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Innovations In Diagnostics: Next Generation Molecular and Point-of-Care Diagnostics Driving Personalized Healthcare

Published by: Business Insights

Published: Sep. 1, 2006 - 126 Pages


Table of Contents


Executive Summary

Introduction to diagnostics

Challenges and opportunities in diagnostic innovation

Molecular technology innovations

Innovation in infectious disease diagnostics

Personalized medicine

Point-of-care testing

Competitive landscape




Chapter 1 Introduction to diagnostics

Summary

Introduction

The global IVD market


Market segments

Market dynamics

Market growth


Key IVD players


Industry profile


Overview of diagnostic technologies


Immunoassays

Nucleic acid (NA) assays

Biosensors

Microarrays


Future trends




Chapter 2 Challenges and opportunities in diagnostic innovation

Summary

Introduction

A changing healthcare environment

Challenges & opportunities


Regulatory hurdles

Reimbursement

Technology requirements

Connectivity

Communication

New partnerships/new players




Chapter 3 Molecular technology innovations

Summary

Introduction

IVD technologies


PCR

FISH

Arrays

Nanotechnology

DNA methylation

DNA biosensors




Chapter 4 Innovation in infectious disease diagnostics

Summary

Introduction

Emerging infections


Avian influenza H5N1

SARS


Multiple detection of infectious agents

Future challenges


Hospital-acquired infections

Gonorrhea

Early onset sepsis

Other infections




Chapter 5 Personalized medicine

Summary

Introduction


Imaging: part of the Dx+PGx+Rx equation


Pharmacogenomics


Clinical application of pharmacogenomics

Pharmacogenetic tests


Case Study: AmpliChip CYP450

Other pharmacogenetic tests


Biomarkers


Case study: Diabetes

Case study: Heart disease



Oncology


Breast cancer

Colorectal cancer

Leukemia

Lung cancer

Prostate cancer


Future challenges




Chapter 6 Point-of-care testing

Summary

Introduction

Blood glucose tests


Case study: Scout test for diabetes screening


Infectious diseases


Rapid Step B test

Urinary tract infection (UTI) biosensor

Active tuberculosis (TB)


Cardiac diagnostics


Blood coagulation

Cardiac markers

Direct LDL cholesterol test

Stroke


Bladder cancer rapid test

HIV home tests

Future challenges




Chapter 7 Competitive landscape

Summary

Introduction

Key mergers & acquisitions

Competitive landscape

Pharma companies with Dx divisions


Roche Diagnostics


Diabetes Care

Centralized Diagnostics

Molecular Diagnostics

Near Patient Testing

Applied Science

Product Pipeline


Abbott


Diabetes Care

Immunodiagnostics, clinical chemistry and hematology

Molecular Diagnostics

Point-of-Care



MedTech companies with Dx divisions


Becton Dickinson


Diagnostics

Biosciences



Dx Specialists


Gen-Probe


Clinical Diagnostics

Blood Screening

Molecular Diagnostics


Inverness Medical Innovations (IMI)


Consumer Diagnostics Products

Professional Diagnostics Products

Research & Development

Acquisitions


Tm Bioscience


Human Genetics

Infectious disease

PGx



Technology specialists


Affymetrix


Collaborations

Competition


Nanogen




Chapter 8 Appendix

Index




List of Figures

Figure 1.1: IVD market segments, 2005

Figure 1.2: IVD market segments projected growth, 2004-2010

Figure 3.3: Orion Genomics’ Second Code technology

Figure 5.4: The healthcare model of the future: Personalized medicine

Figure 5.5: Breast cancer management in the future

Figure 5.6: From diagnostic market candidate to a product: Three development phases

Figure 5.7: Potential roles of genomics in cancer

Figure 7.8: New cancer marker launches

Figure 7.9: Gen-Probe leads US STD market, 2002-05

Figure 7.10: IMI product sales by business segment, 2005

Figure 7.11: IMI’s leading market position in consumer diagnostics




List of Tables

Table 1.1: Top 15 IVD companies, 2005

Table 2.2: Development costs and timeframes to produce a new IVD in the US, 2006

Table 5.3: Cancer markers used in Dx tests

Table 7.4: Pure-play diagnostic companies and ownership of IVD companies by medical device and pharmaceutical companies

Table 7.5: Roche Diagnostics sales, H1 2006

Table 7.6: Gen-Probe product sales, 2005

Abstract

The global diagnostics market is undergoing radical change; novel technologies driven by miniaturization and advances in genomics will enhance the role of diagnostics in the healthcare market, allowing more tests to be performed at the point-of-care and facilitating the shift towards personalized medicine. “Innovation in Diagnostics” examines the advances in the rapidly growing field of molecular technologies that are enabling personalized healthcare to move into mainstream medicine. New opportunities in infectious disease testing, molecular oncology and pharmacogenomics are explored in detail, enabling you to understand the forces that are driving in vitro diagnostics (IVDs) into centre stage of the healthcare arena. Understand the changing relationship between IVD companies and the pharmaceutical industry, assess the convergence of IVDs and medical imaging, and develop an understanding of new technologies that will influence diagnostic product development and drug development programs.

Key findings of the report:
  • Consolidation in the IVD industry is highlighted by the dominance of the leading 15 companies, which account for almost 90% of the global IVD market. Roche is the major player with a 20% market share.
  • Fewer than 10% of practising doctors have been educated in molecular medicine, thus adoption of molecular tests in clinical practice will demand training and educational materials from the IVD industry.
  • The full clinical potential of molecular diagnostics has yet to be realized. Clinical applications beyond the field of infectious disease testing will make this the fastest-growing market segment in the next decade.
  • IVD companies devote 35% of revenues to R&D, significantly more than the pharmaceutical industry, underlining the driving force of technology innovation which is forcing the pace of change among players in the industry .
  • Genotyping of known biomarkers will reduce drug toxicity problems and contribute to better dosing regimens, offering the potential for fewer drug withdrawals resulting from safety concerns.
Key questions answered in this report:
  • What will the IVD market be worth by the end of the decade?
  • Which market segments will drive IVD market growth?
  • Which new technologies will reach the market in the next 2-3 years?
  • How is technology innovation impacting the dynamics and ownership of the IVD industry?
  • What are the key challenges in gaining acceptance of new technologies by users, payers and regulators?
  • How is technology innovation facilitating the transition of personalized medicine into standard healthcare practice?
  • How will IVD technology developments impact labelling of existing and future drugs?


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