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

US IVD Market Witnesses Pricing Fluctuations Due to the PAMA Regulation

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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?

Table of Contents

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
Big Growth Themes for US IVD Industry
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

Infographic



List of Figures & Charts

1. Total IVD Market: Key Market Drivers and Restraints, US, 2017–2021
2. Total IVD Market: Medicare Part B Lab Test Payments, US, 2016
3. Total IVD Market: Proposed Timeline for Execution, US, 2016–2021
4. Total IVD Market: Revised PAMA Payment Rates, US, 2016
5. Total IVD Market: Medicare Growth Opportunities for Suppliers, US, 2016
6. Total IVD Market: Liquid Biopsy Companies, US, 2016
7. Total IVD Market: Revenue Forecast by Segment, US, 2011–2021
8. Total IVD Market: Market Share Revenue, US, 2016
9. Total IVD Market: Market Participant Strategies, US, 2016
10. Total IVD Market: Competitor Matrix, US, 2016
11. Total IVD Market: Segment Share Analysis, US, 2016
12. Total IVD Market: Competitor Segment Ranking Matrix, US, 2016
13. Total IVD Market: M&A Assessment, US, 2014–2016
14. Total IVD Market: Hematology Market Share, US, 2016
15. Hematology Market: New Products to Watch, US, 2017
16. Total IVD Market: Hemostasis Market Share, US, 2016
17. Hemostasis Market: New Products to Watch, US, 2017
18. Total IVD Market: POCT Market Share Analysis, US, 2016
19. POCT Market: New Products to Watch, US, 2017
20. Total IVD Market: Molecular Diagnostics Market Share Analysis, US, 2016
21. Molecular Diagnostics Market: New Products to Watch, US, 2017
22. Total IVD Market: Tissue Diagnostics Market Share Analysis, US, 2016
23. Tissue Diagnostics Market: New Products to Watch, US, 2017
24. Tissue Diagnostics Market: CPT Code Analysis, US, 2016–2017
25. Total IVD Market: SMBG Market Share Analysis, US, 2016
26. SMBG Market: New Products to Watch, US, 2017
27. Total IVD Market: Clinical Microbiology Market Share Analysis, US, 2017
28. Clinical Microbiology Market: New Products to Watch, US, 2017
29. Total IVD Market: Immunochemistry Market Share Analysis, US, 2016
30. Immunochemistry Market: Comparative Analysis of Competitor Customer Coverage, US, 2016
31. Total IVD Market: Key Conclusions and Future Outlook, US, 2016
32. Total IVD Market: Hematology-Installed Base and Pricing Analysis, US, 2016
33. Total IVD Market: Hematology-Installed Base and Pricing Analysis, US, 2016
34. Total IVD Market: Hemostasis-Installed Base and Pricing Analysis, US, 2016
35. Total IVD Market: NGS-Capital Pricing Analysis, US,2016
36. Total IVD Market: Thermal Cyclers-Capital Pricing Analysis, US, 2016
37. Total IVD Market: Microarrays-Capital Pricing Analysis, US, 2016
38. Total IVD Market: Slide Stainers-Capital Pricing Analysis, US, 2016
39. Total IVD Market: Slides and Cassettes-Capital Pricing Analysis, US, 2016
40. Total IVD Market: Microtome-Capital Pricing Analysis, US, 2016
41. Total IVD Market: Tissue Diagnostics-Capital Pricing Analysis, US, 2016
42. Total IVD Market: Immunoassay Systems-Installed Base and Capital Pricing Analysis, US, 2016
43. Total IVD Market: Immunoassay Systems-Installed Base and Capital Pricing Analysis, US, 2016
44. Total IVD Market: Immunoassay Systems-Installed Base & Capital Pricing Analysis, US, 2016
45. Total IVD Market: Immunoassay Systems-Installed Base & Capital Pricing Analysis, US, 2016
46. Total IVD Market: Immunoassay Systems-Installed Base and Capital Pricing Analysis, US, 2016
47. Total IVD Market: Chemistry Analyzers-Installed Base and Capital Pricing Analysis, US, 2016
48. Total IVD Market: Urine Analyzers-Capital Pricing Analysis, US, 2016


1. Total IVD Market: Percent of Lab test and Medicare Payments, US, 2016
2. Total IVD Market: Key Areas of Growth, Global, 2025
3. Total IVD Market: Revenue Forecast, Global, 2016 and 2025
4. Total IVD Market: Revenue Forecast, US, 2011–2021
5. Total IVD Market: Revenue Growth Rate by Segment, US, 2012–2021
6. Total IVD Market: Percent Revenue Forecast by Segment, US, 2016–2021
7. Total IVD Market: Percent Revenue Breakdown, US, 2016
8. Total IVD Market: Market Share Analysis, US, 2016
9. Hematology Market: Revenue Forecast, US, 2011–2021
10. Hematology Market: Percent Revenue Breakdown, US, 2016
11. Hemostasis Market: Revenue Forecast, US, 2011–2021
12. Hemostasis Market: Market Share Analysis, US, 2016
13. POCT Market: Revenue Forecast, US, 2011–2021
14. POCT Market: Percent Revenue Breakdown, US, 2016
15. Molecular Diagnostics Market: Revenue Forecast, US, 2011–2021
16. Molecular Diagnostics Market: Percent Revenue Breakdown, US, 2016
17. Tissue Diagnostics Market: Revenue Forecast, US, 2011–2021
18. Tissue Diagnostics Market: Percent Revenue Breakdown, US, 2016
19. SMBG Market: Revenue Forecast, US, 2011–2021
20. SMBG Market: Percent Revenue Breakdown, US, 2016
21. Clinical Microbiology Market: Revenue Forecast, US, 2011–2021
22. Clinical Microbiology Market: Percent Revenue Breakdown, US, 2016
23. Immunochemistry Market: Revenue Forecast, US, 2011–2021
24. Immunochemistry Market: Percent Revenue Breakdown, US, 2016
25. Total IVD Market: Clinical Chemistry Brand Interest by Hospitals, US, Dec 2015-Dec 2016
26. Total IVD Market: Automated Urine Analyzers Brand Interest, US, Dec 2015-Dec 2016
27. Total IVD Market: Immunoassay Brand Interest by Hospitals, US, Dec 2015-Dec 2016
28. Total IVD Market: Hematology-Sales Channel % (OEM Vs Distributors), US, 2016
29. Total IVD Market: Hematology-Service Providers (OEM Vs 3rd Party), US, 2016
30. Total IVD Market: Hemostasis–Sales Channel % (OEM Vs Distributors), US, 2016
31. Total IVD Market: Hemostasis–Service Providers (OEM Vs 3rd Party), US, 2016
32. Total IVD Market: NGS-Sales Channel % (OEM Vs Distributors), US, 2016
33. Total IVD Market: NGS-Service Providers (OEM Vs 3rd Party), US, 2016
34. Total IVD Market: Thermal Cyclers-Sales Channel % (OEM Vs Distributors), US, 2016
35. Total IVD Market: Thermal Cyclers-Service Providers (OEM Vs 3rd Party), US, 2016
36. Total IVD Market: Microarrays-Sales Channel % (OEM Vs Distributors), US, 2016
37. Total IVD Market: Microarrays-Service Providers (OEM Vs 3rd Party), US, 2016
38. Total IVD Market: Sales Channel % (OEM Vs Distributors), US, 2016
39. Total IVD Market: Service Providers (OEM Vs 3rd Party), US, 2016



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