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Active Pharmaceutical Ingredients: Global Markets

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    Report

  • 119 Pages
  • October 2024
  • Region: Global
  • BCC Research
  • ID: 5232555
UP TO OFF until Aug 31st 2033
The Active Pharmaceutical Ingredients Market was valued at USD 247.8 billion in 2024, and is expected to reach USD 347.9 billion by 2029, rising at a CAGR of 5.90%. In the global pharmaceutical supply chain, APIs act as the building blocks for drug development and manufacturing. The rising demand for specialty drugs and the widespread use of generic medicines is driving this growth. Technological advances in API production, scaling production capacities, the rising incidence of chronic diseases, expanding global healthcare infrastructures and increased investments in drug development are also driving this growth.

Chemical synthesis of APIs is the main method for the production of APIs and acts as a replacement for natural extraction procedures to improve economies of scale. The global market for synthetically manufactured APIs was valued at $181.3 billion in 2023, and this market is expected to achieve a CAGR of 5.4% and reach a value of $246.1 billion by the end of 2029. The importance of biotech production methods is growing due to the rise of biologic drug products made almost exclusively this way. Advances in synthetic biology technologies, such as genetic engineering, metabolic pathway optimization and analytical instrumentation, have further enhanced the efficiency and yield of biotechnology processes, making them more commercially viable. The global market for APIs manufactured through biotech methods was valued at $66.5 billion in 2023, and this market is expected to have a CAGR of 7.4% and reach a value of $101.7 billion by the end of 2029.

The COVID-19 pandemic exposed the risks of over-reliance on specific regions for API production. As a result, there is a trend toward diversifying the supply chain and increasing domestic API manufacturing capabilities in the U.S., Europe, Japan and India to enhance supply chain resilience.

Report Scope

This goal of this report is to impart in-depth knowledge of the global market for active pharmaceutical ingredients (APIs), in terms of both qualitative and quantitative data, to help readers assess the market landscape, develop business/growth strategies, and analyze their market position. BCC Research estimates market size for 2023 (the base year) and forecasts values for 2024 by the end of 2029. It is important to note that market size reflects the demand for APIs within a region or country rather than the API industry itself. In this report, the API market is analyzed by manufacturer type, production method, molecule type, region and country. Industry growth trends, drivers, restraints and opportunities in the API market are also discussed in detail. The scope of the study is global.

The report includes:

  • 64 data tables and 38 additional tables
  • An analysis of the global markets for active pharmaceutical ingredients (APIs)
  • Analyses of global market trends, with market revenue data from 2022 to 2023, estimates for 2024, forecast for 2025, and projected CAGRs through 2029
  • Estimates of the size and revenue prospects of the global market, along with a market share analysis by origin, drug molecular entity type, manufacturer type, end use and region
  • Facts and figures pertaining to the market dynamics, technical advances, API sources, production methods, route of synthesis, regulations, and the impact of macroeconomic variables
  • A Porter's Five Forces model, and global supply chain and PESTLE analyses
  • Patent activity featuring issues like patent expiry and its impact on the pharmaceutical market, and details of changes in pharmaceutical drug development
  • Overview of sustainability trends and ESG developments, with emphasis on consumer attitudes, ESG score analysis, and the ESG practices of leading companies
  • Analysis of the industry structure, including companies' market shares, strategic alliances, M&A activity and a venture funding outlook
  • Company profiles of major players within the industry, including Pfizer Inc., Thermo Fisher Scientific Inc., EuroAPI, Lonza, Siegfried Holding AG, and Divi's Laboratories Ltd.

Table of Contents

Chapter 1 Executive Summary
  • Market Outlook
  • Scope of Report
  • Market Summary
Chapter 2 Market Overview
  • APIs Defined
  • Global API Supply Chain
  • API Production Methods
  • API Production: Route of Synthesis
  • Production Methods
Chapter 3 Market Dynamics
  • Market Dynamics Snapshot
  • Market Drivers
  • Resilient Pharmaceutical Demand
  • Increase in Adoption of Generics
  • Shift to More Complex Chemical Entities
  • Growth in the Biologics Market
  • Advances in API Manufacturing
  • Government Support
  • Market Restraints
  • Strict Regulations and Compliance Requirements
  • Pricing Pressure in the Generic API Industry
  • Shortage of Skilled Professionals
  • Market Trends
  • Increasing Demand for Complex APIs
  • Regional Diversification and Supply Chain Resilience
  • Continuous Flow Manufacturing
  • Expansion of Single-Use Technologies
  • Growing Sustainability Practices in API Manufacturing
  • Increased Outsourcing and CDMO Partnerships
Chapter 4 Emerging Technologies and Developments
  • Biocatalysis for Complex Synthetic API Manufacturing
  • Integration of AI and ML
  • Flexible Manufacturing
Chapter 5 Market Segmentation Analysis
  • Segmentation Breakdown
  • API Market, by Manufacturer Type
  • Captive and Contract Manufacturing Market
  • Merchant Market
  • API Market, by Production Method
  • Chemical Synthesis
  • Biotech
  • API Market, by Molecule Type
  • Small-Molecule APIs
  • Large Molecule
  • Geographic Breakdown
  • API Market, by Region
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
Chapter 6 Competitive Intelligence
  • Supplier Landscape
  • Captive Manufacturers
  • Contract Manufacturers
  • Merchant Manufacturers
  • Generic API Market Landscape
  • Innovative API Market Landscape
  • Porter’s Five Forces Analysis
Chapter 7 Appendix
  • Methodology
  • Sources
  • Abbreviations
  • Company Profiles
  • AUROBINDO PHARMA
  • DIVI’S LABORATORIES LTD.
  • EUROAPI
  • EVONIK INDUSTRIES AG
  • LONZA
  • PFIZER INC.
  • SIEGFRIED HOLDING AG
  • TEVA PHARMACEUTICAL INDUSTRIES LTD.
  • THERMO FISHER SCIENTIFIC INC.
  • WUXI APPTEC
List of Tables
Summary Table: Global Market for APIs, by Production Method, Through 2029
Table 1: Regulatory Requirements of GMP and Supply Chain Integrity for APIs
Table 2: Recent Spin-offs and Separations of API Companies
Table 3: Biocatalysis in API Production: Benefits and Challenges
Table 4: Global Market for APIs, by Manufacturer Type, Through 2029
Table 5: Global Market for Captive and Contract Manufacturer APIs, by Region, Through 2029
Table 6: Global Market for Merchant APIs, by Region, Through 2029
Table 7: Global Market for APIs, by Production Method, Through 2029
Table 8: Biotech Production Methods: Attributes and Applications
Table 9: Global Market for Biotech APIs, by Production Method, Through 2029
Table 10: Global Market for APIs, by Molecule Type, Through 2029
Table 11: Characteristics of Small Molecules
Table 12: Global Market for Small-Molecule APIs, by Type, Through 2029
Table 13: Global Market for Small-Molecule APIs, by Manufacturer Type, Through 2029
Table 14: Characteristics of Large Molecules/Biologics
Table 15: Global Market for Large-Molecule APIs, by Type, Through 2029
Table 16: Global Market for Large-Molecule APIs, by Manufacturer Type, Through 2029
Table 17: Global Market for APIs, by Region, Through 2029
Table 18: North American Market for APIs, by Manufacturer Type, Through 2029
Table 19: North American Market for APIs, by Production Method, Through 2029
Table 20: North American Market for APIs, by Molecule Type, Through 2029
Table 21: North American Market for APIs, by Country, Through 2029
Table 22: U.S. Market for APIs, by Production Method, Through 2029
Table 23: U.S. Market for APIs, by Molecule Type, Through 2029
Table 24: Canadian Market for APIs, by Production Method, Through 2029
Table 25: Canadian Market for APIs, by Molecule Type, Through 2029
Table 26: Mexican Market for APIs, by Production Method, Through 2029
Table 27: Mexican Market for APIs, by Molecule Type, Through 2029
Table 28: European Market for APIs, by Manufacturer Type, Through 2029
Table 29: European Market for APIs, by Production Method, Through 2029
Table 30: European Market for APIs, by Molecule Type, Through 2029
Table 31: European Market for APIs, by Country, Through 2029
Table 32: German Market for APIs, by Production Method, Through 2029
Table 33: German Market for APIs, by Molecule Type, Through 2029
Table 34: French Market for APIs, by Production Method, Through 2029
Table 35: French Market for APIs, by Molecule Type, Through 2029
Table 36: U.K. Market for APIs, by Production Method, Through 2029
Table 37: U.K. Market for APIs, by Molecule Type, Through 2029
Table 38: Italian Market for APIs, by Production Method, Through 2029
Table 39: Italian Market for APIs, by Molecule Type, Through 2029
Table 40: Spanish Market for APIs, by Production Method, Through 2029
Table 41: Spanish Market for APIs, by Molecule Type, Through 2029
Table 42: Rest of European Market for APIs, by Production Method, Through 2029
Table 43: Rest of European Market for APIs, by Molecule Type, Through 2029
Table 44: Asia-Pacific Market for APIs, by Manufacturer Type, Through 2029
Table 45: Asia-Pacific Market for APIs, by Production Method, Through 2029
Table 46: Asia-Pacific Market for APIs, by Molecule Type, Through 2029
Table 47: Asia-Pacific Market for APIs, by Country, Through 2029
Table 48: Chinese Market for APIs, by Production Method, Through 2029
Table 49: Chinese Market for APIs, by Molecule Type, Through 2029
Table 50: Japanese Market for APIs, by Production Method, Through 2029
Table 51: Japanese Market for APIs, by Molecule Type, Through 2029
Table 52: Indian Market for APIs, by Production Method, Through 2029
Table 53: Indian Market for APIs, by Molecule Type, Through 2029
Table 54: Rest of APAC Market for APIs, by Production Method, Through 2029
Table 55: Rest of APAC Market for APIs, by Molecule Type, Through 2029
Table 56: RoW Market for APIs, by Manufacturer Type, Through 2029
Table 57: RoW Market for APIs, by Production Method, Through 2029
Table 58: RoW Market for APIs, by Molecule Type, Through 2029
Table 59: RoW Market for APIs, by Country, Through 2029
Table 60: Key API Manufacturers
Table 61: Report Sources
Table 62: Abbreviations Used in this Report
Table 63: Aurobindo Pharma: Company Snapshot
Table 64: Aurobindo Pharma: Financial Performance, FY 2023 and 2024
Table 65: Aurobindo Pharma: Product Portfolio
Table 66: Aurobindo Pharma: News/Key Developments, 2022-2024
Table 67: Divi’s Laboratories Ltd.: Company Snapshot
Table 68: Divi’s Laboratories Ltd.: Financial Performance, FY 2023 and 2024
Table 69: Divi’s Laboratories Ltd.: Product Portfolio
Table 70: EUROAPI: Company Snapshot
Table 71: EUROAPI: Financial Performance, FY 2022 and 2023
Table 72: EUROAPI: Product Portfolio
Table 73: EUROAPI: News/Key Developments, 2022-2024
Table 74: Evonik Industries AG: Company Snapshot
Table 75: Evonik Industries AG: Financial Performance, FY 2022 and 2023
Table 76: Evonik Industries AG: Product Portfolio
Table 77: Evonik Industries AG: News/Key Developments, 2022-2024
Table 78: Lonza: Company Snapshot
Table 79: Lonza: Financial Performance, FY 2022 and 2023
Table 80: Lonza: Product Portfolio
Table 81: Lonza: News/Key Developments, 2022-2024
Table 82: Pfizer Inc.: Company Snapshot
Table 83: Pfizer Inc.: Financial Performance, FY 2022 and 2023
Table 84: Pfizer Inc: Product Portfolio
Table 85: Pfizer Inc.: News/Key Developments, 2022-2024
Table 86: Siegfried Holding AG: Company Snapshot
Table 87: Siegfried Holding AG: Financial Performance, FY 2022 and 2023
Table 88: Siegfried Holding AG: Product Portfolio
Table 89: Siegfried Holding AG: News/Key Developments, 2022-2024
Table 90: Teva Pharmaceutical Industries Ltd.: Company Snapshot
Table 91: Teva Pharmaceutical Industries Ltd.: Financial Performance, FY 2022 and 2023
Table 92: Teva Pharmaceutical Industries Ltd.: Product Portfolio
Table 93: Teva Pharmaceutical Industries Ltd.: News/Key Developments, 2022-2024
Table 94: Thermo Fisher Scientific Inc.: Company Snapshot
Table 95: Thermo Fisher Scientific Inc.: Financial Performance, FY 2022 and 2023
Table 96: Thermo Fisher Scientific Inc.: Product Portfolio
Table 97: Thermo Fisher Scientific Inc.: News/Key Developments, 2023 and 2024
Table 98: WuXi AppTec: Company Snapshot
Table 99: WuXi AppTec: Financial Performance, FY 2022 and 2023
Table 100: WuXi AppTec: Product Portfolio
Table 101: WuXi AppTec: News/Key Developments, 2022-2024
List of Figures
Summary Figure: Global Market Shares of APIs, by Production Method, 2023
Figure 1: End-to-End Pharmaceutical Supply Chain
Figure 2: API Market Supply Chain
Figure 3: Chemical Synthetic Process
Figure 4: Schematic Representation of Biological Production Process for APIs
Figure 5: Market Dynamics of Active Pharmaceutical Ingredients (APIs)
Figure 6: U.S. FDA ANDA Approvals, by Fiscal Year, 2020-2023
Figure 7: Share of U.S. FDA ANDA Approvals, by Generic Drug Type, 2020-2023
Figure 8: Share of Drug Molecules Approved by the FDA, by Molecule Type, 2016 to 2023
Figure 9: Novel Drugs Approved by the FDA, by Drug Type, 2018-2023
Figure 10: Global Market Shares of APIs, by Manufacturer Type, 2023
Figure 11: Global Market Shares of Captive and Contract Manufacturer APIs, by Region, 2023
Figure 12: Global Market Shares of Merchant APIs, by Region, 2023
Figure 13: Global Market Shares of APIs, by Production Method, 2023
Figure 14: Global Market Shares of Biotech APIs, by Production Method, 2023
Figure 15: Global Market Shares of APIs, by Molecule Type, 2023
Figure 16: Global Market Shares of Small-Molecule APIs, by Type, 2023
Figure 17: Global Market Shares of Small-Molecule APIs, by Manufacturer Type, 2023
Figure 18: Global Market Shares of Large-Molecule APIs, by Type, 2023
Figure 19: Global Market Shares of Large-Molecule APIs, by Manufacturer Type, 2023
Figure 20: Global Market Shares of APIs, by Region, 2023
Figure 21: Location of API Manufacturers Serving the U.S. Market, as of August 2023
Figure 22: Location of Finished Dosage Forms (FDF) Manufacturers Serving U.S. Market, as of August 2023
Figure 23: Sources of APIs Used in Medications Consumed in the U.S., Market Share by Dollar Value, 2021
Figure 24: Biopharmaceutical Manufacturing Facilities in the U.S., 2018-2023
Figure 25: North American Market for APIs, by Manufacturer Type, 2023
Figure 26: North American Market for APIs, by Production Method, 2023
Figure 27: North American Market for APIs, by Molecule Type, 2023
Figure 28: North American Market for APIs, by Country, 2023
Figure 29: European Market Shares of APIs, by Manufacturer Type, 2023
Figure 30: European Market Shares of APIs, by Production Method, 2023
Figure 31: European Market Shares of APIs, by Molecule Type, 2023
Figure 32: European Market Shares of APIs, by Country, 2023
Figure 33: Share of Manufacturing Sites of APIs for U.S. Market, by Country/Region, August 2019
Figure 34: India’s Drug and Pharmaceuticals Exports, 2016/2017 to 2023/2024
Figure 35: Asia-Pacific Market Shares of APIs, by Manufacturer Type, 2023
Figure 36: Asia-Pacific Market Shares of APIs, by Production Method, 2023
Figure 37: Asia-Pacific Market Shares of APIs, by Molecule Type, 2023
Figure 38: Asia-Pacific Market Shares of APIs, by Country, 2023
Figure 39: RoW Market Shares of APIs, by Manufacturer Type, 2023
Figure 40: RoW Market Shares of APIs, by Production Method, 2023
Figure 41: RoW Market Shares of APIs, by Molecule Type, 2023
Figure 42: RoW Market Shares of APIs, by Country, 2023
Figure 43: Aurobindo Pharma: Revenue Share, by Business Unit, FY 2024
Figure 44: Aurobindo Pharma: Revenue Share: Revenue Share, by Country/Region, FY 2024
Figure 45: Divi’s Laboratories Ltd.: Revenue Share, by Country/Region, FY 2024
Figure 46: EUROAPI: Revenue Share, by Business Unit, FY 2023
Figure 47: Evonik Industries AG: Revenue Share, by Business Unit, FY 2023
Figure 48: Evonik Industries AG: Revenue Share, by Region, FY 2023
Figure 49: Lonza: Revenue Share, by Business Unit, FY 2023
Figure 50: Lonza: Revenue Share, by Region, FY 2023
Figure 51: Pfizer Inc.: Revenue Share, by Business Unit, 2023
Figure 52: Pfizer Inc.: Revenue Share, by Country/Region, 2023
Figure 53: Siegfried Holding AG: Market Share, by Business Unit, 2023
Figure 54: Teva Pharmaceutical Industries Ltd.: Market Share, by Business Unit, 2023
Figure 55: Thermo Fisher Scientific Inc.: Market Share, by Business Unit, 2023
Figure 56: Thermo Fisher Scientific Inc.: Revenue Share, by Country/Region, 2023
Figure 57: WuXi AppTec: Revenue Share, by Business Unit, FY 2023
Figure 58: WuXi AppTec: Revenue Share, by Country/Region, FY 2023

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Executive Summary

The global API market is expected to grow over the next five years, driven by the increasing demand for pharmaceutical products such as generics and biological drugs, price impacts from COVID-19 and the increasing demand for critical drugs, which are in short supply due to the pandemic.

Reasons for Doing This Study:

This dynamic market is changing the context of new developments, such as product launches, mergers and acquisitions, and partnership activities. The pharmaceutical market landscape has been undergoing myriad changes relative to outsourcing activities and patent expiry. The perceptions of different stakeholders in the pharmaceutical industry and the overall attractiveness of the market are the focus of the analysis in this report.


Companies Mentioned

  • Aurobindo Pharma
  • Divi's Laboratories Ltd.
  • Euroapi
  • Evonik Industries AG
  • Lonza
  • Pfizer Inc.
  • Siegfried Holding AG
  • Teva Pharmaceutical Industries Ltd.
  • Thermo Fisher Scientific Inc.
  • Wuxi Apptec

Table Information