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Isotope labeling is a technique that identifies pharmaceuticals and detects counterfeits. Worldwide, pharmaceutical companies are facing a major problem of counterfeit drugs, and the adoption of isotope-labeled excipients helps reduce manufactured products either without active pharmaceutical ingredients (APIs), fake APIs , either with an incorrect amount of API. Counterfeit issues are a major concern in the pharmaceutical market due to a poor regulatory scenario, a high number of intermediaries and a lack of end user awareness.
The Isotope-Labeled Excipients Market
A tremendous transformation with the ever-changing regulatory scenario. In the United States, an amendment to the US Prescription Drug Marketing Act (PDMA) 1987 states that wholesalers must provide registrations before each wholesale distribution of prescription drugs. Such measures will regulate the health system and strengthen the market for isotope-labeled excipients. Anti-counterfeiting technology using isotope-labeled excipients has a high level of security, high product applications, authentication, proven quality standards, easily identifiable and compliant with laws.
U.S. The Food & Drug Administration also recommends that industries periodically use multiple, authentic, and changing measures for each specific product, which will lead to a growth in the market for isotope-labeled excipients.
Isotope-Labeled Excipients Market: Dynamics
] Isotope-Labeled Excipients The market is primarily dependent on a few key factors such as pharmacologically inactive, toxicologically inert and compliant with US Food & Drug Administration regulations. In addition to this, the market for isotope-labeled excipients also shows significant growth due to the non-radioactive nature that is safe for humans. The market for isotope-labeled excipients is well regulated by various government agencies. The market for isotope-labeled excipients acquires a significant boost from applications such that each batch of drug products can be differentiated with a varying amount of isotopes, which further contributes to the specific identity to the lot. The market for isotope-labeled excipients will also strengthen the packaging industry as pharmaceutical companies turn to innovative packaging technologies to differentiate products.
Isotope-labeled excipients, however, require specialized facilities, rigorous R & D that limits access to these excipients. Isotope-labeled excipients are badociated with high cost and the isotopic ratio mbad spectrometry instrument required to quantify isotopes is expensive, limiting the growth of isotopically labeled excipients.
19659003] On the basis of geography, the market for isotope-labeled excipients can be segmented into five major regions: North America, Europe, Asia-Pacific, Latin America and the Middle East and Africa. At present, North America occupies a leading position in the market for isotope-labeled excipients, followed by Europe. The main factors that have contributed to the growth of the market of isotope-labeled excipients in this region are the increase in regulation and monitoring of safety and health, the pressure on health facilities to reduce costs and counterfeiting. After North America, European countries are also expected to post steady growth in the market for isotope-labeled excipients. Over the next few years, the Asia Pacific region is expected to experience remarkable growth in the market for isotope-labeled excipients, as it is growing very rapidly and has shown the emergence of many regional players. Factors that would fuel the growth of the market for isotope-labeled excipients in Asia-Pacific are counterfeit problems in the region that have resulted in health risks for patients, resulting in downstream expenditures and resource constraints. Isotope-labeled excipients would evolve rapidly across the region. However, North America should maintain its position in the global market for isotope-labeled excipients
Isotope-labeled excipients market: key players
In the last decade, the market for labeled isotopes experienced a mbadive 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. The market for isotope-labeled excipients includes many regional players with a huge market share in emerging markets.
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