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  5. > Impact of US Healthcare Reform on the In Vitro Diagnostics Market

Patient Influx and Increased Testing Will Steer Clinical Labs toward ACO Models

This Market Insight highlights the effects of the US Patient Protection and Affordable Care Act on the in vitro diagnostics (IVD) market, diagnostic test service providers, and IVD manufacturers. The deliverable also focuses on global trends and the outlook for the IVD market. Estimates and trends for all IVD segments—immunochemistry, point-of-care testing, molecular diagnostics, clinical microbiology, tissue diagnostics, hematology, hemostasis, and self-monitoring blood glucose—are provided. Key market drivers and restraints and the competitive landscape for the global market are discussed. The base year is 2013.

Executive Summary
-The US healthcare reform act, commonly called the Affordable Care Act (ACA), has created both challenges and opportunities for clinical laboratories and manufacturers of in vitro diagnostics (IVD). Negative effects include reimbursement reductions and cost containment measures due to decreased operating margins; positive effects include increased prevention and wellness services that will increase test volumes for labs.
-Home care, healthcare information technology (HCIT), pharmaceuticals, and wellness services are expected to benefit as a result of healthcare reform.
-As a result of reimbursement issues and greater awareness, laboratory-based testing is becoming decentralized, which will result in the growth of point-of-care testing (POCT) and molecular diagnostics segments of the IVD industry.
-Next-generation sequencing and digital polymerase chain reaction (dPCR) remain popular molecular diagnostic technologies.
-Clinical microbiology, tissue diagnostics, hemostasis, hematology, and immunochemistry are moving toward automation. These are well-established, mature segments dominated by IVD market leaders. Competition between market participants is stiff.
-With personalized medicine on the horizon, more pharmaceutical and IVD industry partnerships are being observed to develop companion diagnostic products.

Opportunities for IVD Manufacturers and Clinical Labs
The following are macro-level trends for the IVD industry:
-Decentralization: The move to reduce costs and perform diagnosis during single patient visits generate more demand for point-of-care testing (POCT) applications.
-Molecular testing: Technologies and tests based on genetic material and protein composition that facilitate early detection and a personalized approach are on the horizon. As of 2013, the National Institutes of Health (NIH) Genetic Testing Repository had about tests available for conditions for genes.
-Automation: New testing methods are coupled with laboratory information management systems to suit growing demand and staffing shortages.

Table Of Contents

Impact of US Healthcare Reform on the In Vitro Diagnostics Market

1. Executive Summary

Executive Summary

2. Effects of Healthcare Reform

The Patient Protection and Affordable Care Act
Effects on Clinical Labs
Opportunities for IVD Manufacturers and Clinical Labs
Care Delivery Transformation: Acute Care to Prevention
Opportunity Impact Dashboard
Laboratory Test Reimbursement
Factors Affecting Pathology Labs
Most Impacted Specialty
MandAs Declined in 2012 and Remained Flat in 2013
6 Factors Affecting the CLFS
Short-term Projection of CLFS Cuts from the ACA
Projected CLFS Reductions
Affordable Care Act Effects
Accountable Care Organizations
Positioning a Clinical Lab within an ACO Ecosystem
Value of Clinical Analytics to a Clinical Lab
Potential Laboratory Strategies
Demands and Expectations of ACOs

3. IVD Market Overview

Market Segmentation
Market Overview
Key Market Principles
Test Volume by Specialty
Competitive Landscape
Segment Life Cycle Analysis
Decentralization vs. Centralization

4. Technology and Market Trends—Tissue Diagnostics Segment

Tissue Diagnostics Segment Snapshot
Tissue Diagnostics Segment—US Pricing Analysis
Tissue Diagnostics Segment—Global Strategies
Tissue Diagnostics Segment—Three Big Predictions

5. Technology and Market Trends—Molecular Diagnostics Segment

Molecular Diagnostics Segment Snapshot
Molecular Diagnostics Segment—Application Areas
Molecular Diagnostics Segment—Market Size and Growth
Molecular Diagnostics Segment—Next-generation Sequencing Snapshot
Molecular Diagnostics Segment—Evolution of NGS Technologies
Molecular Diagnostics Segment—Applications Based on NGS
Molecular Diagnostics Segment—Key NGS Technology Partnerships and Acquisitions
Molecular Diagnostics Segment—Molecular Technologies in Companion Diagnostics
Molecular Diagnostics Segment—Miniaturization
Molecular Diagnostics Segment—Three Big Predictions

6. Technology and Market Trends—Point-of-care Testing Segment

Point-of-care Testing Segment Snapshot
Point-of-care Testing Segment—Sales Breakdown
Point-of-care Testing Segment—POCT vs. Laboratory Testing
Point-of-care Testing Segment—Key Trends
Point-of-care Testing Segment—Key Trends (continued)
Point-of-care Testing Segment—Metrics Analysis
Point-of-care Testing Segment—Metrics Analysis (continued)
Point-of-care Testing Segment—Potential Opportunities
Point-of-care Testing Segment—Three Big Predictions

7. Technology and Market Trends—Self-monitoring Blood Glucose

Self-monitoring Blood Glucose Segment Snapshot
Self-monitoring Blood Glucose Segment—Test Strips Market Metrics Analysis
Self-monitoring Blood Glucose Segment—Meters Market Metrics Analysis
Self-monitoring Blood Glucose Segment—Product Analysis

8. Technology and Market Trends—Clinical Microbiology Segment

Clinical Microbiology Segment Snapshot
Clinical Microbiology Segment—Microbiology Segmentation
Clinical Microbiology Segment—Emerging Opportunities
Clinical Microbiology Segment—Unmet Demands by Manufacturers
Clinical Microbiology Segment—Technology Trends

9. Technology and Market Trends—Hematology and Hemostasis Segments

Hematology Segment Snapshot
Hemostasis Segment Snapshot
Hematology and Hemostasis Segments—Opportunities for Market Vendors

10. Technology and Market Trends—Immunochemistry Segment

Immunochemistry Segment Snapshot
Immunochemistry Segment—Installed Base

11. Conclusions

Legal Disclaimer

12. The Frost and Sullivan Story

The Frost and Sullivan Story
Value Proposition
Global Perspective
Industry Convergence
360º Research Perspective
Implementation Excellence
Our Blue Ocean Strategy


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