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In-Vitro Diagnostics (IVD) Global Market - Forecast To 2028

In-Vitro Diagnostics (IVD) Global Market - Forecast To 2028

In-vitro diagnostic (IVD) are tests where reagents, instruments, and systems determine the state of health, to cure, mitigate, treat, or prevent disease. These tests can be performed on a variety of instruments such as small, handheld tests to complex laboratory instruments allowing doctors to diagnose patients effectively and decide to provide appropriate treatments.

According to IQ4I analysis, the In vitro diagnostic global market is expected to grow at low single digit CAGR from 2021 to 2028 to reach $96,485.2 million by 2028. The factors such as the growing incidence of chronic and infectious diseases, increasing adoption of point-of-care testing, the emergence of Next-generation molecular diagnostics, minimally invasive and non-invasive in-vitro diagnostics, rising number of CLIA-waived tests are driving the growth of the IVD market. However, the rising number of product recalls, lack of skilled laboratory technicians in developing nations, inadequate reimbursements, and stringent regulatory framework is expected to hamper the market growth.

The in-vitro diagnostics global market is segmented based on products, technology, applications, sample source, end-users and geography. The products market is segmented into instruments, reagents and software & services, where, reagents commanded the largest share of the market in 2021 and is expected to grow at low single digit CAGR from 2021 to 2028.

The IVD global market based on technology is segmented into immunochemistry, clinical chemistry, molecular diagnostics, clinical microbiology, hematology, coagulation and hemostasis and others. Among these, the immunochemistry segment commanded the largest share in 2021 and the market is expected to grow at low single digit CAGR from 2021 to 2028. The immunochemistry market is further sub-segmented based on techniques into Enzyme-Linked Immunosorbent Assay (ELISA), Enzyme-Linked Immunospot (Elispot) Assay, Radioimmunoassay (RIA), Rapid Tests, Chemiluminescence Immunoassay (CLIA), Fluoro Immunoassay (FIA), and Others. Among these, ELISA commanded the largest share in 2021; the rapid test segment occupied a significant share of the techniques market in 2021. The clinical chemistry market is sub-segmented based on technique into basic metabolic profile, electrolyte panel, liver panel, lipid profile, renal profile, thyroid function panel and others, among which, the basic metabolic profile commanded the largest share of the market in 2021, the lipid profile segment is expected to grow at a high single digit CAGR from 2021 to 2028. The molecular diagnostics market is further sub-segmented into PCR, microfluidics & microarray, INAAT, in-situ hybridization, NGS and others. Among these, the PCR segment generated the largest revenue in 2021, Microfluidics & microarray segment is expected to grow at early teen CAGR from 2021 to 2028.

The IVD global market based on application is segmented into oncology, diabetes, infectious diseases, genetic testing, cardiology, autoimmune diseases, drug testing, nephrology, transplantation, Blood & related disorders, and others, among them, the infectious disease segment commanded the largest revenue in 2021, the transplantation segment is expected to grow at high double digit CAGR from 2021 to 2028. The oncology market is further sub-segmented based on cancer types into lung cancer, breast cancer, colorectal cancer, prostate cancer, melanoma, ovarian cancer and others, among which, colorectal cancer commanded the largest share in 2021 and the market is expected to grow at a high single digit CAGR from 2021 to 2028. The oncology market based on cancer care is further sub-segmented into diagnosis, early screening, companion diagnostics, prognosis and recurrence monitoring, where, diagnosis commanded the largest share of the market in 2021, the companion diagnostics segment is expected to grow at high single digit CAGR from 2021 to 2028. The infectious disease market is further sub-segment into bacterial, viral infection, fungal and others among which the viral infection commanded the largest share of the market in 2021. The bacterial infection global market is further segmented based on infection agent into Treponema pallidum, Gardnerella, Staphylococcus aureus, Clostridium difficile, Streptococcus (A&B), Methicillin-resistant Staphylococcus aureus (MRSA), Chlamydia trachomatis (CT) & Neisseria gonorrhea (NG) and tuberculosis (TB) and others. Among these, Staphylococcus aureus commanded the largest revenue in 2021. The MRSA segment is expected to grow at low single digit CAGR from 2021 to 2028. The Viral infection global market is segmented based on the type of infection into HIV-1, influenza, dengue, Hepatitis B, Hepatitis C, Human papillomavirus (HPV), herpes simplex virus (HSC), zika virus, and COVID & others. Among these, the COVID & others segment contributed the largest share of the market in 2021, HIV-1 segment is expected to grow at a double digit CAGR from 2021 to 2028. The Fungal infection global market based on the type of infection is segmented into Candida, Aspergillus, and others. Among these, Candida commanded the largest revenue in 2021. The other infections segment is further sub-segmented into malaria, trichomonas vaginalis and others, among this, Trichomonas vaginalis commanded the largest share in 2021, and malaria is expected to grow at low single digit CAGR from 2021 to 2028.

The IVD global market based on sample source is segmented into blood, urine, mucus and others, among which blood commanded the largest share of the market in 2021, and is expected to grow at mid single digit CAGR from 2021 to 2028. The blood-based tests provide accurate results when compare to other sources, and, they are suitable sample sources for early diagnosis before the occurrence of symptoms.

The In-vitro diagnostics end-user market is segmented into diagnostic laboratories, hospitals, academics and research centers, homecare and other end-users. The hospitals' segment accounted for the largest revenue in 2021 and is estimated to grow at low single digit CAGR from 2021 to 2028 due to the availability of advanced and novel technologies for the diagnosis and also the availability of skilled professionals with more capital investments.

Geographical-wise, the North America region commanded the largest revenue in 2021 owing to the high demand for early detection, treatment and prevention tests with advanced technology. However, the Asia-Pacific region is expected to grow at mid single digit CAGR from 2021 to 2028 with increasing awareness for the highly precise, rapid and advanced tests for a better outcome.

The in-vitro diagnostics global market is competitive and all the active players in this market are involved in innovating new and advanced products to maintain their market shares. The key players in the IVD global market include Abbott Laboratories, Inc. (U.S.), F.Hoffmann-La Roche AG (Switzerland), Siemens Healthineers(Germany), Biomerieux SA (France), Becton Dickinson and Company (U.S.), Bio-Rad Laboratories (U.S.), Danaher Corporation (U.S.), Sysmex (Japan), Dexcom (U.S), Hologic (U.S), Quidel (U.S) Qiagen N.V. (the Netherlands) and Thermo Fisher Scientific, Inc. (U.S.).

The report provides an in-depth market analysis of the above-mentioned segments across the following regions:
• North America
• Europe
• Asia-Pacific
• Rest of the World (RoW)

1 EXECUTIVE SUMMARY 34
2 INTRODUCTION 41
2.1 KEY TAKE AWAYS 41
2.2 SCOPE OF THE REPORT 42
2.3 REPORT DESCRIPTION 42
2.4 MARKETS COVERED 45
2.5 STAKEHOLDERS 50
2.6 RESEARCH METHODOLOGY 50
2.6.1 MARKET SIZE ESTIMATION 52
2.6.2 MARKET BREAKDOWN & DATA TRIANGULATION 55
2.6.3 SECONDARY SOURCES 56
2.6.4 PRIMARY SOURCES 57
2.6.5 KEY DATA POINTS FROM SECONDARY SOURCES 57
2.6.6 KEY DATA POINTS FROM PRIMARY SOURCES 58
2.6.7 ASSUMPTIONS 59
3 MARKET ANALYSIS 61
3.1 INTRODUCTION 61
3.2 MARKET SEGMENTATION 62
3.3 FACTORS INFLUENCING MARKET 66
3.3.1 DRIVERS AND OPPORTUNITIES 66
3.3.1.1 Growing incidence of chronic and infectious diseases 66
3.3.1.2 Increase in demand for IVD tests due to COVID-19 pandemic 68
3.3.1.3 Increasing adoption of point-of-care testing 68
3.3.1.4 The emergence of next-generation molecular diagnostics 70
3.3.1.5 Growing awareness of companion diagnostics and personalized medicine 70
3.3.1.6 The emergence of minimally invasive and non-invasive diagnostics 72
3.3.1.7 Rising number of CLIA-waived IVD tests 73
3.3.2 RESTRAINTS & THREATS 74
3.3.2.1 Rising incidence of product recalls 74
3.3.2.2 Lack of skilled laboratory technicians in developing nations 75
3.3.2.3 Inadequate reimbursement 75
3.3.2.4 Stringent regulatory framework 77
3.4 PORTER’S FIVE FORCE ANALYSIS 78
3.4.1 THREAT OF NEW ENTRANTS 79
3.4.2 THREAT OF SUBSTITUTES 80
3.4.3 COMPETITIVE RIVALRY 81
3.4.4 BARGAINING POWER OF SUPPLIERS 82
3.4.5 BARGAINING POWER OF BUYERS 82
3.5 REGULATORY AFFAIRS 83
3.5.1 U.S.A 83
3.5.2 EUROPE 86
3.5.3 CHINA 87
3.5.4 INDIA 88
3.5.5 JAPAN 89
3.5.6 AUSTRALIA 90
3.5.7 SOUTH KOREA 91
3.6 TECHNOLOGICAL ADVANCEMENTS 92
3.7 FUNDING SCENARIO 97
3.8 MERGERS & ACQUISITIONS 110
3.9 SUPPLY CHAIN ANALYSIS 114
3.10 IMPACT OF COVID-19 117
3.11 CLINICAL TRIALS 118
3.11.1 CFDNA CLINICALTRIALS 118
3.11.2 CIRCULATING TUMOR CELLS (CTC) 119
3.11.3 COMPANION DIAGNOSTICS 120
3.11.4 IMMUNOASSAYS 121
3.11.5 LIPID PROFILE 122
3.11.6 MICROARRAY 123
3.11.7 GENETIC DISEASES 124
3.12 MARKET SHARE ANALYSIS BY IN-VITRO DIAGNOSTICS MAJOR PLAYERS 125
3.12.1 IN-VITRO DIAGNOSTICS GLOBAL MARKET SHARE ANALYSIS 125
3.12.2 IMMUNOCHEMISTRY GLOBAL MARKET SHARE ANALYSIS 130
3.12.3 CLINICAL CHEMISTRY GLOBAL MARKET SHARE ANALYSIS 134
3.12.4 MOLECULAR DIAGNOSTICS GLOBAL MARKET SHARE ANALYSIS 137
3.12.5 CLINICAL MICROBIOLOGY GLOBAL MARKET SHARE ANALYSIS BY MAJOR PLAYERS 141
3.12.6 HEMATOLOGY GLOBAL MARKET SHARE ANALYSIS BY MAJOR PLAYERS 144
3.12.7 COAGULATION AND HEMOSTASIS MARKET SHARE ANALYSIS BY MAJOR PLAYERS 147
4 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY PRODUCT 150
4.1 INTRODUCTION 150
4.2 INSTRUMENTS 152
4.3 REAGENTS 156
4.4 SOFTWARE AND SERVICES 160
5 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY TECHNOLOGY 163
5.1 INTRODUCTION 163
5.2 IMMUNOCHEMISTRY 166
5.2.1 ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) 170
5.2.2 ENZYME-LINKED IMMUNOSPOT (ELISPOT) ASSAY 174
5.2.3 RADIOIMMUNOASSAY (RIA) 176
5.2.4 RAPID TESTS 179
5.2.5 CHEMILUMINESCENCE IMMUNOASSAYS (CLIA) 183
5.2.6 FLUORESCENCE IMMUNOASSAYS (FIA) 185
5.2.7 OTHER IMMUNOASSAYS 188
5.3 CLINICAL CHEMISTRY 191
5.3.1 BASIC METABOLIC PROFILE 197
5.3.2 ELECTROLYTE PANEL 200
5.3.3 LIVER PANEL 203
5.3.4 LIPID PANEL 206
5.3.5 RENAL PANEL 209
5.3.6 THYROID FUNCTION PANEL 212
5.3.7 OTHERS (CLINICAL CHEMISTRY TESTS) 214
5.4 MOLECULAR DIAGNOSTICS (MDX) 216
5.4.1 PCR (POLYMERASE CHAIN REACTION) 223
5.4.2 ISOTHERMAL NUCLEIC ACID AMPLIFICATION TECHNOLOGY (INAAT) 227
5.4.3 MICROFLUIDICS & MICROARRAY 230
5.4.4 IN SITU HYBRIDIZATION (ISH) 234
5.4.5 NEXT-GENERATION SEQUENCING (NGS) 238
5.4.6 OTHER MDX TECHNOLOGIES 241
5.5 CLINICAL MICROBIOLOGY 244
5.6 HEMATOLOGY 247
5.7 COAGULATION AND HEMOSTASIS 250
5.8 OTHERS 254
6 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY APPLICATION 257
6.1 INTRODUCTION 257
6.2 ONCOLOGY 261
6.2.1 CANCER TYPES 265
6.2.1.1 Introduction 265
6.2.1.2 Lung Cancer 265
6.2.1.3 Breast Cancer 268
6.2.1.4 Colorectal Cancer 270
6.2.1.5 Prostate Cancer 272
6.2.1.6 Melanoma 274
6.2.1.7 Ovarian Cancer 276
6.2.1.8 Others 278
6.2.2 CANCER CARE 281
6.2.2.1 Introduction 281
6.2.2.2 Diagnosis 285
6.2.2.3 Early Screening 287
6.2.2.4 Companion Diagnostics 290
6.2.2.5 Prognosis Monitoring 292
6.2.2.6 Recurrence Monitoring 293
6.3 DIABETES 295
6.4 INFECTIOUS DISEASES 298
6.4.1 BACTERIAL INFECTION 302
6.4.1.1 Treponema pallidum 306
6.4.1.2 Gardnerella vaginalis 310
6.4.1.3 Staphylococcus aureus 312
6.4.1.4 Clostridium difficile 315
6.4.1.5 Streptococcus (A & B) 318
6.4.1.6 Methicillin-Resistant Staphylococcus Aureus (MRSA) 320
6.4.1.7 Chlamydia trachomatis (CT) And Neisseria gonorrhoeae (NG) 323
6.4.1.8 Tuberculosis (TB) 326
6.4.1.9 Other Bacterial Infection 329
6.4.2 VIRAL INFECTION 333
6.4.2.1 HIV-1 338
6.4.2.2 Influenza 342
6.4.2.3 Dengue 345
6.4.2.4 Hepatitis B 348
6.4.2.5 Hepatitis C 351
6.4.2.6 Human Papilloma Virus (HPV) 353
6.4.2.7 Herpes Simplex Virus (HSV) 355
6.4.2.8 Zika Virus 359
6.4.2.9 COVID and Other Viral Infection 361
6.4.3 FUNGAL INFECTION 366
6.4.3.1 Candida 369
6.4.3.2 Aspergillus 371
6.4.3.3 Other Fungal Infection 372
6.4.4 OTHER INFECTION 374
6.4.4.1 Malaria 376
6.4.4.2 Trichomonas vaginalis 378
6.4.4.3 Other Infections 380
6.5 GENETIC TESTING 383
6.6 CARDIOLOGY DISEASES 392
6.7 AUTOIMMUNE DISEASES 395
6.8 DRUG TESTING 398
6.9 NEPHROLOGY 402
6.10 TRANSPLANTATION 404
6.11 BLOOD AND RELATED DISORDERS 413
6.12 OTHER DISEASES 416
7 IN-VITRO DIAGNOSTICS MARKET, BY SAMPLE TYPE 419
7.1 INTRODUCTION 419
7.2 BLOOD 421
7.3 MUCUS 425
7.4 URINE 426
7.5 OTHERS 430
8 IN-VITRO DIAGNOSTICS GLOBAL MARKET, BY END-USER 436
8.1 INTRODUCTION 436
8.2 DIAGNOSTIC LABORATORIES 439
8.3 HOSPITALS 443
8.4 ACADEMIC & RESEARCH CENTRES 446
8.5 HOME CARE 449
8.6 OTHER END-USERS 452
9 REGIONAL MARKET ANALYSIS 455
9.1 INTRODUCTION 455
9.2 NORTH AMERICA 459
9.2.1 U.S. 493
9.2.2 REST OF NORTH AMERICA 500
9.3 EUROPE 505
9.3.1 GERMANY 539
9.3.2 U.K. 544
9.3.3 FRANCE 548
9.3.4 REST OF E.U. 552
9.4 ASIA PACIFIC 557
9.4.1 JAPAN 590
9.4.2 CHINA 595
9.4.3 INDIA 600
9.4.4 REST OF APAC 606
9.5 REST OF THE WORLD 611
9.5.1 BRAZIL 644
9.5.2 REST OF LATIN AMERICA 650
9.5.3 MIDDLE EAST AND OTHERS 654
10 COMPANY DEVELOPMENTS 659
10.1 INTRODUCTION 659
10.1.1 REGULATORY APPROVAL AS A MAJOR GROWTH STRATEGY OF IN-VITRO DIAGNOSTICS MARKET PLAYERS 660
10.2 APPROVAL 660
10.3 NEW PRODUCT LAUNCH 670
10.4 AGREEMENTS PARTNERSHIPS, COLLABORATIONS & JOINT VENTURES 677
10.5 MERGERS AND ACQUISITIONS 681
10.6 BUSINESS EXPANSION 684
11 COMPANY PROFILES 685
11.1 ABBOTT LABORATORIES 685
11.1.1 OVERVIEW 685
11.1.2 FINANCIALS 686
11.1.3 PRODUCT PORTFOLIO 690
11.1.4 KEY DEVELOPMENTS 691
11.1.5 BUSINESS STRATEGY 692
11.1.6 SWOT ANALYSIS 693
11.2 BIOMERIEUX 694
11.2.1 OVERVIEW 694
11.2.2 FINANCIALS 695
11.2.3 PRODUCT PORTFOLIO 698
11.2.4 KEY DEVELOPMENTS 701
11.2.5 BUSINESS STRATEGY 704
11.2.6 SWOT ANALYSIS 705
11.3 DANAHER CORPORATION 706
11.3.1 OVERVIEW 706
11.3.2 FINANCIALS 707
11.3.3 PRODUCT PORTFOLIO 709
11.3.4 KEY DEVELOPMENTS 721
11.3.5 BUSINESS STRATEGY 725
11.3.6 SWOT ANALYSIS 727
11.4 DEXCOM, INC. 728
11.4.1 OVERVIEW 728
11.4.2 FINANCIALS 729
11.4.3 PRODUCT PORTFOLIO 731
11.4.4 KEY DEVELOPMENTS 732
11.4.5 BUSINESS STRATEGY 733
11.4.6 SWOT ANALYSIS 734
11.5 F. HOFFMANN LA ROCHE 735
11.5.1 OVERVIEW 735
11.5.2 FINANCIALS 736
11.5.3 PRODUCT PORTFOLIO 740
11.5.4 KEY DEVELOPMENTS 742
11.5.5 BUSINESS STRATEGY 746
11.5.6 SWOT ANALYSIS 747
11.6 HOLOGIC, INC. 748
11.6.1 OVERVIEW 748
11.6.2 FINANCIALS 749
11.6.3 PRODUCT PORTFOLIO 752
11.6.4 KEY DEVELOPMENTS 754
11.6.5 BUSINESS STRATEGY 755
11.6.6 SWOT ANALYSIS 756
11.7 QUIDEL CORPORATION 757
11.7.1 OVERVIEW 757
11.7.2 FINANCIALS 758
11.7.3 PRODUCT PORTFOLIO 760
11.7.4 KEY DEVELOPMENTS 761
11.7.5 BUSINESS STRATEGY 764
11.7.6 SWOT ANALYSIS 765
11.8 SIEMENS HEALTHINEERS 766
11.8.1 OVERVIEW 766
11.8.2 FINANCIALS 767
11.8.3 PRODUCT PORTFOLIO 770
11.8.4 KEY DEVELOPMENTS 773
11.8.5 BUSINESS STRATEGY 775
11.8.6 SWOT ANALYSIS 776
11.9 SYSMEX 777
11.9.1 OVERVIEW 777
11.9.2 FINANCIALS 778
11.9.3 PRODUCT PORTFOLIO 780
11.9.4 KEY DEVELOPMENTS 781
11.9.5 BUSINESS STRATEGY 781
11.9.6 SWOT ANALYSIS 782
11.10 THERMO FISHER SCIENTIFIC 783
11.10.1 OVERVIEW 783
11.10.2 FINANCIALS 784
11.10.3 PRODUCT PORTFOLIO 787
11.10.4 KEY DEVELOPMENTS 788
11.10.5 BUSINESS STRATEGY 791
11.10.6 SWOT ANALYSIS 792

Report Title: In-Vitro Diagnostics (IVD) Global Market - Forecast To 2028


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