The Neurology Pipeline: A Strategic Review

Abstract

Introduction

Mega-blockbuster status would be quick and sure for any safe, effective agent that prevents the death and damage of neurons associated with neurodegenerative diseases. The potential of such a neuroprotectant is one of the motivations for the 188 companies currently involved in the development of 263 neurological pipeline agents, despite the plethora of marketed agents for these diseases and disorders. Meanwhile, less-debilitating neurological disorders that nonetheless affect patients' quality of life (e.g., migraine, insomnia) also face signifi cant unmet needs. Today' s pipeline of new molecular entities (NMEs) and reformulations holds a range of agents with potential to improve treatment and infl uence market dynamics, as well as drive market growth through 2015.

• The neurology market experienced steady growth from 2004 through 2008. Which drug classes contributed most to this increase in sales? Which drug classes are projected to contribute to an increase or decrease in future sales?
• Clinical trial design and end points are a signifi cant constraint on drug development and market growth in the neurology indication. Which neurology indications are particularly affected by these constraints? What specifi c effects do these constraints have on the market?
• The development of a safe, effi cacious neuroprotectant is the elusive “holy grail” in the neurology market. Why is the development of a neuroprotectant so tantalizing to the neurology fi eld? What barriers have prevented the development and launch of a successful neuroprotectant? Which companies have latestage neuroprotectants in the pipeline?
• The neurology market is signifi cant in terms of sales and is projected to continue growing in the near future. Which companies are the current market leaders, and which companies are projected to be the market leaders in 2015? Which companies are attempting to enter, grow, or protect their position in this market? Which indications will drive the majority of the growth?

Scope

• The neurology pipeline: Number of agents in development; disease focus; NMEs versus reformulations; formulations by disease; drug targets; phase analysis; development by company type; number of agents by phase; number of agents by disease; profi les of GlaxoSmithKline, Roche, and Eli Lilly.
• Historical and projected neurology sales: 2004-2015 sales; leading drug classes; current and projected market-leading companies; key patent expiries impacting neurology sales; R&D spend of market-leading companies.
• Market opportunities/drivers: Room for an effective neuroprotectant; new formulations/delivery systems; an aging population.
• Market constraints: Clinical trial end points; time to treatment versus disease progression; generics.

• Abbott Laboratories
• Aguettant
• Alliance Pharma
• Almirall
• Amgen
• Aspreva
• Astellas Pharma
• AstraZeneca
• Banyu Seiyaku
• Baxter International
• Bayer Schering
• Biofutura
• Biogen Idec
• Boehringer Ingelheim
• Bracco
• Bristol-Myers Squibb
• Britannia Pharmaceuticals
• Cambridge Labs
• Cephalon
• Chiesi
• Chugai Seiyaku
• Daiichi Sankyo
• Dainippon Sumitomo
• Dava Pharmaceuticals
• Desma
• DuPont Pharma
• Eisai
• Eli Lilly
• Endo Pharmaceuticals
• Esteve
• Forest Laboratories
• Genentech
• GlaxoSmithKline
• Grupo Ferrer
• Grupo Grunenthal
• Impax Laboratories
• Janssen
• Johnson & Johnson
• King Pharmaceuticals
• Kyowa Hakko Kirin
• Lundbeck
• Meda
• Menarini
• Merck & Co.
• Merck Serono
• Merz
• Mitsubishi Tanabe Pharma
• Novartis
• Onko
• Organon
• Orion
• Orphan Europe
• Ortho-McNeil Neurologics
• Par Pharma
• Pfi zer
• Prometheus Laboratories
• Roche
• Sanofi -Aventis
• Schwartz Pharma
• Sepracor
• Shire Pharmaceuticals
• Solvay
• Takeda
• Teofarma
• Teva
• UCB
• Valeant Pharma
• Vernalis
• Wyeth

• Alzheimer' s disease (AD)
• Amyotrophic lateral sclerosis (ALS)
• Epilepsy
• Huntington' s disease (HD)
• Insomnia
• Migraine
• Multiple sclerosis (MS)
• Parkinson' s disease (PD)
• Restless legs syndrome (RLS)
• Stroke