The US in-vitro diagnostics market has been estimated at USD 13.57 billion in 2017 and is expected to register a CAGR of 5.57% during the forecast period, 2018 to 2023. Due to increasing incidences of chronic diseases and rapid adoption of point-of-care testing, along with increasing preference for personalized medicine, the in-vitro diagnostics market in the United States is expected to lead the global In-vitro diagnostics market during the forecast period.
Increasing Incidences of Chronic Diseases
According to Centers for Disease Control and Prevention, chronic diseases were the leading cause of death and disability in the United States. It also states that, in 2012, there were more than 117 million people or nearly half of all adults who had one or more chronic health condition. As of 2015, chronic diseases were responsible for 7 out of 10 deaths among Americans each year, and has also accounted for approximately 86% of the nation’s healthcare costs. This trend of prevalence of chronic diseases is likely to continue in the near future. Considering most of the chronic diseases are diagnosed by In-vitro tests, the increasing trend of chronic diseases is expected to drive the US in-vitro diagnostics market during forecast period.
In addition, increasing government healthcare expenditure, along with rapid adoption of point-of-care testing, is also expected to boost the in-vitro diagnostics market in the United States.
Stringent Regulatory Framework
According to FDA (Food and Drug Administration) in the United States, in-vitro diagnostics are considered devices, and more specifically as medical devices category. Since IVDs include products used to collect specimens, or to prepare or examine specimens (e.g., blood, serum, urine, spinal fluid, tissue samples) after they are removed from the human body, maximum precaution is needed to prevent contamination even within the device. The guidelines laid for these devices are to be strictly followed, denial of which may result in product recalls, and thus, many companies are reluctant to enter into this market, which is acting as a major restraint for the US in-vitro diagnostics market.
Additionally, lack of favorable reimbursement policies in the field of in-vitro diagnostics is also hindering the growth of the market in the United States.
Immunoassay to Dominate the Market
The in-vitro diagnostics market is segmented by technique, product type, application type, and end user.
By technology type, immunoassay dominates the in-vitro diagnostics market in the United States, due to high accuracy of these tests, along with less time consumed. The advent of point-of-care testing, which mainly utilizes immunoassay technology is also a major factor responsible for driving the market for in-vitro diagnostics in the United States. Although immunoassay dominates the market, the molecular diagnostics segment is expected to witness the highest CAGR in the overall In-vitro diagnostics market.
Key Developments in the Market
- January 2018: Qiagen and DiaSorin partnered to offer Qiagen’s QuantiFERON-TB Gold Plus on Diasorin’s LIAISON analyzer systems. Qiagen has already reached a milestone of over 40 million QuantiFERON-TB tests since the launch, and is expected to increase this number during the forecast years.
- January 2018: Clearbridge Bio Medics announced that it has successfully registered the ClearCell FX1 system with U.S FDA. It has registered ClearCell FX1 system as a Class I medical device for use in in-vitro diagnostics.
Major Players: Abbott Laboratories, Inc., Johnson & Johnson, Becton, Dickson and Company, Danaher Corporation, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Alere, Inc., Roche Diagnostics Limited, and Siemens Healthcare, among others.
Reasons to Purchase this Report
- Market analysis of the US in-vitro diagnostics market, with region-specific assessments and competition analysis on a global and regional scale
- Analyze various perspectives of the industry with the help of Porter’s five forces analysis
- The treatment type that is expected to dominate the market
- Regions that are expected to witness fastest growth during the forecast period
- Identify the latest developments, market shares, and strategies employed by the major market players
- 3 months analyst support, along with the Market Estimate sheet (in excel)
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1.1 MARKET DEFINITION
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. KEY INFERENCES
5. MARKET OVERVIEW
5.1 CURRENT MARKET SCENARIO
5.2 PORTER'S FIVE FORCES ANALYSIS
5.2.1 BARGAINING POWER OF SUPPLIERS
5.2.2 BARGAINING POWER OF CONSUMERS
5.2.3 THREATS OF NEW ENTRANTS
5.2.4 THREAT OF SUBSTITUTE PRODUCT AND SERVICES
5.2.5 COMPETITIVE RIVALRY WITHIN THE INDUSTRY
6. DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES ANALYSIS (DROC)
6.1 MARKET DRIVERS
6.1.1 INCREASING INCIDENCES OF CHRONIC DISEASES
6.1.2 INCREASING GOVERNMENT HEALHTCARE EXPENDITURE AND CONSUMER'S HEALTHCARE SPENDING
6.1.3 RAPID ADOPTION OF POINT OF CARE TESTING
6.2 MARKET RESTRAINTS
6.2.1 UNFAVORABLE REIMBURSEMENT POLICIES
6.2.2 STRINGENT REGULATORY FRAMEWORK
6.4 KEY CHALLENGES
7. MARKET SEGMENTATION
7.1 SEGMENTATION - BY TECHNIQUE
7.1.1 CLINICAL CHEMISTRY
7.1.5 MOLECULAR DIAGNOSTICS
7.2 SEGMENTATION - BY PRODUCT
7.3 SEGMENTATION - BY APPLICATION
7.4 SEGMENTATION - BY END USER
7.4.2 HOSPITALS & LABORATORIES
7.4.3 PHARMACEUTICAL & BIOTECHNOLOGY
8. COMPETITIVE LANDSCAPE
8.1 MERGERS & ACQUISITION ANALYSIS
8.2 AGREEMENTS, COLLABORATIONS, AND PARTNERSHIPS
8.3 NEW PRODUCTS LAUNCHES
9. KEY PLAYERS
9.1 ABBOTT LABORATORIES, INC.
9.2 JOHNSON & JOHNSON
9.3 BECTON, DICKSON AND COMPANY
9.4 DANAHER CORPORATION
9.5 THERMO FISHER SCIENTIFIC, INC.
9.6 BIO-RAD LABORATORIES, INC.
9.7 ALERE, INC.
9.8 ROCHE DIAGNOSTICS LIMITED
9.9 SIEMENS HEALTHCARE
10. FUTURE OF THE MARKET