インビトロ診断 - 業界への影響

Abstract

Significant Product Benefits to Break Down Customer Reluctance toward Adopting New Assays

End-user skepticism regarding the reliability of new assays for in-vitro diagnostics can be remedied with effective demonstrations and customer education about their remarkable benefits. Companies need to train lab personnel on the use of these new tests as well as educate physicians about the ability of these tests to improve the overall cost efficiency and patient outcomes. These assays allow accurate and early diagnosis of life-threatening diseases along with continuous patient monitoring. The evidence of their success is the wider acceptance of newly developed tumor and prostrate markers, breast cancer tests, and assay technologies known for higher sensitivity and specificity, fast turn-around times, easy-to-use interfaces, and low cross reactivity.

This Technical Insights study examines the impact of in-vitro diagnostics on the healthcare market. It offers an analysis of recent developments in the in-vitro diagnostics industry and identifies commercial applications. This research service enables companies to align their positioning strategies to benefit from these technologies.

Molecular Diagnostic Assays Show Immense Promise

Molecular diagnostics is the most promising area of growth in the in-vitro diagnostics space, since it is now used to cure several infectious diseases. "Companies are focusing on developing new assays in the human immunodeficiency virus/hepatitis C virus (HIV/HCV) area using innovative technologies," says the analyst of this research service. "The healthcare industry is also witnessing a shift toward personalized medicine and gene-based detection tests, especially for cancer."

The platform for diagnosable diseases has broadened with scientists developing molecular diagnostic assays for diseases such as cancer, AIDS, influenza, and Alzheimer's. The continuous discovery of new gene targets has further helped in expanding the base of curable diseases.

Inadequate Reimbursement Poses a Stiff Adoption Barrier for New Assays

Budgetary pressures have compelled governments to cut back on providing reimbursements for new assays. Healthcare systems have to choose between better clinical tests at higher prices and those that offer lesser sensitivity and accuracy at lower prices. "Studies have demonstrated that reimbursement from Medicare is severely flawed and that often, new assays with greater benefits may be reimbursed with an equivalent or lesser amount than an existing one," notes the analyst. "Moreover, the Medicare fee schedule has not been revised due to inflation for 13 of the last 15 years and is not expected to be updated again till the end of 2008."

Since Medicare coding and payment processes are time consuming, non-transparent, and used inconsistently, physicians are left with little or no incentive to prescribe new diagnostic assays having greater sensitivity and speed.

Table of Contents

1 EXECUTIVE SUMMARY

• Scope and Methodology
  • Scope
  • Methodology
• Key Findings
  • Noteworthy Emerging Technologies
  • Noteworthy Applications

2 TECHNOLOGY AND APPLICATIONS VIEWPOINT

• Technology Primer
  • DNA Microarray
  • Polymerase Chain Reaction (PCR)
  • Immunoassays
• Technology and Applications Analysis
  • Application Analysis and Trends
  • Technology Roadmap
• Assessment of Stakeholder Innovation in Companies and Universities
  • Noteworthy Innovation at Key Companies
  • Noteworthy Innovation at Key Academic and Government-Related Institutions
• Influential Market Factors
  • Mergers and Acquisitions
  • Regulatory/Reimbursement Issues
  • Industry Trends and Future

3 TECHNOLOGY ADOPTION FACTOR ANALYSIS

• Key Challenges
  • Market Needs
  • Technology
  • Commercialization
  • Education/Training
• Key Drivers and Restraints
  • Drivers
  • Restraints

4 ASSESSMENT OF INNOVATION AND OPPORTUNITIES

• Innovative Development in Companies (North America)
  • Bayer Continues To Broaden Assay Menus
  • Biomerieux's New Generation Platform for Isolation of Nucleic Acids
  • Oral-Fluid Based Testing for Drugs of Abuse by Avitar
  • BioMerieux's Latest Offering for Bacterial Identification and Antibiotic Susceptibility Testing
  • First-ever Instant Testing Device for Anemia
  • Ciphergen's SELDI Technology as a Diagnostic Platform
  • Dade Behring's New Generation Integrated System for Clinical Laboratories
  • New Screening Tool for Point-of-care Detection of Diabetes and Pre-Diabetes
  • Abbott's Latest Offering for Hematology
  • Caliper's LabChip Technology for Diagnostic Applications
  • ICT's Whole-cell Protease Kits for Cancer and Neurogenerative Diseases Detection
  • First Blood Test for Mesothelioma from FDI
  • Veridex's Focus On Cancer Diagnostics
  • SideKick--the World's Smallest Diabetes System
  • Abaxis' Clinical Chemistry System for PoC Testing
  • CeMines Focus on Biomarkers for Detecting Cancer
• Innovative Development in Companies (Europe/APAC)
  • Roche's HPV Genotyping Test for Cervical Cancer
  • Hemocue's PoC system for Testing Glucose and Hemoglobin
  • A New Test to Assess Osteoporosis-Related Fracture Risk
  • DiaGenic's Microarray Platform for Diagnosis of Breast Cancer and Alzheimer's
  • Greiner Bio-One's Kit for Detection of Periodontal Pathogens
  • Syft Technologies' Novel Instrument for Diagnostic Solutions
• Innovative Developments in Universities
  • Handheld Diagnostic Device for Detection of Gum and Heart Disease
  • Bio-Barcode Amplification Technology for Detection of Cancer and Infectious Diseases
  • Nanowire Detectors with Key Applications in Diagnostics
  • Interferon-Gamma Assays for Diagnosis of Latent Tuberculosis
  • Spanish University Unveils a Unique Portable Diagnostic Tool

5 PATENTS; CONTACTS AND GLOSSARY

• Patents
  • Patents 1
  • Patents 2
  • Patents 3
• Contacts and Glossary
  • Contacts
  • Glossary

6 FROST & SULLIVAN 2005 SCIENCE AND TECHNOLOGY AWARDS

• Product Innovation Award
  • Award Description
  • Award Recipient
• Technology Innovation Award
  • Award Description
  • Award Recipient

7 CRITICAL REFERENCE TABLES

• Decision Support Database Tables
  • Diabetes Prevalence (1999-2006)
  • HIV Prevalence (1999-2006)
  • AIDS Mortality (1999-2006)
  • HIB Immunization (1999-2006)
  • Breast Cancer Incidence (1999-2006)
  • Breast Cancer Mortality (1999-2006)
  • Prevalence of Alzheimer's Disease (1999-2006)
  • Alzheimer Disease's Mortality (1999-2006)