Number of pages: 100 | Report Format: PDF | Published date: June 21, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global mitotane drug market was valued at US$ 15.1 million in 2022 and is expected to register a revenue CAGR of 4.3% to reach US$ 22.05 million by 2031.
Mitotane Drug Market Fundamentals
Mitotane, known by its trade name Lysodren, is a medication primarily used to treat adrenocortical carcinoma (ACC), a rare cancer affecting the adrenal glands. It belongs to a class of drugs called adrenal cytotoxic agents, which means it selectively destroys or inhibits the function of cells in the adrenal cortex. It is believed to work by damaging the mitochondria, the energy-producing structures within cells. By disrupting the mitochondria, mitotane interferes with the production of hormones in the adrenal cortex, including cortisol, aldosterone, and androgens. Mitotane is usually taken orally in the form of tablets. The dosage and treatment duration can vary depending on the individual patient and the severity of the condition. It typically starts at a low dose, gradually increasing to achieve the desired therapeutic effect.
Mitotane Drug Market Dynamics
Mitotane is primarily used to treat adrenocortical carcinoma (ACC), a rare and aggressive cancer affecting the adrenal glands. The incidence of ACC is relatively low, but the demand for mitotane is driven by the need for effective treatment options for patients diagnosed with this condition. For instance, according to the National Cancer Institute, 300 people are diagnosed with ACC every year. Additionally, surgery is the primary treatment for ACC, but it may not always be curative, especially in advanced cases or when cancer has spread to other organs. Mitotane is crucial as adjuvant therapy in managing ACC and improving patient outcomes. The limited availability of alternative treatment options further contributes to the demand for the global mitotane drug market. Moreover, mitotane has been granted orphan drug designation by regulatory authorities in some countries. This status is given to drugs used to treat rare diseases, providing certain incentives to pharmaceutical companies, such as extended market exclusivity and tax credits. Orphan drug status can encourage research, development, and commercialization of mitotane. Furthermore, ongoing research and development activities focused on understanding the biology of ACC and identifying new treatment approaches can drive the market for mitotane. Clinical trials evaluating the efficacy of mitotane in combination with other drugs or therapies are conducted to explore potential treatment synergies and improve patient outcomes.
However, adrenocortical carcinoma (ACC) is a rare form of cancer, and the patient population it affects is relatively small. The limited number of patients with ACC can restrict the market size for mitotane, as the drug is primarily indicated for this specific condition. The absence of effective targeted therapies or immunotherapies specifically approved for ACC leaves mitotane as the primary systemic treatment option. Moreover, the cost of mitotane can be a significant restraint. The drug's pricing and the potential need for long-term treatment can pose financial challenges for patients and healthcare systems. The high cost may limit accessibility and affordability, particularly in regions with limited healthcare resources. Additionally, adverse effects and tolerability, high cost, limited awareness, and diagnosis challenges are some of the restraints impeding the overall market growth.
Mitotane Drug Market Ecosystem
The global mitotane drug market is analyzed from the following perspectives: indication, distribution channel, and region.
Mitotane Drug Market by Indication
Based on the Indication, the global mitotane drug market is segmented into adrenocortical carcinoma and Cushing's Disease.
The adrenocortical carcinoma segment dominated the market with a principal revenue share of 59.2% in 2022. Adrenocortical carcinoma is a rare and aggressive form of cancer affecting the adrenal cortex, which produces hormones such as cortisol, aldosterone, and androgens. Mitotane is a drug primarily indicated for treating ACC, making the ACC segment a significant component of the mitotane drug market. The limited prevalence of ACC contributes to the relatively small patient population in the ACC segment of the mitotane drug market. Mitotane has received orphan drug designation in some countries for the treatment of ACC. This status provides certain incentives to pharmaceutical companies, such as extended market exclusivity and financial benefits, which can encourage research, development, and commercialization of mitotane for ACC. These aspects contribute to the growth of the adrenocortical carcinoma segment.
Cushing's disease segment accounts for a significant market share in 2022. Cushing's disease is a specific condition within the broader category of Cushing's syndrome. It is caused by a pituitary tumor or adenoma that secretes excessive amounts of adrenocorticotropic hormone (ACTH). This, in turn, stimulates the adrenal glands to produce high cortisol levels, leading to a range of symptoms and health complications. For instance, according to the National Organization of Rare Disorders article of August 2021, endogenous Cushing syndrome is estimated to affect roughly 13 persons per million people yearly. Although primarily indicated for adrenocortical carcinoma (ACC), Mitotane has been used off-label in treating Cushing's disease. It is often considered when other treatment options, such as surgery or radiation therapy, are not feasible or have not controlled the disease. As research and understanding of Cushing's disease continue to evolve, the market dynamics for mitotane in this Cushing's disease may change. These aspects contribute to the growth of Cushing's disease segment.
Mitotane Drug Market by Distribution Channel
Based on the distribution channel, the global mitotane drug market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.
The hospital pharmacies segment accounted for a prominent share of the market of about 51% in 2022. The hospital pharmacies segment plays a vital role in distributing and dispensing mitotane, a medication primarily used to treat adrenocortical carcinoma. Hospital pharmacies are responsible for dispensing mitotane to patients undergoing ACC treatment. Upon receiving physician prescriptions, hospital pharmacists accurately prepare and dispense the appropriate dosage of mitotane to patients. They ensure patients receive the prescribed medication and provide instructions on proper administration and potential side effects. These factors contribute to the growth of the hospital pharmacies segment.
The online pharmacies segment is expected to be the fastest-growing segment throughout the forecast period, with a CAGR of 4.7% during the forecast period, owing to the rising demand for online purchases of medicine globally. Online pharmacies have emerged as a significant component in the distribution and accessibility of medications, including mitotane, in the pharmaceutical market. Online pharmacies, also known as internet or e-pharmacies, operate via digital platforms, allowing consumers to order prescription medications over the internet. While the sale of prescription drugs online is regulated and subject to certain restrictions in many countries, the presence of online pharmacies in the mitotane drug market has both advantages and considerations. Online pharmacies provide a convenient way for patients to access mitotane, especially for those with limited mobility, who live in remote areas, or who face challenges physically visiting traditional brick-and-mortar pharmacies. Patients can browse through online platforms, submit their prescriptions, and have the medication delivered to their doorstep. These factors contribute to the growth of the online pharmacies segment.
Mitotane Drug Market by Region
Geographically, the global mitotane drug market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominated the global mitotane drug market with the largest revenue share in 2022, attributed to established healthcare infrastructure, advanced medical research capabilities, and a high prevalence of ACC compared to other regions. Additionally, companies across the region are continuously involved in partnerships, mergers, and acquisitions, which are also expected to improve the mitotane drug market outlook. North America is home to numerous academic and research institutions that contribute to mitotane's clinical research and development. Clinical trials, investigator-initiated studies, and collaborative research efforts in the region enhance the understanding of mitotane's efficacy, safety, and potential combination therapies. Furthermore, the North American region's strong healthcare infrastructure, regulatory oversight, research contributions, and patient support mechanisms collectively contribute to the development and utilization of mitotane in the treatment of ACC.
Mitotane Drug Market Competitive Landscape
The prominent players operating in the global mitotane drug market are:
Mitotane Drug Market Strategic Developments
Mitotane, also known by its trade name Lysodren, is a medication primarily used in the treatment of adrenocortical carcinoma (ACC), a rare form of cancer that affects the adrenal glands.
The global mitotane drug market was valued at US$ 15.1 million in 2022.
The estimated market size of the global mitotane drug market in 2031 is US$ 20.05 million.
The revenue CAGR of the mitotane drug market during the forecast period will be 4.3% from 2023 to 2031.
Some key companies operating in the global mitotane drug market areHRA Pharma Rare Diseases, TherDose Pharma Pvt. Ltd. and Tizig Pharma Private Limited
*Insights on financial performance are subject to the availability of information in the public domain