Stringent Regulations to Drive the Market

Stringent Regulations to Drive the Market

With recent advances in clinical research and MS technology, mass spectrometer is positioning itself to become a routine diagnostic tool for clinical laboratories and researchers.

Mass spectrometry (MS) was first developed several decades ago and confined deep in research laboratories. Many advances took place over the next several decades including development of the first time-of-flight (TOF) mass analyzer in the 1940s; quadrupole/time-of-flight mass analyzers, and also matrix-assisted laser desorption ionization (MALDI), were developed in the 1980s. MALDI imaging and several other new technologies were developed in the 1990s. Mass spectrometry has continued to progress in this century. These are just a few of the many advances in mass spectrometry that have taken place over the last one hundred years. An important early example has been the development and introduction of MALDI-TOF mass spectrometers for bacterial identification.

The use of MALDI-TOF MS for microbiology testing is a somewhat distinct application, which appears poised for explosive growth over the next several years. The major advantages over alternatives are its ability to identify microbes in a much shorter time, with less work, and with greater accuracy. From a culture or colony, the system can identify the microbes in minutes rather than many hours required with older techniques. In a clinical diagnostic setting, the time savings can equate to a major benefit in terms of treatment and economics. The patient receives a more accurate diagnosis and/or earlier treatment, and this results in significant savings.

While MS has grown rapidly and holds great promise, there are several challenges relating to its use in clinical applications, including its complexity, high upfront cost, lack of user-friendliness, low throughput (except MALDI), as well as the complexity of the science and the associated regulatory process. These will need to be addressed in order to penetrate further into more routine testing settings.

Several MS systems and kits have now received regulatory approval for diagnostic use. These enable labs to run the tests without the extra work and expense involved with laboratory-developed tests (LDTs), also referred to as homebrew tests. The area of LDTs has also been evolving in recent years as the FDA and other related agencies determine how best to regulate an area that has been somewhat of a grey area.

Indian Market Dynamics

The Indian mass spectrometers market is estimated at 260 crore in 2016. Triple quadrupoles dominate with a 48 percent share, with Q Trap contributing about 17 percent in this category. This is closely followed by high-resolution mass spectrometry (HRMS), including Q TOF and Orbitrap at a 32 percent share. MALDI-TOF continues to be popular, contributing  12 percent to the market. Single quadrupole and ion trap constitute about 4 percent of the market. Fourier transform ion cyclotron resonance mass spectrometers (FTICR – MS) have gradually become obsolete.

AB Sciex, with major presence in triple quadrupole, HRMS, and MALDI TOF, has a commanding market share. Thermo Fisher followed by Waters, Agilent, Shimadzu, Bruker, and Perkin Elmer has major presence in the market.

This segment is poised to grow over the next couple of years with the enforcement of stringent regulations. The Indian authorities are seriously looking at the level of residual, pesticides, enzymes across various segments, including melamine added in milk. The market trend is toward qualifying residuals, and quantifying impurities.

Global Market Dynamics

Innovations in mass spectrometry technologies, coupled with rising application in the life sciences and clinical analysis sectors, are creating rich opportunities for mergers and acquisitions in the global market. Mass spectrometry vendors will be keen to partner with clinical diagnostic companies to widen the market for new products that can quantify low trace levels of disease biomarkers.

In 2016, the global mass spectrometry market generated USD 3.22 billion in revenue, expected to reach USD 5.03 billion by 2022, reflecting a six-year compound annual growth rate (CAGR) of 6.9 percent. The market is moving away from traditional systems to high-resolution technologies such as the Q-TOF mass spectrometry. The MALDI-TOF segment is expected to grow rapidly due to its benefits of improved resolution, accuracy, and sensitivity for clinical diagnostic applications.

Miniaturization of the instruments has been an important innovation in the mass spectrometry market, as it allows the instrument to be used outside of the laboratory environment for applications such as the testing of water quality and oil exploration. To stay relevant, vendors need to continually launch such novel products as well as aid end users make a seamless transition from traditional systems to high-end instruments.

Currently, North America leads the global market due to the presence of a large number of pharmaceutical and biotechnology companies. However, Asia-Pacific holds the greatest potential due to the increasing government funding, business expansion activities by major players, and enhanced adoption by pharmaceutical and life science sectors.

Furthermore, mature markets such as North America and Europe are likely to outsource a substantial number of R&D activities in the pharmaceutical industry to emerging regions such as Asia-Pacific and rest-of-the-world (RoW). Africa and Latin America are expected to grow at a steady pace as countries in these RoW regions have shown considerable interest in research and obtaining funds.

Meanwhile, stringent safety regulations will drive the adoption of mass spectrometry in the pharmaceutical, environmental, and food and beverage testing industries. The pharmaceuticals, biotechnology/biopharmaceuticals segment, which comprises pharmaceutical companies, biotechnology companies, and contract research labs, contributed the most revenue toward sales due to their intensified focus on research and testing.

The most successful companies are likely to be solution providers rather than stand-alone instrument or software providers. It is critical for advanced technologies to be bundled with service and support, as customers may not have the expertise to operate the high-resolution instruments. Overall, the escalating adoption of mass spectrometry in clinical diagnostics, applied testing in emerging economies, and its expanding use in the pharmaceutical industry will ensure rapid market growth, despite the long replacement cycles.

Refurbished mass spectrometers are also a growing segment within this market. Buyers consider top players as the most suitable choice to procure these technologies. Being a mature market, there are several MS suppliers, yet top players find the largest buyers due to a competitive post-sales services and maintenance services. The expensive nature of these devices has resulted in manufacturers opting to provide several discounts and extensive negotiations in terms of supplying accessories and reagents used in MS experiments. This also forms a mainstay of marketing and sales strategies as well, and is frequently off the record. MS market began to grow significantly through the usage of LCMS around 15 years ago, as the large clinical laboratories began to adopt liquid chromatography-tandem mass spectrometry (LC-MS/MS).

As with most other technologies, there is a growing trend and demand for smaller bench-top MS systems and portable systems for on-field applications. Natural resource exploration and detection of toxins in environment has been a primary need for hundreds of research institutes. The application of MS systems in detection of explosives and drugs is another approach that is currently researched by technology developers. SA-BRC also expects greater automation and conjoint software applications for greater data processing capability. Major future trends to look out for include bacterial identification, tissue imaging, and functional assays. These are also the major areas for investment for companies.

Configuration Options

Depending on the type of sample being analyzed, as well as the analytical interests of the researcher, there are some configuration options possible.

Analyte of interest and sample type influence the type of MS used. Depending on the type of sample being analyzed, as well as the analytical interests of the researcher, there are some configuration options which need to be considered beforehand. First, the preferred method of ionization for the sample type – such as electron impact ionization, electrospray ionization, matrix-assisted laser desorption ionization, and inductively coupled plasma – should be determined. As a result of the ionization technique used, the type of detector best suited may change as well – for example, time-of-flight detectors are commonly used with MALDI.

Data interpretation and manipulation requirements influence the ideal MS set-up. The data produced by an MS can be extremely thorough, as well as immense. Sifting through raw data can take even the most talented researchers a considerable amount of time. As such, many vendors and third-party companies have developed integrated software solutions to match the needs of many laboratories. Purchasing an MS that has the required software solutions – or can accommodate the required software – is an important consideration.

Sample throughput needs affect the installation of the ideal MS. For laboratories, which have high sample volumes and need faster turnaround times, the configuration of the ideal MS may be impacted. Automation solutions exist for a variety of applications, from robotic sample changers to liquid handling and automatic dilution technologies. By automating the analysis process, technicians and researchers can focus on other tasks, greatly increasing efficiency.

Maintenance. Because mass spectrometers are specialized instruments, trained service technicians from the manufacturer or a third party are required for any major maintenance. Venting the unit and cleaning key components such as the ion source and regular visual inspections can also help spot problems before they become disasters.

Advancing Technologies and Potential Applications

Recent advances in clinical research and MS technology promise even more sophisticated extensions to current clinical applications and potential new LDTs.

MALDI-IMS now supports direct tissue analysis with diagnostic potential and reduced analysis time. Pathologists are now able to examine biological tissue directly, detecting cancerous tissue in real time during an operation using MS with smart electroknives. Mass spectrometry imaging (MSI) enables histologists to define tissue types by chemical composition rather than structure.

Able to distinguish and measure the separate contributions of molecules such as the 25-hydroxy vitamins D2 and D3 and thyroid hormones, MS/MS methods have enabled clinical laboratories to overcome the limitations of immunoassays caused by nonspecific antibody binding and cross-reactivity with metabolites. Endocrinologists are also now investigating a lab-on-a-plate method to more accurately predict risk of heart attack and stroke in diabetes patients. Application of MS technology in clinical and translational research is opening up new lines of discovery in blood-based biomarkers, tumor markers, and even endogenous metabolites as new disease biomarkers.

More sensitive urine screening methods capable of detecting designer drugs are available in the market, and vendor investments assure continued development. Some clinical research and forensic toxicology laboratories already use high-resolution, accurate-mass (HRAM) or TOF MS, for multi-analyte drug screens. Whereas triple quad-based techniques can quantitate targeted analytes, newer HRAM systems can simultaneously detect and deliver the full product ion spectrum, and retain high selectivity with greater resolution and mass accuracy.

Advanced mass spectrometry methods are producing novel functional assays. Liquid chromatography MS/MS using online solid-phase extraction (XLC-MS/MS) was used to develop a plasma renin activity (PRA) assay for monitoring mineralocorticoid therapy and screening hypertensive individuals for primary aldosteronism (PA). A further LC-MS/MS method for quantifying iothalamate in plasma and urine can accurately assess glomerular filtration rate (GFR) in early stages of renal dysfunction to screen potential kidney donors.

Analyte multiplexing and automation deliver superior and highly reproducible data to simplify increasingly sophisticated LDT methods and support clinical test validation. HRMS using triple quadrupole MS/MS is now used to screen and quantify toxic drugs, offering novel metabolomic methods to distinguish between and eliminate candidate isomers. Electrospray MS/MS and a computer-assisted metabolic profiling algorithm can automatically flag abnormal profiles in newborns from a single spot of blood. Automated MALDI-TOF MS enables clinical microbiology laboratories to identify and classify bacteria and other microorganisms.

Exponential growth in MS methods in clinical laboratories is expected in high-throughput and quantitative clinical and translational workflows, bacterial identification, imaging of tissue sections, diagnostic testing, and functional assays. Improvements in automation will support validation and seamless communication with laboratory information management systems (LIMS) to bring mass spectrometry-based detection into larger and more complex clinical laboratories. The development of handheld mass spectrometers will enable clinical measurements in remote environments opening up the possibility of point-of-care applications.

In conclusion, as technology advances and technological challenges, such as sample preparation, online extraction, throughput, automation, and system interfacing, are overcome, one can expect the impact of MS in clinical laboratories to mature. Mass spec will increasingly be relied upon for sensitive, highly reproducible, accurate results.

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