North America Active Pharmaceutical Ingredients (API) Market 2020-2026 by Synthesis (Synthetic, Biotech, HPAPI), Manufacturing Process (Captive, Merchant), Therapeutic Application, Drug Type, and Country: Trend Forecast and Growth Opportunity

128 pages | Grace Market Data
North America active pharmaceutical ingredients (API) market is expected to grow by 5.7% annually in the forecast period and reach $101.03 billion by 2026 driven by the rising need for medicine and pharmaceutical agents amid the COVID-19 pandemic.
Highlighted with 31 tables and 62 figures, this 128-page report “North America Active Pharmaceutical Ingredients (API) Market 2020-2026 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 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 2015-2019 and provides forecast from 2020 till 2026 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 API 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 for 2015-2026 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 for 2015-2026 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

Based on Therapeutic Application, the North America market is segmented into the following sub-markets with annual revenue for 2015-2026 included in each section.
• Infectious Diseases
• Oncology
• Ophthalmology
• Cardiovascular Disorders
• Central Nervous System
• Pulmonary Disorders
• Orthopedics
• Other Applications

Based on Drug Type, the North America market is segmented into the following sub-markets with annual revenue for 2015-2026 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 aforementioned country, detailed analysis and data for annual revenue are available for 2015-2026. 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.
Specifically, potential risks associated with investing in North America API market are assayed quantitatively and qualitatively through GMD’s Risk Assessment System. According to the risk analysis and evaluation, Critical Success Factors (CSFs) are generated as a guidance to help investors & stockholders identify emerging opportunities, manage and minimize the risks, develop appropriate business models, and make wise strategies and decisions.
Key Players (this may not be a complete list and extra companies can be added upon request):
AbbVie Inc.
Astrazeneca
Aurobindo Pharma Ltd.
Bayer Healthcare
Bioniche Animal Health
Boehringer Ingelheim
Bristol-Myers Squibb
Ceva Animal Health, Inc.
Elanco Animal Health
Eli Lilly and Company
F. Hoffmann-La Roche
Glaxosmithkline PLC
Heska Co.
Lonza Group
Merck & Co., Inc.
Novartis International AG
Pfizer, Inc.
Ranbaxy Laboratories
Sanofi
Sun Pharmaceutical Industries 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 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 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

2.2 Major Growth Drivers 21

2.3 Market Restraints and Challenges 25

2.4 Emerging Opportunities and Market Trends 28

2.5 Porter’s Fiver Forces Analysis 32

3 Segmentation of North America Market by Synthesis 36

3.1 Market Overview by Synthesis 36

3.2 Synthetic API 38

3.2.1 Branded Synthetic API 39

3.2.2 Generic Synthetic API 40

3.3 Biotech API 41

3.3.1 Biotech API by Drug Type 42

3.3.1.1 Monoclonal Antibodies 43

3.3.1.2 Recombinant Proteins 44

3.3.1.3 Vaccines 45

3.3.1.4 Other Biotech APIs 46

3.3.2 Biotech API by Customer Base 47

3.3.2.1 Innovative Biologic API 48

3.3.2.2 Generic Biosimilar API 49

3.3.3 Biotech API by Expression Technology 50

3.3.3.1 Mammalian Expression 51

3.3.3.2 Microbial Expression 52

3.3.3.3 Yeast Expression 53

3.3.3.4 Insect Expression 54

3.3.3.5 Other Expression Technologies 55

3.4 HPAPI 56

3.4.1 Branded HPAPI 57

3.4.2 Generic HPAPI 58

4 Segmentation of North America Market by Manufacturing Process 59

4.1 Market Overview by Manufacturing Process 59

4.2 Captive Manufacturing 61

4.2.1 Branded Captive API 62

4.2.2 Generic Captive API 63

4.3 Merchant Manufacturing 64

4.3.1 Merchant Manufacturing by Drug Type 65

4.3.1.1 Branded Merchant API 66

4.3.1.2 Generic Merchant API 67

4.3.2 Merchant Manufacturing by Drug Synthesis 68

4.3.2.1 Merchant Synthetic API 69

4.3.2.2 Merchant Biotech API 70

5 Segmentation of North America Market by Therapeutic Application 71

5.1 Market Overview by Therapeutic Application 71

5.2 Infectious Diseases 73

5.3 Oncology 74

5.4 Ophthalmology 75

5.5 Cardiovascular Disorders 76

5.6 Central Nervous System 77

5.7 Pulmonary Disorders 78

5.8 Orthopedics 79

5.9 Other Applications 80

6 Segmentation of North America Market by Drug Type 81

6.1 Market Overview by Drug Type 81

6.2 Branded Prescription Drugs 83

6.3 Generic Prescription Drugs 84

6.4 OTC Drugs 85

7 North America Market 2019-2026 by Country 86

7.1 Overview of North America Market 86

7.2 U.S. 89

7.3 Canada 93

7.4 Mexico 95

8 Competitive Landscape 97

8.1 Overview of Key Vendors 97

8.2 New Product Launch, Partnership, Investment, and M&A 100

8.3 Company Profiles 101

AbbVie Inc. 101

Astrazeneca 103

Aurobindo Pharma Ltd. 104

Bayer Healthcare 105

Bioniche Animal Health 106

Boehringer Ingelheim 107

Bristol-Myers Squibb 108

Ceva Animal Health, Inc. 109

Elanco Animal Health 110

Eli Lilly and Company 111

F. Hoffmann-La Roche 112

Glaxosmithkline PLC 113

Heska Co. 114

Lonza Group 115

Merck & Co., Inc. 116

Novartis International AG 117

Pfizer, Inc. 118

Ranbaxy Laboratories 119

Sanofi 120

Sun Pharmaceutical Industries Ltd. 121

9 Investing in North America Market: Risk Assessment and Management 122

9.1 Risk Evaluation of North America Market 122

9.2 Critical Success Factors (CSFs) 125

Related Reports and Products 128



Table 1. Snapshot of North America Active Pharmaceutical Ingredients (API) Market, 2019-2026 19

Table 2. Main Product Trends and Market Opportunities in North America Active Pharmaceutical Ingredients (API) Market 28

Table 3. North America Active Pharmaceutical Ingredients (API) Market by Synthesis, 2015-2026, $ bn 36

Table 4. North America Active Pharmaceutical Ingredients (API) Market: Synthetic API by Drug Type, 2015-2026, $ bn 38

Table 5. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Drug Type, 2015-2026, $ bn 42

Table 6. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Customer Base, 2015-2026, $ bn 47

Table 7. North America Active Pharmaceutical Ingredients (API) Market: Biotech API by Expression Technology, 2015-2026, $ bn 50

Table 8. North America Active Pharmaceutical Ingredients (API) Market: HPAPI by Drug Type, 2015-2026, $ bn 56

Table 9. North America Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2015-2026, $ bn 59

Table 10. North America Active Pharmaceutical Ingredients (API) Market: Captive Manufacturing by Drug Type, 2015-2026, $ bn 61

Table 11. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing by Drug Type, 2015-2026, $ bn 65

Table 12. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing by Drug Synthesis, 2015-2026, $ bn 68

Table 13. North America Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2015-2026, $ bn 71

Table 14. North America Active Pharmaceutical Ingredients (API) Market by Drug Type, 2015-2026, $ bn 81

Table 15. North America Active Pharmaceutical Ingredients (API) Market by Country, 2015-2026, $ bn 87

Table 16. U.S. Active Pharmaceutical Ingredients (API) Market by Synthesis, 2015-2026, $ bn 91

Table 17. U.S. Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2015-2026, $ bn 91

Table 18. U.S. Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2015-2026, $ bn 91

Table 19. Canada Active Pharmaceutical Ingredients (API) Market by Synthesis, 2015-2026, $ bn 94

Table 20. Canada Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2015-2026, $ bn 94

Table 21. Canada Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2015-2026, $ bn 94

Table 22. Mexico Active Pharmaceutical Ingredients (API) Market by Synthesis, 2015-2026, $ bn 96

Table 23. Mexico Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2015-2026, $ bn 96

Table 24. Mexico Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2015-2026, $ bn 96

Table 25. AbbVie Inc.: Company Snapshot 101

Table 26. AbbVie Inc.: Business Segmentation 101

Table 27. AbbVie Inc.: Product Portfolio 102

Table 28. AbbVie Inc.: Revenue, 2016-2018, $ bn 102

Table 29. AbbVie Inc.: Recent Developments 102

Table 30. Risk Evaluation for Investing in North America Market, 2019-2026 123

Table 31. Critical Success Factors and Key Takeaways 126



Figure 1. Research Method Flow Chart 12

Figure 2. Breakdown of Primary Research 14

Figure 3. Bottom-up Approach and Top-down Approach for Market Estimation 16

Figure 4. North America Market Forecast in Optimistic, Conservative and Balanced Perspectives, 2019-2026 18

Figure 5. North America Active Pharmaceutical Ingredients (API) Market, 2019-2026, $ bn 20

Figure 6. Primary Drivers and Impact Factors of North America Active Pharmaceutical Ingredients (API) Market 21

Figure 7. GDP per capita in the World, 1960-2018, $ thousand 24

Figure 8. Forecast of Middle-class Population by Region, 2015-2030, million 24

Figure 9. Primary Restraints and Impact Factors of North America Active Pharmaceutical Ingredients (API) Market 25

Figure 10. Investment Opportunity Analysis 29

Figure 11. Porter’s Fiver Forces Analysis of North America Active Pharmaceutical Ingredients (API) Market 32

Figure 12. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Synthesis, 2019-2026, % of Revenue 36

Figure 13. Contribution to North America 2020-2026 Cumulative Revenue by Synthesis, Value ($ bn) and Share (%) 37

Figure 14. North America Active Pharmaceutical Ingredients (API) Market: Synthetic API, 2015-2026, $ bn 38

Figure 15. North America Active Pharmaceutical Ingredients (API) Market: Branded Synthetic API, 2015-2026, $ bn 39

Figure 16. North America Active Pharmaceutical Ingredients (API) Market: Generic Synthetic API, 2015-2026, $ bn 40

Figure 17. North America Active Pharmaceutical Ingredients (API) Market: Biotech API, 2015-2026, $ bn 41

Figure 18. North America Active Pharmaceutical Ingredients (API) Market: Monoclonal Antibodies, 2015-2026, $ bn 43

Figure 19. North America Active Pharmaceutical Ingredients (API) Market: Recombinant Proteins, 2015-2026, $ bn 44

Figure 20. North America Active Pharmaceutical Ingredients (API) Market: Vaccines, 2015-2026, $ bn 45

Figure 21. North America Active Pharmaceutical Ingredients (API) Market: Other Biotech APIs, 2015-2026, $ bn 46

Figure 22. North America Active Pharmaceutical Ingredients (API) Market: Innovative Biologic API, 2015-2026, $ bn 48

Figure 23. North America Active Pharmaceutical Ingredients (API) Market: Generic Biosimilar API, 2015-2026, $ bn 49

Figure 24. North America Active Pharmaceutical Ingredients (API) Market: Mammalian Expression, 2015-2026, $ bn 51

Figure 25. North America Active Pharmaceutical Ingredients (API) Market: Microbial Expression, 2015-2026, $ bn 52

Figure 26. North America Active Pharmaceutical Ingredients (API) Market: Yeast Expression, 2015-2026, $ bn 53

Figure 27. North America Active Pharmaceutical Ingredients (API) Market: Insect Expression, 2015-2026, $ bn 54

Figure 28. North America Active Pharmaceutical Ingredients (API) Market: Other Expression Technologies, 2015-2026, $ bn 55

Figure 29. North America Active Pharmaceutical Ingredients (API) Market: HPAPI, 2015-2026, $ bn 56

Figure 30. North America Active Pharmaceutical Ingredients (API) Market: Branded HPAPI, 2015-2026, $ bn 57

Figure 31. North America Active Pharmaceutical Ingredients (API) Market: Generic HPAPI, 2015-2026, $ bn 58

Figure 32. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Manufacturing Process, 2019-2026, % of Revenue 59

Figure 33. Contribution to North America 2020-2026 Cumulative Revenue by Manufacturing Process, Value ($ bn) and Share (%) 60

Figure 34. North America Active Pharmaceutical Ingredients (API) Market: Captive Manufacturing, 2015-2026, $ bn 61

Figure 35. North America Active Pharmaceutical Ingredients (API) Market: Branded Captive API, 2015-2026, $ bn 62

Figure 36. North America Active Pharmaceutical Ingredients (API) Market: Generic Captive API, 2015-2026, $ bn 63

Figure 37. North America Active Pharmaceutical Ingredients (API) Market: Merchant Manufacturing, 2015-2026, $ bn 64

Figure 38. North America Active Pharmaceutical Ingredients (API) Market: Branded Merchant API, 2015-2026, $ bn 66

Figure 39. North America Active Pharmaceutical Ingredients (API) Market: Generic Merchant API, 2015-2026, $ bn 67

Figure 40. North America Active Pharmaceutical Ingredients (API) Market: Merchant Synthetic API, 2015-2026, $ bn 69

Figure 41. North America Active Pharmaceutical Ingredients (API) Market: Merchant Biotech API, 2015-2026, $ bn 70

Figure 42. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Therapeutic Application, 2019-2026, % of Revenue 71

Figure 43. Contribution to North America 2020-2026 Cumulative Revenue by Therapeutic Application, Value ($ bn) and Share (%) 72

Figure 44. North America Active Pharmaceutical Ingredients (API) Market: Infectious Diseases, 2015-2026, $ bn 73

Figure 45. North America Active Pharmaceutical Ingredients (API) Market: Oncology, 2015-2026, $ bn 74

Figure 46. North America Active Pharmaceutical Ingredients (API) Market: Ophthalmology , 2015-2026, $ bn 75

Figure 47. North America Active Pharmaceutical Ingredients (API) Market: Cardiovascular Disorders, 2015-2026, $ bn 76

Figure 48. North America Active Pharmaceutical Ingredients (API) Market: Central Nervous System, 2015-2026, $ bn 77

Figure 49. North America Active Pharmaceutical Ingredients (API) Market: Pulmonary Disorders, 2015-2026, $ bn 78

Figure 50. North America Active Pharmaceutical Ingredients (API) Market: Orthopedics, 2015-2026, $ bn 79

Figure 51. North America Active Pharmaceutical Ingredients (API) Market: Other Applications, 2015-2026, $ bn 80

Figure 52. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Drug Type, 2019-2026, % of Revenue 81

Figure 53. Contribution to North America 2020-2026 Cumulative Revenue by Drug Type, Value ($ bn) and Share (%) 82

Figure 54. North America Active Pharmaceutical Ingredients (API) Market: Branded Prescription Drugs, 2015-2026, $ bn 83

Figure 55. North America Active Pharmaceutical Ingredients (API) Market: Generic Prescription Drugs, 2015-2026, $ bn 84

Figure 56. North America Active Pharmaceutical Ingredients (API) Market: OTC Drugs, 2015-2026, $ bn 85

Figure 57. Breakdown of North America Active Pharmaceutical Ingredients (API) Market by Country, 2019 and 2026, % of Revenue 87

Figure 58. Contribution to North America 2020-2026 Cumulative Revenue by Country, Value ($ bn) and Share (%) 88

Figure 59. U.S. Active Pharmaceutical Ingredients (API) Market, 2015-2026, $ bn 90

Figure 60. Canada Active Pharmaceutical Ingredients (API) Market, 2015-2026, $ bn 93

Figure 61. Active Pharmaceutical Ingredients (API) Market in Mexico, 2015-2026, $ bn 95

Figure 62. Growth Stage of North America Active Pharmaceutical Ingredients (API) Industry over the Forecast Period 97



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