North America Small Molecule API Market Outlook, 2029

The North America Small Molecule API Market is projected to reach a staggering USD 90.67 billion by 2031, driven by rise in prelevance of chronic disease.

According to publisher, The North American small molecule API market stands tall as a global leader, driven by a robust pharmaceutical industry, high research and development (R&D) spending, and an aging population with increasing healthcare needs. Market Insights

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Market Size and Growth: The North American small molecule API market is projected to reach a staggering USD 90.67 billion by 2031, with a steady CAGR exceeding 3.6%. This growth signifies the continued reliance on small molecule APIs for the development and manufacturing of life-saving medications. Growth Drivers: Several factors propel the North American small molecule API market forward: Strong Pharmaceutical Industry: North America boasts a well-established pharmaceutical industry with leading companies and research institutions at the forefront of drug discovery and development.

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Manmayi Raval

Manmayi Raval

Research Consultant

Example: Pharmaceutical giants like Pfizer and Merck, headquartered in the U.S., invest heavily in R&D for innovative small molecule drugs to treat various diseases. Rising Prevalence of Chronic Diseases: The growing prevalence of chronic diseases like diabetes, cancer, and cardiovascular diseases in North America increases the demand for small molecule APIs used in their treatment. Example: The rising number of diabetes cases in the U.S. fuels the demand for small molecule APIs used in insulin production. Aging Population: North America's aging population creates a higher demand for healthcare services and medications, including those reliant on small molecule APIs. Market Dynamics

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Manmayi Raval

The North American small molecule API market faces both opportunities and challenges: Focus on Cost-Effectiveness: Healthcare payers and governments in North America emphasize cost-effective healthcare solutions. This can lead to pressure on small molecule API pricing and competition from overseas manufacturers. Stringent Regulations: Stringent regulations from the U.S. Food and Drug Administration (FDA) ensure the safety and efficacy of small molecule APIs. However, navigating these regulations can add complexity and cost to the R&D and manufacturing processes. Supply Chain Disruptions: Global events can disrupt the supply chain for small molecule APIs, impacting availability and potentially causing drug shortages. Market Segments The North American small molecule API market can be segmented based on various criteria: Therapeutic Area: The market caters to various therapeutic areas, including oncology, cardiology, neurology, and infectious diseases. Each area has specific API requirements. Example: The oncology segment has a high demand for small molecule APIs used in cancer treatment drugs, such as chemotherapeutic agents. API Type: The market offers a variety of small molecule APIs, including generics, branded drugs, and complex APIs with intricate synthesis processes. Example: Generic drug manufacturers rely on readily available small molecule APIs to produce affordable versions of brand-name medications. Regional Analysis The North American market is primarily driven by the United States, with a strong concentration of pharmaceutical companies and research institutions. However, Canada and Mexico also contribute to the market's growth. Key Developments Investments in Biosimilar Production: There's a growing focus on biosimilar production in North America, which utilizes small molecule APIs to create similar versions of complex biologic drugs. Focus on Sustainable Manufacturing: Pharmaceutical companies are increasingly adopting sustainable practices for small molecule API production, minimizing environmental impact. Competitive Landscape The North American small molecule API market is a competitive landscape with established pharmaceutical companies, contract manufacturing organizations (CMOs), and specialty API manufacturers. Pharmaceutical Companies: Leading pharmaceutical companies often have their own small molecule API production capabilities. Contract Manufacturing Organizations (CMOs): CMOs offer outsourced manufacturing services for small molecule APIs, catering to various pharmaceutical companies. Specialty API Manufacturers: Specialty API manufacturers focus on niche areas requiring expertise in complex API synthesis. By understanding these key aspects, stakeholders in the North American small molecule API market can navigate the evolving landscape and capitalize on growth opportunities.

Table of Contents

  • 1 Introduction 8
  • 1.1 Industry Definition and Research Scope 8
  • 1.1.1 Industry Definition 8
  • 1.1.2 Research Scope 9
  • 1.2 Research Methodology 12
  • 1.2.1 Overview of Market Research Methodology 12
  • 1.2.2 Market Assumption 13
  • 1.2.3 Secondary Data 13
  • 1.2.4 Primary Data 13
  • 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 24
  • 2.1.3 Impact of Russia-Ukraine Conflict: War Slows Economic Recovery 26
  • 2.2 Major Growth Drivers 30
  • 2.3 Market Restraints and Challenges 34
  • 2.4 Emerging Opportunities and Market Trends 37
  • 2.5 Porter’s Fiver Forces Analysis 41
  • 3 Segmentation of North America Market by Source 45
  • 3.1 Market Overview by Source 45
  • 3.2 Synthetic API 47
  • 3.2.1 Branded Synthetic API 48
  • 3.2.2 Generic Synthetic API 49
  • 3.3 Semi-synthetic API 50
  • 3.4 Natural Origin 51
  • 4 Segmentation of North America Market by Product Type 52
  • 4.1 Market Overview by Product Type 52
  • 4.2 Standard API 54
  • 4.3 High Potency API (HPAPI) 55
  • 4.3.1 Branded HPAPI 56
  • 4.3.2 Generic HPAPI 57
  • 5 Segmentation of North America Market by Therapeutic Area 58
  • 5.1 Market Overview by Therapeutic Area 58
  • 5.2 Infectious Diseases 60
  • 5.3 Oncology 61
  • 5.4 Ophthalmology 62
  • 5.5 Cardiovascular Disorders 63
  • 5.6 Central Nervous System 64
  • 5.7 Respiratory Disorders 65
  • 5.8 Metabolic Diseases 66
  • 5.9 Other Therapeutic Areas 67
  • 6 Segmentation of North America Market by Application 68
  • 6.1 Market Overview by Application 68
  • 6.2 Clinical Use 70
  • 6.3 Commercial Use 71
  • 7 Segmentation of North America Market by Manufacturer Type 72
  • 7.1 Market Overview by Manufacturer Type 72
  • 7.2 Pharmaceutical Companies 74
  • 7.3 CMOs 76
  • 8 North America Market 2022-2032 by Country 78
  • 8.1 Overview of North America Market 78
  • 8.2 U.S. 81
  • 8.3 Canada 84
  • 8.4 Mexico 86
  • 9 Competitive Landscape 88
  • 9.1 Overview of Key Vendors 88
  • 9.2 New Product Launch, Partnership, Investment, and M&A 91
  • 9.3 Company Profiles 92
  • Aurobindo Pharma Ltd. 92
  • Cambrex Corporation 94
  • Catalent Inc. 95
  • Dr. Reddy's Laboratories 98
  • GlaxoSmithKline plc 101
  • Lonza Group 105
  • Merck & Co., Inc. 108
  • Mylan N.V. 110
  • Novartis AG 112
  • Pfizer Inc. 114
  • Sun Pharmaceutical Industries Ltd. 118
  • Teva Pharmaceutical Industries Ltd. 121
  • Wuxi AppTec Co., Ltd. 123
  • RELATED REPORTS 125



Table 1. Snapshot of North America Small Molecule API Market in Balanced Perspective, 2022-2032 18
Table 2. World Economic Outlook, 2021-2031 22
Table 3. World Economic Outlook, 2021-2023 23
Table 4. Scenarios for Economic Impact of Ukraine Crisis 27
Table 5. World Health Spending by Region, $ bn, 2013-2020 32
Table 6. World Top 10 Pharmaceutical Companies Based on Projected R&D Spending in 2026, $ bn 33
Table 7. Main Product Trends and Market Opportunities in North America Small Molecule API Market 37
Table 8. North America Small Molecule API Market by Source, 2022-2032, $ mn 45
Table 9. North America Small Molecule API Market: Synthetic API by Drug Type, 2022-2032, $ mn 47
Table 10. North America Small Molecule API Market by Product Type, 2022-2032, $ mn 52
Table 11. North America Small Molecule API Market: HPAPI by Drug Type, 2022-2032, $ mn 55
Table 12. North America Small Molecule API Market by Therapeutic Area, 2022-2032, $ mn 58
Table 13. North America Small Molecule API Market by Application, 2022-2032, $ mn 68
Table 14. North America Small Molecule API Market by Manufacturer Type, 2022-2032, $ mn 72
Table 15. North America Small Molecule API Market by Country, 2022-2032, $ mn 79
Table 16. U.S. Small Molecule API Market by Product Type, 2022-2032, $ mn 83
Table 17. U.S. Small Molecule API Market by Therapeutic Area, 2022-2032, $ mn 83
Table 18. U.S. Small Molecule API Market by Manufacturer Type, 2022-2032, $ mn 83
Table 19. Canada Small Molecule API Market by Product Type, 2022-2032, $ mn 85
Table 20. Canada Small Molecule API Market by Therapeutic Area, 2022-2032, $ mn 85
Table 21. Canada Small Molecule API Market by Manufacturer Type, 2022-2032, $ mn 85
Table 22. Mexico Small Molecule API Market by Product Type, 2022-2032, $ mn 87
Table 23. Mexico Small Molecule API Market by Therapeutic Area, 2022-2032, $ mn 87
Table 24. Mexico Small Molecule API Market by Manufacturer Type, 2022-2032, $ mn 87
Table 25. Aurobindo Pharma Ltd.: Company Snapshot 92
Table 26. Aurobindo Pharma Ltd.: Business Segmentation 93
Table 27. Aurobindo Pharma Ltd.: Product Portfolio 93
Table 28. Cambrex Corporation: Company Snapshot 94
Table 29. Catalent Inc.: Company Snapshot 95
Table 30. Catalent Inc.: Business Segmentation in 2018 95
Table 31. Catalent Inc.: Product Portfolio 96
Table 32. Catalent Inc.: Revenue, 2018-2020, $ million 96
Table 33. Catalent Inc.: Revenue by Region in 2018 97
Table 34. Dr. Reddy's Laboratories: Company Snapshot 98
Table 35. Dr. Reddy's Laboratories: Business Segmentation 98
Table 36. Dr. Reddy's Laboratories: Revenue, 2018-2020, $ bn 99
Table 37. GlaxoSmithKline: Company Snapshot 101
Table 38. GlaxoSmithKline: Business Segmentation 102
Table 39. GlaxoSmithKline: Product Portfolio 103
Table 40. GlaxoSmithKline: Revenue, 2018-2020, $ bn 104
Table 41. Lonza Group: Company Snapshot 105
Table 42. Lonza Group: Business Segmentation in 2018 105
Table 43. Lonza Group: Product Portfolio 106
Table 44. Lonza Group: Revenue by Region in 2018 106
Table 45. Merck & Co., Inc.: Company Snapshot 108
Table 46. Merck & Co., Inc.: Business Segmentation 108
Table 47. Merck & Co., Inc.: Revenue, 2018-2020, $ bn 109
Table 48. Mylan NV: Company Snapshot 110
Table 49. Mylan NV: Revenue, 2017-2019, $ bn 111
Table 50. Novartis International AG: Company Snapshot 112
Table 51. Novartis International AG: Business Segmentation 112
Table 52. Novartis International AG: Revenue, 2017-2019, $ bn 113
Table 53. Pfizer Inc.: Company Snapshot 114
Table 54. Pfizer Inc.: Business Segmentation 115
Table 55. Pfizer Inc.: Product Portfolio 116
Table 56. Pfizer Inc.: Revenue, 2018-2020, $ bn 116
Table 57. Sun Pharmaceutical Industries Limited: Company Snapshot 118
Table 58. Teva Pharmaceutical Industries Ltd.: Company Snapshot 121
Table 59. Teva Pharmaceutical Industries Ltd.: Business Segmentation 122
Table 60. WuXi AppTec Inc.: Company Snapshot 123



Figure 1. Research Method Flow Chart 12
Figure 2. Bottom-up Approach and Top-down Approach for Market Estimation 15
Figure 3. North America Market Forecast in Optimistic, Conservative and Balanced Perspectives, 2022-2032 17
Figure 4. North America Small Molecule API Market, 2022-2032, $ mn 20
Figure 5. Impact of COVID-19 on Business 24
Figure 6. Primary Drivers and Impact Factors of North America Small Molecule API Market 30
Figure 7. Primary Restraints and Impact Factors of North America Small Molecule API Market 34
Figure 8. Investment Opportunity Analysis 38
Figure 9. Porter’s Fiver Forces Analysis of North America Small Molecule API Market 41
Figure 10. Breakdown of North America Small Molecule API Market by Source, 2022-2032, % of Revenue 46
Figure 11. North America Addressable Market Cap in 2023-2032 by Source, Value ($ mn) and Share (%) 46
Figure 12. North America Small Molecule API Market by Source: Synthetic API, 2022-2032, $ mn 47
Figure 13. North America Small Molecule API Market by Synthetic API: Branded Synthetic API, 2022-2032, $ mn 48
Figure 14. North America Small Molecule API Market by Synthetic API: Generic Synthetic API, 2022-2032, $ mn 49
Figure 15. North America Small Molecule API Market by Source: Semi-synthetic API, 2022-2032, $ mn 50
Figure 16. North America Small Molecule API Market by Source: Natural Origin, 2022-2032, $ mn 51
Figure 17. Breakdown of North America Small Molecule API Market by Product Type, 2022-2032, % of Sales Revenue 53
Figure 18. North America Addressable Market Cap in 2023-2032 by Product Type, Value ($ mn) and Share (%) 53
Figure 19. North America Small Molecule API Market by Product Type: Standard API, 2022-2032, $ mn 54
Figure 20. North America Small Molecule API Market by Product Type: High Potency API (HPAPI), 2022-2032, $ mn 55
Figure 21. North America Small Molecule API Market by HPAPI: Branded HPAPI, 2022-2032, $ mn 56
Figure 22. North America Small Molecule API Market by HPAPI: Generic HPAPI, 2022-2032, $ mn 57
Figure 23. Breakdown of North America Small Molecule API Market by Therapeutic Area, 2022-2032, % of Sales Revenue 59
Figure 24. North America Addressable Market Cap in 2023-2032 by Therapeutic Area, Value ($ mn) and Share (%) 59
Figure 25. North America Small Molecule API Market by Therapeutic Area: Infectious Diseases, 2022-2032, $ mn 60
Figure 26. North America Small Molecule API Market by Therapeutic Area: Oncology, 2022-2032, $ mn 61
Figure 27. North America Small Molecule API Market by Therapeutic Area: Ophthalmology, 2022-2032, $ mn 62
Figure 28. North America Small Molecule API Market by Therapeutic Area: Cardiovascular Disorders, 2022-2032, $ mn 63
Figure 29. North America Small Molecule API Market by Therapeutic Area: Central Nervous System, 2022-2032, $ mn 64
Figure 30. North America Small Molecule API Market by Therapeutic Area: Respiratory Disorders, 2022-2032, $ mn 65
Figure 31. North America Small Molecule API Market by Therapeutic Area: Metabolic Diseases, 2022-2032, $ mn 66
Figure 32. North America Small Molecule API Market by Therapeutic Area: Other Therapeutic Areas, 2022-2032, $ mn 67
Figure 33. Breakdown of North America Small Molecule API Market by Application, 2022-2032, % of Revenue 69
Figure 34. North America Addressable Market Cap in 2023-2032 by Application, Value ($ mn) and Share (%) 69
Figure 35. North America Small Molecule API Market by Application: Clinical Use, 2022-2032, $ mn 70
Figure 36. North America Small Molecule API Market by Application: Commercial Use, 2022-2032, $ mn 71
Figure 37. Breakdown of North America Small Molecule API Market by Manufacturer Type, 2022-2032, % of Revenue 73
Figure 38. North America Addressable Market Cap in 2023-2032 by Manufacturer Type, Value ($ mn) and Share (%) 73
Figure 39. North America Small Molecule API Market by Manufacturer Type: Pharmaceutical Companies, 2022-2032, $ mn 74
Figure 40. Breakdown of North America Small Molecule API In-house Synthesis Market by Region, 2020-2027, % of Revenue 75
Figure 41. North America Small Molecule API Market by Manufacturer Type: CMOs, 2022-2032, $ mn 76
Figure 42. Breakdown of North America Small Molecule API Contract Synthesis Market by Region, 2020-2027, % of Revenue 77
Figure 43. Breakdown of North America Small Molecule API Market by Country, 2022 and 2032, % of Revenue 79
Figure 44. Contribution to North America 2023-2032 Cumulative Market by Country, Value ($ mn) and Share (%) 80
Figure 45. U.S. Small Molecule API Market, 2022-2032, $ mn 82
Figure 46. Canada Small Molecule API Market, 2022-2032, $ mn 84
Figure 47. Small Molecule API Market in Mexico, 2022-2032, $ mn 86
Figure 48. Growth Stage of North America Small Molecule API Industry over the Forecast Period 88
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North America Small Molecule API Market Outlook, 2029

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