North America Active Pharmaceutical Ingredients (API) Market 2021-2028

Bonafide Trust 03-04-2022 193 Pages
Region : North America Category : Lifescience Pharmaceutical

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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

List of Figures:

Figure 1. Research Method Flow Chart 13
Figure 2. Bottom-up Approach and Top-down Approach for Market Estimation 16
Figure 3. North America Market Forecast in Optimistic, Conservative and Balanced Perspectives, 2021-2028 18
Figure 4. North America Active Pharmaceutical Ingredients (API) Market, 2021-2028, $ bn 20
Figure 5. Impact of COVID-19 on Business 23
Figure 6. Primary Drivers and Impact Factors of North America Active Pharmaceutical Ingredients (API) Market 30
Figure 7. GDP per capita in the World, 1960-2018, $ thousand 33
Figure 8. Leading Causes of Death in the World, 2019-2020, million 34
Figure 9. Worldwide Geriatric Population (60 years and above) by Regions, 2015 & 2030, million 35
Figure 10. World Population 65 and Over, % of Total Population, 1950-2060 35
Figure 11. Primary Restraints and Impact Factors of North America Active Pharmaceutical Ingredients (API) Market 38
Figure 12. Investment Opportunity Analysis 42
Figure 13. Porter’s Fiver Forces Analysis of North America Active Pharmaceutical Ingredients (API) Market 45
Figure 14. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Synthesis, 2018-2028, % of Revenue 49
Figure 15. Contribution to North America 2022-2028 Cumulative Revenue by Synthesis, Value ($ bn) and Share (%) 50
Figure 16. North America Active Pharmaceutical Ingredients (API) Market: Synthetic API, 2018-2028, $ bn 51
Figure 17. North America Active Pharmaceutical Ingredients (API) Market: Branded Synthetic API, 2018-2028, $ bn 52
Figure 18. North America Active Pharmaceutical Ingredients (API) Market: Generic Synthetic API, 2018-2028, $ bn 53
Figure 19. North America Active Pharmaceutical Ingredients (API) Market: Biotech API, 2018-2028, $ bn 54
Figure 20. North America Active Pharmaceutical Ingredients (API) Market: Monoclonal Antibodies, 2018-2028, $ bn 56
Figure 21. North America Active Pharmaceutical Ingredients (API) Market: Recombinant Proteins, 2018-2028, $ bn 57
Figure 22. North America Active Pharmaceutical Ingredients (API) Market: Vaccines, 2018-2028, $ bn 58
Figure 23. North America Active Pharmaceutical Ingredients (API) Market: Other Biotech APIs, 2018-2028, $ bn 59
Figure 24. North America Active Pharmaceutical Ingredients (API) Market: Innovative Biologic API, 2018-2028, $ bn 61
Figure 25. North America Active Pharmaceutical Ingredients (API) Market: Generic Biosimilar API, 2018-2028, $ bn 62
Figure 26. North America Active Pharmaceutical Ingredients (API) Market: Mammalian Expression, 2018-2028, $ bn 64
Figure 27. North America Active Pharmaceutical Ingredients (API) Market: Microbial Expression, 2018-2028, $ bn 65
Figure 28. North America Active Pharmaceutical Ingredients (API) Market: Yeast Expression, 2018-2028, $ bn 66
Figure 29. North America Active Pharmaceutical Ingredients (API) Market: Insect Expression, 2018-2028, $ bn 67
Figure 30. North America Active Pharmaceutical Ingredients (API) Market: Other Expression Technologies, 2018-2028, $ bn 68
Figure 31. North America Active Pharmaceutical Ingredients (API) Market: HPAPI, 2018-2028, $ bn 69
Figure 32. North America Active Pharmaceutical Ingredients (API) Market: Branded HPAPI, 2018-2028, $ bn 70
Figure 33. North America Active Pharmaceutical Ingredients (API) Market: Generic HPAPI, 2018-2028, $ bn 71
Figure 34. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, % of Revenue 72
Figure 35. Contribution to North America 2022-2028 Cumulative Revenue by Manufacturing Process, Value ($ bn) and Share (%) 73
Figure 36. North America Active Pharmaceutical Ingredients (API) Market: Captive Manufacturing, 2018-2028, $ bn 74
Figure 37. North America Active Pharmaceutical Ingredients (API) Market: Branded Captive API, 2018-2028, $ bn 75
Figure 38. North America Active Pharmaceutical Ingredients (API) Market: Generic Captive API, 2018-2028, $ bn 76
Figure 39. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing, 2018-2028, $ bn 77
Figure 40. North America Active Pharmaceutical Ingredients (API) Market: Branded Merchant API, 2018-2028, $ bn 79
Figure 41. North America Active Pharmaceutical Ingredients (API) Market: Generic Merchant API, 2018-2028, $ bn 80
Figure 42. North America Active Pharmaceutical Ingredients (API) Market: Merchant Synthetic API, 2018-2028, $ bn 82
Figure 43. North America Active Pharmaceutical Ingredients (API) Market: Merchant Biotech API, 2018-2028, $ bn 83
Figure 44. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, % of Revenue 84
Figure 45. Contribution to North America 2022-2028 Cumulative Revenue by Therapeutic Application, Value ($ bn) and Share (%) 85
Figure 46. North America Active Pharmaceutical Ingredients (API) Market: Infectious Diseases, 2018-2028, $ bn 86
Figure 47. North America Active Pharmaceutical Ingredients (API) Market: Oncology, 2018-2028, $ bn 87
Figure 48. North America Active Pharmaceutical Ingredients (API) Market: Ophthalmology , 2018-2028, $ bn 88
Figure 49. North America Active Pharmaceutical Ingredients (API) Market: Cardiovascular Disorders, 2018-2028, $ bn 89
Figure 50. North America Active Pharmaceutical Ingredients (API) Market: Central Nervous System, 2018-2028, $ bn 90
Figure 51. North America Active Pharmaceutical Ingredients (API) Market: Pulmonary Disorders, 2018-2028, $ bn 91
Figure 52. North America Active Pharmaceutical Ingredients (API) Market: Orthopedics, 2018-2028, $ bn 92
Figure 53. North America Active Pharmaceutical Ingredients (API) Market: Other Applications, 2018-2028, $ bn 93
Figure 54. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Drug Type, 2018-2028, % of Revenue 94
Figure 55. Contribution to North America 2022-2028 Cumulative Revenue by Drug Type, Value ($ bn) and Share (%) 95
Figure 56. North America Active Pharmaceutical Ingredients (API) Market: Branded Prescription Drugs, 2018-2028, $ bn 96
Figure 57. North America Active Pharmaceutical Ingredients (API) Market: Generic Prescription Drugs, 2018-2028, $ bn 97
Figure 58. North America Active Pharmaceutical Ingredients (API) Market: OTC Drugs, 2018-2028, $ bn 98
Figure 59. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Country, 2021 and 2028, % of Revenue 100
Figure 60. Contribution to North America 2022-2028 Cumulative Revenue by Country, Value ($ bn) and Share (%) 101
Figure 61. U.S. Active Pharmaceutical Ingredients (API) Market, 2018-2028, $ bn 103
Figure 62. Manufacturing Sites of APIs for U.S. Market by Country or Region, 109
Figure 63. Number and Percentage of API Facilities for the 370 U.S. Marketed Drugs on the 2019 WHO Essential Medicines List 109
Figure 64. Number and Percentage of API Facilities for the 370 U.S. Marketed Drugs on the 2019 WHO Essential Medicines List 110
Figure 65. Canada Active Pharmaceutical Ingredients (API) Market, 2018-2028, $ bn 113
Figure 66. Active Pharmaceutical Ingredients (API) Market in Mexico, 2018-2028, $ bn 115
Figure 67. Growth Stage of North America Active Pharmaceutical Ingredients (API) Industry over the Forecast Period 117
Figure 68. Top products of AstraZeneca based on revenue from 2016 to 2019 (in million U.S. dollars) 124

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North America Active Pharmaceutical Ingredients (API) Market 2021-2028

North America Active Pharmaceutical Ingredients (API) Market 2021-2028