Global Market Study on Compounding Pharmacies: Regulatory Harmonization and Innovative Therapeutic Areas to Boost Demand for Compounded Drugs

  • Published On : Oct-2015 |
  • Pages : 160 Pages |
  • Format :

Compounding Pharmacies are pharmacies that produce drugs tailored to needs of individual patients, by altering, combining, or mixing active pharmaceutical ingredients of drugs. Compounded drugs are prepared under prescription from physicians. Compounding includes the combination of two or more drug ingredients in varied proportions. Most regulatory agencies across the world do not approve compounded medications and do not verify the safety or effectiveness of compounded drugs. These drugs are mostly not reimbursed by pharmaceutical benefits agencies.

This Persistence Market Research (PMR) report examines the Global Compounding Pharmacies Market for the period 2015 - 2021. The primary objective of the report is to offer updates and information related to market opportunities in the global compounding pharmacies market.

The global compounding pharmacies market report deals with compounded drugs, which are customized medicines, prepared by a pharmacist, or a physician and are available in strengths not commercially available. These medicines are easily available at community pharmacies and are known to provide personalized relief. Compounded drugs are available in various forms such as oral applications (capsules, mixtures, etc.), topical applications (creams, gels, lotions, ointments, etc.), and suppositories. These drugs can be formulated for both human beings and animals. The global compounded drug market is expected to expand at a CAGR of 6% over the forecast period (2015–2021) to account for US$ 9,751 Mn by 2021.

To understand and assess the opportunities in this market, the report is categorically split into three sections, namely, market analysis by product, therapeutic area, and region. The report analyzes the global compounding pharmacies market in terms of market value (US$ Mn).

The report starts with an overview of the global compounding pharmacies market and its usage in various applications across the globe. In the same section, PMR covers the global compounding pharmacies market performance in terms of revenue. This section includes PMR’s analysis of key trends, drivers, and restraints from supply and demand perspectives.

The next section of the report analyzes the market on the basis of application and presents the forecast in terms of value for all the years till 2021.

Products covered in the report are as follows:

  • Oral Medications
  • Topical Medications
  • Mouthwashes
  • Suppositories

The next section of the report analyzes the market on the basis of application segments and presents the forecast in terms of value for the following six years.

Drug applications covered in the report are as follows:

  • Medications for adults
  • Medication for veterinary purposes
  • Medications for children
  • Medications for the geriatric population

Post applications, the following section of the report analyzes the market on the basis of therapeutic areas and presents the forecast in terms of value for the forecast period.

Therapeutic areas covered in the report are as follows:

  • Pain medications
  • Hormone replacement therapy

The section that follows analyzes the market on the basis of region and presents the forecast in terms of value for the forecast period.

Regions covered in the report are as follows:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • The Middle East & Africa

To arrive at the market size, the report considers market value of global compounding pharmacies across the aforementioned geographies. The forecast presented here assesses the total revenue generated by the global compounding pharmacies market. When developing the market forecast, the starting point involves sizing the current market, which forms the basis for the forecast of how the market is anticipated to take shape in the near future. For this, PMR referred to several subject matter experts in the compounding pharmacy domain. Given the characteristics of the market, we triangulated the outcome based on different analysis based on supply side, demand side and dynamics of the market such as regulations and GMP guidelines of the compounding pharmacies market. Quantification of data has been considered along with the provision of quality insights collected directly from the market through discussion with pharmacists, suppliers, physicians and subject matter experts. This is how market analysis for the forecast period is carried out.

We have also taken into consideration year-on-year growth based on regional growth analysis to understand the predictability of the market and to identify right opportunities in the global compounding pharmacies market.

As previously highlighted, the market for global compounding pharmacies is split into various segments on the basis of region, application, product and therapeutic area. All these segments have been analyzed in terms of Basis Point Share (BPS) to understand the individual segments’ relative contribution to market growth. This detailed level of information is important for identification of various key trends in the global compounding pharmacies market.

Also, another key feature of this report is the analysis of the global compounding pharmacies market, by region further segmented on the basis of countries and revenue forecast in terms of absolute dollar opportunity. Regional trends have been introspected, identified and applied while forecasting the growth rates in the market. Additionally, the absolute dollar opportunity provided in the report is critical and is expected to help in assessing the level of opportunity that a provider can look to achieve from a sales perspective in the global compounding pharmacies market.

Furthermore, PMR has developed the market attractiveness index for all four segments, namely, regional, application, therapeutic area and product segments. This index helps in identifying the real opportunities in the market.

In the final section of the report, the global compounding pharmacies market landscape is included to provide report audiences with a dashboard view, based on categories of providers in the global compounding pharmacies product portfolio; their key developments and strategies have also been included wherever possible.  

Globally, compounding pharmacies are estimated to account for market value of US$ 6,786 Mn by the end of 2015, and is projected to witness stable growth across all global regions due to rising demand for personalized medicines from customers.     

The prime driver for the compounding pharmacies market is medicinal drought. Currently, there’s a shortage of over 300 drugs for various diseases in the U.S. When the need for critical drugs are not met through commercially available branded equivalents, compounded drugs are sought after. Furthermore, increasing demand for anti-ageing products that use custom compounded drugs is a prevalent trend across the globe. Innovative sub-therapeutic areas such as bio-identical hormone replacement therapy are also contributing to growing popularity of compounded drugs.  

Ease of administering compounded drugs is especially noted in critical illnesses such as cancer, where a patient is unable to swallow a pain-reducing drug. The drug is either administered as a lollipop, transdermal application, or sterile preparation. 

Various applications have their own specifications, which can be altered as per custom requirements, and as such these medicines are gaining popularity over traditional medication in regions such as MEA. 

The increasing need to conform to regulatory specifications is, however, becoming a necessity for compounding pharmacies all over the world.

Globally, Asia Pacific is expected to emerge as the market portraying the healthiest growth rates throughout the forecast period.  Certain markets in Asia Pacific such as Singapore are estimated to witness double-digit growth rates. Growing regulatory harmonization, adherence of local manufacturing to international standards stated in the leading pharmacopeias are expected to lead to standardization of the market in the region. Pain management products dominate the region in terms of product popularity. However, cost issues and lack of reimbursement options are expected to slightly hamper the growth of the market.

Europe is the second-most lucrative destination for compounding pharmacies. Obtaining of manufacturing authorizations before actually preparing a compounded formulation is expected to become the norm in the region over the next few years. The Europe market is expected to expand at a stable CAGR over the forecast period. Major companies based in Europe are looking to expand their base outside Europe to better cater to growing global demand. 

The North America compounding pharmacy market is by far the largest and is expected to experience stable growth in terms of market value. However, regulatory overhauls are anticipated to lead to market consolidation in the region. Compounded drugs are formulations, which are not approved by the FDA. Moreover, the FDA has also started tracking manufacturing process of compounded drugs, following a case of drug contamination that led to over 50 drug-related deaths and left over 700 people sickened due to spread of fungal meningitis in over 14 states in the U.S. in 2012. 

Globally, Asia Pacific market is expected to expand at the highest CAGR, followed by Latin America and Europe. The Middle East & Africa accounts for a nominal share of the overall compound pharmacies market but is expected to evolve over time with the expansion of infrastructural facilities and skill base of pharmacists.

Key market participants covered in the report include B. Braun Melsungen AG Company, Fagron, PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, Triangle Compounding Pharmacies, Lorraine’s Pharmacy, and Fresenius Kabi AG.


Key market participants covered in the report:

  • B. Braun Melsungen AG Company.
  • Fagron.
  • PharMEDium Services, LLC.
  • Institutional Pharmacy Solutions.
  • Cantrell Drug Company.
  • Triangle Compounding Pharmacies.
  • Lorraine’s Pharmacy.
  • Fresenius Kabi AG.
  • Other.
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