Market Report Source

Overview

This completely updated edition of Kalorama’s comprehensive and indispensable report covers the breadth of traditional IVD testing. The report contains complete market statistics and analysis for all areas of IVD, including:

• Point-of-Care


• Core Lab


• Immunoassays


• Molecular Assays


• Hematology


• Coagulation


• Microbiology and Virology


• Blood Banking


• Histology and Cytology

Market size, growth, share, and geographic distribution, as well as trends in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Projections are made through 2012.

A New Report Design for a Changing Industry

In this sixth edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information has reorganized the presentation of the IVD market in a manner that better reflects how the industry has evolved since the first edition was published in 1997.

At that time, molecular testing was a small emerging discipline that related to chlamydia, gonorrhea, TB, and some inherited diseases. That first edition didn’t even have a chapter for molecular diagnostics; it was a miscellaneous. Now, molecular tests are common in several segments – infectious diseases, bacterial identification, coagulopathologies, blood unit screening, histology and soon as POC devices. Therefore the molecular chapter in this report presents technology and market issues that are common to all segments and concentrates on purely molecular tests for inherited diseases. Molecular tests used in other segments are included in the appropriate chapter.

In 1997, POC testing meant glucose testing. Similar to molecular testing, rapid and POC tests are becoming an important part of testing on all fronts. Here too the POC chapter presents technology and market issues that are common to all segments and concentrates on blood glucose monitoring.

The multisegment core lab has become a reality. The chemistry lab is the hub of some 80% of the routine test workload. Thus a new chapter: Core Lab that will include clinical chemistry.

Age of the Giants (and Smaller Colossuses)

Since 2000 or so IVD manufacturers have introduced a new generation of immunoassays and molecular tests that have renewed industry growth. In the past 2-3 years, several product innovators have seen their annual revenues double and triple, while some of the top IVD companies experienced negative growth or sluggish single digit revenue increments.

The mix of established distribution experts and newer products and technologies has resulted in numerous acquisitions and marketing alliances.

This new 1,100-page edition greatly expands coverage of the field and tracks the most important developments. Expanded or added in this edition are sections on:

• the status of POC and decentralization in lab medicine


• miniaturization and molecularization of devices


• geo-economic and demographic influences on markets


• non-invasive sampling


• greatly expanded market data on PGx and SNP testing


• revamped segmentation for clinical chemistry to include workstations and immunoanalyzers


• more information about more immunoassays


• the renewed interest in microbiology/virology based on resistance and the re-emergence of serious hospital- and community-based organisms


• world blood banking developments


• expanded sections on histology/cytology developments including emerging areas such as tissue microarrays, circulating tumor cells, and genomics-fueled innovation.

In addition, there are now profiles of more than established and emerging players in IVD with profiles of more than 276 companies, from the top tier to emerging and niche competitors to watch.

Table of Contents

1 Executive Summary

• Introduction


• Scope and Methodology


• Size and Growth of the Market


• Market Trends – a ten year review

2 Introduction

• Background
  
• Lab Medicine Disciplines And Applications, new report design


• Market Analysis of IVD Market Segments


• Age of the giants and smaller colossuses


• Licenses and distribution agreements


• Point of View

3 Overview Of Global In Vitro Diagnostic Markets

• Background


• The global community strives for regulatory harmonization


• World Segments of the IVD Market and IVD Market Evolution


• The United States of America – a free market in disguise


• – holding its own


• Europe – economic crisis drives reorganizations


• China – the WTO powerhouse


• The lure of emerging markets


• IVD Market Growth – segments and technologies


• Traditional IVDs
  
• Emerging Tests and Technologies

4 Trends and Innovation

• Background


• HIV Testing, a 25 year phenomenon


• Diabetes innovation


• Miniaturization And Chip Progress


• Non-Invasive Techniques And Alternative Samples


• Commercialization Issues : Patents and market innovation


• Direct to consumer marketing


• Patient Management and Outcomes-Based Medicine


• Economics of New Tests and Technologies – the old don’t disappear


• Post Genomics and Pharmacogenomics – reality check


• Growing Globalization of Public Health Crises – SARS, West Nile, Biowar impact


• Regulatory and Reimbursement Issues And Novel Devices

5 Point-of-Care Test Platforms

• Overview of POC Tests


• Leading Innovations


• Cost Pressures and Perceived Barriers for POC Tests


• Institutional Users of POC Tests


• The Commercial Outlook for POC Tests


• Companies to Watch

6 The Core Lab: ClinicalChemistry / Immunoassays / Hematology / Coagulation / Urinalysis / Microbiology

• Overview


• Market Analysis : Leading Suppliers and Growth Potential


• Lab Automation and Work Station Consolidation


• Decentralization Imperative


• The Commercial Outlook for the Core Lab


• Companies to Watch

7 Immunoassays

• Overview of Immunoassays


• Market Analysis : Leading Suppliers and Growth Potential


• Immunoassay Test Segments – Mature and Emerging


• Point-of-care OTC and Professional Use


• The Commercial Outlook for Immunoassays


• Companies to watch

8 Molecular Assay Platforms