Stakeholder Opinions: Diagnostics in Neurology - Predictive biomarkers expand drug revenues

As advances in omics technologies enable the development of high value molecular diagnostics, neurological conditions represent an attractive target for diagnostic companies. In this report, Datamonitor identifies the diseases in which early detection with a biomarker could significantly benefit the patient, gain payer approval, and ultimately expand the pharmaceutical market.

Report Highlights
A battery or algorithm of tests for each disease is likely to be available within the next 10 years. This is already the case for multiple sclerosis, the most mature neurological diagnostic market, with both clinical, imaging and in vitro diagnostics incorporated in a clear algorithm.

Revenue gained from earlier use (identification and incorporation of mild cognitively impaired patients) of potentially disease-modifying drugs in Alzheimer's disease could generate an additional $5 billion by 2017 across the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK).

Neurology biomarker discovery and development is an attractive market for small biotechnology companies. The regulation of in vitro diagnostics is significantly less stringent than for pharmaceutical drugs. This decreases the considerable financial barriers to entry usually faced by biotechnology companies orientated towards drug discovery.
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DATAMONITOR VIEW 1
CATALYST 1
SUMMARY 1
ANALYSIS 2
The market declined while competition intensified and substitute products competed for consumer spending 2
Both value and volume revealed a slight decline in 2007 after growth in 2006 2
Average consumer expenditure on yogurt has shown a consecutive decline since 2005 3
Expenditure on yogurt does not show significant seasonality 4
Competition from private label products has forced branded products to drop their price 5
Competition from substitute products test the positioning of yogurt products in the market place 5
Yogurts face a direct challenge from lactic acid bacteria drinks on the positioning of supporting gut health 5
Vegetable juice competes with yogurt through its healthy product positioning 7
Dessert products compete for store display and shelf space 8
The types of yogurt products being sold and the focus of new product development has shifted in the past decade 8
Soft / fruit type yogurt continued to gain market share while the plain type declined in 2007 8
The way forward: focus on the direction of new product development 10
Good taste profiles and functional features are expected to be the key emphasis 10
Single portion size and convenience are key points in packaging 10
Major companies in the market: Meiji Dairies had more than a 35% market share in 2007 10
Meiji Dairies and Morinaga Milk Industry are the clear leaders in the market 10
Key product developments from major manufacturers 11
APPENDIX 14
Definitions 14
New health checkup system in Japan 14
FOSHU system 14
Further reading 14
Ask the analyst 14
Datamonitor consulting 14
Disclaimer 14
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Table 1: Comparative biomarker potential across key neurological diseases 19
Table 2: DSM-IV criteria for Alzheimer's disease type dementia 23
Table 3: Unified Parkinson's Disease Rating Scale-cognition, behavior and mood 34
Table 4: New multiple sclerosis diagnostic criteria (McDonald criteria) 40
Table 5: Prevalence rate of mild cognitive impairment (MCI) 83
Table 6: A(1-42 in cerebrospinal fluid 124
Figure 1: Typical diagnostic biomarker development process 12
Figure 2: Distribution graph of biomarker accuracy 16
Figure 3: False positives and false negatives - distribution curve 17
Figure 4: Mean time between initial presentation to accurate diagnosis of Alzheimer's disease, Parkinson's disease and multiple sclerosis 20
Figure 5: Time (months) from presentation to accurate diagnosis of Alzheimer's disease, 2006 30
Figure 6: Percentage of neurologists using each diagnostic imaging technique to make a diagnosis of Parkinson's disease, 2007 37
Figure 7: Time (months) from presentation to accurate diagnosis of Parkinson's disease, 2007 38
Figure 8: Current diagnostic algorithm for multiple sclerosis 41
Figure 9: MRI scan image of a multiple sclerosis patients brain, and a normal individual 43
Figure 10: Magnetic resonance imaging (MRI) scanner 44
Figure 11: Time (months) from presentation to accurate diagnosis of multiple sclerosis (MS), 2006 49
Figure 12: An electroencephalograph (EEG) 52
Figure 13: Photograph of a portable eletroencephalography (EEG) unit 55
Figure 14: Genetic risk of developing Huntington's disease 60
Figure 15: Points of diagnosis of Alzheimer's disease 69
Figure 16: Revenue gain in the Alzheimer's disease market value with the inclusion of patients with amnestic mild cognitive impairment (amMCI), 2013-17 84
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