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Growth Opportunities in the US In Vitro Diagnostics (IVD) Market, Forecast to 2021

  • ID: 4298789
  • Report
  • May 2017
  • Region: United States
  • 118 Pages
  • Frost & Sullivan
US IVD Market Witnesses Pricing Fluctuations Due to the PAMA Regulation


  • Abbott
  • Bayer
  • bioMerieux
  • Danaher
  • Orthi Clinical
  • Siemens
  • MORE

The In Vitro Diagnostics (IVD) landscape in the United States is extremely dynamic, with a high level of merger and acquisition activity with many high-value deals still pending. Both clinical laboratories and manufacturers are increasingly vying for smaller specialized niche technology companies to increase their market share. Molecular point of care testing (POCT) and liquid biopsy continue to attract investment opportunities from private equity and venture capitalists. The new government in the United States aims to provide a retail-like experience for healthcare services. As a result, innovative and clinically vetted direct to consumer (DTC) diagnostic testing services are expected to thrive. Partnerships with non-healthcare (HC) companies are expected to empower core diagnostic companies with artificial intelligence (AI) and big data capabilities are on the rise. Given these market trends, it is important to understand the market dynamics to remain competitive and successful in the IVD market in the United States of America.

Research Scope:

The key objectives of this growth opportunity study are to track the changes in the IVD market landscape in the United States for 2016-2021. The study aims to identify growth segments and disruptive companies to invest into. Further, the study provides an in-depth revenue and market share analysis of over 8 segments within the IVD landscape: POCT, tissue diagnostics, self-monitoring blood glucose meter (SMBG), hemostasis, hematology, clinical chemistry, microbiology, immunochemistry, and molecular diagnostics. The study highlights industry challenges, growth drivers, restraints, competitive developments, mergers and acquisition, and investment opportunities. It also discusses the impact of Protecting Access to Medicare Act (PAMA), identifies transforming business models, and makes strategic recommendations to understand the dynamics of the US IVD market. The study also covers key trends and growth opportunities, game-changing companies, disruptive technologies and transforming business models, as well as strategic recommendations.

Key Questions this Study will Answer:

  • What are some of the current issues that concern the US IVD industry? How would these impact the different stakeholders in the healthcare landscape?
  • Which are the major segments of growth and why should you invest in them?
  • How to identify partners outside the conventional IVD realm?
  • How can big data support the growth of the IVD industry?
  • What are some of the newer products to watch in 2017 and beyond?
  • Which companies are categorized as early disruptors in this space? Who are the possible candidates to acquire, invest in, and help grow your business?
Note: Product cover images may vary from those shown


  • Abbott
  • Bayer
  • bioMerieux
  • Danaher
  • Orthi Clinical
  • Siemens
  • MORE
1. Executive Dashboard
  • Purpose of this Experiential Study
  • 5 Step Process to Transformational Growth
  • Scope and Segmentation
  • Market Highlights
  • Strategic Imperatives for Suppliers and Laboratories
  • 6 Big Growth Themes for US IVD Industry
  • Key Questions this Study will Answer
2. Growth Environment-Market Overview
  • Market Definition and Segments Covered
  • Market Drivers and Restraints
  • Reasons for Considering PAMA
  • Impact of the PAMA Regulations
  • Proposed Timeline for Implementation
  • Foreseeing the Effects of PAMA
  • CLFS Rate/Code Determination
  • Value Chain of IVD Industry
  • Key Disruptive IVD Concepts to Impact Healthcare by 2021
  • Snapshot of Growth Technologies in In-vitro Diagnostics Market
3. Vision and Strategy-Emerging Growth Opportunities
  • Transformation in the IVD Industry Ecosystem-2016
  • Growth Opportunities for Suppliers in Top 3 Segments
  • Macro to Micro Visioning
  • 5 Major Growth Opportunities
  • Opportunity 1-Use of Big Data
  • Opportunity 2-Liquid Biopsy and CDx
  • Opportunity 3-Molecular POCT
  • Opportunity 4-Direct-to-Consumer Testing
  • Opportunity 5-PGx Testing
  • Top Predictions for the US IVD Market
4. Total Market Forecasts
  • Total IVD Market-Revenue Forecast
  • Revenue Forecast by Segment
  • Revenue Growth Rate by Segment
  • Percent Revenue Forecast by Segment
  • Overall US IVD Market Share
  • Overall US IVD Market Share Analysis
5. Competitive Analysis
  • 2016 IVD Market Participant Strategies
  • Competitor IVD Matrix
  • Segment Sales Analysis
  • Top 13 Companies-US IVD Market
  • Competitor Segment Ranking Matrix
  • Notable Activities
  • Venture Radar-Additional Investment Opportunities
6. Hematology Segment Breakdown
  • Opportunities and Challenges-Hematology
  • Revenue Forecast-Hematology
  • Market Share Analysis-Hematology
  • Products to Watch in 2017
7. Hemostasis Segment Breakdown
  • Opportunities and Challenges-Hemostasis
  • Revenue Forecast-Hemostasis
  • Market Share Analysis-Hemostasis
  • Products to Watch in 2017
8. POCT Segment Breakdown
  • Opportunities and Challenges-POCT
  • Revenue Forecast-POCT
  • Market Share Analysis-POCT
  • Products to Watch in 2017
9. Molecular Diagnostics Segment Breakdown
  • Opportunities and Challenges-Molecular Diagnostics
  • Revenue Forecast-Molecular Diagnostics
  • Market Share Analysis-Molecular Diagnostics
  • Products to Watch in 2017
10. Tissue Diagnostics Segment Breakdown
  • Opportunities and Challenges-Tissue Diagnostics
  • Revenue Forecast-Tissue Diagnostics
  • Market Share Analysis-Tissue Diagnostics
  • Products to Watch in 2017
  • Reimbursement Analysis for Key AP Codes
11. SMBG Segment Breakdown
  • Opportunities and Challenges-SMBG
  • Revenue Forecast-SMBG
  • Market Share Analysis-SMBG
  • Product to Watch in 2017
12. Clinical Microbiology Segment Breakdown
  • Opportunities and Challenges-Clinical Microbiology
  • Revenue Forecast-Clinical Microbiology
  • Market Share Analysis-Clinical Microbiology
  • Products to Watch in 2017
13. Immunochemistry Segment Breakdown (Includes Revenues for Immunossay, Clinical Chemistry, and Urinalysis)
  • Opportunities and Challenges-Immunochemistry
  • Revenue Forecast-Immunochemistry
  • Market Share Analysis-Immunochemistry
  • Competitor Customer Coverage
14. Last Word
  • Key Conclusions and Future Outlook
  • Legal Disclaimer
15. Appendix (Capital Pricing and Installed Base)
  • Installed Base and Pricing Analysis-Hematology
  • Installed Base and Pricing Analysis-Hemostasis
  • Pricing Analysis-NGS
  • Pricing Analysis-Thermal Cyclers
  • Pricing Analysis-Microarrays
  • Pricing Analysis-Tissue Diagnostics
  • Installed Base and Pricing Analysis-Immunoassay Systems
  • Installed Base and Pricing Analysis-Chemistry Analyzers
  • Pricing Analysis-Automated Urine Analyzers
  • Key Abbreviations
  • List of Other Companies Includes
Note: Product cover images may vary from those shown
  • Abbott
  • Alere
  • Bayer
  • Becton Dickinson
  • bioMerieux
  • BioRad
  • Danaher
  • LifeScan (JnJ)
  • Orthi Clinical
  • Roche
  • Siemens
  • Sysmex
  • Thermo Fisher Scientific
Note: Product cover images may vary from those shown