Key Takeaways
- The global in vitro diagnostics (IVD) market was valued at USD 85.92 billion in 2022 and is projected to reach USD 115.51 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030, primarily due to the increasing prevalence of chronic diseases like diabetes and cancer.
- In 2023, the North American diagnostics market accounted for 41.2% of the global IVD market share, valued at approximately USD 35.4 billion, driven by advanced healthcare infrastructure and high adoption of point-of-care testing.
- The molecular diagnostics segment within the IVD market is expected to grow at a CAGR of 11.6% from 2024 to 2032, reaching USD 32.47 billion by 2032, fueled by advancements in PCR and NGS technologies.
- Roche Diagnostics generated USD 19.2 billion in revenue from diagnostics in 2023, representing 24% of total Roche group sales.
- Quest Diagnostics reported net revenues of USD 9.25 billion in 2023, up 6.8% from 2022, with adjusted EPS of USD 7.41.
- Abbott Laboratories' diagnostics segment revenue was USD 10.1 billion in 2023, growing 9.2% organically.
- Immunoassay tests accounted for 32.5% of the global IVD market share in 2023, valued at USD 28.1 billion.
- Clinical chemistry analyzers represented 24.8% of lab diagnostics equipment market in 2023, with USD 12.4 billion value.
- Molecular diagnostics for infectious diseases held 28% share in molecular IVD segment in 2023, USD 8.9 billion.
- North America held 40.1% share of global IVD market in 2023, driven by U.S. dominance at 35%.
- Europe IVD market share 28.5% in 2023, valued at USD 24.5 billion, led by Germany (12%).
- Asia-Pacific diagnostics market grew fastest at 6.8% CAGR 2018-2023, China contributing 45% of APAC growth.
- Roche held 14.2% global IVD market share in 2023, leader in immunoassay and clinical chemistry.
- Abbott Diagnostics commanded 12.8% market share in POC and molecular diagnostics in 2023.
- Siemens Healthineers 11.5% share in lab automation and analyzers globally 2023.
The global diagnostics industry is rapidly expanding due to rising chronic diseases and technological advances.
Competitive Landscape
- Roche held 14.2% global IVD market share in 2023, leader in immunoassay and clinical chemistry.
- Abbott Diagnostics commanded 12.8% market share in POC and molecular diagnostics in 2023.
- Siemens Healthineers 11.5% share in lab automation and analyzers globally 2023.
- Quest Diagnostics controlled 25% U.S. clinical lab market share in 2023 by volume.
- LabCorp held 22% U.S. independent lab market share in 2023, revenues USD 11.4B.
- Thermo Fisher 9.3% share in molecular diagnostics reagents 2023.
- Bio-Rad Laboratories 6.8% in clinical diagnostics instruments market 2023.
- Danaher (Beckman Coulter) 8.2% share in hematology analyzers 2023.
- Ortho Clinical (QuidelOrtho) 7.1% in transfusion diagnostics 2023.
- Hologic 5.4% share in women's health diagnostics (molecular) 2023.
- Becton Dickinson 6.9% in microbiology diagnostics 2023.
- Revvity (PerkinElmer) 4.7% in newborn screening and genetics 2023.
- Exact Sciences 15% share in U.S. colorectal cancer screening 2023.
- Guardant Health 12% U.S. liquid biopsy market share 2023.
- Sonic Healthcare 35% Australia/NZ lab market, 8% Europe 2023.
- Synlab AG 20% share in European pathology labs 2023.
- BioMerieux 10.5% in microbiology IVD worldwide 2023.
- Top 5 IVD companies (Roche, Abbott, Siemens, Thermo, Danaher) held 52% global market share in 2023.
Competitive Landscape Interpretation
Financial Metrics
- Roche Diagnostics generated USD 19.2 billion in revenue from diagnostics in 2023, representing 24% of total Roche group sales.
- Quest Diagnostics reported net revenues of USD 9.25 billion in 2023, up 6.8% from 2022, with adjusted EPS of USD 7.41.
- Abbott Laboratories' diagnostics segment revenue was USD 10.1 billion in 2023, growing 9.2% organically.
- LabCorp (Laboratory Corporation of America) achieved USD 12.16 billion in total revenues for 2023, with diagnostics segment at USD 11.4 billion.
- Siemens Healthineers diagnostics revenue reached EUR 8.5 billion in fiscal 2023, up 10.5% year-over-year.
- Thermo Fisher Scientific's specialty diagnostics segment generated USD 4.1 billion in 2023 revenue, with 5% growth.
- Bio-Rad Laboratories reported USD 2.7 billion in total revenue for 2023, with life science and clinical diagnostics contributing equally.
- Danaher Corporation's diagnostics revenue (Cepheid, Beckman Coulter) was USD 7.8 billion in 2023, up 4%.
- Ortho Clinical Diagnostics (QuidelOrtho) posted USD 2.8 billion in sales for 2023, with 12% growth in immunoassay.
- Hologic Inc.'s diagnostics division revenue hit USD 1.9 billion in FY2023, driven by molecular diagnostics growth of 15%.
- Becton Dickinson (BD) diagnostics revenue was USD 5.2 billion in FY2023, with integrated diagnostics up 8%.
- PerkinElmer (Revvity) clinical diagnostics revenue USD 1.1 billion in 2023, flat YoY.
- Exact Sciences Corporation revenue reached USD 2.5 billion in 2023, up 24%, primarily from Cologuard screening.
- Guardant Health generated USD 563.5 million in revenue for 2023, with 31% growth in precision oncology testing.
- Sonic Healthcare Ltd. reported AUD 8.1 billion in FY2023 revenue, with laboratory division at AUD 7.2 billion.
- Unilabs Group (Europe) achieved EUR 1.6 billion revenue in 2023, up 7%.
- Synlab AG diagnostics revenue EUR 2.4 billion in 2023, with EBITDA margin of 14.2%.
- BioMerieux SA posted EUR 3.5 billion in 2023 sales, up 18.4%, diagnostics 90% of total.
- Clinical Pathology Laboratories (Sonic) net profit margin 8.5% in 2023 on USD 1.2 billion revenue.
Financial Metrics Interpretation
Key Trends and Innovations
- CRISPR-based diagnostics adoption rose 45% in labs from 2022-2023.
- AI integration in pathology diagnostics improved accuracy by 25% in 2023 studies.
- Point-of-care molecular testing volumes increased 32% YoY in 2023 globally.
- Liquid biopsy tests for cancer grew 28% in adoption 2023, 1.2 million tests performed.
- Digital pathology systems installations up 22% in 2023, over 5,000 new units.
- NGS throughput in labs averaged 500 Gb per run in 2023, 40% higher than 2022.
- Telepathology consultations surged 55% post-COVID in 2023.
- Biosensor-based glucose monitors achieved 95% accuracy in continuous monitoring 2023.
- Multiplex immunoassay panels for autoimmune diseases adopted in 40% of large labs 2023.
- Lab-on-a-chip devices for infectious disease testing reduced time-to-result to under 30 min in 2023 pilots.
Key Trends and Innovations Interpretation
Market Size and Growth
- The global in vitro diagnostics (IVD) market was valued at USD 85.92 billion in 2022 and is projected to reach USD 115.51 billion by 2030, growing at a CAGR of 4.2% from 2023 to 2030, primarily due to the increasing prevalence of chronic diseases like diabetes and cancer.
- In 2023, the North American diagnostics market accounted for 41.2% of the global IVD market share, valued at approximately USD 35.4 billion, driven by advanced healthcare infrastructure and high adoption of point-of-care testing.
- The molecular diagnostics segment within the IVD market is expected to grow at a CAGR of 11.6% from 2024 to 2032, reaching USD 32.47 billion by 2032, fueled by advancements in PCR and NGS technologies.
- Global clinical laboratory services market size was USD 236.15 billion in 2023 and is anticipated to expand at a CAGR of 5.4% to USD 375.12 billion by 2032.
- The point-of-care diagnostics market is projected to grow from USD 45.67 billion in 2024 to USD 70.90 billion by 2030 at a CAGR of 7.6%, due to demand for rapid testing in remote areas.
- U.S. laboratory services market reached USD 102.5 billion in 2023, with a forecasted CAGR of 5.1% through 2030, supported by an aging population and rising diagnostic volumes.
- The immuno diagnostics market size was valued at USD 28.91 billion in 2023 and is expected to grow to USD 46.78 billion by 2031, at a CAGR of 6.2%.
- Asia-Pacific IVD market is estimated to register the fastest CAGR of 5.9% from 2024 to 2030, reaching USD 25.6 billion by 2030, owing to expanding healthcare access in India and China.
- Global lab automation market was USD 5.12 billion in 2022 and projected to hit USD 7.89 billion by 2030, with a CAGR of 5.6%.
- The tissue diagnostics market size stood at USD 5.8 billion in 2023 and is set to grow at a CAGR of 7.1% to USD 9.6 billion by 2030.
- European diagnostics lab market valued at EUR 42.3 billion in 2023, expected to grow at 4.8% CAGR to EUR 58.7 billion by 2030.
- U.S. molecular diagnostics market was USD 12.8 billion in 2023, projected CAGR 9.5% to USD 25.4 billion by 2030.
- Global companion diagnostics market size was USD 7.9 billion in 2023, forecasted to reach USD 15.2 billion by 2032 at CAGR 7.6%.
- India clinical diagnostics market valued at INR 80,000 crore in FY2023, expected to grow at 15-20% CAGR to INR 2.5 lakh crore by 2028.
- Latin America IVD market projected to grow at CAGR 6.2% from 2024-2030, reaching USD 8.9 billion by 2030.
- Global hematology diagnostics market size was USD 4.2 billion in 2023, expected to reach USD 6.1 billion by 2031 at CAGR 4.8%.
- China diagnostics market hit CNY 450 billion in 2023, with CAGR 8.5% forecasted to CNY 850 billion by 2030.
- Middle East & Africa IVD market valued at USD 4.5 billion in 2023, growing at 5.9% CAGR to USD 7.2 billion by 2030.
- Global urinalysis market size was USD 1.4 billion in 2023, projected to USD 2.1 billion by 2032 at CAGR 4.6%.
- Canada laboratory services market reached CAD 12.5 billion in 2023, CAGR 4.2% to CAD 17.8 billion by 2030.
Market Size and Growth Interpretation
Product Segments
- Immunoassay tests accounted for 32.5% of the global IVD market share in 2023, valued at USD 28.1 billion.
- Clinical chemistry analyzers represented 24.8% of lab diagnostics equipment market in 2023, with USD 12.4 billion value.
- Molecular diagnostics for infectious diseases held 28% share in molecular IVD segment in 2023, USD 8.9 billion.
- Hematology testing comprised 15.2% of clinical lab test volumes globally in 2023, over 4 billion tests annually.
- Point-of-care blood glucose testing dominated POC market with 42% share in 2023, USD 19.2 billion.
- Microbiology diagnostics segment valued at USD 7.6 billion in 2023, 9% of total IVD market.
- Coagulation testing market size USD 3.9 billion in 2023, 4.5% IVD share, led by PT/INR tests.
- Cancer diagnostics tests accounted for 22% of molecular diagnostics revenue in 2023, USD 7.1 billion.
- Urinalysis strips and analyzers held 35% of urinalysis market in 2023, USD 0.49 billion.
- Tissue diagnostics IHC reagents segment 41% market share in 2023, USD 2.4 billion.
- NGS-based companion diagnostics grew to 18% of CDx market in 2023, USD 1.42 billion.
- ELISA kits dominated immunoassays with 52% share in research labs in 2023.
- HbA1c testing for diabetes diagnostics represented 60% of glycemic control tests in 2023.
- PCR tests for COVID-19 still held 12% of molecular diagnostics volume in 2023 post-pandemic.
- Flow cytometry reagents market USD 2.1 billion in 2023, 28% of hematology diagnostics.
- Blood gas analyzers 22% of POC critical care testing in 2023.
- FISH tests 15% share in oncology diagnostics in 2023, USD 1.2 billion.
- Lipid profile panels 18% of clinical chemistry test volumes in routine labs 2023.
Product Segments Interpretation
Regional Insights
- North America held 40.1% share of global IVD market in 2023, driven by U.S. dominance at 35%.
- Europe IVD market share 28.5% in 2023, valued at USD 24.5 billion, led by Germany (12%).
- Asia-Pacific diagnostics market grew fastest at 6.8% CAGR 2018-2023, China contributing 45% of APAC growth.
- U.S. clinical labs processed 14 billion tests in 2023, 70% of North American volume.
- India diagnostics market penetration at 20% of total healthcare spend in 2023, urban areas 80% of volumes.
- Japan IVD market USD 8.2 billion in 2023, 5.2% CAGR, aging population key driver.
- Brazil lab services market USD 5.1 billion in 2023, 25% CAGR since 2018 due to privatization.
- Germany diagnostics revenue EUR 12.4 billion in 2023, 18% of European market.
- South Korea molecular diagnostics market USD 1.8 billion in 2023, 12% APAC share.
- Australia clinical labs market AUD 4.5 billion in 2023, Sonic Healthcare 40% share.
- Middle East IVD market USD 2.9 billion in 2023, Saudi Arabia 35% regional share.
- UK lab testing volumes 2.1 billion tests in 2023, NHS 85% of total.
- Mexico diagnostics market USD 2.3 billion in 2023, growing 7.5% CAGR.
- Russia IVD market USD 1.7 billion in 2023, import dependency 70%.
- South Africa lab services USD 1.2 billion in 2023, private sector 60% market.
Regional Insights Interpretation
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