Compounding Pharmacies Market

Compounding Pharmacies Market Outlook (2023-2033)

Worldwide revenue from the compounding pharmacies market was about US$ 10.3 Bn in 2022, with the global market estimated to surge ahead at a CAGR of 8.6% to reach a valuation of US$ 25.4 Bn by the end of 2033.

As assessed by Persistence Market Research, oral medications are expected to hold a market value of US$ 4.9 Bn by 2023. Overall, compounding pharmacies market sales account for approximately 1.9% revenue share in the global  personalized medicine market, which was valued at around US$ 535.67 Bn in 2022.

Sales Analysis of the Global Market from 2012 to 2022 Vs Market Outlook for 2023 to 2033

The global market for compounding pharmacies recorded a historic CAGR of 5.6% in the last 10 years from 2012 to 2022.

A compounding pharmacy's traditional function is to formulate drugs utilising unique doses, components, and forms in order to best serve a patient's needs. The modern compounding pharmacy has its origins in the 19th century, when doctors would prescribe and create drugs for the patients.

The practise of medicine and pharmacy has drifted apart throughout time, and now, medications are mass-produced. While the majority of patients benefit from these over-the-counter drugs, some patients require the individualised attention of a compounding pharmacy.

Additionally, patients must also use compounded medications if they need a customised dose or are allergic to a component (such a dye) in the FDA-approved, commercially accessible version of the treatment. They are particularly essential for elderly patients or children who are unable to chew pills and require a liquid version of medication that is not commonly available.

Increased palatability and adherence can be achieved by using flavouring agents, effervescent liquids, or specialised dosage forms like lollipops. Additionally, medications can be made for people adopting particular diets including those that are gluten-free, sugar-free, casein-free, vegetarian, vegan, or Kosher.

Medications for pain relief (such as gabapentin, cyclobenzaprine, baclofen, diclofenac, lidocaine, ketamine, bupivacaine, and flurbiprofen) or hormone replacement are the most often compounded pharmaceuticals (progesterone, estriol, estradiol, testosterone). Compound medications are widely used in dermatology to enhance therapeutic outcomes by the focused actions of a specific chemical combination.

Over the coming years, demand for compounded drugs is expected to rise as a result of increasing worldwide drug shortages, growing costs for branded prescription alternatives, and restricted access to medicines.

Many significant specialty pharmacies are putting their efforts into strengthening their positions through alliances with local manufacturers and the pursuit of acquisitions to boost their revenues.

Additionally, businesses are focusing on North America, Asia Pacific, and Europe through the implementation of R&D and market alliances.

The global market is thus likely to show high growth over the coming years at a CAGR of 8.6% and reach a global market size of US$ 25.4 Bn by 2033.

What Factors Will Drive the Market to Grow Over Forecast Period?

“Rising Pharmaceutical R&D”

Pharmaceutical R&D for the treatment of different illnesses in novel media, forms, and doses is projected to offer market participants a profitable development potential. The growing acceptance of veterinary and animal pharmaceutical compounding, particularly in Europe and North America, will benefit manufacturers.

Compounding pharmacies need to adopt hybrid retail strategies in addition to a compounding department if they want to increase their revenue. Market participants must concentrate more on pharmacies that perform non-sterile compounding in order to reduce errors brought on by sterile compounding.

To increase their market share, major market industry players are primarily concentrating on global expansion and the introduction of cutting-edge products that respond to consumer needs. For instance, In June 2016, PharMEDium collaborated with Kit Check to provide RFID tags for prefilled syringes made by PharMEDium.

Additionally, to improve their market positioning and develop sustainable positioning, large medical and pharmaceutical corporations are working with small compounding solution providers and research institutions in Asia Pacific and Europe. The target markets for significant compounding pharmacies at the moment are North America, Europe, and Asia-Pacific.

Additionally, rising FDA approvals for new medicine applications and business partnerships are promoting the use of good-quality drugs and products. Sales of compounding pharmacies might increase soon as regulatory procedures in emerging nations are likely to be improved and streamlined.

Is there Any Impact on the Growth of the Compounding Pharmacies Market?

“Limitations on the Production of Complicated Formulations”

Inadequate compounding practises, such as contamination during the compounding process and disregard for GMP rules, are the main factors limiting the utilization of compounded drugs. This is especially apparent in the sterile compounding of injection-ready drugs and intravenous solutions.

The sales prospects of compounded pharmaceuticals from complex drug pharmacies are expected to negatively impact the rise in the number of restricted drugs. In this regard, the U.S. FDA stated that, starting in June 2015, it would add four drugs to its register of those that are "not allowed to be compounded" in large amounts by outside facilities. These includes bromocriptine mesylate (Tylenol), cetaminophen, aprotinin (Trasylol), and ondansetron hydrochloride (Zofran).

A ruling banning the compounding of these medicines might decrease the need for mutual compounded medications like Tylenol.

When done in non-sterile surroundings, compounding sterile pharmaceuticals or medications that comprise both sterile and non-sterile constituents pose a serious risk to the safety of the drugs being used. This is yet another significant barrier to market expansion. Recalling potentially dangerous compound medications can make a scarcity issue.

Growing regulatory pressure is projected to impede the growth of compounding pharmacies worldwide. Registration with the FDA, accessibility for inspections, and adherence to GMP guidelines are required for producing bulk pharmaceuticals and ingredients as well as trans-boundary drug compounding.

Selling medications that are compounded as injectable has become more challenging due to an increase in label warnings for sterility compounding. For instance, the American Food and Drug Administration (US FDA) has increased its initial caution on Becton-Dickinson (BD) general use syringes in the sizes of 1mL, 3mL, 5mL, 10mL, 20mL, and 30mL. To prevent interactions with the rubber stoppers on some batches, the FDA encouraged consumers to use these syringes as soon as they have been filled with medication.

Additionally, because sterile medications are more susceptible to suffer chemical contamination and are not FDA-approved, they have been the subject of more recalls than other types of drugs globally.

Country-wise Insights

Why is the U.S. Market Booming?

“Increased Dermatological Diseases”

The U.S. accounted for around 77.4% market share in the North America compounding pharmacies market in 2022.

In North America, the prevalence of skin disorders is rising as a result of a number of causes, including poor skincare practises, unhealthy eating patterns, and a family medical history of the condition. Acute illnesses including dermatitis and melanoma are becoming more prevalent at a concerning rate.

Psoriasis is a persistent skin ailment that affects roughly 7.5 million Americans, according to the American Academy of Dermatology (AAD). The demand for online compounding pharmacies, which formulate the right medication to prevent allergic or other unfavourable medical reactions upon ingestion of the drugs, has increased as a result of these health conditions.

Will Germany Be a Lucrative Market for Compounding Pharmacies Manufacturers?

“Rise in Geriatric Population”

Germany held around 15.7% market share of the Europe compounding pharmacies market in 2022.

Increasing life expectancy and an increasing geriatric population base will both contribute to the market's rise in this region. The World Health Organization (WHO) predicts that by 2050, there will be about 40 million people in the European region who are 85 years of age or older.

The demand for customised medicine has increased as a result of the elderly population's longer lifespan. The demand for anti-aging treatments and products such as bioidentical hormone replacement therapy and human growth hormone has increased due to a higher percentage of individuals living to old age and a rising desire to look young.

Similarly, as many of these are largely developed in compounding pharmacies, rising utilisation of testosterone therapy and high-quality dermatological goods among the elderly will propel the total market expansion in Germany.

How is Australia Emerging as a Prominent Market for Compounding Pharmacies?

“New developments for patient care”

Australia is expected to hold a market share of about 8.1% of the global compounding pharmacies market in 2023. According to Australasian Menopause Society Limited, the number of women seeking hormone-related treatment has increased, and the pharmaceutical industry has responded by ramping up manufacture of pills, patches, and lotions.

The most typical application of bio-identical hormone replacement therapy (BHRT) is to treat menopause symptoms, and yet it can also be used to treat a wide variety of disorders that afflict women of all ages.

A compounding pharmacist can assist a woman in starting and maintaining a bio-identical hormone replacement prescription that balances her hormones and closely resembles what patient's body has been doing naturally for years by working closely with her and her healthcare practitioner. The pharmacist can produce hormones with a doctor's prescription in a range of dosage forms and strengths, including capsules, suppositories, topical or vaginal creams and gels, and others. This therapeutic use of compounding pharmacy is supposed to boost the regional growth.

Category-wise Insights

Which Product is Driving Growth of the Global Market?

“Various Beneficial Advantages”

The oral medication segment held around 44.0% share of the total compounding pharmacies market in 2022.

Drugs taken orally often pass through the liver and gut wall, which both have a number of inactivating enzymes. The term "pre-systemic" or "first-pass" metabolism refers to this process. This shows that only a small portion of the medication really enters the systemic circulation after being delivered.

Oral medication is the most popular method of drug administration, due to benefits like patient choice, simplicity of manufacturing oral dosage forms on a wide scale, and comfort of drug administration via the oral route.

Additionally, this medication is cost-effective because the patient imposes no additional expenses. When taking a solid medication, such as tablets and capsules, the patient just requires one or two cups of water, which is typically readily available. If the medication is in liquid form, only a measuring device, which typically comes with the medication, is required.

Furthermore, as no sterile precautions are needed even danger of acute drug reaction is minimal. These affirmatory factors have increased the consumption of oral medications than others and even patients preferably uses oral medications than others.

Which Application Offers the Global Market a Profitable Outlook?

“Rising Health Consciousness”

Medication for adults hold a market share of around 54.0% in 2022 due to rising demand spurred on by an increase in health-related situations, as well as a rise in the need for dietary supplements, topical dermatological treatments, and personalised medicine.

Rising consumer awareness for staying fit and healthy has increased which has resulted in the segment’s growth. Busy schedules and evolving lifestyles have made difficult for people to exercise daily, increasing the consumption of products such as tablets and capsules containing omega, minerals, and vitamins. The industry is anticipated to grow increasingly dependent on supplements to meet nutritional needs due to their high level of convenience.

Moreover, beauty and good looks have become prominent factors in the growing youth globally. Most of the doctors suggest creams and ointments for dermatological problems or infections. Most of the time it is not possible for everyone to apply it regularly. Therefore, most people prefer oral medications, which are easily adaptable.

Which Therapeutic Area Accounts for Highest Market Share in Compounding Pharmacies?

“Growing Public Acceptance of Hormone Replacement Therapy”

In terms of therapeutic area, hormone replacement therapy accounts for 64.7% of the global market share in 2022.

The growth of compounded hormone replacement therapy (HRT) medications is being pushed by the increasing utilization of HRTs as APIs are readily available in range of doses. As individuals have become more conscious about critical health problems such as mood swings, acute depression, hot flashes, osteoporosis, erectile longevity, breast and bone health, etc., the demand for customized hormone replacement therapies has surged recently.

Additionally, the need for hormones such progesterone after hysterectomy, hormones that treat infertility, testosterone replacement, etc. has increased as a result of the dosage required for certain customized solutions.

Due to the rapid rise of lifestyle-related disorders in the younger population due to changing lifestyles and rising stress levels, these therapies are expensive and in high demand. Progesterone, estradiol, oestrogen, and testosterone are some of the active pharmaceutical chemicals that are now in high demand in the HRT industry.

Competition Landscape

Compounding pharmacies employ partnerships and acquisitions as essential tactics to set themselves apart from the competition. These strategies give participants the chance to combine the resources needed to guarantee the sustainability of their companies in the market.

Compounding pharmacies are concentrating on product launches and expansion to better position themselves in the market.

Key instances include:

• In April 2019, California was added to Pentec Health, Inc.'s list of 43 approved states. The company offers advanced in-home clinical services and patient-specific compounded sterile pharmaceuticals.
• In May 2019, Fagron agreed into a deal to buy Central de Drogas, S.A. de C.V., a provider of raw resources to pharmaceutical industry and compounding pharmacies in Mexico.
• In March 2021, Osceola Capital and seasoned entrepreneur Jacob Beckel have announced the creation of Revelation Pharma Corp. to look into financing and strategic alliances in the pharmaceutical compounding market.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies in the compounding pharmacies market, which are available in the full report.

Compounding Pharmacies Industry Report Scope

Key Segments Covered in Compounding Pharmacies Industry Research

Product:

• Oral Medication
  • Capsules
  • Tablets
  • Mixtures
  • Lollipops
  • Lozenges
• Topical Medications
  • Gels
  • Ointments
  • Cream
  • Lotions
• Mouthwashes
• Suppositories

Application:

• Medication for Adults
• Medication for Veterinary
• Medication for Children
• Medication for Geriatric

Therapeutic Area:

• Pain Management
• Hormone Replacement Therapy

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

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