are promoting the development of new technologies in synthesis and green manufacturing techniques. Contract development and manufacturing organizations (CDMOs) are important in offering specialized API manufacturing services, assisting pharmaceutical firms in complying with regulatory requirements and ensuring supply chain effectiveness. Local market players are also concentrating on producing affordable APIs for export and local consumption. Mergers, acquisitions, and alliances are prevalent means of improving production capacity and geographical presence. Furthermore, advances in biotechnology and increased emphasis on individualized medicine are adding to the competitive landscape, driving ongoing innovation and effective manufacturing in the international API market.

The report provides a comprehensive analysis of the competitive landscape in the active pharmaceutical ingredients (API) market with detailed profiles of all major companies, including:

• 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.

Key Questions Answered in This Report

• 1.How big is the active pharmaceutical ingredients (API) market?
• 2.What is the future outlook of active pharmaceutical ingredients (API) market?
• 3.What are the key factors driving the active pharmaceutical ingredients (API) market?
• 4.Which region accounts for the largest active pharmaceutical ingredients (API) market share?
• 5.Which are the leading 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