원료의약품 시장 : 유형, 합성, 제조업체, 치료 용도별 - 세계 예측(2025-2030년)

The Active Pharmaceutical Ingredients Market was valued at USD 152.77 billion in 2023, expected to reach USD 164.34 billion in 2024, and is projected to grow at a CAGR of 7.88%, to USD 259.97 billion by 2030.

Active Pharmaceutical Ingredients (APIs) form the critical components in pharmaceuticals, responsible for the intended effects of drugs. The scope of APIs encompasses their necessity in drug formulation, wide-ranging applications across disease treatments, and end-use in pharmaceuticals, biotechnology, and contract manufacturing organizations. The growing prevalence of chronic diseases, increasing geriatric population, and advancements in drug development technologies are pivotal growth factors in the API market. The rising adoption of biologics and the surge in demand for specialty medicines present notable opportunities. Factors such as patent expirations, increased generic drug production, and a focus on personalized medicine further bolster market advancements. Regulatory mandates that stress drug efficacy and safety are driving innovations in manufacturing processes, fostering opportunities especially within green chemistry and biotechnological advancements.

However, the market is not devoid of challenges. Stringent regulatory frameworks, high production costs, and complex manufacturing processes pose significant hurdles. The threat of raw material supply disruptions, particularly due to geopolitical tensions and dependency on a limited number of suppliers, can hinder market growth. Moreover, evolving compliance norms across regions necessitate constant adaptation, potentially impacting firms' operational efficiencies. To capitalize on emerging opportunities, companies should invest in the development of sustainable and eco-friendly manufacturing processes, leveraging AI and machine learning to optimize production and enhance quality control. Pursuing biosimilars and novel drug delivery systems can offer competitive advantages.

The API market is highly dynamic, characterized by strategic collaborations and mergers aimed at expanding product portfolios and geographical outreach. Emphasis on research and development, particularly in non-traditional APIs like nucleic acids and peptides, marks a promising area for innovation. While being technology-intensive, the industry also thrives on adaptability to regulatory changes and market demands, making it crucial for players to maintain a proactive approach in risk management and production adaptability to sustain long-term growth.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Active Pharmaceutical Ingredients Market

The Active Pharmaceutical Ingredients Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Increasing research & development activities by pharmaceutical companies
  • Government support for advanced pharmaceutical manufacturing techniques
  • Rising investments to enhance drug manufacturing capabilities by CDMOs
• Market Restraints
  • High cost associated with advanced API technologies
• Market Opportunities
  • Technological advancements in active pharmaceutical ingredients techniques
  • Adoption of micronization techniques to develop novel drug therapeutics
• Market Challenges
  • Technical complexity associated with achieving and maintaining the desired particle size distribution

Porter's Five Forces: A Strategic Tool for Navigating the Active Pharmaceutical Ingredients Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Active Pharmaceutical Ingredients Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Active Pharmaceutical Ingredients Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Active Pharmaceutical Ingredients Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Active Pharmaceutical Ingredients Market

A detailed market share analysis in the Active Pharmaceutical Ingredients Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Active Pharmaceutical Ingredients Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Active Pharmaceutical Ingredients Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Active Pharmaceutical Ingredients Market

A strategic analysis of the Active Pharmaceutical Ingredients Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Active Pharmaceutical Ingredients Market, highlighting leading vendors and their innovative profiles. These include Abbvie Inc., API Pharma Tech, AstraZeneca PLC, Aurobindo Pharma Limited, BASF SE, BDR Pharmaceuticals Internationals Pvt. Ltd., Bristol-Myers Squibb Company, C.H. Boehringer Sohn AG & Co. KG, Cipla, Inc., Dr. Reddy's Laboratories Ltd, ELI Lilly and Company, F. Hoffmann-La Roche AG, Glaxosmithkline PLC, Lonza Group Ltd., Lupin Ltd., Merck & Co., Inc., Novartis International AG, Pfizer, Inc., Sanofi S.A., Sun Pharmaceutical Industries Ltd, Teva Pharmaceutical Industries Ltd, and Viatris Inc..

Market Segmentation & Coverage

This research report categorizes the Active Pharmaceutical Ingredients Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Type, market is studied across Generic Active Pharmaceutical Ingredients and Innovative Active Pharmaceutical Ingredients.
• Based on Synthesis, market is studied across Biotech Active Pharmaceutical Ingredients and Synthetic Active Pharmaceutical Ingredients.
• Based on Manufacturer, market is studied across Captive API Manufacturers and Merchant API Manufacturers.
• Based on Therapeutic Application, market is studied across Cardiovascular Diseases, Communicable Diseases, Diabetes, Oncology, Pain Management, and Respiratory Diseases.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Increasing research & development activities by pharmaceutical companies
    • 5.1.1.2. Government support for advanced pharmaceutical manufacturing techniques
    • 5.1.1.3. Rising investments to enhance drug manufacturing capabilities by CDMOs
  • 5.1.2. Restraints
    • 5.1.2.1. High cost associated with advanced API technologies
  • 5.1.3. Opportunities
    • 5.1.3.1. Technological advancements in active pharmaceutical ingredients techniques
    • 5.1.3.2. Adoption of micronization techniques to develop novel drug therapeutics
  • 5.1.4. Challenges
    • 5.1.4.1. Technical complexity associated with achieving and maintaining the desired particle size distribution
• 5.2. Market Segmentation Analysis
  • 5.2.1. Type: Increasing accessibility of generic APIs due to eliminated R&D expenses
  • 5.2.2. Therapeutic Application: Increasing prevalence of diabetes globally boost the R&D for active pharmaceutical ingredients
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Active Pharmaceutical Ingredients Market, by Type

• 6.1. Introduction
• 6.2. Generic Active Pharmaceutical Ingredients
• 6.3. Innovative Active Pharmaceutical Ingredients

7. Active Pharmaceutical Ingredients Market, by Synthesis

• 7.1. Introduction
• 7.2. Biotech Active Pharmaceutical Ingredients
• 7.3. Synthetic Active Pharmaceutical Ingredients

8. Active Pharmaceutical Ingredients Market, by Manufacturer

• 8.1. Introduction
• 8.2. Captive API Manufacturers
• 8.3. Merchant API Manufacturers

9. Active Pharmaceutical Ingredients Market, by Therapeutic Application

• 9.1. Introduction
• 9.2. Cardiovascular Diseases
• 9.3. Communicable Diseases
• 9.4. Diabetes
• 9.5. Oncology
• 9.6. Pain Management
• 9.7. Respiratory Diseases

10. Americas Active Pharmaceutical Ingredients Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Active Pharmaceutical Ingredients Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Active Pharmaceutical Ingredients Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Eli Lilly's Record-Breaking USD 9 Billion Investment to Boost API Manufacturing for Diabetes and Obesity Treatments
  • 13.3.2. United States Collaboration Enhances Production of Essential Glioblastoma Drug with New Oncology Suite in Missouri
  • 13.3.3. Noramco Group Strengthening North America's Pharmaceutical Supply Chain
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Abbvie Inc.
• 2. API Pharma Tech
• 3. AstraZeneca PLC
• 4. Aurobindo Pharma Limited
• 5. BASF SE
• 6. BDR Pharmaceuticals Internationals Pvt. Ltd.
• 7. Bristol-Myers Squibb Company
• 8. C.H. Boehringer Sohn AG & Co. KG
• 9. Cipla, Inc.
• 10. Dr. Reddy's Laboratories Ltd
• 11. ELI Lilly and Company
• 12. F. Hoffmann-La Roche AG
• 13. Glaxosmithkline PLC
• 14. Lonza Group Ltd.
• 15. Lupin Ltd.
• 16. Merck & Co., Inc.
• 17. Novartis International AG
• 18. Pfizer, Inc.
• 19. Sanofi S.A.
• 20. Sun Pharmaceutical Industries Ltd
• 21. Teva Pharmaceutical Industries Ltd
• 22. Viatris Inc.