Clinical Chemistry
Clinical chemistry – Poised for continued transformation
Clinical chemistry continues to be central to diagnostic procedures. It plays a pivotal role in disease detection, drug monitoring, and organ functioning evaluation.
Clinical chemistry accounts for the most significant volume of tests in laboratory medicine, and is the basis of the majority of clinical decisions impacted by laboratory results.
The futuristic approach to gathering insights for the clinical chemistry analyzer systems market involves utilizing advanced technologies, such as artificial intelligence (AI), machine learning (ML), and big data analytics to track and analyze market trends in real time. These tools provide a more accurate and timely understanding of customer preferences, market dynamics, and competitive landscape, enabling companies to make data-driven decisions and stay ahead of the competition.
The potential impact of these insights on shaping future market trends is significant, as companies can identify emerging opportunities, understand customer needs more effectively, and anticipate changing market demands. This proactive approach allows businesses to adapt quickly, innovate, and develop competitive strategies to stay relevant in a rapidly evolving market landscape.
The testing process includes laboratory procedures, instruments, technology, and human skills intended to warrant accurate, precise, and appropriate diagnosis and treatment decisions. Divided into three stages, the pre-analytical, analytical, and post-analytical, laboratory errors can arise in any of the phases. Identifying and reducing errors and the risk of errors in laboratory medicine is challenging.
The primary source of laboratory errors occurs in the pre-analytical phase, with over 46 percent to 68 percent. Quality controls and quality assurance in this phase are needed to monitor existing errors and improve patient safety and laboratory diagnosis.
The analytical phase begins when the lab prepares a patient specimen for testing and culminates in verifying and interpreting the test results. Advances in lab automation tools have improved analytical techniques within the lab, provided superior instrumentation, and decreased error rates.
Human and instrumental errors may be encountered during the analytical phase. Occasionally, random errors may also occur. Errors that skew sample measurement due to human mistakes or instrumental malfunctions are more common.
Even with automation in place, analytical quality remains a significant issue. Issues can arise due to inadequate sample preparation or the accidental presence of substances that can interfere with the accuracy, sensitivity, and precision of results.
The post-analytical phase is the final stage of the testing process, in which clinicians review the test results. During this phase, the results should also be promptly released. This is particularly important for critical results and those needed to help medical professionals make critical health decisions for their patients.
Even in the post-analytics phase, errors can still occur. This can happen at the data entry stage, during data transmission, through incorrect calculations, or through delayed turnaround time for results.
Automation and traceability solutions have significantly reduced pre-pre-analytical error rates in laboratories and outpatient facilities. Therefore, an open ecosystem of innovative companies is proposed as a solution for improving lab pre-pre-analytical operations.
Implementing an automated system for identifying, storing, and tracking samples can eliminate errors at the front end and reduce the labor intensiveness of manual implementation. Once an error has been detected, the system can be used to reject related samples.
Market dynamics
Modern clinical chemistry is built on the foundation of traditional manual laboratory tests. However, as technology has progressed, testing methods have developed, and various tests may now be performed in automated laboratories, utilizing complex devices such as chemical analyzers. The global clinical chemistry market is estimated to reach USD 21.46 billion by 2032, from USD 14.13 billion in 2024, growing at a CAGR of 5.4 percent.
The increasing demand for advanced clinical chemistry analyzers is prompting prominent players to focus on research and development (R&D) activities. These efforts aim to launch analyzers with high productivity and throughput, supporting their growing adoption. Government approvals and new product launches are shifting toward advanced analyzers for early disease detection, treatment, and management.
Clinical chemistry involves the biochemical analysis of body fluids, such as blood, serum, and urine, to diagnose and treat diseases. Instruments in this field use chemical reactions to identify or quantify compounds like electrolytes and lipid profiles. The rise in diagnostic tests, such as liver and renal assessments, is boosting the adoption of clinical analyzers.
The prevalence of disorders like cardiovascular disease is increasing patient visits to hospitals and clinics, leading to more diagnostic procedures and greater use of clinical analyzers. The precision and accuracy of these devices in early disorder detection further drive demand. Additionally, acquisitions and collaborations among significant market players strengthen their presence and contribute to market growth.
Despite their diagnostic benefits, the clinical chemistry market faces several challenges. The Covid-19 pandemic negatively impacted the global market due to government-imposed restrictions, leading to decreased patient visits and reduced testing. This, along with supply chain disruptions for instruments, reagents, and consumables, resulted in a decline in annual revenue and market growth.
Additionally, the high cost of analyzers limits their adoption, particularly in emerging countries, including India. Growing technological advancements further increase product costs, and the high maintenance expenses of these analyzers also hamper demand. These factors collectively restrain the growth of the clinical chemistry market.
By product type, the reagents and consumables segment held the lion’s share of the market in 2023. This dominance is attributed to the growing adoption of testing kits in diagnostic procedures for improved accuracy and precision. This, along with the increasing focus of key players on launching innovative testing kits, including reagents and kits, is likely to support the growth of the segment in the market.
On the other hand, the instruments segment is also growing. This growth is owing to the increasing prevalence of chronic disorders, such as cardiovascular and liver disorders, which result in increasing patient admissions to healthcare facilities. Furthermore, the growing adoption of analyzers in healthcare facilities is expected to spur the segment’s growth.
In 2023, the liver tests segment dominated and accounted for the highest market share by application due to the increasing prevalence of liver disorders, such as non-alcoholic fatty liver disease. The balance contribution came from electrolyte panels, basic and comprehensive metabolic panels, renal tests, and lipid panels.
The lipid panel and renal test segments are also growing due to increased diagnostic procedures for assessing renal function and lipid profiles, aiding in disease detection. Adopting advanced analyzers in clinical laboratories for early detection of cardiovascular and kidney-related diseases supports this growth.
Additionally, segments like electrolytes and metabolic panels are expanding due to patients’ preference for routine check-ups to identify early health issues. Growing awareness of routine health check-ups further drives the adoption of these analyzers, contributing to market growth.
The hospitals and clinics segment is expected to grow significantly in 2024 due to rising patient admissions for diagnosing chronic conditions like cardiovascular diseases. This increase in diagnostic procedures supports the growing adoption of these products in healthcare facilities.
Laboratory accreditation and data management
Jason Armstrong
Scientific Content Creator,
Randox Laboratories Ltd
In laboratory medicine, accreditation plays a crucial role in ensuring quality, accuracy, and reliability in testing. Accreditation bodies like NABL (National Accreditation Board for Testing and Calibration Laboratories) and ISO15189 set stringent standards that laboratories must meet to guarantee the integrity of their results. To navigate these requirements effectively, robust data management systems are essential.
One of the pivotal components in achieving and maintaining accreditation is comprehensive quality control (QC). Effective QC management tools enable laboratories to monitor performance, detect trends, and shifts in data, and implement corrective actions promptly. For instance, ISO15189:2022 emphasizes the importance of recording data to identify trends and using statistical techniques for data review. This ensures that any deviations are quickly addressed, maintaining the accuracy and reliability of test results.
Moreover, ISO15189:2022 guidelines require detailed documentation of QC activities, including remedial actions and maintenance records. These records must be meticulously maintained and reviewed to ensure compliance. Similarly, graphical representation of QC data, such as Levey-Jennings charts, and the documentation of corrective actions taken in response to any shifts or trends observed, are crucial for accreditation.
Measurement uncertainty (MU) is another critical aspect of laboratory accreditation. It provides an estimate of the variability in measurement results, helping laboratories understand the reliability of their data. Regular evaluation and documentation of MU are mandatory under ISO15189:2022. Although calculating MU can be complex and time-consuming, advanced QC software can streamline this process, providing accurate calculations in a fraction of the time it would take manually.
Peer group reporting is also a valuable tool for laboratories. By comparing their performance with that of peers, laboratories can quickly identify whether issues are unique to them or widespread. This comparison enhances confidence in test results and helps in meeting external quality assessment (EQA) requirements.
In conclusion, achieving and maintaining laboratory accreditation demands meticulous adherence to standards and robust data management practices. Quality control software that offers comprehensive statistical analysis, interactive data visualization, and efficient documentation can significantly ease this process. By integrating these tools, laboratories can ensure continuous compliance, improve operational efficiency, and ultimately deliver reliable and accurate diagnostic results.
Regional insights
In 2023, the market size in North America stood at USD 4.78 billion. This regional dominance is driven by the rising demand for clinical chemistry analyzers, which have been increasingly adopted in healthcare facilities for early disease detection, management, and treatment.
Europe contributed significantly to the market in 2023 due to the rising prevalence of disorders like cardiovascular diseases. This has led to more diagnostic procedures and government initiatives, promoting disease diagnosis, further supporting the adoption of clinical chemistry analyzers.
Increasing demand for point-of-care testing is driven by patients seeking quicker, more convenient options. The integration of advanced technologies like AI and automation enhances test efficiency and accuracy. The shift toward personalized medicine demands more tailored testing options, fostering the development of innovative systems. Additionally, healthcare providers’ focus on cost-effective solutions drives the creation of affordable and efficient clinical chemistry analyzers.
Automation is transforming clinical research operations
In 2023, the FDA approved 55 novel therapies, a 48.6-percent increase from the 37 approved in 2022, bringing the industry back to pre-pandemic levels. Despite this increase, the 10-year average of new therapies approved remains below 50 per year, even with higher R&D spending. However, clinical research over the past five years has laid the groundwork for a significant increase in therapy approvals, driven by technological advancements and AI-enabled clinical trials.
Emerging trends in India’s clinical chemistry market
Dr Rajesh Rengarajan
Product Manager – Clinical Chemistry Reagents,
DiaSys Diagnostics India Pvt. Ltd.
The Indian clinical chemistry market has seen notable growth due to rising chronic diseases, advancements in diagnostic technologies, and increased healthcare spending. The market includes reagents, analyzers, and consumables, with reagents being the most dominant due to their frequent use. Key tests include liver and kidney function, cardiac profiles, lipid profiles, and glucose monitoring, particularly for diabetes management. Major end-users are hospitals, diagnostic laboratories, and research institutions, with diagnostic labs conducting the highest volume of tests.
Key drivers
- Rising prevalence of chronic diseases. Increased cases of diabetes, hypertension, and cardiovascular diseases have heightened the demand for diagnostic tests.
- Technological advancements. Adoption of automated analyzers, point-of-care testing devices, and integrated laboratory systems has improved test accuracy and efficiency.
- Healthcare infrastructure development. Government initiatives like the National Health Mission (NHM) have expanded diagnostic services, especially in rural and semi-urban areas.
- Growing awareness and health consciousness. More routine health check-ups and screenings are driving the demand for clinical chemistry tests.
- Rising healthcare expenditure. Increased public and private healthcare spending and schemes like Ayushman Bharat are enhancing access to diagnostic services.
Market segmentation
- Product type. Reagents dominate the market due to their recurring use.
- Test type. Common tests include liver and kidney function, lipid profiles, and glucose monitoring, with the latter being very common due to diabetes.
- End user. Diagnostic laboratories hold the largest market share due to the high volume of tests.
Regional insights
- The market is divided into North, South, East, and West India. Southern and western regions lead due to better healthcare infrastructure and awareness. Northern and eastern regions are growing quickly due to increased healthcare investments.
Challenges
The market faces challenges such as high costs of advanced diagnostic equipment, lack of skilled professionals, and regulatory issues. Addressing these is essential for sustained growth.
In conclusion, the Indian clinical chemistry market is set for significant growth, driven by disease prevalence, technological advancements, and government initiatives. Continued investment in healthcare infrastructure and awareness campaigns will further boost this market in the coming years.
Historically, clinical development could have been improved by manual processes and human-operated services, slowing the trial pace and limiting participants. Now, the rapid emergence of digital technology is overcoming these barriers, driving clinical development forward. The industry is transitioning to a phase of extensive technology integration in clinical trials, moving away from traditional human dependence.
Automation’s real-life use cases. Automation perfectly matches many clinical research needs, handling tasks like data parsing and system configuration. Paired with AI, it streamlines manual processes, monitors trial progress, predicts outcomes, ensures real-time protocol adherence, and conducts efficient clinical trials.
Top pharmaceutical companies use automation to reduce testing, validation, and manual input, shortening timelines by removing laborious manual processes and complex technology roadblocks, such as electronic clinical outcome assessment (eCOA), from the critical path to going live and enrolling patients.
Sweeping clinical research potential, automation can streamline various clinical research operations, such as data entry, scheduling, and administrative tasks. In recruitment, it quickly identifies better participants by parsing large data volumes. Real-time data collection and AI algorithms eliminate delays from manual input, helping researchers quickly identify trends and patterns. The greatest potential of automation lies in combining it with AI and digital health technologies (DHTs).
The Big Three-Automation, DHTs, and AI, in the past five years, the use of digital health technologies (DHTs) in clinical trials increased by 97 percent, showcasing their transformative impact. For example, a top pharmaceutical company reduced the required participants for detecting Huntington’s disease progression by 80 percent, using digital biomarkers. Another collaboration enhanced safety monitoring and digital biomarker development with electronic patient-reported outcomes (ePROs) and sensor-collected performance outcome (PerfO) data.
Digital biomarkers allow for smaller sample sizes, sometimes 70 percent less than standard, through precise measurements. Automation accelerates clinical research, revolutionizing trials and yielding faster, more precise, and clinically significant results.
Clinical chemistry – Then, now, and future
Sameer Arora
National Sales Manager,
Vector Biotek (A Beacon Group Company)
Clinical chemistry is a crucial component in the early detection, treatment, and management of human diseases. The discipline uses variety of techniques starting from simple colorimetry to most complicated high-end technologies, and it is useful for wide range of clinical conditions, serving as front and center of diagnosis in patient care.
The global clinical chemistry market size was valued at USD 13.47 billion in 2023. The market is projected to grow from USD 14.13 billion in 2024 to USD 21.46 billion by 2032, exhibiting a CAGR of 5.4 percent during the forecast period. The increasing prevalence of disorders is leading to an increase in the number of patient visits to hospitals and clinics. This is further supporting the increasing adoption of clinical analyzers. The growing demand enforces the development of analyzers with advance technology, including higher throughput and productivity.
More recent advances in instrument technology and engineering have opened the door for sophisticated testing capabilities on chemistry systems, such as consolidating specialty assays into routine chemistry operations and longer, uninterrupted run times to improve testing capacity and efficiency. Additionally, reducing patient sample sizes through pre-dilution can reduce the impact of draw volumes for sensitive patients. Even the barrier to entry for automation in smaller-size laboratories has decreased with laboratory staffing shortages, and the ability for pre- and post-analytical solutions to handle more complex tests and workflows for labs has improved over the past decade.
In addition to automation, development of novel biomarkers for variety of complex clinical conditions is also gaining importance as the awareness is growing and that will also become an important factor for increasing futuristic trends of clinical chemistry.
With introduction of artificial intelligence, numerous researchers have demonstrated its promising role across all phases of testing, including pre-analytical, analytical, and post-analytical phases; this includes novel methods of detecting common specimen collection errors, predicting laboratory results and diagnosis, and enhancing auto verification of workflows.
From the beginning, clinical chemistry has remained a major tool for diagnosis and with growing modern developments, it will continue to work as a navigator for clinical diagnosis in the coming years.
Trends in chemistry analyzers
Laboratory testing is a cornerstone of modern healthcare, enabling clinicians and medical professionals to diagnose, monitor, and treat various health conditions. Clinical chemistry analyzers, hi-tech devices that examine samples like blood, urine, and other body fluids to provide important information about a patient’s health, are central to this diagnostic procedure. These analyzers play a pivotal role in disease detection, drug monitoring, and the evaluation of organ functioning.
As technology advances, so do the capabilities of these instruments, with leading chemistry analyzer brands continually innovating to enhance accuracy, speed, and efficiency.
Miniaturization and portability. The trend toward smaller, more portable chemistry analyzers revolutionizes laboratory testing, offering unprecedented flexibility and accessibility. Miniaturization allows for point-of-care testing, bringing diagnostics closer to patients and reducing turnaround times significantly. Examples of current miniaturization efforts include handheld spectrophotometers, microfluidic devices, and portable gas chromatographs. These innovations have profoundly impacted rapid and accurate analysis in diverse settings, from remote locations to ambulances and even in-home care. As analytical chemistry examples, these advancements highlight the potential for miniaturization to revolutionize healthcare delivery.
Automation and efficiency. Automation is transforming laboratory testing processes, streamlining workflows, and improving efficiency. Different chemistry analyzers offer unparalleled speed and accuracy, reducing human error and increasing throughput. These analyzers can handle various sample types and require minimal user intervention, making them ideal for high-volume testing environments. As technology advances, future automation advancements may include enhanced integration with laboratory information systems, robotics for sample handling, and ML algorithms for intelligent result interpretation. These developments will keep transforming analytical chemistry examples and boosting productivity in lab environments.
Revolutionizing Indian IVD – Automated hematology and electrolyte analyzers
Sanjay Gajjar
Director,
B&E Diagnostics India Pvt. Ltd.
The Indian in vitro diagnostics (IVD) industry is undergoing a significant transformation with the integration of advanced automated hematology and electrolyte analyzers equipped with autoloaders. These innovations are enhancing efficiency, accuracy, and productivity in diagnostic laboratories.
Automated hematology analyzers. Modern hematology analyzers, now integrated with autoloaders, streamline the blood analysis process. They employ advanced optical and flow cytometry technologies for precise cell counting and morphological analysis, alongside sophisticated software algorithms for accurate data interpretation. The autoloaders facilitate continuous sample loading, significantly increasing throughput and reducing turnaround time. The integration of autoloaders minimizes the risk of human error and ensures high-quality results, which is crucial for patient diagnosis and treatment.
Electrolyte analyzers. Electrolyte analyzers measure vital ions, such as sodium, potassium, and chloride in body fluids. With autoloaders, these systems enhance operational efficiency through continuous sample processing, ensuring consistent, reliable results. User-friendly interfaces, featuring touchscreens and automated calibration, simplify operation and maintenance. These features enhance laboratory workflows, allowing for more rapid and accurate electrolyte testing, essential in critical care settings.
The shift toward walk-away analyzers, which allow for automated, uninterrupted operation, is driven by several factors; increased lab workload is necessitating high-throughput, automated solutions. Reduced human error and improved result consistency are also essential for clinical decisions. Though initial costs are high, long-term savings on labor and operational efficiency make these systems a viable investment. Advances in automation, AI, and machine learning are enhancing analyzers’ capabilities and integration with laboratory information systems (LIS).
As healthcare infrastructure expands and the demand for advanced diagnostics grows, these automated systems are becoming increasingly vital. They offer the scalability needed to meet the demands of both urban and rural healthcare settings in India.
Automated hematology and electrolyte analyzers with autoloaders are reshaping the Indian IVD industry by improving accuracy, efficiency, and scalability. The trend toward walk-away analyzers marks a new era in diagnostics, promising enhanced laboratory productivity and patient care.
As the Indian IVD market continues to evolve, the adoption of these advanced technologies will be crucial in meeting the increasing demand for high-quality diagnostic services, and ultimately benefiting patient outcomes and healthcare delivery across the country.
Integration of AI and ML is revolutionizing chemistry analyzers, enhancing their capabilities, and expanding their potential in laboratory testing. AI algorithms can analyze complex data sets with remarkable speed and accuracy, aiding in identifying patterns and anomalies that traditional methods may miss. Examples of AI applications in laboratory testing include image recognition for cell counting, predictive modelling for drug interactions, and data mining for biomarker discovery.
Enhanced connectivity and data sharing is crucial in modern healthcare systems, facilitating seamless communication and data sharing between devices and platforms. Clinical chemistry analyzers are increasingly integrated with digital health platforms, allowing remote monitoring, data analysis, and real-time collaboration among healthcare providers. This integration enables more efficient patient care and better-informed decision-making.
Personalized medicine and biomarker detection. The shift toward personalized medicine is transforming laboratory testing, emphasizing tailored treatment plans. Clinical chemistry analyzers are crucial, detecting biomarkers that inform these decisions. They help medical professionals identify molecular signatures linked to various illnesses, enabling more precise and minimally side-effect treatments. Future trends in biomarker detection will focus on improving sensitivity and specificity and exploring new biomarkers for a broader range of conditions. Leading chemistry analyzer brands drive innovation in these technologies, enhancing personalized medicine and improving patient outcomes.
Impact on patient care. Chemistry analyzers, including immunology and microbiology types, have significantly improved disease management with faster, more accurate diagnoses. These advanced instruments provide precise data for early detection and intervention, aiding informed treatment decisions. They monitor treatment effectiveness, ensuring optimal patient care with tailored precision medicine. By enhancing diagnostic efficiency and accuracy, these analyzers quickly identify pathogens, guide appropriate treatment, and reduce healthcare costs associated with misdiagnosis or prolonged treatments. Ultimately, they enhance patient outcomes and improve lives.
Regulatory and ethical considerations. Navigating regulatory challenges is crucial for chemistry analyzer brands adopting new technologies in lab testing. Compliance ensures device safety and effectiveness but can slow innovation.
Ethical concerns, especially with AI and personalized medicine, involve patient privacy, consent, and algorithm bias. Addressing these issues builds trust and promotes equitable technology access. As these factors evolve, they will shape how analyzers are developed and adopted, impacting healthcare direction and outcomes.
Crossing the chasm
The changing landscape of the healthcare industry forces clinical laboratory leaders to meet the needs of their stakeholders, maximize operational efficiency, and improve the overall quality of patient care simultaneously.
Laboratories are knowledge–and service-based enterprises that can also be considered complex information systems and essential parts of healthcare networks. Laboratory practice involves the acquisition, creation, evaluation, and dissemination of information.
The increasing daily data drives clinical laboratory leaders to navigate their strategies. It has become imperative for healthcare and clinical laboratory services. Clinical laboratories are in the chasm of digital transformation. Those who cannot cross this chasm will lose their competitive advantage and have less chance to survive in the future–in the digital health era.
Practices and processes involved in laboratory management have the potential to be improved by digital transformation. The patient results and data produced during the total testing process are very beneficial in giving insight into managerial decision-making. However, there are challenges like accessing, processing, sharing, real-time analysis, and data visualization in clinical laboratories. To overcome these challenges, clinical laboratories should take action to overview their existing processes and find solutions and tools to re-design the system.
Outlook
Driven by relentless technological innovation and a steadfast commitment to improving patient care, clinical chemistry is poised for continued transformation. As advancements in AI, automation, and personalized medicine converge, the analyzers will play an increasingly pivotal role in healthcare delivery, offering faster, more accurate diagnostics and tailored treatment options. With enhanced connectivity and the integration of cutting-edge technologies, the potential to revolutionize disease management and patient outcomes is limitless.
