North America active pharmaceutical ingredients market is projected to grow by 5.3% annually in the forecast period and reach $111.44 billion by 2028, driven by rising adoption of biologics in disease management, increasing regulatory approvals, patent expiration of major drugs, growing trend of outsourcing and increase in geriatric population.
Highlighted with 86 tables and 68 figures, this 193-page report “North America Active Pharmaceutical Ingredients (API) Market 2021-2028 by Synthesis (Synthetic, Biotech, HPAPI), Manufacturing Process (Captive, Merchant), Therapeutic Application, Drug Type, and Country: Trend Forecast and Growth Opportunity” is based on a comprehensive research of the entire North America active pharmaceutical ingredients market and all its sub-segments through extensively detailed classifications. Profound analysis and assessment are generated from premium primary and secondary information sources with inputs derived from industry professionals across the value chain. The report is based on studies on 2018-2021 and provides forecast from 2022 till 2028 with 2021 as the base year. (Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
In-depth qualitative analyses include identification and investigation of the following aspects:
• Market Structure
• Growth Drivers
• Restraints and Challenges
• Emerging Product Trends & Market Opportunities
• Porter’s Fiver Forces
The trend and outlook of North America market is forecast in optimistic, balanced, and conservative view by taking into account of COVID-19. The balanced (most likely) projection is used to quantify North America active pharmaceutical ingredients market in every aspect of the classification from perspectives of Synthesis, Manufacturing Process, Therapeutic Application, Drug Type, and Country.
Based on Synthesis, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2018-2028 included in each section.
Synthetic API
• Branded Synthetic API
• Generic Synthetic API
Biotech API by Drug Type:
• Monoclonal Antibodies
• Recombinant Proteins
• Vaccines
• Other Biotech APIs
Biotech API by Customer Base:
• Innovative Biologic API
• Generic Biosimilar API
Biotech API by Expression Technology:
• Mammalian Expression
• Microbial Expression
• Yeast Expression
• Insect Expression
• Other Expression Technologies
HPAPI
• Branded HPAPI
• Generic HPAPI
Based on Manufacturing Process, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2018-2028 included in each section.
Captive Manufacturing
• Branded Captive API
• Generic Captive API
Merchant Manufacturing by Drug Type:
• Branded Merchant API
• Generic Merchant API
Merchant Manufacturing by Drug Synthesis:
• Merchant Synthetic API
• Merchant Biotech API
By Therapeutic Application, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2018-2028 included in each section.
• Infectious Diseases
• Oncology
• Ophthalmology
• Cardiovascular Disorders
• Central Nervous System
• Pulmonary Disorders
• Orthopedics
• Other Applications
By Drug Type, the North America market is segmented into the following sub-markets with annual revenue ($ bn) for 2018-2028 included in each section.
• Branded Prescription Drugs
• Generic Prescription Drugs
• OTC Drugs
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 2018-2028. The breakdown of key national markets by Synthesis, Manufacturing Process, and Therapeutic Application 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.
Selected Key Players:
AbbVie Inc.
Astrazeneca
Aurobindo Pharma Ltd.
BASF
Bayer AG
Boehringer Ingelheim
Catalent Inc.
Dr. Reddy's Laboratories
F. Hoffmann-La Roche
GlaxoSmithKline plc
Lonza Group
Lupin Limited
Merck & Co., Inc.
Mylan NV
Novartis International AG
Pfizer Inc.
Sanofi
Sun Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
Thermo Fisher Scientific
(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 9
1.1 Industry Definition and Research Scope 9
1.1.1 Industry Definition 9
1.1.2 Research Scope 10
1.2 Research Methodology 13
1.2.1 Overview of Market Research Methodology 13
1.2.2 Market Assumption 14
1.2.3 Secondary Data 14
1.2.4 Primary Data 14
1.2.5 Data Filtration and Model Design 15
1.2.6 Market Size/Share Estimation 16
1.2.7 Research Limitations 17
1.3 Executive Summary 18
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 30
2.3 Market Restraints and Challenges 38
2.4 Emerging Opportunities and Market Trends 41
2.5 Porter’s Fiver Forces Analysis 45
3 Segmentation of North America Market by Synthesis 49
3.1 Market Overview by Synthesis 49
3.2 Synthetic API 51
3.2.1 Branded Synthetic API 52
3.2.2 Generic Synthetic API 53
3.3 Biotech API 54
3.3.1 Biotech API by Drug Type 55
3.3.1.1 Monoclonal Antibodies 56
3.3.1.2 Recombinant Proteins 57
3.3.1.3 Vaccines 58
3.3.1.4 Other Biotech APIs 59
3.3.2 Biotech API by Category 60
3.3.2.1 Innovative Biologic API 61
3.3.2.2 Generic Biosimilar API 62
3.3.3 Biotech API by Expression Technology 63
3.3.3.1 Mammalian Expression 64
3.3.3.2 Microbial Expression 65
3.3.3.3 Yeast Expression 66
3.3.3.4 Insect Expression 67
3.3.3.5 Other Expression Technologies 68
3.4 HPAPI 69
3.4.1 Branded HPAPI 70
3.4.2 Generic HPAPI 71
4 Segmentation of North America Market by Manufacturing Process 72
4.1 Market Overview by Manufacturing Process 72
4.2 Captive Manufacturing 74
4.2.1 Branded Captive API 75
4.2.2 Generic Captive API 76
4.3 Merchant Manufacturing 77
4.3.1 Merchant Manufacturing by Drug Type 78
4.3.1.1 Branded Merchant API 79
4.3.1.2 Generic Merchant API 80
4.3.2 Merchant Manufacturing by Drug Synthesis 81
4.3.2.1 Merchant Synthetic API 82
4.3.2.2 Merchant Biotech API 83
5 Segmentation of North America Market by Therapeutic Application 84
5.1 Market Overview by Therapeutic Application 84
5.2 Infectious Diseases 86
5.3 Oncology 87
5.4 Ophthalmology 88
5.5 Cardiovascular Disorders 89
5.6 Central Nervous System 90
5.7 Pulmonary Disorders 91
5.8 Orthopedics 92
5.9 Other Applications 93
6 Segmentation of North America Market by Drug Type 94
6.1 Market Overview by Drug Type 94
6.2 Branded Prescription Drugs 96
6.3 Generic Prescription Drugs 97
6.4 OTC Drugs 98
7 North America Market 2021-2028 by Country 99
7.1 Overview of North America Market 99
7.2 U.S. 102
7.3 Canada 113
7.4 Mexico 115
8 Competitive Landscape 117
8.1 Overview of Key Vendors 117
8.2 New Product Launch, Partnership, Investment, and M&A 120
8.3 Company Profiles 121
AbbVie Inc. 121
Astrazeneca 123
Aurobindo Pharma Ltd. 128
BASF 131
Bayer AG 134
Boehringer Ingelheim 138
Catalent Inc. 143
Dr. Reddy's Laboratories 146
F. Hoffmann-La Roche 148
GlaxoSmithKline plc 150
Lonza Group 155
Lupin Limited 160
Merck & Co., Inc. 163
Mylan NV 166
Novartis International AG 169
Pfizer Inc. 172
Sanofi 177
Sun Pharmaceutical Industries Ltd. 180
Teva Pharmaceutical Industries Ltd. 183
Thermo Fisher Scientific 185
9 Investing in North America Market: Risk Assessment and Management 187
9.1 Risk Evaluation of North America Market 187
9.2 Critical Success Factors (CSFs) 190
Related Reports and Products 193
List of Tables:
Table 1. Snapshot of North America Active Pharmaceutical Ingredients (API) Market in Balanced Perspective, 2021-2028 19
Table 2. World Economic Outlook, 2021-2031 22
Table 3. World Top 10 Pharmaceutical Companies Based on Projected R&D Spending in 2026, $ bn 37
Table 4. Main Product Trends and Market Opportunities in North America Active Pharmaceutical Ingredients (API) Market 41
Table 5. North America Active Pharmaceutical Ingredients (API) Market by Synthesis, 2018-2028, $ bn 49
Table 6. North America Active Pharmaceutical Ingredients (API) Market: Synthetic API by Drug Type, 2018-2028, $ bn 51
Table 7. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Drug Type, 2018-2028, $ bn 55
Table 8. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Category, 2018-2028, $ bn 60
Table 9. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Expression Technology, 2018-2028, $ bn 63
Table 10. North America Active Pharmaceutical Ingredients (API) Market: HPAPI by Drug Type, 2018-2028, $ bn 69
Table 11. North America Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, $ bn 72
Table 12. North America Active Pharmaceutical Ingredients (API) Market: Captive Manufacturing by Drug Type, 2018-2028, $ bn 74
Table 13. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing by Drug Type, 2018-2028, $ bn 78
Table 14. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing by Drug Synthesis, 2018-2028, $ bn 81
Table 15. North America Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, $ bn 84
Table 16. North America Active Pharmaceutical Ingredients (API) Market by Drug Type, 2018-2028, $ bn 94
Table 17. North America Active Pharmaceutical Ingredients (API) Market by Country, 2018-2028, $ bn 100
Table 18. U.S. Active Pharmaceutical Ingredients (API) Market by Synthesis, 2018-2028, $ bn 104
Table 19. U.S. Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, $ bn 104
Table 20. U.S. Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, $ bn 104
Table 21. Top 15 Countries Supplying API for Medicines Consumed in the US, 2019, % based on Dollar Value 107
Table 22. Canada Active Pharmaceutical Ingredients (API) Market by Synthesis, 2018-2028, $ bn 114
Table 23. Canada Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, $ bn 114
Table 24. Canada Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, $ bn 114
Table 25. Mexico Active Pharmaceutical Ingredients (API) Market by Synthesis, 2018-2028, $ bn 116
Table 26. Mexico Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, $ bn 116
Table 27. Mexico Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, $ bn 116
Table 28. AbbVie Inc.: Company Snapshot 121
Table 29. AbbVie Inc.: Product Portfolio 121
Table 30. AbbVie Inc.: Revenue, 2018-2020, $ bn 122
Table 31. Astrazeneca: Company Snapshot 123
Table 32. Astrazeneca: Revenue, 2018-2020, $ bn 124
Table 33. Aurobindo Pharma Ltd.: Company Snapshot 128
Table 34. Aurobindo Pharma Ltd.: Product Portfolio 129
Table 35. BASF: Company Snapshot 131
Table 36. BASF: Business Segmentation 132
Table 37. BASF: Revenue by Region 132
Table 38. Bayer AG: Company Snapshot 134
Table 39. Bayer AG: Business Segmentation 135
Table 40. Bayer AG: Revenue, 2018-2020, € bn 135
Table 41. Boehringer Ingelheim: Company Snapshot 138
Table 42. Boehringer Ingelheim: Business Segmentation in 2019 139
Table 43. Boehringer Ingelheim: Product Portfolio 139
Table 44. Boehringer Ingelheim: Revenue, 2018-2020, EUR billion 140
Table 45. Boehringer Ingelheim: Revenue by Region in 2019 140
Table 46. Catalent Inc.: Company Snapshot 143
Table 47. Catalent Inc.: Business Segmentation in 2018 144
Table 48. Catalent Inc.: Product Portfolio 144
Table 49. Catalent Inc.: Revenue, 2018-2020, $ million 145
Table 50. Catalent Inc.: Revenue by Region in 2018 145
Table 51. Dr. Reddy's Laboratories: Company Snapshot 146
Table 52. Dr. Reddy's Laboratories: Business Segmentation 146
Table 53. Dr. Reddy's Laboratories: Revenue, 2019-2021, $ bn 147
Table 54. F. Hoffmann-La Roche: Company Snapshot 148
Table 55. F. Hoffmann-La Roche: Business Segmentation 149
Table 56. GlaxoSmithKline: Company Snapshot 150
Table 57. GlaxoSmithKline: Business Segmentation 151
Table 58. GlaxoSmithKline: Product Portfolio 152
Table 59. GlaxoSmithKline: Revenue, 2018-2020, $ bn 153
Table 60. Lonza Group: Company Snapshot 155
Table 61. Lonza Group: Business Segmentation in 2018 156
Table 62. Lonza Group: Product Portfolio 156
Table 63. Lonza Group: Revenue by Region in 2018 157
Table 64. Lupin Limited: Company Snapshot 160
Table 65. Lupin Limited: Business Segmentation 160
Table 66. Merck & Co., Inc.: Company Snapshot 163
Table 67. Merck & Co., Inc.: Business Segmentation 163
Table 68. Merck & Co., Inc.: Revenue, 2018-2020, $ bn 164
Table 69. Mylan NV: Company Snapshot 166
Table 70. Mylan NV: Revenue, 2017-2019, $ bn 167
Table 71. Novartis International AG: Company Snapshot 169
Table 72. Novartis International AG: Business Segmentation 169
Table 73. Novartis International AG: Revenue, 2017-2019, $ bn 170
Table 74. Pfizer Inc.: Company Snapshot 172
Table 75. Pfizer Inc.: Business Segmentation 173
Table 76. Pfizer Inc.: Product Portfolio 174
Table 77. Pfizer Inc.: Revenue, 2018-2020, $ bn 174
Table 78. Sanofi: Company Snapshot 177
Table 79. Sanofi: Business Segmentation 177
Table 80. Sanofi: Revenue, 2018-2020, $ bn 178
Table 81. Sun Pharmaceutical Industries Limited: Company Snapshot 180
Table 82. Teva Pharmaceutical Industries Ltd.: Company Snapshot 183
Table 83. Teva Pharmaceutical Industries Ltd.: Business Segmentation 184
Table 84. Thermo Fisher Scientific: Company Snapshot 185
Table 85. Risk Evaluation for Investing in North America Market, 2021-2028 188
Table 86. Critical Success Factors and Key Takeaways 191
