Biochemistry Analyzers Market Outlook:
Biochemistry Analyzers Market size was USD 4.1 billion in 2024 and is estimated to reach USD 7.2 billion by the end of 2037, expanding at a CAGR of 5.9% during the forecast period, i.e., 2025-2037. In 2025, the industry size of biochemistry analyzers is estimated at USD 4.9 billion.
The worldwide demand for the market is highly attributed to the continuous increase in the patient pool, which requires diagnostic evaluation, especially for infectious and chronic disorders. As per an article published by the World Health Organization (WHO) in 2023, non-communicable diseases (NCDs), including kidney, cardiovascular, and diabetic diseases, jointly account for 75% of international deaths every year, which has necessitated extensive biochemical evaluation. Besides, the 2023 CDC report reported that an estimated 37.5 million patients in America suffer from diabetes, with approximately 97 million adults in a prediabetic state, further enhancing the requirement for diagnostic equipment.
Furthermore, the supply chain aspect for the market comprises numerous stages, such as distribution, manufacturing, and raw material procurement. Besides, the U.S. Bureau of Labor Statistics (BLS) has indicated that the producer price index has upsurged by 3.3% year-over-year (YoY) basis for medical supplies and equipment by 2023, which in turn, has reflected production expenses. Meanwhile, the consumer price index grew by 4.2% YoY for medical diagnostic equipment, effectively propelled by high demand and disruptions in the supply chain system. Moreover, the export-import dynamics also play a major role in the market growth, with the USITC demonstrating a USD 2.9 billion in exports as of 2023.
Biochemistry Analyzers Market - Growth Drivers and Challenges
Growth Drivers
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Rising chronic disorder prevalence: The surge in chronic disorders is positively fueling the demand for the market internationally. As per the 2024 CDC data report, almost 42.5% of adults in the U.S. currently have obesity, which is readily driving glucose and lipid testing volumes up by approximately 9.5% every year. Likewise, 8.7 million patients in Germany require biochemistry evaluation for kidney and diabetes disease as of 2025, denoting an 18.5% increase since 2020. Besides, the National Health Commission in China demonstrated that an estimated 145 million people are affected by diabetes, of which 55% are undiagnosed, thereby necessitating 50,200 newest analyzers.
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Technical progression and AI adoption: Both automation and artificial intelligence are positively revolutionizing the market. In this regard, the NIH made an investment of USD 480 million in 2024 for AI-specific diagnostics, which includes autonomous analyzers that tend to diminish human errors by almost 37.5%. Besides, in the same year, the U.S. FDA cleared Roche’s cobas pro, which utilizes machine learning to flag abnormal results rapidly by 25%. In addition, the Horizon Europe program in the EU allocated €655 million for smart labs by integrating analyzers with EHRs for gaining real-time analytics, thus suitable for market development.
Manufacturer Strategies Shaping the Biochemistry Analyzers Market
The market comprises leading manufacturers that have leveraged localized production, tactical partnerships and collaboration, along with product innovation to dominate the overall market. For instance, Roche Diagnostics has expanded its position in the market by unveiling cobas pro integrated systems, which tend to diminish processing time by almost 44%, and capture USD 325 million in incremental revenue. Likewise, Siemens Healthineers has strengthened in emerging economies through its Atellica CI1900 deployments, particularly in India, which has surged its market share by an estimated 15%. Meanwhile, Abbott’s i-STAT Alinity has gained increased exposure, owing to the adoption of 5,500 units by MSF clinics, which has bolstered revenue by USD 157 million.
Revenue Potential for Key Manufacturers (2023-2025)
|
Company |
Strategy |
Revenue Impact |
Market Share Change |
|
Roche Diagnostics |
Launched cobas pro (FDA-cleared) |
+USD 325 million (2024) |
+9% in NA/EU |
|
Siemens Healthineers |
Atellica CI1900 rollout in India |
+USD 215 million (2023-2025) |
+15% in APAC |
|
Abbott Laboratories |
i-STAT Alinity in African clinics |
+USD 157 million (2023-2024) |
+5.5% in MEA |
|
Thermo Fisher |
Acquired Binding Site Group (2023) |
+USD 750 million oncology diagnostics |
+9.2% globally |
|
BioMérieux |
JV with India’s Mylab (50K units/yr) |
Projected +USD 188 million by 2026 |
+6.7% in India |
Feasible Expansion Models Shaping the Future of the Biochemistry Analyzers Market
Emerging economies in the biochemistry analyzers market are deliberately driving growth through cost-optimized manufacturing processes, administrative-based procurement, and localized partnership models. For instance, suppliers in India, including Transasia Bio-Medicals, entered into a partnership with Apollo Hospitals and deployed 5,500 semi-automated analyzers and increased revenue by almost 15% between 2022 and 2024. The In-Vitro Diagnostic Regulation (IVDR) in the EU has mandated localized service facilities and prompted Siemens Healthineers to create more than 9 regional support hubs, which bolstered their after-sales revenue by €88 million yearly, thus fueling the market growth internationally.
Feasibility Models for Market Expansion (2022-2024)
|
Model |
Region |
Key Player |
Revenue Impact |
Market Growth |
|
Hospital Partnerships |
India |
Transasia Bio-Medicals |
+15% Revenue |
5,500 Units Deployed |
|
Localized Service Hubs |
EU |
Siemens Healthineers |
+€ 88 million/Year |
+9 Support Centers |
|
Gavi-Funded POC Rollout |
Africa |
Abbott Laboratories |
+USD 55 million (2023) |
220 Clinics Served |
|
Leasing/Subscription |
U.S. |
Beckman Coulter |
+USD 127 million (2023) |
33% Uptake in Rural Labs |
Challenges
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Barriers in reimbursement and governmental pricing strategies: The administrative-imposed price strategies and strict reimbursement policies have hindered the expansion of the biochemistry analyzers market globally. For instance, there have been limitations in Medicaid reimbursement reforms in the U.S., which have excluded almost 45% of biochemistry evaluations from the overall coverage, owing to disproportionate cost thresholds that affect low-income patients. Besides, emerging economies, including India, is undergoing a huge challenge, wherein allocated public health and medical budgets are less than USD 6 per capita yearly for diagnostics. This has pressurized manufacturers in the country to operate on razor-thin margins, thus hampering market expansion.
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Complications and delays in regulatory approvals: The presence of fragmented and strict administrative frameworks tends to delay product launches, which in turn results in inflating research and development expenses, thus negatively impacting the biochemistry analyzers market. For example, in 2024, the FDA’s 510(k) backlog deferred Thermo Fisher’s Cascadion SM Clinical Analyzer by almost 8.5 months, which has cost the organization approximately USD 56 million in lost revenue. Likewise, the IVDR’s requirement for Notified Body audits in the EU has developed a 13 to 19-month acceptance bottleneck, which also includes only 47.5% of legacy devices re-certified by the end of 2024.
Biochemistry Analyzers Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
5.9% |
|
Base Year Market Size (2024) |
USD 4.1 billion |
|
Forecast Year Market Size (2037) |
USD 7.2 billion |
|
Regional Scope |
|
Biochemistry Analyzers Market Segmentation:
Application Segment Analysis
The diagnostics segment is projected to hold the largest share of 63.8% in the biochemistry analyzers market by the end of 2037, which is effectively fueled by a surge in the need for infectious and chronic disease testing. As per an article published by the WHO in 2024, non-communicable diseases (NCDs), such as heart and diabetes disorders, account for 75% of worldwide deaths, which necessitates routine biochemical testing for early detection. Besides, the CDC government report has demonstrated that approximately 37.5 million adults are diabetic and 96.5 million are prediabetic, thus propelling 9.5% yearly growth in lipid and glucose panel volumes.
Technology Segment Analysis
The colorimetric and photometric segment is expected to hold the second-largest share of 55.8% in the biochemistry analyzers market during the forecast period. This segment is the gold standard for tedious clinical chemistry evaluation. Additionally, its growth is attributed to the aspect of reliability, particularly in high-volume settings, with the FDA showcasing almost 98.5% accuracy rates for metabolic panels. Additionally, the MHLW reported that more than 82% of hospitals in Japan deliberately prefer photometric systems for kidney and liver functions, owing to their low operational expenses, thus suitable for the segment’s growth.
Portability Segment Analysis
The benchtop analyzers segment is anticipated to hold the third-largest share of 53.7% in the biochemistry analyzers market during the forecast timeline. This particular segment readily serves as the backbone of reference laboratory and hospital operations internationally. In addition, their leadership originates from larger throughput capabilities, with MHLW showcasing benchtop systems processes to range between 550 to 1,250 tests per hour in comparison to 55 to 250 tests per hour, especially for portable units. The 2024 Laboratory Network Report by the CDC has confirmed that approximately 80% of core laboratories in the U.S. depend on benchtop analyzers, thus suitable for the segment’s upliftment.
Our in-depth analysis of the biochemistry analyzers market includes the following segments:
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Segment |
Subsegment |
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Application |
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Technology |
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Portability |
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Product Type |
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End User |
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Test Type |
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Vishnu Nair
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Biochemistry Analyzers Market - Regional Synopsis
North America Market Insights
North America in the biochemistry analyzers market is projected to be the dominant region with the highest share of 42.9%, growing at a rate of 5.3% by the end of 2037. The U.S. readily dominates the region with 90.5% of the demand, attributed to an expansion in Medicaid and Medicare coverage, along with a surge in chronic illnesses prevalence. Meanwhile, Canada contributes the remaining 8.5% of the regional revenue, with the availability of provincial health services. Besides, automation mandates, a boost in the POC testing, and artificial intelligence-integrated analyzers are other trends effectively propelling the market development in the region.
The biochemistry analyzers market in the U.S. is significantly growing, with a USD 6.1 billion allocation for laboratory testing as of 2024. In addition, the 2024 policy of Medicare at present provides HbA1c test coverage for approximately 11 million prediabetic patients, bolstering the demand for analyzers. Besides, fully automated systems effectively dominate almost 77.5% of the overall country’s share, since they diminish misdiagnosis by almost 35%. Additionally, the AI-based investment of USD 2.3 billion by the NIH has accelerated smart analyzer implementation, which in turn, has reduced operational expenses by almost 27%, thus positively impacting the market in the country.
The biochemistry analyzers market in Canada is steadily growing at a 4.8% rate, primarily led by the existence of local health and medical reforms. As per the 2024 CIHI data report, almost USD 3.7 billion has been spent on diagnostics, with Ontario specifically allocating 22.5% for analyzer upgradation. In addition, the Precision Health Initiative by Health Canada has prioritized POC analyzers for indigenous communities, with an objective to overcome diagnostic delays by almost 33%. Besides, portable systems have gained increased traction in the country with a share of 28%, particularly for managing diabetes, accounting for 15.5% of test volume between 2022 and 2024, thereby creating an optimistic outlook for the overall market growth.
Europe Market Insights
Europe in the biochemistry analyzers market is projected to be the fastest-growing region with a share of 33.5% by the end of the forecast timeline. This growth is effectively driven by the healthcare digitalization, chronic illness burden, and surge in aging demographics. Germany and France are readily dominating, jointly with 48% of the regional revenue. The aspect of administrative investments, a surge in rare conditions, and the presence of the EU IVDR compliance are other factors responsible for uplifting the market in the region. For instance, according to the WHO Europe report, an estimated 60% of deaths are inevitably connected with NCDs, which has necessitated an expansion in testing, and in turn, boosts the market.
The biochemistry analyzers market in Germany is projected to grab 23.5% of the regional market share by the end of 2037, which is attributed to the implementation of innovation in health and medical infrastructure. Besides, the Federal Joint Committee has strengthened reimbursement policies for lipid and HbA1c testing as of 2024, further fueling 16% YoY demand growth, especially for automated analyzers. Moreover, the EMA data have demonstrated that 47.5% of EU-accepted artificial intelligence analyzers are installed in domestic laboratories, which has reduced diagnostic errors by 22%, thus suitable for market upliftment.
The biochemistry analyzers market in France accounts for 19.5% of the region’s market share, which is readily supported by HAS’s 2024 regulations that have prioritized decentralized-based testing. POC analyzers in the country can cater to 37 million yearly metabolic tests, which have increased by 20.8% since 2022. Besides, the EU Health Data Space has made an allocation of €550 million to implement analyzers with regional EHRs by reducing report delays by 30.5%. In addition, localized strategies have diminished import reliance from 52% to 32%, further reducing expenses by 11%, thereby bolstering market expansion in the country.
Key Biochemistry Analyzers Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The international biochemistry analyzers market is effectively affiliated, with the existence of organizations, including Siemens, Roche, and Abbott, jointly dominating the overall market with a 57.8% share. These companies have adopted suitable strategies, such as administrative partnerships, cost optimization, artificial intelligence integration, and expansion in developing countries. For instance, as stated in the WHO article, Abbott’s i-STAT Alinity has successfully targeted India and Africa with portable systems. Meanwhile, Siemens effectively collaborated with the EU’s EHDS to ensure interoperable systems, thus a prolific opportunity for the market globally.
Here is a list of key players operating in the global market:
|
Company Name (Country) |
Industry Focus |
Market Share (2024) |
|
Roche Diagnostics (Switzerland) |
Leader in fully automated systems (cobas series) & AI-driven lab solutions |
24% |
|
Siemens Healthineers (Germany) |
High-throughput analyzers (Atellica) & POC diagnostics |
21% |
|
Abbott Laboratories (U.S.) |
Portable systems (i-STAT Alinity) & chronic disease testing |
19% |
|
Thermo Fisher Scientific (U.S.) |
Precision diagnostics (Cascadion) & research-grade analyzers |
15% |
|
Danaher Corporation (U.S.) |
Beckman Coulter analyzers & lab automation (AU5800) |
13% |
|
bioMérieux (France) |
Microbiology & infectious disease testing (VITEK) |
xx% |
|
Ortho Clinical Diagnostics (U.S.) |
Blood chemistry systems (VITROS) & transfusion diagnostics |
xx% |
|
Sysmex Corporation (U.S.) |
Hematology-biochemistry integrated systems (XN-Series) |
xx% |
|
Mindray (China) |
Cost-effective analyzers (BS-2000M) for emerging markets |
xx% |
|
Bio-Rad Laboratories (U.S.) |
Quality control systems & diabetes testing (D-100) |
xx% |
|
Randox Laboratories (UK) |
Niche toxicology & customized test panels (RX series) |
xx% |
|
Transasia Bio-Medicals (India) |
Semi-automated analyzers (Erba Mannheim) for mid-tier labs |
xx% |
|
Horiba Medical (France) |
Compact analyzers (Pentra) for small clinics |
xx% |
|
ELITechGroup (France) |
Specialty assays (Platelia) & low-volume systems |
xx% |
|
Agappe Diagnostics (India) |
Affordable POC systems (Mispa) for rural healthcare |
xx% |
Below are the areas covered for each company in the biochemistry analyzers market:
Recent Developments
- In July 2024, Abbott Laboratories achieved the WHO prequalification for i-STAT Alinity handheld analyzers, specifically in more than 10 countries in Africa, which has enabled HIV/CD4 monitoring at USD 4.50 per test.
- In April 2024, Thermo Fisher Scientific successfully completed the USD 1.4 billion acquisition of Binding Site Group by adding protein testing capacities to Cascadion™ SM clinical analyzers.
Author Credits: Radhika Pawar
- Report ID: 7823
- Published Date: Jun 26, 2025
- Report Format: PDF, PPT
