Abstract
Summary
The global companion diagnostics market is projected to reach USD 13.6 billion by 2029 from USD 7.5 billion in 2024, at a CAGR of 12.6% during the forecast period. Factors such as the increasing importance of companion diagnostics in drug development, rising cancer incidence, and the growing adoption of targeted therapies are driving market growth.
“The assays, reagents & kits segment expected to achieve the highest growth rate in the companion diagnostics market, by product & service, during the forecast period”
The companion diagnostics market is categorized into assays, kits & reagents, instruments/systems and software & services based on product & service. In 2023, the assays, kits & reagents segment held the largest share of the market. This can be attributed to factors such as the wide range of available products, the rising utilization of assays and kits across various therapeutic fields, and the increasing demand for these products in both basic research and commercial applications.
“Pharmaceutical & biotechnology companies segment projected to account for the highest CAGR during the forecast period”
Based on end user, the companion diagnostics market is segmented into pharmaceutical & biotechnology companies, reference laboratories, CROs, and other end users.
In 2023, pharmaceutical & biotechnology companies stood out as the primary users of companion diagnostics within the market. This notable position is primarily attributed to the increasing adoption of companion diagnostics in drug development and the growing significance of companion diagnostic biomarkers. Furthermore, the rising interest in personalized medicine, along with the pressing need for targeted therapies across various diseases and disorders, is forecasted to boost the demand and integration of companion diagnostics among pharmaceutical & biotechnology companies.
“Asia Pacific: The fastest-growing region in companion diagnostics care market”
The global companion diagnostics market is divided into North America, Europe, Asia Pacific, Latin America, Middle East & Africa and the GCC Countries. The Asia Pacific region is expected to record the highest CAGR during the forecast period. This growth is attributed to factors such as increased healthcare expenditure, rising pharmaceutical research funding, government initiatives to raise awareness about early disease detection, expansion of private-sector hospitals into rural areas in various APAC countries, and the presence of high-growth markets in the region.
The primary interviews conducted for this report can be categorized as follows:
• By Company Type: Tier 1 - 20%, Tier 2 - 45%, and Tier 3 -35%
• By Designation: C-level - 30%, D-level - 20%, and Others - 50%
• By Region: North America - 42%, Europe - 31%, Asia Pacific - 20%, and Rest of the World -7%
Lists of Companies Profiled in the Report:
• F. Hoffmann-La Roche Ltd (Switzerland)
• Agilent Technologies, Inc. (US)
• QIAGEN (Netherlands)
• Thermo Fisher Scientific Inc. (US)
• Abbott (US)
• Almac Group (UK)
• Danaher (US
• Illumina, Inc. (US)
• bioMérieux (France)
• Myriad Genetics, Inc. (US)
• Sysmex Corporation (Japan)
• ARUP Laboratories (UK)
• Abnova Corporation (Taiwan)
• Guardant Health (US)
• ICON Plc (Ireland)
• BioGenex (US)
• Invivoscribe, Inc. (US)
• ArcherDX, Inc. (Integrated DNA Technologies, Inc.) (US)
• NG Biotech (France)
• Q² Solutions (US)
• Amoy Diagnostics Co., Ltd. (China)
• Uniogen (Abacus Diagnostica) (Finland)
• Asuragen, Inc. (Bio-Techne) (US)
• NG Biotech (France)
• Meso Scale Diagnostics, LLC. (US)
• Creative Biolabs (US)
Research Coverage:
This research report categorizes the companion diagnostics market by products, type, application and region. The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the companion diagnostics market. A detailed analysis of the key industry players has been done to provide insights into their business overview, solutions, key strategies; contracts, partnerships, agreements, new product launches, mergers and acquisitions, and recent developments associated with the companion diagnostics market. Competitive analysis of upcoming startups in the companion diagnostics market ecosystem is covered in this report.
Key Benefits of Buying the Report:
The report will help market leaders/new entrants by providing them with the closest approximations of the revenue numbers for the overall companion diagnostics market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to better position their business and make suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide them with information on the key market drivers, restraints, challenges, and opportunities.
The report provides insights on the following pointers:
• Analysis of key drivers, restraints, opportunities, and challenges influencing the growth of the companion diagnostics market.
• Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the companion diagnostics market.
• Market Development: Comprehensive information about lucrative markets – the report analyses the companion diagnostics market across varied regions.
• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the companion diagnostics market.
• Competitive Assessment: In-depth assessment of market ranking, growth strategies and product offerings of leading players like F. Hoffmann-La Roche Ltd (Switzerland), Agilent Technologies, Inc. (US), QIAGEN (Netherlands), Thermo Fisher Scientific Inc. (US) and Abbott (US).
Table of Contents
1 INTRODUCTION 46
1.1 STUDY OBJECTIVES 46
1.2 MARKET DEFINITION 46
1.2.1 INCLUSIONS & EXCLUSIONS 47
1.3 MARKET SEGMENTATION 48
1.3.1 MARKETS COVERED 48
1.3.2 REGIONS COVERED 49
1.3.3 YEARS CONSIDERED 49
1.4 CURRENCY CONSIDERED 50
1.5 RESEARCH LIMITATIONS 50
1.6 MARKET STAKEHOLDERS 50
1.7 SUMMARY OF CHANGES 51
1.7.1 RECESSION IMPACT 51
2 RESEARCH METHODOLOGY 52
2.1 RESEARCH DATA 52
2.2 RESEARCH APPROACH 52
2.2.1 SECONDARY DATA 53
- 2.2.1.1 Key data from secondary sources 54
2.2.2 PRIMARY DATA 55
- 2.2.2.1 Primary sources 55
- 2.2.2.2 Key data from primary sources 56
- 2.2.2.3 Key industry insights 57
- 2.2.2.4 Breakdown of primary interviews 57
2.3 MARKET SIZE ESTIMATION 58
2.3.1 BOTTOM-UP APPROACH 59
- 2.3.1.1 Approach 1: Company revenue estimation approach 59
- 2.3.1.2 Approach 2: Presentations of companies and primary interviews 59
- 2.3.1.3 Growth forecast 60
- 2.3.1.4 CAGR projections 60
2.3.2 TOP-DOWN APPROACH 60
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION 62
2.5 STUDY ASSUMPTIONS 63
2.6 GROWTH RATE ASSUMPTIONS 63
2.7 LIMITATIONS 63
2.8 RISK ASSESSMENT 64
2.8.1 RISK ASSESSMENT ANALYSIS 64
2.9 RECESSION IMPACT ANALYSIS 64
3 EXECUTIVE SUMMARY 66
4 PREMIUM INSIGHTS 71
4.1 COMPANION DIAGNOSTICS MARKET OVERVIEW 71
4.2 COMPANION DIAGNOSTICS MARKET SHARE, BY PRODUCT & SERVICE, 2024 VS. 2029 71
4.3 COMPANION DIAGNOSTICS MARKET SHARE, BY TECHNOLOGY, 2024 VS. 2029 72
4.4 COMPANION DIAGNOSTICS MARKET SHARE, BY INDICATION, 2024 VS. 2029 72
4.5 COMPANION DIAGNOSTICS MARKET SHARE, BY SAMPLE TYPE, 2024 VS. 2029 73
4.6 COMPANION DIAGNOSTICS MARKET SHARE, BY END USER, 2024 VS. 2029 73
4.7 COMPANION DIAGNOSTICS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES 74
5 MARKET OVERVIEW 75
5.1 INTRODUCTION 75
5.2 MARKET DYNAMICS 75
5.2.1 DRIVERS 76
- 5.2.1.1 Ability of CDx tests to reduce healthcare costs and increase efficiency 76
- 5.2.1.2 Growing focus on targeted therapy 76
- 5.2.1.3 Rising demand for personalized medicine 77
- 5.2.1.4 Increasing incidence of cancer and subsequent adoption of CDx-based oncology medicine 78
- 5.2.1.5 Growing application areas for companion diagnostics 79
5.2.2 RESTRAINTS 79
- 5.2.2.1 Significant capital investment and low cost-benefit ratio 79
- 5.2.2.2 High cost of companion diagnostic tests 80
- 5.2.2.3 Unfavorable reimbursements 80
- 5.2.2.4 High cost of immunotherapy treatment 81
5.2.3 OPPORTUNITIES 82
- 5.2.3.1 Increasing demand for next-generation sequencing 82
- 5.2.3.2 Growing significance of companion diagnostics in drug development 83
- 5.2.3.3 Advancements in genomics research and rising clinical trials 83
5.2.4 CHALLENGES 84
- 5.2.4.1 Shortage of healthcare professionals 84
- 5.2.4.2 Limited awareness in emerging markets 84
5.3 PRICING ANALYSIS 85
5.4 PATENT ANALYSIS 86
5.5 TRADE ANALYSIS 87
5.5.1 TRADE ANALYSIS FOR DIAGNOSTIC & LABORATORY REAGENTS 87
5.6 VALUE CHAIN ANALYSIS 87
5.7 SUPPLY CHAIN ANALYSIS 89
5.8 ECOSYSTEM ANALYSIS 90
5.9 PORTER’S FIVE FORCES ANALYSIS 91
5.9.1 THREAT OF NEW ENTRANTS 91
5.9.2 THREAT OF SUBSTITUTES 91
5.9.3 BARGAINING POWER OF BUYERS 91
5.9.4 BARGAINING POWER OF SUPPLIERS 92
5.9.5 INTENSITY OF COMPETITIVE RIVALRY 92
5.10 REGULATORY LANDSCAPE 92
5.10.1 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 92
5.10.2 NORTH AMERICA 94
- 5.10.2.1 US 94
- 5.10.2.2 Canada 94
5.10.3 EUROPE 94
5.10.4 ASIA PACIFIC 95
- 5.10.4.1 China 95
- 5.10.4.2 Japan 95
- 5.10.4.3 India 96
5.10.5 LATIN AMERICA 96
- 5.10.5.1 Brazil 96
- 5.10.5.2 Mexico 97
5.10.6 MIDDLE EAST 97
5.10.7 AFRICA 97
5.11 TECHNOLOGY ANALYSIS 97
5.11.1 KEY TECHNOLOGIES 98
- 5.11.1.1 Polymerase chain reaction (PCR) 98
- 5.11.1.2 Next-generation sequencing (NGS) 98
5.11.2 COMPLIMENTARY TECHNOLOGIES 98
- 5.11.2.1 In situ hybridization (ISH) 98
5.11.3 ADJACENT TECHNOLOGIES 98
- 5.11.3.1 Immunohistochemistry (IHC) 98
5.12 KEY CONFERENCES & EVENTS IN 2024-2025 99
5.13 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 100
5.13.1 REVENUE POCKETS FOR COMPANION DIAGNOSTICS MARKET 100
5.14 KEY STAKEHOLDERS & BUYING CRITERIA 101
5.14.1 KEY STAKEHOLDERS IN BUYING PROCESS 101
5.14.2 BUYING CRITERIA 102
5.15 INVESTMENT AND FUNDING SCENARIO 103
6 COMPANION DIAGNOSTICS MARKET, BY PRODUCT & SERVICE 104
6.1 INTRODUCTION 105
6.2 ASSAYS, KITS, AND REAGENTS 105
6.2.1 INCREASING VOLUME OF CDX TESTS IN LABORATORIES TO SUPPORT ADOPTION OF ASSAYS & KITS 105
6.3 INSTRUMENTS & SYSTEMS 109
6.3.1 LATEST ADVANCEMENTS IN NGS TECHNOLOGIES TO ENSURE MARKET GROWTH 109
6.4 SOFTWARE & SERVICES 112
6.4.1 NEED TO DELIVER ACCURATE AND TIMELY ANALYSIS OF DIAGNOSTICS TESTS TO SUPPORT MARKET GROWTH 112
7 COMPANION DIAGNOSTICS MARKET, BY TECHNOLOGY 116
7.1 INTRODUCTION 117
7.2 POLYMERASE CHAIN REACTION 117
7.2.1 GROWING APPLICATIONS IN PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS TO DRIVE GROWTH 117
7.3 IN SITU HYBRIDIZATION 121
7.3.1 INCREASING DEMAND IN SMALL TUMOR DIAGNOSTICS TO DRIVE GROWTH 121
7.4 NEXT-GENERATION SEQUENCING 124
7.4.1 ADVANTAGES SUCH AS ACCURACY, SENSITIVITY, AND SPEED TO SUPPORT MARKET GROWTH 124
7.5 IMMUNOHISTOCHEMISTRY 128
7.5.1 INCREASING DEMAND FOR USER-FRIENDLY AND COST-EFFECTIVE TECHNOLOGIES TO SUPPORT GROWTH 128
7.6 OTHER TECHNOLOGIES 131
8 COMPANION DIAGNOSTICS MARKET, BY INDICATION 135
8.1 INTRODUCTION 136
8.2 CANCER 136
8.2.1 LUNG CANCER 139
- 8.2.1.1 Growing demand for effective therapeutic drugs to increase CDx adoption 139
8.2.2 BREAST CANCER 143
- 8.2.2.1 Wide prevalence of breast cancer to boost market growth 143
8.2.3 BLOOD CANCER 146
- 8.2.3.1 Growing incidence of blood cancer to drive market 146
8.2.4 COLORECTAL CANCER 149
- 8.2.4.1 Rising need for molecular profiling of primary tumors to drive segment growth 149
8.2.5 OTHER CANCERS 152
8.3 NEUROLOGICAL DISEASES 154
8.3.1 GROWING NUMBER OF ADVANCED TECHNOLOGIES TO BOOST ADOPTION OF COMPANION DIAGNOSTICS 154
8.4 CARDIOVASCULAR DISEASES 157
8.4.1 INCREASING DEMAND FOR TARGETED THERAPIES TO DRIVE SEGMENT GROWTH 157
8.5 INFECTIOUS DISEASES 160
8.5.1 INCREASING AWARENESS OF TARGETED THERAPIES TO PROPEL GROWTH 160
8.6 OTHER INDICATIONS 163
9 COMPANION DIAGNOSTICS MARKET, BY SAMPLE TYPE 166
9.1 INTRODUCTION 167
9.2 TISSUE SAMPLES 167
9.2.1 COMPREHENSIVE PROFILING AND HIGH SENSITIVITY TO DRIVE MARKET 167
9.3 BLOOD SAMPLES 170
9.3.1 LESS INVASIVE METHOD-KEY FACTOR DRIVING ADOPTION 170
9.4 OTHER SAMPLE TYPES 173
10 COMPANION DIAGNOSTICS MARKET, BY END USER 177
10.1 INTRODUCTION 178
10.2 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES 178
10.2.1 RISING DEMAND FOR PERSONALIZED MEDICINE TO DRIVE MARKET 178
10.3 REFERENCE LABORATORIES 181
10.3.1 RISING DEMAND FOR TARGETED THERAPIES TO DRIVE GROWTH 181
10.4 CONTRACT RESEARCH ORGANIZATIONS 184
10.4.1 RISING DEMAND FOR COMPANION DIAGNOSTIC PRODUCTS FOR USE IN THERAPY-RELATED CLINICAL TRIALS TO PROPEL GROWTH 184
10.5 OTHER END USERS 187
11 COMPANION DIAGNOSTICS MARKET, BY REGION 191
11.1 INTRODUCTION 192
11.2 NORTH AMERICA 192
11.2.1 NORTH AMERICA: RECESSION IMPACT 197
11.2.2 US 198
- 11.2.2.1 Increasing use of companion diagnostics for cancer treatment to boost market growth 198
11.2.3 CANADA 201
- 11.2.3.1 Increasing government initiatives to drive market 201
11.3 EUROPE 205
11.3.1 EUROPE: RECESSION IMPACT 209
11.3.2 GERMANY 210
- 11.3.2.1 Increasing healthcare expenditure to drive market 210
11.3.3 UK 213
- 11.3.3.1 Growing life science industry and increasing focus on research to propel market 213
11.3.4 SWITZERLAND 217
- 11.3.4.1 Strong research-oriented pharma industry to support market growth 217
11.3.5 FRANCE 220
- 11.3.5.1 Increasing government funding for research to support market growth 220
11.3.6 ITALY 224
- 11.3.6.1 Growing geriatric population in region to drive market 224
11.3.7 SPAIN 227
- 11.3.7.1 Increasing focus on advancement of personalized medicine to drive market growth 227
11.3.8 REST OF EUROPE 231
11.4 ASIA PACIFIC 235
11.4.1 ASIA PACIFIC: RECESSION IMPACT 240
11.4.2 CHINA 240
- 11.4.2.1 Advancements in healthcare facilities to drive market 240
11.4.3 JAPAN 244
- 11.4.3.1 Increasing research initiatives to support market growth 244
11.4.4 INDIA 247
- 11.4.4.1 Increased demand for early cancer diagnosis to fuel market growth 247
11.4.5 AUSTRALIA 251
- 11.4.5.1 Initiatives to enhance healthcare access and infrastructure for aging population to drive market 251
11.4.6 REST OF ASIA PACIFIC 255
11.5 LATIN AMERICA 258
11.5.1 LATIN AMERICA: RECESSION IMPACT 262
11.5.2 BRAZIL 262
- 11.5.2.1 Increasing incidence of lifestyle diseases to favor market growth 262
11.5.3 MEXICO 265
- 11.5.3.1 Growing medical tourism to fuel demand for companion diagnostics 265
11.5.4 REST OF LATIN AMERICA 269
11.6 MIDDLE EAST & AFRICA 272
11.6.1 INCREASING FOCUS ON PRECISION MEDICINE TO DRIVE MARKET GROWTH 272
11.6.2 MIDDLE EAST & AFRICA: RECESSION IMPACT 275
11.7 GCC COUNTRIES 276
11.7.1 GROWING HEALTHCARE INFRASTRUCTURE TO FUEL MARKET GROWTH 276
11.7.2 GCC COUNTRIES: RECESSION IMPACT 279
12 COMPETITIVE LANDSCAPE 280
12.1 INTRODUCTION 280
12.2 RIGHT-TO-WIN APPROACHES ADOPTED BY KEY PLAYERS 280
12.3 REVENUE SHARE ANALYSIS 282
12.4 MARKET SHARE ANALYSIS 282
12.5 COMPANY EVALUATION MATRIX: KEY PLAYERS 284
12.5.1 STARS 284
12.5.2 EMERGING LEADERS 284
12.5.3 PERVASIVE PLAYERS 284
12.5.4 PARTICIPANTS 285
12.5.5 COMPANY FOOTPRINT 286
- 12.5.5.1 Overall footprint 286
- 12.5.5.2 Product footprint 286
- 12.5.5.3 Technology footprint 287
- 12.5.5.4 Indication footprint 287
- 12.5.5.5 Regional footprint 288
12.6 COMPETITIVE EVALUATION MATRIX: START-UPS/SMES 288
12.6.1 PROGRESSIVE COMPANIES 288
12.6.2 RESPONSIVE COMPANIES 288
12.6.3 DYNAMIC COMPANIES 288
12.6.4 STARTING BLOCKS 289
12.6.5 COMPETITIVE BENCHMARKING 290
12.7 VALUATION AND FINANCIAL METRICS OF COMPANION DIAGNOSTICS VENDORS 291
12.8 BRAND/PRODUCT COMPARATIVE ANALYSIS 292
12.8.1 F. HOFFMANN-LA ROCHE LTD 292
12.8.2 AGILENT TECHNOLOGIES, INC 292
12.8.3 QIAGEN 292
12.8.4 THERMO FISHER SCIENTIFIC INC 293
12.8.5 ABBOTT 293
12.9 COMPETITIVE SCENARIO 293
12.9.1 PRODUCT LAUNCHES & APPROVALS 293
12.9.2 DEALS 294
13 COMPANY PROFILES 295
13.1 KEY PLAYERS 295
13.1.1 F. HOFFMANN-LA ROCHE LTD 295
13.1.2 AGILENT TECHNOLOGIES, INC 302
13.1.3 QIAGEN 307
13.1.4 THERMO FISHER SCIENTIFIC INC 312
13.1.5 ABBOTT 318
13.1.6 DANAHER 322
13.1.7 GUARDANT HEALTH 325
13.1.8 ILLUMINA, INC 329
13.1.9 BIOMÉRIEUX 333
13.1.10 ICON PLC 335
13.1.11 MYRIAD GENETICS, INC 337
13.1.12 SYSMEX CORPORATION 340
13.2 OTHER PLAYERS 343
13.2.1 ALMAC GROUP 343
13.2.2 ARUP LABORATORIES 344
13.2.3 ABNOVA CORPORATION 345
13.2.4 BIOGENEX 346
13.2.5 INVIVOSCRIBE, INC 347
13.2.6 ARCHERDX, INC 348
13.2.7 Q² SOLUTIONS 349
13.2.8 AMOY DIAGNOSTICS CO., LTD 350
13.2.9 UNIOGEN 351
13.2.10 ASURAGEN, INC 352
13.2.11 MESO SCALE DIAGNOSTICS, LLC 353
13.2.12 CREATIVE BIOLABS 354
13.2.13 NG BIOTECH 355
14 APPENDIX 356
14.1 DISCUSSION GUIDE 356
14.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 361
14.3 CUSTOMIZATION OPTIONS 363
14.4 RELATED REPORTS 363
14.5 AUTHOR DETAILS 364