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(Focus on Product Type, Test Type, Application, and Competitive Landscape)

1 The Research Scope and Methodology

1.1 Scope of the Report
The report constitutes of an in-depth study of the global In-Vitro Diagnostics (IVD)

market, including a thorough analysis of the product across different countries. The
study also presents a detailed analysis of the market dynamics and the estimation for
market size over the forecast period, 2017 to 2023.

The purpose of the study is to gain a holistic view of the global In-Vitro Diagnostics
(IVD) market in terms of various factors influencing it like recent trends, technological
advancements, and regulatory aspects of automation systems. In addition, the study
also comprises of exhaustive information on the product shortcomings, unmet needs,
perception on the new products, preferences, competitive landscape, restraints and
opportunities and the other vital information with respect to IVD products. The scope
of this report is centred upon conducting a detailed study of the solutions allied with
the global IVD market. The market has been segmented into Product, Application,
Test, End Users and Region. Moreover, the global IVD market report deliberates in
detail, the analysis of all the macro & micro factors. It also evaluate the opportunities
in the market for stakeholders and provide details of a competitive landscape for
market leaders. The IVD market report is an exertion to provide the clear picture of
the state of the market and sub markets over the next seven years. The report also
sheds light on a very interesting market figure: Although, new tests and technologies
have come to market in recent years but the very same major companies generate
about 90% of product sales.

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Report coverage of the global IVD market includes key elements considered for the detailed analysis
of the market:
An in-depth analysis of the different product divisions across various countries consists of valuable
insights into the trend followed in the market
Valuation of the top investment areas in IVD space and captivating strategies will aid in channelizing
investments in the precise directions to harvest better outcomes
Geographical fragmentation and forecasts of the entire market; providing valuable insights on the
major countries/regions in which this industry is flourishing and also identifies highly untapped
Segment-level analysis in terms of products, end users, and pricing along with market size forecasts
and estimations to detect key areas of industry growth
Revisiting various micro environment factors that regulate the overall success of an Industry, using
Porters Five Force analysis for estimating the level of competition and formulation of business
A comprehensive list comprising of key market players in conjunction with their product portfolio,
current strategic interests, financial information, legal status, and SWOT analysis

Figure 1 Key Elements Considered

In-Depth Market Dynamics Analysis

Exhaustive Product Segmentation

Comprehensive Competitive Insights

Detailed Market Share Analysis

Extensive Coverage of Market Players

Thorough Analysis of Business Opportunities

BIS Research Analysis

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The global IVD market is further segmented as below:

Figure 2 Global IVD Market Segmentation

Data Management
Product Software/Hardware
Type Services
Whole Blood Glucose
Clinical Chemistry
By Test Molecular Diagnostics
Type Microbiology
Anatomic Pathology

Global IVD Infectious Diseases
Market Oncology/Cancer
Segmentation By Cardiology
Applicati Nephrology
on Type Autoimmune Diseases
Drug Testing
Infectious Diseases

Central Lab
Point-of-care (POC)
By End General Practitioner
User (GP) and Clinics
Home Based
Academic Institutes

North America
Asia Pacific (APAC)
Rest of the World

BIS Research Analysis

1.2 BIS Research Market Research Methodology

The research methodology design adopted for this specific study includes a mix of data collected
from primary and secondary sources. Both primary sources (in-house experts, industry leaders and
market players) and secondary sources (a host of paid and unpaid databases) along with analytical
tools have been used exhaustively to build the forecast and predictive models.

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Figure 3 BIS Research Market Research Methodology



The primary sources from the supply side include industry experts such as CEOs, vice presidents,
Mainly used to obtain key information about the industrys value marketing directors, technology and innovation directors, and related key executives from various
chain, the total pool of key players vendors providing technology solutions, associated service providers, and system integrators
operating in the targeted regions.
E.g. CIOs, VP, Director New Product Development, Director operations
Understand market classification, and segmentation according to
industry trends to the bottom-most level, regional markets, and key A detailed questionnaire is shared with the primary respondent covering all the aspects related to
developments from both market- and technology-oriented the report topic
Appointments are scheduled with CIOs, VP healthcare companies, Director with prior
INTEGRATE INFORMATION appointments and the discussion guide is shared with the primary respondent prior to the call
Integrate information within relevant documents to form launch pad
for primary research 4. CALL EXECUTION

A roundtable discussion is held with the KIP with the aim to gather first hand information about the
CONSULTANT VENDORS technology, recent developments in the technology and future outlook/ growth or decline

The interview is recorded and the information gathered in put on the drawing board with the
information collected through secondary research.

BIS Research Analysis

Primary Data Sources

The key data points taken from Primary Sources includes:

Validation and Triangulation of all the numbers and graphs

Validation of report segmentation and key qualitative findings
Understanding the competitive landscape
Understanding and considering the market dynamics factors for various market segment and
Validation of impact analysis of macro and micro factors in different countries
Percentage split of individual markets for geographical analysis

Secondary Data Sources

The research study involves the usage of extensive secondary sources such as databases, company
websites, and annual reports, among others.

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The following figure exhibits key secondary data sources considered in this report:

Figure 4 Secondary Data Sources


Seeking Alpha Annual Reports
Yahoo Finance Press Releases
Wiki finance SEC Filings
The Wall Street Journal Investor Presentations
Financial Disclosures



The Centre for Disease Control (CDC) PubMed
The World Health Organization (WHO) National Library of Medicine
The National Health Services (NHS) ProQuest
The National Center for Biotechnology Thin Database
Information (NCBI) CMS Datasets
The Food & Drug Administration of United Medicare Beneficiaries Database
States (U.S. FDA) Oxon Epidemiology

BIS Research Analysis

The key data points taken from secondary sources include:

Segmentation breakups, split-ups, and percentage shares
Data for market value
Key industry trends of the top players of the market

Qualitative insights into various aspects of the market, key trends, and emerging areas of
Quantitative data for mathematical and statistical calculations

The following figure exhibits the methodology adopted for estimating the global IVD market:

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Figure 5 Top Down and Bottom Up Approach

Total global IVD market size ($million)

value of
global IVD
Percent split for the product type market
and sub-types of global IVD market

Summation of x & y
Geographical split

Average selling price (ASP) for

each type of product (Y)
Regional and
country-wise market
for each sub-
Products into number of units (X)

Analysis of macro & micro factors

BIS Research Analysis

Note: The above approach has been followed for the market estimation of all the product segments related to IVD market

Having estimated the global market size, the forecast employs a set of macro factors such as the
population, disease prevalence rate, population, healthcare expenditure, disposable income, and
Gross Domestic Product (GDP), among others.

Assumptions and Limitations

The following figure exhibits the standard assumptions and limitations which have been followed
throughout the research study of the global IVD market:

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Figure 6 Assumptions and Limitations


The base currency considered for this study is U.S. $ Technologies currently used are expected to persist
In the Company Profiles section, for the companies through the forecast with no major breakthrough in
having revenues in any other currencies, is converted technology
in to U.S. $ The economic downturn in future was not taken
The currencies other than U.S. $ are converted to U.S. under consideration for market estimation and
$ for all statistical calculations considering the average forecast
conversion rate for the particular year
The currency conversion rate is taken from historical
exchange rate of Oanda website


The ASP is calculated for the year 2015 & 2016 and The base year considered for the calculation of market
the currency considered is U.S. $ size was 2015. Instances where the market size for the
For calculating the ASP of the market products, the FY 2015 were not available from primary or secondary
weighted average of the list price of products has sources, at such instances the values were estimated
been considered based on the Delphi method.
The historical year analysis was done from the FY 2010
to FY 2014 and the market size was estimated for the
FY 2016 and projected from the year 2016 to 2023

BIS Research Analysis

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Executive Summary
1 Research Scope and Methodology
1.1 Scope of the Report
1.2 Global IVD Market Research Methodology
2 Market Overview
2.1 Global IVD Market Overview (Addressable Market Size and Growth Potential), 2015-2023
2.1.1 North America
2.1.2 Europe
2.1.3 Asia Pacific
2.1.4 Latin America
2.1.5 Middle East and Africa
2.2 Historical Trends
2.3 World Economic Outlook of IVD Market, 2016
2.3.1 Global Diagnostics Expenditures
2.3.2 Global Laboratory Expenditure
2.3.3 Pricing Patterns for Diagnostics (IVD)
2.4 Technology Trends
2.4.1 An Era of Point of Care Testing
2.4.2 Exome Sequencing
2.4.3 Importance of Metabolomics profiling
2.4.4 Upsurge in the Adoption of Liquid Biopsy/Cell Free DNA Solutions
2.4.5 Emergence of Multigene Panels
2.5 Legal & Regulatory Environment
2.5.1 FDA Regulation Key Aspect of IVD Regulation
2.5.2 European Commission Regulation Key Changes in EU IVD Regulation
3 Market Dynamics
3.1 Market Drivers
3.1.1 Demand for Rapid, Minimally Invasive and Non-Invasive Diagnostics Tools &
3.1.2 Upsurge in the Number of Patients with Infectious and Chronic Diseases
3.1.3 Increasing Global Healthcare Expenditure
3.1.4 Demand of POC Testing
3.2 Market Challenges
3.2.1 Reimbursement Challenges
3.2.2 Uncertain and Ambiguous Regulatory Environment Restraints IVD market
3.2.3 Ethical Issues
3.3 Market Opportunities
3.3.1 Upsurge in the Demand of Molecular Diagnostics
3.3.2 Epigenomics Based Diagnostics Expected to be an Emerging Segment
4 IVD Market Demand and Supply Analysis

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4.1 Demand and Supply
4.2 Demand Determinant
4.3 End-User Demand and Supply
5 Competitive Insights
5.1 Key Market Developments & Strategies
5.1.1 Patent, Approvals and Certifications
5.1.2 Product Launch and Development
5.1.3 Collaborations, Joint Ventures & Partnerships
5.1.4 Mergers and Acquisitions
5.1.5 Business Expansion and Contracts
5.2 Porters Five Forces Analysis
5.3 Market Attractiveness Analysis of the IVD Market, by Geography
6 Global IVD Market by Product Type, 2016-2023
6.1 Overview
6.2 Instruments
6.2.1 Different Types of IVD Instruments
6.2.2 Clinical Chemistry Analyzers Manual Photometer and Spectrophotometer Glucose Monitoring Systems Dedicated Glycated Hemoglobin/HbA1 Systems Semi/Fully Automated Analyzers Dedicated Multi-Parameter Clinical Chemistry Systems Small Manual and Semi-Automated CC Systems Semi-Automated CC Analyser Medium Automated Clinical Chemistry Analyzer Large Automated CC Analyser Electrolyte- Flame Photometer Electrolyte/ISE Only Biogas Analyzer Urine Analyzer
6.2.3 Immunochemistry Instruments Immunoassay Analyzer Nucleic Acid Processors
6.2.4 Haematology Instruments Hemoglobin Analyser
6.2.5 Coagulation Systems
6.2.6 Microbiology Instruments
6.3 Reagents & Consumables
6.4 Data Management Software/Hardware
6.5 Global IVD Services Market
7 Global IVD Market by Test Type, 2016-2023
7.1 Overview
7.2 Clinical Chemistry
7.3 Immunoassays

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7.4 Whole Blood Glucose Monitoring
7.5 Molecular Diagnostics
7.6 Microbiology
7.7 Anatomic Pathology
7.8 Haematology
7.9 Coagulation
7.10 Critical Care
7.11 Urinalysis
7.12 Others
8 Global IVD Market by Application Type, 2016-2023
8.1 Diabetes
8.2 Infectious diseases
8.3 Oncology/Cancer
8.4 Cardiology
8.5 Nephrology
8.6 Autoimmune Diseases
8.7 Drug Testing/Pharmacogenomics
8.9 Women Health
8.10 Other IVD Application
9 Global IVD Market by End User Type, 2016-2023
9.1 Central Laboratories
9.2 Point-of Care (POC)
9.3 General Practitioner (GP) and Clinics
9.4 Academic Institutions
9.5 Hospitals
9.6 Others
10 Global IVD Market by Geography, 2016-2023
10.1 North America
10.1.1 U.S.
10.1.2 Canada
10.2 Europe
10.2.1 Germany
10.2.2 U.K.
10.2.3 France
10.2.4 Italy
10.2.5 Spain
10.2.6 Sweden
10.2.7 Norway
10.2.8 Switzerland
10.2.9 Austria
10.2.10 Denmark
10.2.11 Belgium

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10.2.12 Portugal
10.2.13 Netherlands
10.2.14 Finland
10.2.15 Turkey
10.2.16 Rest of Europe
10.3 APAC
10.3.1 China
10.3.2 Japan
10.3.3 Australia
10.3.4 India
10.3.5 Singapore
10.3.6 Malaysia
10.3.7 Indonesia
10.3.8 South Korea
10.3.9 Vietnam
10.3.10 Rest of Asia Pacific (RoAPAC)
10.4 Latin America
10.4.1 Brazil
10.4.2 Mexico
10.4.3 Rest of Latin America
10.5 Middle East
10.5.1 Saudi Arabia
10.5.2 Israel
10.5.3 U.A.E.
10.5.4 Qatar
10.5.5 Oman
10.5.6 Bahrain
10.5.7 Kuwait
10.5.8 Rest of Middle East
10.6 Rest of the World
11 End User Perception About IVD
11.1 Key Factors Influencing Decision About IVD Market
11.2 Influence of GPs, labs and KOLs on Decision Making
11.3 Innovation Trends in IVD
11.4 Level of Competition Among Players
11.5 Perception About Pricing
11.6 Technology Preferences
11.7 Brand Perception
11.8 Selection Criteria for IVD
11.9 Information Required to Purchase a New Product
11.10 Preferred Channel for Purchasing
11.11 Reason for Preferences
12 Market Analytics & Recommendations

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12.1 Product Benchmarking
12.1.1 Instruments
12.1.2 Consumables Pregnancy Kits
12.1.3 IVD Reagents
12.2 Competitor Benchmarking
12.2.1 Clinical Chemistry Products
12.2.2 HIV Simple Assays/Rapid Diagnostics Tests (RDTs)
12.2.3 HIV Enzyme Immunoassays (EIAs)
12.2.4 HCV Enzyme Immunoassays (EIA)
12.2.5 CD4 Enumeration Technologies
12.2.6 HIV Quantitative Nucleic Acid Testing Technologies
12.2.7 HIV Qualitative Nucleic Acid Testing Technologies for HIV Diagnosis, Including Early
Infant Diagnosis
12.2.8 Haematology Analyzers
13 Competitive Landscape
13.1 Market Share Analysis
13.2 Growth Share Matrix
13.3 Comprehensive Competitive Index
13.4 Supply Chain
13.5 Value Chain
14 Company Profile
14.1 F. Hoffmann-La Roche AG
14.1.1 Overview
14.1.2 Financials Financial Summary
14.1.3 SWOT Analysis
14.2 Danaher Corporation
14.2.1 Overview
14.2.2 Financials Financial Summary
14.2.3 SWOT Analysis
14.3 Agilent Technologies
14.3.1 Overview
14.3.2 Financials Financial Summary
14.3.3 SWOT Analysis
14.4 Novartis International AG
14.4.1 Overview
14.4.2 Financial Financial Summary
14.4.3 SWOT Analysis
14.5 Illumina, Inc.

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14.5.1 Overview
14.5.2 Financials Financial Summary
14.5.3 SWOT Analysis
14.6 Myriad Genetics, Inc.
14.6.1 Overview
14.6.2 Financials Financial Summary
14.6.3 SWOT Analysis
14.7 GE Healthcare
14.7.1 Overview
14.7.2 Financials Financial Summary
14.7.3 SWOT Analysis
14.8 Qiagen, Inc.
14.8.1 Overview
14.8.2 Financials Financial Summary
14.8.3 SWOT Analysis
14.9 Abbott Laboratories
14.9.1 Overview
14.9.2 Financials Financial Summary
14.9.3 SWOT Analysis
14.10 Becton, Dickinson and Company
14.10.1 Overview
14.10.2 Financials Financial Summary
14.10.2 SWOT Analysis
14.11 GlaxoSmithKline PLC (GSK)
14.11.1 Overview
14.11.2 Financials Financial Summary
14.11.3 SWOT Analysis
14.12 Laboratory Corporation of America Holdings
14.12.1 Overview
14.12.2 Financials Financial Summary
14.12.3 SWOT Analysis
14.13 Thermo Fisher Scientific
14.13.1 Overview
14.13.2 Financials Financial Summary

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14.13.3 SWOT Analysis
14.14 Johnson & Johnson
14.14.1 Overview
14.14.2 Financials Financial Summary
14.14.3 SWOT Analysis
14.15 Siemens Healthineers
14.15.1 Overview
14.15.2 Financials Financial Summary
14.15.3 SWOT Analysis
14.16 Quest Diagnostics Incorporated
14.16.1 Overview
14.16.2 Financials Financial Summary
14.16.3 SWOT Analysis
14.17 Bio-Rad Laboratories, Inc.
14.17.1 Overview
14.17.2 Financials Financial Summary
14.17.3 SWOT Analysis
14.18 Ortho Clinical Diagnostics
14.18.1 Overview
14.18.2 SWOT Analysis

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