Product Code: GDHC202PIDR
Pulmonary arterial hypertension is a rare, fatal cardiopulmonary disease with an annual mortality rate around 10%. The disease is a subset (Group 1) within the World Health Organization's (WHO's) classification of the different types of pulmonary hypertension. PAH is characterized by an abnormal rise in the resting mean pulmonary artery pressure (PAP) (>25mmHg compared with normal levels of around 14mmHg), a pulmonary vascular resistance of more than 3 Wood units, and a pulmonary capillary wedge pressure less than 15mmHg
The PAH market 2019 sales is estimated at approximately $4.5B across the 7MM, encompassing the US, the five major European countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2029, GlobalData expects the overall market to grow at a moderate compound annual growth rate (CAGR) of 4.9% to reach sales of $7.2B over the 10-year period. The 5EU market is anticipated to grow the fastest of the three regions, recording a CAGR of 7.3%, while the US and Japan will record CAGRs of 4.3% and 0.4%, respectively. At the end of 2029, the US will contribute around 72% of global sales, while the 5EU and Japan will account for 26% and 2% of global sales, respectively. The higher sales numbers for the US can be attributed to the higher price of pharmaceuticals and the greater diagnosed prevalence of PAH in the region. The extremely low PAH market size in Japan can be attributed to the low disease prevalence, which is probably a result of under-diagnosis of PAH in Japan.
Over the 10-year forecast period, the PAH market is expected to grow at a compound annual growth rate (CAGR) of 4.9%, reaching around $7.2B in 2029. The major driver for this growth will be the increased use of drugs from different classes in combination with each other, which will lead to increased treatment costs. According to KOLs, combination therapy will become a mainstay in PAH treatment during the forecast period, with greater use of upfront dual and triple combinations. This, in turn, will be the major driver of the market, despite the patent expirations of most currently marketed drugs and generic erosion.
Overall, the greatest unmet need in the PAH space is for novel drugs with curative or disease-stabilizing properties. The currently available drugs work in slowing the disease progression, and lead to improvements in FC. However, there is no marketed drug that addresses the underlying disease mechanism and is targeted at curing patients. The treatment algorithm for PAH has shifted from the use of monotherapies to using drugs in combination with each other
- The proportion of people at risk of developing PAH is expected to increase over the 10-year forecast period due to the growing aging population.
- The potential launch of 8 late-stage pipeline agents will increase the number of patients who can be offered pharmacological treatment options. In addition, three of these drugs in late-stage development are expected to have a high annual cost of therapy (ACOT), a factor that will contribute to notable profitability.
- Despite multiple therapies currently available to PAH patients, there is still a high level of unmet need within the treatment space. The most recognizable is the need for novel disease-modifying properties.
KEY QUESTIONS ANSWERED
Despite the existence of numerous well-established treatment options in the PAH space, a few - yet significant - unmet needs remain.
- Which unmet needs are the most pressing in the 7MM?
- Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space?
The PAH market hasn't seen novel drug launches, though, clinical development activity has picked up.
- What are the most promising late-stage candidates and how much they expected to generate over the forecast period?
- What do KOLs say about their clinical and commercial positioning?
Although there is currently no cure for PAH, small companies are developing drugs to target new pathways .
- Which have been historically the companies leading the way?
- What new companies are emerging in the space?
- Overview of Pulmonary Arterial Hypertension including epidemiology, disease etiology and management.
- Topline PAH drugs market revenue, annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.
- Key topics covered include assessment of current and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5U and Japan over the 10-year forecast period.
- Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global PAH therapeutics market. Insightful review of the key industry drivers, restraints and challenges.
Reasons to Buy
The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
- Develop business strategies by understanding the trends shaping and driving the global PAH therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global PAH market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global PAH therapeutics market from 2019-2029.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
1 Table of Contents
- 1.1 List of Tables
- 1.2 List of Figures
2 Pulmonary Arterial Hypertension: Executive Summary
- 2.1 PAH Market Will Exhibit Moderate Growth Between 2019 and 2029
- 2.2 Sotatercept Has the Potential to Become a Blockbuster Therapy and Address an Unmet Need in PAH
- 2.3 Reformulation of Existing Drugs Will Continue to Dominate the PAH Pipeline
- 2.4 What Do Physicians Think?
- 3.1 Catalyst
- 3.2 Related Reports
4 Disease Overview
- 4.1 Etiology and Pathophysiology
- 4.2 Classification or Staging Systems
- 5.1 Disease Background
- 5.2 Risk Factors and Comorbidities
- 5.3 Global and Historical Trends
- 5.4 Forecast Methodology
- 5.5 Epidemiological Forecast for PAH (2019-2029)
- 5.6 Discussion
6 Disease Management
- 6.1 Diagnosis and Treatment Overview
- 6.2 Clinical Practice
- 6.3 Overview of Treatment Guidelines
- 6.4 US
- 6.5 5EU
- 6.6 Japan
7 Competitive Assessment
8 Unmet Needs and Opportunity Assessment
- 8.1 Overview
- 8.2 Curative or Stabilizing Therapeutics Targeting a Novel, Fourth Pathway
- 8.3 Improved Drug Administration and Side Effects
- 8.4 Improved Clinical Trial Design and Slowing Disease Progression
- 8.5 Drugs to Prevent Right Heart Failure
9 Pipeline Assessment
- 9.1 Overview
- 9.2 Promising Drugs in Clinical Development
10 Current and Future Players
11 Market Outlook
List of Tables
List of Tables
- Table 1: PAH: Key Metrics in the 7MM
- Table 2: NYHA/WHO Functional Class (FC)
- Table 3: Risk Factors and Comorbidities for PAH
- Table 4: Diagnosed Prevalent Cases of PAH by Comorbidities, N, Both Sexes, All Ages, 2019
- Table 5: Treatment Guidelines for PAH
- Table 6: Country Profile - US
- Table 7: Country Profile - 5EU
- Table 8: Country Profile - Japan
- Table 9: Leading Treatments for PAH, 2020
- Table 10: United Therapeutics' Disease Portfolio Assessment, 2020
- Table 11: GSK's Disease Portfolio Assessment, 2020
- Table 12: Actelion's Disease Portfolio Assessment, 2020
- Table 13: Steady Therapeutics' Disease Portfolio Assessment, 2020
- Table 14: Acceleron Pharma's Disease Portfolio Assessment, 2020
- Table 15: Apeiron Biologics' Disease Portfolio Assessment, 2020
- Table 16: Northern Therapeutics' Disease Portfolio Assessment, 2020
- Table 17: PhaseBio Pharmaceuticals' Disease Portfolio Assessment, 2020
- Table 18: Liquidia Technologies' Disease Portfolio Assessment, 2020
- Table 19: Mezzion Pharma's Disease Portfolio Assessment, 2020
- Table 20: PAH Market - Global Drivers and Barriers, 2019-2029
- Table 21: Key Events Impacting Sales for PAH in the US, 2019-2029
- Table 22: PAH Market - Drivers and Barriers in the US, 2019-2029
- Table 23: Key Events Impacting Sales for PAH in the 5EU, 2019-2029
- Table 24: PAH Market - Drivers and Barriers in the 5EU, 2019-2029
- Table 25: Key Events Impacting Sales for PAH in Japan, 2019-2029
- Table 26: PAH Market - Global Drivers and Barriers in Japan, 2019-2029
- Table 27: Key Historical and Projected Launch Dates for PAH
- Table 28 summarizes the key historical and projected patent expiry dates for PAH across the 7MM.
- Table 29: Key Historical and Projected Patent Expiry Dates for PAH
- Table 30: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
List of Figures
- Figure 1: Global Sales Forecast by Country for PAH in 2019 and 2029
- Figure 2: Analysis of the Company Portfolio Gap in PAH During the Forecast Period
- Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of PAH During the Forecast Period
- Figure 4: Target Pathways of the Currently Marketed Drugs for PAH
- Figure 5: 7MM, Diagnosed Incidence of PAH (Cases per 100,000 Population), Both Sexes, All Ages, 2019
- Figure 6: 7MM, Diagnosed Prevalence of PAH (%), Both Sexes, All Ages, 2019
- Figure 7: 7MM, Sources Used and Not Used to Forecast the Diagnosed Incident and Diagnosed Prevalent Cases of PAH
- Figure 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of PAH by NYHA Functional Classes
- Figure 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of PAH by Comorbidities: CTD, PH, CHD, and COPD
- Figure 10: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of PAH by Comorbidities: Scleroderma, Diabetes
- Figure 11: 7MM, Diagnosed Incident Cases of PAH, N, Both Sexes, All Ages, 2019
- Figure 12: 7MM, Diagnosed Incident Cases of PAH, N, by Sex, All Ages, 2019
- Figure 13: 7MM, Diagnosed Incident Cases of PAH by Age, N, Both Sexes, 2019
- Figure 14: 7MM, Diagnosed Prevalent Cases of PAH, N, Both Sexes, All Ages, 2019
- Figure 15: 7MM, Diagnosed Prevalent Cases of PAH, N, by Sex, All Ages, 2019
- Figure 16: 7MM, Diagnosed Prevalent Cases of PAH by Age, N, Both Sexes, 2019
- Figure 17: 7MM, Diagnosed Prevalent Cases of PAH by NYHA Functional Classes, N, Both Sexes, All Ages, 2019
- Figure 18: Diagnostic Approach to PAH
- Figure 19: Unmet Needs and Opportunities in PAH
- Figure 20: Overview of the Development Pipeline in Pulmonary Arterial Hypertension
- Figure 21: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for PAH in the 7MM During the Forecast Period
- Figure 22: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of PAH During the Forecast Period
- Figure 23: Analysis of the Company Portfolio Gap in PAH During the Forecast Period
- Figure 24: Global (7MM) Sales Forecast by Country for PAH in 2019 and 2029
- Figure 25: Sales Forecast by Class for PAH in the US in 2019 and 2029