Pharmabiz
 

Tech advancements to drive global MS market

Our Bureau , MumbaiThursday, October 16, 2014, 08:00 Hrs  [IST]

Technological advancements and breakthroughs such as increased speed, higher accuracy, improved resolution, and miniaturization are likely to drive the global mass spectrometry (MS) market in the coming years, according to a report.

These advancements have increased the applications for the technology while enabling laboratories worldwide to improve their productivity and efficiency. The other factors that are driving the growth of the global market include the increasing use of mass spectrometry in proteomics and the increasing usage amongst emerging nations, the report adds.

The demand for MS,over the years, has increased significantly owing to the rise in use to address the growing concerns in food safety and the increasing number of government funds and spending on research.

The global MS market estimated at $3.9 billion in 2013 is expected to reach $5.9 billion by 2018, growing at a CAGR of 8.7 per cent from 2013 to 2018.

North America dominated the global MS market in 2013, followed by Europe and Asia. The North American market is likely to be driven by factors such as the increasing number of government investments in pharmaceutical, biotechnology, medical, and academic research studies that make use of mass spectrometry techniques. On the other hand, Asia is expected to grow at the highest CAGR due to the presence of high-growth markets such as India and China, the improved funding scenario in this region, increasing number of conferences and exhibitions on mass spectrometry, and increased focus of the giant players in these countries.

Applications
The technology finds its applications across multiple sectors, including the government research, energy, utilities, pharmaceuticals, diagnostics and environmental, food and beverage, security and defence, and industrial chemicals fields.

 Among the fields that continue to benefit from improvements in mass spectrometry are drug discovery, neonatal screening, food analysis, biotechnology and air quality control.

MS has been applied in life science research for over 40 years. Over these years several technological advancements have evolved to cater specific requirements in various life science areas. MS has observed a progressive growth due to increasing demand from research facilities, increased government funding in healthcare and life science, increasing demand from developing countries particularly in Asia, Middle East and South America. The increasing demand came particularly as drug discovery and development growth spurt took place since patent expiry of several billion dollar blockbuster API's were expected to lose patent in the coming few years.

 Generic companies who were experts in reverse engineering of drugs in India, Brazil and China among a few others increased investment in healthcare research funding which has further fuelled the investment of research facilities in better equipment and tools.

The miniaturization of MS systems will usher a new era in the field of mass spectrometry. Several companies and engineering research institutions have been attempting to miniaturize the size of mass spectrometers for on-field applications. Companies such as Kore Technology, now offer portable mass spectrometers that can suit on-site applications for gas analysis that could be helpful in mining, petroleum and determining air quality.

The global MS market is a very mature consolidated market. The demand for MS in healthcare is focused on applications such as drug discovery and development and biological analyses such as proteomics and chemicals. Emerging applications such as metabolomics is expected to push the growth of MS market in the future. In recent times the demand for FT-ICR systems has increased tremendously due to the greater investment by research facilities and the need for high resolution MS in protein and peptide research. The major applications of mass spectrometry are in drug discovery and disease research through proteomics and genomics along with other applications such as environmental toxicology, forensics and security. The primary end users are pharma/biopharmaceutical companies, research centres and academic institutions.

The growth of MS is to a large extent driven by the advancements in technology that have happened over all these years. While initially MS was used simply to confirm the molecular weight, the development of tandem MS opened new frontiers by enabling structural confirmation and quantisation at the lowest levels of detection.

Adaptation of this technology in various markets would not have been possible without a very close and successful collaboration between the scientific community and the instrument manufacturers. The ever-increasing demands of scientists for more and more analytical power pushed the instrument manufacturers to innovate and bring out newer technologies at frequent intervals.

A mass spectrometer can be used to describe unknown and quantify known compounds and obtain information about chemical structure. It ionises chemical compounds to generate charged molecules or molecular fragments and allows the measurement of the molecular mass of a sample. Ions in the samples, which may be solid, liquid or gas, are detected and separated according to their mass-to-charge ratio and then processed according to their relative abundance. Ions are used because they are easier to manipulate and detect than neutral molecules. The ions are then identified by comparing observed masses to known masses or through their typical fragmentation pattern.

Frequently used with gas chromatography (GC) or liquid chromatography (LC) techniques that separate compounds, MS usually consists of three main sections: the ionisation source, analyser and detector. Separated ions are detected, feeding signals into a data system where these m/z ratios are stored, together with their relative abundance, for presentation in the format of a mass-to-charge ratio spectrum. The three MS parts are usually all kept in a high vacuum to give ions a good chance of travelling from one end of the instrument to the other without any obstruction from air molecules. Tandem mass spectrometry (MS/MS) adds a second round of ion selection after a fragmentation step to get structural data. Modern mass spectrometers now use software to control and monitor the procedure.

Beginnings
The technique of MS had its beginnings in the early part of the century through J.J. Thomson's vacuum tube wherein the existence of electrons and positive rays was demonstrated. In the 1950s, Roland Gohlke and Fred McLafferty demonstrated the use of mass spectrometer as a detector in gas chromatography. Electronic Associates, Inc. (EAI), a leading U.S. supplier of analogue computers introduced computer controlled quadruple mass spectrometer under the direction of Robert E. Finnigan.

In 1976, Hewlett Packard introduced the first integrated, digital benchtop GC MS system. Today, mass spectrometer as a detector for GC is extremely popular and there are several mass spectrometers available GC-MS system in the market - single quadrupole, triple quadrupole, Ion trap, Time of flight and Magnetic sectors.

Entry into Indian market
In the mid-nineties when it was considered as a technology primarily for basic research in the premium scientific institutions or pharma, LC-MS entered the Indian market. The initial uptake of this technology in the Indian market place was slow. However once it proved its utility and delivered expected ROIs to the early adaptors, the acceptability grew exponentially post 2000.

The early adaptors in India were pharma and the CRO industry which, in fact, was the key driver for growth of LC-MS in India. While the early use of this technology in pharma was more related to qualitative work like confirmation of synthesis, MS-driven preparative scale purification and impurity profiling, CRO industry thrived on clinical trials for BA/BE studies and opened the doors for in-sourcing of projects from across the globe and brought the Indian CRO industry on a global map. The pharma and CRO industry grew rapidly in early 2000s and recorded a phenomenal growth of over 60 per cent in 2004-2005 which also translated into a significant growth of business for the associated industries like mass spectrometry.

With the strong pharmaceutical and CRO presence in the country, this segment will continue to be an important market for mass spectrometry. Total compliance to regulatory requirements, both by the industry and vendors, constant drive to improve sensitivity for both qualitative and quantitative assays and enabling analyses of highly potent drugs at lowest concentrations will be the key to success here.

This technology did not remain confined to the pharma CRO and started spreading its wings also in various other markets. In early 2000s, it was adapted as a technology of choice for contaminant testing in marine products under the ambit of Marine Products Export Development Authority (MPEDA) which opened the doors for this technology to be used in contaminant testing in various other food products as well. While MPEDA's mandate was to monitor the quality of exports of sea food products, Agricultural Products Export Development Authority( APEDA) started monitoring and assisting in the setting up of labs for contaminant testing in non marine food products. Both these nodal agencies were also mandated with promoting referral labs such as National Research Centre for Grapes( NRCG) to frame testing guidelines for the other labs being set-up for this purpose. Spices board, another autonomous body, set-up their own lab with forward looking technologies like QqTrap (Hybrid Quadrupole - Linear Ion trap) to ensure exports of contaminant free spices, another significant contributor to the forex earnings for the country.

An ideal technology to analyse various contaminants in food and food products, its use was primarily driven by the regulations imposed by importers in the western world. These regulations were driving set-up of several labs, either private or with federal subsidy to test and certify the export consignments. There was very little or negligible focus on the food testing for domestic consumption. This was in fact the inhibiting factor for the growth of this market which has an enormous potential owing to the size of Indian populace and food consumed. The Food Safety and Standards Authority of India (FSSAI) set-up under the Food Safety and Standards Act, 2006, has started changing this.

As a result, there has been steady progress towards implementation of the regulations for contaminant testing for domestic market as well and this drive will only gain momentum in time to come. The market is likely to pick up once the strict implementation of these regulations in the domestic market happen. While the growth of this market has been inconsistent so far, today it accounts for nearly 20 per cent of the total LC-MS units purchased in India.

Around similar time, there was also a major initiative to adapt this technology for proteomics research by premium CSIR labs. Their success with the planned experiments gave a major boost to adaptation of this technology in numerous research labs over the years that followed. Again heavily dependent on the federal funding, this market has been quite inconsistent and has varied from as low as 11 per cent to as high as 25 per cent of the total market in a given year. Although there has been some investment in this sector by private industry, the ratio of public to private investment has been heavily biased towards the federal investment for basic research in proteomics. This is also likely to change in the not too distant future with the pharma companies increasing their investment and shifting the focus towards biologies and large molecule-based drugs.

 
[Close]