Global Chromatography Instrumentation Market - Segmented by Systems, End-users, and Geography - Growth, Trends, and Forecast (2018 - 2023)
The global chromatography instrumentation market is valued at USD 13,000 million approximately in 2017 and is expected to grow at a CAGR of 7% approximately, during the forecast period. North America holds the largest share geography-wise, which is followed by Europe and Asia-Pacific.
Introduction of Chromatography Tests in Drug Approvals
Chromatography procedures are largely used for analytical procedures and method validation of drugs and biologics. Chromatography techniques generate accurate results to validate characters, such as specificity, linearity, accuracy, precision, range, quantitation limit, and detection limit of various drugs. Gas chromatography (GC) is widely accepted, as one of the most powerful analytical techniques for the separation, quantification, and identification of drug analytes, especially at low levels of concentration, in both scientific and legal arenas. The analytical approach mostly uses hybrid techniques, like gas chromatography / mass spectrometry systems, or high-performance liquid chromatography (HPLC)/mass spectrometry systems, according to a recent publication by the Clinical and Laboratory Standards Institute. Recent guidelines of the US Food and Drug Administration (FDA) for filing investigational new drug application (NDA,) recommends chromatographic techniques for obtaining sufficient information to ensure the proper identity, quality, purity, strength, and/or potency of new drugs used in clinical trials phases. The European Medical Agency (EMA) also has similar guidelines for drug analytics. Identification to discriminate between compounds of closely-related structures, which are likely to be present, are mostly done through GC/MS or HPLC/MS systems. However, EMA does not regard the interpretation by chromatography techniques as specific. The National Institute of Health Sciences (NIHS), Japan, has also approved GC and liquid chromatography for drug testing, especially to determine the purity and efficacy of new drug analytes. Acceptance of chromatographic techniques, as a standard instrumentation for testing the validity and specificity of drug analytes, by the regulatory market, is thus going to contribute to the growth of the chromatography market, across the world.
Lack of Skilled Personnel for Equipment Handling
The substantial growth of the chromatography instrumentation industry has resulted in booming demand for technicians with expertise in chromatographic techniques. Despite the advantages offered by various chromatography techniques, and regardless of the technological innovations, the availability of skilled labor is still an issue. This can be attributed to the fact that some of the chromatographic instruments are complex, and hence, they are driving the need for new paradigms of data computation and knowledge extraction. These instruments also require timely standardization protocols and maintenance procedures that need skilled personnel. Broadly-trained technicians with technical skills on chromatography, add great value to drug discovery teams. This technique involves a large amount of analysis from a skilled technician, as the technician must correlate computer calculations with system conditions, to avoid human error within the data. Also, sample preparation is one of the important factors for producing accurate results, as chromatography techniques like fluid chromatography are sensitive. A crudely prepared biological sample will probably contain impurities, which may form adducts with the analyte molecules, in certain analyses and therefore, lead to false positive or false negative results. This factor has greatly restrained the growth of the chromatography instrumentation market.
The United States has the Largest Market Share in the Global Chromatography Instrumentation Market
The United States accounted for more than 70% of the chromatography instrumentation market in North America, and is expected to witness a steady growth during the forecast period. The advanced scientific research trends and high drifts in the adoption of technologically-advanced instruments, are propelling the growth of the US chromatography instrumentation market. The government policies and funding, like those from the National Institute of Health, are propelling the growth of the market in the country. Also, the United States has a high budget allocation for research & development, when compared to other countries.
Key Developments in the Market