The US image-guided surgical (IGS) neuronavigation and external beam radiation therapy (EBRT) systems market totaled more than $284m in 2015.
Neurointerventional radiology/surgery, or neurovascular intervention, is a relatively new medical specialty employing minimally invasive endovascular techniques to treat vascular diseases of the brain. Neurointerventional devices, which contributed sales of more than $870m in the US in 2015, involve a variety of standard and application-specific transcatheter tools and techniques for the treatment of cerebrovascular pathologies (such as aneurysms, arteriovenous malformations [AVMs], and acute and chronic thromboembolic and atherosclerotic occlusions) that prompt clinically significant distortions of cerebral blood flow and carry a high risk of catastrophic breakdowns of cerebrovascular circulation manifested by hemorrhagic or ischemic stroke.
Neurointerventional radiology/surgery, or neurovascular intervention, is a relatively new medical specialty employing minimally invasive endovascular techniques to treat vascular diseases of the brain.
Historically, few pricing controls have been implemented in the US; however, there is greater pressure to implement controls to help contain costs associated with the expansion of public healthcare provision.
Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.
Novartis, under license from Vectura and Sosei, developed Utibron, a once-daily long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination product containing indacaterol and glycopyrrolate.
Merck & Co’s V114 is a 15-valent pneumococcal capsular polysaccharide conjugate vaccine, which is currently in Phase III development in the US and EU.
Merck & Co’s adjuvanted, tetravalent subunit vaccine V180 comprises truncated forms of envelope proteins (DEN-80E), derived from strains of all four dengue virus serotypes (DEN-1 strain 258848, DEN-2 strain PR159 S1, DEN-3 strain CH53489, and DEN-4 strain H241).
Emerging markets account for approximately 18% of the global vaccines market, which is valued at more than $24bn. However, there are indications that this is an underestimate, and some observers forecast that the overall marketplace will reach $50bn by the mid2020s.
Valoctocogene roxaparvovec (BioMarin), also known as valrox, is an adeno-associated virus-mediated gene therapy that delivers human B domain-deleted coagulation factor VIII (fVIII) to patients with hemophilia A.
A new value-based assessment (VBA) process is scheduled to come into effect in the UK in late 2014. There have been significant delays in determining how this would work in practice, reflecting VBA’s complexity.
Boehringer Ingelheim will hope to increase Vargatef’s (nintedanib) market share at second-line despite
rising competition in this setting.
Vascepa (icosapent ethyl) is marketed by Amarin for the treatment of severe hypertriglyceridemia. The molecule itself is a semi-synthetic, highly purified derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA).
Vasotec’s (enalapril; Merck & Co/Valeant) role in chronic heart failure (CHF) is severely limited by
competition from generic equivalents.
VB-111 (VBL Therapeutics) will be able to succeed in the US as an add-on therapy to Avastin
(bevacizumab; Genentech/Roche/Chugai) in the second-line of therapy, should it present positive data
from the Phase III GLOBE study.
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