Drivers: India Analytical Chromatography in Pharma Quality Control Market
Increasing government initiatives in pharmaceutical sector
India has a prominent place in the global pharmaceutical industry. Currently, 80.0% of antiretroviral drugs used for the treatment of AIDS globally are provided by Indian pharmaceutical companies. India is the biggest provider and supplier of generic drugs across the globe. According to India Brand Equity Foundation, the Indian pharmaceutical industry supplies approximately 50.0% of the demand for different vaccines globally, 40.0% of demand for generics in the U.S. and 25.0% of all drugs in United Kingdom.
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- According to the Department of Industrial Policy and Promotion (DIPP), the drugs and pharmaceuticals sector attracted a total foreign direct investment FDI inflow worth of USD 15.83 billion between April 2000 and June 2018.
Increased investment by end-user companies
Pharmaceutical analytical techniques are the processes that help to identify a substance, the constituents of a pharmaceutical mixture or solution or to determine the structures of chemical compounds used in the manufacturing of pharmaceutical products. The components that are monitored involves chiral or achiral drugs, residual solvents, process impurities, excipients and among others. The pharmaceutical industry spends more amounts in research and development as compared to other industries.
- R&D investment of few companies in 2017 is.
- Merck KGaA(Germany) – USD 2,140.00 million
- GlaxoSmithKline plc.(U.K.)- USD 5,056.53 million
- Reddy’s Laboratories Ltd.(India) - USD 291.30 million
Restraint:
High maintenance cost of advanced equipment and solvents
The maintenance cost of chromatography equipment is large because of repairing, refurbishing, calibration services and regular cleaning.
- A column and packing station of 90-L would cost about USD 200,000. If the column costs are divided over 1,000 cycles, the equipment expense would amount to approximately USD200 per cycle. The apparatus of chromatography (the medium used for a 90-L column) costs about USD 70,000. If the media is used for 50 cycles, the cost per cycle is would approximately cost USD 1,400, amounting the per-cycle cost (equipment and media) to about USD1,600. The initial spending for one large membrane chromatography equivalent amounts up to USD 3,500.0 and every membrane is used for just one cycle. Therefore the per-cycle cost for equipment is USD 3,500.0 — which is almost more than double the cost of the column and medium.
Less number of Indian manufacturers to serve the Pharma market
The maximum global pharmaceutical sales take place in the “Triad”-US, European Union and Japan, and together they amount for almost 80.0% of the global market. At the regional level, 45.0% of global pharmaceutical sales are in the US which makes it a major pharmaceutical market, Europe (24.0%) is the second and Japan (11.0%) being third. There is a tremendous growth in the global market of pharmaceuticals in the last decade, but the geographic growth has majorly been uneven. China had a contribution of 2.0% and India’s contribution makes up to a meagre 1.8% in 2009.
- In 2017, the company made approx. USD 52.5 billion in pharmaceutical sales. Other top global players from the United States include Merck & Co, Johnson & Johnson and AbbVie. The European big five players are GlaxoSmithKline and AstraZeneca from the United Kingdom, Novartis and Roche from Switzerland and French Sanofi
OPPORTUNITIES:
Development and commercialization of new types of chiral HPLC columns
Chiral chromatography has recently become the method of choice for rapid separation of enantiopure compounds in the pharmaceutical industry, directly proportionate to the speed with which a chromatographic method can be executed and developed as well as the comparatively small labour requirements of the chromatographic approach. The enantiomerically pure drug has various advantages:
- increased clinical efficacy
- decreased metabolic burden
- fewer side effects
Globalization of the drug market
Globalization is the removal of the barriers of trade and the amalgamation of the economies of the nations through corporate investments and financial flow between nations and trade in goods and services. Globalization has spread throughout the world in recent times because of the rapid progression that has been achieved in technology. In 1991, the Indian Government changed their economic policy which leads to opening of economy to foreign companies that led to the Globalization of Indian Pharmaceutical Industry.
The various advantages of globalization in Indian pharmaceutical industry are:
- It helped to boost the Indian economy by getting large amounts of foreign currency in the industry.
- One of the major benefits of globalization of Indian Pharmaceutical Industry is the introduction of highly advanced technology into the industry, thus, improving the quality of medicines.
Many mergers and acquisitions happened between Indian pharmaceutical companies and international pharmaceutical companies such as WOCKHARDT.(India) acquired Merind Limited(India)), Ranbaxy Laboratories Limited(India) merged with Croslands(ndia)I and others.
CHALLENGES:
Issues related to drug safety
The FDA launched the The Safety First Initiative in 2008, which provides a framework for assessing, identifying, and acting upon drug safety issues in the post-market period.
Table 1: Recent drug recalls by the FDA
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Date
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Brand Name
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Product Description
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Reason/ Problem
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Company
|
|
08/11/2018
|
Losartan
|
Losartan Potassium Hydrochlorothiazide
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Product has NDEA impurity
|
Sandoz AG(U.S.)
|
|
30/10/2018
|
WP Westminster, more
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Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms
|
Due to the presence of N-nitrosodiethylamine (NDEA)
|
ScieGen Pharmaceuticals, Inc.(U.S.)
|
Stringent Government Regulations:
Some of the stringent regulation policies that should be adhered by the analytical chromatography market are as follows:
- In 2005, global chemical declarable substance list was declared for all chemical industry suppliers which entailed all the details of the required reportable substances including those which are prohibited and restricted. This has a major impact on the chemical manufacturers of the medical industry as everyone has to be conscious about the added composition of their products.
- In 2008, with the enforcement of the framework of registration, evaluation, authorization and restriction of chemicals (REACH) initiated a wave of global legislation which had a very high impact on the medical industry. With this advancement, information on chemical formulations had to be communicated with the entire supply chain. Hence the manufacturing companies and suppliers had to submit expensive dossiers.
Market Trends:
On the basis of product, the market is segmented into devices and consumables and accessories. Devices are further segmented into Liquid chromatography system, gas chromatography system, supercritical fluid chromatography system, thin layer chromatography systems and system components. Liquid chromatography systems is further sub segmented into high performance liquid chromatography system, ultra-high performance liquid chromatography systems, medium pressure liquid chromatography systems, flash chromatography systems and other LC systems. Similarly system components are sub segmented into detectors, auto samplers and fraction collectors. Liquid chromatography detectors are further sub segmented as UV/UV-Visible detectors, refractive index detectors, fluorescence detectors and other LC detectors. Similarly gas chromatography detectors are further sub segmented as flame ionization detectors, mass spectrometer detectors, thermal conductivity detectors and other GC detectors. Consumables and accessories are segmented into columns, solvents/ reagents/ adsorbents, syringes/ needles, vials, fittings and tubing, pumps and other accessories. In 2019, chromatography devices segment is growing at the highest CAGR and expected to reach USD in the forecast period of 2019 to 2026.
On the basis of techniques, the market is segmented into thin layer chromatography, liquid chromatography, gas chromatography, ion exchange chromatography and others. In 2019, thin layer chromatography segment is growing at the highest CAGR in the forecast period of 2019 to 2026.
Major Players: India Analytical Chromatography in Pharma Quality Control Market
Some of the prominent participants operating in this market are Waters, Perkinelmer Inc, Agilent Technologies Inc, Merck KgaA, Jasco, Scion Instruments, Thermo Fisher Scientific Inc., Bio -Rad Laboratories Inc., Restek Corporation.
