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市場調查報告書
生物標記的實用化動向
Trends in the Commercialization of Biomarkers: Tests and Companies
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本報告已在2011年12月21日停止出版。
在醫療市場朝個人醫療發展的同時,生物標記能提供效率及高品質的護理而增加其重要性。
本報告書內容包括:現在的生物標記技術、針對癌症治療的生物標記診斷、投藥時利用的生物標記、實用化的生物標記、今後的市場機會等。內容綱要摘記如下:
實施概要
生物標記的重要性提昇
各種生物標記技術及測試規格
癌症用生物標記:針對癌症治療的結合診斷
- 概要
- 商業的成功
- 新的生物標記測試:乳癌預後診斷及治療選擇用的解決方案
- Gleevec開發及針對組合慢性骨髓性白血病的生物標記測試
為了投藥的生物標記
主要企業介紹
- Dako
- Roche Diagnostic
- Genomic Health
- Agendia
- third Wave Technologies
- Genzyme Genetics
- Veridex
教訓
預測
- 生物標記及標的疾病
- 平台技術的優點
- 償付問題
- 許可及醫療實驗
- 產品開發及商業策略的調整
圖表
Abstract
Introduction
As health care moves toward personalized medicine, biomarkers have gained an
increasingly important role in the delivery of effi cient, quality care. The
FDA has established specifi c defi nitions for biomarkers, and diagnostics,
biotechnology, and pharmaceutical companies have woken up to biomarkers'
potential following the publicity surrounding biomarkers associated with
Genentech' s Herceptin. A large number of companies now have commercialized
biomarker tests employing a variety of technologies, and activity is
particularly prevalent in the oncology and drug dosing arenas. Although larger
companies such as Roche have dominated molecular diagnostics, smaller
companies willing to invest in niche product areas have seized the opportunity
to develop equally valuable products.
Get the Answers You Need to Shape Your Strategy
- Oncology and infectious diseases have proven to be the most popular
targets of new biomarker development; however, oncology is favored because it
has one specifi c advantage. What is that advantage?
- Although companies have already successfully commercialized oncology
markers in breast cancer, new opportunities lie in other oncology areas. Which
company is developing biomarker tests to detect signs of prostate and colon
cancer, and which company is developing tests to detect the most common causes
of cervical cancer?
- Focusing on generating scientifi c publications and clinical trial data
throughout the development of a new biomarker test can allow for early
commercialization of the test. Which company successfully employed this
strategy to develop and commercialize its biomarker test-now reimbursable
under the insurance plans of 125 million people?
- Increased regulatory oversight may make marketing some types of diagnostic
tests more diffi cult. Which biomarker tests has the FDA specifi cally
suggested it will seek to regulate?
- The approval of Genentech' s Herceptin, requiring the co-development of a
test for HER2/NEU to qualify patients for treatment, has inspired other
companies to try similar co-development strategies. Which companies have
attempted to duplicate Herceptin' s success? Have these companies' attempts
been successful?
- Companies having platform technologies that can provide simpler biomarker
assays capable of being automated have an advantage over those companies that
cannot provide such assays. Which companies have this capability?
- Roche is currently the dominant player in the fi eld of molecular
diagnostics. What types of diagnostic systems have helped Roche to become the
dominant player in this fi eld? What strategies has Roche pursued to improve
on its diagnostics position?
Scope
- Current biomarker technologies: in vitro diagnostic tests (IVDs),
immunohistochemistry (IHC) tests, fl uorescent in situ hybridization (FISH)
tests, microarrays, and circulating tumor cells (CTCs)
- Biomarker diagnostics for targeted cancer therapies: Herceptin and its
companion biomarkers; Genomic Health' s Oncotype DX biomarker test and
Agendia' s MammaPrint test for breast cancer; Veridex' s CellSearch system to
aid monitoring of metastatic breast cancer; biomarker tests to diagnose and
monitor chronic myelogenous leukemia and determine initiation of Gleevec
- Companion biomarker diagnostics for drug dosing: biomarkers for Pfi zer' s
Camptosar and Bristol-Myers Squibb' s Coumadin
- Commercialized biomarker products: successful products from Dako, Roche
Diagnostics, Genomic Health, Agendia, Third Wave Technologies, Genzyme
Genetics, and Veridex
- Opportunities: continued commercialization of oncology biomarkers;
attractions of NAT technology; increasing importance of drug labeling; small
companies' successes; signifi cant room for improvement
- Challenges: the reluctance of drug companies to restrict the use of their
drugs through biomarker tests; uncertain regulatory environment; low
reimbursement rates for diagnostic products; the diffi culties of developing
companion diagnostics for EGFR-targeted drugs
- Outlook: licensing opportunities for smaller players; the advantages of
platform biomarker technologies; reimbursement issues; the launch of
validation and clinical trials; increasing chances of early adoption by
coordinating product development with business strategy
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- The Increasing Importance of Biomarkers
- A Wide Variety of Biomarker Technologies and Test Formats
- Oncology Biomarkers: Companion Diagnostics for Targeted Cancer Therapies
- Overview
- Commercial Success: Biomarker Tests for HER2/NEU/ERB2 Used with
Herceptin in Breast Cancer
- New Biomarker Tests: Possible Solutions for Prognosis and Therapy
Selection in Breast Cancer
- Biomarker Tests for Chronic Myelogenous Leukemia Incorporated Throughout
Gleevec Development
- Biomarkers Used for Drug Dosing
- Overview
- Camptosar
- Coumadin
- Profi les of Select Companies
- Dako (Glostrup, Denmark)
- Roche Diagnostics (Basel, Switzerland)
- Genomic Health (Redwood City, California)
- Agendia (Amsterdam, the Netherlands)
- Third Wave Technologies (Madison, WI)
- Genzyme Genetics (Framingham, MA)
- Veridex (Raritan, NJ)
- Lessons Learned
- Outlook
- Biomarkers and Target Diseases
- Advantages of a Platform Technology
- Reimbursement Issues
- Validation and Clinical Trials
- Coordination of Product Development and Business Strategies
Tables
- 1. Major Technologies Currently Used for Biomarker Assays
- 2. Select Biomarkers Included in Drug Labeling
- 3. Select Commercialized Biomarkers, Analyte-Specifi c Reagents, and
Products in Advanced Stages of Development
Figures
- 1. Applications of Biomarkers in Cancer Management
- 2. EGFR Family
- 3. Approximate Percentages of Drug Labels in the United States That
Include Pharmacogenomic Information or Information Regarding Recommended or
Required Tests
Sidebars
- FDA Biomarker Defi nitions
- Targeting EGFR-In Search of Biomarkers
- FDA Guidance on In Vitro Diagnostic Multivariate Index Assays
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