Isotopic labeling is a technique which identifies drug products and detects counterfeits. Over the globe, pharmaceutical companies face a major problem of drug counterfeit, and the adoption of isotope-labeled excipients helps in reducing such products which are either manufactured with no active pharmaceutical ingredients (API), wrong API, or an incorrect amount of API. Counterfeiting issues are a major concern in the pharmaceutical market owing to poor regulatory scenario, a high number of intermediaries, and lack of awareness among end users.
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Isotope-labeled excipients market is undergoing a tremendous transformation with the ever changing regulatory scenario. In U.S., an amendment in the US Prescription Drug Marketing Act of 1987 (PDMA) states that wholesalers have to provide records before each wholesale distribution of prescription drugs. Such steps will regulate the healthcare system and strengthen the isotope-labeled excipients market. Anti-counterfeit technology utilizing isotope-labeled excipients possess a high level of security, high product applications, authentication, proven quality standards, easily identifiable, and legally compliant.
U.S. Food & Drug Administration also recommends that industries should utilize periodically changing, multiple, authentic measures for each specific product which will further lead to growth in isotope-labeled excipients market.
Isotope-Labeled Excipients Market is primarily driven by a few key factors such as the substances being pharmacologically inactive, toxicologically inert which is in compliance with the U.S. Food & Drug Administration regulations. In addition to this, the isotope-labeled excipients market also observes significant growth due to the non-radioactive nature which is safe for humans. The isotope-labeled excipients market is well regulated by various government agencies. Isotope-labeled excipients market gains a significant drive from applications such as each batch of drug products can be differentiated with varying amount of isotopes which further assists in batch-specific identity. Isotope-labeled excipients market will also strengthen the packaging industry as pharmaceutical companies are moving towards innovative packaging technologies for product differentiation.
Isotope-labeled excipients, however, require specialized facilities, rigorous R&D, which limits access to such excipients. Isotope-labeled excipients are associated with high cost and the isotope ratio mass spectrometry instrument which is required to quantify isotopes is expensive which restraints the growth of the isotope-labeled excipients market.
Based on geography, the Isotope-Labeled Excipients Market can be segmented into five major regions: North America, Europe, Asia-Pacific, Latin America and the Middle East & Africa. At present, North America holds a leading position in the Isotope-Labeled Excipients Market followed by Europe. The major factors which have driven the growth of the isotope-labeled excipients market in this region are the increase in regulations and oversight by the U.S. Food & Drug Administration for safety and health issues, pressure on healthcare institutions to reduce costs and reduce drug counterfeiting. Following North America, European countries are also anticipated to show steady growth in the Isotope-Labeled Excipients Market. In the next few years, Asia-Pacific is expected to show remarkable growth in the Isotope-Labeled Excipients Market as it is developing at a very rapid pace and has shown the emergence of many regional players. The factors which would fuel the growth of Isotope-Labeled Excipients Market in Asia-Pacific are increased counterfeiting issues arising from the region which has led to health risks for patients, causing downstream expenses, and leading to limitation of resources. Isotope-Labeled Excipients Market would evolve at a rapid rate across the region. However, North America is anticipated to maintain its position in the overall Isotope-Labeled Excipients Market.
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In the past decade, the isotope-labeled excipients market has witnessed a massive influx of players. Some of the major players operating in the Isotope-Labeled Excipients Market are Molecular Isotope Technologies LLC, Cambridge Isotope Laboratories, Inc., CIL Isotope Separations, LLC, Membrane Receptor Technologies, LLC, Marshall Isotopes Ltd., CortecNet, Medical Isotopes, Inc. and many others. Isotope-Labeled Excipients Market has presence of many regional players which have a huge market share in emerging countries.
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