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市場調查報告書
附帶診斷的最新動向
Disruption or Advantage? Update on Companion Diagnostics
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附帶診斷的最新動向 是由出版商Decision Resources, Inc.在2009年09月所出版的。
這份英文市場調查報告書包含25 Pages 價格從美金4600起跳。
附帶診斷用於藥劑反應及治療效果的預測、有效率的藥劑開發裡醞釀很高的潛力。
本報告書內容包括:小細胞肺癌及結腸直腸癌、乳癌、心律不整等各種適應、附帶診斷的最新動向、參加企業的介紹、今後的動向等、內容綱要摘記如下:
實施摘要
介紹
利害關係人的捲入及不斷的努力
各治療領域的附帶診斷：癌
藥劑和診斷藥的意見交換：作業中
- 技術的進歩
- 複雜的共同開發工作程序
- 償還規範：並非無課題
- 規範當局的解說是否足夠
容量架構：主要企業
- 製藥公司
- 診斷藥廠商
- Clinical Data
- Dako
- DxS
- LabCorp
今後的展望
Abstract
Introduction
Some naysayers disagree, but we regard companion diagnostics as a win-win
scenario for all stakeholders. Companion diagnostics combines drug and
diagnostic test development. The potential for effi cient drug development is
huge because companion diagnostics can be used to predict drug response and
treatment effi cacy - therefore, companion diagnostics are also the perfect
means to fulfi llment of the promise of personalized medicine. But the
advantages of companion diagnostics are only one side of the equation: they
are also seen as disruptors of the pharmaceutical market that could restrict
the size of treatable populations. Bringing the differing viewpoints together
to form a unifi ed idea of what companion diagnostics really mean to the
industry is a challenge, but one that companies must heed because companion
diagnostics are making their mark - like it or not.
Questions Answered in This Report
- Regulatory and payer decisions on certain types of testing are
increasingly infl uencing physician, patient, and industry perspectives. For
instance, how has the FDA' s recent decision to alter the Vectibix and Erbitux
labels affected industry dynamics?
- Companies that have developed companion diagnostics are viewed as valuable
acquisition targets. Which companies are attracting potential buyers? What is
the perceived impact of these acquisitions on the overall strategies of
pharmaceutical companies?
- The availability of companion diagnostics in oncology is greater than in
other therapy areas. Why is oncology such an attractive area for growth in
personalized medicine? In what other areas is development of personalized
medicine growing?
Scope
- Stakeholder analysis: Pharmaceutical companies, diagnostics
companies, payers, regulatory agencies, physicians, and patients.
- Recent trends and decisions: Regulating KRAS mutation tests,
identifi cation of genetic markers of response to Vanda' s Fanapt
(iloperidone), reimbursement for warfarin testing, partnering and dealmaking
in companion diagnostics.
- Indications: Non-small-cell lung cancer (NSCLC), colorectal cancer
(CRC), breast cancer, heart failure, arthritis, depression, chronic
myelogenous leukemia (CML).
- Company profi les: Pharmaceutical companies - Wyeth, Vanda
Pharmaceuticals, Roche, Pfi zer, Novartis, Johnson & Johnson, Eli Lilly, ARCA
BioPharma, Amgen, and Abbott. Diagnostics companies - LabCorp, DxS, Dako, and
Clinical Data.
- Outlook: Spectrum Expert Commentary on future growth, therapeutic
area emphasis, the promise of personalized medicine.
Mentioned in This Spectrum Report
- Companies
- Abbott
- Abbott Molecular
- Amgen
- ARCA BioPharma
- Arup Laboratories
- AstraZeneca
- Asuragen
- Bayer
- Biogen Idec
- BioGenex
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Celera
- Chugai
- Clinical Data
- Dako
- DiaSorin
- DxS
- Eli Lilly
- Genentech
- General Electric
- Genomic Health
- Genzyme Genetics
- GlaxoSmithKline
- ImClone
- Johnson & Johnson
- LabCorp
- Merck & Co.
- Monogram Biosciences
- Novartis
- OSI Pharmaceuticals
- Pfi zer
- Prometheus Laboratories
- Roche
- Source MDx
- TcLand Expression
- Third Wave Technologies (now Hologic)
- Vanda Pharmaceuticals
- Ventana Medical Systems
- Vysis
- Wyeth
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Continued Efforts to Engage Stakeholders
- Companion Diagnostics by Therapeutic Area: Focus on Oncology
- Drug-Diagnostics Dialogue - Work in Progress
- Technological Advances
- Complex Codevelopment Workfl ows
- Reimbursement Rules! But Not Without Challenges
- Is Guidance from Regulators Suffi cient?
- Building Capacity - Key Companies
- Pharmaceutical Companies
- Diagnostics Companies
- Clinical Data
- Dako
- DxS
- LabCorp
- Outlook
- Ugly Myth, Annoying Truth, or Advantage?
- Bottom Line
Expert Commentary
- Companion Diagnostics - Looking to the Future
- by Cheryl Barton, Ph.D., PharmaVision
Tables
- 1. Select Companion Diagnostic Tests and Corresponding Targets
- 2. Select KRAS Testing Companion Diagnostics
- 3. Common Technologies Underlying Companion Diagnostic Tests
- 4. Recent Companion Diagnostic-Drug Development Collaboration Activity
- 5. Dako' s Companion Diagnostic Tests
- A. Examples of Targeted Drugs and Associated Companion Diagnostics
Launched in the Past Five Years
Figures
- 1. The FDA Vision of Drug-Diagnostic Codevelopment
- 2. Coverage of Select Targeted Cancer Therapies by Private Health Plans
- 3. Coverage of Select Targeted Cancer Therapies by Medicare Plans
- 4. Benefi t of the Personalized Medicine Model
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