Stakeholder Opinions: Spinal Cord Injury - Attractive niche market with multi-billion dollar potential

Stakeholder Opinions: Spinal Cord Injury - Attractive niche market with multi-billion dollar potential published by Datamonitor in March, 2010. This report consists of Pages: 124 and the price starts from US $ 3800.

Introduction

Abstract

Introduction

Advances in understanding the pathophysiology of spinal cord injury (SCI) over the past 2 decades have given rise to several therapeutic strategies that are presently being examined in Phase II/I clinical trials. Furthermore, President Obama' s March 2009 decision to overturn restrictions on human embryonic stem cell research represents a new era in the field of spinal cord injuries.

Scope of this research

• Analysis of the patient potential of spinal cord injury across the seven major markets and rest of world.
• Review of key unmet clinical needs in the treatment of spinal cord injury and current pipeline treatments.
• Identification of key opportunities and threats facing developers of treatments for spinal cord injury.
• Insight from four internationally recognized key opinion leaders in the field of spinal cord injuries.

Research and analysis highlights

Therapeutic interventions for SCI need not necessarily provide a complete restoration of anatomic connections in order to lead to functional improvements and enhance patients' quality of life. Controversy continues to surround the use of methylprednisolone as an acute treatment for SCI, indicating a need for approved neuroprotective treatments.

Alseres Pharmaceuticals' s Cethrin (a recombinant fusion protein) has demonstrated a measurable effect on neurological recovery after SCI in a Phase I/IIa clinical trial. However, with its Phase II clinical program currently on hold, future development of Cethrin is uncertain.

President Obama' s March 2009 decision to lift restrictions on US federal funding for research involving human embryonic stem cells has provided developers with a greater deal of freedom with regards to research into SCI.

Key reasons to purchase this research

• Quantify the incidence of spinal cord injury and identify key clinical unmet needs.
• Assess the opportunities and threats facing developers in the spinal cord injury market.
• Utilize pipeline product profiles to identify potential in-licensing opportunities.

Table of Contents

OVERVIEW

• Catalyst
• Summary

EXECUTIVE SUMMARY

• Strategic scoping and focus
• Datamonitor insight into the spinal cord injury market
• Upcoming reports

SPINAL CORD INJURY: PATIENT POTENTIAL

• Key findings
• Definition of spinal cord injury
  • Classification of spinal cord injury

• Etiology of spinal cord injury
  • Road traffic accidents are the leading cause of SCI in developed countries

• Pathophysiology of spinal cord injury
  • Primary injury
  • Secondary injury

• Diagnosis of spinal cord injury
• Epidemiology of spinal cord injury
  • Seven major markets
  • Rest of the world
  • Epidemiological trends in spinal cord injury

• Economic consequences of spinal cord injury

CURRENT TREATMENT PRACTICES AND UNMET NEEDS

• Key findings
• Current management of spinal cord injury
  • Surgery
  • Methylprednisolone is a pharmacological treatment option for acute spinal cord injury
  • Rehabilitation

• Patient care path
  • The acute hospital setting is the key intervention point for neuroprotective treatments
  • For manufacturers of neurorestorative treatments, rehabilitation and community settings are key targets
  • Further opportunities exist in the management of complications of SCI

• Unmet need in spinal cord injury
  • Neurorestorative treatments
  • Neuroprotective treatments
  • Symptomatic treatments

MARKET POTENTIAL

• Key findings
• Datamonitor' s estimate of market potential
• Spinal cord injury: opportunities and threats
  • Opportunities
  • Threats

PIPELINE ANALYSIS

• Key findings
• Clinical trial design in spinal cord injury
  • ICCP guidelines for the conduct of clinical trials in spinal cord injury

• Clinical pipeline overview
  • Novartis represents the only Big Pharma company in the sparse clinical pipeline for SCI
  • The pipeline is dominated by neurorestorative treatments for acute SCI

• Cethrin (BA-210; Alseres Pharmaceuticals)
  • Drug profile: intraoperatively administered Rho GTPase protein inhibitor
  • Development overview
  • Product positioning
  • SWOT analysis

• XP19986 (arbaclofen placarbil; Xenoport)
  • Drug profile: GABAb receptor agonist in Phase II development for spasticity due to SCI
  • Development overview
  • Product positioning
  • SWOT analysis

• ProCord (Proneuron Biotechnologies)
  • Drug profile: autologous blood-derived macrophage therapy for the treatment of acute SCI
  • Development overview
  • Product positioning

• ATI355 (reticulon 4 monoclonal antibody; Novartis AG)
  • Drug profile: first human monoclonal antibody to neutralize Nogo-A
  • Development overview
  • Product positioning

• Autologous Combination Stem Cell Therapy (TCA Cellular Therapy)
  • SCI represents the least advanced indication for Autologous Combination Stem Cell Therapy

• Astrostem (RNL Bio)
  • Human clinical study of Astrostem approved by Korean FDA in April 2009

• Neu2000 (Neurotech Pharmaceuticals)
  • Improved locomotor outcomes associated with Neu2000 in rat model of moderate SCI

• Cordaneurin (Spinal Cord Therapeutics)
  • Cordaneurin prevents the formation of growth inhibiting scars

• Preclinical pipeline overview
  • Spinal Cord Therapeutics and SanBio represent key developers in the preclinical SCI pipeline
  • Initiation of world' s first human clinical trial of embryonic stem cell-based therapy is expected in Q3 2010
  • Neureva is presently seeking a co-development partner for NVA0011 (gacyclidine)

• Discontinued pipeline candidates for spinal cord injury
• The future of treatment in spinal cord injury
  • Key opinion leaders view partially restorative therapies to be the most likely advance in the mid-term
  • Combination treatments offer the greatest potential according to key opinion leaders
  • Geographical availability of efficacious SCI treatments will be limited by expertise of physicians and cost

BIBLIOGRAPHY

• Books and journal papers
• Websites
• Datamonitor reports

APPENDIX

• Contributing experts
• Conferences attended
• Report methodology

TABLES

• Table: ASIA impairment scale
• Table: Studies of the incidence of spinal cord injuries in the seven major markets
• Table: Incidence of spinal cord injury in the seven major markets, 2010 - 2020 (actual numbers)
• Table: Studies of the incidence of spinal cord injuries in the rest of the world
• Table: Incidence of spinal cord injury in the rest of world markets, 2010 - 2020 (actual numbers)
• Table: Average yearly healthcare and living expenses and estimated lifetime costs directly attributable to spinal cord injury
• Table: Studies of the prevalence of neuropathic pain in the spinal cord injury population
• Table: Results of published studies investigating the efficacy of oral pharmacological treatments in neuropathic spinal cord injury pain
• Table: Estimation of the US spinal cord injury market potential
• Table: Spinal cord injury market opportunities and threats
• Table: Products in clinical development for spinal cord injury, 2010
• Table: Cethrin - drug profile, 2010
• Table: Key facts: Phase II trial of Cethrin in patients with acute spinal cord injury
• Table: XP19986 - drug profile, 2010
• Table: ProCord - drug profile, 2010
• Table: Key facts: Phase II trial of ProCord in patients with complete spinal cord injury
• Table: ATI355 - drug profile, 2010
• Table: Key facts: Phase I trial of ATI355 in patients with acute spinal cord injury
• Table: Products in preclinical development for spinal cord injury, 2010
• Table: Discontinued R&D projects in spinal cord injury, 2002 - 2010

FIGURES

• Figure: Key causes of traumatic spinal cord injury in the US, 2005 - 09
• Figure: Spinal cord injury patient care path
• Figure: Key unmet clinical needs in spinal cord injury, 2010
• Figure: Comparison of incentives conferred by orphan product policies across the US, EU and Japan, 2010
• Figure: Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel
• Figure: Composition of clinical pipeline for spinal cord injury by stage of development
• Figure: Cethrin: Phase I/IIa trial results
• Figure: Cethrin: SWOT analysis
• Figure: XP19986: Phase II trial results
• Figure: XP19986: SWOT analysis
• Figure: Autologous activated macrophage therapy: Phase I trial results

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