Sterile Compounding Pharmacies Market
Sterile Compounding Pharmacies Market By Product (Injectables, Nasal, Ocular, Otic), By Therapeutic Area (Hormone Replacement Therapy, Pain Management, Dermatology, Oncology, Hematology, Dental), By End User - Global Market Insights 2021 to 2031
Sterile Compounding Pharmacies Market Outlook
Fact.MR's sterile compounding pharmacies market analysis predicts the market to attain a valuation of US$ 8.9 Bn by the end of the decade, which is 1.8X its current valuation. This survey forecasts the global sterile compounding pharmacies market to expand at a significant CAGR of around 7.2% through 2031, with the U.S. slated to account for over 70% market share.
|Data Points||Market Insights|
|Market Value (2020)||US$ 5.07 Bn|
|Market Value (2031)||US$ 8.9 Bn|
Demand Analysis of Sterile Compounding Pharmacies from 2016 to 2020 Compared to Market Outlook for 2021-2031
According to Fact.MR, a market research and competitive intelligence provider, the global market for sterile compounding pharmacies was valued at US$ 5.07 Bn in 2020 and has been expanding at a CAGR of 5.8% over the past five years.
Compounding of a product is mainly prepared to due to a patient’s sensitivity to an ingredient in commercially available products or formulations. According to the U.S. FDA, in 2020, due to the COVID-19 pandemic, hospitals had faced a huge shortage of formulations used for pain management.
Rising prevalence of chronic diseases is expected to drive demand for pain management, which is expected to boost market growth. Moreover, increasing demand for custom compounded formulations and increasing pharmaceutical spending are expected to have a positive impact on market growth.
As a result, Fact.MR expects the global market to surge at 7.2% CAGR through 2031.
Which Driving Factors are Influencing Demand for Sterile Compounding?
Rising geriatric population and increasing longevity of customized formulations over commercially available products have surged demand for sterile compounded products. Additionally, several key players are focusing on inorganic growth strategies to innovate and develop effective products. Thus, product approvals and launches are expected to complement market growth.
- For instance, in May 2020, Central Admixture Pharmacy Services, Inc. launched three new sterile compounded suspensions. One is a sedative: Midazolam 125 mg added to NS (1mg/mL), and the other two are vasodilators: Vasopressin 50 units added to 50 mL normal saline Norepinephrine 8 mg added to 250 mL normal saline, which are in in short supply for ICU patients.
What are the Key Opportunities for Sterile Compounding Pharmacy Product Manufacturers?
Focusing on several factors such as developing customized formulations in ground-breaking forms, varying dosages for different indications, can make customized formulations more popular across the globe. Upcoming areas include geriatric and long-term care drugs and innovative hormone replacement therapy applications.
Additionally, growing regulatory compliance has led manufacturers to invest hugely in the pharmaceutical industry. On 27th November 2013, the Drug Quality and Security Act (DQSA) was signed into law to minimize safety risks related to pharmacy compounding and improve regulation of compounding pharmacies.
Thus, such regulations are expected to offer lucrative opportunities for investors as a result of increasing sales of sterile compounded solutions.
Growing innovations have resulted in it becoming easier to conduct sterile compounding for specialty drugs.
- For instance, COMECER S.p.A. introduced an automated and patented device – Pharmoduct - used for the preparation of sterile formulations and personalized oncology drugs, including chemotherapy and biologicals.
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What is Expected to Impede Demand for Sterile Compounding?
There are various barriers that manufacturers have to face while investing in the sterile compounding industry.
The primary factor restraining usage of sterile compounded formulations is unsafe compounding practices, which include contamination and non-adherence to GMP regulations during the compounding process. Contaminated sterile environments lead to the spread of pathogens and fungal infections, which have resulted in various hazards and drug-related deaths, thus dampening the prospects for demand for sterile dosage forms.
Additionally, Exacerbating API’s shortage and quick flotation of compounding pharmacies may also hamper market growth and adoption of sterile preparations over the coming years.
Why is the U.S. a Leading Market for Compounding Pharmacies?
The U.S. is estimated to account for nearly 77.2% share of the North American market in 2021. Increasing pharmaceutical spending and well-built healthcare infrastructure lead to the dominance of the country in this space.
The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that can manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use. The safety and compliance of compounded drugs are covered in the BPOR article ‘Fifteen per cent of 503B Compounding Outsourcing Facilities Have Violated FDA Regulations’ (B/POR, July 2018).
Around 75% of U.S. hospitals outsource sterile compounding preparations to 503B facilities so that they can ensure stability, cope with drug shortages, obtain a ready-to-administer form of the drug, extend shelf-life, or compensate for inability to compound required amounts in-house.
Moreover, increasing geriatric population and rising adoption of customized formulations over commercial products are major factors that are expected to drive growth of the U.S. compounding pharmacies market over the coming years.
What’s Driving Sales of Sterile Compounded Medications in Canada?
Canada currently accounts for 23% market share in North America. The Canadian Pharmacists has reviewed the “Guidelines to Pharmacy Compounding” published by the National Association of Pharmacy Regulatory Authorities (NAPRA) in October 2006. These guidelines evolved the compounding practice and awareness of the inherent dangers of compounding sterile preparations on the health of patients and compounding personnel.
Growing government initiatives towards awareness and implementation of favorable policies have led the market in Canada to witness growth, which is set to exhibit 8.9% CAGR and account for nearly 28% market share by 2031.
What’s Enabling Growth of the Market for Sterile Compounding Pharmacies in Australia & New Zealand?
Australia & New Zealand accounted for 54% market share of Asia Pacific in 2021. Therapeutic Goods Administration (TGA) manufacturing license is essential for regulatory approval of sterile compounding pharmacies or should comply with GMP relating to the manufacture of sterile products.
In April 2011, the Pharmacy Guild of Australia’s Quality Care Pharmacy Program (QCPP) was republished as Australian Standard S 85000:2011 Quality Care Pharmacy Standard - quality management system for pharmacies in Australia. This standard includes the statement that pharmacies should maintain and follow a system for compounding.
Additionally, rise in patient pool and growing chronic disease among the population in the country are significant contributing factors for rising sales of sterile compounding for specialty drugs.
How is Demand for Sterile Compounding in the U.K. Shaping Up?
The U.K. market for sterile compounding pharmacies is set to exhibit over 6% CAGR. Presence of leading players in the country and growing adoption of sterile compounding formulations will allow the country to hold around 34% of the European market share.
What is the Scope of Adoption of Sterile Preparations in Singapore?
The market for sterile compounding pharmacies in Singapore is set to exhibit around 8.6% CAGR and account for nearly 27% share of the Asia Pacific market.
Emerging economies such as Singapore show significant potential to capitalize on the growth opportunities in this region, primarily due to continuous focus on improving the compounding pharmacy industry by providing sterile compounding services as well as training that would gain more opportunities in the industry.
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Why is Demand for Ocular Compounding on the Rise?
Followed by injectables, ocular sales of sterile compounded ophthalmic medications are expected to account for the second-largest market share of 15.5% by 2031. The high share of this test is primarily attributed to growing prevalence of ophthalmic disorders or other ocular anti-infective therapies.
Why Does Sterile Compounding for Hormone Replacement Account for the Highest Share?
Hormone replacement therapy has gained traction in the global market. The segment is projected to expand at a CAGR of 5% over the forecast period.
Growing adoption of sterile preparations for hormone replacement therapy will surge demand for sterile compounded formulations. For example, testosterone injections are used to maintain therapeutic levels, which is essential for ensuring the best outcomes for patients.
The global sterile compounding pharmacies industry is marked by the presence of emerging as well as top sterile compounding pharmacy manufacturers. Rising adoption of inorganic growth strategies by key players operating in the market and increasing novel product approvals and launches are major factors that are expected to drive market growth.
Further, to strengthen their footprint across the globe, key players are focused on pursuing mergers and acquisitions as their key growth strategy.
- For instance, in May 2021, Slade Health, part of Icon Group entered into a long-term agreement with Auckland District Health Board (ADHB) to provide sterile compounding services to meet the growing needs of cancer patients. This agreement would build and operate a world-class, GMP (Medsafe) licensed sterile compounding facility delivering chemotherapy, antibiotics, analgesics, and nutritional infusions for public and private hospitals across New Zealand.
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Sterile Compounding Pharmacies Industry Report Scope
|Historical Data Available for||2016-2020|
|Market Analysis||USD Million for Value|
|Key Regions Covered||
|Key Countries Covered||
|Key Market Segments Covered||
|Key Companies Profiled||
|Customization & Pricing||Available upon Request|
Key Segments as per Global Sterile Compounding Pharmacies Industry Research
By Therapeutic Area
- Hormone Replacement Therapy
- Pain Management
By End User
- FAQs -
At present, the global sterile compounding pharmacies market is worth US$ 4.2 Bn.
Sales of injections are expected to top US$ 5.3 Bn by the end of 2031, with revenue expected to register a CAGR of 6% over the same period.
From 2016-2020, the market expanded at the rate of 5.8%, owing to growing demand for compounded formulations.
Diversification of services, increasing FDA compliance, changing pharmacy store formats, increasing mergers & acquisitions by leading players, new product launches, and approvals are some of the key trends shaping market expansion.
The U.S., Canada, Australia & New Zealand, Singapore, and U.K. are expected to drive most demand for sterile compounding pharmacies over the next ten years.
North America is a key market for sterile compounding pharmacies, with the U.S. expected to account for 72% regional market share through 2031.
Demand for sterile compounding pharmacies in Europe is expected to register a growth rate of 7.6% CAGR through the decade.
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