Compounding Pharmacies Market Analysis by Therapeutic Area (Pain Management, Hormone Replacement Therapy, Dermal Disorders, and Nutritional Supplements); by Route of Administration (Oral, and Topical); and by Sterility (Non-Sterile Compounding Drugs, and Sterile Compounding Drugs) – Global Supply & Demand Analysis & Opportunity Outlook 2023-2035
Buy Now Report ID: 4762 | Published Date: Mar 29, 2023
The global compounding pharmacies market is estimated to garner a revenue of USD 27 Billion by the end of 2035 by growing at a CAGR of ~9% over the forecast period, i.e., 2023 – 2035. Further, the market generated a revenue of USD 11 Billion in the year 2022. The growth of the market can be attributed to growing prevalence of chronic disease. Almost 59% of American adults in 2022 had at least one chronic illness. Moreover, dysphagia could be brought on by some chronic conditions, including Parkinson's disease, muscular dystrophy, and multiple sclerosis which could cause harm to the brain. The capacity to swallow may be impacted by sudden neurological damage, such as that caused by a stroke, brain injury, or spinal cord injury. Hence, the demand for compounding pharmacies is estimated to boost, which in turn is expected to boost the growth of the market. Moreover, pharmacy chains that specialize in compounding make it easier for patients to take their prescription medications. Given that they assemble the prescriptions for customers, they are able to create easier-to-take treatments including liquid suspension and chewable tablets.
Moreover, there has been a growing drug shortage and rise in drug failure all around the globe. Medication scarcity is a global problem that impacts high-, middle-, and low-income nations. Since, the problem is escalating and affecting the entire globe, many nations have produced a variety of solutions which also includes focusing more on compounding. All sorts of medications are susceptible to the shortage, including vital life-saving medications, cancer treatments, antimicrobial drugs, analgesics, opioids, cardiovascular medications, radiopharmaceuticals, and parenteral goods. However, the major factor contributing to the shortage of drugs is a regulatory issue. The approval of pharmacy drugs is one of the most time-consuming processes, and in the case of compounding medication, it doesn’t require any approval from the FDA and could be commercially distributed. Hence, the demand for compounding pharmacies is estimated to increase.
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Base Year |
2022 |
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Forecast Year |
2023-2035 |
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CAGR |
~9% |
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Base Year Market Size (2022) |
~ USD 11 Billion |
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Forecast Year Market Size (2035) |
~ USD 27 Billion |
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Regional Scope |
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Growth Drivers
According to the World Health Organization, one in six individuals on the planet would be 60 or older by 2030. By this point, there are projected to be 1.4 billion people over the age of 60, up from 1 billion in 2020. The number of persons in the globe who are 60 years or older would double (2.1 billion) by 2050. Hence, the demand for compounding medication is estimated to boost. Difficulty in swallowing and other oral problems such as dysphagia is very common in older people. A person's capacity to absorb particular drugs changes as they age. For instance, a slowing metabolism makes it more difficult for medications to be broken down. As a result, the medication's desired effectivity could not manifest as quickly as expected. Therefore, the preference for compounding drugs is growing further boosting the market growth.
A successful medicine takes 10 to 15 years and about 2 billion to produce. Despite, these enormous time and financial investments, approximately 89% of medication ideas in clinical trials are unsuccessful.
1 to 3 percent of prescriptions written in the US are for compounded medications.
In the United States, there are about 55,000 community-based pharmacies, of which approximately 7,499 are compounding pharmacies.
According to the World Health Organization, around 900 million people worldwide are currently afflicted with skin disorders, which are among the most prevalent illnesses affecting people's health. Hence, the market is estimated to grow. With dermatology compounding, the pharmacist could develop customized dermatological medications by fusing various ingredients to produce a drug that is catered to your unique requirements. Some chemicals, unneeded additives, and preservatives could be omitted from compounded drugs to accommodate the allergies or sensitivities of specific patients.
Challenges
The global compounding pharmacies market is segmented and analyzed for demand and supply by therapeutic area into pain management, hormone replacement therapy, dermal disorders, and nutritional supplements. Out of which, the pain management segment is anticipated to garner the highest revenue by the end of 2035. The growth of the segment can be attributed to growing prevalence of chronic pain among people. Chronic pain is one of the most common among adults. For instance, the 2019 National Health Interview Survey (NHIS) data were utilized by the Centers for Disease Control and Prevention (CDC) to estimate that 50.2 million US adults suffer from chronic pain. Chronic pain is persistent pain that lasts longer than the typical healing time or coexists with a chronic health condition, such as arthritis. Chronic pain could be ongoing or intermittent. It leads to one inability to work and eat properly, or engage in physical activity. Hence, its treatment is necessary. Oral painkillers are frequently used to treat it, however not everyone may find these to be the most effective. People's experiences with chronic pain might differ greatly from one another, thus for some, the personalized approach provided by pain management compounding may be a preferable choice.
The global compounding pharmacies market is also segmented and analyzed for demand and supply by route of administration into oral and topical. Amongst which, the oral segment is anticipated to have a significant growth over the forecast period. Orally administered medications frequently pass through the liver and gut wall, which both have a number of enzymes that render them inactive. This procedure is referred to as "first-pass" or "pre-systemic" metabolism. This demonstrates that, after being administered, only a small percentage of the medicine really penetrates the systemic circulation. Moreover, there is less risk of an acute medication reaction since no sterile measures are required. These favorable aspects have increased the use of oral drugs over others, and even patients prefer them over other forms of treatment.
Our in-depth analysis of the global compounding pharmacies market includes the following segments:
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By Therapeutic Area |
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By Route of Administration |
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By Sterility |
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The North American compounding pharmacies market, amongst the market in all the other regions, is projected to hold the largest market share by the end of 2035, backed by growing shortage of drugs in this region, and surge in utilization of personalized medicines. Moreover, there has been growing demand for oral medication is this region which is also estimated to boost the growth of the market. Also, the prevalence of oral disease in high in this region. The two most common oral disorders in America continue to be tooth decay (which affects about 89% of persons aged 20 to 64) and gum disease (which affects roughly approximately 49% of adults aged 45 to 64). When compared to drugs that are taken systemically, compounded topical therapies that are locally absorbed and work only at the affected site may prove more effective while causing less systemic side effects for many disorders treated with oral medicine. Hence, its demand is growing in this region.
The Asia Pacific compounding pharmacies market, amongst the market in all the other regions, is projected to grow with the highest CAGR during the forecast period. The growth of the market in this region can be attributed to growing drug shortages, particularly those for cancer treatments and other urgent medicines. Drug shortages have been linked to production delays as well as supply chain problems, including delays in getting raw materials, which further contributed to a limited supply of pharmaceuticals. Medication shortages increase the risk of medication errors, which could also harm patient outcomes and have an impact on healthcare finances as a result of higher healthcare costs. Hence, the demand for compounding pharmacies is estimated to boost in this region. Moreover, the ageing population and longer life expectancies have caused a rise in the number of patients with hormone imbalance, which is further estimated to boost the market growth.
Additionally, the market in Europe region in estimated to have a significant growth over the forecast period, backed by growing geriatric population who are demanding testosterone therapy and high-quality dermatological products. Further, patients who are allergic to commercial treatments could use dermatology customized remedies. Depending on the patient's needs, compounded drugs could be created with or without specific preservatives, components, and additives, advancing the segment. A wide range of formulations, including solutions, gels, sprays, ointments, foams, and others, are available for dermatology compounding products to treat a number of skin conditions, including eczema, acne, psoriasis, and others. Thus, it is anticipated that the availability of a wide range of compounding formulations for dermatology applications would accelerate market expansion in this region
The PTCB Certified Compounded Sterile Preparation Technician (CSPT) Program was introduced by the Pharmacy Technician Certification Board. Since the establishment of the organisation in 1995 and the release of its Certified Pharmacy Technician (CPhT) Program, the PTCB has only offered the CSPTTM Program as a new certification programme. A crucial component in achieving PTCB's aim to promote pharmaceutical safety is the PTCB CSPT Program.
The top company in the world for pharmaceutical compounding, Fagron, purchased a 503B outsourcing facility in Boston from Fresenius Kabi. The acquisition included a supply agreement with Fresenius Kabi as well as all operational facets of the facility, including clients, vendors, and about 80 staff. In order to achieve our strategic goal of being the top global platform for sterile outsourced services, this purchase was a crucial step for them.
In 2023, market players might incur losses due to huge gap in currency translation followed by contracting revenues, shrinking profit margins & cost pressure on logistics and supply chain.
Controlling Inflation has become the first priority for global economies from last quarter of 2022 and to be followed in 2023. With skewed economic situations, rise in interest rate by governments to control spending and inflation, spiked oil and gas prices, high inflation, geo-political issues including U.S. & China trade war, Russia-Ukraine conflict to intensify the global economic issues.
The interest rates in the U.S. may be less sensitive in 2023 as compared to 2022; sigh of relief for businesses. Positive business sentiments, healthy business balance sheets, growth in construction spending (private construction value in 2022 stood at $1,429.2 billion, 11.7 percent (±1.0 percent) above the $1,279.5 billion spent in 2021, Residential construction in 2022 was $899.1 billion, up by 13.3 percent (±2.1 percent) from $793.7 billion in 2021, non-residential construction touched $530.1 billion, 9.1 percent (±1.0 percent) above the $485.8 billion in 2021.) showcases minimal impact of recession in the country.
Similarly, spiked spending in the European and major Asia economics including, India, China & Japan to showcase less impact on the global demand.
Author Credits: Radhika Gupta, Shivam Bhutani
Ans: The major factors driving the growth of the market are growing geriatric population, rise in drug failure, surge in prescription for compounded medications, and others.
Ans: The market is anticipated to attain a CAGR of ~9% over the forecast period, i.e., 2023 – 2035.
Ans: lack of skilled pharmacist, growing restrictions on manufacturing of compounding medication, and lack of consumer preference for compounding drugs are estimated to be the growth hindering factors for the market expansion.
Ans: The market in the North American region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.
Ans: The major players in the market are B. Braun SE, Pharmacy Technician Certification Board, Institutional Pharmacy Solutions, LLC, Fagron, and more.
Ans: The company profiles are selected based on the revenues generated from the product segment, the geographical presence of the company which determines the revenue generating capacity as well as the new products being launched into the market by the company.
Ans: The market is segmented by therapeutic area, route of administration, sterility, and by region.
Ans: The pain management segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.
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