North America Small Molecule API Market 2020-2027 by Source (Synthetic, Semi-synthetic, Natural), Type (Standard, HPAPI), Therapeutic Area, Application (Clinical, Commercial), Manufacturer Type (Pharma, CMO), and Country: Trend Forecast and Growth Opportunity
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North America small molecule active pharmaceutical ingredient (API) market is expected to grow by 5.7% annually in the forecast period and reach $90.22 billion by 2027 owing to increasing incidences of diseases, development of companies engaged in the manufacturing of small molecule APIs, the increasing technological developments in manufacturing sector, and surge in healthcare expenditure amid COVID-19 pandemic.
Highlighted with 26 tables and 49 figures, this 107-page report “North America Small Molecule API Market 2020-2027 by Source (Synthetic, Semi-synthetic, Natural), Type (Standard, HPAPI), Therapeutic Area, Application (Clinical, Commercial), Manufacturer Type (Pharma, CMO), and Country: Trend Forecast and Growth Opportunity” is based on a comprehensive research of the entire North America small molecule API market and all its sub-segments through extensively detailed classifications. Profound analysis and assessment are generated from premium primary and secondary information sources with inputs derived from industry professionals across the value chain. The report is based on studies on 2017-2019 and provides estimate for 2020 and forecast from 2021 till 2027 with 2019 as the base year. (Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
In-depth qualitative analyses include identification and investigation of the following aspects:
• Market Structure
• Growth Drivers
• Restraints and Challenges
• Emerging Product Trends & Market Opportunities
• Porter’s Fiver Forces
The trend and outlook of North America market is forecast in optimistic, balanced, and conservative view by taking into account of COVID-19. The balanced (most likely) projection is used to quantify North America small molecule API market in every aspect of the classification from perspectives of Source, Type, Therapeutic Area, Application, Manufacturer Type, and Country.
Based on Source, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2017-2027 included in each section.
• Synthetic API
o Branded Synthetic API
o Generic Synthetic API
• Semi-synthetic API
• Natural Origin
Based on Type, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2017-2027 included in each section.
• Standard API
• High Potency API (HPAPI)
o Branded HPAPI
o Generic HPAPI
Based on Therapeutic Area, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2017-2027 included in each section.
• Infectious Diseases
• Oncology
• Ophthalmology
• Cardiovascular Disorders
• Central Nervous System
• Respiratory Disorders
• Metabolic Diseases
• Other Applications
Based on Application, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2017-2027 included in each section.
o Clinical Use
o Commercial Use
Based on Manufacturer Type, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2017-2027 included in each section.
• Pharmaceutical Companies
• CMOs
Geographically, the following national/local markets are fully investigated:
• U.S.
• Canada
• Mexico
For each key country, detailed analysis and data for annual revenue ($ bn) are available for 2017-2027. The breakdown of key national markets by Type, Therapeutic Area, and Manufacturer Type over the forecast years are also included.
The report also covers current competitive scenario and the predicted trend; and profiles key vendors including market leaders and important emerging players.
Key Players (this may not be a complete list and extra companies can be added upon request):
Aurobindo Pharma Ltd.
Cambrex Corporation
Catalent, Inc.
Dr. Reddy's Laboratories Ltd.
GlaxoSmithKline plc
Lonza Group
Merck & Co., Inc.
Mylan N.V.
Novartis AG
Pfizer Inc.
Sun Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
Wuxi AppTec Co., Ltd.
(Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
1 Introduction 7
1.1 Industry Definition and Research Scope 7
1.1.1 Industry Definition 7
1.1.2 Research Scope 8
1.2 Research Methodology 11
1.2.1 Overview of Market Research Methodology 11
1.2.2 Market Assumption 12
1.2.3 Secondary Data 12
1.2.4 Primary Data 12
1.2.5 Data Filtration and Model Design 14
1.2.6 Market Size/Share Estimation 15
1.2.7 Research Limitations 16
1.3 Executive Summary 17
2 Market Overview and Dynamics 20
2.1 Market Size and Forecast 20
2.1.1 Impact of COVID-19 on World Economy 21
2.1.2 Impact of COVID-19 on the Market 23
2.2 Major Growth Drivers 25
2.3 Market Restraints and Challenges 28
2.4 Emerging Opportunities and Market Trends 31
2.5 Porter’s Fiver Forces Analysis 35
3 Segmentation of North America Market by Source 39
3.1 Market Overview by Source 39
3.2 Synthetic API 41
3.2.1 Branded Synthetic API 42
3.2.2 Generic Synthetic API 43
3.3 Semi-synthetic API 44
3.4 Natural Origin 45
4 Segmentation of North America Market by Type 46
4.1 Market Overview by Type 46
4.2 Standard API 48
4.3 High Potency API (HPAPI) 49
4.3.1 Branded HPAPI 50
4.3.2 Generic HPAPI 51
5 Segmentation of North America Market by Therapeutic Area 52
5.1 Market Overview by Therapeutic Area 52
5.2 Infectious Diseases 54
5.3 Oncology 55
5.4 Ophthalmology 56
5.5 Cardiovascular Disorders 57
5.6 Central Nervous System 58
5.7 Respiratory Disorders 59
5.8 Metabolic Diseases 60
5.9 Other Applications 61
6 Segmentation of North America Market by Application 62
6.1 Market Overview by Application 62
6.2 Clinical Use 64
6.3 Commercial Use 65
7 Segmentation of North America Market by Manufacturer Type 66
7.1 Market Overview by Manufacturer Type 66
7.2 Pharmaceutical Companies 68
7.3 CMOs 70
8 North America Market 2020-2027 by Country 72
8.1 Overview of North America Market 72
8.2 U.S. 75
8.3 Canada 79
8.4 Mexico 81
9 Competitive Landscape 83
9.1 Overview of Key Vendors 83
9.2 New Product Launch, Partnership, Investment, and M&A 86
9.3 Company Profiles 87
Aurobindo Pharma Ltd. 87
Cambrex Corporation 89
Catalent, Inc. 90
Dr. Reddy's Laboratories Ltd. 91
GlaxoSmithKline plc 92
Lonza Group 93
Merck & Co., Inc. 94
Mylan N.V. 95
Novartis AG 96
Pfizer Inc. 97
Sun Pharmaceutical Industries Ltd. 98
Teva Pharmaceutical Industries Ltd. 99
Wuxi AppTec Co., Ltd. 100
10 Investing in North America Market: Risk Assessment and Management 101
10.1 Risk Evaluation of North America Market 101
10.2 Critical Success Factors (CSFs) 104
Related Reports and Products 107
Research Methodology:
Small Molecule API Market Size Estimation
To estimate market size and trends, we use a combination of top-down and bottom-up methods. This allows us to evaluate the market from various perspectives—by company, region, product type, and end users.
Our estimates are based on actual sales data, excluding any discounts. Segment breakdowns and market shares are calculated using weighted averages based on usage rates and average prices. Regional insights are determined by how widely a product or service is adopted in each area.
Key companies are identified through secondary sources like industry reports and company filings. We then verify revenue estimates and other key data points through primary research, including interviews with industry experts, company executives, and decision-makers.
We take into account all relevant factors that could influence the market and validate our findings with real-world input. Our final insights combine both qualitative and quantitative data to provide a well-rounded view. Please note, these estimates do not account for unexpected changes such as inflation, economic downturns, or policy shifts.
Data Source
Secondary Sources
This study draws on a wide range of secondary sources, including press releases, annual reports, non-profit organizations, industry associations, government agencies, and customs data. We also referred to reputable databases and directories such as Bloomberg, Wind Info, Hoovers, Factiva, Trading Economics, Statista, and others. Additional references include investor presentations, company filings (e.g., SEC), economic data, and documents from regulatory and industry bodies.
These sources were used to gather technical and market-focused insights, identify key players, analyze market segmentation and classification, and track major trends and developments across industries.
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Primary Sources
As part of our primary research, we interviewed a variety of stakeholders from both the supply and demand sides to gather valuable qualitative and quantitative insights.
On the supply side, we spoke with product manufacturers, competitors, industry experts, research institutions, distributors, traders, and raw material suppliers. On the demand side, we engaged with business leaders, marketing and sales heads, technology and innovation directors, supply chain executives, and end users across key organizations.
These conversations helped us better understand market segmentation, pricing, applications, leading players, supply chains, demand trends, industry outlook, and key market dynamics—including risks, opportunities, barriers, and strategic developments.
Key Data Information from Primary Sources
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