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

About the Report

About the Report

North America active pharmaceutical ingredients market is projected to grow by 5.3% annually in the forecast period and reach USD 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 (USD 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 (USD 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 (USD 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 (USD 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 (USD 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.)

Products


Companies

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.)

Table Of Content

Table Of Content

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 Figure

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, USD 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, USD 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 (USD bn) and Share (%) 50

Figure 16. North America Active Pharmaceutical Ingredients (API) Market: Synthetic API, 2018-2028, USD bn 51

Figure 17. North America Active Pharmaceutical Ingredients (API) Market: Branded Synthetic API, 2018-2028, USD bn 52

Figure 18. North America Active Pharmaceutical Ingredients (API) Market: Generic Synthetic API, 2018-2028, USD bn 53

Figure 19. North America Active Pharmaceutical Ingredients (API) Market: Biotech API, 2018-2028, USD bn 54

Figure 20. North America Active Pharmaceutical Ingredients (API) Market: Monoclonal Antibodies, 2018-2028, USD bn 56

Figure 21. North America Active Pharmaceutical Ingredients (API) Market: Recombinant Proteins, 2018-2028, USD bn 57

Figure 22. North America Active Pharmaceutical Ingredients (API) Market: Vaccines, 2018-2028, USD bn 58

Figure 23. North America Active Pharmaceutical Ingredients (API) Market: Other Biotech APIs, 2018-2028, USD bn 59

Figure 24. North America Active Pharmaceutical Ingredients (API) Market: Innovative Biologic API, 2018-2028, USD bn 61

Figure 25. North America Active Pharmaceutical Ingredients (API) Market: Generic Biosimilar API, 2018-2028, USD bn 62

Figure 26. North America Active Pharmaceutical Ingredients (API) Market: Mammalian Expression, 2018-2028, USD bn 64

Figure 27. North America Active Pharmaceutical Ingredients (API) Market: Microbial Expression, 2018-2028, USD bn 65

Figure 28. North America Active Pharmaceutical Ingredients (API) Market: Yeast Expression, 2018-2028, USD bn 66

Figure 29. North America Active Pharmaceutical Ingredients (API) Market: Insect Expression, 2018-2028, USD bn 67

Figure 30. North America Active Pharmaceutical Ingredients (API) Market: Other Expression Technologies, 2018-2028, USD bn 68

Figure 31. North America Active Pharmaceutical Ingredients (API) Market: HPAPI, 2018-2028, USD bn 69

Figure 32. North America Active Pharmaceutical Ingredients (API) Market: Branded HPAPI, 2018-2028, USD bn 70

Figure 33. North America Active Pharmaceutical Ingredients (API) Market: Generic HPAPI, 2018-2028, USD 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 (USD bn) and Share (%) 73

Figure 36. North America Active Pharmaceutical Ingredients (API) Market: Captive Manufacturing, 2018-2028, USD bn 74

Figure 37. North America Active Pharmaceutical Ingredients (API) Market: Branded Captive API, 2018-2028, USD bn 75

Figure 38. North America Active Pharmaceutical Ingredients (API) Market: Generic Captive API, 2018-2028, USD bn 76

Figure 39. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing, 2018-2028, USD bn 77

Figure 40. North America Active Pharmaceutical Ingredients (API) Market: Branded Merchant API, 2018-2028, USD bn 79

Figure 41. North America Active Pharmaceutical Ingredients (API) Market: Generic Merchant API, 2018-2028, USD bn 80

Figure 42. North America Active Pharmaceutical Ingredients (API) Market: Merchant Synthetic API, 2018-2028, USD bn 82

Figure 43. North America Active Pharmaceutical Ingredients (API) Market: Merchant Biotech API, 2018-2028, USD 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 (USD bn) and Share (%) 85

Figure 46. North America Active Pharmaceutical Ingredients (API) Market: Infectious Diseases, 2018-2028, USD bn 86

Figure 47. North America Active Pharmaceutical Ingredients (API) Market: Oncology, 2018-2028, USD bn 87

Figure 48. North America Active Pharmaceutical Ingredients (API) Market: Ophthalmology , 2018-2028, USD bn 88

Figure 49. North America Active Pharmaceutical Ingredients (API) Market: Cardiovascular Disorders, 2018-2028, USD bn 89

Figure 50. North America Active Pharmaceutical Ingredients (API) Market: Central Nervous System, 2018-2028, USD bn 90

Figure 51. North America Active Pharmaceutical Ingredients (API) Market: Pulmonary Disorders, 2018-2028, USD bn 91

Figure 52. North America Active Pharmaceutical Ingredients (API) Market: Orthopedics, 2018-2028, USD bn 92

Figure 53. North America Active Pharmaceutical Ingredients (API) Market: Other Applications, 2018-2028, USD 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 (USD bn) and Share (%) 95

Figure 56. North America Active Pharmaceutical Ingredients (API) Market: Branded Prescription Drugs, 2018-2028, USD bn 96

Figure 57. North America Active Pharmaceutical Ingredients (API) Market: Generic Prescription Drugs, 2018-2028, USD bn 97

Figure 58. North America Active Pharmaceutical Ingredients (API) Market: OTC Drugs, 2018-2028, USD 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 (USD bn) and Share (%) 101

Figure 61. U.S. Active Pharmaceutical Ingredients (API) Market, 2018-2028, USD 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, USD bn 113

Figure 66. Active Pharmaceutical Ingredients (API) Market in Mexico, 2018-2028, USD 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


List Of Table

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, USD 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, USD bn 49

Table 6. North America Active Pharmaceutical Ingredients (API) Market: Synthetic API by Drug Type, 2018-2028, USD bn 51

Table 7. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Drug Type, 2018-2028, USD bn 55

Table 8. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Category, 2018-2028, USD bn 60

Table 9. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Expression Technology, 2018-2028, USD bn 63

Table 10. North America Active Pharmaceutical Ingredients (API) Market: HPAPI by Drug Type, 2018-2028, USD bn 69

Table 11. North America Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, USD bn 72

Table 12. North America Active Pharmaceutical Ingredients (API) Market: Captive Manufacturing by Drug Type, 2018-2028, USD bn 74

Table 13. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing by Drug Type, 2018-2028, USD bn 78

Table 14. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing by Drug Synthesis, 2018-2028, USD bn 81

Table 15. North America Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, USD bn 84

Table 16. North America Active Pharmaceutical Ingredients (API) Market by Drug Type, 2018-2028, USD bn 94

Table 17. North America Active Pharmaceutical Ingredients (API) Market by Country, 2018-2028, USD bn 100

Table 18. U.S. Active Pharmaceutical Ingredients (API) Market by Synthesis, 2018-2028, USD bn 104

Table 19. U.S. Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, USD bn 104

Table 20. U.S. Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, USD 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, USD bn 114

Table 23. Canada Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, USD bn 114

Table 24. Canada Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, USD bn 114

Table 25. Mexico Active Pharmaceutical Ingredients (API) Market by Synthesis, 2018-2028, USD bn 116

Table 26. Mexico Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2018-2028, USD bn 116

Table 27. Mexico Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2018-2028, USD bn 116

Table 28. AbbVie Inc.: Company Snapshot 121

Table 29. AbbVie Inc.: Product Portfolio 121

Table 30. AbbVie Inc.: Revenue, 2018-2020, USD bn 122

Table 31. Astrazeneca: Company Snapshot 123

Table 32. Astrazeneca: Revenue, 2018-2020, USD 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, EUR 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, USD 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, USD 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, USD 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, USD bn 164

Table 69. Mylan NV: Company Snapshot 166

Table 70. Mylan NV: Revenue, 2017-2019, USD 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, USD 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, USD bn 174

Table 78. Sanofi: Company Snapshot 177

Table 79. Sanofi: Business Segmentation 177

Table 80. Sanofi: Revenue, 2018-2020, USD 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

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