The North America pulmonary arterial hypertension market is expected to grow from US$ 3,147.76 million in 2022 to US$ 4,456.90 million by 2028; it is estimated to grow at a CAGR of 6.0% from 2022 to 2028.
In September 2020, Alembic Pharmaceuticals Limited announced that its subsidiary Alembic Global Holdings SA received tentative FDA approval for its Abbreviated New Drugs Application (ANDA) Treprostinil Injection is administered in 20-mL multidose vials in five strengths, containing 50 mg, 20 mg, 100 mg, and 200 mg (2.5 mg/mL, 1 mg/mL, 5 mg/mL, and 10 mg/mL) of treprostinil, respectively. In May 2022, United Therapeutic Corporation received FDA approval for Tyvaso DPI (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) and pulmonary arterial hypertension (PAH; WHO Group 1) to enhance exercise ability.
Thus, the rising number of pulmonary arterial hypertension drug approvals is boosting the growth of the North America pulmonary arterial hypertension market.
According to the American Lung Association, PAH is a rare and progressive disorder that accounts for ~500-1000 new cases being diagnosed each year in the US. Additionally, as per the same source, approximately 15-20% of PAH patients are suffering from heritable PAH, which is caused by genetic mutations. Further, manufacturers are taking various initiatives to provide information and resources to healthcare practitioners, fueling the market growth. For instance, the PAH Initiative, supported by United Therapeutics, provides resources and information to assist healthcare providers in treating patients impacted by PAH. Thus, the rising cases of PAH diagnosed each year and initiatives undertaken by drug manufacturers fuel the demand for pulmonary arterial hypertension drugs and other treatment methods, further bolstering the pulmonary arterial hypertension market growth in the US.
Rising Approvals of Pulmonary Arterial Hypertension Drugs Drives North America Pulmonary Arterial Hypertension Market
In November 2021, the US Food and Drugs Administration (FDA) granted tentative approval for Yutrepia (treprostinil) inhalation powder. Yutrepia is indicated to treat PAH to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. In July 2021, The Janssen Pharmaceutical Companies of Johnson & Johnson received the FDA's approval for UPTRAVI (selexipag) injection for intravenous (IV) to treat pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II-III. These patients are temporarily unable to take oral therapy. Similarly, in August 2021, Aerami Therapeutics, Inc. announced that the FDA granted the company an orphan drug designation for imatinib to treat PAH patients. AER-901, a drug-device combination product candidate for inhaled imatinib for the treatment of PAH, completed its Phase 1 trial in 2021. Aerami plans to advance AER-901 into a Phase 2 trial by the first half of 2023, following an amendment to the open AER-901 IND application with the FDA.In September 2020, Alembic Pharmaceuticals Limited announced that its subsidiary Alembic Global Holdings SA received tentative FDA approval for its Abbreviated New Drugs Application (ANDA) Treprostinil Injection is administered in 20-mL multidose vials in five strengths, containing 50 mg, 20 mg, 100 mg, and 200 mg (2.5 mg/mL, 1 mg/mL, 5 mg/mL, and 10 mg/mL) of treprostinil, respectively. In May 2022, United Therapeutic Corporation received FDA approval for Tyvaso DPI (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) and pulmonary arterial hypertension (PAH; WHO Group 1) to enhance exercise ability.
Thus, the rising number of pulmonary arterial hypertension drug approvals is boosting the growth of the North America pulmonary arterial hypertension market.
North America Pulmonary Arterial Hypertension Market Overview
The North America pulmonary arterial hypertension market is segmented into the US, Canada, and Mexico. The market growth in this region is attributed due to a surge in health expenditure, the high prevalence of pulmonary arterial hypertension, and a rise in initiatives by the government and manufacturers. The US pulmonary arterial hypertension market holds a significant share in North America. The rising healthcare expenditure is fueling the drug development of pulmonary arterial hypertension (PAH). According to US Centers for Medicare & Medicaid Services, the national healthcare expenditure in the US increased by 9.7% in 2019 and reached US$ 4.1 trillion in 2020. Furthermore, as per the same source, national health spending is expected to grow at a 5.4% annual rate from 2019 to 2028, and it is expected to reach US$ 6.2 trillion by 2028. The rising healthcare expenditure is estimated to increase the research and development of PAH drugs due to the availability of limited drugs in the market for treating PAH.According to the American Lung Association, PAH is a rare and progressive disorder that accounts for ~500-1000 new cases being diagnosed each year in the US. Additionally, as per the same source, approximately 15-20% of PAH patients are suffering from heritable PAH, which is caused by genetic mutations. Further, manufacturers are taking various initiatives to provide information and resources to healthcare practitioners, fueling the market growth. For instance, the PAH Initiative, supported by United Therapeutics, provides resources and information to assist healthcare providers in treating patients impacted by PAH. Thus, the rising cases of PAH diagnosed each year and initiatives undertaken by drug manufacturers fuel the demand for pulmonary arterial hypertension drugs and other treatment methods, further bolstering the pulmonary arterial hypertension market growth in the US.
North America Pulmonary Arterial Hypertension Market Revenue and Forecast to 2028 (US$ Million)
North America Pulmonary Arterial Hypertension Market Segmentation
The North America pulmonary arterial hypertension market is segmented on the basis of drugs, type, route of administration, distribution channel, and country.- Based on drugs, the North America pulmonary arterial hypertension market is segmented into endothelin receptor antagonists (ERAs), prostacyclin and prostacyclin analogs, sGC stimulators, and pde-5 dipsticks. In 2022, the prostacyclin and prostacyclin analogs segment registered the largest share in the North America pulmonary arterial hypertension market.
- Based on type, the North America pulmonary arterial hypertension market is bifurcated into branded and generics. In 2022, the branded segment registered a larger share in the North America pulmonary arterial hypertension market.
- Based on route of administration, the North America pulmonary arterial hypertension market is segmented into oral, intravenous/subcutaneous, and inhalational. In 2022, the oral segment registered the largest share in the North America pulmonary arterial hypertension market.
- Based on distribution channel, the North America pulmonary arterial hypertension market is segmented into hospital pharmacies and clinics, online pharmacies, and retail pharmacies. In 2022, the hospital pharmacies and clinics segment registered the largest share in the North America pulmonary arterial hypertension market.
- Based on country, the North America pulmonary arterial hypertension market is segmented into the US, Canada, and Mexico. In 2022, the US registered the largest share in the North America pulmonary arterial hypertension market.
Table of Contents
1. Introduction1.1 Scope of the Study
1.2 Research Report Guidance
1.3 Market Segmentation
1.3.1 North America Pulmonary Arterial Hypertension Market - By Drugs
1.3.2 North America Pulmonary Arterial Hypertension Market - By Type
1.3.3 North America Pulmonary Arterial Hypertension Market - By Route of Administration
1.3.4 North America Pulmonary Arterial Hypertension Market - By Distribution Channel
1.3.5 North America Pulmonary Arterial Hypertension Market - By Country
2. North America Pulmonary Arterial Hypertension Market - Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. North America Pulmonary Arterial Hypertension Market - Market Landscape
4.1 Overview
4.2 North America PEST Analysis
4.3 Experts Opinion
5. North America Pulmonary Arterial Hypertension Market - Key Market Dynamics
5.1 Market Drivers
5.1.1 Growing Incidence of Pulmonary Arterial Hypertension
5.1.2 Rising Approvals of Pulmonary Arterial Hypertension Drugs
5.2 Market Restraints
5.2.1 Side Effects of Drugs Used for Treatment of Pulmonary Arterial Hypertension
5.3 Market Opportunities
5.3.1 Availability of Generics at Affordable Costs Due to Growing Patent Expiration
5.3.2 Drugs Patents Expiration Data
5.4 Future Trend
5.4.1 Rising Clinical Trials for Drugs Development to Treat Pulmonary Arterial Hypertension
5.5 Impact analysis
6. Pulmonary Arterial Hypertension Market - North America Analysis
6.1 North America Pulmonary Arterial Hypertension Market Revenue Forecast and Analysis
7. North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 - by Drugs
7.1 Overview
7.2 North America Pulmonary Arterial Hypertension Market Revenue Share, by Drugs 2021 & 2028 (%)
7.3 Endothelin Receptor Antagonists (ERAs)
7.3.1 Overview
7.3.2 Endothelin Receptor Antagonists (ERAs): North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
7.4 Prostacyclin and Prostacyclin Analogs
7.4.1 Overview
7.4.2 Prostacyclin and Prostacyclin Analogs: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
7.5 SGC Stimulators
7.5.1 Overview
7.5.2 sGC Stimulators: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
7.6 Pde-5 Dipsticks
7.6.1 Overview
7.6.2 Pde-5 Dipsticks: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
8. North America Pulmonary Arterial Hypertension Market Analysis and Forecasts to 2028 - by Type
8.1 Overview
8.2 North America Pulmonary Arterial Hypertension Market, by Type 2021 & 2028 (%)
8.3 Branded
8.3.1 Overview
8.3.2 Branded: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
8.4 Generics
8.4.1 Overview
8.4.2 Generics: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
9. North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 - by Route of Administration
9.1 Overview
9.2 North America Pulmonary Arterial Hypertension Market Revenue Share, by Route of Administration 2021 & 2028 (%)
9.3 Oral
9.3.1 Overview
9.3.2 Oral: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
9.4 Intravenous/ Subcutaneous
9.4.1 Overview
9.4.2 Intravenous/ Subcutaneous: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
9.5 Inhalational
9.5.1 Overview
9.5.2 Inhalational: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
10. North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 - by Distribution Channel
10.1 Overview
10.2 North America Pulmonary Arterial Hypertension Market Revenue Share, by Distribution Channel 2021 & 2028 (%)
10.3 Hospital Pharmacies and Clinics
10.3.1 Overview
10.3.2 Hospital Pharmacies and Clinics: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
10.4 Online Pharmacies
10.4.1 Overview
10.4.2 Online Pharmacies: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
10.5 Retail Pharmacies
10.5.1 Overview
10.5.2 Retail Pharmacies: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
11. North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 - Country Analysis
11.1 Overview
11.1.1.1 US: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
11.1.1.1.1 Overview
11.1.1.1.2 US: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
11.1.1.1.3 US: Pulmonary Arterial Hypertension Market, by Drugs, 2019-2028 (US$ Million)
11.1.1.1.4 US: Pulmonary Arterial Hypertension Market, by Type, 2019-2028 (US$ Million)
11.1.1.1.5 US: Pulmonary Arterial Hypertension Market, by Route of Administration, 2019-2028 (US$ Million)
11.1.1.1.6 US: Pulmonary Arterial Hypertension Market, by Distribution Channel, 2019-2028 (US$ Million)
11.1.1.2 Canada: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
11.1.1.2.1 Overview
11.1.1.2.2 Canada: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
11.1.1.2.3 Canada: Pulmonary Arterial Hypertension Market, by Drugs, 2019-2028 (US$ Million)
11.1.1.2.4 Canada: Pulmonary Arterial Hypertension Market, by Type, 2019-2028 (US$ Million)
11.1.1.2.5 Canada: Pulmonary Arterial Hypertension Market, by Route of Administration, 2019-2028 (US$ Million)
11.1.1.2.6 Canada: Pulmonary Arterial Hypertension Market, by Distribution Channel, 2019-2028 (US$ Million)
11.1.1.3 Mexico: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
11.1.1.3.1 Overview
11.1.1.3.2 Mexico: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
11.1.1.3.3 Mexico: Pulmonary Arterial Hypertension Market, by Drugs, 2019-2028 (US$ Million)
11.1.1.3.4 Mexico: Pulmonary Arterial Hypertension Market, by Type, 2019-2028 (US$ Million)
11.1.1.3.5 Mexico: Pulmonary Arterial Hypertension Market, by Route of Administration, 2019-2028 (US$ Million)
11.1.1.3.6 Mexico: Pulmonary Arterial Hypertension Market, by Distribution Channel, 2019-2028 (US$ Million)
12. North America Pulmonary Arterial Hypertension Market - Industry Landscape
12.1 Overview
12.2 Organic Developments
12.2.1 Overview
12.3 Inorganic Developments
12.3.1 Overview
13. Company Profiles
13.1 Johnson & Johnson
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Gilead Sciences Inc
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 United Therapeutics Corp
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Bayer AG
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 Aerami Therapeutics Holdings Inc
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Novartis AG
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 GSK Plc
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 Teva Pharmaceutical Industries Ltd
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Lupin Ltd
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 Pfizer Inc
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments
14. Appendix
14.1 About the Publisher
14.2 Glossary of Terms
List of Tables
Table 1 Drugs Patents Expiration Data
Table 2. North America Pulmonary Arterial Hypertension Market, by Type - Revenue and Forecast to 2028 (US$ Million)
Table 3. US Pulmonary Arterial Hypertension Market, by Drugs - Revenue and Forecast to 2028 (US$ Million)
Table 4. US Pulmonary Arterial Hypertension Market, by Type - Revenue and Forecast to 2028 (US$ Million)
Table 5. US Pulmonary Arterial Hypertension Market, by Route of Administration - Revenue and Forecast to 2028 (US$ Million)
Table 6. US Pulmonary Arterial Hypertension Market, by Distribution Channel - Revenue and Forecast to 2028 (US$ Million)
Table 7. Canada Pulmonary Arterial Hypertension Market, by Drugs - Revenue and Forecast to 2028 (US$ Million)
Table 8. Canada Pulmonary Arterial Hypertension Market, by Type - Revenue and Forecast to 2028 (US$ Million)
Table 9. Canada Pulmonary Arterial Hypertension Market, by Route of Administration - Revenue and Forecast to 2028 (US$ Million)
Table 10. Canada Pulmonary Arterial Hypertension Market, by Distribution Channel - Revenue and Forecast to 2028 (US$ Million)
Table 11. Mexico Pulmonary Arterial Hypertension Market, by Drugs - Revenue and Forecast to 2028 (US$ Million)
Table 12. Mexico Pulmonary Arterial Hypertension Market, by Type - Revenue and Forecast to 2028 (US$ Million)
Table 13. Mexico Pulmonary Arterial Hypertension Market, by Route of Administration - Revenue and Forecast to 2028 (US$ Million)
Table 14. Mexico Pulmonary Arterial Hypertension Market, by Distribution Channel - Revenue and Forecast to 2028 (US$ Million)
Table 15. Organic Developments in the North America pulmonary arterial hypertension market
Table 16. Inorganic Developments in the North America pulmonary arterial hypertension market
Table 17. Glossary of Terms
List of Figures
Figure 1. North America Pulmonary Arterial Hypertension Market Segmentation
Figure 2. North America Pulmonary Arterial Hypertension Market - By Country
Figure 3. North America Pulmonary Arterial Hypertension Market Overview
Figure 4. Prostacyclin and Prostacyclin Analogs Segment Held Largest Share by Drugs of the North America Pulmonary Arterial Hypertension Market
Figure 5. US to Show Significant Growth During Forecast Period
Figure 6. North America: PEST Analysis
Figure 7. Experts Opinion
Figure 8. North America Pulmonary Arterial Hypertension Market Impact Analysis of Drivers and Restraint
Figure 9. North America Pulmonary Arterial Hypertension Market- Revenue Forecast and Analysis - 2020 - 2028
Figure 10. North America Pulmonary Arterial Hypertension Market Revenue Share, by Drugs 2021 & 2028 (%)
Figure 11. Endothelin Receptor Antagonists (ERAs): North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 12. Prostacyclin and Prostacyclin Analogs: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 13. sGC Stimulators: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 14. Pde-5 Dipsticks: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 15. North America Pulmonary Arterial Hypertension Market, by Type 2021 & 2028 (%)
Figure 16. Branded: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 17. Generics: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 18. North America Pulmonary Arterial Hypertension Market Revenue Share, by Route of Administration 2021 & 2028 (%)
Figure 19. Oral: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 20. Intravenous/ Subcutaneous: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 21. Inhalational: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 22. North America Pulmonary Arterial Hypertension Market Revenue Share, by Distribution Channel 2021 & 2028 (%)
Figure 23. Hospital Pharmacies and Clinics: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 24. Online Pharmacies: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 25. Retail Pharmacies: North America Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 26. North America: Pulmonary Arterial Hypertension Market, by Key Country - Revenue (2021) (US$ Million)
Figure 27. North America: Pulmonary Arterial Hypertension Market, by Country, 2021 & 2028 (%)
Figure 28. US: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 29. Canada: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Figure 30. Mexico: Pulmonary Arterial Hypertension Market - Revenue and Forecast to 2028 (US$ Million)
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Aerami Therapeutics Holdings Inc
- Bayer AG
- Gilead Sciences Inc
- GSK Plc
- Johnson & Johnson
- Lupin Ltd
- Novartis AG
- Pfizer Inc
- Teva Pharmaceutical Industries Ltd
- United Therapeutics Corp
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 143 |
| Published | February 2023 |
| Forecast Period | 2022 - 2028 |
| Estimated Market Value ( USD | $ 3147.76 Million |
| Forecasted Market Value ( USD | $ 4456.9 Million |
| Compound Annual Growth Rate | 6.0% |
| Regions Covered | North America |
