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Biochemistry Instruments and Reagents

Disruptive technologies to revolutionize the labs

There are multiple reasons to encourage disruptive innovations in the clinical laboratory, including the escalating cost of healthcare, the need for better accessibility of diagnostic care, and the increased demand on the laboratory in the era of precision diagnostics.

At the center of most lab operations is clinical chemistry, which performs tests on body fluids to assess human health and monitor chronic diseases. As is the case in other parts of the laboratory, clinical chemistry is becoming increasingly automated, with sophisticated instrumentation, capable of performing hundreds to thousands of tests per hour. As two in every three senior citizens in India suffer from some chronic disease, the field of clinical chemistry is likely to continue its prominent role in patient care.

Chemistry analyzers are constantly evolving, and fully automated equipment are now readily available on the market. These analyzers are capable of carrying out tasks like dilution, automated re-run, cap piercing, and tube sampling. The practice of outsourcing laboratory tests to clinical reference laboratories is known as value-based outsourcing. Clinical laboratories have collaborations with small hospitals that lack the fundamental infrastructure needed for clinical diagnosis. Patients are sent by hospitals to these labs for a variety of diagnostic testing. Laboratory services are now being outsourced to diagnostic vendors as the market shifts from a fee-for-service to a value-based care paradigm. The market for clinical chemistry analyzers will be significantly influenced in the upcoming years by the shift from hospital outsourcing services to reference laboratories.

Amid the Covid-19 crisis, the global market for clinical chemistry analyzers estimated at USD 12.3 billion in the year 2021, is projected to reach a revised size of USD 15.7 billion by 2026, growing at a CAGR of 4.5 percent. The exponential growth of the market is ascribed to the increasing advancements in technology and the rising healthcare industry requirements.

The introduction of robust software, and upgraded production methods are some of the other factors that are projected to drive the growth of the clinical chemistry analyzers market. The high capital investment required in this field and inadequately skilled laboratory technicians limit the overall market growth.

Reagents segment is projected to grow at a 4.9-percent CAGR to reach USD 10.6 billion by 2026. This is due to the presence of a vast collection of reagents in the market, serving various clinics’ requirements. Most importantly, the reagents are cost-beneficial, have optimal sensitivity, linearity, and accuracy, which as a result, ensures limited performance variations.

After a thorough analysis of business implications of the pandemic and its induced economic crisis, growth in the analyzers segment is readjusted to a revised 4.1 percent CAGR for the next seven-year period. This segment currently accounts for a 25-percent share of the global clinical chemistry analyzers market. The high uptake of reagents is attributed to their cost-effective nature, optimal sensitivity, superior precision, and linearity that ensure desirable performance. These advantages are prompting a large number of clinicians to rely on reagents for precise and accurate diagnosis.

The rising geriatric population in developed and developing regions will positively influence the growth of the clinical chemistry analyzers market. Due to rapid growth in the senior population, the prevalence of age-associated diseases, such as hypertension, diabetes, cardiovascular, liver, and kidney diseases are expected to increase significantly. The diagnosis and management of such diseases are responsible for the increasing number of prescriptions for tests, such as basic metabolic panel, lipid profile, and liver and renal
panel. The rise in chronic illnesses will increase the demand for tests prescribed for the prevention, diagnosis, and treatment of the same. These factors, alongside the growing trend for preventive medicine, are expected to drive the demand for clinical chemistry analyzers during the forecast period. These tests are performed by clinical chemistry analyzers; hence, these are expected to have a positive impact on this market.

The government initiatives, schemes, or funding that supports and promotes the innovation and development of the diagnostics market provides growth opportunities in the clinical chemical analyzers market.

The high-volume clinical chemistry analyzers may be affordable only for large hospitals and reference laboratories with good capital budgets. Most small laboratories, physicians’ offices, and sole practitioners have no capital budgets and may not be able to afford a large or very-large-sized analyzer. Thus, the high fixed-cost requirements limit the growth of the clinical chemistry analyzers market.

At present, there is a significant shortage of laboratory technicians in both developed and developing nations. This is mainly attributed to the increasing patient population base, the retirement of elderly technicians, and the increasing number of cash-strapped colleges closing their clinical lab programs. Thus, there is a gap between the supply and demand of pathologists and lab technicians worldwide, therefore, expecting to restrain the market growth.

The clinical chemistry analyzers market in the US is estimated at USD 4.4 billion in the year 2021. The country currently accounts for a 34.17 percent share in the global market. China, the world’s second-largest economy, is forecast to reach an estimated market size of USD 1.6 billion in the year 2026, trailing a CAGR of 6 percent. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 3.7 percent and 4.2 percent, respectively, over the next four years.

Within Europe, Germany is forecast to grow at approximately 4.1 percent CAGR while Rest of European market will reach USD 1.7 billion by the end of 2026. North America enjoys a dominant position due to rising aging population and increasing cases of lifestyle and chronic medical conditions.

The regional market is gaining from rising healthcare expenditure, presence of well-established healthcare infrastructure, high penetration of sophisticated instruments and supportive initiatives by governments. High growth is expected in the Asia-Pacific region as a result of outsourcing of clinical chemistry analyzer production to countries like China and India. China and India are witnessing an increase in medical tourism, which is expected to stimulate the clinical chemistry analyzers market.

The basic metabolic test panels are widely used to test and analyze indicators related to various diseases through routine or disease-specific tests. The segment is bound to gain from increasing prevalence of chronic medical conditions, coupled with the preventive healthcare trend.

In the global basic metabolic panel (test) segment, USA, Canada, Japan, China, and Europe will drive the 4.8-percent CAGR estimated for this segment. These regional markets accounting for a combined market size of USD 3.6 billion in the year 2021 will reach a projected size of USD 4.6 billion by 2026. China will remain among the fastest-growing in this cluster of regional markets. Led by countries such as Australia, India, and South Korea, the market in Asia-Pacific is forecast to reach USD 582.5 million by the year 2026, while Latin America will expand at a 5.7 percent CAGR.

Clinical chemistry – Advancements and trends
Abhijit Pathak
Group Product Manager,
Beacon Group

Pathological chemistry, which started with the purpose of analyzing body fluids to diagnose diseases, is today the leading and front-runner branch of laboratory medicine. In today’s time, it combines chemistry, biochemistry, immunochemistry, endocrinology, toxicology along with engineering and informatics with a view to provide support to clinicians for improving diagnosis and treatment.

Technological developments and scientific innovations in the last few decades have helped to reduce analytical errors significantly and uplift the higher standards of accuracy and precision. Today’s automation systems with complex integration of robotics, liquid handling, and numerous other machineries help in improving performance through elimination of human errors and reduced risk of cross contamination.

These automation systems use from simple to most innovative technologies; as a result, factors like sample handling, degree of automation, TAT, STAT facilities, reducing operational costs, and service dependability are efficiently addressed.

Significant implementation of QC, together with automatic interfacing using laboratory informatics and process management software, is helping to improve both quality and productivity that creates straightforward operation where minimal operative training is required.

On the other hand, from dry powder reagents to liquid stable reagents and single-reagent chemistry developments have made the workflow simple and efficient. Now the new technologies that incorporate use of microfluidics are adding value by minimizing use of costly reagents and yet offering desired accuracy and precision in clinical chemistry.

With the pandemic, clinicians have understood the significance of diagnosis, which is leading the way to open up new areas for certain parameters that were having limited use in the past. LDH, PCT, and IL, which were niche contributors, are today in great demand, giving challenges to IVD manufacturers to design efficient methodology for these parameters. These developments are ensuring that the scope of clinical chemistry is sky high in near future.

From the time of its inception, Beacon has always considered clinical chemistry as its major product line and, over a period of time, we have always made innovative approaches to bring time-tested best solutions for reagents and automation in clinical chemistry. Our efforts are well recognized and appreciated by our customers across the globe.

The worldwide clinical chemistry market is dominated by a small number of competitors, all of whom may pursue various growth strategies to stay competitive. Furthermore, to grow their market presence and increase their revenue share, the major players in the clinical chemistry market may choose to partner with smaller companies. Government and private-sector funds may be used to assist minor clinical chemistry industry participants in their long-term expansion. Some of the leading players operating in the global clinical chemistry analyzers market include HORIBA Ltd., Sysmex Corporation, Randox Laboratories Ltd., Trivitron Healthcare Pvt. Ltd., Mindray Medical International Ltd., Thermo Fisher Scientific Inc., Abbott Laboratories, F. Hoffmann-La Roche Ltd., Ortho Clinical Diagnostics, EKF Diagnostics, ELITech Group, Danaher Corporation, Biobase Group, and SFRI Medical Diagnostics.

The healthcare industry is at the beginning of a new era of revolutionized practice in the clinical laboratory. There is currently a great shakeup in the history of pathology and laboratory medicine that will move pathologists and laboratory scientists into the center of patient care, and redefine their role from being diagnostic specialists into active participants in patient care through prediction of disease risk, assessment of prognosis, and guiding treatment decision in addition to patient follow up after treatment. This revolution is triggered by two distinct classes of innovations – sustaining and disruptive innovations. Sustaining innovations can be simply defined as improvements in the performance of currently existing technologies and methodologies that eventually lead to an improved product (e.g., a laboratory test) or a better function (e.g., making an existing technology more efficient or enhancing the capability of a current platform). There are plenty of examples of sustaining innovations in a laboratory setting. Disruptive innovation, on the other hand, is the introduction of a new concept/technology.

Disruptive technologies have their fingerprints in healthcare. Pathology and laboratory medicine are fertile soils for disruptive innovations because they are heavily reliant on technology. Disruptive innovations have resulted in a revolution of our diagnostic ability and will take laboratory medicine to the next level of patient care. There are several examples of disruptive innovations in the clinical laboratory. Digitizing pathology practice is an example of disruptive technology, with many advantages and an extended scope of applications. Next-generation sequencing can be disruptive in two ways.

The first is by replacing an array of laboratory tests, which each requires expensive and specialized instruments and expertise, with a single cost-effective technology. The second is by disrupting the current paradigm of the clinical laboratory as a diagnostic service by taking it into a new era of preventive or primary care pathology. Other disruptive innovations include the use of dry chemistry reagents in chemistry analyzers in the core laboratory and point-of-care testing (POCT).

The latter is defined as an investigation done close to the patient at the time of the consultation. These are usually performed by a nurse without the need for a laboratory technologist, with instant availability of results to make immediate informed decisions about patient care. There is a growing list of POCT, including pregnancy tests, measuring blood sugar level by glucometers, cardiac biomarker tests, and the list continues to grow. POCT has the typical features of a disruptive innovation, including being cheaper, quicker, and easier to perform, but with less accuracy compared to a standard laboratory test. Handheld analyzers for testing whole blood are another example of a disruptive technology that can be used for POCT, even at home.

The switch from manual labor-intensive laboratories into fully automated chemistry analyzers is another example of successful disruptive thinking. Manufacturers are now incorporating even more advanced technology in the chemistry core laboratory, including mobile general-purpose dual arm robots that mark a new horizon for automations. These robots can perform certain repetitive tasks faster, cheaper, and more accurately than humans. They can be employed to perform sophisticated multiple-step tests like the enzyme-linked immunosorbent assay.

Disruptive innovations include the use of matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry as a clinical tool for pathogen identification. Another emerging disruptive innovation, jointly developed by Google and Novartis, includes a glucose-sensing electrode with telemetry so that glucose levels are monitored from the tears of the eye and transmitted to remote devices. The use of disposable electronics is an interesting example of a disruptive innovation in POCT.

An example of this is the digital pregnancy test, FirstResponse Pregnancy Pro, which is a wireless technology-enabled pregnancy test that connects via Bluetooth to a smartphone. Another example is the rHEALTH sensor, which is a small portable device that is able to perform a large number of laboratory tests using one drop of blood.

Disruptive innovations also extend into inventing robotic devices for automated blood drawing. These devices have the potential to replace standard blood drawing in clinical laboratories and thus save money, labor, and time. It also has the ability to improve the workflow in hospitals and private clinics, especially those associated with POCT equipment to provide quick results.

“Pandemic has shown a positive impact on global biochemistry analyzer market due to increased demand for laboratory tests to diagnose and monitor Covid-19. So, the demand for global biochemistry market has increased. In addition, factors such as growing demand for biochemistry analyzers in hospitals, increasing prevalence of chronic diseases, and rising demand for automated analyzers are some of the major factors driving the growth of the global biochemistry analyzer market. Manufacturers are developing biochemistry analyzers with multiplexing analyzers. Such type of analyzers possess the feature of positive identification that reduces the process of repeated pathogen testing. This becomes a critical feature in cases of samples that have low volume, such as neonatal units. This type of system with shorter turnaround time gives advantages of high clarity and result accuracy. The feature of positive identification helps acquire accurate results in shorter run time by avoiding the inclusion of too many targets.

Some major key players of global biochemistry analyzers are Abbott, Danaher, F. Hoffmann-La-Roche Ltd., Meril Life Science Pvt. Ltd., Siemens AG, Hologic, Inc., Thermo Fisher Scientific, Inc., Randox Laboratories Ltd., Beckman Coulter, Inc., Horiba Ltd., and others. Function of these analyzers is mostly based on optical measurements, which include calorimetric, absorption, spectrometric, and fluoroscopic detection. These processes can measure chemicals, such as antigen molecules and proteins in the body fluid. These analyzers are mostly used in hospitals, clinics, and epidemic-prevention stations. Biochemical analyzers are made up of an optical engine, which includes light source, detectors, and other optical elements. For greater accuracy, biochemistry analyzers are highly automated. They automate sample loading, tube cleaning, mechanical control, and data processing. Dr Debasish Kar, Assistant Professor, Department of Biotechnology, Ramaiah University of Applied Sciences.

There are multiple reasons to encourage disruptive innovations in the clinical laboratory, including the escalating cost of healthcare, the need for better accessibility of diagnostic care, and the increased demand on the laboratory in the era of precision diagnostics. There are, however, a number of challenges that need to be overcome, such as the significant resistance to disruptive innovations by current technology providers and governmental regulatory bodies. The hesitance of healthcare providers and insurance companies must also be addressed.

Adoption of disruptive innovations requires a multifaceted approach that involves orchestrated solutions to key aspects of the process, including creating successful business models, multidisciplinary collaborations, and innovative accreditation and regulatory oversight. It also must be coupled with successful commercialization plans and modernization of healthcare structure. Fostering a culture of disruptive innovation requires establishing unique collaborative models between academia and industry. It also requires uncovering new sources of unconventional funding that are open to high-risk high-reward projects. It should also be matched with innovative thinking, including new approaches for delivery of care and identifying novel cohorts of patients who can benefit from disruptive technology.

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