북미의 원료의약품 시장 규모, 점유율, 동향 분석 보고서 : 합성 유형별, 제조업체별, 유형별, 용도별, 국가별, 부문별 예측(2025-2033년)

North America Active Pharmaceutical Ingredients Market Summary

The North America active pharmaceutical ingredients market was estimated at USD 96.64 million in 2024 and is projected to reach USD 147.34 million by 2033, growing at a CAGR of 4.76% from 2025 to 2033. The increasing demand for generic drugs, advancements in biotechnology, a rising aging population, and favorable regulatory support drive this growth.

The presence of established pharmaceutical companies with strong manufacturing capabilities further supports the market's expansion. The North America API market is undergoing a significant transformation, driven by various dynamic factors, including regulatory initiatives, technological advancements, and strategic investments to bolster domestic manufacturing capabilities. One of the most prominent developments in this market is the U.S. government's efforts to ensure a more resilient pharmaceutical supply chain. In August 2025, President Donald Trump signed an executive order to establish the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to stockpile critical drug components necessary for national health and security. This strategic initiative, supported by the U.S. Department of Health and Human Services, highlights the growing recognition of the vulnerabilities in the global API supply chain, especially following the disruptions caused by the COVID-19 pandemic. This move is intended to reduce dependence on foreign suppliers, ensuring that essential medicines are readily available during emergencies and disruptions.

Simultaneously, major pharmaceutical companies have announced significant investments in domestic API manufacturing. In February 2025, Eli Lilly, one of the largest pharmaceutical companies in North America, revealed plans to invest USD 27 billion to construct four new manufacturing facilities in the United States, with three of these facilities dedicated to API production. The purpose of this expansion is twofold: to reduce reliance on foreign sources of APIs and to mitigate the impact of potential pharmaceutical import tariffs. This strategic shift reflects broader trends in the pharmaceutical industry, where companies are increasingly bringing production back to North America, driven by factors such as trade uncertainties and rising costs of overseas manufacturing. As part of this initiative, Eli Lilly also confirmed in August 2025 that it would sell a New Jersey plant, focusing on consolidating its manufacturing operations to align with its U.S.-centric production strategy. Such large-scale investments are expected to impact the market significantly, increasing local production capacity and enhancing supply chain resilience.

Alongside these developments, regulatory changes are shaping the landscape of API manufacturing in North America. In June 2024, the U.S. Food and Drug Administration (FDA) amended 21 CFR Part 211, enhancing Current Good Manufacturing Practices (CGMP) for drug products, including APIs. These revisions aim to improve quality assurance and manufacturing processes across the industry, ensuring that APIs meet the highest safety and efficacy standards. Such regulatory updates push pharmaceutical manufacturers to adopt state-of-the-art technologies and quality control measures. Furthermore, in January 2024, the FDA released new draft guidance clarifying that the human drug CGMP guidelines (ICH Q7) now apply to manufacturing veterinary APIs. This move reflects the FDA's commitment to enhancing oversight and aligning practices across various pharmaceutical industry segments. By expanding regulatory oversight to include veterinary APIs, the FDA ensures that APIs used in human and animal health meet the same rigorous standards, thereby improving the overall safety and effectiveness of medications.

In addition to regulatory and investment-driven changes, technological advancements are pivotal in shaping the API manufacturing sector. A significant trend is the shift toward continuous manufacturing, which allows for more efficient, scalable, and cost-effective production of APIs. In May 2023, Cambrex, an API manufacturer, completed a large-scale expansion of its API production plant in Massachusetts, increasing its capacity to meet the growing demand for high-quality, high-potency APIs. This expansion is part of a broader strategy by companies to invest in advanced manufacturing technologies that enhance production efficiency and enable faster response times to changing market demands. Continuous manufacturing, which involves automated, real-time monitoring systems, helps companies reduce production lead times, lower operational costs, and minimize the risk of human error. These technological innovations are expected to be a key factor in sustaining market growth, as they offer greater flexibility and responsiveness to shifts in the demand for pharmaceutical products.

These developments indicate a concerted effort to strengthen North America's domestic API manufacturing sector. By leveraging investments in manufacturing facilities, regulatory updates, and cutting-edge technologies, the region is positioning itself to become more self-reliant and resilient in the face of global disruptions. With increasing demand for generic and innovative drugs, the North American API market is set to continue evolving, driven by these factors contributing to a more robust and future-proof pharmaceutical supply chain. The industry's focus on enhancing manufacturing capacity, improving regulatory compliance, and adopting advanced technologies will help ensure North America remains at the forefront of the global API market.

North America Active Pharmaceutical Ingredients Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the North America active pharmaceutical ingredients market report based on type of synthesis, type of manufacturer, type, application, and country:

• Type of Synthesis Outlook (Revenue, USD Million, 2021 - 2033)
• Biotech
  • Biotech APIs Market, By Type
  • Generic API
  • Innovative API
  • Biotech APIs Market, By Product
  • Monoclonal Antibodies
  • Hormones
  • Cytokines
  • Recombinant Proteins
  • Therapeutic Enzymes
  • Vaccines
  • Blood Factors
• Synthetic
  • Synthetic APIs Market, By Type
  • Generic API
  • Innovative API
• Type of Manufacturer Outlook (Revenue, USD Million, 2021 - 2033)
• Captive APIs
• Merchant APIs
  • Merchant APIs Market, By Type
  • Generic API
  • Innovative API
  • Merchant APIs Market, By Type of Synthesis
  • Biotech
  • Synthetic
• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Generic API
• Innovative API
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Cardiology
• Oncology
• CNS and Neurology
• Orthopedic
• Endocrinology
• Pulmonology
• Gastroenterology
• Nephrology
• Ophthalmology
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Type of Synthesis
  • 1.2.2. Type of Manufacturer
  • 1.2.3. Type
  • 1.2.4. Application
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Source
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Source
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. North America Active Pharmaceutical Ingredients Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Environment Analysis
  • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrants
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTLE Analysis
  • 3.3.3. Pipeline Analysis
  • 3.3.4. Patent Expiry Analysis
  • 3.3.5. Pricing Analysis

Chapter 4. North America Active Pharmaceutical Ingredients Market: Type of Synthesis Business Analysis

• 4.1. Type of Synthesis Market Share, 2024 & 2033
• 4.2. Type of Synthesis Segment Dashboard
• 4.3. Market Size & Forecasts and Trend Analysis, by Type of Synthesis, 2021 to 2033 (USD Million)
• 4.4. Biotech
  • 4.4.1. Biotech Market, 2021 - 2033 (USD Million)
  • 4.4.2. Biotech APIs Market, By Type
    • 4.4.2.1. Biotech APIs Market, By Type Market, 2021 - 2033 (USD Million)
    • 4.4.2.2. Generic API
      • 4.4.2.2.1. Generic API Market, 2021 - 2033 (USD Million)
    • 4.4.2.3. Innovative API
      • 4.4.2.3.1. Innovative API Market, 2021 - 2033 (USD Million)
  • 4.4.3. Biotech APIs Market, By Product
    • 4.4.3.1. Biotech APIs Market, By Product Market, 2021 - 2033 (USD Million)
    • 4.4.3.2. Monoclonal Antibodies
      • 4.4.3.2.1. Monoclonal Antibodies Market, 2021 - 2033 (USD Million)
    • 4.4.3.3. Hormones
      • 4.4.3.3.1. Hormones Market, 2021 - 2033 (USD Million)
    • 4.4.3.4. Cytokines
      • 4.4.3.4.1. Cytokines Market, 2021 - 2033 (USD Million)
    • 4.4.3.5. Recombinant Proteins
      • 4.4.3.5.1. Recombinant Proteins Market, 2021 - 2033 (USD Million)
    • 4.4.3.6. Therapeutic Enzymes
      • 4.4.3.6.1. Therapeutic Enzymes Market, 2021 - 2033 (USD Million)
    • 4.4.3.7. Vaccines
      • 4.4.3.7.1. Vaccines Market, 2021 - 2033 (USD Million)
    • 4.4.3.8. Blood Factors
      • 4.4.3.8.1. Blood Factors Market, 2021 - 2033 (USD Million)
• 4.5. Synthetic
  • 4.5.1. Synthetic Market, 2021 - 2033 (USD Million)
  • 4.5.2. Synthetic APIs Market, By Type
    • 4.5.2.1. Synthetic APIs Market, By Type Market, 2021 - 2033 (USD Million)
    • 4.5.2.2. Generic API
      • 4.5.2.2.1. Generic API Market, 2021 - 2033 (USD Million)
    • 4.5.2.3. Innovative API
      • 4.5.2.3.1. Innovative API Market, 2021 - 2033 (USD Million)

Chapter 5. North America Active Pharmaceutical Ingredients Market: Type of Manufacturer Business Analysis

• 5.1. Type of Manufacturer Market Share, 2024 & 2033
• 5.2. Type of Manufacturer Segment Dashboard
• 5.3. Market Size & Forecasts and Trend Analysis, by Type of Manufacturer, 2021 to 2033 (USD Million)
• 5.4. Captive APIs
  • 5.4.1. Captive APIs Market, 2021 - 2033 (USD Million)
• 5.5. Merchant APIs
  • 5.5.1. Merchant APIs Market, 2021 - 2033 (USD Million)
• 5.6. Merchant APIs Market, By Type
  • 5.6.1. Merchant APIs Market, By Type Market, 2021 - 2033 (USD Million)
  • 5.6.2. Generic API
    • 5.6.2.1. Generic API Market, 2021 - 2033 (USD Million)
  • 5.6.3. Innovative API
    • 5.6.3.1. Innovative API Market, 2021 - 2033 (USD Million)
• 5.7. Merchant APIs Market, By Type of Synthesis
  • 5.7.1. Merchant APIs Market, By Type of Synthesis Market, 2021 - 2033 (USD Million)
  • 5.7.2. Biotech
    • 5.7.2.1. Biotech Market, 2021 - 2033 (USD Million)
  • 5.7.3. Synthetic
    • 5.7.3.1. Synthetic Market, 2021 - 2033 (USD Million)

Chapter 6. North America Active Pharmaceutical Ingredients Market: Type Business Analysis

• 6.1. Type Market Share, 2024 & 2033
• 6.2. Type Segment Dashboard
• 6.3. Market Size & Forecasts and Trend Analysis, by Type, 2021 to 2033 (USD Million)
• 6.4. Generic API
  • 6.4.1. Generic API Market, 2021 - 2033 (USD Million)
• 6.5. Innovative API
  • 6.5.1. Innovative API Market, 2021 - 2033 (USD Million)

Chapter 7. North America Active Pharmaceutical Ingredients Market: Application Business Analysis

• 7.1. Application Market Share, 2024 & 2033
• 7.2. Application Segment Dashboard
• 7.3. Market Size & Forecasts and Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 7.4. Cardiology
  • 7.4.1. Cardiology Market, 2021 - 2033 (USD Million)
• 7.5. Oncology
  • 7.5.1. Oncology Market, 2021 - 2033 (USD Million)
• 7.6. CNS and Neurology
  • 7.6.1. CNS and Neurology Market, 2021 - 2033 (USD Million)
• 7.7. Orthopedic
  • 7.7.1. Orthopedic Market, 2021 - 2033 (USD Million)
• 7.8. Endocrinology
  • 7.8.1. Endocrinology Market, 2021 - 2033 (USD Million)
• 7.9. Pulmonology
  • 7.9.1. Pulmonology Market, 2021 - 2033 (USD Million)
• 7.10. Gastroenterology
  • 7.10.1. Gastroenterology Market, 2021 - 2033 (USD Million)
• 7.11. Nephrology
  • 7.11.1. Nephrology Market, 2021 - 2033 (USD Million)
• 7.12. Ophthalmology
  • 7.12.1. Ophthalmology Market, 2021 - 2033 (USD Million)
• 7.13. Others
  • 7.13.1. Others Market, 2021 - 2033 (USD Million)

Chapter 8. North America Active Pharmaceutical Ingredients Market: Country Estimates & Trend Analysis

• 8.1. Active Pharmaceutical Ingredients Market Share By Country, 2024 & 2033
• 8.2. North America
  • 8.2.1. North America Active pharmaceutical ingredients market, 2021 - 2033 (USD Million)
  • 8.2.2. U.S.
    • 8.2.2.1. Key Country Dynamics
    • 8.2.2.2. Target Disease Prevalence
    • 8.2.2.3. Competitive Scenario
    • 8.2.2.4. Regulatory Framework
    • 8.2.2.5. Reimbursement Scenario
    • 8.2.2.6. U.S. Active pharmaceutical ingredients market, 2021 - 2033 (USD Million)
  • 8.2.3. Canada
    • 8.2.3.1. Key Country Dynamics
    • 8.2.3.2. Target Disease Prevalence
    • 8.2.3.3. Competitive Scenario
    • 8.2.3.4. Regulatory Framework
    • 8.2.3.5. Reimbursement Scenario
    • 8.2.3.6. Canada Active pharmaceutical ingredients market, 2021 - 2033 (USD Million)
  • 8.2.4. Mexico
    • 8.2.4.1. Key Country Dynamics
    • 8.2.4.2. Target Disease Prevalence
    • 8.2.4.3. Competitive Scenario
    • 8.2.4.4. Regulatory Framework
    • 8.2.4.5. Reimbursement Scenario
    • 8.2.4.6. Mexico Active pharmaceutical ingredients market, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Participant Overview
• 9.2. Company Market Position Analysis
• 9.3. Company Categorization
• 9.4. Strategy Mapping
• 9.5. Company Profiles/Listing
  • 9.5.1. Dr. Reddy's Laboratories Ltd.
    • 9.5.1.1. Overview
    • 9.5.1.2. Financial Performance
    • 9.5.1.3. Product Benchmarking
    • 9.5.1.4. Strategic Initiatives
  • 9.5.2. Sun Pharmaceutical Industries Ltd.
    • 9.5.2.1. Overview
    • 9.5.2.2. Financial Performance
    • 9.5.2.3. Product Benchmarking
    • 9.5.2.4. Strategic Initiatives
  • 9.5.3. Teva Pharmaceutical Industries Ltd.
    • 9.5.3.1. Overview
    • 9.5.3.2. Financial Performance
    • 9.5.3.3. Product Benchmarking
    • 9.5.3.4. Strategic Initiatives
  • 9.5.4. Cipla Inc.
    • 9.5.4.1. Overview
    • 9.5.4.2. Financial Performance
    • 9.5.4.3. Product Benchmarking
    • 9.5.4.4. Strategic Initiatives
  • 9.5.5. AbbVie Inc.
    • 9.5.5.1. Overview
    • 9.5.5.2. Financial Performance
    • 9.5.5.3. Product Benchmarking
    • 9.5.5.4. Strategic Initiatives
  • 9.5.6. Aurobindo Pharma
    • 9.5.6.1. Overview
    • 9.5.6.2. Financial Performance
    • 9.5.6.3. Product Benchmarking
    • 9.5.6.4. Strategic Initiatives
  • 9.5.7. Sandoz International GmbH (Novartis AG)
    • 9.5.7.1. Overview
    • 9.5.7.2. Financial Performance
    • 9.5.7.3. Product Benchmarking
    • 9.5.7.4. Strategic Initiatives
  • 9.5.8. Viatris Inc.
    • 9.5.8.1. Overview
    • 9.5.8.2. Financial Performance
    • 9.5.8.3. Product Benchmarking
    • 9.5.8.4. Strategic Initiatives
  • 9.5.9. Fresenius Kabi AG
    • 9.5.9.1. Overview
    • 9.5.9.2. Financial Performance
    • 9.5.9.3. Product Benchmarking
    • 9.5.9.4. Strategic Initiatives
  • 9.5.10. STADA Arzneimittel AG
    • 9.5.10.1. Overview
    • 9.5.10.2. Financial Performance
    • 9.5.10.3. Product Benchmarking
    • 9.5.10.4. Strategic Initiatives
  • 9.5.11. Lonza
    • 9.5.11.1. Overview
    • 9.5.11.2. Financial Performance
    • 9.5.11.3. Product Benchmarking
    • 9.5.11.4. Strategic Initiatives
  • 9.5.12. Curia
    • 9.5.12.1. Overview
    • 9.5.12.2. Financial Performance
    • 9.5.12.3. Product Benchmarking
    • 9.5.12.4. Strategic Initiatives
  • 9.5.13. Pfizer Inc
    • 9.5.13.1. Overview
    • 9.5.13.2. Financial Performance
    • 9.5.13.3. Product Benchmarking
    • 9.5.13.4. Strategic Initiatives
  • 9.5.14. Bristol-Myers Squibb Company
    • 9.5.14.1. Overview
    • 9.5.14.2. Financial Performance
    • 9.5.14.3. Product Benchmarking
    • 9.5.14.4. Strategic Initiatives
  • 9.5.15. Merck KGaA
    • 9.5.15.1. Overview
    • 9.5.15.2. Financial Performance
    • 9.5.15.3. Product Benchmarking
    • 9.5.15.4. Strategic Initiatives
  • 9.5.16. Catalent, Inc.
    • 9.5.16.1. Overview
    • 9.5.16.2. Financial Performance
    • 9.5.16.3. Product Benchmarking
    • 9.5.16.4. Strategic Initiatives