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市場調查報告書
基因檢測之過熱趨勢
Key Trends Fueling the Boom in Genetic Testing
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基因檢測之過熱趨勢 是由出版商Decision Resources, Inc.在2009年06月所出版的。
這份英文市場調查報告書包含30 Pages 價格從美金3450起跳。
本報告為生物製藥相關之革新趨勢、進軍市場企業之戰略、次世代定序與償還、品牌等與影響今後基因檢測市場之要因做匯整,並由下列摘要形式闡述。
實施概要
簡介
基因引起之疾病
- 基因突變為新開發之關鍵
- 為因應更廣泛之尚未滿足需求之潛在性
個人基因組學
藥物基因組學之復甦
以成長促進因子為主之個別化醫療
- 標靶療法與搭配診斷
- 對其他治療領域過分之注目
- 轉換過往失敗經驗為成功案例
同一領域之相關成長
- 次世代定序技術之改良
- 審批程序之方針修正
- AmgenのVectibix
- Pfizer之Selzentry與Monogram Biosciences之Trofile
- 年法規評估
- 針對新檢測之有效付款人的介入
- 大型基因研究之推進
- 經濟危機之克服
結論
圖表
Abstract
Introduction
“Progress” aptly describes the expanding field of genetic testing.
The field is more than finding linkages of genes with diseases: it encompasses
technologies that have made it easier to quickly and more efficiently discover
genetic markers that predict disease, diagnose disease, and guide prescribing.
Applications of genetic tests are evolving as the technologies to refine them
are improving - in addition to the typical diagnostic/biopharma client,
interest is flourishing among vendors that are targeting consumer health. This
combined push is creating strong incentives for select populations and payers
to request such tests, which could translate to large payoffs for those
driving genetic diagnostic development efforts.
Get the Answers You Need to Shape Your Strategy
- Being able to dispense accurate prescribing information for patients to
reduce negative side effects, increase compliance, and improve prognosis is a
key goal of personalized medicine. How is genetic testing transforming the
personalized medicine space?
- Pharmaceutical companies use various strategies to secure the highly
sought-after regulatory approval. Biomarker-based diagnostics can play (and
have already demonstrated to an extent) an instrumental role in this journey.
How can biomarker-based genetic tests influence the federal approval for
pharmaceuticals? A handful of pharmaceutical companies have successfully used
companion diagnostics; the looming question in this field is: How many will
follow, and will this become a major strategy?
- Breast cancer has emerged as a hotbed of development for personalized
medicine, and it is no surprise that oncology is, by far, the most active
arena for genetic testing. How can the successful use of genetic testing in
breast cancer be mirrored in other disease states within and outside of
oncology?
- New legislation, payer involvement, and regulatory interest are among the
key factors fueling the boom in genetic testing. How influential are they
in development of new tests? What are the pitfalls for industry players in the
genetic testing market?
- Companies such as Hologic, Quest, LabCorp, and Sonic Healthcare were
responsible for dozens of acquisitions up through 2008, but M&A activity for
biomarkers and diagnostics companies was essentially null in the first quarter
of 2009. How has the present economic situation affected investment in
genetic testing? Why should companies consider seeking innovation through
partnership?
Scope
- Key factors influencing biopharmaceutical innovation: gene-based
targeted therapies and companion diagnostics, the need to avoid adverse drug
reactions, building better clinical trials, personalized medicine, federal
commitment.
- Two Spectrum Expert Commentaries: one details the value of
investing in genetic testing companies, and the other provides a perspective
on approval strategies for gene-based companion diagnostic tests.
- Information on genetic variance studies: salient findings from
clinical studies for select genes under investigation for drug and diagnostic
development.
- Analysis of key issues affecting growth of the genetic testing
market: large-scale genetic studies, next-generation sequencing, GINA,
regulatory perspectives, reimbursement, branding, DTC advertising, economic
climate.
Mentioned in This Report
Companies
- 23 and Me
- Abbott Molecular
- Agendia
- Amgen
- Applied Genomics
- Arca Biopharma
- Aviara Diagnostics
- Biocept Laboratories
- Bio-Reference Laboratories
- Bristol-Myers Squibb
- BTG
- Celera
- Chugai
- Clarient
- Clinical Data
- Combimatrix Molecular Diagnostics
- Correlagen
- Dako
- deCode
- Delphic Diagnostics
- DNA Direct
- Eli Lilly
- eXagen
- Genelex
- Genentech
- Genomic Health
- Genzyme Genetics
- GlaxoSmithKline
- Ikonisys
- Knome
- Laboratory Corp. of America
- Monogram Biosciences
- Myriad Genetics
- Nanosphere
- Navigenics
- NeoGenomics
- Novartis
- OSI
- Osmetech Molecular Diagnostics
- ParagonDX
- PerkinElmer
- Pfizer
- Plasmagene Biosciences
- Prometheus Laboratories
- Quest Diagnostics
- Roche
- Roche Molecular Diagnostics
- SanofiAventis
- Sciona
- Sequenom
- Signature Genomic Laboratories
- Third Wave Technologies
- Vysis/Abbott
- Xenomics
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Connecting the Dots: Gene to Disease
- Genetic Variation Is Key to Novel Developments
- Potential to Address Broader Unmet Needs
- Individualizing Personal Genomics.
- Rekindling Pharmacogenomics
- Personalized Medicine as a Driver for Growth
- Targeted Therapies and Companion Diagnostics
- Fueling Interest in Other Therapy Areas
- Turning Yesterday' s Failures into Today' s Personalized Medicine Success
Stories
- Creating Sustainable Growth in the Field
- Refine Next-Generation Sequencing Technologies
- Correctly Navigate the Approval Process
- Amgen' s Vectibix - A Cautionary Tale
- Pfizer' s Selzentry and Monogram Biosciences' Trofile
- Capitalize on Recent Legislative Support
- Effectively Engage Payers for Novel Tests
- Push for Large-Scale Genomic Studies
- Gracefully Ride Out the Economic Crisis
- Conclusions
Expert Commentaries
- Finding Value in Genetic Testing
- A Perspective on Approval Strategies for Gene-Based Companion Diagnostics
- Keith F. Batchelder, M.D., CEO and Founder, Genomic Health Care Strategies.
Sidebar
- Impact of the Economic Crisis on Emerging Diagnostics Companies
Tables
- 1. Select Genetic Testing Companies
- 2. Select Prenatal Diagnostic Tests for Genetic Analysis
- 3. Select Findings from Recent Genetic Variation Studies
- 4. Select Personal Genomics Services and Costs
- 5. Select Gene-Based Companion Diagnostic Tests for Breast Cancer
- 6. Targeted Therapies for Which Genetic Testing May Be Useful to Guide
Prescribing
- 7. Select Genetic Companion Diagnostic Tests and Associated Therapeutics
- 8. Select Large-Scale Genetic Variation Studies
Figures
- 1. Potential Market Impact by Select Companies That Offer Novel Prenatal
Diagnostics
- 2. Teams Competing for Archon X Prize for Genomics
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