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1754188

2025 年至 2033 年，活性藥物成分 (API) 市場規模、佔有率、趨勢及預測（按藥物類型、製造商類型、合成類型、治療應用和地區分類）

Active Pharmaceutical Ingredients (API) Market Size, Share, Trends and Forecast by Drug Type, Type of Manufacturer, Type of Synthesis, Therapeutic Application, and Region, 2025-2033
出版日期: | 出版商: IMARC | 英文 140 Pages | 商品交期: 2-3個工作天內

價格

2024年，全球活性藥物成分 (API) 市場規模為 2,455.9 億美元。展望未來， IMARC Group估計，到 2033 年，市場規模將達到 3,689.8 億美元，2025 年至 2033 年的複合年成長率為 4.40%。北美目前佔據市場主導地位，2024 年的市佔率將超過 38.0%。強大的醫藥研發實力、先進的製造能力、對生物製劑和專科療法日益成長的需求、慢性病患病率的上升以及鼓勵藥物開發和製造的支持性監管政策是市場發展的主導因素。

在美國，創新藥和學名藥需求的不斷成長刺激了活性藥物成分 (API) 市場的成長，佔比高達 90.8%。其強大的醫療基礎設施和對藥物研發的大力投入是 API 市場成長的主要驅動力。加速藥品核准程序和孤兒藥開發獎勵措施等監管措施促進了新療法的推出。消息人士透露，2024 年 3 月，Catalyst Pharmaceuticals 在美國商業化推出了 AGAMREE(R)（vamorolone）口服混懸液，用於治療兩歲及以上患者的杜氏肌肉營養不良症。此外，慢性疾病（尤其是心血管疾病、糖尿病和癌症）發生率的上升，刺激了對有效治療藥物 API 的需求。生物製劑和特殊藥物的日益成長的趨勢也推動了 API 的生產。美國政府致力於加強國內製藥業，以最大限度地減少對外國製藥商的依賴，這刺激了對 API 製造工廠的投資。此外，連續生產和綠色化學實踐等先進生產技術提高了生產效率，並減少了環境足跡。不斷成長的製藥產品線以及日益成長的醫療支出進一步推動了美國原料藥市場的發展。

活性藥物成分 (API) 市場趨勢：

慢性病盛行率上升

癌症、心血管疾病和糖尿病等慢性病的增加對市場的發展做出了積極的貢獻。例如，根據國際糖尿病聯盟 (IDF) 發布的 2022 年資料，預計到 2030 年和 2045 年糖尿病病例將分別增至 6.43 億美元和 7.84 億美元。同時，澳洲統計局在 2023 年 12 月報告稱，2022 年約有 130 萬澳洲人患有糖尿病，佔澳洲人口的 5.3%。此外，API 在新型創新藥物開發中的廣泛應用也推動了全球市場的發展。例如，2023 年 3 月，《印度醫學研究雜誌》的另一項研究顯示，印度的癌症盛行率將從 2022 年的 146 萬人上升到 2025 年的 157 萬人。所有這些資料都表明該國癌症病例數量的成長速度有多快。

生物技術和生物製藥的進展

將數位技術和資料分析融入原料藥 (API) 生產流程，以追蹤生產方法、最大限度提高效率並提升產品質量，是推動活性藥物成分市場佔有率成長的關鍵因素。生技產業強勁的投資前景也支撐了這一趨勢。據報道，截至 2024 年 5 月，已有超過 100 家新創公司在融資輪次中籌集了 1 億美元或以上的資金，超過了 2023 年的數字。值得注意的是，這些高價值交易中近一半屬於生技產業，反映出投資人的強烈樂觀情緒。此外，疫苗、單株抗體和重組蛋白等生物製藥領域的進展也推動了市場的成長。例如，2022年9月，生物製品評估與研究中心 (CBER) 批准了Bluebird Bio, Inc. 的 SKYSONA (elivaldogene autotemcel)，該藥物獲批用於延緩4-17歲早期活動性腦腎上腺腦白質營養不良 (CALD) 男孩的神經功能障礙進展。同樣，2022年6月，CBER 批准了葛蘭素史克的 PRIORIX，這是一種用於治療麻疹、腮腺炎和德國麻疹的活疫苗。因此，這些產品的批准增強了新藥的市場佔有率，預計在預測期內將推動市場成長。

專注於個人化醫療和標靶藥物傳輸系統

市場領導者對患者友善療法的需求不斷成長，這推動了活性藥物成分業務的成長。此外，針對藥物傳遞系統的持續創新，旨在提高藥物療效、降低副作用並增強患者依從性，也已被證明有利於市場成長。美國食品藥物管理局 (FDA) 宣布，2024 年，藥品評估與研究中心 (CDER) 將批准 50 種新藥，這標誌著新療法核准的里程碑。例如，2022 年 4 月，《自然醫學》雜誌的一篇報告指出，基因組分析在多種腫瘤診斷和治療選擇中的應用日益廣泛，這增強了精準醫療在癌症患者中的應用。此外，北京博銳生物製藥有限公司的Zuberitamab也已獲準。此外，全球首個TYK2變構抑制劑索泰克圖（deucravacitinib）獲準用於治療乾癬，阿斯特捷利康與默沙東（MSD）共同開發的MEK抑制劑司美替尼成為國內首個獲準用於治療I型神經纖維瘤病（NF1）的藥物。

目錄

第1章：前言

第2章：範圍與方法

  • 研究目標
  • 利害關係人
  • 資料來源
    • 主要來源
    • 次要來源
  • 市場評估
    • 自下而上的方法
    • 自上而下的方法
  • 預測方法

第3章：執行摘要

第4章：簡介

  • 概述
  • 主要行業趨勢

第5章：全球活性藥物成分 (API) 市場

  • 市場概覽
  • 市場表現
  • COVID-19的影響
  • 市場區隔：依藥物類型
  • 市場區隔：按製造商類型
  • 市場區隔：依合成類型
  • 市場區隔：按治療應用
  • 市場區隔：按地區
  • 市場預測
  • SWOT分析
  • 價值鏈分析
  • 波特五力分析
  • 價格分析

第6章：市場區隔：依藥物類型

  • 創新活性藥物成分 (API)
  • 通用活性藥物成分 (API)

第7章：市場細分：依製造商類型

  • 專屬製造商
  • 商家 API 製造商
    • 創新商家 API 製造商
    • 通用商家 API 製造商

第8章：市場區隔：依合成類型

  • 合成活性藥物成分 (API)
    • 市場區隔：按類型
      • 創新合成 API
      • 通用合成 API
  • 生物技術活性藥物成分 (API)
    • 市場區隔：按類型
      • 創新生物技術 API
      • 生物相似藥
    • 市場區隔：按產品
      • 單株抗體
      • 疫苗
      • 細胞因子
      • 融合蛋白
      • 治療性酵素
      • 血液因素
    • 市場區隔：按表達系統
      • 哺乳動物表達系統
      • 微生物表現系統
      • 酵母表現系統
      • 基因改造動物系統
      • 其他

第9章：市場區隔：依治療應用

  • 腫瘤學
  • 心血管和呼吸系統
  • 糖尿病
  • 中樞神經系統疾病
  • 神經系統疾病
  • 其他

第10章：市場細分：按地區

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙
    • 俄羅斯
    • 其他
  • 亞太地區
    • 中國
    • 日本
    • 印度
    • 韓國
    • 澳洲
    • 印尼
    • 其他
  • 拉丁美洲
  • 中東和非洲

第 11 章：API 生產流程

  • 產品概述
  • 原料需求
  • 製造過程
  • 關鍵成功因素與風險因素

第 12 章：競爭格局

  • 市場結構
  • 關鍵參與者
  • 關鍵參與者簡介
    • 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
Product Code: SR112025A1142

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

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