15-05-2025
Cushing's Disease Market Poised for Significant Growth Across the 7MM During the Study Period (2020-2034) with Rising Awareness and Diagnostic Improvements
The Cushing's disease pipeline possesses some drugs in mid and late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including relacorilant, clofutriben, atumelnant, and others. The expected launch of these therapies shall further create a positive impact on the Cushing's disease market.
LAS VEGAS, May 15, 2025 /PRNewswire/ -- DelveInsight's Cushing's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Cushing's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Cushing's Disease Market Report
According to DelveInsight's analysis, the market size for Cushing's disease was found to be USD 1 billion in the 7MM in 2024.
In 2024, among all the current therapies for Cushing's disease, the highest revenue was generated by Mifepristone (KORLYM and generics) in the US.
Based on DelveInsight's assessment in 2024, the 7MM had approximately 37K diagnosed prevalent cases of Cushing's disease. These cases are expected to rise due to advancements in diagnostic capabilities and increased awareness about the disease during the forecast period (2025–2034).
Leading Cushing's disease companies developing emerging therapies, such as Corcept Therapeutics, Sparrow Pharmaceuticals, Crinetics Pharmaceuticals, H. Lundbeck, Stero Therapeutics, and others, are developing novel Cushing's disease drugs that can be available in the Cushing's disease market in the coming years.
The promising Cushing's disease therapies in the pipeline include DUPIXENT (dupilumab), Linerixibat (GSK2330672), NEMLUVIO/MITCHGA (nemolizumab), Volixibat, and others.
In March 2025, Corcept Therapeutics announced that the FDA had assigned a PDUFA target action date of December 30, 2025, for relacorilant to treat patients with endogenous hypercortisolism.
In February 2025, Crinetics Pharmaceuticals mentioned that the company anticipates beginning enrollment for Atumelnant (CRN04894) in Phase Ib/IIa trials for Cushing's disease in late 2025 or early 2026.
In October 2024, Sparrow Pharmaceuticals announced that clofutriben had been granted Orphan Drug Designation (ODD) by the US FDA for the treatment of endogenous Cushing's syndrome.
Discover which therapies are expected to grab the major Cushing's disease market share @ Cushing's Disease Market Report
Cushing's Disease Overview
Cushing's disease is a rare but serious endocrine disorder caused by a pituitary tumor that triggers excessive cortisol production. It presents with a variety of symptoms such as weight gain, fatigue, mood disturbances, high blood pressure, and impaired glucose tolerance. Cushing's syndrome is responsible for 80–85% of hypercortisolism cases, with 75–80% of those linked to ACTH-producing pituitary adenomas. Without treatment, the 5-year survival rate is only about 50%, emphasizing the urgent need for effective therapies.
Diagnosing Cushing's disease is especially difficult because it is rare, shares symptoms with other disorders, and presents in various ways. Only 40–60% of patients have a detectable tumor on standard Magnetic Resonance Imaging (MRI), and the diagnosis is often delayed by an average of 7 years.
Cushing's Disease Epidemiology Segmentation
The Cushing's disease epidemiology section provides insights into the historical and current Cushing's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The Cushing's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalent Cases of Cushing's Disease
Total Diagnosed Prevalent Cases of Cushing's Disease
Gender-Specific Diagnosed Prevalent Cases of Cushing's Disease
Age-Specific Diagnosed Prevalent Cases of Cushing's Disease
Cushing's Disease Treatment Market
The primary treatment for Cushing's disease is usually transsphenoidal surgery to remove the pituitary tumor, which often leads to remission. However, some patients may experience a recurrence. When surgery is unsuccessful or not an option, medical therapies are used to control cortisol levels.
Various medications are available for managing Cushing's disease, especially in cases where surgery is ineffective or not feasible. One such drug is KORLYM, developed by Corcept Therapeutics, approved for treating hyperglycemia in patients with Cushing's syndrome who also have Type 2 diabetes or glucose intolerance. In 2024, a generic version by Teva Pharmaceuticals entered the market, adding competition, and Corcept itself has released a generic version as well. Other approved options include SIGNIFOR and SIGNIFOR LAR, ISTURISA, and RECORLEV. In addition, off-label drugs like ketoconazole, metyrapone, cabergoline, mitotane, and etomidate are also used in the U.S., with some marketed in Europe by HRA Pharma.
SIGNIFOR (pasireotide), developed by Recordati, was the first drug specifically approved for Cushing's disease by the FDA in 2012, and also gained EU approval. Recordati also markets SIGNIFOR LAR, a long-acting injectable version approved by the FDA and Japan's PMDA in 2018. This formulation, administered intramuscularly once every four weeks, shares the same mechanism as SIGNIFOR but offers a different delivery route.
Recordati is recognized as a leading player in this therapeutic area. Another key product from the company is ISTURISA (osilodrostat), the first FDA-approved oral drug that inhibits cortisol production by targeting the enzyme 11β-hydroxylase (CYP11B1), which is involved in the final step of cortisol synthesis. Its oral administration makes it more convenient for patients compared to injectable therapies. ISTURISA is also being studied for pediatric use in an ongoing Phase II trial (NCT03708900).
RECORLEV, originally developed by Strongbridge Biopharma and later acquired by Xeris Pharmaceuticals, was approved by the FDA in 2021. It is indicated for adults with endogenous Cushing's syndrome who are not surgical candidates or did not achieve a cure through surgery. Unlike ISTURISA, RECORLEV works by inhibiting cortisol production at multiple points in the steroidogenesis pathway, offering a distinct mechanism of action.
To know more about Cushing's disease treatment guidelines, visit @ Cushing's Disease Management
Cushing's Disease Pipeline Therapies and Key Companies
Relacorilant (CORT125134): Corcept Therapeutics
Clofutriben (SPI-62): Sparrow Pharmaceuticals
Atumelnant (CRN04894): Crinetics Pharmaceuticals
Lu AG13909: H. Lundbeck
ST-002: Stero Therapeutics
Discover more about Cushing's disease drugs in development @ Cushing's Disease Clinical Trials
Cushing's Disease Market Dynamics
The Cushing's disease market dynamics are expected to change in the coming years. Although Cushing's disease is generally considered a rare condition, growing awareness and recent advances in research suggest that diagnoses may rise in the future; despite a seemingly crowded market, many current hypercortisolism treatments fail to normalize cortisol levels effectively and pose significant side effects highlighting a substantial opportunity for innovation, especially given the limited therapies specifically targeting Cushing's disease and the potential of newer oral alternatives like ISTURISA and RECORLEV to offer greater flexibility compared to SC and intramuscular options such as SIGNIFOR and SIGNIFOR LAR.
Furthermore, potential therapies are being investigated for the treatment of Cushing's disease, and it is safe to predict that the treatment space will significantly impact the Cushing's disease market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the Cushing's disease market in the 7MM.
However, several factors may impede the growth of the Cushing's disease market. Due to non-specific guidelines and recommendations, patients with Cushing's disease often face suboptimal care, delayed diagnosis, and inconsistent treatment approaches, further compounded by the diagnostic complexity, frequent misdiagnosis, and symptom overlap with more common conditions, which leave many undiagnosed or untreated; while existing therapies such as ketoconazole and metyrapone approved in Europe based on limited retrospective data and used off-label in the US despite high costs are widely trusted and entrenched in clinical practice, posing a significant barrier to the adoption of emerging therapies.
Moreover, Cushing's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Cushing's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Cushing's disease market growth.
Cushing's Disease Market Report Metrics
Details
Study Period
2020–2034
Coverage
7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and The United Kingdom, and Japan].
Cushing's Disease Market Size in 2024
USD 1 Billion
Key Cushing's Disease Companies
Xeris Pharmaceuticals, Recordati, Corcept Therapeutics, Sparrow Pharmaceuticals, H. Lundbeck, Stero Therapeutics, Crinetics Pharmaceuticals, and others
Key Cushing's Disease Therapies
RECORLEV, ISTURISA, SIGNIFOR, SIGNIFOR LAR, KORLYM, Relacorilant, Clofutriben, Lu AG13909, ST-002, Atumelnant, and others
Scope of the Cushing's Disease Market Report
Therapeutic Assessment: Cushing's Disease current marketed and emerging therapies
Cushing's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Cushing's Disease Drugs and Market Outlook
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's views, Analyst's views, Cushing's Disease Market Access and Reimbursement
Download the report to understand which factors are driving Cushing's disease market trends @ Cushing's Disease Market Trends
Table of Contents
1
Key Insights
2
Report Introduction
3
Executive Summary
4
Key Events
5
Epidemiology and Market Forecast Methodology
6
Cushing's Disease Market Overview at a Glance
6.1
Market Share (%) Distribution by Therapies of Cushing's Disease in 2024
6.2
Market Share (%) Distribution by Therapies of Cushing's Disease in 2034
7
Disease Background and Overview
7.1
Introduction
7.2
Clinical and Biological Characteristics
7.3
Genetics of Cushing's Disease
7.4
Pathogenesis and Pathophysiology
7.5
Complications of Cushing's Disease
7.6
Diagnosis of Cushing's Disease
7.6.1
Diagnostic Algorithm
7.7
Treatment and Management of Cushing's Disease
7.7.1
Treatment Algorithm of Cushing's Disease
8
Guidelines, Recommendations, and Management for Cushing's Disease
8.1
Consensus on Diagnosis and Management of Cushing's Disease: A Guideline Update (2020) (The United States)
8.2
Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline (2015) (Europe)
8.3
Clinical Significance of Screening for Subclinical Cushing's Disease in Patients With Pituitary Tumors (2010) (Japan)
9
Epidemiology and Patient Population
9.1
Key Findings
9.2
Assumptions and Rationales
9.3
Total Diagnosed Prevalent Cases of Cushing's Disease in the 7MM
9.4
The United States
9.4.1
Total Diagnosed Prevalent Cases of Cushing's Disease in the US
9.4.2
Gender-specific Diagnosed Prevalent Cases of Cushing's Disease in the US
9.4.3
Age-specific Diagnosed Prevalent Cases of Cushing's Disease in the US
9.5
EU4 and the UK
9.5.1
Total Diagnosed Prevalent Cases of Cushing's Disease in EU4 and the UK
9.5.2
Gender-specific Diagnosed Prevalent Cases of Cushing's Disease in EU4 and the UK
9.5.3
Age-specific Diagnosed Prevalent Cases of Cushing's Disease in EU4 and the UK
9.6
Japan
9.6.1
Total Diagnosed Prevalent Cases of Cushing's Disease in Japan
9.6.2
Gender-specific Diagnosed Prevalent Cases of Cushing's Disease in Japan
9.6.3
Age-specific Diagnosed Prevalent Cases of Cushing's Disease in Japan
10
Patient Journey
11
Marketed Drug
11.1
Marketed Drug Details
11.2
ISTURISA (osilodrostat): Recordati
11.2.1
Product Description
11.2.2
Regulatory Milestones
11.2.3
Other Developmental Activities
11.2.4
Clinical Development Activities
11.2.4.1
Clinical Trials Information
11.2.5
Safety and Efficacy
11.3
RECORLEV (levoketoconazole): Xeris Pharmaceuticals
11.3.1
Product Description
11.3.2
Regulatory Milestones
11.3.3
Other Developmental Activities
11.3.4
Safety and Efficacy
11.4
SIGNIFOR (pasireotide): Recordati
11.4.1
Product Description
11.4.2
Regulatory Milestones
11.4.3
Other Developmental Activities
11.4.4
Safety and Efficacy
11.5
SIGNIFOR LAR (pasireotide pamoate): Recordati
11.5.1
Product Description
11.5.2
Regulatory Milestones
11.5.3
Other Developmental Activities
11.5.4
Safety and Efficacy
12
Emerging Drugs
12.1
Key Cross Competition
12.2
Relacorilant (CORT125134): Corcept Therapeutics
12.2.1
Product Description
12.2.2
Other Development Activity
12.2.3
Clinical Development
12.2.3.1
Clinical Trial Information
12.2.4
Safety and Efficacy
12.3
Clofutriben (SPI-62): Sparrow Pharmaceuticals
12.3.1
Product Description
12.3.2
Other Development Activity
12.3.3
Clinical Development
12.3.3.1
Clinical Trial Information
12.3.4
Safety and Efficacy
12.4
Atumelnant (CRN04894): Crinetics Pharmaceuticals
12.4.1
Product Description
12.4.2
Other Development Activity
12.4.3
Clinical Development
12.4.3.1
Clinical Trial Information
12.4.4
Safety and Efficacy
13
Cushing's Disease: Seven Major Market Analysis
13.1
Key Findings
13.2
Market Outlook
13.3
Key Market Forecast Assumptions
13.3.1
Cost Assumptions and Rebates
13.3.2
Pricing Trends
13.3.3
Analogue Assessment
13.3.4
Launch Year and Therapy Uptakes
13.4
Conjoint Analysis
13.5
Total Market Size of Cushing's Disease in the 7MM
13.6
Market Size of Cushing's Disease by Therapies in 7MM
13.7
The United States
13.7.1
Total Market Size of Cushing's Disease in the US
13.7.2
Market Size of Cushing's Disease by Therapies in the US
13.8
EU4 and the UK
13.8.1
Total Market Size of Cushing's Disease in the EU4 and the UK
13.8.2
Market Size of Cushing's Disease by Therapies in EU4 and the UK
13.9
Japan
13.9.1
Total Market Size of Cushing's Disease in Japan
13.9.2
The Market Size of Cushing's Disease by Therapies in Japan
14
Unmet Needs
15
SWOT Analysis
16
KOL Views
17
Market Access and Reimbursement
17.1
The United States
17.1.1
Centre for Medicare and Medicaid Services (CMS)
17.2
EU4 and the UK
17.2.1
Germany
17.2.2
France
17.2.3
Italy
17.2.4
Spain
17.2.5
United Kingdom
17.3
Japan
17.3.1
MHLW
17.4
Market Access and Reimbursement of Cushing's Disease
18
Appendix
18.1
Bibliography
18.2
Report Methodology
19
DelveInsight Capabilities
20
Disclaimer
21
About DelveInsight
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