COMPOUNDING CHEMOTHERAPY MARKET ANALYSIS

The Global Compounding Chemotherapy Market size was valued at US$ 5.29 Bn in 2023 and is projected to reach US$ 7.41 Bn by 2030, growing at a CAGR of 4.9% from 2023 to 2030.

The growth of the compounding chemotherapy market is driven by the increasing prevalence of cancer, rising demand for personalized cancer care, and growing preference for compounded chemotherapy over commercial chemotherapy. Additionally, the increasing adoption of advanced technologies in compounding pharmacies and the growing demand for compounded drugs in emerging economies are expected to propel the growth of the market in the coming years.

The compounding chemotherapy market is segmented by drug type, compounding setting, route of administration, patient type, cancer type, distribution channel compounding method, packaging type, regulatory compliance and region. By drug type, the market is segmented into cytotoxic drugs, hormonal agents, immunomodulatory agents, targeted therapies, and supportive care drugs. The compounding setting segment is further segmented into hospital compounding, compounding pharmacies, specialty clinics, and homecare settings. The route of administration segment is segmented into intravenous (IV) oral, subcutaneous (SC), intramuscular (IM), and intrathecal (IT). The patient type segment is segmented into adult patients, pediatric patients, and geriatric patients. The cancer type segment is segmented into breast cancer, lung cancer, colorectal cancer, prostate cancer, leukemia, lymphoma, and other specific cancer types. The distribution channel segment is segmented into hospital pharmacies, retail pharmacies and online pharmacies. The distribution channel segment is segmented into aseptic compounding and non-aseptic compounding. The compounding method segment is segmented into aseptic compounding and non-aseptic compounding. The packaging type segment is segmented into vials, ampoules, pre-filled syringes, and bottles. The regulatory compliance segment is segmented into USP Chapter <797> Compliance, and FDA Regulations.

Compounding Chemotherapy Market Regional Insights

• North America is the leading market for compounding chemotherapy, accounting for a share of 45.80% in 2022. The high prevalence of cancer, rising demand for personalized cancer care, and growing preference for compounded chemotherapy over commercial chemotherapy are the key factors driving the growth of the market in this region.
• Europe is the second-largest market for compounding chemotherapy, accounting for a share of 29.20% in 2022. The rising adoption of advanced technologies in compounding pharmacies and the growing demand for compounded drugs in the region are the key factors driving the growth of the market in this region.
• Asia Pacific is the third-largest market for compounding chemotherapy, accounting for a share of 15.00% in 2022. The increasing prevalence of cancer, rising demand for personalized cancer care, and growing preference for compounded chemotherapy over commercial chemotherapy are the key factors driving the growth of the market in this region.

Figure 1. Global Compounding Chemotherapy Market Share (%), by Region, 2023

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Analyst View

The global compounding chemotherapy market is expected to witness steady growth over the next few years. The market is driven by the growing incidences of cancer worldwide and the increasing demand for customized chemotherapy drugs. North America dominates the market currently owing to the high adoption of personalized medication in the region. Asia Pacific is likely to be the fastest growing market due to rising healthcare spending and growing cancer prevalence in China and India.

Some of the major opportunities in the compounded chemotherapy drug space include the development of specific formulations for pediatric patients who need alternative dosages. There is also scope for leveraging technology to improve the safety and efficacy of compounded drugs. However, the market also faces challenges in terms of a lack of stability studies and standardization. Additional costs associated with compounding and storage issues also restrain the market's growth to some extent.

Regulatory concerns around the quality, safety, and efficacy of compounded drugs continue to be a key challenge for major market players operating in this market. A lack of clinical data to prove therapeutic equivalence with branded drugs also limits the widespread adoption of compounded therapies. Nonetheless, with the rising demand for personalized medicine, players could focus on strategies around targeted Research & Development and alliances to capitalize on the opportunities present in this niche segment.

Compounding Chemotherapy Market Drivers

• Personalized Medicine: Compounding chemotherapy allows for personalized treatment approaches tailored to individual patients. Every patient's cancer is unique, and their response to standard chemotherapy drugs may vary. Compounding chemotherapy enables healthcare providers to customize medications, adjust dosages, and combine drugs to optimize treatment outcomes, increase efficacy, and minimize adverse effects.
• Increased Prevalence of Cancer: The global incidence of cancer continues to rise, with a growing number of patients requiring chemotherapy. As the number of cancer cases increases, there is a greater demand for compounding chemotherapy to provide tailored treatments that meet specific patient needs.
• Drug Resistance: Chemotherapy resistance is a significant challenge in cancer treatment. Some cancer cells develop resistance to standard chemotherapy drugs, reducing their effectiveness. Compounding chemotherapy allows for the combination of different drugs or adjustments in drug formulations to overcome drug resistance and improve treatment outcomes.
• Pediatric Oncology: Pediatric cancer cases require specialized treatment due to the unique needs and vulnerabilities of children. Compounding chemotherapy allows for precise dosing based on a child's age, weight, and individual characteristics. It also enables the formulation of drugs with child-friendly flavors or delivery methods, enhancing treatment compliance in pediatric oncology.

Compounding Chemotherapy Market Opportunities

• Growing Demand for Personalized Medicine: The shift towards personalized medicine is a significant opportunity for compounding chemotherapy. As healthcare providers increasingly recognize the importance of individualized treatment approaches, the demand for customized chemotherapy medications will continue to rise. Compounding chemotherapy enables tailored therapies based on patient-specific factors, such as genetic profiles, disease characteristics, and treatment responses.
• Expansion of Precision Oncology: Precision oncology aims to identify specific molecular alterations driving an individual's cancer and target them with precise treatments. Compounding chemotherapy plays a vital role in precision oncology by facilitating the preparation of drugs that target specific genetic mutations or biomarkers. The expansion of precision oncology opens doors for compounding pharmacists to develop and provide specialized medications for targeted therapies.
• Advancements in Pharmacogenomics: Pharmacogenomics studies the influence of an individual's genetic makeup on their response to medications. By understanding how genetic variations affect drug metabolism and efficacy, healthcare providers can optimize treatment outcomes. Compounding chemotherapy can leverage pharmacogenomic information to prepare customized medications that align with a patient's genetic profile, maximizing treatment effectiveness and minimizing adverse effects.
• Collaboration with Oncology Specialists: Collaboration between compounding pharmacists and oncology specialists presents an opportunity for comprehensive and integrated cancer care. By working closely with oncologists, compounding pharmacists can contribute their expertise in customizing chemotherapy medications, providing dosing recommendations, and managing drug interactions. This collaboration can lead to improved treatment outcomes and patient satisfaction.

Compounding Chemotherapy Market Trends

• Increasing Adoption of Precision Medicine: Precision medicine, which focuses on tailoring treatments based on individual patient characteristics, is gaining momentum in oncology. The compounding chemotherapy market is aligning with this trend by providing customized medications that target specific genetic alterations or biomarkers. The integration of molecular profiling and genetic testing into treatment decision-making is driving the demand for compounding chemotherapy services to deliver personalized therapies.
• Growing Demand for Combination Therapies: Combination therapies, involving the use of multiple drugs to target different aspects of cancer, are becoming more prevalent. Compounding chemotherapy facilitates the preparation of combination therapies by pharmacists, allowing for the simultaneous administration of multiple drugs in specific ratios and dosages. This trend is driven by the need to overcome drug resistance, enhance treatment efficacy, and reduce the risk of cancer recurrence.
• Emphasis on Quality and Safety: There is an increasing focus on ensuring the quality and safety of compounded chemotherapy medications. Regulatory bodies and healthcare organizations are implementing stricter guidelines and standards for compounding practices. The use of automated compounding systems, advanced technologies, and rigorous quality control measures is being adopted to minimize errors, contamination risks, and variability in compounded medications.
• Integration of Technology and Automation: Technology and automation are playing a significant role in the compounding chemotherapy market. Automated compounding systems and robotic technologies are being employed to streamline the compounding process, improve accuracy, and enhance efficiency. These advancements not only reduce human errors but also enable compounding pharmacists to compound medications on a larger scale, meeting the increasing demand for personalized chemotherapy.

Compounding Chemotherapy Market Restraints

• Regulatory Compliance: Compliance with regulatory standards and guidelines is a significant challenge in the compounding chemotherapy market. Compounding pharmacies must adhere to strict regulations set by local and international authorities to ensure patient safety, quality control, and proper handling of hazardous drugs. Meeting these requirements can be complex and costly, requiring investments in infrastructure, training, and compliance procedures. While regulations aim to uphold safety, their stringent norms end up increasing financial burden on all stakeholders. This disproportionately impacts resource constrained areas and acts as a significant roadblock in the path of global compounding chemotherapy market growth. Collaborative efforts are needed between regulators and industry to lower compliance costs and promote quality services through optimal regulatory oversight.
• Safety Concerns: Compounding chemotherapy involves the manipulation and preparation of hazardous drugs, which pose inherent risks to healthcare professionals and patients. Ensuring proper handling, storage, and disposal of these drugs is crucial to minimizing the risk of exposure and contamination. Safety concerns related to drug compounding, including potential errors, microbial contamination, and sterility issues, can affect the reputation of compounding pharmacies and undermine patient confidence.
• Lack of Standardization: The lack of standardized compounding practices and formulations poses a challenge in the market. Compounded chemotherapy medications may vary in terms of formulation, stability, and potency, leading to inconsistencies in treatment outcomes. The absence of standardized protocols for compounding chemotherapy drugs can make it challenging for healthcare providers to compare and evaluate different compounded formulations.
• Intellectual Property and Patent Issues: Compounding chemotherapy involves the modification or combination of existing drugs, which can raise intellectual property concerns. Pharmaceutical companies holding patents for certain drugs may limit the availability or accessibility of those drugs for compounding purposes. This can restrict the options for compounding pharmacists and impact the availability of specific medications for customized chemotherapy.

Recent Developments

New product launches/Approvals

• In November 2022, ImmunoGen Inc., a biotechnology company, announced that the US Food and Drug Administration has granted approval for ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
• In December 2022, Novartis AG, a pharmaceutical company, announced that the European Commission (EC) had approved Pluvicto, a targeted radioligand therapy. Pluvicto is approved in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC).

Acquisition and partnerships

• In July 13, 2023, Revelation Pharma, a pharmaceutical company, acquired Eagle Pharmacy, LLC., a compounding pharmacy, and Lee Silsby Pharmacy, a compounding pharmacy that serves healthcare facilities. Eagle Pharmacy, LLC., is an outsourced compounding pharmacy that provides services to patients, prescribers, medical facilities, and over 29 states and territories in the U.S. Revelation will be able to leverage Eagle's capabilities to guarantee medication availability for office use, as well as to diversify and create new growth avenues for the rest of the Revelation platform. Lee Silsby Pharmacy is also a compounding pharmacy that serves patients and prescribers in over 45 U.S. states and territories.
• On October 20, 2023, FarmaKeio Custom Compounding, a pharmaceutical company, announced the acquisition of its newest location in Conway. The goal of FarmaKeio Custom Compounding is to promote the healthcare revolution by offering patients and practitioners nationwide individualized compounded pharmaceuticals and exceptional service.

Figure 2. Global Compounding Chemotherapy Market Share (%), by Drug type, 2023

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Top companies in Compounding Chemotherapy Market

• B. Braun Melsungen AG
• Fagron NV
• PharMEDium Services, LLC (AmerisourceBergen Corporation)
• Baxter International Inc.
• Fresenius Kabi AG
• Advanced Pharma, Inc.
• McGuff Compounding Pharmacy Services, Inc.
• Central Admixture Pharmacy Services, Inc. (CAPS)
• Institutional Pharmacy Solutions, LLC
• Wedgewood Pharmacy
• Medisca Inc.
• Dougherty's Holdings, Inc.
• PharMEDium Services, LLC (AmerisourceBergen Corporation)
• BioScrip, Inc.

Definition: The compounding compounding describes the process of specifically creating compounded drugs for cancer treatment. No two cancer patients share the same comorbidities, genetic code, daily habits, and health history. As a result, everyone has unique treatment needs, and their medication should be compounded to fit these requirements. Chemo compounding allows healthcare specialists to customize a patient’s antineoplastic medication