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Published by: Datamonitor
Published: Aug. 22, 2002 - 166 Pages
Table of Contents
Overview
Introduction
Personalized Medicine evaluates the effect of pharmacogenomics on key stages of the value chain. Datamonitor assesses which therapy areas are most appropriate for pharmacogenomics and how alliances with niche technology providers can boost the commercial potential of the abundance of targets available in the post-genomic era. Best practice recommendations to maximize sales of pharmacogenomics-derived products reflect pharma’s need to develop portfolios of best-in-segment or ‘multi-buster’ drugs.
Scope
Application of proprietary cost-effectiveness framework to assess which therapy areas are best suited to pharmacogenomics
Best practice recommendations to position the benefits of
pharmacogenomics-derived drugs to patients, physicians and healthcare payers
Evaluation of the impact of key niche genomic-based technologies on the pharmacogenomics industry until 2012
Analysis of the revenue opportunities associated with the ‘new generation’ of blockbuster products offered by post-genomic science
Assessment of the ability of pharmacogenomics to transform the pharmaceutical industry’s current R&D productivity crisis
Report Highlights
Micro-segmented markets do not necessarily mean reduced revenue streams for pharmacogenomics-derived products because genotype screening identifies areas of high unmet need. In fact, the application of pharmacogenomics in cancer significantly increases the revenue potential of drugs with narrow therapeutic indices.
Pharma must urgently overcome two key hurdles if they are to successfully integrate pharmacogenomics. Firstly, post-genomic science guarantees an almost 10-fold increase in the number of drug targets but target validation bottlenecks must be overcome. Secondly, traditional mass marketing is ineffective at positioning pharmacogenomic interventions. By 2010, regulatory bodies will require a diagnostic test before pharmacogenomics-derived products are approved.
Reasons to Purchase
Maximize the commercial potential of pharmacogenomics-derived products through effective targeting of patients, physicians and payers
Identify which clinical trial stages benefit most from integrating pharmacogenomics
Target therapeutic markets effectively by applying Datamonitor’s proprietary pharmacogenomics cost-effectiveness framework
Minimize the investment risk in accessing niche genomic-based technologies to improve pipeline quality
Reduce time and costs by learning from the industry’s leaders when optimizingthe commercial potential of your genomics-based development strategies
Drivers and trends
The potential of post-genomic enabling technologies on pharmaceutical R&D, sales and marketing productivity remains unclear. Datamonitor analyzes the impact of pharmacogenomics on pharmaceutical profitability and the value of forming alliances with key technology providers until 2012.
Will post-genomic science guarantee high quality pharmaceutical pipelines?
Do genomics-derived products offer higher returns than traditional products?
Which therapy areas will benefit most from pharmacogenomics and how should this affect my company’s therapeutic focus?
How will personalized medicines impact drug pricing and reimbursement?
Which promotional strategies can accelerate physician acceptance of pharmacogenomics-derived products?
IMPACT OF PHARMACOGENOMICS ON DRUG SALES
Genomics, pharmacogenomics and proteomics present new opportunities for pharma to generate market leading products. However, market micro-segmentation through the targeting of high response patients has been heralded by many as the end of blockbusters. Datamonitor disagrees with such sweeping generalizations and, instead, analyzes key revenue generating strategies in a post-genomics era: Creating ‘multi-busters’ or a series of personalized therapies that dominate specific therapy areas
Identifying key tactics to substantially increase a pharmacogenomics-based product’s revenue potential
Providing recommendations to optimize market penetration of
pharmacogenomics-derived products
Applying a cost-effectiveness framework to analyze revenue opportunities offered by different indications
Presenting a new sales and marketing model to overcome key obstacles to the acceptance of personalized medicine
MAXIMIZING R&D PRODUCTIVITY
The current pharmaceutical R&D productivity crisis is affecting future company revenue growth and investor confidence. Post-genomic science is the only guarantee of a 10-fold increase in targets. Personalized Medicine evaluates the impact of pharmacogenomics on improving R&D pipelines and the value of strategic alliances with enabling niche technology providers from the genomics sector.
Analyzing factors that maximize R&D productivity and increase the return on investment from integrating pharmacogenomics
Deciding which clinical trial stages benefit most from pharmacogenomic studies
Learning from the industry’s leaders when optimizing the commercial potential of genomics-focused portfolios
Examining the inter-dependence of six niche technologies - pharmacogenomics, proteomics, DNA microarray, bioinformatics, diagnostics and target validation -
on pharmaceutical productivity
Evaluating how strategic alliances in each niche technology area can improve drug discovery and development opportunities
ACTION POINTS
Five key action points for pharma
Action point 1 - Market-driven genotype screening to identify areas of high unmet need is a key tactic when justifying premium drug prices.
Action point 2 - Pharmas must increasingly be seen as leading providers of healthcare information services to sustain demand for their pharmacogenomic interventions
Action point 3 - The target validation bottleneck must be addressed to minimize the risk of increased downstream attrition rates
Action point 4 - Companies must target therapy areas, such as cancer, that lack clear benefits from traditional phenotype-based disease management
Action point 5 - Pharmas must rapidly acquire diagnostics expertise to ensure that their pharmacogenomics-derived products succeed in the marketplace
APPENDIX
Proprietary methodology to derive R&D spend per new molecular entity in 2001
The 2001 blockbuster market
DATASETS
Table 1: Selected examples of top tier companies licensing products from external sources
Table 2: Proportion of patients administered certain drug classes that are identified as ‘poor or ‘non’ responders
Table 3: Prominent drug withdrawals from the US market
Table 4: Leading alliances between pharmaceutical companies and the genomics industry in the last decade
Table 5: Selected examples of genetic polymorphisms and associated drug responses
Table 6: Cost-effectiveness criteria for evaluating the value of pharmacogenomics-based therapies in different disease markets
Table 7: 2001 US sales force size for the top 10 pharmaceutical companies ranked by US ethical sales
Table 8: Mergers and acquisitions in the genomics industry in 2001
Table 9: Human Genome Sciences’ nine products in clinical development
Table 10: Global R&D spend of US-based companies, 1980-2001
Table 11: NDAs and NMEs approved by the FDA, 1986-2001
Table 12: US R&D spend per NME approved, 1986-2001
Table 13: Global R&D spend per NME approved, 1986-2001
Table 14: Drug development times (years), 1960-1998
Table 15: The 2001 blockbuster market
AbstractIntroduction: This analysis evaluates the effect of pharmacogenomics on key stages of the value chain. Datamonitor assesses which therapy areas are most appropriate for pharmacogenomics and how alliances with niche technology providers can boost the commercial potential of the abundance of targets available in the post-genomic era. Best practice recommendations to maximize sales of pharmacogenomics-derived products reflect pharma's need to develop portfolios of best-in-segment or 'multi-buster' drugs. Scope of this Report: * Application of proprietary cost-effectiveness framework to assess the therapy areas that are best suited to pharmacogenomics * Best practice recommendations to position the benefits of pharmacogenomics-derived drugs to patients, physicians and healthcare payers * Evaluation of the impact of key niche genomic-based technologies on the pharmacogenomics industry until 2012 * Analysis of the revenue opportunities associated with the 'new generation' of blockbuster products offered by post-genomic science * Assessment of the ability of pharmacogenomics to solve the pharmaceutical industry's current R&D productivity crisis Report Highlights: Micro-segmented markets do not necessarily mean reduced revenue streams for pharmacogenomics-derived products because genotype screening identifies areas of high unmet need. In fact, the application of pharmacogenomics in cancer significantly increases the revenue potential of drugs with narrow therapeutic indices. Pharma must urgently overcome two key hurdles if they are to integrate pharmacogenomics successfully. Firstly, post-genomic science guarantees a 10-fold increase in the number of drug targets but target validation bottlenecks must be overcome. Secondly, traditional mass marketing is ineffective at positioning pharmacogenomic interventions and radical new approaches are required. By 2010, regulatory bodies will require a diagnostic test before pharmacogenomics-derived products are approved. Key Reasons to Buy this Report: * Maximize the commercial potential of pharmacogenomics-derived products through effective targeting of patients, physicians and payers * Identify the clinical trial stages that benefit most from integrating pharmacogenomics * Target therapeutic markets effectively by applying Datamonitor's proprietary pharmacogenomics cost-effectiveness framework * Minimize the investment risk in accessing niche genomic-based technologies to improve pipeline quality * Reduce time and costs by learning from the industry's leaders when optimizing the commercial potential of genomics-based development strategies.
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