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Published Date: 2013-07-31Number of Pages: 124

In Vitro Diagnostics Market (Clinical Chemistry, Immunoassay, Diabetes Testing, Blood Testing, Molecular Diagnostics) - Global Industry Analysis, Size, Share, Growth and Forecast, 2012 - 2018

In vitro diagnostics testing is a key tool in modern medicine and these tests are employed by using a number of medical devices in order to diagnose various diseases. Owing to the advancement in biotechnology, a number of cutting-edge tests can be conducted for the diagnosis of numerous diseases, thus helping physicians carry out treatment and diagnosis of diseases effectively and promptly. 

This report presents a detailed evaluation of the market for in vitro diagnostics and elaborates on key components such as applications, classification, definition, and the chain structure of the industry. An analysis has also been included on the key development trends, prime players, and market expansion in key regions. To understand the market thoroughly, the tables within the report have been segregated in terms of revenue generated, product, application, and region.

The report predicts the state of the market for the six-year period from 2012 to 2018. An evaluation has also been provided on the basis of both revenue and volume. Market dynamics such as market drivers, inhibitors, opportunities, trends, and challenges prominent in the market have also been discussed in the report, along with stating their impact analysis. The key players dominant in the market, coupled with their key product introductions, are also an integral part of this study.

Overview of the In Vitro Diagnostics Market

In vitro diagnostics are the tools and medical processes, including apparatus, instruments, kits, equipment, systems, and reagents, utilized on their own or in combination with other diagnostic tools in order to acquire critical information on the health of a patient. In vitro diagnostics present valuable data on the pathological and physiological state of the human body and hence help in taking well-informed medical decisions.

As per the report, the increasing count of patients having chronic and infectious diseases and the rising healthcare expenditure globally are amongst the chief factors stimulating the growth of the market. In addition, the rising demand for minimally invasive or non-invasive diagnostic techniques and tools is also a key factor augmenting the market. On the other hand, the unpredictability in the regulatory environment and the increasing reimbursement challenges globally are amongst the prime factors that may impede the growth of the market for in vitro diagnostics in the coming years.

In terms of product, the in vitro diagnostics market is segmented into clinical chemistry, diabetes testing, blood testing, immunoassay, molecular testing, and others including microbiological diagnostic techniques and flow cytometry. Amongst these, the segment of clinical chemistry led the market in 2011, particularly in India, China, and the U.S. However, the segment of molecular diagnostics is predicted to expand exponentially in the forecast horizon due to its ability of disease detection at an early development stage.

On the basis of geography, the market is segmented into Europe, North America, Asia Pacific, and Rest of the World (RoW). Amongst these, North America and Europe led the in vitro diagnostics market in 2011. This is due to the highly structured network of clinical laboratories and the increasing healthcare expenditure in these regions. However, the rising budgetary pressure in Europe may impede the growth of the market in this region.

Key Players in the In Vitro Diagnostics Market

The prominent players dominant in the market are Abbott Laboratories Inc., Bayer AG, Biomerieux SA, Danaher Corporation, Johnson and Johnson, F. Hoffmann-La Roche Ltd., and Thermo Fisher Scientific Corporation, among others.

Major geographies analyzed under this research report are:

  • North America
  • Europe
  • Asia Pacific
  • Rest of the World

This report gives you access to decisive data such as:

  • Market growth drivers
  • Factors limiting market growth
  • Current market trends
  • Market structure
  • Market projections for the coming years

Key highlights of this report:

  • Overview of key market forces propelling and restraining market growth
  • Up-to-date analyses of market trends and technological improvements
  • Pin-point analyses of market competition dynamics to offer you a competitive edge
  • An analysis of strategies of major competitors
  • An array of graphics and SWOT analysis of major industry segments
  • Detailed analyses of industry trends
  • A well-defined technological growth map with an impact-analysis
  • Offers a clear understanding of the competitive landscape and key product segments

 

Chapter 1 Preface

1.1 Report Description

1.2 Research Methodology

1.3 Market Segmentation

 

Chapter 2 Executive Summary

 

Chapter 3 Market Overview

3.1 Market Trend and Future Outlook

       3.1.1 Global In Vitro Diagnostics Market, 2010 – 2018 (USD Million)

3.2 Market Dynamics

       3.2.1 Market drivers

                3.2.1.1 Rising Number of Patients with Infectious and Chronic Diseases

                3.2.1.2 Increasing Global Healthcare Expenditure

                3.2.1.3 Demand for Rapid and Minimally- or Non-Invasive Diagnostic Tools & Techniques

                3.2.1.4 Impact Analysis of the Market Drivers

       3.2.2 Market Restraints

                3.2.2.1 Reimbursement Challenges Retards the Growth of Market

                3.2.2.2 Uncertain and Ambiguous Regulatory environment restrains In Vitro Diagnostics market

                3.2.2.3 Impact Analysis of the Market Restraints

       3.2.3 Market Opportunities

                3.2.3.1 Molecular Diagnostics: Key to Future

                3.2.3.2 Epigenomics-Based Diagnostics expected to be an Emerging segment in In-Vitro Diagnostic Market

       3.2.4 Porter’s Five Forces Analysis for In Vitro Diagnostic Market

                3.2.4.1 Bargaining Power of Suppliers

                3.2.4.2 Bargaining Power of Buyers

                3.2.4.3 Threat of new entrants

                3.2.4.4 Threat of substitutes

       3.2.5 Competitive rivalry

3.3 Market Attractiveness Analysis of the Global In-Vitro Diagnostics Market, by Geography

 

Chapter 4 Global In Vitro Diagnostics Market, by Products (Qualitative information)

4.1 Overview

4.2 Clinical Chemistry

4.3 Immunoassay

4.4 Diabetes Testing

4.5 Blood Testing

4.6 Molecular Diagnosis

4.7 Others

 

Chapter 5 Global In Vitro Diagnostics Market, by Geography

5.1 Overview

5.2 North America

       5.2.1 North America In Vitro Diagnostics Market, 2010-2018 (USD Million)

5.3 Europe

       5.3.1 Europe In Vitro Diagnostics Market, 2010-2018 (USD Million)

5.4 Asia Pacific

       5.4.1 Asia Pacific In Vitro Diagnostics Market, 2010-2018 (USD Million)

5.5 Rest of the World

       5.5.1 ROW In Vitro Diagnostics Market, 2010-2018 USD Million)

 

Chapter 6 U.S. In Vitro Diagnostics Market, by Products

6.1 Overview

6.2 Clinical Chemistry IVD Market, 2010 – 2018 (USD Million)

6.3 Immunoassay IVD Market, 2010 – 2018 (USD Million)

6.4 Diabetes Testing IVD Market, 2010 – 2018 (USD Million)

6.5 Blood Testing IVD Market, 2010 – 2018 (USD Million)

6.6 Molecular Diagnosis IVD Market, 2010 – 2018 (USD Million)

6.7 Others IVD Market, 2010 – 2018 (USD Million)

 

Chapter 7 China In Vitro Diagnostics Market, by Products

7.1 Overview

7.2 Clinical Chemistry IVD Market, 2010 – 2018 (USD Million)

7.3 Immunoassay IVD Market, 2010 – 2018 (USD Million)

7.4 Diabetes Testing IVD Market, 2010 – 2018 (USD Million)

7.5 Blood Testing IVD Market, 2010 – 2018 (USD Million)

7.6 Molecular Diagnosis IVD Market, 2010 – 2018 (USD Million)

7.7 Others IVD Market, 2010 – 2018 (USD Million)

 

Chapter 8 India In Vitro Diagnostics Market, by Products

8.1 Overview

8.2 Clinical Chemistry IVD Market, 2010 – 2018 (USD Million)

8.3 Immunoassay IVD Market, 2010 – 2018 (USD Million)

8.4 Diabetes Testing IVD Market, 2010 – 2018 (USD Million)

8.5 Blood Testing IVD Market, 2010 – 2018 (USD Million)

8.6 Molecular Diagnosis IVD Market, 2010 – 2018 (USD Million)

8.7 Others IVD Market, 2010 – 2018 (USD Million)

 

Chapter 9 Competitive Landscape

9.1 Global In Vitro Diagnostics Market Share, by Key Players, 2011 (%)

 

Chapter 10 Company Profiles

10.1 Abbott Laboratories Inc.

       10.1.1 Company Overview

       10.1.2 Financial overview

       10.1.3 Business Strategies

       10.1.4 Product Portfolio

       10.1.5 Recent Developments

10.2 Alere, Inc.

       10.2.1 Company Overview

       10.2.2 Financial Overview

       10.2.3 Business Strategies

       10.2.4 Product Portfolio

       10.2.5 Recent Developments

10.3 Bayer AG

       10.3.1 Company Overview

       10.3.2 Financial Overview

       10.3.3 Business Strategies

       10.3.4 Product Portfolio

       10.3.5 Recent Developments

10.4 Becton, Dickinson and Company

       10.4.1 Company Overview

       10.4.2 Financial Overview

       10.4.3 Business Strategies

       10.4.4 Product Portfolio

       10.4.5 Recent Developments

10.5 Biomerieux SA

       10.5.1 Company Overview

       10.5.2 Financial Overview

       10.5.3 Business Strategies

       10.5.4 Product Portfolio

       10.5.5 Recent Developments

10.6 Beckman Coulter, Inc.

       10.6.1 Company Overview

       10.6.2 Financial overview

       10.6.3 Business Strategies

       10.6.4 Product portfolio

       10.6.5 Recent developments

10.7 Gen-Probe Incorporated

       10.7.1 Company Overview

       10.7.2 Financial Overview

       10.7.3 Business Strategies

       10.7.4 Product Portfolio

       10.7.5 Recent Developments

10.8 Johnson and Johnson

       10.8.1 Company Overview

       10.8.2 Financial Overview

       10.8.3 Business Strategies

       10.8.4 Product Portfolio

       10.8.5 Recent Developments

10.9 Life Technologies Corporation

       10.9.1 Company Overview

       10.9.2 Financial Overview

       10.9.3 Business Strategies

       10.9.4 Product Portfolio

       10.9.5 Recent Developments

10.10 F. Hoffmann-La Roche Ltd

       10.10.1 Company Overview

       10.10.2 Financial Overview

       10.10.3 Business strategies

       10.10.4 Product portfolio

       10.10.5 Recent developments

10.11 Siemens Healthcare

       10.11.1 Company Overview

       10.11.2 Financial Overview

       10.11.3 Business Strategies

       10.11.4 Product Portfolio

       10.11.5 Recent Developments

10.12 Thermo Fisher Scientific, Inc.

       10.12.1 Company Overview

       10.12.2 Financial overview

       10.12.3 Business strategies

       10.12.4 Product portfolio

       10.12.5 Recent developments

List of Figures 

 

FIG. 1 Market Segmentation for the In Vitro Diagnostics Market

FIG. 2 Global In Vitro Diagnostics Market, U.S., 2011 (USD Million)

FIG. 3 Global In Vitro Diagnostics Market, China., 2011 (USD Million)

FIG. 4 Global In Vitro Diagnostics Market, India, 2011 (USD Million)

FIG. 5 Global In Vitro Diagnostics Market, 2010 – 2018 (USD Million)

FIG. 6 Total Healthcare Expenditure, Per Capita ( in USD)

FIG. 7 Porter’s Five Forces Analysis for In Vitro Diagnostic Market

FIG. 8 Market Attractiveness Analysis of the Microscopy Devices Market, by geography

FIG. 9 Comparative Analysis of the Global IVD Market, by Geography, 2011 & 2018 (%)

FIG. 10 N. America In Vitro Diagnostics Market , 2010 – 2018 (USD Million)

FIG. 11 Europe In Vitro Diagnostics Market, 2010 – 2018 (USD Million)

FIG. 12 Asia Pacific In Vitro Diagnostics Market, 2010 – 2018 (USD Million)

FIG. 13 RoW In Vitro Diagnostics Market, U.S., 2010 – 2018 (USD Million)

FIG. 14 Comparative Analysis of the U.S. In Vitro Diagnostics Market, by Products, 2011 & 2018 (%)

FIG. 15 Clinical Chemistry IVD Market, U.S., 2010 – 2018 (USD Million)

FIG. 16 Immunoassay IVD Market, U.S., 2010 – 2018 (USD Million)

FIG. 17 Diabetes IVD Market, U.S., Market, 2010 – 2018 (USD Million)

FIG. 18 Blood Testing IVD Market, U.S., 2010 – 2018 (USD Million)

FIG. 19 Molecular Diagnosis IVD Market, U.S., 2010 – 2018 (USD Million)

FIG. 20 Other IVD Market, U.S., 2010 – 2018 (USD Million)

FIG. 21 Comparative Analysis of the China In Vitro Diagnostics Market, by Products, 2011 & 2018 (%)

FIG. 22 Clinical Chemistry IVD Market, China, 2010 – 2018 (USD Million)

FIG. 23 Immunoassay IVD Market, China, 2010 – 2018 (USD Million)

FIG. 24 Diabetes IVD Market, China, Market, 2010 – 2018 (USD Million)

FIG. 25 Blood Testing IVD Market, China, 2010 – 2018 (USD Million)

FIG. 26 Molecular Diagnosis IVD Market, China, 2010 – 2018 (USD Million)

FIG. 27 Other IVD Market, China, 2010 – 2018 (USD Million)

FIG. 28 Comparative Analysis of the Indian In Vitro Diagnostics Market, by Products, 2011 & 2018 (%)

FIG. 29 Clinical Chemistry IVD Market, India, 2010 – 2018 (USD Million)

FIG. 30 Immunoassay IVD Market, India, 2010 – 2018 (USD Million)

FIG. 31 Diabetes testing IVD Market, India, Market, 2010 – 2018 (USD Million)

FIG. 32 Blood Testing IVD Market, India, 2010 – 2018 (USD Million)

FIG. 33 Molecular Diagnosis IVD Market, India, 2010 – 2018 (USD Million)

FIG. 34 Other IVD Market, India, 2010 – 2018 (USD Million)

FIG. 35 Global In Vitro Diagnostics Market Share, by Key Players, 2011 (%)

FIG. 36 Annual Revenue of Abbott Laboratories Inc., Diagnostics Division, 2010 – 2012 (USD million)

FIG. 37 Annual Revenue of Alere Inc., 2009– 2011 (USD million)

FIG. 38 Annual Sales of Bayer Healthcare, a division of Bayer AG, 2010–2012 (USD million)

FIG. 39 Annual revenue of BD Company,  2010 – 2012 (USD million)

FIG. 40 Annual revenue of BioMerieux SA, 2010 – 2012 (USD million)

FIG. 41 Annual revenue of Beckman Coulter, Inc., 2009 – 2010 (USD million)

FIG. 42 Annual revenue of Gen-Probe, Inc., 2010 – 2012 (USD Million)

FIG. 43 Annual revenue of Johnson and Johnson, Medical Devices an d Diagnostics Segment , 2010 – 2012 (USD Million)

FIG. 44 Annual revenue of Life Technologies Corporation, 2010 – 2012 (USD Million)

FIG. 45 Annual revenue of Roche Diagnostics, division of Roche Holdings, 2010 – 2012 (USD Million)

FIG. 46 Annual Revenue of Siemens Healthcare, 2009–2011 (USD million)

FIG. 47 (Conversion rate: 1 Euro = 1.33 USD)

FIG. 48 Annual revenue of Thermo Fisher Scientific, Inc., 2010 – 2012 (USD million)

List of Tables

 

TABLE 1 Market Snapshot: Global In Vitro Diagnostics Market

TABLE 2 Impact Analysis of the Market Drivers for In-Vitro Diagnostics Market

TABLE 3 Impact Analysis of the Market Restraints for Stem Cells Market

TABLE 4 Global IVD Market, by Geography, 2010 – 2018 (USD Million) 

TABLE 5 U.S. IVD Market, by Products, 2010 – 2018 (USD Million) 

TABLE 6 China IVD Market, by Products, 2010 – 2018 (USD Million) 

TABLE 7 Indian IVD Market, by Products, 2010 – 2018 (USD Million) 

In vitro diagnostic products are medical devices in the form of a reagent, kit, instrument, equipment, apparatus or system and are used either alone or in combination with other diagnostic tools for gaining critical information for health and drug/therapy monitoring. The market landscape for in vitro diagnostics is changing rapidly due to surging demand for IVDs from regions such as Asia-Pacific and Latin America. In 2011, majority share of the in vitro diagnostics market was held by North America and Europe owing to the high healthcare expenditure and structured network of clinical laboratories. However, this scenario is changing gradually since major market players in the in vitro diagnostics market are focusing on emerging economies to accelerate growth via capitalization of unmet opportunities available in these regions.


Clinical chemistry IVDs held majority of the market share in 2011, across the U.S, India and China market. However, the molecular diagnostics segment is expected to have a robust growth during the forecast period owing to their ability to detect the disease at an early stage of development. Moreover, dramatic rise in the number of diabetes patients globally is driving the diabetes testing IVDs such as blood glucose meters and glucose testing strips.


Europe followed North America in terms of market share in 2011. This market is majorly driven by the presence of strong healthcare support from public as well as private healthcare spending. Some of the other major factors which drive the in vitro diagnostics market in Europe are:

  • Rising number of infectious diseases such as pneumonia, tuberculosis, malaria, and sexually transmitted diseases, etc.
  • Aging population and the related rise in the chronic diseases such as cardiovascular diseases (CVDs), diabetes mellitus, cancer, etc.
  • Demand for advanced and automated diagnostics technologies
  • Increasing demand for the rapid diagnostics and point-of-care testing

Significant differences in the reimbursement coverage throughout the region and the presence of ambiguous regulatory environment restraints the growth of this market. Although the healthcare system in Europe is better than many parts in the world, the increasing budgetary pressure is curbing the healthcare expenditure in this region.

This is resulting into slower growth rate of in vitro diagnostics market in Europe in comparison to that of the Asia-Pacific region.

The emergence of molecular diagnostics and the epigenomics-based diagnostics are expected to drive in vitro diagnostics market in Europe. In addition, a trend of diagnostic companies collaborating with pharmaceutical companies to launch companion diagnostics will open a premium segment of in vitro diagnostics market in the near future. 


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