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

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

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:

1. What are some of the current issues that concern the US IVD industry? How would these impact the different stakeholders in the healthcare landscape?
2. Which are the major segments of growth and why should you invest in them?
3. How to identify partners outside the conventional IVD realm?
4. How can big data support the growth of the IVD industry?
5. What are some of the newer products to watch in 2017 and beyond?
6. Which companies are categorized as early disruptors in this space? Who are the possible candidates to acquire, invest in, and help grow your business?


  • 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
  • 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
      • Table Total IVD Market: Revised PAMA Payment Rates, US, 2016
    • Value Chain of IVD Industry
    • Key Disruptive IVD Concepts to Impact Healthcare by 2021
    • Snapshot of Growth Technologies in In-vitro Diagnostics Market
  • 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
  • Total Market Forecasts
    • Total IVD Market-Revenue Forecast
      • Table Total IVD Market: Revenue Forecast, US, 2011-2021
    • Revenue Forecast by Segment
      • Table Total IVD Market: Revenue Forecast by Segment, US, 2011-2021
    • Revenue Growth Rate by Segment
      • Table Total IVD Market: Revenue Growth Rate by Segment, US, 2012-2021
    • Percent Revenue Forecast by Segment
    • Overall US IVD Market Share
    • Overall US IVD Market Share Analysis
      • Table Total IVD Market: Market Share Revenue, US, 2016
  • 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
  • Hematology Segment Breakdown
    • Opportunities and Challenges-Hematology
    • Revenue Forecast-Hematology
      • Table Hematology Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-Hematology
      • Table Total IVD Market: Hematology Market Share, US, 2016
    • Products to Watch in 2017
  • Hemostasis Segment Breakdown
    • Opportunities and Challenges-Hemostasis
    • Revenue Forecast-Hemostasis
      • Table Hemostasis Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-Hemostasis
      • Table Total IVD Market: Hemostasis Market Share, US, 2016
    • Products to Watch in 2017
  • POCT Segment Breakdown
    • Opportunities and Challenges-POCT
    • Revenue Forecast-POCT
      • Table POCT Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-POCT
      • Table Total IVD Market: POCT Market Share Analysis, US, 2016
    • Products to Watch in 2017
  • Molecular Diagnostics Segment Breakdown
    • Opportunities and Challenges- Molecular Diagnostics
    • Revenue Forecast-Molecular Diagnostics
      • Table Molecular Diagnostics Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-Molecular Diagnostics
      • Table Total IVD Market: Molecular Diagnostics Market Share Analysis, US, 2016
    • Products to Watch in 2017
  • Tissue Diagnostics Segment Breakdown
    • Opportunities and Challenges-Tissue Diagnostics
    • Revenue Forecast-Tissue Diagnostics
      • Table Tissue Diagnostics Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-Tissue Diagnostics
      • Table Total IVD Market: Tissue Diagnostics Market Share Analysis, US, 2016
    • Products to Watch in 2017
    • Reimbursement Analysis for Key AP Codes
      • Table Tissue Diagnostics Market: CPT Code Analysis, US, 2016-2017
  • SMBG Segment Breakdown
    • Opportunities and Challenges-SMBG
    • Revenue Forecast-SMBG
      • Table SMBG Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-SMBG
      • Table Total IVD Market: SMBG Market Share Analysis, US, 2016
    • Product to Watch in 2017
  • Clinical Microbiology Segment Breakdown
    • Opportunities and Challenges-Clinical Microbiology
    • Revenue Forecast-Clinical Microbiology
      • Table Clinical Microbiology Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-Clinical Microbiology
      • Table Total IVD Market: Clinical Microbiology Market Share Analysis, US, 2017
    • Products to Watch in 2017
  • Immunochemistry Segment Breakdown (Includes Revenues for Immunossay, Clinical Chemistry, and Urinalysis)
    • Opportunities and Challenges- Immunochemistry
    • Revenue Forecast-Immunochemistry
      • Table Immunochemistry Market: Revenue Forecast, US, 2011-2021
    • Market Share Analysis-Immunochemistry
      • Table Total IVD Market: Immunochemistry Market Share Analysis, US, 2016
    • Competitor Customer Coverage
  • Last Word
    • Key Conclusions and Future Outlook
  • Appendix (Capital Pricing and Installed Base)
    • Installed Base and Pricing Analysis-Hematology
      • Table Total IVD Market: Hematology-Sales Channel % (OEM Vs Distributors), US, 2016
      • Table Total IVD Market: Hematology-Service Providers (OEM Vs 3rd Party), US, 2016
      • Table Total IVD Market: Hematology-Installed Base and Pricing Analysis, US, 2016
    • Installed Base and Pricing Analysis-Hemostasis
      • Table Total IVD Market: Hemostasis -Installed Base and Pricing Analysis, US, 2016
      • Table Total IVD Market: Hemostasis-Sales Channel % (OEM Vs Distributors), US, 2016
      • Table Total IVD Market: Hemostasis-Service Providers (OEM Vs 3rd Party), US, 2016
    • Pricing Analysis-NGS
      • Table Total IVD Market: NGS-Capital Pricing Analysis, US,2016
      • Table Total IVD Market: NGS-Sales Channel % (OEM Vs Distributors), US, 2016
      • Table Total IVD Market: NGS-Service Providers (OEM Vs 3rd Party), US, 2016
    • Pricing Analysis-Thermal Cyclers
      • Table Total IVD Market: Thermal Cyclers-Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Thermal Cyclers-Sales Channel % (OEM Vs Distributors), US, 2016
      • Table Total IVD Market: Thermal Cyclers-Service Providers (OEM Vs 3rd Party), US, 2016
    • Pricing Analysis-Microarrays
      • Table Total IVD Market: Microarrays-Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Microarrays-Sales Channel % (OEM Vs Distributors), US, 2016
      • Table Total IVD Market: Microarrays-Service Providers (OEM Vs 3rd Party), US, 2016
    • Pricing Analysis-Tissue Diagnostics
      • Table Total IVD Market: Slide Stainers-Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Sales Channel % (OEM Vs Distributors), US, 2016
      • Table Total IVD Market: Service Providers (OEM Vs 3rd Party), US, 2016
      • Table Total IVD Market: Slides and Cassettes-Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Microtome-Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Tissue Diagnostics-Capital Pricing Analysis, US, 2016
    • Installed Base and Pricing Analysis-Immunoassay Systems
      • Table Total IVD Market: Immunoassay Systems-Installed Base and Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Immunoassay Systems-Installed Base and Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Immunoassay Systems-Installed Base & Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Immunoassay Systems-Installed Base & Capital Pricing Analysis, US, 2016
      • Table Total IVD Market: Immunoassay Systems-Installed Base and Capital Pricing Analysis, US, 2016
    • Installed Base and Pricing Analysis-Chemistry Analyzers
      • Table Total IVD Market: Chemistry Analyzers-Installed Base and Capital Pricing Analysis, US, 2016
    • Pricing Analysis-Automated Urine Analyzers
      • Table Total IVD Market: Urine Analyzers-Capital Pricing Analysis, US, 2016
    • Key Abbreviations
    • List of Other Companies Includes

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