A variety of unique health conditions, which are not cured with commercially available standard manufactured medicines or off-the-shelf formulations, affect millions of people across the globe. For such conditions, personalized medications, which are prescribed by licensed pharmacy practitioners and prepared by licensed pharmacists, are the way to better health.
In coordination with a physician, compounding pharmacists can meet the specific and individual needs of children, adults, and animals. An allergy to an ingredient, preference for a different form of dosage, or of a different strength, compounding pharmacists provide patients with solutions for their specific needs.
The global market for compounding pharmacies market is a million dollar industry, driven chiefly owing to the shortage of drugs across the globe, the rising demand for personalized medicines for a variety of unique health conditions, and ease of administration of compounded drugs. The market research firm Persistence Market Research, in one of its market studies states that the global compounding pharmacies market totaled at US$6.5 bn in 2014. Expanding at a moderate 6% CAGR between 2015 and 2021, the market is expected to reach US$9.7 bn by 2021.
While the shortage of many drugs is a primary factor driving the demand for compounding pharmaceuticals, factors such as the rising demand for anti-agent products that use personalized compounded medications and the rising popularity of sub-therapeutic fields such as bio-identical hormone replacement therapy are also propelling the global compounding pharmaceuticals market.
How is it Regulated?
While the regulatory specifications for monitoring of compounding pharmacies may differ with regions, compounding, being a core component of pharmacy, is also regulated by state and national boards of pharmacy. In the U.S., the Food and Drug Administration has some authority over some aspects of compounding pharmacy at the federal level. Compounded drug formulations are not approved by the U.S. FDA.
However, the agency has lately started tracking the manufacturing process of compounded drugs following an instance of drug contamination that led to the death of 50 people and left nearly 700 people sickened with fungal meningitis in over 14 states in the U.S. in 2012. Day-to-day compounding pharmacy practices adhere to principles and standards set by the United States Pharmacopeia (USP). The standards and principles set by the USP are also mandated in many state laws. A variety of non-profit agencies survey and establish guidelines designed for improving the overall quality of compounding processes.
Asia Pacific Sought to Propel Market’s Growth Prospects
Of the key regional markets for compounded pharmaceuticals across the globe, Asia Pacific is expected to emerge as one exhibiting the healthiest growth in the near future. Some markets in the region, such as Singapore, are also projected to witness growth at double-digit rates in the coming years. Factors such as improved regulatory harmonization and the adherence of international standards for local manufacturing practices in leading pharmacopeias are expected to be reasons for standardization of the market in Asia Pacific. However, factors such as a lack of reimbursement options and cost issues are expected to slightly hamper the market’s growth in the region.
Some of the key businesses operating in the global compounding pharmaceuticals market include PharMEDium Services, LLC, B. Braun Melsungen AG Company, Triangle Compounding Pharmacies, Fagron, Fresenius Kabi AG, Institutional Pharmacy Solutions, Lorraine’s Pharmacy, and Cantrell Drug Company.
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