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In Vitro Diagnostics Market Analysis 2009-2024

Published by: Visiongain

Published: May. 29, 2009 - 130 Pages


Table of Contents


1 Executive Summary

1.1 Focus of this Report

1.1.1 This Report Discusses IVD Tests According to Applications

1.1.2 How Companies are Discussed

1.1.3 Forecasts Include Laboratory-Only Companies

1.2 Crucial Points

1.2.1 Worldwide IVD Market Will Grow Well for the Next 15 Years

1.2.2 Short-Term Growth Led by Pregnancy, Influenza and Oncology Tests

1.2.3 SWOT Analysis

1.3 Aim, Scope and Format of this Report

1.3.1 Chapter Outlines

1.4 Research Methods

2 In Vitro Diagnostics (IVD) and Point of Care

2.1 What Are IVD Tests?

2.1.1 Biomarkers

2.2 How IVDs are Regulated by the FDA

2.3 Types of IVD Tests

2.4 Diagnostics Historically Separate from Pharmacological Treatment

2.5 Relative Costs of IVDs

2.6 Point of Care Tests (POCTs)

2.6.1 POCTs and Hospital Stays

2.6.2 What Home POCTs Say About the IVD Market

2.7 Laboratory IVD Tests versus Point of Care Testing

2.7.1 Diagnosis Turnover Rates

2.7.2 How Quickly Are Results Needed?

2.7.3 How Much do Shorter Turnaround Times Improve Treatment?

2.7.4 Economies of Scale

3 IVD Market Summary

3.1 Whole Market Analysis

3.2 Market Summary of Five IVD Tests with 2008 Sales of Over $5bn

3.3 Market Summary of Four IVD Tests with 2008 Sales Under $5bn

4 Genetic Tests

4.1 Genetic Tests: Medicine of the Future?

4.1.1 Genetic Tests and Tailored Medicine

4.2 Market Forecast, 2009-2024

4.3 2009 Call for Genetic Test Standards

4.4 Genetics and Oncology

4.4.1 BRCA1 and BRCA2 Genetic Tests

4.4.2 Genetics and HER2: Success Story

4.4.3 HER2 and Cancer: How IVDs and Therapy Interconnect

4.4.4 Genetics and Response to Gleevec for Gastrointestinal Cancer

4.5 Genetics and Statins

4.5.1 Celera's Genetic Test for Statin Responsiveness: the KIF6 Allele

4.5.2 Interview with Thomas White, PhD, Chief Scientific Officer and VP of Research, Celera

4.6 Genetic Test Companies

4.6.1 Myriad Genetics

4.6.2 deCODE Genetics

4.6.3 23andMe

4.6.4 Navigenics

4.7 Market by Region: Forecast Discussion

4.7.1 US

4.7.2 Japan and China

4.7.3 Europe

5 Oncology Tests

5.1 How Cancer is Diagnosed: Currently and in the Future

5.2 Market Forecast: 2009-2024

5.3 Lung Cancer

5.3.1 Almac Diagnostics

5.3.2 Lung Cancer IVD: Worldwide Unmet Need

5.4 Prostate Cancer

5.4.1 Gen-Probe Incorporated

5.4.2 Gen-Probe and DiagnoCure Incorporated

5.4.3 Timeline for a PCA3 Point of Care Test

5.5 Colorectal Cancer

5.5.1 Quest Diagnostics

5.5.2 DiagnoCure Inc.: Molecular Diagnostics for Cancer

5.5.3 Aventir Biotech LLC: First FDA-Approved Faecal Occult Blood Test

5.5.4 Alpha Laboratories

5.6 Human Papillomavirus (HPV) and Cervical Cancer

5.6.1 Digene/Qiagen

5.6.2 Cytyc and Hologic

6 Diabetes/Glucose Tests and Monitoring

6.1 Brief Overview of Diabetes

6.2 Market Forecast, 2009-2024

6.3 Glucose IVD Market by Subdivision: Diagnostic Tests and Monitoring Devices

6.4 Types of Tests

6.4.1 Blood Tests

6.4.2 Urine Tests

6.5 Diabetes IVD Assessment Targets

6.5.1 Ketones

6.5.2 Microalbuminurea

6.5.3 Glucose

6.6 Top Diabetes IVD Companies

6.6.1 Lifescan/Johnson & Johnson

6.6.2 Roche

6.6.3 Abbott

6.6.4 Bayer Diagnostics

6.6.5 Home Diagnostics, Inc.

6.7 Immediate Results: Crucial for Glucose Monitoring and Point of Care Testing

6.8 Future Opportunities in the Diabetes/Glucose IVD Market

6.9 Market by Region: Forecast Discussion

6.9.1 India and China

6.9.2 United States

6.9.3 Europe

7 Cholesterol Tests

7.1 Market Forecast, 2009-2024

7.2 Cholesterol Testing Companies

7.2.1 Polymer Technology Systems (PTS)

7.2.2 Roche Diagnostics

7.2.3 Home Access Health Corporation

7.2.4 Atherotech, Inc.

7.3 Market by Region: Forecast Discussion

7.3.1 Europe

7.3.2 US

7.3.3 India

7.3.4 South America

8 HIV Tests

8.1 Market Forecast, 2009-2024

8.2 OTC HIV Tests: The Debate

8.2.1 Home Testing vs. Home Sampling

8.2.2 Home Tests and Home Results Not Approved

8.3 HIV Testing Companies

8.3.1 Home Access Health Corporation

8.3.2 OraSure Technologies

8.3.3 MedMira

8.3.4 Novartis/Chiron

8.4 Market by Region: Forecast Discussion

8.4.1 Europe

8.4.2 US

8.4.3 Asia

8.4.4 Africa: Where the HIV Problem is Worst

9 Influenza Tests

9.1 Market Forecast, 2009-2024

9.2 Test Targets

9.3 Typing: A and B Strains

9.3.1 Rapid Tests: 15 Minutes or Less

9.4 Rapid Test Companies

9.4.1 Becton, Dickinson and Company

9.4.2 Inverness Medical Innovations, Inc.

9.4.3 Quidel

9.4.4 SA Scientific, Ltd.

9.4.5 Meridian Bioscience, Inc.

9.5 2009 Swine Flu as Case Study

9.6 Avian Flu: H5N1

9.6.1 IVD Market Forecast and Avian Flu

9.6.2 Avian Flu Tests

9.6.3 Arbor Vita Corporation

9.7 Market by Region: Forecast Discussion

9.7.1 US

9.7.2 Japan: The Second-Largest Flu Market

9.7.3 Europe

9.7.4 Hong Kong: Site of Original Avian Flu Outbreak in Human Beings

9.7.5 Sites of Recent Avian Flu Outbreaks

10 Drugs of Abuse Tests

10.1 Market Forecast

10.2 Types of Tests: Individual and Multiple Assays

10.3 OTC Test Companies

10.3.1 Inverness Medical Innovations/First Check Diagnostics

10.3.2 BTNX Inc.

10.3.3 Phamatech

10.3.4 Alfa Scientific

10.3.5 ACON Laboratories/Inverness Medical Innovations

10.4 Market by Region: Forecast Discussion

10.4.1 US

10.4.2 Europe: The European Workplace Drug Testing Society

11 Fertility, Ovulation and Pregnancy Tests

11.1 Market Forecast

11.2 Male and Fertility Tests: Relative Sales

11.3 Over-the-Counter Tests: The Largest Market?

11.3.1 Pregnancy Tests

11.3.2 Ovulation Tests: As Contraceptive and Pro-Conception Tools

11.3.3 Female Fertility Tests

11.3.4 Male Fertility Tests: Improving Products

11.4 OTC Test Companies

11.4.1 Church & Dwight Co, Inc.

11.4.2 Swiss Precision Diagnostics: Inverness Medical Innovations and Procter & Gamble

11.4.3 Johnson & Johnson

11.4.4 Genosis PLC/The LifeStyle Company

11.5 Market by Region: Forecast Discussion

11.5.1 US

11.5.2 Europe

11.5.3 Japan

11.5.4 South America

12 Conclusions

12.1 Most IVD Test Markets are Growth Markets

12.2 Growth Drivers

12.2.1 The Greatest Unmet IVD Need

12.3 Growth-Limiting Factors

12.3.1 Growth-Limiting Factors for Specific Markets

12.3.2 Saturated Markets

12.4 Over the Counter Tests: The Added Value of Convenience

12.5 Diagnostic Innovation: Improving the Future of Medicine

List of Tables

Table 1.1 Strengths and Weaknesses in the Current IVD Market
Table 1.2 Opportunities and Threats in the Future IVD Market

Table 3.1 IVD Tests Whole Market Forecast with Subdivisions, 2009-2024 ($bn)

Table 3.2 IVD Tests Whole Market Forecast 2009-2024 ($bn)

Table 4.1 Genetic Tests Forecast, 2009-2024 ($bn)

Table 5.1 Oncology Market Forecast, 2009-2024 ($bn)

Table 5.2 Top Five Cancers and Associated Deaths per Year

Table 6.1 Diabetes / Glucose Tests Forecast, 2009-2024 ($bn)

Table 6.2 Diabetes IVD Market Forecast by Subdivision, 2009-2024 ($bn)

Table 6.3 Glucose Meter Companies and Products, 2009 Table 6.4 Glucose Meter Companies and Percentage of Paediatric Users, 2006

Table 7.1 Cholesterol Levels and Associated Risks

Table 7.2 Cholesterol Tests Forecast, 2009-2024 ($bn)

Table 8.1 HIV IVD Tests Market Forecast, 2009-2024 ($bn)

Table 8.2 HIV Infection Numbers and Prevalence Rates in Asian Countries, 2007

Table 9.1 Influenza Market Forecast, 2009-2024 ($bn) Table 9.2 Types of Laboratory Influenza Tests (Non-rapid), 2009

Table 9.3 Rapid Influenza Tests Appropriate for Any Clinical Setting, 2009

Table 9.4 Rapid Influenza Tests Requiring Specific Laboratory Conditions, 2009

Table 9.5 Influenza Market Forecast, Including Avian Flu Test, 2009-2024 ($m)

Table 9.6 Countries with Confirmed Human Avian Flu Cases, 2009 Table 9.7 Month, Year, and Country of Human Avian Flu Cases, January 08-March 09

Table 10.1 Drugs of Abuse IVD Forecast, 2009-2024 ($bn)

Table 10.2 European Country WDT Regulations and Industries

Table 11.1 Pregnancy and Fertility Tests Forecast, 2009-2024 ($m)

Table 11.2 Sales Forecast for Male and Female Fertility Tests, 2009-2024 ($m)

List of Figures

Figure 3.1 IVD Test Whole Market Forecast, 2009-2024 ($bn)
Figure 3.2 Market Forecast 2009-2024: IVD Tests with Over $5bn in 2008 Sales ($bn)

Figure 3.3 Market Forecast 2009-2024: IVD Tests with Less Than $5bn in 2008 Sales ($bn)
Figure 4.1 Genetic Tests Forecast, 2009-2024 ($bn)

Figure 5.1 Oncology Market Forecast, 2009-2024 ($bn)

Figure 6.1 Diabetes / Glucose Tests Forecast, 2009-2024 ($bn)

Figure 6.2 Diabetes IVD Market Forecast by Subdivision, 2009-2024 ($bn)

Figure 6.3 Glucose Meter Companies and Percentage of Paediatric Users, 2006

Figure 7.1 Cholesterol Tests Forecast, 2009-2024 ($bn)

Figure 8.1 HIV IVD Tests Market Forecast, 2009-2024 ($bn)

Figure 9.1 Influenza Market Forecast, 2009-2024 ($bn)

Figure 9.2 Influenza Market Forecast, Showing Avian Flu Test ($m), 2008-2024

Figure 10.1 Drugs of Abuse IVD Forecast, 2009-2024 ($bn)

Figure 11.1 Pregnancy and Fertility Tests Forecast, 2009-2024 ($m)

Figure 11.2 Sales Forecast for Male and Female Fertility Tests, 2009-2024 ($m)

Figure 11.3 Fertility Test Market Breakdown, 2008

 

Abstract

New innovative report discusses how the global IVD market will develop in light of commercial opportunities and high technological potential

In vitro diagnostics constitute an important, growing healthcare industry and market, one that is increasingly biotechnological and closely aligned with pharma. In vitro diagnostic (IVD) tests provide essential information about physiological states, aiding diagnoses and choice of treatments. IVD’s usefulness in drug development - especially via biomarkers - constitutes a major advance, and an expanding market opportunity. Our new report - In Vitro Diagnostics: Market Analysis 2009-2024 - analyses the global IVD market comprehensively. This new study provides sales forecasts and discussions of emerging technologies and commercial opportunities, along with other information that you require.

From 2009 onwards, visiongain believes that worldwide investment in IVD testing will increase, due to a variety of factors including:
  • Greater awareness of tests’ availability and usefulness
  • More-widely applicable, accurate and usable tests emerging
  • Increasing appreciation of early diagnosis, both for patient quality of life and cost efficiencies
  • Progressive harnessing of biotechnologies, especially in more-personalised medicine, including theranostics, as well as medical research.
  • The global IVD market generated sales of over $40bn in 2008. Visiongain predicts that the market will generate nearly $60bn in 2014. What will it be worth in 2019 and in 2024? Which tests will be most commercially successful? How will sales for genetic screening perform in coming years? In Vitro Diagnostics: Market Analysis 2009-2024 answers these and other crucial questions.
Highlights of In Vitro Diagnostics: Market Analysis 2009-2024

Highlights of this report include:
  • Market sizes and sales growth of major IVD test types from 2009 to 2024 -Individual market forecasts and discussion of the following diagnostic areas:
  • Cholesterol
  • HIV
  • Pregnancy/fertility
  • Diabetes/glucose
  • Genetics
  • Influenza
  • Cancer/oncology
  • Drugs of abuse
  • Regional market analyses for IVD tests Analyses of commercial drivers and restraints, including SWOT analysis Discussion of the value of over-the-counter/at-home products Discussion of diagnostic test companies.
Comprehensive analysis of the IVD market area

In Vitro Diagnostics: Market Analysis 2009-2024 examines that sector critically, through a comprehensive review of information sources, both primary and secondary. This report provides detailed sales forecasts, discussions of pipeline developments and analysis of commercial drivers and restraints. There are detailed tables and figures included, as well as expert opinion from an original survey. The result is a comprehensive market- and industry-centred report, with detailed analyses and informed opinion to benefit your work.

Why you should buy In Vitro Diagnostics: Market Analysis 2009-2024

Benefits from purchasing this report include your receiving:
  • Detailed sales forecasts for specific IVD markets, with market shares and growth data
  • Discussions why certain IVD test markets will grow more quickly than others, with future and pipeline developments covered
  • A review of leading IVD companies, and recent alliances/mergers
  • Insights into regional differences in IVD adoption
  • Analyses of which markets are most saturated
  • Analyses of which markets have the most scope and potential for expansion
  • A discussion of unmet medical needs and how these will affect certain markets, as well as assessment of commercial drivers and restraints.
Visiongain believes that there will be increasing adoption of diagnostic tests worldwide, especially in prevention of disease and in early diagnosis. The market for IVD tests will expand, but some fields and national markets will grow more quickly than others. Continuing advances in diagnostic tools, greater availability of over-the-counter tests and quicker response times will make IVD testing more valuable to patients, medical professionals, industry and healthcare systems. In which countries will IVD sales grow the most? How will pregnancy test sales perform in the future? Will at-home HIV tests reach the worldwide market? In which countries are drugs of abuse tests most commonly used? What is the market outlook for cholesterol tests? This report covers these and other crucial questions about the IVD market and industry from 2009 onwards.

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