원료의약품(API) 시장 : 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The Active Pharmaceutical Ingredients Market size is estimated at USD 232.13 billion in 2025, and is expected to reach USD 328.94 billion by 2030, at a CAGR of 7.22% during the forecast period (2025-2030).

Sustained growth stems from the pharmaceutical sector's pivot toward specialized, higher-value molecules, rising demand for targeted therapies, and greater reliance on outsourcing. North America retains leadership on account of stringent regulatory oversight and an established manufacturing base, while Asia is capturing incremental volumes by offering cost-competitive, technologically sophisticated capacity. Strategic reshoring in the United States and Europe, growing adoption of continuous manufacturing, and accelerated development of mRNA platforms are reshaping competitive dynamics. Capital inflows into high-potency and biologic APIs, together with heightened emphasis on supply-chain resilience, are creating further expansion opportunities for companies that combine quality systems with advanced process know-how.

Global Active Pharmaceutical Ingredients (API) Market Trends and Insights

Surging Demand for High-Potency APIs (HPAPIs)

Heightened focus on precision oncology is driving a sharp uptick in HPAPI requirements, with these molecules already comprising more than 30% of the research pipeline. HPAPIs allow lower dosages yet deliver superior therapeutic outcomes, compelling manufacturers to invest in highly contained facilities. Lonza alone has developed over 50 HPAPI compounds during the past 15 years, operating dedicated lines in Visp and Nansha while meeting FDA and ANVISA standards [1]Lonza AG, "HPAPI Handling and Development," lonza.com. Such specialised infrastructure creates formidable entry barriers, enabling established firms to secure premium pricing and long-term supply agreements. The swell in potent-compound programs is reshaping capital allocation, prompting both innovators and CDMOs to expand isolator-based suites and advanced analytics capabilities. As oncology pipelines mature, HPAPI volumes are likely to keep rising, reinforcing the segment's role as a core value driver in the active pharmaceutical ingredients market.

Rapid Expansion of Contract Development & Manufacturing Organizations (CDMOs)

Pharmaceutical companies are increasingly outsourcing API development and commercial manufacturing to CDMOs to optimise capital deployment and accelerate launch timelines. Merchant API output is projected to grow at an 8.07% CAGR through 2030, outpacing captive production. CDMOs now deliver integrated solutions that encompass route scouting, scale-up, analytical development, and regulatory documentation, thereby reducing clients' risk and infrastructure burden. Investment momentum is most visible in capabilities for high-potency, sterile, and complex synthetic processes that demand niche expertise. Competition among CDMOs is shifting from pure cost advantages toward differentiation based on quality systems and end-to-end technical support, a trend that is redefining value creation across the active pharmaceutical ingredients market.

Volatility in Supply of Key Starting Materials from China & India

USP data show that only 4% of 2023 US drug master files cited domestic manufacturing, whereas India and China together accounted for more than 80%. Disruptions in either hub can ripple through global supply chains, triggering spot shortages and cost spikes. Reliance on single-region sources also complicates regulatory inspections and heightens geopolitical risk. Manufacturers are therefore assessing dual-sourcing strategies, investing in supply-chain visibility tools, and lobbying for incentives to localise critical starting materials. These measures increase compliance costs and elongate development timelines, tempering headline growth in the active pharmaceutical ingredients market.

Other drivers and restraints analyzed in the detailed report include:

1. Accelerated Vaccine & mRNA Platform Commercialisation Post-COVID-19
2. Shift Toward Continuous Manufacturing Boosting Output Efficiency
3. Capacity Fragmentation Intensifying Price Pressure in Generic Small Molecules

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Merchant suppliers generated 48.91% of 2024 revenue, while captive operations retained a narrow majority at 51.09%. The merchant segment's 8.07% projected CAGR indicates rising confidence in external partners to handle scale-up under stringent quality expectations. Pharmaceutical companies are reserving in-house capacity for proprietary, high-value molecules yet are transferring late-life-cycle and generic APIs to CDMOs to maximise asset utilisation. The active pharmaceutical ingredients market size for outsourced production is forecast to accelerate further as complex synthetic routes and potency requirements favour specialist providers.

Investment flows into containment suites, continuous processing lines, and advanced analytical laboratories underscore the structural shift in favour of CDMOs. The active pharmaceutical ingredients market therefore rewards suppliers that combine end-to-end development services with proven regulatory track records, particularly for oncology and rare-disease programs that necessitate flexible, small-batch production.

Synthetic pathways still underpin 65.35% of 2024 shipments, yet biotech APIs are set to grow at 9.07% through 2030, narrowing the gap. Recent progress in cell-line engineering, expression optimisation, and downstream purification is lowering unit costs, bringing complex biologics within reach of broader therapeutic categories. The active pharmaceutical ingredients market size for biotech routes is expanding fastest in monoclonal antibodies, peptides, and nucleic-acid-based therapeutics.

Meanwhile, synthetic manufacturers are integrating biocatalysis and chemoenzymatic cascades to shorten step counts and improve yields. This convergence blurs historical distinctions and diversifies risk, anchoring both synthesis modes within a single, more resilient supply architecture. In the near term, synthetic APIs will remain indispensable for small molecules that benefit from mature, scalable chemistries, yet the growth trajectory clearly favours biotech processes.

The Active Pharmaceutical Ingredients (API) Market Report Segments Into by Business Mode (Captive API, Merchant API), by Synthesis Type (Synthetic APIs, Biotech APIs), by Molecule Size (Small Molecule, Large Molecule), by Potency (High Potency, Low/Medium Potency), by Application (Oncology, Cardiovascular, and More), and Geography ( North America, Europe and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America retained a 41% revenue share in 2024 on the back of a robust R&D ecosystem, premium pricing, and supportive intellectual-property frameworks. Washington's May 2025 executive order to streamline facility approvals is expected to accelerate domestic capacity additions, with Eli Lilly allocating USD 5.3 billion to a new Indiana API complex [2] Eli Lilly & Co., "Lilly to Invest USD 5.3 Billion in Indiana Facilities," lilly.com

. These developments aim to mitigate concentration risk by re-establishing local production for critical medicines.

Asia-Pacific represents the strongest growth engine, posting a projected 7.70% CAGR through 2030. India and China file 82% of FDA DMFs, anchoring their dominance in cost-sensitive segments. Beijing's sizeable antibiotic and analgesic output underscores substantial scale advantages, while India's Production Linked Incentive scheme is funding greenfield units for fermentation and complex synthesis. Fast-growing biologic and HPAPI pipelines are further attracting multinational partnerships, cementing Asia's central role in the active pharmaceutical ingredients market.

Europe maintains a notable position in complex, high-value APIs owing to stringent quality standards and deep scientific talent. Although its global share is edging downward, the region continues to lead in continuous manufacturing, green chemistry, and potency containment. European firms are differentiating with expertise in controlled substances and low-volume biologics, fostering resilient niches within the broader active pharmaceutical ingredients market.

List of Companies Covered in this Report:

1. Teva Pharmaceutical Industries
2. Novartis
3. Pfizer
4. Aurobindo Pharma
5. Sun Pharmaceuticals Industries
6. Dr. Reddy's Laboratories Ltd
7. Viatris
8. BASF
9. Merck
10. Lupin
11. Cipla
12. Lonza Group
13. Catalent
14. Cambrex Corp
15. Thermo Fisher Scientific (Patheon)
16. Boehringer Ingelheim
17. Sanofi
18. GlaxoSmithKline
19. Corden Pharma
20. Samsung Group
21. WuXi App Tec
22. Abbvie

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 A. Title and Table of Contents - Active Pharmaceutical Ingredients (API) Market

2 Introduction

• 2.1 Study Assumptions & Market Definition
• 2.2 Scope of the Study

3 Research Methodology

4 Executive Summary

5 Market Landscape

• 5.1 Market Overview
• 5.2 Market Drivers
  • 5.2.1 Surging Demand for High-Potency APIs (HPAPIs)
  • 5.2.2 Rapid Expansion of Contract Development & Manufacturing Organizations (CDMOs) Supporting Small/Mid-Sized Pharma
  • 5.2.3 Accelerated Vaccine & mRNA Platform Commercialization Post-COVID-19
  • 5.2.4 Shift Toward Continuous Manufacturing Boosting Output Efficiency
  • 5.2.5 Re-shoring Initiatives in US & EU to Reduce China Dependency for Key Starting Materials
  • 5.2.6 Growing Demand for Sustainable "Green Chemistry" Routes Driven by ESG Mandates
• 5.3 Market Restraints
  • 5.3.1 Volatility in Supply of Key Starting Materials From China & India
  • 5.3.2 Capacity Fragmentation Intensifying Price Pressure in Generic Small Molecules
  • 5.3.3 Inflation-Linked Escalation in Energy & Solvent Costs Impacting Margins
  • 5.3.4 Complex Global Regulatory Harmonization for Biotech APIs
• 5.4 Supply-Chain Analysis
• 5.5 Technological Outlook
• 5.6 Porter's Five Forces
  • 5.6.1 Threat of New Entrants
  • 5.6.2 Bargaining Power of Buyers
  • 5.6.3 Bargaining Power of Suppliers
  • 5.6.4 Threat of Substitutes
  • 5.6.5 Intensity of Competitive Rivalry

6 Market Size & Growth Forecasts (Value, USD)

• 6.1 By Business Model
  • 6.1.1 Captive API
  • 6.1.2 Merchant / Contract API
• 6.2 By Synthesis Type
  • 6.2.1 Synthetic APIs
  • 6.2.2 Biotech APIs
• 6.3 By Molecule Size
  • 6.3.1 Small Molecule
  • 6.3.2 Large Molecule / Biologics
• 6.4 By Potency
  • 6.4.1 High-Potency APIs
  • 6.4.2 Low-/Medium-Potency APIs
• 6.5 By Therapeutic Area
  • 6.5.1 Oncology
  • 6.5.2 Cardiovascular
  • 6.5.3 Infectious Diseases
  • 6.5.4 Metabolic Disorders
  • 6.5.5 CNS & Neurology
  • 6.5.6 Respiratory
  • 6.5.7 Ophthalmology
  • 6.5.8 Others
• 6.6 Geography
  • 6.6.1 North America
    • 6.6.1.1 United States
    • 6.6.1.2 Canada
    • 6.6.1.3 Mexico
  • 6.6.2 Europe
    • 6.6.2.1 Germany
    • 6.6.2.2 United Kingdom
    • 6.6.2.3 France
    • 6.6.2.4 Italy
    • 6.6.2.5 Spain
    • 6.6.2.6 Rest of Europe
  • 6.6.3 Asia-Pacific
    • 6.6.3.1 China
    • 6.6.3.2 Japan
    • 6.6.3.3 India
    • 6.6.3.4 South Korea
    • 6.6.3.5 Australia
    • 6.6.3.6 Rest of Asia
  • 6.6.4 Middle East and Africa
    • 6.6.4.1 GCC
    • 6.6.4.2 South Africa
    • 6.6.4.3 Rest of Middle East and Africa
  • 6.6.5 South America
    • 6.6.5.1 Brazil
    • 6.6.5.2 Argentina
    • 6.6.5.3 Rest of South America

7 Competitive Landscape

• 7.1 Market Concentration
• 7.2 Market Share Analysis
• 7.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments))
  • 7.3.1 Teva Pharmaceutical Industries Ltd
  • 7.3.2 Novartis AG
  • 7.3.3 Pfizer Inc
  • 7.3.4 Aurobindo Pharma Ltd
  • 7.3.5 Sun Pharmaceutical Industries Ltd
  • 7.3.6 Dr. Reddy's Laboratories Ltd
  • 7.3.7 Viatris Inc
  • 7.3.8 BASF SE
  • 7.3.9 Merck KGaA
  • 7.3.10 Lupin Ltd
  • 7.3.11 Cipla Ltd
  • 7.3.12 Lonza Group AG
  • 7.3.13 Catalent Inc
  • 7.3.14 Cambrex Corp
  • 7.3.15 Thermo Fisher Scientific (Patheon)
  • 7.3.16 Boehringer Ingelheim
  • 7.3.17 Sanofi SA
  • 7.3.18 GSK plc
  • 7.3.19 Corden Pharma
  • 7.3.20 Samsung Biologics
  • 7.3.21 WuXi AppTec
  • 7.3.22 AbbVie Inc

8 Market Opportunities & Future Outlook

• 8.1 White-Space & Unmet-Need Assessment