Product Code: DMKC0180962
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.
- 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.
TABLE OF CONTENTS
- C1-INH concentrates
- Plasma-derived C1-INH (PdC1-INH)
- Recombinant C1-INH (RhC1-INH)
- Kallikrein inhibitor
- Bradykinin receptor antagonist
KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
- Pharming Regains Rights To Ruconest, Seizing More Control Over Its Destiny
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Shire Sees Another Way To Compete With CSL Behring In HAE With New Version Of Cinryze
- Shire CEO Says SHP643 Results Vindicate Dyax Buy, M&A Strategy
- CSL Behring Nears Market With Easier-To-Administer HAE Prophylactic
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