Mitotane Market

Growing incidence of adrenal cancer and rising demand for adjuvant therapy to increase adoption of mitotane drug, thereby driving the global market

Mitotane Market Segmented By Adrenal Cortical Carcinoma, Cushing’s Syndrome Indication in Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Specialty Clinics

Report ID: PMRREP30052

Number of Pages: 206

Format: PPT*, PDF, EXCEL

Industry: Healthcare

Published Date: March-2023

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Mitotane Market Outlook (2023-2033)

The global revenue from the mitotane market stands at US$ 14.8 Million in 2022, with the global market expected to grow at a CAGR of 4.5% to reach a valuation of around US$ 24.1 Million by the end of 2033.

Market Size (2023)

US$ 15.4 Million

Projected Market Value (2033)

US$ 24.1 Million

Global Market Growth Rate (2023-2033)

4.5% CAGR

Market Share of Top 5 Countries


As assessed by Persistence Market Research, the adrenocortical carcinoma indication segment held a market share of around 60.8% in the global market, in 2022. Overall, mitotane market sales account for around 2.0% of revenue share in the global adrenocortical carcinoma treatment market, which was valued at around US$ 715.2 Million in 2022.

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Sales Analysis of Market from 2014 - 2022 Vs Market Outlook for 2023 - 2033

The global market recorded a historic CAGR of 4.0% in the last 8 years from 2014 – 2022.

Mitotane is primarily used to treat adrenal cancer, and demand for the drug rises as the disease becomes more common. Due to rising awareness and diagnoses of adrenal cancer, the mitotane market is anticipated to expand gradually over the next years. Mitotane regulates the number of hormones produced by the adrenal gland. The drug works by destroying the cells in the adrenal gland that produce these hormones. Mitotane is also sometimes used to manage Cushing's syndrome, a hormonal disorder that results from prolonged exposure to high levels of cortisol.

Producers of mitotane may also be able to expand their product lines into similar markets, such as those for oncology medications or other therapies for endocrine disorders. Manufacturers may have the chance to invest in research & development activities to increase the effectiveness and security of mitotane as well as create new uses for the medication. The businesses are also collaborating together to sell and market mitotane. Such advancements are anticipated to encourage market growth in underserved areas and meet the demand for treatment.

It is also projected that the creation of novel formulations and combination medicines will fuel market expansion. Also, the future expansion of the market for mitotane may be influenced by positive government initiatives to raise awareness of rare diseases and their treatment as well as the development of healthcare infrastructure in emerging nations.

Due to successful drug commercialization, sales, and marketing partnerships, the mitotane industry is expanding. For Instance,

  • For the Canadian distribution of Lysodren (Mitotane), HRA pharma and Medunik Canada entered into an exclusive agreement.

The global market is likely to show high growth over the coming years at a CAGR of 4.5% and reach a global market size of US$ 24.1 Million by 2033.

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How Can the Global Market Grow?

“Late Recurrence and Lower Diagnosis Rate at Early Stage”

Most adults with Cushing's syndrome are between the ages of 30 and 50. Consuming glucocorticoids can cause Cushing's syndrome to develop. Due to adults' high spending power and the expansion of healthcare insurance, one of the major drivers fuelling the market's growth is the late age of detection and diagnosis. Adrenal cancer is a rare disorder, but it is becoming more common everywhere. More patients are looking for therapeutic alternatives as knowledge of adrenal cancer rises. In the next years, this is anticipated to propel the market for mitotane upward.

  • According to the American Cancer Society, around 1,500 new cases of adrenal cancer are diagnosed in the United States each year. The need for mitotane is anticipated to increase due to this increased incidence. The need for mitotane is anticipated to increase due to this increased incidence.

Mitotane is one of the successful therapy options for later stages of adrenal cancer. As a result, patients and healthcare professionals are increasingly in need of medicine. Governments across the world are also increasing their healthcare expenditure to provide better treatment options for patients.

The pharmaceutical business is always coming up with new ideas and creating new medications. This is anticipated to result in the creation of fresh and enhanced mitotane formulations, thus fuelling the market's expansion.

Adjuvant therapy is also used after surgically removing a tumor because of the high recurrence rate and the poor result of adrenocortical carcinoma. Although there have been some inconsistent outcomes, mitotane has been utilized widely in this environment.

It was also discovered that patients with adrenocortical cancer who received an independent component had a considerably higher disease-free survival rate than those who did not receive the drug. Adjuvants used in conjunction with mitotane have also been said to increase the likelihood of recurrence-free survival. Besides its advantages and disadvantages, mitotane is still one of the most frequently prescribed therapeutic agents for the treatment of adrenocortical carcinoma, particularly when used as an adjuvant.

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Can the Market Growth Be Affected in Any Way?

“Less Number of Companies to Manufacture and Distribute Drug

The market for mitotane is relatively small due to the rarity of adrenal gland cancer and Cushing's syndrome. As a result, only a few companies manufacture and distribute the drug. This limited market can lead to significant prices for the medication. Despite being an effective treatment, mitotane has some potential restraints. The drug can cause several side effects, including nausea, vomiting, and loss of appetite.

It can also harm the liver and result in neurological issues including disorientation and seizures. Doctors closely watch their patients as they take mitotane because of this potential adverse effect. The market for mitotane is modest since the illnesses it treats are uncommon, and the medication has serious side effects that call for careful monitoring. Which hampers the growth of the mitotane market.

Other treatments for adrenal gland tumors are readily available and can compete with mitotane on the market, which restricts its market growth

Country-wise Insights

Why is the U.S. Market Booming?

“Regulatory Environment and Drug Manufacturers Pricing Strategy to Influence Market Growth”

The U.S. accounted for around 31.8% market share in the global market in 2022.

Adrenal gland cancer is treated with the prescription medication mitotane. The prevalence of adrenal gland cancer, the efficacy of mitotane in treating the condition, the regulatory environment, and the drug manufacturer's pricing strategy are some of the factors that influence the market for this medication in the United States.

Variables including competition from other medications, developments in medical research, and adjustments in healthcare regulations may have a positive impact on the market. In the end, a mix of these and other variables are likely to drive the mitotane market in the United States.

Will Germany Be a Lucrative Market for Mitotane?

“Rising Prevalence of Adrenal Gland Cancer and Creation of Novel Technologies”

The German market held around 13.1% market share of the global market in 2022.

Several pharmaceutical firms, notably HRA Pharma Deutschland GmbH and Novartis Pharma GmbH, advertise the prescription-only drug mitotane in Germany.

In the upcoming years, the market for mitotane is anticipated to expand as a result of the rising prevalence of adrenal gland cancer and the creation of novel therapeutic options.

  • According to the German Cancer Society, around 200 new cases of adrenal gland cancer are diagnosed each year in Germany.

The availability of generic versions of the drug, however, can potentially drive the market.

How is France Emerging as a Prominent Market?

“Improvements in Cancer Treatment and Increasing Number of Healthcare Professionals”

France held a market share of about 8.7% of the global market in 2022.

The prevalence of adrenocortical carcinoma, improvements in cancer treatment options, the accessibility of alternative medicines, and healthcare regulations are anticipated to have an impact on the market for mitotane in France. It is significant to remember that only healthcare professionals can give precise details on the mitotane industry trends in France.

The healthcare system in France is well-established, with a number of hospitals, clinics, and medical facilities there. This might make mitotane more accessible and promote its use across the nation.

In order to assess the effectiveness of mitotane in treating different forms of cancer, several studies are being carried out in France. These investigations may produce fresh understandings of the drug's mode of action and result in the creation of brand-new therapeutic regimens. This might increase the nation's need for mitotane even more.

Adrenal carcinoma is known to respond well to mitotane therapy. Since that France has a universal healthcare system, patients may find the medicine to be an appealing treatment option due to its affordability.

Category-wise Insights

Which Indication is Driving Demand within the Global Market?

“Frequent Usage of Mitotane in Combination with Chemotherapy for Adrenocortical Carcinoma Treatment”

The adrenocortical carcinoma indication segment held around 60.8% share of the total market in 2022.

Adrenocortical carcinoma is a rare but aggressive tumor in adrenal cortex and develops late with a large mass.

The outer layer of the adrenal gland is where uncommon cancer known as adrenocortical carcinoma develops. It is a very aggressive malignancy that has the potential to spread to other body parts. The main course of treatment is surgical excision of the tumor. Cancer has typically spread by the time it is discovered, though.

A chemotherapeutic medication called mitotane is used to treat adrenocortical carcinoma. It functions by lowering the amount of cortisol the adrenal gland produces, which can inhibit the development of cancer cells. To lower the chance of recurrence following surgery, mitotane can also be taken. The need for mitotane may also rise as more research on adrenocortical carcinoma and its treatment is done, which contributes to the growth of the mitotane market globally.

Which Distribution Channel is Largely Adopted within the Global Market?

“Hospital Pharmacies Highly Regulated and Tracked”

Hospital pharmacies distribution channels held around 49.9% share of the total market in 2022.

Hospital pharmacies are important to the market expansion for mitotane. In hospitals, oncologists or endocrinologists frequently prescribe the drug mitotane to treat malignancies of the adrenal gland. Hospital pharmacists are in charge of keeping track of the inventory and giving patients their mitotane prescriptions.

In order to guarantee that patients receive the right dosage and post-treatment care, hospital pharmacies also collaborate closely with doctors and other healthcare professionals. Also, they monitor the patient's development and record any negative drug interactions. They also inform patients about mitotane, its adverse effects, and the value of medication adherence may be another function of hospital pharmacies. In the end, hospital pharmacies' efforts ensure that patients receive efficient and secure medical care, which supports the expansion of the mitotane industry.

Competition Landscape

The prominent manufacturer of mitotane are committed to putting fresh, distinctive ideas into practice in order to satisfy consumer demand for their products as well as to dominate the local market. For growth prospects and development, mergers, and acquisitions have been one of the key strategy adopted by businesses to increase their worldwide reach, developing new sales opportunities, and leveraging their current client base.

Some key instances of development include:

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

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

Mitotane Industry Report Scope



Forecast Period

2023 – 2033

Historical Data Available for

2014 – 2022

Market Analysis

USD Million for Value

Key Countries Covered

  • U.S.
  • Canada
  • Brazil
  • Argentina
  • Mexico
  • Germany
  • France
  • U.K.
  • Italy
  • Spain
  • Russia
  • India
  • Thailand
  • Malaysia
  • Indonesia
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand
  • Türkiye
  • GCC Countries
  • North Africa
  • South Africa

Key Market Segments Covered

  • Indication
  • Distribution Channel
  • Region

Key Companies Covered

  • HRA Pharma Rare Diseases
  • Bristol-Myers Squibb Company

Report Coverage

  • Market Forecast
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Key Segments Covered in Mitotane Industry Research


  • Cushing’s Disease (CD)
  • Adrenocortical carcinoma

Distribution Channel:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Specialty Clinics


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

For report customisation and delivery information contact our sales representative.

Companies Covered in This Report

  • HRA Pharma Rare Diseases
  • Bristol-Myers Squibb Company

Frequently Asked Questions

The global market is currently valued at around US$ 14.8 Million in 2022.

The mitotane market is expected to reach US$ 15.4 million in 2023.

The market valuation of the mitotane market in 2033 will be around US$ 24.1 million.

The CAGR of the mitotane market was 4.0% in the last 8 years.

The projected CAGR of the market from 2023 to 2033 is 4.5%.

The adrenocortical carcinoma indication segment contribute a significant value in 2022.

The U.S., Germany, France, the U.K., and Spain account for most demand within the market, currently holding around 64.7% market share.

The U.S. accounts for around 31.8% share of the global market in 2022.

Germany accounts for around 13.1% share of the global market in 2022.

The mitotane market in France accounts for 8.7% of the global revenue share in 2022.

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