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

The global companion diagnostics market is expected to grow at a CAGR of 22.7% from 2014 to 2019. Factors such as rising need for personalized medicine in cancer treatment, growing adoption of companion diagnostics by the pharmaceutical industry, support from regulatory authorities, and emerging technologies such as next-generation sequencing (NGS) are expected to boost the global companion diagnostics market.
Among technologies, PCR is the most preferred test in the companion diagnostics market, which accounted for a share of 65.5% in 2014. This large share can be attributed to its ease of use, better results, faster turnaround time, and cost-effective solutions. The companion diagnostics market is expected to gain a larger market share in neurology and new oncology applications (leukemia, prostate cancer, and ovarian cancer) due to its efficient detection of biomarkers. Moreover, with the advancement in the bioinformatics field, NGS-based tests have the capability to target multiple genomes simultaneously and are likely to take over the existing technologies in the companion diagnostics market. The need for personalized medicine is increasing and it has gained importance in the research and medical centers, hospitals, and CROs. In the coming years, Asia is expected to be the key growth area in this market.

However, growth of this market is hampered by the non-validated home brew tests that account for a large market share due to its low costs and minimal approval procedures. Moreover, uncertain reimbursement and coverage policies restrict the growth of the global companion diagnostic market, thus limiting the commercialization process.

Reasons to Buy the Report

The report will enrich both established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn will help firms garner a greater market share. Firms purchasing the report can use any one or a combination of the below mentioned five strategies (market penetration, product development/innovation, market development, market diversification, and competitive assessment) for strengthening their market shares.

The report provides insights on the following pointers:
‧ Market Penetration: Comprehensive information on product portfolios of the top players in the companion diagnostics market. The report analyzes the companion diagnostics market by technology, application, end-user, and geography
‧ Product Development/Innovation: Detailed insights on upcoming technologies, research and development activities, and new product launches in the companion diagnostics market
‧ Competitive Assessment: In-depth assessment of the market strategies, geographical and business segments, and product portfolios of the leading players in the companion diagnostics market
‧ Market Development: Comprehensive information about the emerging markets. The report analyzes the market for various companion diagnostics tests/kits across geographies
‧ Market Diversification: Exhaustive information about new products and services, untapped geographies, recent developments, and investments in the companion diagnostics market

Table of Contents

1 INTRODUCTION 14
1.1 OBJECTIVES OF THE STUDY 14
1.2 MARKETS COVERED 14
1.3 STAKEHOLDERS 15
1.4 MARKET SCOPE 15
2 RESEARCH METHODOLOGY 17
2.1 MARKET SIZE ESTIMATION 18
2.2 MARKET CRACKDOWN AND DATA TRIANGULATION 21
2.3 MARKET SHARE ESTIMATION 21
2.3.1 KEY DATA TAKEN FROM SECONDARY SOURCES 21
2.3.2 KEY DATA FROM PRIMARY SOURCES 22
2.3.3 KEY INDUSTRY INSIGHTS 22
2.3.4 ASSUMPTIONS 23
3 EXECUTIVE SUMMARY 24
4 PREMIUM INSIGHTS 27
5 MARKET OVERVIEW 31
5.1 INTRODUCTION 32
5.2 EVOLUTION 32
5.3 MARKET SEGMENTATION 33
5.3.1 COMPANION DIAGNOSTICS MARKET 33
5.4 MARKET DYNAMICS 34
5.4.1 MARKET DRIVERS 35
5.4.1.1 Regulatory bodies encouraging implementation of companion diagnostics 35
5.4.1.2 Rising demand for targeted cancer treatment & tailored drugs ensure robust market growth in companion diagnostic tests 35
5.4.1.3 Growing adoption of companion diagnostics by pharmaceutical companies & reference laboratories to boost the market 36
5.4.2 MARKET RESTRAINTS 37
5.4.2.1 Reimbursement scenarios in different regions hamper the companion diagnostics market growth 37
5.4.2.2 Laboratory developed tests (home brew tests) affect adoption of companion diagnostic tests 37
5.4.3 MARKET OPPORTUNITIES 38
5.4.3.1 Emerging technologies such as next-generation sequencing (NGS) likely to stimulate the companion diagnostics market 38
5.4.3.2 Increasing scope for companion diagnostics in other cancer indications (ovarian, leukemia, prostate) & neurology 39
6 INDUSTRY TRENDS 41
6.1 PORTER’S FIVE FORCES ANALYSIS 41
6.1.1 THREAT FROM NEW ENTRANTS 41
6.1.2 THREAT FROM SUBSTITUTES 42
6.1.3 BARGAINING POWER OF SUPPLIERS 42
6.1.4 BARGAINING POWER OF BUYERS 42
6.1.5 INTENSITY OF COMPETITIVE RIVALRY 42
6.2 STRATEGIC BENCHMARKING 43
6.2.1 TECHNOLOGY INTEGRATION & PRODUCT ENHANCEMENT 43
7 GLOBAL COMPANION DIAGNOSTICS MARKET, BY APPLICATIONS 44
7.1 INTRODUCTION 45
7.2 BREAST CANCER 47
7.3 LUNG CANCER 48
7.4 COLORECTAL CANCER 49
7.5 MELANOMA 50
7.6 GASTRIC CANCER 51
7.7 OTHER INDICATIONS (PROSTATE CANCER, OVARIAN CANCER, LEUKEMIA, NEUROLOGICAL, AND INFECTIOUS DISEASES) 51
8 GLOBAL COMPANION DIAGNOSTICS MARKET, BY TECHNOLOGY 53
8.1 INTRODUCTION 54
8.2 POLYMERASE CHAIN REACTION (PCR) 54
8.3 IN-SITU HYBRIDIZATION (ISH) 55
8.4 IMMUNOHISTOCHEMISTRY (IHC) 56
8.5 OTHER TECHNOLOGIES (NGS,MULTIPLEX ASSAY, & MAB) 58
9 GLOBAL COMPANION DIAGNOSTICS MARKET, BY END USER 59
9.1 INTRODUCTION 60
9.2 PHARMACEUTICAL COMPANIES 61
9.2.1 ACCURATE IDENTIFICATION & RECRUITMENT OF PARTICIPANTS IN CLINICAL TRIALS 61
9.2.2 PHARMACEUTICAL COMPANIES UNDERWENT PARTNERSHIPS & COLLABORATIONS WITH COMPANION DIAGNOSTICS MANUFACTURERS 62
9.2.3 BREAST CANCER & NON-SMALL CELL LUNG CANCER (NSCLC) THE MAJOR FOCUS AREAS FOR PHARMACEUTICAL COMPANIES 62
9.3 REFERENCE LAB 64
9.3.1 IMPORTANCE OF REFERENCE LABORATORIES IN GLOBAL COMPANION DIAGNOSTICS MARKET 64

9.4 OTHER END-USERS (CRO, PHYSICIANS, HOSPITALS & ACADEMIC MEDICAL CENTERS) 66
10 GLOBAL COMPANION DIAGNOSTICS MARKET, BY GEOGRAPHY 68
10.1 INTRODUCTION 69
10.2 NORTH AMERICA 70
10.2.1 KEY PLAYERS FOCUSING ON COMPANION DIAGNOSTICS FOR BREAST AND LUNG CANCER 72
10.2.2 FDA INITIATIVES IN THE U.S. TO ENCOURAGE SIGNIFICANT ADOPTION OF COMPANION DIAGNOSTICS 73
10.2.3 ADOPTION OF PAY-FOR-PERFORMANCE PROGRAM STIMULATES PAYORS TO REIMBURSE FOR COMPANION DIAGNOSTIC TESTS 73
10.2.4 FOCUS ON PERSONALIZED MEDICINE IS A MAJOR DRIVER FOR COMPANION DIAGNOSTICS 73
10.3 EUROPE 78
10.3.1 EMA SUPPORTS THE DEVELOPMENT OF COMPANION DIAGNOSTIC TESTS 80
10.3.2 RISING INCIDENCE OF BREAST CANCER IN EUROPE 81
10.3.3 FRAGMENTED REIMBURSEMENT POLICY IN EUROPE HINDERING IN VITRO DIAGNOSTIC MANUFACTURERS FROM INVESTING IN COMPANION DIAGNOSTIC TESTS 81
10.4 ASIA 86
10.4.1 REGULATORY & REIMBURSEMENT FACTORS AFFECT PENETRATION OF COMPANION DIAGNOSTICS IN ASIA 87
10.5 REST OF THE W0RLD 92
11 COMPETITIVE LANDSCAPE 98
11.1 OVERVIEW 98
11.2 MARKET SHARE ANALYSIS, GLOBAL COMPANION DIAGNOSTICS MARKET 99
11.3 AGREEMENTS, PARTNERSHIPS & COLLABORATIONS 102
11.4 MERGER AND ACQUISITIONS 103
11.5 NEW PRODUCT LAUNCHES 104
11.6 EXPANSION 105
12 COMPANY PROFILES 106
12.1 INTRODUCTION 106
12.2 ABBOTT LABORATORIES, INC. 106
12.3 AGILENT TECHNOLOGIES, INC. 109
12.4 BIOMERIEUX 113
12.5 BIOGENEX LABORATORIES 115
12.6 DANAHER CORPORATION 116
12.7 GE HEALTHCARE 118
12.8 MYRIAD GENETICS, INC. 121
12.9 QIAGEN N.V. 124

12.10 ROCHE DIAGNOSTICS 128
12.11 THERMO FISHER SCIENTIFIC, INC. 133
*Details on Business Overview, Products & Services, Key Strategy, & Recent Developments might not be captured in case of unlisted companies.