Disease Overview
Pulmonary arterial hypertension is one of a group of rare and life-threatening diseases collectively known as pulmonary hypertension (PH). Each PH subgroup shares similar pathophysiology, clinical presentation, and therapeutic approaches. The diseases are characterized by abnormal vascular proliferation and remodeling of the small pulmonary arteries and arterioles, vasoconstriction, and in situ thrombosis. This leads to increased pulmonary arterial pressure and localized hypertension, which can eventually result in heart failure.
Report Highlights
CONTENTS
7 OVERVIEW
9 DISEASE BACKGROUND
9 Definition
9 Etiology
9 Symptoms
10 Diagnosis and testing
10 Risk factors
10 Patient segmentation
14 Genetics
16 TREATMENT
16 Drug classes
20 Treatment guidelines
26 EPIDEMIOLOGY
26 Prevalence methodology
30 MARKETED DRUGS
34 PIPELINE DRUGS
42 KEY REGULATORY EVENTS
42 Keeping Track Of US FDA Decisions: Approvals For Ongentys And New Keytruda, Darzalex Dosing, But Not For Trevyent
42 Keeping Track: US FDA Approves Koselugo, Bestows BTDs on Bavencio, Sotatercept
42 United Files Trevyent Following Design Verification Testing
43 PROBABILITY OF SUCCESS
44 LICENSING AND ASSET ACQUISITION DEALS
44 $3bn Roivant Deal To Fill Holes At Dainippon
45 CLINICAL TRIAL LANDSCAPE
46 Sponsors by status
47 Sponsors by phase
48 Recent events
49 DRUG ASSESSMENT MODEL
49 ERAs
50 PDE5 inhibitors
50 Guanyl cyclase stimulator
51 Prostacyclin analogs and agonists
52 Pipeline candidates
53 MARKET DYNAMICS
54 FUTURE TRENDS
54 The PH market will continue to grow due to label expansions into non-PAH subtypes
54 Positive data on morbidity/mortality endpoints will increase uptake of drugs
55 Prostacyclins will be the most lucrative drug class
55 Johnson & Johnson will boast both market leaders
56 Pipeline candidates will diversify the market and introduce improved delivery systems
57 CONSENSUS FORECASTS
60 RECENT EVENTS AND ANALYST OPINION
60 Simdax for PAH and PH (June 2, 2020)
61 Tyvaso for PAH and PH (February 24, 2020)
62 Sotatercept for PAH and PH (January 27, 2020)
65 Revatio for PH and PAH (June 28, 2019)
66 LIQ861 for PH and PAH (June 28, 2019)
67 Opsumit for PAH and PH (June 25, 2019)
68 Udenafil for PAH and PH (June 25, 2019)
69 Beraprost 314d for PH and PAH (April 8, 2019)
71 INOpulse for PH and PAH (January 7, 2019)
72 KEY UPCOMING EVENTS
73 UNMET NEEDS
74 BIBLIOGRAPHY
75 Prescription Information:
76 APPENDIX
LIST OF FIGURES
28 Figure 1: Trends in prevalent cases of pulmonary arterial hypertension, 2018–27
34 Figure 2: Overview of pipeline drugs for pulmonary hypertension in the US
35 Figure 3: Pipeline drugs for pulmonary hypertension, by company
35 Figure 4: Pipeline drugs for pulmonary hypertension, by drug type
36 Figure 5: Pipeline drugs for pulmonary hypertension, by classification
43 Figure 6: Probability of success in the pulmonary hypertension pipeline
45 Figure 7: Clinical trials in hypertension
45 Figure 8: Top 10 drugs for clinical trials in hypertension
46 Figure 9: Top 10 companies for clinical trials in hypertension
46 Figure 10: Trial locations in hypertension
47 Figure 11: Hypertension trials status
48 Figure 12: Hypertension trials sponsors, by phase
49 Figure 13: Datamonitor Healthcare’s drug assessment summary for pulmonary hypertension
53 Figure 14: Market dynamics in pulmonary hypertension
54 Figure 15: Future trends in pulmonary hypertension
61 Figure 16: Simdax for PAH and PH (June 2, 2020)
62 Figure 17: Tyvaso for PAH and PH (February 24, 2020): Phase II/III – INCREASE (ILD Patients)
65 Figure 18: Sotatercept for PAH and PH (January 27, 2020): Phase II PULSAR
66 Figure 19: Revatio for PAH and PH (June 28, 2019): Phase III – Neonates
72 Figure 20: Key upcoming events in pulmonary hypertension
LIST OF TABLES
11 Table 1: Pulmonary hypertension clinical classification groups
12 Table 2: Pulmonary hypertension clinical classification sub-groups
15 Table 3: Classification groups by genetic influences
17 Table 4: Pulmonary hypertension drug classes
21 Table 5: 2019 ACCP guidelines
24 Table 6: 2015 ESC/ERA guidelines
27 Table 7: Prevalent cases of pulmonary arterial hypertension, 2018–27
29 Table 8: Prevalent cases of pulmonary arterial hypertension, by subtype
29 Table 9: Prevalent cases of pulmonary arterial hypertension, by NYHA functional class
31 Table 10: Marketed drugs for pulmonary hypertension
37 Table 11: Pipeline drugs for pulmonary hypertension
58 Table 12: Historical global sales, by drug ($m), 2015–19
59 Table 13: Forecasted global sales, by drug ($m), 2020–24
60 Table 14: Simdax for PAH and PH (June 2, 2020)
62 Table 15: Tyvaso for PAH and PH (February 24, 2020)
63 Table 16: Sotatercept for PAH and PH (January 27, 2020)
65 Table 17: Revatio for PH and PAH (June 28, 2019)
67 Table 18: LIQ861 for PH and PAH (June 28, 2019)
68 Table 19: Opsumit for PAH and PH (June 25, 2019)
69 Table 20: Udenafil for PAH and PH (June 25, 2019)
70 Table 21: Beraprost 314d for PH and PAH (April 8, 2019)
71 Table 22: INOpulse for PH and PAH (January 7, 2019)
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