Summary

The MRD testing market will rise in value from estimated USD 1.43 Billion in 2024 to USD 2.55 Billion in 2029, at a CAGR of 12.2% over the forecast period. Increased funding and grants for cancer control programs across the globe have emerged as an important growth factor in the MRD testing market. Substantial funding is now being committed by governments and international bodies, including WHO and the Global Fund, to address the increasing burden of cancer, especially in terms of early detection and prevention. These funds are being channelled into increasing access to diagnostic facilities, especially in high-burden regions where the healthcare infrastructure is generally weak. The availability of funds also encourages the training of healthcare professionals who work with a patient to accurately diagnose and properly manage cases of cancer. Apart from that, research grants and international collaborations are also enabling cancer testing integration into routine health care services. Thus, this growing funding is rendering MRD tests available and enhancing the efforts to control cancer globally. This, in turn, is fuelling the growth of the global minimal residual disease testing market.
“MRD Assay Kits & Reagents segment is expected to have the fastest growth rate in the MRD testing market, by product, during the forecast period.”
The MRD testing market is segmented into assay kits & reagents, and instruments based on product. Assay kits & reagents are projected to account for the highest CAGR during the forecast period. One major driving factor is its higher accuracy of tests. Growing penetration of these tests in high-risk populations, continue to support increased demand. Favourable regulatory approvals and recommendations by various international health bodies, including the WHO, have also helped increase their adoption. Along with such factors, rising funding for research in cancer and advancements in diagnostics are also driving the high growth of the test kits segment in the MRD testing market.
“Haematological malignancies segment accounted for the highest growth rate in the MRD testing market, by application, during the forecast period.”
Based on application, the minimal residual disease testing market is segmented into hematological malignancies, solid tumors, and other applications. In 2021, the hematological malignancies application segment accounted for the largest share. Factors contributing to the growth of this segment are increasing incidences of leukemia, lymphoma and their types and awareness about continuous monitoring of patients with these diseases.
“Asia Pacific: The fastest-growing region in MRD testing market.”
The worldwide market for MRD testing is categorized into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Notably, the Asia Pacific region is anticipated to experience the most substantial growth in the forecast period. The Asia Pacific region bears a high burden of tuberculosis, such as in India and China, which record a high incidence rate and thereby drives the need for essential cancer screening and management. Growth in government and international organization funding and campaigns against cancer has also led to better access to diagnostics and healthcare infrastructure in Asia Pacific. Awareness among the communities and among healthcare workers regarding the need for early detection of cancer has also been significantly increasing the demand for further testing. Another major growth driver of this segment in the MRD testing market is the increasing healthcare expenditure, along with supportive regulatory frameworks. All these factors propel increased growth of the MRD testing market in the Asia Pacific region.
The break-up of the profile of primary participants in the MRD testing market:
• By Company Type: Tier 1 - 55%, Tier 2 - 25%, and Tier 3 – 20%
• By Designation: Managers - 30%, D-level - 50%, and Others - 20%
• By Region: North America - 51%, Europe - 21%, Asia Pacific - 18%, Latin America – 6%, and Others - 4%
The key players in this market are are F. Hoffmann-La Roche Ltd. (Switzerland), Labcorp Inc. (US), Guardant Health (US), Sysmex Corporation (Japan), NeoGenomics Laboratories, Inc. (US), Adaptive Biotechnologies Corporation (US), ArcherDX, Inc. (US), Asuragen Inc. (US), Arup Laboratories Inc. (US), Bio-Rad Laboratories, Inc. (US), Cergentis B.V. (Netherlands), Molecular MD (ICON plc) (Ireland), Invivoscribe, Inc. (US), Mission Bio, Inc. (US), Natera, Inc. (US), Opko Health, Inc. (US), Quest Diagnostics (US), and Genetron Health (China).
Research Coverage:
This research report categorizes the MRD testing market by product (assay kits & reagents, instruments), by technology (PCR, NGS, flow cytometry, and other applications), by application (hematological malignancies, solid tumors, multiple myeloma, and other applications), by end user (diagnostic laboratories, hospitals & clinics, academic & research institutes, and other end users), and region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa and GCC Countries). The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, opportunities, and challenges influencing the growth of the MRD testing market. A detailed analysis of the key industry players has been done to provide insights into their business overview, solutions, key strategies, acquisitions, and agreements. New product & service launches, and recent developments associated with the MRD testing market. Competitive analysis of upcoming startups in the MRD testing market ecosystem is covered in this report.
Reasons to buy this report:
The report will help the market leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall MRD testing market and the subsegments. This report will help stakeholders understand the competitive landscape and gain more insights to position their businesses better and plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the market and provides them with information on key market drivers, restraints, opportunities, and challenges.
The report provides insights on the following pointers:
• Analysis of key drivers (rising incidence of cancer, and increased funding and grants for cancer control programs), opportunities (Growth opportunities in emerging economies), restraints (Unfavorable reimbursement scenario), and challenges (changing regulatory landscape and operational barriers and labor shortage) influencing the growth of the MRD testing market.
• Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the MRD testing market.
• Market Development: Comprehensive information about lucrative markets – the report analyses the MRD testing market across varied regions.
• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the MRD testing market.
• Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings of leading players like F. Hoffmann-La Roche Ltd. (Switzerland), Labcorp Inc. (US), Guardant Health (US), Sysmex Corporation (Japan), NeoGenomics Laboratories, Inc. (US), Adaptive Biotechnologies Corporation (US).

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Table of Contents

1 INTRODUCTION 26
1.1 STUDY OBJECTIVES 26
1.2 MARKET DEFINITION 26
1.3 STUDY SCOPE 27
1.3.1 MARKETS COVERED & REGIONAL SCOPE 27
1.3.2 INCLUSIONS & EXCLUSIONS 28
1.3.3 YEARS CONSIDERED 28
1.4 CURRENCY CONSIDERED 29
1.5 LIMITATIONS 29
1.6 STAKEHOLDERS 29
1.7 SUMMARY OF CHANGES 30
2 RESEARCH METHODOLOGY 31
2.1 RESEARCH DATA 31
2.2 RESEARCH APPROACH 31
2.2.1 SECONDARY DATA 32
2.2.1.1 Key data from secondary sources 32
2.2.2 PRIMARY DATA 33
2.2.2.1 Primary sources 34
2.2.2.2 Key data from primary sources 34
2.2.2.3 Key industry insights 35
2.2.2.4 Breakdown of primary interviews 35
2.3 MARKET SIZE ESTIMATION 36
2.3.1 BOTTOM-UP APPROACH 37
2.3.1.1 Approach 1: Company revenue estimation 37
2.3.1.2 Approach 2: Presentations of companies and primary interviews 37
2.3.1.3 Growth forecast 38
2.3.1.4 CAGR projections 38
2.3.2 TOP-DOWN APPROACH 38
2.4 MARKET BREAKDOWN & DATA TRIANGULATION 40
2.5 MARKET SHARE ESTIMATION 40
2.6 STUDY ASSUMPTIONS 41
2.7 GROWTH RATE ASSUMPTIONS 41
2.8 RESEARCH LIMITATIONS 42
2.9 RISK ASSESSMENT 42
2.9.1 RISK ASSESSMENT: MINIMAL RESIDUAL DISEASE TESTING MARKET 42
3 EXECUTIVE SUMMARY 43
4 PREMIUM INSIGHTS 47
4.1 MINIMAL RESIDUAL DISEASE TESTING MARKET OVERVIEW 47
4.2 MINIMAL RESIDUAL DISEASE TESTING MARKET SHARE, BY PRODUCT, 2024 VS. 2029 48
4.3 MINIMAL RESIDUAL DISEASE TESTING MARKET SHARE, BY TECHNOLOGY,
2024 VS. 2029 48
4.4 MINIMAL RESIDUAL DISEASE TESTING MARKET SHARE, BY APPLICATION,
2024 VS. 2029 49
4.5 MINIMAL RESIDUAL DISEASE TESTING MARKET SHARE, BY END USER, 2024 VS. 2029 49
4.6 MINIMAL RESIDUAL DISEASE TESTING MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES 50
5 MARKET OVERVIEW 51
5.1 INTRODUCTION 51
5.2 MARKET DYNAMICS 51
5.2.1 DRIVERS 52
5.2.1.1 Rising incidence of hematological malignancies 52
5.2.1.2 Increasing collaborations and partnerships between pharmaceutical companies and product manufacturers 52
5.2.1.3 Increasing cancer awareness initiatives by global health organizations 53
5.2.2 RESTRAINTS 54
5.2.2.1 Complex regulatory frameworks delaying approvals of new molecular diagnostics tests 54
5.2.2.2 High cost of minimal residual disease testing kits 54
5.2.3 OPPORTUNITIES 54
5.2.3.1 Growth opportunities in emerging countries 54
5.2.4 CHALLENGES 55
5.2.4.1 Unclear reimbursement scenario and policies for patients 55
5.3 PRICING ANALYSIS 56
5.3.1 INDICATIVE PRICING TREND OF KEY PLAYERS, BY PRODUCT & REGION 56
5.4 PATENT ANALYSIS 58
5.4.1 LIST OF MAJOR PATENTS 59
5.5 VALUE CHAIN ANALYSIS 60
5.6 SUPPLY CHAIN ANALYSIS 61
5.7 TRADE ANALYSIS 62
5.7.1 IMPORT DATA 62
5.7.2 EXPORT DATA 63
5.8 ECOSYSTEM ANALYSIS 63
5.8.1 ROLE IN ECOSYSTEM 64
5.9 PORTER’S FIVE FORCES ANALYSIS 64
5.9.1 THREAT OF NEW ENTRANTS 65
5.9.2 THREAT OF SUBSTITUTES 65
5.9.3 BARGAINING POWER OF BUYERS 66
5.9.4 BARGAINING POWER OF SUPPLIERS 66
5.9.5 INTENSITY OF COMPETITIVE RIVALRY 66
5.10 KEY STAKEHOLDERS & BUYING CRITERIA 67
5.10.1 KEY STAKEHOLDERS IN BUYING PROCESS 67
5.10.2 BUYING CRITERIA 68
5.11 REGULATORY ANALYSIS 69
5.11.1 REGULATORY LANDSCAPE 69
5.11.1.1 North America 69
5.11.1.1.1 US 69
5.11.1.1.2 Canada 69
5.11.1.2 Europe 69
5.11.1.3 Asia Pacific 70
5.11.1.3.1 China 70
5.11.1.3.2 Japan 71
5.11.1.4 Latin America 72
5.11.1.4.1 Brazil 72
5.11.1.4.2 Mexico 72
5.11.1.5 Middle East 73
5.11.1.6 Africa 73
5.11.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 73
5.12 TECHNOLOGY ANALYSIS 75
5.12.1 KEY TECHNOLOGIES 75
5.12.1.1 PCR and NGS 75
5.12.2 ADJACENT TECHNOLOGIES 76
5.12.2.1 Digital PCR 76
5.13 KEY CONFERENCES & EVENTS IN 2023–2024 76
5.14 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 78
5.15 INVESTMENT & FUNDING SCENARIO 79
5.16 CASE STUDY ANALYSIS 79
5.17 IMPACT OF AI/GEN AI ON MINIMAL RESIDUAL DISEASE TESTING MARKET 80
6 MINIMAL RESIDUAL DISEASE TESTING MARKET, BY PRODUCT 82
6.1 INTRODUCTION 83
6.2 ASSAY KITS & REAGENTS 83
6.2.1 INCREASING AWARENESS ABOUT EARLY DISEASE DETECTION AND PREVENTIVE HEALTHCARE TO PROPEL MARKET 83
6.3 INSTRUMENTS 85
6.3.1 RISING NEED FOR FASTER AND MORE ACCURATE TEST RESULTS TO DRIVE MARKET GROWTH 85

7 MINIMAL RESIDUAL DISEASE TESTING MARKET, BY TECHNOLOGY 86
7.1 INTRODUCTION 87
7.2 POLYMERASE CHAIN REACTION 87
7.2.1 COST BENEFITS OF PCR TECHNOLOGY TO DRIVE ADOPTION 87
7.3 NEXT-GENERATION SEQUENCING 88
7.3.1 HIGH SENSITIVITY AND ECONOMIC BENEFITS TO SUPPORT ADOPTION 88
7.4 FLOW CYTOMETRY 89
7.4.1 GROWING INCIDENCE AND PREVALENCE OF CANCER TO PROPEL MARKET GROWTH 89
7.5 OTHER TECHNOLOGIES 90
8 MINIMAL RESIDUAL DISEASE TESTING MARKET, BY APPLICATION 92
8.1 INTRODUCTION 93
8.2 HEMATOLOGICAL MALIGNANCIES 93
8.2.1 LEUKEMIA 95
8.2.1.1 Myeloid leukemia 98
8.2.1.1.1 High prevalence of AML in adults to support growth 98
8.2.1.2 Lymphocytic leukemia 100
8.2.1.2.1 High incidence of ALL in children to drive market 100
8.2.1.3 Other leukemias 103
8.2.2 LYMPHOMA 105
8.2.2.1 Non-Hodgkin lymphoma 108
8.2.2.1.1 Growing consumption of medications that suppress immune system to drive growth 108
8.2.2.2 Hodgkin lymphoma 110
8.2.2.2.1 Growing incidence of Hodgkin lymphoma to propel demand for MRD testing 110
8.3 SOLID TUMORS 112
8.3.1 ABILITY OF MRD TO ASSESS TREATMENT RESPONSE TO FUEL GROWTH 112
8.4 MULTIPLE MYELOMA 114
8.4.1 RISING INCIDENCE OF MULTIPLE MYELOMAS TO DRIVE MARKET 114
8.5 OTHER APPLICATIONS 116
9 MINIMAL RESIDUAL DISEASE TESTING MARKET, BY END USER 119
9.1 INTRODUCTION 120
9.2 HOSPITALS & SPECIALTY CLINICS 120
9.2.1 INCREASING NUMBER OF PATIENTS VISITING HOSPITALS TO DRIVE GROWTH 120
9.3 DIAGNOSTIC LABORATORIES 121
9.3.1 ROBUST INFRASTRUCTURE AND SPECIALIZED TESTING CAPABILITIES TO SUPPORT GROWTH 121
9.4 ACADEMIC & RESEARCH INSTITUTES 122
9.4.1 INCREASING RESEARCH ACTIVITIES TO BOOST MARKET 122
9.5 OTHER END USERS 123
10 MINIMAL RESIDUAL DISEASE TESTING MARKET, BY REGION 124
10.1 INTRODUCTION 125
10.2 NORTH AMERICA 125
10.2.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA 129
10.2.2 US 129
10.2.2.1 Increasing prevalence of cancer to drive market 129
10.2.3 CANADA 132
10.2.3.1 Availability of various cancer screening programs to support market growth 132
10.3 EUROPE 136
10.3.1 MACROECONOMIC OUTLOOK FOR EUROPE 136
10.3.2 GERMANY 140
10.3.2.1 Government support for research funding to support MRD testing market 140
10.3.3 UK 143
10.3.3.1 Increasing number of diagnostic laboratories to propel market growth 143
10.3.4 FRANCE 146
10.3.4.1 Rising R&D expenditure in France to drive market 146
10.3.5 ITALY 149
10.3.5.1 Favorable funding scenario to drive market 149
10.3.6 SPAIN 152
10.3.6.1 Consolidation of laboratories in Spain to support market growth 152
10.3.7 REST OF EUROPE 155
10.4 ASIA PACIFIC 158
10.4.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC 158
10.4.2 CHINA 163
10.4.2.1 Growing public access to advanced healthcare facilities to drive market 163
10.4.3 JAPAN 166
10.4.3.1 Universal healthcare reimbursement policy to support market growth 166
10.4.4 INDIA 169
10.4.4.1 Increasing private and public investments in healthcare system to drive market 169
10.4.5 REST OF ASIA PACIFIC 172
10.5 LATIN AMERICA 176
10.5.1 INCREASING PRIVATE AND PUBLIC INVESTMENTS TO DRIVE MARKET 176
10.5.2 MACROECONOMIC OUTLOOK FOR LATIN AMERICA 176
10.6 MIDDLE EAST & AFRICA 179
10.6.1 INCREASING FUNDING IN RESEARCH TO DRIVE MARKET 179
10.6.2 MACROECONOMIC OUTLOOK FOR MIDDLE EAST & AFRICA 180

10.7 GCC COUNTRIES 183
10.7.1 RISING FOCUS ON ADVANCED HEALTH INFRASTRUCTURE AND FUNDING IN RESEARCH TO DRIVE GCC MARKET 183
10.7.2 MACROECONOMIC OUTLOOK FOR GCC COUNTRIES 183
11 COMPETITIVE LANDSCAPE 187
11.1 OVERVIEW 187
11.2 KEY PLAYER STRATEGY/RIGHT TO WIN 187
11.2.1 OVERVIEW OF STRATEGIES DEPLOYED BY PLAYERS IN MINIMAL RESIDUAL DISEASE TESTING MARKET 187
11.3 REVENUE ANALYSIS, 2019–2023 190
11.4 MARKET SHARE ANALYSIS, 2023 191
11.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2023 193
11.5.1 LIST OF EVALUATED VENDORS 193
11.5.2 STARS 193
11.5.3 EMERGING LEADERS 193
11.5.4 PERVASIVE PLAYERS 193
11.5.5 PARTICIPANTS 193
11.5.6 COMPANY FOOTPRINT: KEY PLAYERS, 2023 195
11.5.6.1 Company footprint 195
11.5.6.2 Product footprint 195
11.5.6.3 Technology footprint 196
11.5.6.4 Application footprint 196
11.5.6.5 Region footprint 197
11.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2023 197
11.6.1 PROGRESSIVE COMPANIES 197
11.6.2 RESPONSIVE COMPANIES 197
11.6.3 DYNAMIC COMPANIES 197
11.6.4 STARTING BLOCKS 198
11.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2023 199
11.7 COMPANY VALUATION & FINANCIAL METRICS 201
11.8 BRAND/PRODUCT COMPARISON 202
11.9 COMPETITIVE SCENARIO 203
11.9.1 PRODUCT LAUNCHES 203
11.9.2 DEALS 204

12 COMPANY PROFILES 206
12.1 KEY PLAYERS 206
12.1.1 F. HOFFMANN-LA ROCHE AG 206
12.1.1.1 Business overview 206
12.1.1.2 Products offered 207
12.1.1.3 Recent developments 208
12.1.1.3.1 Product launches 208
12.1.1.4 MnM view 208
12.1.1.4.1 Right to win 208
12.1.1.4.2 Strategic choices 208
12.1.1.4.3 Weaknesses & competitive threats 208
12.1.2 LABORATORY CORPORATION OF AMERICA HOLDINGS 209
12.1.2.1 Business overview 209
12.1.2.2 Products offered 210
12.1.2.3 Recent developments 211
12.1.2.3.1 Deals 211
12.1.2.4 MnM view 211
12.1.2.4.1 Right to win 211
12.1.2.4.2 Strategic choices 211
12.1.2.4.3 Weaknesses & competitive threats 211
12.1.3 GUARDANT HEALTH, INC. 212
12.1.3.1 Business overview 212
12.1.3.2 Products offered 213
12.1.3.3 Recent developments 214
12.1.3.3.1 Product launches & approvals 214
12.1.3.3.2 Deals 215
12.1.3.4 MnM view 215
12.1.3.4.1 Right to win 215
12.1.3.4.2 Strategic choices 215
12.1.3.4.3 Weaknesses & competitive threats 215
12.1.4 SYSMEX CORPORATION 216
12.1.4.1 Business overview 216
12.1.4.2 Products offered 217
12.1.4.3 Recent developments 217
12.1.4.3.1 Product launches 217
12.1.4.4 MnM view 218
12.1.4.4.1 Right to win 218
12.1.4.4.2 Strategic choices 218
12.1.4.4.3 Weaknesses & competitive threats 218

12.1.5 NEOGENOMICS LABORATORIES 219
12.1.5.1 Business overview 219
12.1.5.2 Products offered 219
12.1.5.3 Recent developments 220
12.1.5.3.1 Deals 220
12.1.5.4 MnM view 220
12.1.5.4.1 Right to win 220
12.1.5.4.2 Strategic choices 220
12.1.5.4.3 Weaknesses & competitive threats 220
12.1.6 MOLECULARMD (A SUBSIDIARY OF ICON PLC) 221
12.1.6.1 Business overview 221
12.1.6.2 Products offered 222
12.1.7 ADAPTIVE BIOTECHNOLOGIES 223
12.1.7.1 Business overview 223
12.1.7.2 Products offered 224
12.1.7.3 Recent developments 224
12.1.7.3.1 Deals 224
12.1.8 ARCHERDX (INVITAE CORPORATION) 225
12.1.8.1 Business overview 225
12.1.8.2 Products offered 226
12.1.8.3 Recent developments 227
12.1.8.3.1 Product launches 227
12.1.8.3.2 Deals 227
12.1.9 BIO-RAD LABORATORIES, INC. 228
12.1.9.1 Business overview 228
12.1.9.2 Products offered 229
12.1.10 NATERA, INC. 230
12.1.10.1 Business overview 230
12.1.10.2 Products offered 231
12.2 OTHER PLAYERS 232
12.2.1 OPKO HEALTH, INC. 232
12.2.2 GENETRON HEALTH 233
12.2.3 QUEST DIAGNOSTICS, INC. 234
12.2.4 ASURAGEN, INC. 235
12.2.5 INVIVOSCRIBE, INC. 236
12.2.6 ARUP LABORATORIES INC. 237
12.2.7 MISSION BIO, INC. 237
12.2.8 CERGENTIS B.V. 238

13 APPENDIX 239
13.1 DISCUSSION GUIDE 239
13.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 242
13.3 CUSTOMIZATION OPTIONS 244
13.4 RELATED REPORTS 244
13.5 AUTHOR DETAILS 245