Table of Content

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 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

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