Beneath the surface of every routine blood test and rapid diagnostic lies an $84.5 billion global industry, where a handful of powerful companies and relentless technological innovation are reshaping how we detect and manage disease.
Key Takeaways
- Global in vitro diagnostics (IVD) market size was valued at USD 84.5 billion in 2022 and is expected to grow at a CAGR of 4.2% from 2023 to 2030.
- IVD reagents segment generated revenue of USD 49.2 billion in 2022, representing the largest product segment.
- U.S. IVD market size reached USD 35.6 billion in 2022, with a projected CAGR of 4.5% to 2030.
- The IVD market in North America accounted for over 41% revenue share in 2022, driven by advanced healthcare infrastructure.
- Europe IVD market is projected to grow at a CAGR of 5.1% from 2023 to 2028, supported by aging population.
- Asia Pacific IVD market grew at 6.8% CAGR from 2018-2022, fastest regionally due to rising healthcare access.
- Clinical chemistry segment dominated the IVD market with a revenue share of 52.3% in 2022 due to high demand for routine testing.
- Immunoassay analyzers segment accounted for 38.5% of the IVD instruments market in 2022.
- Molecular diagnostics segment in IVD market valued at USD 18.7 billion in 2022.
- Infectious diseases application held the largest market share of 28.4% in the IVD market in 2022, boosted by COVID-19 diagnostics.
- Oncology IVD market share was 22.1% in 2022 within disease diagnostics applications.
- Diabetes management IVD applications generated USD 12.4 billion in revenue in 2022.
- Roche Diagnostics held the leading position in the IVD market with approximately 15% market share in 2022.
- Abbott Laboratories captured 12.8% of the global IVD market revenue in 2022.
- Siemens Healthineers market share in IVD stood at 11.2% globally in 2022.
The IVD diagnostics market is large, growing steadily, and dominated by reagents and routine testing.
Application Segments
- Infectious diseases application held the largest market share of 28.4% in the IVD market in 2022, boosted by COVID-19 diagnostics.
- Oncology IVD market share was 22.1% in 2022 within disease diagnostics applications.
- Diabetes management IVD applications generated USD 12.4 billion in revenue in 2022.
- Cardiology diagnostics in IVD accounted for 15.7% application market share in 2022.
- Autoimmune diseases IVD testing market share was 11.3% in 2022.
- Nephrology IVD applications contributed 9.2% market share in 2022.
- Neurology diagnostics IVD share was 7.5% in 2022 applications.
- Gastroenterology IVD market share 6.8% in 2022.
- Respiratory diseases IVD testing surged to 18.9% share post-COVID in 2022.
- Drug testing IVD applications 10.4% market share in 2022.
- Endocrinology IVD testing 13.6% share in 2022 applications.
- Rheumatology IVD share 5.2% in 2022.
- Hematology testing IVD 14.8% application share 2022.
- Infectious disease POCT 42.7% share in applications 2022.
- Lipid profile testing IVD 11.2% cardiology share 2022.
- Thyroid testing IVD 9.7% endocrinology share 2022.
- CRP testing in inflammation IVD 8.4% share 2022.
- PSA testing oncology IVD 12.5% share 2022.
- HbA1c diabetes IVD 16.3% share 2022.
- Vitamin D testing 10.1% endocrinology IVD 2022.
- Troponin cardiac biomarkers 14.9% share 2022.
- D-dimer thrombosis IVD 11.7% share 2022.
- Influenza rapid tests 22.3% respiratory IVD 2022.
- BNP/NT-proBNP heart failure IVD 13.2% 2022.
- CA-125 ovarian cancer marker 9.4% oncology IVD 2022.
- Ferritin iron deficiency IVD 7.8% hematology 2022.
Application Segments Interpretation
The IVD market's 2022 story reads like a medical drama: infectious diseases seized the starring role thanks to COVID-19, while oncology played a formidable supporting character, and every other specialty—from cardiology to endocrinology—jostled for a piece of the diagnostic revenue pie.
Competitive Landscape
- Roche Diagnostics held the leading position in the IVD market with approximately 15% market share in 2022.
- Abbott Laboratories captured 12.8% of the global IVD market revenue in 2022.
- Siemens Healthineers market share in IVD stood at 11.2% globally in 2022.
- Danaher Corporation (Beckman Coulter) had 9.5% IVD market share in 2022.
- Thermo Fisher Scientific occupied 8.7% of global IVD market in 2022.
- Bio-Rad Laboratories held 6.4% share in IVD reagents market in 2022.
- Ortho Clinical Diagnostics market share was 5.9% in 2022 globally.
- Becton Dickinson & Co. had 7.1% IVD market share in 2022.
- Arkray Inc. captured niche 3.2% in glucose monitoring IVD segment 2022.
- Hologic Inc. market share 4.8% in women's health IVD 2022.
- bioMérieux SA held 6.9% in microbiology IVD segment 2022.
- Qiagen NV market share 5.3% in molecular diagnostics IVD 2022.
- Sysmex Corporation 7.6% share in hematology analyzers 2022.
- LumiraDx Ltd. emerging with 2.1% in POCT IVD 2022.
- DiaSorin S.p.A. 5.7% share in immunoassay IVD 2022.
- Response Biomedical Corp. 1.8% in cardiac POCT IVD 2022.
- Eiken Chemical Co. 3.9% in TB diagnostics IVD 2022.
- Fujirebio Inc. 4.2% share in tumor markers IVD 2022.
- Immucor Inc. 2.9% in transfusion diagnostics IVD 2022.
- Grifols SA 6.2% share in coagulation IVD 2022.
- Bio-Rad Laboratories 6.4% overall IVD share reiterated 2022.
- Accelerate Diagnostics Inc. 1.5% emerging tech share 2022.
- Meridian Bioscience 3.6% in molecular POCT IVD 2022.
- BioFire Diagnostics (bioMérieux) 4.1% PCR panel share 2022.
- GenMark Diagnostics 2.7% syndromic panel IVD 2022.
- Alere Inc. (Abbott) 8.2% POCT share 2022.
Competitive Landscape Interpretation
It appears Roche still runs the diagnostic world, but the sheer number of specialists carving out their own kingdoms suggests the throne room is getting awfully crowded.
Market Size and Growth
- Global in vitro diagnostics (IVD) market size was valued at USD 84.5 billion in 2022 and is expected to grow at a CAGR of 4.2% from 2023 to 2030.
- IVD reagents segment generated revenue of USD 49.2 billion in 2022, representing the largest product segment.
- U.S. IVD market size reached USD 35.6 billion in 2022, with a projected CAGR of 4.5% to 2030.
- Global IVD market projected to reach USD 123.5 billion by 2030 at 4.9% CAGR from 2023 base.
- IVD point-of-care testing market size was USD 28.4 billion in 2022, growing at 7.1% CAGR.
- European IVD market size stood at USD 22.3 billion in 2022 with steady growth.
- Global IVD software market within the industry was USD 4.1 billion in 2022.
- IVD consumables market size estimated at USD 55.7 billion in 2023 projection.
- Lab-based IVD testing dominated with 68.4% revenue share in 2022 globally.
- POCT IVD market expected to hit USD 49.3 billion by 2028 at 8.6% CAGR.
- Self-testing IVD kits market USD 6.7 billion in 2022 globally.
- Digital IVD market integration projected USD 12.4 billion by 2030.
- Hospital end-use segment 55.3% IVD market share in 2022.
- Over-the-counter IVD market USD 8.9 billion projected 2023.
- IVD market for NGS-based tests USD 3.6 billion in 2022.
- Companion diagnostics IVD market USD 7.1 billion 2022 growth.
- IVD AI integration market projected USD 2.5 billion by 2027.
- Home-based IVD testing market USD 15.4 billion 2022.
- IVD for pharmacogenomics USD 1.9 billion 2022.
- Centralized lab IVD services USD 40.2 billion 2022.
- IVD newborn screening market USD 1.2 billion 2022.
- Remote diagnostics IVD trend USD 4.7 billion projection 2023.
- IVD CRISPR diagnostics market nascent USD 0.8 billion 2022.
- IVD for rare diseases USD 2.2 billion 2022.
- Wearable-integrated IVD sensors USD 1.4 billion emerging 2022.
- IVD telemedicine linkage market USD 3.3 billion 2022.
Market Size and Growth Interpretation
The global IVD industry, now an $84.5 billion behemoth, is quietly staging a revolution from within, as the humble lab coat is being steadily outflanked by the nimble, at-home test kit and the supercharged software, all racing toward a future where the diagnosis increasingly meets you right where you are.
Product Segments
- Clinical chemistry segment dominated the IVD market with a revenue share of 52.3% in 2022 due to high demand for routine testing.
- Immunoassay analyzers segment accounted for 38.5% of the IVD instruments market in 2022.
- Molecular diagnostics segment in IVD market valued at USD 18.7 billion in 2022.
- Fully automated analyzers held 45.2% share in IVD systems market in 2022.
- Microbiology IVD segment revenue reached USD 14.2 billion in 2022.
- Tissue diagnostics segment in IVD valued at USD 7.8 billion in 2022.
- Hematology analyzers segment captured 31.6% of IVD instruments in 2022.
- Coagulation testing segment revenue USD 9.3 billion in IVD 2022.
- ELISA tests in immunoassay segment held 42.1% share in 2022.
- PCR-based molecular diagnostics revenue USD 10.5 billion in 2022.
- Chemiluminescence immunoassay led with 35.7% in reagents 2022.
- Urinalysis products segment USD 5.4 billion revenue 2022.
- Flow cytometry analyzers 22.4% in immunology products 2022.
- Biosensors in POCT IVD generated USD 9.2 billion 2022.
- Lateral flow assays in rapid tests 28.5% segment share 2022.
- Glucose monitoring strips USD 11.8 billion revenue 2022.
- Mass spectrometry reagents USD 2.3 billion in IVD 2022.
- Western blot tests 18.2% in protein diagnostics 2022.
- Turbidimetry methods 26.1% clinical chemistry share 2022.
- Microarrays in genomics IVD USD 3.1 billion 2022.
- Nephelometry in immunoassays 19.8% share 2022.
- Electrochemical sensors 33.4% POCT segment 2022.
- Real-time PCR instruments USD 4.9 billion 2022.
- Immunoturbidimetric assays 24.6% clinical chem 2022.
- Digital PCR tech USD 5.2 billion forecast base 2022.
- Blotting techniques 15.9% molecular IVD 2022.
Product Segments Interpretation
While clinical chemistry still rules the testing kingdom by bulk demand, a closer look reveals a bustling and specialized court where immunoassay generals, molecular diagnostics wizards, and automated machine overlords all vie for their own lucrative slices of the diagnostic pie.
Regional Markets
- The IVD market in North America accounted for over 41% revenue share in 2022, driven by advanced healthcare infrastructure.
- Europe IVD market is projected to grow at a CAGR of 5.1% from 2023 to 2028, supported by aging population.
- Asia Pacific IVD market grew at 6.8% CAGR from 2018-2022, fastest regionally due to rising healthcare access.
- China IVD market valued at USD 12.1 billion in 2022, with 8.2% annual growth.
- Latin America IVD market expected to grow at 5.5% CAGR to 2030 from emerging economies.
- Middle East & Africa IVD market CAGR projected at 6.3% from 2023-2028.
- Japan IVD market grew at 4.8% CAGR over 2019-2022 period.
- India IVD market valued at USD 1.9 billion in 2022 with rapid urbanization boost.
- Germany IVD market size USD 5.2 billion in 2022, leader in Europe.
- Brazil IVD market grew 5.9% annually 2020-2022.
- South Korea IVD market CAGR 7.2% from 2021-2022.
- Australia IVD market size USD 2.1 billion in 2022.
- UK IVD market valued at USD 4.3 billion 2022.
- Mexico IVD market CAGR 6.1% 2020-2022.
- France IVD market size USD 3.9 billion 2022.
- Canada IVD market USD 3.2 billion in 2022.
- Italy IVD market CAGR 4.7% 2019-2022.
- Spain IVD market size USD 2.8 billion 2022.
- Netherlands IVD market grew 5.3% CAGR recent years.
- Russia IVD market USD 2.4 billion despite challenges 2022.
- Turkey IVD market CAGR 7.4% 2020-2022.
- Saudi Arabia IVD market size USD 1.5 billion 2022.
- UAE IVD market grew 6.9% annually recent period.
- Argentina IVD market USD 1.1 billion 2022.
- Poland IVD market CAGR 5.8% 2021-2022.
- Egypt IVD market size USD 0.9 billion 2022.
Regional Markets Interpretation
While North America's massive and well-equipped IVD market remains the wealthy grandparent of the industry, the true global pulse is quickening fastest in the ambitious, access-seeking patients of Asia Pacific and the emerging economies, proving that diagnostics are no longer a luxury but a global necessity.
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