Market Spotlight:  Hereditary Angioedema (HAE) 

 

Disease Overview

This Market Spotlight report covers the Hereditary Angioedema market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Market Snapshot

Datamonitor Healthcare estimates that in 2016 the estimated number of cases ranged from 49,600–743,300.

The approved drugs in the hereditary angioedema space target complement proteins, androgen receptors, follicle-stimulating hormones, gonadotropin-releasing hormones, progesterone receptors, bradykinin B2 receptors, and the kinin-kallikrein system.

These are commonly administered via the intravenous or subcutaneous routes, with one product being available in oral formulation.

Therapies in mid-to-late-stage development for hereditary angioedema focus on targets such as the kinin-kallikrein system and complement proteins. These drugs are administered via the subcutaneous and oral routes.

High impact upcoming events for drugs in the hereditary angioedema space include topline Phase III trial results and loss of product exclusivity.

Licensing and asset acquisition activity involving hereditary angioedema drugs has been weak during 201217, with only five deals over this time period. The $125m agreement between Pharming and Valeant for the acquisition of all the North American rights to Ruconest, was the largest deal during 2012–17.

Firzyr’s US parent product patent is set to expire in 2019, which will open the door to generic entry.

Cinryze’s sales ranked highest among drugs available for hereditary angioedema during 2012–16, and revenues are expected to remain high until 2021.

The clinical trials distribution across Phase I–IV indicates that the majority of trials for hereditary angioedema have been in late phases of development, with 52.6% of trials in Phase III–IV, and 47.4% in Phase I–II.

The US has a substantial lead in the number of hereditary angioedema clinical trials globally. The UK leads the major EU markets, while Israel has the top spot in Asia.

Clinical trial activity in the hereditary angioedema space is dominated by completed trials. Shire has the highest number of completed trials for hereditary angioedema.

Shire leads industry sponsors with the highest number of clinical trials for hereditary angioedema.

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Major TOC of Hereditary Angioedema, Market:

1 KEY TAKEAWAYS

2 DISEASE BACKGROUND
3 Subtypes

4 TREATMENT
5 C1-INH concentrates
6 Plasma-derived C1-INH (PdC1-INH)
7 Recombinant C1-INH (RhC1-INH)
8 Kallikrein inhibitor
9 Bradykinin receptor antagonist
10 EPIDEMIOLOGY

11 MARKETED DRUGS
12 Approvals by country

13 PIPELINE DRUGS

14 KEY UPCOMING EVENTS

15 LICENSING AND ASSET ACQUISITION DEALS
16 Pharming Regains Rights To Ruconest, Seizing More Control Over Its Destiny

17 PARENT PATENTS

18 REVENUE OPPORTUNITY

19 CLINICAL TRIAL LANDSCAPE
20 Sponsors by status
21 Sponsors by phase
22 Shire Sees Another Way To Compete With CSL Behring In HAE With New Version Of Cinryze
23 Shire CEO Says SHP643 Results Vindicate Dyax Buy, M&A Strategy
23 CSL Behring Nears Market With Easier-To-Administer HAE Prophylactic

24 BIBLIOGRAPHY
25 Prescription information

26 APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of hereditary angioedema, 2016–25
Figure 2: Pipeline drugs for hereditary angioedema in the US
Figure 3: Pipeline drugs for hereditary angioedema, by company
Figure 4: Pipeline drugs for hereditary angioedema, by drug type
Figure 5: Pipeline drugs for hereditary angioedema, by classifications
Figure 6: Key upcoming events in hereditary angioedema
Figure 7: Parent patents in hereditary angioedema
Figure 8: Clinical trials in hereditary angioedema
Figure 9: Top 10 drugs for clinical trials in hereditary angioedema
Figure 10: Top 10 companies for clinical trials in hereditary angioedema
Figure 11: Trial locations in hereditary angioedema
Figure 12: Hereditary angioedema trials sponsors, by status
Figure 13: Hereditary angioedema trials sponsors, by phase

LIST OF TABLES
Table 1: Prevalent cases of hereditary angioedema, 2016–25
Table 2: Marketed drugs for hereditary angioedema
Table 3: Approvals by country for hereditary angioedema
Table 4: Pipeline drugs for hereditary angioedema in the US
Table 5: Historical global sales, by drug ($m), 2012–16
Table 6: Forecasted global sales, by drug ($m), 2017–22

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