Mitotane Market

Mitotane Market Study by Cushing’s Disease (CD) and Adrenocortical Carcinoma through Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, and Specialty Clinics from 2024 to 2034

Analysis of Mitotane Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Mitotane Market Outlook (2024 to 2034)

Worldwide revenue from the mitotane market is poised to reach US$ 17.6 million in 2024 and further increase at a CAGR of 5.4% to climb to US$ 29.9 million by the end of 2034.

Demand for mitotane is rising at a steady rate as people become more aware of cancer, prompting individuals to take proactive measures to improve their chances of survival. Mitotane is instrumental in treating adrenal gland cancer, targeting the adrenal cortex specifically. It works by reducing steroid production in this part of the body. When surgery does not help halt the spread of cancer cells, mitotane is injected into the body.

Mitotane, also known as Lysodren, is a form of chemotherapy uniquely approved for advanced adrenocortical carcinoma treatment and postoperative adjuvant therapy. With no alternative options available, the market for mitotane has become lucrative, leading to increased sales.

Key Market Growth Drivers

  • Besides humans, mitotane is also used for dogs and cats to treat a condition called Cushing’s disease, or hyperadrenocorticism. This condition occurs when the adrenal glands are overproducing cortisol. This has led to a further upward trend in the market due to the treatment being useful for both humans and animals.
  • Mitotane typically begins its action in the body within 1 to 2 days, a faster onset compared to many other available medications. Those seeking rapid relief from hormone overproduction often turn to mitotane.
  • Adrenal gland cancer predominantly affects children under 5 and adults in their 40s and 50s, making them the primary demographic for mitotane suppliers. These suppliers maintain close ties with hospitals and clinics to gather data on these age groups, enhancing their profit potential.
  • Mitotane is also utilized in treating neuroblastoma, a cancer originating from immature nerve cells in various parts of the body. Suppliers are actively researching this disease to further refine their medication and combat its progression.
  • Mitotane tablets are commonly used in treating carcinoid tumors that excessively produce cortisol and other hormones. Mitotane’s efficacy in managing both cancer and tumors has made it a preferred option among patients dealing with these conditions.
Report Attribute Detail
Mitotane Market Size (2024E) US$ 17.6 Million
Forecasted Market Value (2034F) US$ 29.9 Million
Global Market Growth Rate (2024 to 2034) 5.4% CAGR
Canada Market Growth Rate (2024 to 2034) 5.6% CAGR
China Market Value (2024E) US$ 900 Thousand
North America Market Share (2024E) 38.9%
East Asia Market Share (2034F) 5%
Key Companies Profiled HRA Pharma Rare Diseases; Bristol-Myers Squibb Company; TherDose Pharma Pvt. Ltd.; Hikma Pharmaceuticals; Tizig Pharma Pvt. Ltd.; Aspen Pharmacare; Prime Therapeutics; Novartis Pharmaceuticals Corporation.

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Which Factors are Contributing to Rising Demand for Mitotane in the Treatment of Adrenal Cancer?

“Expansion of Healthcare Coverage and Increased Adoption of Alternative Treatment Modalities”

Most individuals diagnosed with Cushing's syndrome are within the age range of 30 to 40. Consumption of glucocorticoids can expedite the onset of Cushing's syndrome. Due to the considerable expansion of healthcare coverage, delayed identification and diagnosis in later stages are significant contributors to mitotane market growth. Adrenal cancer, once rare, is now exhibiting a rising incidence globally. With increasing awareness of adrenal cancer, more patients are exploring alternative treatment modalities.

Mitotane is an effective option for managing advanced adrenal cancer, boosting the necessity for this medication among patients and healthcare providers. Governments worldwide are increasing their healthcare expenditure to enhance treatment provisions for patients.

The pharmaceutical sector continually innovates and develops novel medications, with a focus on introducing enhanced formulations of mitotane. Given the high recurrence rates and unfavorable prognosis of adrenocortical carcinoma, adjuvant therapy post-surgery is imperative to mitigate risks. Despite some variability in outcomes, mitotane remains widely employed in this adjunctive capacity.

“Strong Healthcare Infrastructures in Developing Countries”

Mitotane drug use extends to combination therapies and rare cancer types, thus broadening treatment possibilities. Robust healthcare infrastructures in developing countries, coupled with prevalent unmet medical demands, present lucrative opportunities for mitotane drug producers to augment their revenue streams.

Channeling investments into research and development for novel formulations and drug delivery mechanisms, alongside strategic partnerships and regulatory endorsements, holds the potential to drive the market's growth trajectory. Patient advocacy groups and support networks for patients are playing a crucial role in heightening awareness surrounding adrenal cancer and advocating for improved accessibility to mitotane treatments, thereby contributing to the mitotane market size.

Which Key Restraints are Weighing Down Sales of Mitotane?

“Limited Patient Base Due to Rarity of Adrenocortical Carcinoma”

Constrained applications and specialized market for mitotane drugs present a notable hurdle. Mitotane is primarily used to treat adrenocortical carcinoma (ACC), a rare and aggressive cancer of the adrenal cortex. ACC is a rare condition, accounting for only a small percentage of cancer cases worldwide. Because of its rarity, the patient population requiring mitotane is relatively small. Pharmaceutical companies may struggle to invest in and conduct clinical trials for mitotane due to its limited market availability. However, the niche market offers potential for revenue generation.

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Country-wise Insights

Cancer remains a significant global concern, and governments worldwide are striving to comprehend this ailment and allocate resources for research to combat various types of cancers. Nations like the United States, Canada, Mexico, China, Japan, and South Korea are projected to have promising prospects, with each country making substantial investments in mitotane research to enhance the effectiveness of the medication in combating the prevalence of the disease within their borders.

  • The market in South Korea is evaluated to expand at a CAGR of 4.5% from 2024 to 2034. In addition, the country is projected to occupy a mitotane market share of 13.1% in the East Asia region by 2034.

Why is the United States Becoming a Lucrative Market for Mitotane Suppliers?

“Increased Prevalence of Adrenal Gland Cancer and Favorable Regulatory Environment”

Attribute United States
Market Value (2024E) US$ 5.6 Million
Growth Rate (2024 to 2034) 5.2% CAGR
Projected Value (2034F) US$ 9.32 Million

Mitotane is a pharmaceutical prescribed for the treatment of adrenal gland cancer. Factors such as the prevalence of adrenal gland cancer, the efficacy of mitotane in addressing the condition, the regulatory landscape, and the pricing strategy adopted by drug manufacturers all play pivotal roles in shaping the market for this medication in the United States.

Variables including competition from alternative medications, advancements in medical research, and modifications to healthcare regulations could potentially be important mitotane market trends in the United States.

How is the Orphan Drug Status of Mitotane Driving Market Growth in China?

“Reduced Risk of Generic Competition and Increased Pharmaceutical Investments”

Attribute China
Market Value (2024E) US$ 540 Thousand
Growth Rate (2024 to 2034) 5.3% CAGR
Projected Value (2034F) US$ 900 Thousand

Mitotane's orphan drug status presents a unique opportunity for pharmaceutical companies in China. This designation prolongs market exclusivity for mitotane, mitigating the risk of generic competition and fostering a favorable regulatory environment. Pharmaceutical firms are encouraged to invest in the development, manufacturing, and marketing of mitotane in the country. This guarantees a steady supply of the drug and maintains affordability for patients with adrenocortical carcinoma (ACC).

Potential applications of mitotane may broaden beyond ACC through further research and clinical trials. Moreover, it holds promise in treating other rare cancers and conditions, thereby extending its market penetration and revenue prospects. The emergence of new indications for mitotane under the orphan drug framework represents a promising growth opportunity.

Category-wise Evaluation

Based on distribution channel, the specialty clinics segment is evaluated to expand at a CAGR of 4.8% from 2024 to 2034.

Why are Retail Pharmacies Preferred in This Market?

“Preference for Retail Pharmacies Driven by Reduced Wait Times and Patient-Centered Approach”

Attribute Retail Pharmacies
Segment Value (2024E) US$ 6 Million
Growth Rate (2024 to 2034) 5.7% CAGR
Projected Value (2034F) US$ 10.45 Million

Retail pharmacies predominantly offer benefits such as reduced wait times, access to additional services, customer orders, delivery services, and a patient-centered approach. As a result, customers often turn to these retail pharmacies for their medication needs. This enables suppliers to achieve favorable profit margins, thereby maximizing their profitability.

Which Indication is Mitotane Predominantly Used to Treat?

“Status of Mitotane as Only Approved Drug for Adrenocortical Carcinoma”

Attribute ACC
Segment Value (2024E) US$ 10.54 Million
Growth Rate (2024 to 2034) 4.9% CAGR
Projected Value (2034F) US$ 16.97 Million

Adrenocortical carcinoma is a malignancy characterized by its aggressive nature, poor prognosis, and limited treatment choices. Mitotane stands out as one of the few available options, significantly increasing its appeal among patients. Being the sole approved medication, mitotane instills trust among patients, enhancing its popularity and market preference.

Know thy Competitors

Competitive landscape highlights only certain players
Complete list available upon request

Business Competition

Key players in the mitotane market are dedicated to implementing new, innovative ideas to meet consumer demand for their products while also exerting their dominance in the local market. Mergers and acquisitions have been a key strategy used by businesses to increase their global reach, develop new sales opportunities, and leverage their current client base; prominent players are also adapting themselves to the evolving market trends.

  • In March 2018, HRA Pharma completed the acquisition of Lysodren® (mitotane tablets) from Bristol-Myers Squibb Corporation. Lysodren is a chemotherapeutic medication used to treat advanced adrenal cortical carcinoma, a rare cancer of the adrenal glands, and its symptoms.

Fact.MR provides detailed information about the price points of key mitotane producers positioned across the world, sales growth, production capacity, and speculative technological expansion, in this new market report.

Key Segments of Mitotane Market Research

  • By Indication :

    • Cushing’s Disease
    • Adrenocortical Carcinoma
  • By Distribution Channel :

    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
    • Specialty Clinics
  • By Region :

    • North America
    • Latin America
    • Eastern Europe
    • Western Europe
    • East Asia
    • South Asia & Pacific
    • Middle East & Africa

- FAQs -

How big is the mitotane market in 2024?

The global market for mitotane is estimated at US$ 17.6 million in 2024.

What are the projections for the mitotane market for the decade?

The global market for mitotane has been projected to expand at 5.4% CAGR and reach US$ 29.9 million by 2034.

What portion of the North American market does Canada occupy?

Canada holds 10.8% share of the North American market in 2024.

How fast is the market projected to expand in South Korea?

The market in South Korea is forecasted to expand at 4.5% CAGR through 2034.

Who are the leading manufacturers of mitotane?

Leading market players are HRA Pharma Rare Diseases, Bristol-Myers Squibb Company, and TherDose Pharma Pvt Ltd.

What are the estimated sales of ACC drugs?

Revenue from ACC drug sales is estimated to reach US$ 10.5 million in 2024.

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Mitotane Market

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