Analysis of the Global In Vitro Diagnostics Market

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Analysis of the Global In Vitro Diagnostics Market
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Stagnating Local Markets Accelerate the Globalization of In Vitro Diagnostics Companies

Despite global economic and industry challenges, in vitro diagnostics (IVD) markets are growing robustly at double the rate of the global pharmaceutical industry. This research deliverable leverages primary research, secondary sources, and Frost & Sullivan's proprietary database of global research. Market segments include immunochemistry, self-monitoring of blood glucose (SMBG), point-of-care testing (POCT), molecular diagnostics, hematology, clinical microbiology, and hemostasis. Regions include United States, Western Europe, Asia-Pacific, Latin America, and Eastern Europe. Each segment includes revenue forecasts for 2009 to 2017, market share, competitive landscape, and product analysis.

Executive Summary

• Despite global economic and industry challenges, in vitro diagnostics (IVD) markets are growing robustly at double the rate of the global pharmaceutical industry.
• The global IVD market size was $Xbillion in 2012 and is expected to reach $X billion in 2017 growing at a CAGR of X%.
• Global Trends Summary
- The United States and Western Europe are important markets representing X% of global IVD, but the fast rising Asia-Pacific market should be part of every IVD company's long-term strategy.
- Despite challenges in reimbursement and a need for Conformité Européenne (CE) marking reform, Western European markets exhibit an upward trajectory.
- The Asia-Pacific region holds the greatest number of next wave emerging markets, such as Indonesia, Vietnam, and the Philippines.
- Increasing numbers of patients with private health plans and the expansion and modernization of health infrastructure will sustain growth in Latin America, however, a lack of technology and local manufacturing expertise will modulate growth.
• Segment Trends Summary
- China and Eastern Europe drive the demand for integrated analyzers able to run both clinical chemistry and immunoassays.
- Self-monitoring blood glucose (SMBG) segment growth in emerging markets is severely dampened by slowing growth from reimbursement reductions in Europe and the United States.
- The broad applicability of point-of-care test (POCT) in global markets combined with downward pricing trends enabled by microfluidics integration support the long term growth of this segment.
- Developed nations like the United States and Europe continue to drive molecular diagnostics segment growth rather than emerging markets like Asia-Pacific and Eastern Europe.
- New product launches, supporting an existing installed base, and meeting emerging market needs will provide relatively consistent hematology segment growth despite some market uncertainties.
- While rapid tests and molecular identification methods are a threat to traditional clinical microbiology methods, new mass spectrometry-based identification may bolster segment growth if favorably adopted.
- New oral anticoagulant drugs are driving the need for associated laboratory testing and demand for coagulation analyzers.
• Competitive Landscape Summary
- The global IVD market is highly fragmented with the topXmarket participants Roche Diagnostics, Siemens Healthcare, and Abbott Laboratories controlling X% market share.
- Mergers and acquisitions (M&A) continues to be an important competitive strategy to access new technology, expand product offerings, enter emerging markets, or increase market share. Further industry consolidation will intensify the market concentration and occur at a rapid pace as IVD company are being acquired by larger IVD companies, pharmaceutical companies, and even non-traditional healthcare companies.

CEO's Perspective

1. Roche Diagnostics, Siemens Healthcare, and Abbott Laboratories (top X participants) controlled X% market share in 2012.

2. The US and Western Europe regions are the largest IVD markets, but the Asia-Pacific and Eastern Europe regions are growing fastest.

3. Immunochemistry and SMBG are the largest IVD segments, but the molecular diagnostics and POCT segment is growing the fastest.

4. To grow, global IVD market participants will employ a diverse set of strategies rather than rely on comprehensive product portfolios.

5. Diagnostic testing will continue to move towards process simplicity and decentralization.

Definitions

• The IVD market includes reagents, consumables, and analyzers that are used to perform testing outside the body on obtained specimens such as blood or urine, to measure analytes of interest for patient evaluation. The market includes immunochemistry, clinical microbiology, tissue diagnostics, hemostasis, hematology, molecular diagnostics, SMBG, and POCT.
• These are performed in central laboratories, reference laboratories, professional testing near patients (POCT) and patient self-testing.
• This analysis does not include revenue for clinical laboratories provide testing services, such as Genomic Health, Myriad Genetics, and Quest Diagnostics.

Key Questions This Study Will Answer

• Which segments of the market are growing, how long will it continue to grow, and at what rate?
• What primary strategies are the competitors employing to sustain growth?
• What do the key M&A deals indicate about the market?
• What are the market drivers and restraints for global IVD and for emerging markets?
• What percent of the global IVD market does each region contribute? Which regions are growing the fastest?
• Which new technologies following next generation sequencing have the potential to be future IVD applications?

Table Of Contents

1. Executive Summary
2. Market Overview
3. Total IVD Market
- External Challenges: Drivers and Restraints
- Forecasts and Trends
- Market Share and Competitive Analysis
4. Immunochemistry Segment Breakdown
5. Self-Monitoring Blood Glucose Segment Breakdown
6. Point-of-Care Testing Segment Breakdown
7. Molecular Diagnostics Segment Breakdown
8. Hematology Segment Breakdown
9. Clinical Microbiology Segment Breakdown
10. Hemostasis Segment Breakdown
11. Region Breakdown
12. The Last Word
13. Appendix

List of Exhibits

• Total IVD Market: Market Engineering Measurements, Global, 2012
• Total IVD Market: Market Segmentation, Global, 2012
• Total IVD Market: Key Market Drivers and Restraints, Global, 2013-2017
• Total IVD Market: Market Drivers for Emerging Markets, Global, 2013-2017
• Total IVD Market: Market Restraints for Emerging Markets, Global, 2013-2017
• Total IVD Market: Market Engineering Measurements, Global, 2012
• Total IVD Market: Revenue Forecast, Global, 2009-2017
• Total IVD Market: Percent of Sales, Global, 2012
• Total IVD Market: Company Market Share Analysis of Top 11 Participants, Global, 2012
• Total IVD Market: Competitive Structure, Global, 2012
• Total IVD Market: Analysis of Key Mergers and Acquisitions, Global, 2012
• Immunochemistry Segment: Market Engineering Measurements, Global, 2012
• Immunochemistry Segment: Revenue Forecast, Global, 2009-2017
• Immunochemistry Segment: Percent of Sales, Global, 2012
• Immunochemistry Segment: Company Market Share Analysis of Top 8 Participants, Global, 2012
• Immunochemistry Segment: Competitive Structure, Global, 2012
• Immunochemistry Segment: Installed Base, Global, 2012
• Immunochemistry Segment: Number of Immunochemistry Analyzer Models and Configurations, Global, 2012
• Immunochemistry Segment: Common Immunoassay Tests, Global, 2012
• Immunochemistry Segment: Table of Immunochemistry Analyzers, Global, 2012
• Immunochemistry Segment: Table of Common Clinical Chemistry Tests, Global, 2012
• Immunochemistry Segment: Table of Common Immunoassay Tests, Global, 2012
• SMBG Segment: Market Engineering Measurements, Global, 2012
• SMBG Segment: Revenue Forecast, Global, 2009-2017
• SMBG Segment: Percent of Sales, Global, 2012
• SMBG Segment: Company Market Share Analysis of Top 5 Participants, Global, 2012
• SMBG Segment: Competitive Structure, Global, 2012
• SMBG Segment: Product Table, Global, 2012
• POCT Segment: Market Engineering Measurements, Global, 2012
• POCT Segment: Revenue Forecast, Global, 2009-2017
• POCT Segment: Percent of Sales, Global, 2012
• POCT Segment: Company Market Share Analysis of Top 8 Participants, Global, 2012
• POCT Segment: Competitive Structure, Global, 2012
• Molecular Diagnostics Segment: Market Engineering Measurements, Global, 2012
• Molecular Diagnostics Segment: Revenue Forecast, Global, 2009-2017
• Molecular Diagnostics Segment: Percent of Sales, Global, 2012
• Molecular Diagnostics Segment: Company Market Share Analysis of Top 8 Participants, Global, 2012
• Molecular Diagnostics Segment: Competitive Structure, Global, 2012
• Molecular Diagnostics Segment: Selection of FDA Cleared or Approved Tests, Global, 2012
• Molecular Diagnostics Segment: Automated Molecular Platforms that Integrate Both Pre-analytical and Analytical Steps, Global, 2012
• Molecular Diagnostics Segment: Product Table of Next Generation Sequencers, Global, 2012
• Molecular Diagnostics Segment: Table of Automated Molecular Platforms, Global, 2012
• Hematology Segment: Market Engineering Measurements, Global, 2012
• Hematology Segment: Revenue Forecast, Global, 2009-2017
• Hematology Segment: Percent of Sales, Global, 2012
• Hematology Segment: Company Market Share Analysis of Top 5 Participants, Global, 2012
• Hematology Segment: Competitive Structure, Global, 2012
• Hematology Segment: Installed Base, Global, 2012
• Hematology Segment: Percent of Installed Base by Region, Global, 2012
• Hematology Segment: Table of Hematology Analyzers, Global, 2012
• Clinical Microbiology Segment: Market Engineering Measurements, Global, 2012
• Clinical Microbiology Segment: Revenue Forecast, Global, 2009-2017
• Clinical Microbiology Segment: Percent of Sales, Global, 2012
• Clinical Microbiology Segment: Company Market Share Analysis of Top 4 Participants, Global, 2012
• Clinical Microbiology Segment: Competitive Structure, Global, 2012
• Clinical Microbiology Segment: Technology Trends, Global, 2011-2015
• Hemostasis Segment: Market Engineering Measurements, Global, 2012
• Hemostasis Segment: Revenue Forecast, Global, 2009-2017
• Hemostasis Segment: Percent of Sales, Global, 2012
• Hemostasis Segment: Company Market Share Analysis of Top 4 Participants, Global, 2012
• Hemostasis Segment: Competitive Structure, Global, 2012
• Hemostasis Segment: Table of Hemostasis Tests, Global, 2012
• Hemostasis Segment: Table of Hemostasis Analyzers, Global, 2012
• Total IVD Market: Percent Revenue by Region, Global, 2012-2017
• Total IVD Market: Growth by Region, Global, 2012-2017
• IVD Market: Revenue Forecast, United States, 2012-2017
• IVD Market: Revenue Forecast, Western Europe, 2012-2017
• IVD Market: Revenue Forecast, Asia-Pacific, 2012-2017
• IVD Market: Revenue Forecast, Latin America, 2012-2017
• IVD Market: Revenue Forecast, Eastern Europe, 2012-2017
• IVD Market: Revenue Forecast, Rest of World, 2012-2017

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In_Vitro_Diagnostic Industry: Analysis of the Global In Vitro Diagnostics Market

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