There is an emerging trend towards precision health in today’s world to enhance disease diagnosis, treatment, prevention and monitoring by using innovative diagnostic technologies with broader range and bioinformatics. Molecular diagnostics is a set of techniques used for detection and monitoring of genetic variants such as DNA, RNA and proteins associated with a disease. Molecular diagnostic tests are the key drivers for the better management and treatment of diseases thereby providing critical information to patients for right medical decisions. By providing rapid and precise information about the disease, molecular diagnostics have revolutionized the healthcare system across the world.
Some of the advantages of molecular diagnostics are, up to 70% of the healthcare decisions are influenced by molecular based tests, improve the quality of personalized care of the patient, potential improvement in the patient outcome and facilitate early detection of diseases with sensitive assays thereby reducing the cost of healthcare of an individual.
According to IQ4I analysis, molecular diagnostics global market is estimated to reach $18,668.9 million by 2026 growing at a high single digit CAGR from 2019 to 2026. Among the overall molecular diagnostic market is increasing prevalence of different types of cancers, infectious diseases, genetic disorders and other diseases, increasing awareness in personalized medicine and companion diagnostics and also growth in the point of care testing and sequencing-based tests and other molecular techniques. Molecular diagnostics plays a pivotal role in the evaluation of the disease and for the effective response for specific therapy. However, the complex regulations for the approval of molecular diagnostic tests, availability of competing/alternative technologies, high cost of the tests, and also shortage of technical experts are some of the restrains for the growth of the molecular diagnostics market.
The molecular diagnostics global market is segmented based on product, technology, application and end-users. The product market is further categorized into instruments, consumables and software and services. As per IQ4I research estimations, the consumable global market commanded the largest revenue in 2019 and is projected to grow at double digit CAGR from 2019 to 2026.
The molecular diagnostics global market by technology is divided into PCR, microarray and microfluidics, isothermal nucleic acid amplification tests, in-situ hybridization, NGS and other technologies. PCR accounted for the largest revenue in 2019 and is expected to grow at a double digit CAGR from 2019 to 2026 due to low cost and is a common and indispensable technique used for diagnosis when compared to other instruments such as NGS and also due to technological advancements in PCR and their subtypes such as digital droplet PCR with precise and highly sensible results.
The molecular diagnostics by application is classified into infectious diseases, oncology, genetic testing, transplantation, blood screening and other diseases such as metabolic disorders and diseases associated with central nervous system. The largest revenue was contributed by infectious diseases segment in 2019 and this market is expected to grow at a high single digit CAGR from 2019 to 2026 due to high incidence of bacterial and viral infections.
Infectious diseases are further segmented into bacterial, viral and other diseases. The viral diseases commanded the largest revenue in 2019 and the market is expected to grow at a strong double digit CAGR from 2019 to 2026. Viral diseases are further segmented into HIV, hepatitis, HPV, influenza and other viral infections. Among theses, HIV accounted for the largest revenue in 2019 and is expected grow at a double digit CAGR from 2019 to 2026. The bacterial diseases are sub-segmented into sexually transmitted diseases (STD) caused by bacteria, hospital acquired infections, tuberculosis and other diseases such as sepsis, pneumonia and meningitis etc. Sexually transmitted disease accounted for the largest revenue in 2019 and is expected to grow at high single digit CAGR from 2019 to 2026. The growth is attributed to the increase awareness about the molecular based kits available for the diagnoses of STD’s and also increase in the prevalence.
Under genetic testing segment the market is segmented into NIPT, cystic fibrosis and other genetic testing, among them NIPT commanded the largest revenue in 2019 and is expected to grow at a double digit CAGR from 2019 to 2026 as NIPT provides a safer alternative to invasive tests and it analyzes fetal cell-free DNA (cfDNA) from the mother’s circulation, making early detection of genetic disorders such as Down syndrome and other chromosomal aberrations easier.
Based on type of cancer, the oncology market is segmented into lung, breast, colorectal, prostate, ovarian, melanoma, ovarian and other cancers. The largest revenue under oncology was accounted by colorectal cancer with the revenue in 2019 and breast cancer is expected to grow at double digit CAGR from 2019 to 2026. Based on the cancer care, oncology segment is sub divided into early screening, companion diagnostics, prognosis and recurrence. Early screening contributed for largest revenue in 2019 and companion diagnostics is expected to grow at double digit CAGR from 2019 to 2026. Further, transplantation market is segmented into kidney, heart and other transplantation such as lung and pancreatic transplantation. Among them, kidney transplantation commanded the largest revenue in 2019.
Molecular diagnostics, end users market is segmented into hospitals, clinical/centralized laboratories, academics and research and other end users. Clinical/centralized laboratories accounted for the largest revenue due to the rapid adoption of technology and economies of scale in testing large number of samples collected from affiliated hospitals.
Geographical wise, North America region commanded the largest revenue in 2019 and is expected grow at a mid single digit CAGR from 2019 to 2026 owing to the high demand for early detection, treatment selection and prevention of diseases with advanced technology due to diseases associated with the lifestyle. However, Asia-pacific region is expected to grow at a early teen CAGR from 2019 to 2026 attributing to increasing awareness of the molecular based test for the better outcome.
The molecular diagnostics global market is a competitive market and all the existing players in this market are involved in developing new and advanced molecular based techniques for diagnosis to maintain their market shares and also acquiring companies for product expansion.
Some of the key players in molecular diagnostics global market are Abbott Laboratories (U.S.), F.Hoffmann-LA Roche AG (Switzerland), BioMerieux (France), Qiagen (Netherlands) Exact Sciences (U.S.), Grifols (Spain), Danaher Corporation (U.S.), Hologic, Inc. (U.S.), and Myriad Genetics, Inc. (U.S.)
The report provides an in-depth market analysis of the above-mentioned segments across the following regions:
• North America (U.S. and Rest of N.A.)
• Europe (Germany, France, Italy and Rest of E.U.)
• Asia-Pacific (Japan, China, India and Rest of APAC)
• Rest of the World (RoW) (Brazil, Rest of Latin-America and Middle East & Others)
1 EXECUTIVE SUMMARY 28
2 INTRODUCTION 33
2.1 KEY TAKEAWAYS 33
2.2 SCOPE OF THE REPORT 33
2.3 REPORT DESCRIPTION 34
2.4 MARKETS COVERED 37
2.5 STAKEHOLDERS 39
2.6 RESEARCH METHODOLOGY 39
2.6.1 MARKET SIZE ESTIMATION 40
2.6.2 MARKET BREAKDOWN AND DATA TRIANGULATION 43
2.6.3 SECONDARY SOURCES 44
2.6.4 PRIMARY SOURCES 45
2.6.5 KEY DATA POINTS FROM SECONDARY SOURCES 45
2.6.6 KEY DATA POINTS FROM PRIMARY SOURCES 46
2.6.7 ASSUMPTIONS 46
3 MARKET ANALYSIS 48
3.1 INTRODUCTION 48
3.2 MARKET SEGMENTATION 49
3.3 FACTORS INFLUENCING MARKET 52
3.3.1 DRIVERS AND OPPORTUNITY 52
3.3.1.1 Increasing incidence of infectious diseases 52
3.3.1.2 Rising incidence of cancer and non-infectious diseases 54
3.3.1.3 Technological advancements 54
3.3.1.4 Favorable reimbursements 56
3.3.1.5 Investment by major players 57
3.3.2 RESTRAINTS AND THREATS 58
3.3.2.1 Lack of skilled professionals 58
3.3.2.2 High cost of molecular diagnostics products 58
3.3.2.3 Lack of standardization of the molecular diagnostics test 59
3.3.2.4 Stringent and time-consuming regulatory issues 59
3.3.2.5 Lack of reproducibility and repeatability 60
3.3.2.6 Biochemical and alternative tests 60
3.4 MARKET SHARE ANALYSIS 62
3.4.1 MOLECULAR DIAGNOSTICS GLOBAL MARKET SHARE ANALYSIS 62
3.4.2 MOLECULAR DIAGNOSTICS IN INFECTIOUS DISEASES MARKET SHARE 66
3.5 REGULATORY AFFAIRS 69
3.5.1 U.S. 70
3.5.2 EUROPE 71
3.5.3 CHINA 72
3.5.4 INDIA 73
3.5.5 JAPAN 74
3.5.6 AUSTRALIA 74
3.5.7 SOUTH KOREA 75
3.6 REIMBURSEMENT SCENARIO 76
3.7 CLINICAL TRIALS 77
3.7.1 CTDNA CLINICALTRIALS 77
3.7.2 CFDNA CLINICALTRIALS 78
3.7.3 CIRCULATING TUMOR CELLS 79
3.7.4 COMPANION DIAGNOSTICS 80
3.8 LATEST AND UPCOMING PRODUCTS 82
3.9 PORTER’S FIVE FORCE ANALYSIS 89
3.9.1 THREAT OF NEW ENTRANTS 90
3.9.2 THREAT OF SUBSTITUTES 90
3.9.3 COMPETITIVE RIVALRY 91
3.9.4 BARGAINING POWER OF SUPPLIERS 91
3.9.5 BARGAINING POWER OF BUYERS 92
3.10 FUNDING SCENARIO 92
4 MARKET SIZING 94
4.1 U.S.CANCER CARE MARKET SIZING INFORMATION 94
4.1.1 ONCOLOGY TESTING 94
4.1.1.1 Early screening 94
4.1.1.2 Companion diagnostics 94
4.1.1.3 Prognosis monitoring 96
4.1.1.4 Recurrence monitoring 97
4.1.2 NON-INVASIVE PRENATAL SCREENING (NIPT) 98
4.1.3 TRANSPLANTATION DIAGNOSTICS 99
5 MOLECULAR DIAGNOSTICS GLOBAL MARKET, BY PRODUCTS 101
5.1 INTRODUCTION 101
5.2 INSTRUMENTS 105
5.3 CONSUMABLES 107
5.4 SOFTWARE AND SERVICES 109
6 MOLECULAR DIANOSTICS GLOBAL MARKET BY TECHNOLOGY 114
6.1 INTRODUCTION 114
6.2 PCR 117
6.3 MICROFLUIDICS AND MICROARRAY 120
6.4 ISOTHERMAL NUCLEIC ACID AMPLIFICATION TECHNOLOGY (INAAT) 124
6.5 IN-SITU HYBRIDIZATION 126
6.6 NEXT GENERATION SEQUENCING (NGS) 130
6.7 OTHERS 133
7 MOLECULAR DIAGNOSTICS GLOBAL MARKET, BY APPLICATION 136
7.1 INTRODUCTION 136
7.2 INFECTIOUS DISEASES 140
7.2.1 BACTERIAL DISEASES 142
7.2.1.1 Sexually transmitted diseases 146
7.2.1.2 Hospital acquired infections 150
7.2.1.3 Tuberculosis 155
7.2.1.4 Others 157
7.2.2 VIRAL DISEASES 160
7.2.2.1 HIV 165
7.2.2.2 Hepatitis 168
7.2.2.3 Influenza 170
7.2.2.4 Human Papiloma Virus (HPV) 175
7.2.2.5 Other viral diseases 178
7.2.3 OTHER INFECTIOUS DISEASES 184
7.3 GENETIC TESTING 187
7.3.1 NON-INVASIVE PRENATAL TESTING (NIPT) 192
7.3.2 CYSTIC FIBROSIS 198
7.3.3 OTHER GENETIC DISEASES 199
7.4 ONCOLOGY TESTING 202
7.4.1 CANCER TYPES 202
7.4.1.1 Introduction 202
7.4.1.2 Lung cancer 206
7.4.1.3 Breast cancer 209
7.4.1.4 Colorectal cancer 211
7.4.1.5 Prostate cancer 213
7.4.1.6 Melanoma 215
7.4.1.7 Ovarian cancer 217
7.4.1.8 Others 219
7.4.2 CANCER CARE 221
7.4.2.1 Introduction 221
7.4.2.2 Early screening 224
7.4.2.3 Companion diagnostics 226
7.4.2.4 Prognosis monitoring 228
7.4.2.5 Recurrence monitoring 230
7.5 TRANSPLANTATION 232
7.5.1 KIDNEY TRANSPLANTATION 236
7.5.2 HEART TRANSPLANTATION 238
7.5.3 OTHER TRANSPLANTATION 239
7.6 BLOOD SCREENING 243
7.7 OTHER DISEASES 247
8 MOLECULAR DIAGNOSTICS GLOBAL MARKET, BY END USERS 251
8.1 INTRODUCTION 251
8.2 HOSPITALS 254
8.3 CLINICAL/CENTRALIZED LABORATORIES 258
8.4 ACADEMIC AND RESEARCH 260
8.5 OTHERS 263
9 MOLECULAR DIAGNOSTICS GLOBAL MARKET, BY REGION 266
9.1 INTRODUCTION 266
9.2 NORTH AMERICA 270
9.2.1 U.S. 295
9.2.2 REST OF NORTH AMERICA 302
9.3 EUROPE 309
9.3.1 FRANCE 335
9.3.2 GERMANY 340
9.3.3 ITALY 344
9.3.4 REST OF EUROPE 349
9.4 ASIA-PACIFIC REGION 355
9.4.1 CHINA 379
9.4.2 INDIA 384
9.4.3 JAPAN 390
9.4.4 REST OF ASIA-PACIFIC 396
9.5 REST OF THE WORLD 402
9.5.1 BRAZIL 427
9.5.2 REST OF LATIN AMERICA 432
9.5.3 MIDDLE EAST AND OTHERS 437
10 COMPETITIVE LANDSCAPE 443
10.1 INTRODUCTION 443
10.2 APPROVALS 444
10.3 COLLABORATIONS 450
10.4 ACQUISITIONS 454
10.5 NEW PRODUCT LAUNCHES 455
10.6 OTHERS 457
11 MAJOR COMPANIES 459
11.1 ABBOTT LABORATORIES 459
11.1.1 OVERVIEW 459
11.1.2 FINANCIALS 460
11.1.3 PRODUCT PORTFOLIO 463
11.1.4 KEY DEVELOPMENTS 464
11.1.5 BUSINESS STRATEGY 464
11.1.6 SWOT ANALYSIS 465
11.2 BECTON, DICKINSON AND COMPANY 466
11.2.1 OVERVIEW 466
11.2.2 FINANCIALS 467
11.2.3 PRODUCT PORTFOLIO 469
11.2.4 KEY DEVELOPMENTS 469
11.2.5 BUSINESS STRATEGY 470
11.2.6 SWOT ANALYSIS 470
11.3 µþ±õ°¿²Ñɸé±õ·¡±«³Ý 471
11.3.1 OVERVIEW 471
11.3.2 FINANCIALS 472
11.3.3 PRODUCT PORTFOLIO 474
11.3.4 KEY DEVELOPMENTS 475
11.3.5 BUSINESS STRATEGY 476
11.3.6 SWOT ANALYSIS 477
11.4 DANAHER CORPORATION 478
11.4.1 OVERVIEW 478
11.4.2 FINANCIALS 479
11.4.3 PRODUCT PORTFOLIO 482
11.4.4 KEY DEVELOPMENTS 484
11.4.5 BUSINESS STRATEGY 484
11.4.6 SWOT ANALYSIS 485
11.5 EXACT SCIENCES CORPORATION 486
11.5.1 OVERVIEW 486
11.5.2 FINANCIALS 487
11.5.3 PRODUCT PORTFOLIO 488
11.5.4 KEY DEVELOPMENTS 489
11.5.5 BUSINESS STRATEGY 490
11.5.6 SWOT ANALYSIS 491
11.6 GRIFOLS, S.A. 492
11.6.1 OVERVIEW 492
11.6.2 FINANCIALS 493
11.6.3 PRODUCT PORTFOLIO 495
11.6.4 KEY DEVELOPMENTS 496
11.6.5 BUSINESS STRATEGY 498
11.6.6 SWOT ANALYSIS 499
11.7 HOLOGIC, INC. 500
11.7.1 OVERVIEW 500
11.7.2 FINANCIALS 501
11.7.3 PRODUCT PORTFOLIO 505
11.7.4 KEY DEVELOPMENTS 506
11.7.5 BUSINESS STRATEGY 508
11.7.6 SWOT ANALYSIS 509
11.8 MYRIAD GENETICS, INC. 510
11.8.1 OVERVIEW 510
11.8.2 FINANCIALS 511
11.8.3 PRODUCT PORTFOLIO 514
11.8.4 KEY DEVELOPMENTS 514
11.8.5 BUSINESS STRATEGY 517
11.8.6 SWOT ANALYSIS 518
11.9 QIAGEN N.V. 519
11.9.1 OVERVIEW 519
11.9.2 FINANCIALS 520
11.9.3 PRODUCT PORTFOLIO 522
11.9.4 KEY DEVELOPMENTS 526
11.9.5 BUSINESS STRATEGY 527
11.9.6 SWOT ANALYSIS 529
11.10 F. HOFFMANN-LA ROCHE LTD. 530
11.10.1 OVERVIEW 530
11.10.2 FINANCIALS 531
11.10.3 PRODUCT PORTFOLIO 534
11.10.4 KEY DEVELOPMENTS 535
11.10.5 BUSINESS STRATEGY 537
11.10.6 SWOT ANALYSIS 538
ABBOTT LABORATORIES
BECTON, DICKINSON AND COMPANY
BIOMERIEUX
DANAHER CORPORATION
EXACT SCIENCES
GRIFOLS
HOLOGIC, INC
MYRIAD GENETICS, INC
QIAGEN N.V.
ROCHE
LIST OF COMPANIES MENTIONED IN THE REPORT
23 ANDME
3D MEDICINES
ABBOTT LABORATORIES
ABNOVA CORPORATION
ACCUBIOTECH
ACCURAGEN
ADAPTHERAPY
ADAPTIVE BIOTECHNOLOGIES
ADMERA HEALTH
ADVANCED CELL DIAGNOSTICS, INC.
ADX HEALTHCARE
AGENA BIOSCIENCE
AGILENT TECHNOLOGIES INC.
AKONNI BIOSYSTEMS, INC
AMBRY GENETICS
AMOY DIAGNOSTICS
ANALYTIK JENA AG
ANNOROAD GENE TECHNOLOGY
ANPAC TECHNOLOGIES
ASPIRA LABS
AUTOGENOMICS
BECTON, DICKINSON AND COMPANY
BEIJING GENOMICS INSTITUTE (BGI)
BERRY GENOMICS
BINX HEALTH, INC
BIO VIEW
BIOARRAY SL
BIOCARTIS
BIOCEPT, INC.
BIODESIX, INC
BIOFLUIDICA
BIOLYTICAL LABORATORIES INC.
µþ±õ°¿²Ñɸé±õ·¡±«³Ý
BIONEER
BIO-RAD LABORATORIES, INC.
BIOSPHERIX, LTD.
BIOTEK INSTRUMENTS INC.
BIOTYPE
BMG LABTECH INC.
BRUKER CORPORATION
CELLMAX LIFE
CENTOGENE
CERTEST BIOTEC
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
CHRONIX BIOMEDICAL
CIRCULOGENE
CTK BIOTECH CO
DANAHER CORPORATION
DATAR GENETICS LIMITED
DECIPHER BIOSCIENCES
DELTAGENE
DENKA SEIKEN
DIASORIN
DIAZYME LABORATORIES
DISCOVERY LIFE SCIENCES
DR LAL PATH LABS
EDC BIOSYSTEMS INC.
EIKEN CHEMICAL CO., LTD
ENZO LIFE SCIENCES INC
EPIGENOMICS AG
EUROFINS
EUROIMMUN
EXACT SCIENCES CORPORATION
EXOSOME DIAGNOSTICS, INC
F. HOFFMANN-LA ROCHE AG
FAST TRACK DIAGNOSTICS LTD.
FIBROTX
FIRALIS S.A.
FLUIDIGM CORPORATION
FOUNDATION MEDICINE
FUJIREBIO
FUSION GENOMICS
GE HEALTHCARE
GENECENTRIC THERAPEUTICS, INC
GENEKAM BIOTECHNOLOGY AG
GENEPOC INC
GENEVIA TECHNOLOGIES
GENLANTIS INC.
GENOMEME
GREAT BASIN SCIENTIFIC, INC.
GREINER BIO-ONE AG
GRIFOLS, S.A.
GUARDANT HEALTH
GYROS AB
HAMILTON COMPANY
HIBERGENE DIAGNOSTICS
HOLOGIC, INC
HUMASIS
HUMMINGBIRD DIAGNOSTICS GMBH
ICUBATE
ILLUMINA
IMMUCOR, INC.
INFLAMMATIX, INC.
INIVATA
INVITAE CORPORATION
IVYGENE LABS
JENA BIOSCIENCE
KAILOS GENETICS INC
KERN AND SOHN GMBH
LABCYTE INC.
LABORATORY CORP. OF AMERICA HOLDINGS
LCM GENECT SRL
LIFERIVER BIOTECH CORP.
LIQUID BIOTECH USA
LONZA GROUP AG
LUCENCE DIAGNOSTICS
LUCIGEN CORPORATION
LUMINEX CORPORATION
LUNGLIFEAI (CYNVENIO BIOSYSTEMS )
MAPMYGENOME
MDXHEALTH
MEDGENOME
MENARINI SILICON BIOSYSTEMS
MERCK KGAA
MERIDIAN BIOSCIENCE
MICROGENOMICS SRL
MILTENYI BIOTEC
MIRXES PTE LTD
MOLBIO DIAGNOSTICS PVT. LTD.
MYRIAD GENETICS
NANOSTICS
NANOSTRING TECHNOLOGIES
NEOGENOMICS LABORATORIES, INC.
NEUMODX
NOWDIAGNOSTICS
NUCLEIX
OMEGA DIAGNOSTICS
ONCODIAG
ONCODNA
OPKO HEALTH, INC.
OPTIGENE LIMITED
ORASURE TECHNOLOGIES
OXFORD GENE TECHNOLOGY
PACIFIC BIOSCIENCES OF CALIFORNIA
PANAGENE
PATHWAY GENOMICS
PERKIN ELMER, INC.
PERSONAL GENOME DIAGNOSTICS
PERTH OBSTETRICS & GYNECOLOGY ULTRASOUND
PRECIPIODX
PREDICINE, INC
PRIMERADX
PRIMERDESIGN LTD.
PROGENITY
PROMEGA CORPORATION
PTS DIAGNOSTICS
QIAGEN N.V.
QUIDEL CORPORATION
RENISHAW DIAGNOSTICS LTD.,
RESOLUTION BIOSCIENCES
SAGA DIAGNOSTICS
SANOFI
SIEMENS
SPECTRAL MEDICAL INC
SPHINGOTEC GMBH
SPT LABTECH
SQI DIAGNOSTICS
STAGEZERO LIFE SCIENCES
STRAND LIFESCIENCES
SYNLAB INTERNATIONAL
SYSMEX INOSTICS
TAI DIAGNOSTICS
TECAN GROUP LTD
THE ELITECH GROUP
THERADIAG
THERMO FISHER SCIENTIFIC INC.
TRANSPLANT GENOMICS, INC.
TRINITY BIOTECH
TROVAGENE, INC
TULIP GROUP/QUALPRO
VELA DIAGNOSTICS
VERAGEN
VEREDUS LABORATORIES
VICTORIAN CLINICAL GENETICS SERVICES
WELLSBIO
YOURGENE BIOSCIENCES CO., LTD., (PREMAITHA HEALTH)
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*If Applicable.
