Innovations in Diagnostics


Next generation molecular and point-of-care diagnostics driving personalized healthcare

Pages: 126

Publisher: Business Insights

Date Published: September 2006

Format: PDF

Price: Single User $2875

Price: Global / Enterprise $16000

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Overview

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.

Table of Contents

Table of Contents

Innovations in Diagnostics

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