FDA decision on relacorilant for Cushing's expected by year's end

Introduction
Cushing's syndrome is a rare but serious endocrine disorder caused by prolonged exposure to high cortisol levels. It can occur due to long-term use of corticosteroid medications or because of tumors that produce excess adrenocorticotropic hormone (ACTH). Symptoms such as weight gain, hypertension, diabetes, osteoporosis, and psychological changes significantly impact patients' quality of life.

Though rare, Cushing's syndrome has become an important therapeutic focus in endocrinology because of the severe health risks it poses if left untreated. Diagnosis and treatment have historically been difficult due to disease rarity, non-specific symptoms, and limited drug options. However, recent advances in novel therapeutics, targeted therapies, and improved diagnostic tools are reshaping the landscape. Over the next decade, the Cushing's syndrome market is expected to grow steadily, supported by rising awareness, early diagnosis, and expanding treatment pipelines.

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Market Overview
• The global Cushing's syndrome market size in 2024 is estimated at USD 420 million.
• It is projected to reach USD 740 million by 2034, growing at a CAGR of 5.7 % during the forecast period.
• Growth is supported by the introduction of novel drugs, strong clinical pipelines, and increased recognition of rare endocrine disorders by regulatory agencies.

Key Market Drivers:
• Growing prevalence of metabolic disorders and obesity contributing to higher cortisol-related complications.
• Advancements in drug development, including cortisol synthesis inhibitors and glucocorticoid receptor blockers.
• Strong support from regulatory bodies for orphan drug designation and fast-track approvals.
• Increasing awareness among endocrinologists and patients for early detection.
Key Challenges:
• Small patient population limits commercial viability.
• High treatment costs and limited access in developing regions.
• Adverse effects associated with long-term drug therapies.

Leading Players:
Corcept Therapeutics, Novartis AG, HRA Pharma (subsidiary of Perrigo), Recordati Rare Diseases, Strongbridge Biopharma (now part of Xeris Biopharma), and Teva Pharmaceuticals.

Segmentation Analysis
The Cushing's syndrome market can be segmented as follows:
By Treatment Type
• Cortisol Synthesis Inhibitors (e.g.
metyrapone, osilodrostat)
• Glucocorticoid Receptor Antagonists (e.g., mifepristone)
• Pituitary-directed Therapies (e.g., pasireotide)
• Surgery & Radiation Therapy (first-line options for many patients)
• Supportive & Symptomatic Therapies

By Disease Type
• Exogenous Cushing's Syndrome (drug-induced)
• Endogenous Cushing's Syndrome
o ACTH-dependent (Cushing's disease, ectopic ACTH syndrome)
o ACTH-independent (adrenal adenomas/carcinomas)

By End-Use
• Hospitals
• Specialty Clinics
• Research & Academic Institutes

Summary:
Cortisol synthesis inhibitors dominate current pharmacological treatments, while glucocorticoid receptor blockers are gaining attention for patients resistant to other therapies. Surgery remains the gold standard for pituitary tumors, but drug therapy demand is rising due to non-resectable cases and relapse.

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Regional Analysis
North America
• Largest market, accounting for ~40 % of global revenue in 2024.
• Strong regulatory framework supporting orphan drugs.
• The U.S. leads due to widespread adoption of therapies like Korlym (mifepristone) and Isturisa (osilodrostat).
Europe
• High awareness among endocrinologists in Germany, France, and the UK.
• EMA support for rare disease treatments strengthens pipeline launches.
Asia-Pacific (APAC)
• Expected to record the fastest CAGR (~6.8 %) during 2024-2034.
• Growing diagnosis rates in Japan, China, and India.
• Rising healthcare infrastructure and generic drug availability enhance accessibility.
Middle East & Africa (MEA)
• Limited adoption due to lack of diagnostic awareness.
• Gulf nations such as Saudi Arabia and UAE are expanding rare disease treatment access.
Latin America
• Brazil and Mexico are leading regional markets.
• Government partnerships with global pharma companies are improving rare disease treatment coverage.

Regional Summary:
North America and Europe dominate revenues, but Asia-Pacific is emerging as the fastest-growing market due to improved diagnostics, growing healthcare access, and rising government initiatives for rare disease management.

Market Dynamics
Growth Drivers
1. Increasing recognition and awareness of rare endocrine disorders.
2. Expansion of pharmacological treatments beyond traditional surgical approaches.
3. Orphan drug incentives and regulatory support for novel therapies.
4. Rising demand for non-invasive diagnostic tools.

Key Challenges
• High therapy costs limit widespread accessibility.
• Adverse drug side effects require careful monitoring.
• Small patient pool challenges commercial sustainability.

Latest Trends
• Development of next-generation cortisol inhibitors with improved safety.
• Expansion of patient registries and rare disease databases for better tracking.
• Use of AI-based diagnostic tools for earlier detection of hormonal imbalances.
• Partnerships between pharma companies and advocacy groups to accelerate awareness.

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Competitor Analysis
Major Players:
• Corcept Therapeutics (Korlym - mifepristone)
• Novartis AG (Signifor - pasireotide)
• HRA Pharma ( metyrapone portfolio)
• Recordati Rare Diseases (Isturisa - osilodrostat)
• Strongbridge Biopharma / Xeris Biopharma
• Teva Pharmaceuticals (generic formulations)

Competitive Summary:
The market is moderately consolidated, with a few specialized companies dominating due to strong intellectual property and regulatory exclusivity for orphan drugs. Corcept and Recordati lead in commercialized drugs, while Novartis and Xeris focus on pipeline expansion. Collaborations and acquisitions are key strategies to strengthen market positions.

Conclusion
The Cushing's syndrome market is projected to expand from USD 420 million in 2024 to USD 740 million by 2034, at a CAGR of 5.7 %.

This report is also available in the following languages : Japanese (クッシング症候群市場), Korean (쿠싱 증후군 시장), Chinese (库欣综合征市场), French (Marché du syndrome de Cushing), German (Markt für Cushing-Syndrom), and Italian (Mercato della sindrome di Cushing), etc.

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