Report Detail

Medical Devices & Consumables Molecualr Diagnostics Global Market - Forecast to 2026

  • RnM3925069
  • |
  • 12 March, 2020
  • |
  • Global
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  • 539 Pages
  • |
  • IQ4I Research & Consultancy
  • |
  • Medical Devices & Consumables

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 BIOMÉRIEUX 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

    Summary:
    Get latest Market Research Reports on Molecualr Diagnostics. Industry analysis & Market Report on Molecualr Diagnostics is a syndicated market report, published as Molecualr Diagnostics Global Market - Forecast to 2026. It is complete Research Study and Industry Analysis of Molecualr Diagnostics market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.

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