Cushing's Disease Market Poised for Significant Growth Across the 7MM During the Study Period (2020-2034) with Rising Awareness and Diagnostic Improvements | DelveInsight
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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