December 2014 956

Finding the Right Chemistry

The biochemistry analyzers market is exhibiting resilience and reinvention as it employs new R&D and business models to cost-effectively deliver innovation, value, and improved patient outcomes.

moleculesThe Indian in vitro diagnostics (IVD) market is valued at Rs. 3,000 crore, and is expected to reach Rs. 9,000 crore by 2018 growing steady at a CAGR of 20 percent. IVD covers a diverse range of products from individual reagents to testing systems that consist of reagents, instrumentation, and software. Also included are accessories such as dedicated software as well as control and calibration materials. Indian IVD market is one of the fast-paced and growing markets in the world. This is one of the focus markets for most of the organizations connected with it. With biochemistry analyzers becoming increasingly sophisticated, healthcare institutions are recognizing greater value for the improvement of disease management and patient care success rates. Ranging from hospitals to laboratory chains, several biochemistry-related diagnostics providers are highly penetrated in the country among which biochemical reagents accounts for a lion’s share in the market.

Bio-Chemistry

In 2014, Indian biochemistry analyzers and reagents is valued at Rs. 980 crore, a 16.5 percent growth over 2013. Estimated at Rs. 735 crore, reagents contributed a major 75 percent to the total market in 2014. This remarkable growth can be attributed to increased healthcare awareness, desire to undergo preventive health checkups, availability of disease specific tests, corporate setups promoting health focus of employees, and drift from manual to semi-automated and automated instruments.

With escalating healthcare expenditure, declining reimbursements, and new regulations which put downward pressure on the healthcare budgets, diagnostic laboratories are demanding solutions for delivering high-quality efficient and timely testing. According to the Global Data report, this has led to growing adoption of automated solutions, new analyzers that deliver high throughput in lesser time and provide high efficacy. Similarly, Pointof- Care (PoC) testing has gained momentum in the past years as need for quick turnaround time and reliable results have accelerated. Many PoC tests on the market today offer results within a period of few minutes as compared to hours for centralized testing. The fast access to results is particularly useful in critical situations when testing needs to be carried out frequent intervals.

Apart from catering to people in the tier I cities, IVD setups are now eyeing expansion in the tier II and tier III cities. This can be attributed to high revenue generating option that lie untapped in these cities clubbed with minimum investment required in order to generate high revenues. These IVD majors tie-up with the existing high reputation laboratory adding value in terms of providing technical help as well as contributing significantly in the advising physicians panel.

Global scenario
Innovation and entrepreneurship has defined the biochemistry industry since its inception. Despite increased regulation, pricing pressures and the effects of healthcare reforms in many countries, the global biochemistry analyzers market is exhibiting resilience and reinvention as it employs new research and development and business models to cost-effectively deliver innovation, value, and improved patient outcomes.

The global biochemistry analyzers market was estimated at USD 8965 million in 2014. This market is expected to grow at a CAGR of 5.52 percent between 2014 and 2019, to reach USD 11,728 million in 2019.

The biochemistry analyzers market is segmented on the basis of products as analyzers, reagents, and other products. Analyzers segment is further divided on the basis of sizes into four segments: Small Sized (400-800 Test/H), Medium Sized (800-1,200 Tests/H), Large Sized (1,200-2,000 Tests/H), Very large Sized (2,000 Tests/H). The analyzer product segment had the largest share of the biochemistry analyzers market in 2014, whereas the reagents product segment is expected to grow at the highest CAGR between 2014 and 2019. The application segments included tests such as, basic metabolic panel, electrolyte panel, liver panel, lipid profile, renal profile/kidney function panel, thyroid function panel, specialty chemical tests. The basic metabolic panel tests segment had the largest share of the clinical chemistry analyzers market in 2014, whereas the lipid profile test segment is expected to grow at the highest CAGR between 2014 and 2019.

Rise in number of lifestyle diseases, automation of laboratories will aid the growth of this market. The market is expected to be driven by increasing awareness for preventative care, increase in aging population, increase in reagent rental agreements, and laboratory automation.

The major players in the biochemistry analyzers market include Roche Diagnostics, Danaher Corporation, Abbott Diagnostics, Siemens AG, Ortho-Clinical Diagnostics, Thermo Fisher Scientific, Randox Laboratories Ltd, Elitech Group, Mindray,and Horiba.

Apart from catering to people in the tier I cities, IVD setups are now eyeing expansion in the tier II and tier III cities

Function of reagents
Most in vitro diagnostic assays require biochemical and chemical reagents to make them run. To meet this requirement, IVD manufacturers initially developed and produced the reagents. This approach afforded ultimate control over supply of these critical assay components, but came with its own price. IVD manufacturers needed to invest their finite resources in reagent product development, manufacturing equipment, quality programs, and human resources to maintain these programs.

As quoted in Lab Tests Blog by Randox, the reagents used in diagnostic testing assays are one of the most fundamental and critical components necessary for a medical laboratory to properly function. Without them, a laboratory ceases to operate, as it is unable to generate the necessary tests required for the diagnosis, treatment, and monitoring of a patient’s condition. When one considers that almost 70 percent of the information that a physician requires for the assessment of a patient’s general health comes from the information supplied by the clinical laboratory, the importance of these products, and of the laboratory itself, becomes evident.

Diagnostics reagents – be they chemical, biochemical, or biological/ biochemical in design – are dependent upon several different components working together to generate accurate, precise, and reliable patient test results. However, when one examines the basic operational principles these reagents follow, regardless of the format or platform, all of them consist of the following core steps:

The volume of patient sample to be analyzed and a volume of one or more diagnostics reagents are placed together in some type of reaction vessels and mixed together, starting a chemical reaction. This test mixture is then incubated at a given temperature, usually 37C, for a given period of time. The reaction is stopped once the assay reaction time is reached, and some type of quantifiable change is observed. This change varies per given procedure but is most often an increase or decrease in a color, an increase or decrease in spectrophotometric absorbance, a change in the intensity of light produced or not produced, or an increase or decrease in the optical density or turbidity of the test mixture. This change is measured and compared against a known change that has a definitive value assigned to it (most frequently coming from calibration material, or a standard material), and it is calculated into a test result. Most diagnostics reagents can be classified as chemical, biochemical, or biological/biochemical in nature.

Chemical.
These are the most basic of the three diagnostic reagents and are designed as single- or tworeagent systems. They incorporate dyes, buffers, surfactants, and basic chemicals to form working reagents. A primary example is the diagnostic reagent used to measure serum albumin concentrations. This common diagnostic reagent routinely measures this serum component based on the binding of bromocresol green dye specifically with albumin to produce a colored complex. The absorbance of the resulting complex is measured spectrophotometrically and is directly proportional to the albumin concentration in the sample. Another classic test procedure is the measurement of serum creatinine concentrations – first described more than 100 years ago and still routinely used in the clinical laboratory. Here, creatinine in the sample reacts with picrate (picric acid, sodium hydroxide, and water) to form a creatinine-picrate complex. The resulting increase in absorbance at a given wavelength resulting from the formation of this complex is directly proportional to the concentration of creatinine in the sample.

Biochemical.
Biochemical reagents are a bit more complex in design and require more components working in unison together. Designed to perform alone or as part of a two-reagent system, these reagents are frequently enzyme-driven and incorporate buffers, stabilizers, co-enzymes, indicators, surfactants, and preservatives as part of their working components. The diagnostic reagent used for the determination of glucose, one of the commonly run diagnostic tests in the clinical laboratory, fits well into this category. Here, glucose is acted on by the enzyme hexokinase in the presence of adenosine triphosphate and magnesium to produce glucose- 6-phosphate. Glucose-6-phosphate dehydrogenase then specifically reacts with glucose-6-phosphate, with the concurrent reduction of NAD to NADH. The NADH produced absorbs light at a specific wavelength and can be spectrophotometrically detected as an increased absorbance proportional to the glucose in the sample.

Biological.
The biological/biochemical- based diagnostic assays are frequently composed of two or more reagents. These reagent systems are highly complex, incorporating many steps and numerous working components including buffers, conjugates, wash solutions, detection reagents, and serological markers – namely antibodies and antigens as essential elements. These types of diagnostic reagents are typically referred to as immunoassays and are most often employed to measure analytes found at relatively low concentrations in the body. For example, these would include hormones, vitamins, infectiousdisease agents, and specific protein components. However, and as discussed earlier, regardless of their complexity, when you look at the basic operational principles these reagent systems follow, all inherently work exactly the same way.

In today’s environment, suppliers of IVD reagents can employ various strategies to achieve their goals. These include sourcing raw materials and components for in-house development and manufacture of reagents, forming OEM relationships with key trusted suppliers to obtain a finished product, or, in many cases, a combination of both. Supplier expertise can often result in technological advantages, while in-house production of components allows for long-term supply stability of critical components. Regardless of the strategies employed, when considering the sourcing of key diagnostics reagents, be they finished products or raw materials for future reagent test kits, it is important to be aware of the following points when dealing with suppliers and vendors to produce highly reliable and accurate diagnostics reagents that the industry has come to expect.

Manufacturing capabilities.
IVD makers need to manufacture capabilities for their immediate, as well as projected, needs, and make certain that their vendors can address their needs now and in the future. Additional factors to consider are vendors’ flexibility, their ability to handle bulk options, and whether their breadth of product coverage includes other associated assay components that are vital to the IVD company’s operation. An especially important consideration regarding vendors for biological/biochemical- based diagnostics tests (i.e., immunoassays) is whether antibodies are sourced from trusted suppliers rather than produced in-house. Antibody generation is a complicated and intricate process that takes a great deal of time and expertise. An antibody supplier should be able to offer a full range of custom antibody production services, including poly-clonal production, monoclonal production, purification and conjugation, freeze drying, and antibody fragmentation, as well as bulk custom formats, purified antigens, and sera. In addition, since the production of antibodies is complex, and their use in diagnostics assays changes over time, it is critical that an antibody supplier provides a strong quality system, technical support, and industry expertise to keep customers apprised of the latest news, regulatory issues, and potential legislation that can potentially affect key assay components.

Cost considerations.
With regard to costs, it is important to keep an open mind and not to fixate solely on numbers. Since there are so many components in a typical diagnostic reagent, it is important to consider the individual components and the combination of these working together in a particular test. While each element does contribute to the overall cost, it is possible to achieve significant cost savings by changing one element, such as a detection buffer, which can significantly affect the sensitivity of the test, resulting in reduced volume requirements for key reagents and reduced assay costs. End-user value of the test versus component cost should also be taken into consideration. For example, a faster test, or one with improved performance, may cost more to buy, but it may be able to save the end-user valuable time and labor expenses.

Other key elements to consider are the vendor’s experience and knowledge of the IVD market, whether it has a well-established reputation and proven track record within the industry, and its financial soundness. While these factors may appear to be insignificant at first glance, they do carry significant importance in the long run.

Biochemistry analyzer will become faster and more efficient as technology and software are developed and enhanced

Considerations for purchasing
When choosing a clinical analyzer, research the instrument’s throughput capability (which can reach up to 10,000 combined ISE and colorimetric tests per hour), testing speed, and test menu to be sure it is a good fit for your laboratory. Will a STAT mode or random- access capability be required? Is batch, random, or continuous analysis preferred? Consider if additional testing will be offered by the lab in the future to ensure the system offers the required capabilities. Remember that a higher-end instrument that uses less expensive reagents may prove to be more cost-effective over its lifetime. Additional factors include sample handling, the unit’s footprint, and its ability to work with microvolumes, a valuable parameter in neonatal units. Laboratories handling thousands of tests per hour will require bar-code handling and data management software.

Anyone looking to purchase an analyzer may find it useful to ask the following questions:

  • Does it represent value for money?
  • Is it fit for purpose?
  • What are the ‘whole life’ costs?
  • What are the service costs?
  • Is it flexible and easy to operate?
  • Is the product of high quality?

Manufacturers usually offer a number of customizable options and functions depending on the needs of each individual laboratory. For example, throughput of photometric or ISE tests per hour, and the number of tests and assay types available. A variety of analyzers are available to suit the smallest point-of-care clinic, or the most demanding high-throughput clinical laboratory.

Future
Taking into consideration current and future trends is essential in maximizing the lifespan of any analyzer. As systems become more sophisticated, integration, convenience and application specificity are key. New assays are constantly in development to improve the diagnostic capabilities of laboratories and ultimately improve patient care. The continuing emergence of new, clinically significant biomarkers, and technological advancements have a significant impact on such assay development. Biochemistry analyzer will also become faster and more efficient as technology and software is developed and enhanced. Manufacturers strive to take into consideration customer feedback and requirements, and many are developing strategies for making analytical systems ever more user-friendly.

As laboratory workloads increase, and managers look toward total automation solutions, analyzers need to have either modular capabilities or the ability to be connected to a track. At the other extreme, point-of-care testing is very much in demand and technology is being developed to enable near-patient chemistry testing.

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