Compounding Chemotherapy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented by Drug Type (Cytotoxic Drugs, Hormonal Agents, Immunomodulatory Agents, Targeted Therapies, Supportive Care Drugs), By Route of Administration (Intravenous, Oral, Subcutaneous, Intramuscular, Intrathecal), By Cancer Type (Breast Cancer, Lung Cancer, Colorectal Cancer, Prostate Cancer, Leukemia, Lymphoma, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, and Competition

Market Overview

Global Compounding Chemotherapy Market has valued at USD 5.07 billion in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 5.08 % through 2028. Compounding chemotherapy refers to the specialized practice of preparing customized chemotherapy medications tailored to the individual needs of cancer patients. This process is carried out by compounding pharmacies or healthcare facilities with the necessary expertise, equipment, and infrastructure. Compounded chemotherapy medications can be prepared in various dosage forms, such as oral solutions, capsules, topical creams, suppositories, and intravenous (IV) formulations. The choice of dosage form depends on the patient's medical needs, preferences, and the specific requirements of the treatment plan. Compounding chemotherapy is particularly valuable for pediatric and geriatric patients who may have unique dosing requirements or difficulty swallowing conventional pills or capsules. Compounded formulations can be designed to meet the specific needs of these populations.

The shift towards personalized medicine in oncology has driven the demand for compound chemotherapy. Compounded drugs allow healthcare providers to tailor treatment regimens to individual patient profiles, including genetic and molecular characteristics. Ongoing research and development efforts have led to the discovery of new chemotherapy agents and combination therapies. Compounding pharmacies play a crucial role in preparing and supplying these innovative drugs for clinical use. Compounding chemotherapy is often essential for treating rare and orphan cancers, where standardized treatment options may not be available or effective. The importance of managing chemotherapy-related side effects and providing supportive care has grown. Compounded medications, such as antiemetics and pain management drugs, are crucial in enhancing patient comfort during treatment. Early cancer detection and screening programs have led to the diagnosis of cancer at earlier stages, increasing the demand for chemotherapy drugs and compounded treatments.

Key Market Drivers

Advancements in Drug Development

Targeted therapies have revolutionized cancer treatment by specifically targeting molecules or pathways involved in cancer growth. These therapies are designed to be more selective in attacking cancer cells while sparing healthy ones. Compounded chemotherapy drugs now include a range of targeted agents tailored to individual patient profiles. Immunotherapy drugs, such as immune checkpoint inhibitors, have emerged as a promising approach to cancer treatment. These drugs harness the patient's immune system to recognize and attack cancer cells. Compounding pharmacies prepare these immunotherapies for administration, contributing to their widespread use. The development and approval of biosimilar versions of some chemotherapy agents have increased access to these treatments while reducing costs. Compounding pharmacies may be involved in preparing and supplying biosimilars, ensuring their availability. Nanoparticle-based chemotherapy formulations have been developed to improve drug delivery and enhance the therapeutic index of chemotherapy agents. These nanocarriers can target cancer cells more precisely and reduce side effects. Compounding pharmacies are involved in preparing these advanced formulations. Liposomal encapsulation is a drug delivery technique that involves enclosing chemotherapy drugs in liposomes (tiny fat bubbles). This approach improves drug solubility, extends drug circulation in the body, and enhances drug delivery to tumor sites. Compounded liposomal chemotherapy formulations are increasingly used. Ongoing research efforts continue to identify new chemotherapy agents, combination therapies, and treatment regimens. Compounding pharmacies play a pivotal role in preparing and supplying these innovative drugs for clinical use and research purposes.

The emphasis on personalized medicine has led to the development of chemotherapy agents that target specific genetic mutations or molecular markers in cancer. Compounded chemotherapy drugs allow healthcare providers to tailor treatments to individual patient needs. Compounding chemotherapy is often essential for treating rare and orphan cancers for which standardized treatment options may not exist. Advances in orphan drug development have expanded the range of compound treatments available. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), have accelerated the approval process for some cancer drugs, particularly those showing promising results in early clinical trials. Compounded drugs may play a role in providing patients with access to these therapies. The development of combination therapies involving multiple chemotherapy agents or a combination of chemotherapy with targeted or immunotherapies has become more common. Compounded chemotherapy regimens are designed to optimize treatment outcomes. Advances in pharmacogenomics allow healthcare providers to tailor chemotherapy treatments based on an individual's genetic makeup. Compounded chemotherapy regimens can be customized to match patients' genetic profiles. Compounded medications for managing chemotherapy-related side effects, such as antiemetics, pain management drugs, and growth factors, have improved patient comfort and adherence to treatment plans. This factor will help in the development of the Global Compounding Chemotherapy Market.

Evolving Treatment of Rare Cancers

Many rare cancers lack well-established standard treatment protocols due to their low incidence. Consequently, there may be a limited selection of commercially available chemotherapy drugs specifically approved for these rare cancer types. The emphasis on personalized medicine and patient-centric care has led to an increased interest in tailoring treatments to individual patients. For rare cancers, customized chemotherapy regimens are often necessary to address the unique characteristics of each patient's disease. In the absence of FDA-approved treatments for rare cancers, healthcare providers may turn to off-label use of existing chemotherapy drugs. Compounding pharmacies can prepare these drugs in appropriate formulations and dosages to meet the specific needs of patients with rare cancers. Many rare cancer patients participate in clinical trials to access experimental treatments. Compounded chemotherapy drugs are often used in clinical trial settings, contributing to the demand for compounding services. Some rare cancers are designated as orphan diseases, leading to specialized drug development efforts. Compounded medications may be an essential component of these orphan drug treatments.

The variability in how rare cancers respond to treatment necessitates flexibility in drug preparation and dosing. Compounding allows for the precise adjustment of chemotherapy regimens based on patient response. Compounding pharmacies can prepare specialized formulations, such as liposomal or nanoparticle-based chemotherapy, which may be particularly beneficial in treating rare cancers with unique characteristics. Patient advocacy groups for rare cancers often advocate for the development and availability of tailored treatments. Compounding allows for a personalized approach aligned with the goals of these advocacy efforts. The customization of chemotherapy treatments through compounding can lead to better treatment outcomes for individuals with rare cancers, as it considers factors such as the cancer's genetic profile and patient-specific characteristics. Oncologists and healthcare providers who specialize in rare cancers may have extensive experience in developing and implementing compounding-based treatment plans for their patients. This factor will pace up the demand of the Global Compounding Chemotherapy Market.

Rise in Supportive Oncology Care

Chemotherapy often leads to various side effects, such as nausea, vomiting, pain, and immune system suppression. Compounded medications, including antiemetics, analgesics, and supportive medications, are essential for managing these side effects and improving patient comfort and adherence to treatment plans. Supportive oncology care is highly patient-centric and aims to address each patient's unique needs and preferences. Compounded chemotherapy allows for personalized treatment regimens that consider individual patient profiles and tailor supportive medications accordingly. Some patients may be more susceptible to adverse reactions or allergies to commercially available chemotherapy drugs. Compounding pharmacies can prepare alternative formulations or adjust drug components to reduce the risk of such reactions. For patients with advanced or incurable cancers, palliative care focuses on improving the quality of life. Compounded chemotherapy may be part of palliative care regimens to manage symptoms and discomfort associated with cancer progression. Chemotherapy regimens can be challenging to tolerate for some patients, especially those with weakened immune systems or pre-existing health conditions. Compounded supportive medications, such as growth factors and antibiotics, can help patients better tolerate and complete their treatment. Supportive care often requires flexibility in dosing and administration of medications to address the changing needs of patients during their cancer journey. Compounding allows for precise dosing adjustments.

Compounding pharmacies can prepare specialized formulations, such as sustained-release or transdermal preparations, for certain supportive medications. These formulations may offer more convenient and effective delivery methods. Chemotherapy can lead to complications such as infections or anemia. Compounded medications, including antibiotics and blood-supporting drugs, are crucial in managing these complications and reducing the risk of treatment interruptions. Compounding pharmacists collaborate closely with oncologists and other members of the healthcare team to optimize supportive care plans. This teamwork ensures that patients receive comprehensive care that addresses both the cancer itself and the side effects of treatment. Supportive oncology care is aimed at enhancing patients' overall well-being during cancer treatment. Compounded medications contribute to patient comfort and can improve their overall quality of life. Improved management of chemotherapy-related side effects through supportive care can enhance patient adherence to treatment plans, ultimately leading to better treatment outcomes. This factor will accelerate the demand of the Global Compounding Chemotherapy Market.

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Key Market Challenges

Quality Control and Safety

Compounded medications, including chemotherapy drugs, must adhere to strict regulatory guidelines and standards set by government agencies like the U.S. Food and Drug Administration (FDA) in the United States. Compliance with these regulations is critical to ensure the safety and efficacy of compounded drugs. Maintaining consistent quality in compounded chemotherapy drugs is challenging due to variations in raw materials, compounding processes, and equipment. Quality control measures must be in place to ensure that each batch of compounded medication meets established standards. Chemotherapy drugs are typically administered intravenously, which necessitates strict sterility measures during compounding. Contamination can lead to severe infections and adverse patient outcomes. Maintaining sterility is a constant concern. Cross-contamination is a risk when multiple chemotherapy drugs are compounded in the same facility. Stringent cleaning and sanitation procedures are essential to prevent unintended mixing of drugs and contamination. Precise dosing is critical in chemotherapy to achieve the desired therapeutic effect while minimizing side effects. Variability in dosing can lead to treatment failures or toxicity. Ensuring the accuracy of compounded doses is challenging but essential. Some chemotherapy drugs are chemically unstable and can degrade over time. Compounding pharmacies must monitor and manage drug stability to ensure that patients receive medications with the intended potency and efficacy.

Rising Healthcare Costs

Compounded chemotherapy drugs can be more expensive to prepare compared to commercially manufactured drugs due to the customization, specialized equipment, and quality control measures involved. This can add to the overall cost of cancer treatment. Meeting regulatory requirements and quality control standards, as mentioned earlier, can be costly. Compounding pharmacies must invest in infrastructure, training, and ongoing compliance efforts, which can increase operating costs. High healthcare costs, including the cost of chemotherapy, can pose a barrier to patient access. Some patients may face financial challenges in accessing compounded medications, especially if their insurance coverage does not fully cover the expenses. Reimbursement for compounded chemotherapy drugs can vary based on factors like insurance policies, healthcare provider contracts, and regional variations. Some compounded medications may not be fully reimbursed, leading to financial burdens for patients. Healthcare systems and institutions need to allocate resources efficiently to manage the increasing costs of cancer care, including the use of compounded chemotherapy. Balancing the need for personalized treatment with cost considerations is a complex challenge. Compounding pharmacies must invest in specialized equipment, cleanrooms, and quality control measures to ensure the safety and quality of compounded chemotherapy drugs. These investments can be substantial and contribute to higher costs.

Key Market Trends

Rising Interest in Sterile Compounding

Sterile compounding is essential for chemotherapy drugs, which are often administered intravenously or directly into the bloodstream. Ensuring sterility prevents the risk of infections and other complications, which can be life-threatening for cancer patients with compromised immune systems. Many chemotherapy drugs are potent and require precise dosing and administration. Sterile compounding allows for the accurate preparation of these drugs to minimize the risk of dosage errors. Sterile compounding facilitates the customization of chemotherapy regimens based on individual patient profiles, including cancer type, stage, and medical history. This personalized approach aligns with the trend toward precision medicine. The development of advanced drug delivery methods, such as nanoparticle-based formulations and liposomal encapsulation, has increased the demand for sterile compounding. These delivery systems require aseptic preparation. The focus on patient-centered care in oncology emphasizes providing treatments that are safe, effective, and tailored to individual patient needs. Sterile compounding supports this approach by ensuring the highest standards of safety and quality.

Segmental Insights

Drug Type Insights

In 2022, the Global Compounding Chemotherapy Market largest share was held by Immunomodulatory Agents segment in 2022. Immunomodulatory agents have shown significant efficacy in the treatment of various cancers, including hematologic malignancies and solid tumors. They work by modulating the immune system to recognize and attack cancer cells, making them a crucial component of many cancer treatment regimens. Immunotherapy, including immunomodulatory agents, has gained substantial attention in the field of oncology due to its potential to offer durable responses and fewer side effects compared to traditional chemotherapy. As a result, there has been an increased demand for compounded immunomodulatory agents. Many immunomodulatory agents are considered targeted therapies, as they specifically target molecules or pathways involved in cancer growth and immune evasion. This targeted approach enhances their effectiveness and minimizes damage to healthy cells.

Route of Administration Insights

In 2022, the Global Compounding Chemotherapy Market largest share was held by Intravenous (IV) segment in 2022.  The IV route allows for the direct and rapid delivery of chemotherapy drugs into the bloodstream. This method ensures that the medication quickly reaches its target, which is particularly important for aggressive and fast-growing cancers. IV administration allows for precise dosing of chemotherapy drugs, ensuring that patients receive the correct amount of medication tailored to their specific needs. This precision is vital in cancer treatment, where even small variations in dosage can have significant effects on the patient's outcome. Intravenous chemotherapy can be used to treat a wide range of cancer types, including hematologic malignancies, solid tumors, and metastatic diseases. It is a versatile route of administration suitable for various chemotherapy agents. Many cancer patients are diagnosed at advanced stages when the disease has spread throughout the body. IV chemotherapy is well-suited for treating these advanced and metastatic cancers, making it a critical choice for a significant portion of patients.

Cancer Type Insights

In 2022, the Global Compounding Chemotherapy Market largest share was held by Lung Cancer segment in 2022.  Lung cancer is one of the most common cancer types globally, with a significant incidence rate. This high prevalence of lung cancer contributes to a substantial demand for chemotherapy treatments, including compounded medications. Lung cancer is often treated using chemotherapy in combination with other treatment modalities, such as surgery, radiation therapy, and targeted therapy. Chemotherapy plays a central role in the management of both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), covering a broad spectrum of lung cancer cases. It is frequently diagnosed at advanced stages when the disease has spread (metastasized) beyond the lungs. In such cases, chemotherapy is commonly used to control the disease and improve patient outcomes, making it a vital component of treatment. Lung cancer treatment often requires a personalized approach. Compounded chemotherapy drugs allow healthcare providers to tailor treatment regimens to individual patient needs, considering factors like the cancer subtype, stage, genetic markers, and patient-specific characteristics.

Distribution Channel Insights

In 2022, the Global Compounding Chemotherapy Market was dominated by Hospital Pharmacies segment. Hospitals are primary healthcare institutions where a significant portion of cancer patients receive treatment, including chemotherapy. Hospital pharmacies are integral to the healthcare ecosystem, providing a wide range of medications, including compounded chemotherapy drugs, to inpatients and outpatients. Hospitals offer comprehensive medical care, including surgery, radiation therapy, and chemotherapy. This allows them to provide complete cancer care under one roof, and hospital pharmacies play a crucial role in ensuring the availability of chemotherapy medications tailored to individual patient needs. Many hospitals have specialized oncology departments staffed by oncologists and oncology pharmacists who are well-versed in the complexities of cancer treatment, including chemotherapy. This expertise is essential for compounding and administering chemotherapy safely and effectively.

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Regional Insights

The North America region has established itself as the leader in the Global Compounding Chemotherapy Market in 2022. North America, particularly the United States and Canada, boasts advanced healthcare infrastructure, including well-established hospitals, clinics, and compounding facilities. This infrastructure supports the development, production, and delivery of compounded chemotherapy drugs. The region is a hub for pharmaceutical research and innovation, with numerous academic institutions, research centers, and pharmaceutical companies conducting cutting-edge research in oncology and drug development. This fosters the development of new chemotherapy drugs and compounding techniques. North America has a substantial population, and unfortunately, cancer rates are relatively high. The large patient pool creates a significant demand for chemotherapy drugs, including compounded formulations tailored to individual patient needs.

Recent Developments

• In March 2021, The U.S. Food and Drug Administration (FDA) has granted approval to Pfizer Inc.'s supplemental New Drug Application (sNDA) for LORBRENA, expanding its approved usage to encompass first-line treatment for individuals diagnosed with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). This approval extends LORBRENA's indication to include adult patients with metastatic NSCLC whose tumors have tested positive for ALK using an FDA-approved test. Additionally, the FDA's action has converted the accelerated approval granted in 2018 to full approval. Notably, this application received approval under the FDA's Real-Time Oncology Review (RTOR) pilot program. LORBRENA, a third generation ALK inhibitor, is uniquely tailored to suppress the predominant tumour mutations responsible for treatment resistance seen in existing medications. Its design also targets the management of brain metastases, which are a common site of disease progression in individuals with ALK-positive non-small cell lung cancer (NSCLC). It's worth noting that as many as 40% of ALK-positive metastatic NSCLC patients exhibit brain metastases when initially diagnosed.
• In December 2021, G1 Therapeutics, Inc., an oncology company operating at the commercial stage, has disclosed its plans to recruit and assign 20 more sales professionals, resulting in a total of 34 oncology sales representatives. This expansion is aimed at enabling G1 to effectively engage with all accounts, expedite sales efforts, and enhance the adoption of COSELA. Additionally, G1 and Boehringer Ingelheim have reached a mutual agreement to terminate their co-promotion arrangement for COSELA. The indication for COSELA (trilaciclib) involves reducing the occurrence of chemotherapy-induced myelosuppression in adult patients. This effect is achieved when COSELA is administered before a treatment regimen that includes platinum/etoposide or topotecan, specifically for extensive-stage small cell lung cancer.
• In June 2023, Cardinal Health has entered into a binding agreement to transfer its Outcomes business to Transaction Data Systems (TDS). This transaction involves Cardinal Health receiving a minority ownership stake in the merged entity, which is a portfolio company of BlackRock Long Term Private Capital and GTCR. The merged entity will build upon TDS's current offerings related to clinical care delivery, medication therapy management, and broadening revenue sources within the pharmacy sector. This expansion will include the incorporation of Outcomes' digital tools, which encompass patient engagement, virtual verification, order grouping, pill counting, and financial insights. As a result of this collaboration between TDS and Outcomes, there will be increased prospects for pharmacists to engage in sponsored clinical interventions. Additionally, it will enhance access for payors and pharmaceutical firms, ultimately aiming to improve patient care and outcomes.

Key Market Players

• Pfizer Inc.
• Baxter International Inc.
• Grifols SA
• Comecer S.P.A.
• Arxium Inc.
• Dedalus Group
• B. Braun Melsungen AG
• Omnicell Technologies Inc.
• The Metrix Company
• Sterline S.R.L

Report Scope:

In this report, the Global Compounding Chemotherapy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Compounding Chemotherapy Market, By Drug Type:

o   Cytotoxic Drugs

o   Hormonal Agents

o   Immunomodulatory Agents

o   Targeted Therapies

o   Supportive Care Drugs

• Compounding Chemotherapy Market, By Route of Administration:

o   Intravenous

o   Oral

o   Subcutaneous

o   Intramuscular

o   Intrathecal

• Compounding Chemotherapy Market, By Cancer Type:

o   Breast Cancer

o   Lung Cancer

o   Colorectal Cancer

o   Prostate Cancer

o   Leukemia

o   Lymphoma

o   Others

• Compounding Chemotherapy Market, By Distribution Channel:

o   Hospital Pharmacies

o   Retail Pharmacies

o   Online Pharmacies

• Global Compounding Chemotherapy Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Compounding Chemotherapy Market.

Available Customizations:

Global Compounding Chemotherapy Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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