Market Spotlight: Hereditary Angioedema
|出版日||ページ情報||英文 38 Pages
|注目市場の分析：遺伝性血管性浮腫 (HAE) Market Spotlight: Hereditary Angioedema|
|出版日: 2019年11月18日||ページ情報: 英文 38 Pages||
当レポートでは、遺伝性血管性浮腫 (HAE) の治療薬市場について分析し、疾患の概要や患者数の推移・見通し、現段階での主な治療法、現在開発中の治験の進行状況と上市スケジュール、主な治療薬の市場動向見通し (今後10年間分)、資本取引の動きなどを調査しております。
This Market Spotlight report covers the Hereditary Angioedema market, comprising key marketed and pipeline drugs, recent events and analyst opinion, clinical trials, upcoming and regulatory events, probability of success, 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 2017, there were approximately 402,700 prevalent cases of hereditary angioedema (HAE) worldwide, and forecasts that number to increase to 440,600 prevalent cases by
2026. The approved drugs in the HAE space target complement proteins, androgen receptors, follicle-stimulating hormone, gonadotropin-releasing hormone, progesterone receptor, bradykinin B2 receptor, and the kinin-kallikrein system. These are commonly administered via the intravenous or subcutaneous routes, with one product being available in an oral formulation.
The majority of industry-sponsored drugs in active clinical development for HAE are in Phase I. Therapies in development for HAE focus on targets such as the kinin-kallikrein system and bradykinin B2 receptor. The majority of pipeline drugs are administered via the oral route, with two products also being tested in a subcutaneous formulation.
High-impact upcoming events for drugs in the HAE space comprise topline Phase II trial results for KVD900, topline Phase III trial results for BCX7353, and a data exclusivity expiration for Ruconest.
The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 22.5%, and the average probability a drug advances from Phase III is 71.1%. Drugs, on average, take 10.0 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
There have been only four licensing and asset acquisition deals involving HAE drugs during 2014-19. The $125m licensing agreement signed in 2016 between Pharming Group and Bausch Health for the acquisition of North American commercialization rights for Ruconest was the largest deal.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for HAE have been in the early and midphases of development, with 53% of trials in Phase I-II, and 47% in Phase III-IV.
The US has the highest number of HAE clinical trials globally. The UK leads the major EU markets, while Israel has the top spot in Asia.
Clinical trial activity in the HAE space is dominated by completed trials. Takeda has the highest number of completed clinical trials for HAE, with 19 trials.
Takeda leads industry sponsors with the highest overall number of clinical trials for HAE, followed by BioCryst.
9 C1-INH concentrates
9 Plasma-derived C1-INH (pdC1-INH)
9 Recombinant C1-INH (rhC1-INH)
9 Kallikrein inhibitor
9 Bradykinin receptor antagonist
22 BCX7353 for HAE (May 21, 2019)
23 BCX7353 for HAE (September 4, 2018)
27 England's NICE OKs Shire's Takhzyro For Rare Hereditary Disease
27 Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018
32 Sponsors by status
33 Sponsors by phase
33 Recent events
35 Prescription information