HOME Top Market Reports Companion Diagnostics Market byTechnology (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry), Application (Breast, Lung cancer), & by End-user (Pharmaceutical Companies, Reference Lab)] - Global Trends & Forecasts to 2019

Companion Diagnostics Market byTechnology (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry), Application (Breast, Lung cancer), & by End-user (Pharmaceutical Companies, Reference Lab)] - Global Trends & Forecasts to 2019

By: marketsandmarkets.com
Publishing Date: September 2014
Report Code: BT 2698

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The global companion diagnostics market is expected to reach $8,730.7 million by 2019 from $3,136.9 million in 2014, growing at a CAGR of 22.7%. The growth of this market can be attributed to the growing demand of targeted drugs in oncology, neurology, and infectious diseases and the support from regulatory authorities across the globe.

The growth in the companion diagnosticsmarket is attributed to the growing need of personalized cancer treatment and tailored medications, increasing adoption of companion diagnostic tests by end users such as pharmaceutical and biotechnology firms and reference laboratories, and encouragement by regulatory bodies such as FDA and EMA to implement developments of companion diagnostic test at the early stages of drug development procedures. The oncology segment in the pharmaceutical industry and reference laboratories has been the major growth driver for the market. On the other hand, varied reimbursement criteria in different regions, claim coding, technical assessment procedures, and non-validated laboratory development tests (LDTs) are hindering the growth of the market. However, application of companion diagnostic in indications such as neurology, infectious diseases, upcoming next-generation sequencing (NGS)-based companion diagnostics and development in the field of bioinformatics are expected to boost the global market in the coming years.

The major players in the companion diagnostics market are Roche Diagnostics (Switzerland), Abbott Laboratories (U.S.), Agilent Technologies (U.S.), QIAGEN N.V. (Netherlands), Thermo Fisher Scientific Inc. (U.S.), and Myriad Genetics Inc. (U.S.).

Scope of the Report

This research report covers the global market by technology, application, end user, and geography.

Global Companion Diagnostics Market By Technology

  • Polymerase Chain Reaction Test ( PCR)
  • Immunohistochemistry Test (IHC)
  • In Situ Hybridization Test (ISH)
  • Others (Next-generation Sequencing, Multiplex Assay Test, Monoclonal Antibodies Test, and Cellular Immune Testing)

Global Companion Diagnostics Market By Application

  • Breast Cancer
  • Non-small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Melanoma Cancer
  • Gastric Cancer
  • Others (Neurology, Prostate Cancer, Ovarian Cancer, and Infectious Diseases)

Global Companion Diagnostics Market By End User

  • Pharmaceutical Companies
  • Reference Laboratories
  • Others ( Physicians, Hospitals, Academic Medical Centers, and Contract Research Organizations)

Global Companion Diagnostics Market By Geography

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

Table of Contents 
 
1 Introduction (Page No. - 14)
  1.1 Objectives Of The Study
  1.2 Markets Covered
  1.3 Stakeholders
  1.4 Market Scope

2 Research Methodology (Page No. - 17)
  2.1 Market Size Estimation
  2.2 Market Share Estimation
      2.2.1 Key Data Taken From Secondary Sources
      2.2.2 Key Data From Primary Sources
      2.2.3 Key Industry Insights
      2.2.4 Assumptions

3 Executive Summary (Page No. - 23)

4 Premium Insights (Page No. - 25)

5 Market Overview (Page No. - 29)
  5.1 Introduction
  5.2 Evolution
  5.3 Market Segmentation
      5.3.1 Companion Diagnostics Market (Page No. - 31)
  5.4 Market Dynamics
      5.4.1 Market Drivers
            5.4.1.1 Regulatory Bodies Encouraging Implementation Of Companion Diagnostics
            5.4.1.2 Rising Demand For Targeted Cancer Treatment & Tailored Drugs Ensure Robust Market Growth In Companion Diagnostic Tests
            5.4.1.3 Growing Adoption Of Companion Diagnostics By Pharmaceutical Companies & Reference Laboratories To Boost The Market
      5.4.2 Market Restraints
            5.4.2.1 Reimbursement Scenarios In Different Regions Hamper The Companion Diagnostic Market Growth
            5.4.2.2 Laboratory Developed Tests (Home Brew Tests) Affect Adoption Of Companion Diagnostic Tests
      5.4.3 Market Opportunities
            5.4.3.1 Emerging Technologies Such As Next-Generation Sequencing (NGS) Likely To Stimulate The Market
            5.4.3.2 Increasing Scope For Companion Diagnostics In Other Cancer Indications (Ovarian, Leukemia, Prostate) & Neurology

6 Industry Trends (Page No. - 39)
  6.1 Porter’s Five Forces Analysis
      6.1.1 Threat From New Entrants
      6.1.2 Threat From Substitutes
      6.1.3 Bargaining Power Of Suppliers
      6.1.4 Bargaining Power Of Buyers
      6.1.5 Intensity Of Competitive Rivalry
  6.2 Strategic Benchmarking

7 Global Companion Diagnostics Market, By Applications (Page No. - 43)
  7.1 Introduction
  7.2 Breast Cancer
  7.3 Lung Cancer
  7.4 Colorectal Cancer
  7.5 Melanoma
  7.6 Gastric Cancer
  7.7 Other Indications (Prostate, Ovarian, Leukemia, Infectious Disease & Neurology)

8 Global Companion Diagnostics Market, By Technology (Page No. - 56)
  8.1 Introduction
  8.2 Polymerase Chain Reaction (PCR)
  8.3 In Situ Hybridization (ISH)
  8.4 Immunohistochemistry (IHC)
  8.5 Other Technologies (NGS,Multiplex Assay, Cellular Immune Testing, Mab)

9 Global Companion Diagnostics Market, By End User (Page No. - 64)
  9.1 Introduction
  9.2 Pharmaceutical Companies
      9.2.1 Companion Diagnostics Help To Reduce Cost & Aid In Faster Fda Clearance
      9.2.2 Accurate Identification & Recruitment Of Participants In Clinical Trials
      9.2.3 Pharmaceutical Companies Are Undergoing Partnerships & Collaborations With Companion Diagnostics Manufacturers
      9.2.4 Breast Cancer & Non-Small Cell Lung Cancer (NSCLC) Are The Major Focus Areas For Pharmaceutical Companies
      9.2.5 Payors Have Identified The Benefits Of Companion Diagnostics In Near Future
      9.2.6 Regulatory Agencies Encourage Drug Makers To Adopt Companion Diagnostics Test
  9.3 Reference Lab
      9.3.1 Importance Of Reference Laboratries In Global Market
  9.4 Others (Cro, Physicians, Hospitals & Academic Medical Centers)

10 Global Companion Diagnostics Market, By Geography (Page No. - 74)
   10.1 Introduction
   10.2 North America
        10.2.1 Key Players Focusing On Companion Diagnostics For Breast And Lung Cancer
        10.2.2 Fda Initiatives In The U.S. To Encourage Significant Adoption Of Companion Diagnostics
        10.2.3 Adoption Of Pay-For-Performance Program Stimulates Payors To Reimburse For Companion Diagnostic Tests
        10.2.4 Focus On Personalized Medicine Is A Major Driver For Companion Diagnostics
   10.3 Europe
        10.3.1 Ema Supports The Development Of Companion Diagnostic Tests
        10.3.2 Rising Incidence Of Breast Cancer In Europe
        10.3.3 Fragmented Reimbursement Policy In Europe Hindering In Vitro Diagnostic Manufacturers From Investing In Companion Diagnostic Tests
   10.4 Asia
   10.5 Rest Of The W0rld

11 Competitive Landscape (Page No. - 103)
   11.1 Overview
   11.2 Agreements, Partnerships & Collaborations
   11.3 Merger And Acquisitions
   11.4 New Product Launches
   11.5 Expansion

12 Company Profiles (Page No. - 109)
   12.1 Introduction
   12.2 Abbott Laboratories, Inc.
   12.3 Agilent Technologies, Inc.
   12.4 Biomιrieux
   12.5 Biogenex Laboratories
   12.6 Danaher Corporation
   12.7 Ge Healthcare
   12.8 Myriad Genetics, Inc.
   12.9 Qiagen N.V.
   12.10 Roche Diagnostics
   12.11 Thermo Fisher Scientific, Inc.
 
List of Tables  (57 Tables)
   
Table 1 Increasing Need For Targeted Treatment In Oncology Is Propelling The Global arket
Table 2 Reimbursement Issues Hamper Growth Of Market
Table 3 Advanced Technologies Likely To Stimulate Market Growth
Table 1 Global Market, By Applications, 2012–2019 ($Million) 44
Table 2 Breast Cancer Companion Diagnostics  Market, By Geography, 2012–2019 ($Million) 45
Table 3 Lung Cancer Companion Diagnostics  Market, By Geography, 2012–2019 ($Million) 49
Table 4 Colorectal Cancer Companion Diagnostics  Market, By Geography, 2012–2019 ($Million)
Table 5 Melanoma Companion Diagnostics  Market, By Geography, 2012–2019 ($Million) 52
Table 6 Gastric Cancer Companion Diagnostics  Market, By Geography, 2012–2019 ($Million) 53
Table 7 Other Indications Companion Diagnostics Market, By Geography, 2012–2019 ($Million) 54
Table 8 Global Companion Diagnostics Market Size, By Technology, 2012–2019 ($Million) 57
Table 9 Market Size For Polymerase Chain Reaction, By Geography, 2012–2019 ($Million) 58
Table 10 Market Size For In Situ Hybridization, By Geography, 2012–2019 ($Million) 60
Table 11 Market Size For Immunohistochemistry, By Geography, 2012–2019 ($Million) 61
Table 12 Market Size For Other Technologies, By Geography, 2012–2019 ($Million) 63
Table 13 Global Companion Diagnostics Market, By End-Users, 2014–2019 ($Million) 66
Table 14 Pharmaceutical Companies Companion Diagnostics Market, By  Geography, 2014–2019 ($Million) 68
Table 15 Reference Laboratories Companion Diagnostics Market, By  Geography, 2014–2019 ($Million) 71
Table 16 Other End Users Companion Diagnostics Market, By  Geography, 2014–2019 ($Million) 73
Table 17 Companion Diagnostics Market Size, By Geography, 2012–2019 ($Million) 76
Table 18 North America: Companion Diagnostics  Market Size, By Application, 2012–2019 ($Million)
Table 19 North America: Market Size, By End User, 2012–2019 ($Million) 82
Table 20 North America: Market Size For Pharmaceutical Companies, By  Application, 2012–2019 ($Million)
Table 21 North America: Market Size For Reference Laboratories, By Application, 2012–2019 ($Million)
Table 22 North America: Market Size For Other End Users, By Application, 2012–2019 ($Million)
Table 23 North America: Market Size, By Technology, 2012–2019 ($Million)
Table 24 North America: Market Size  For Pharmaceutical Companies, By Technology, 2012–2019 ($Million)
Table 25 North America: Market Size For Reference Laboratories, By Technology, 2012–2019 ($Million)
Table 26 North America: Market Size For Other End Users, By Technology, 2012–2019 ($Million)
Table 27 Europe: Companion Diagnostics Market Size, By Application, 2012–2019 ($Million) 88
Table 28 Europe: Market Size, By End User, 2012–2019 ($Million) 90
Table 29 Europe: Market Size For Pharmaceutical Companies, By  Application, 2012–2019 ($Million)
Table 30 Europe: Market Size For Reference Laboratories, By Application, 2012–2019 ($Million)
Table 31 Europe: Market Size For Other End Users, By Application, 2012–2019 ($Million) 91
Table 32 Europe: Market Size, By Technology, 2012–2019 ($Million) 91
Table 33 Europe: Market Size For Pharmaceutical Companies, By Technology, 2012–2019 ($Million)
Table 34 Europe: Market Size For Reference Laboratories, By Technology, 2012–2019 ($Million)
Table 35 Europe: Market Size  For Other End Users, By Technology, 2012–2019 ($Million) 92
Table 36 Asia: Companion Diagnostics Market Size, By Application, 2012–2019 ($Million) 95
Table 37 Asia: Market Size, By End Users, 2012–2019 ($Million) 95
Table 38 Asia: Market Size For Pharmaceutical Companies, By  Application, 2012–2019 ($Million)
Table 39 Asia: Market Size For Reference Laboratories, By Application, 2012–2019 ($Million)
Table 40 Asia: Market Size For Other End Users, By Application, 2012–2019 ($Million) 96
Table 41 Asia: Market Size, By Technology, 2012–2019 ($Million) 97
Table 42 Asia: Market Size For Pharmaceutical Companies, By Technology, 2012–2019 ($Million)
Table 43 Asia: Market Size For Reference Laboratories, By Technology, 2012–2019 ($Million)
Table 44 Asia: Market Size For Other End Users, By Technology, 2012–2019 ($Million) 98
Table 45 Row: Companion Diagnostics Market Size, By Application, 2012–2019 ($Million) 99
Table 46 Row: Market Size, By End User, 2012–2019 ($Million) 99
Table 47 Row: Market Size For Pharmaceutical Companies, By  Application, 2012–2019 ($Million)
Table 48 Row: Market Size For Reference Laboratories, By Application, 2012–2019 ($Million)
Table 49 Row: Market Size For Other End Users, By Application, 2012–2019 ($Million) 101
Table 50 Row: Market Size, By Technology, 2012–2019 ($Million) 101
Table 51 Row: Market Size For Pharmaceutical Companies, By Technology, 2012–2019 ($Million)
Table 52 Row: Market Size For Reference Laboratories, By Technology, 2012–2019 ($Million)
Table 53 Row: Market Size For Other End Users, By Technology, 2012–2019 ($Million) 102
Table 54 Agreements, Partnerships & Collaborations, 2011–2014
Table 55 Merger And Acquisitions, 2011–2014
Table 56 New Product Launch, 2011–2014
Table 57 Expansion, 2011–2014 
  
List of Figures  (36 Figures)    
 
Figure 1 Research Methodology
Figure 2 Bottom-Up Approach
Figure 3 Top-Down Approach
Figure 4 Break Down Of Primary Interviews: By Company Type, Designation, And Region
Figure 5 Cdx Technology Market Snapshot(2014 Vs 2019) : Ngs Market In Other Technology Is Expected To Grow Aggresively In Next Five Years.
Figure 6 Global Companion Diagnostics Market,By Application,2014
Figure 7 Market Share,2014
Figure 1 Attractive Market Opportunities In Global Market
Figure 2 Breast Cancer Segment Hold The Largest Market Share In Global Companion Diagnostic Market
Figure 3 Asia Is Expected To Commands Larger Share In Global Market
Figure 4 Global Companion Diagnostic Market, By Geography, 2014-2019
Figure 5 Global Companion Diagnostic Market, By Technology(2014-2019)
Figure 6 Asia Is Expected To Enter Exponential Growth Phase Market In Next 5 Years
Figure 7 New Approches Adopted By Leading Players
Figure 8 Technology Advancement Plays An Important Role In The Companion Diagnostic Market.
Figure 9 Market Segmentation :By Technology,Application And End-Users
Figure 10 Companion Diagnostic Gained Increasing Demand In The Oncology Segment
Figure 11 Porter’s Five Forces Analysis
Figure 12 Strategic Benchmarking: Roche And Agilent Technologies, Inc. Largely Adopted Inorganic Growth Strategies For Technology Integration And Product Enhancement
Figure 13 Companion Diagnostics Applications Market Will Be Driven By Lung & Breast Cancer
Figure 14 Breast Cancer
Figure 15 Melanoma
Figure 16 End Users Of Companion Diagnostic Market
Figure 17 The Adoption Of Companion Diagnostic Is Significantly Growing Among  Pharmaceutical Firms And Reference Laboratories
Figure 18 Pharmaceutical Companies  In  North America:Major End User Of Companion Diagnostic
Figure 19 Asia Is Expected To Be The Fastest-Growing Market For Companion Diagnostic
Figure 20 North America Driving The Global Market
Figure 21 Risingprevalence Of Life-Threatening Diseases To Drive Market Growth In North America
Figure 22 Europe Commands One-Third Of The Global Market
Figure 23 Companies Adopted Collaborations/Partnerships/Agreements As The Key Growth Strategy Over The Last Three Years
Figure 24 Battle For Market Share: Partnerships, Collaborations, Agreements Were Preferred Strategies
Figure 25 Geographic Revenue Mix Of Top 5 Market Players - Reference
Figure 26 Abbott Laboratories, Inc.: Business Overview
Figure 27 Agilent Technologies, Inc.: Business Overview
Figure 28 Swot Analysis
Figure 29 Biomeriux : Business Overview
Figure 30 Danaher Corporation : Business Overview
Figure 31 Ge Healthcare : Business Overview
Figure 32 Myriad Genetics : Business Overview
Figure 33 Qiagen N.V. : Business Overview
Figure 34 Swot Analysis
Figure 35 Roche Diagnostics: Business Overview
Figure 36 Thermo Fisher Scientific : Business Overview 

The global companion diagnostics market is expected to reach $8,730.7 million by 2019 from $3,136.9 million in 2014, growing at a CAGR of 22.7% during the forecast period (2014 to 2019).

This market is segmented by technology, application, and end user. Technologies are further subsegmented into immunohistochemistry, in situ hybridization (fluoroscent ISH and chromogenic ISH), polymerase chain reaction (PCR), and next-generation sequencing (NGS)-based tests. The application market is further subsegmented into breast cancer, lung cancer, melanoma cancer, and colorectal cancer. The end users are majorly segmented into pharmaceutical companies and reference laboratories. Among technologies, the polymerase chain reaction (PCR)-based test accounted for the largest share of 65.5% in 2013. The growth of companion diagnostic in the other applications segment (neurological diseases, infectious diseases, ovarian cancer, and leukemia) is expected to grow at a CAGR of 30.3%; whereas, on the basis of end user, reference laboratories is expected to grow at the fastest rate in the market.

The major application driving the global companion diagnostics market is the adoption of companion diagnostic tests in oncology for various indications and for target therapies. Currently, breast, lung colorectal, and melanoma are the major types of cancer for which FDA approved companion diagnostics are available. In addition, encouragement by regulatory bodies and acceptance of tests by end users are the prominent factors for growth of market. Notable restraining factors include varied reimbursement procedures in different regions and usage of non-validated tests for identification of biomarkers. However, advanced technologies such as next-generation sequencing and growth of companion diagnostic in prostate cancer, leukemia, ovarian cancer, Alzheimer’s disease, and Parkinson’s disease are likely to augment the global companion diagnostic market in the future.

In 2013, Roche Diagnostics (Switzerland), Abbott Laboratories (U.S.), Agilent Technologies (U.S.), QIAGEN N.V. (Netherlands), and Thermo Fisher Scientific Inc. (U.S.) together accounted for a share of 86% of the global companion diagnostics market.

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