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Cushing’s Syndrome – Opportunity Assessment and Forecast to 2030

GlobalData estimates that 2020 sales for Cushing’s syndrome (CS) therapies were approximately $121.4 million, with the US and Germany dominating the market. The sales are expected to grow at a CAGR of more than 10% during 2020-2030. GlobalData expects the number of diagnosed prevalent cases of Cushing’s syndrome (CS) to be 25,625 cases in 2020, increasing at a negligible Annual Growth Rate (AGR) of less than 1% across the two major markets.

The US market remains the dominant CS market with more than 70% of the global market share. In 2020, the US had the highest number of diagnosed prevalent cases of CS (endogenous), followed by Germany. There are currently two therapies in the late-stage pipeline: Recorlev (levoketoconazole), which is in pre-registration in the US, and Relacorilant which is in Phase III in the EU and US.

Global Cushing’s Syndrome market overview

Global Cushing’s Syndrome market overview

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What are the treatment options available for Cushing’s syndrome?

In patients with overt CS, the treatment recommendation is to normalize cortisol levels or alter the response of cortisol receptors to eliminate the signs and symptoms of CS. Treatments designed to normalize cortisol or its action, are not recommended when there is only a borderline abnormality in the hypothalamic-pituitary-adrenal (HPA) axis without any specific signs of CS. Unilateral resection should be carried out in all cases of benign unilateral disease. ACTH-secreting tumors need to be localized and resected with node dissection. Transsphenoidal selective (TSS) adenectomy is the optimal treatment for CD in pediatric and adult patients.

Some of the essential molecules or drugs recommended for the treatment of CS include Korlym (mifepristone), Isturisa (osilodrostat phosphate), Signifor (pasireotide), Signifor LAR (pasireotide), Ketoconazole (ketoconazole), Metopirone (metyrapone), and Lysodren (mitotane).

What are the market dynamics of Cushing’s syndrome?

The launch of three new treatments across the forecast period – Recorlev, Relacorilant, and SPI-62 will drive an increase in the overall market size of CS as more efficacious therapeutic options to become available to patients. The increasing access of patients in the EU, specifically Germany, to the novel steroidogenesis inhibitor Isturisa will drive the growth of the CS market and erode the market share of more traditional, less effective therapies such as ketoconazole and Metyrapone.

The lack of late-stage pipeline products for CS represents an opportunity for companies to help develop transformational therapies to expand treatment options by developing trials with meaningful primary endpoints beyond plasma cortisol reduction, which is often used for therapies in development. A need remains for efficacious therapies that target the underlying cause of CD. There is steadily increasing awareness among physicians regarding CS symptomatology as novel therapies enter the market.

What are the major drugs for Cushing’s syndrome?

Signifor/Signifor LAR, Korlym, Isturisa, Metopirone, Lysodren, and Ketoconazole (branded and generic) are the major drugs in Cushing’s syndrome market.

Market report scope

Market size (Year – 2020) $121.4 million
Growth rate CAGR of >10% from 2021 to 2030
Base year for estimation 2020
Forecast period 2021-2030
Key Drugs Signifor/Signifor LAR, Korlym, Isturisa, Metopirone, Lysodren, and Ketoconazole (branded and generic).
Key Therapies Steroidogenesis Inhibitor, GR-II Antagonist, and SPI-62.
Companies covered Corcept Therapeutics Inc., Recordati SpA, Laboratorie HRA Pharma SAS, Strongbridge Biopharma PLC., and Sparrow Pharmaceuticals.

GlobalData’s “Cushing’s Syndrome – Opportunity Assessment and Forecast to 2030” combines data from the Pharma Intelligence Center with in-house analyst expertise to provide a competitive assessment of the disease marketplace.

Reasons to Buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global CS market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CS market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of the various competitor.
  • Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage.

Key Players

Corcept Therapeutics Inc.

Recordati SpA

Laboratorie HRA Pharma SAS

Strongbridge Biopharma PLC.

Sparrow Pharmaceuticals

Table of Contents

1 Executive Summary

1.1 Executive Summary

2 Disease Overview

2.1 Overview of Cushing’s Syndrome

2.2 Cushing’s Syndrome SWOT Analysis

2.3 Classification of Cushing’s Syndrome

3 Epidemiology

3.1 Diagnosed Prevalent Cases of CS, 2020-2030

3.2 Diagnosed Prevalent Cases of CS by Specific Type, 2020

3.3 Sources and Methodology

3.4 Diagnosis of Cushing’s Syndrome – Treatable Population

4 Current Treatment Options

4.1 Treatment Paradigm

4.2 Marketed Products

4.3 Product Profile: Corcept Therapeutics’ Korlym (mifepristone)

4.4 Product Profile: Recordati SpA’s Isturisa (osilodrostat phosphate)

4.5 Product Profile: Recordatii SpAs Signifor (pasireotide)

4.6 Product Profile: Laboratorie HRA Pharma SAS’ Ketoconazole

4.7 Product Profile: Laboratorie HRA Pharma SAS’ Metopirone (metyrapone)

4.8 Product Profile: Laboratorie HRA Pharma SAS’ Lysodren (mitotane)

5 Unmet Needs and Opportunities

5.1 Unmet Needs in CS

5.2 Efficacious Therapies that Target Underlying Causes of CD

5.3 Therapies for Severe CS with Improved Efficacy and Safety

5.4 Physician Awareness of CS Symptomatology

5.5 Improved Referral Systems to Specialists in Secondary Healthcare Settings

5.6 Defined Guidelines for Treatment and Remission

6 Pipeline Assessment

6.1 Cushing’s Syndrome Pipeline Overview

6.2 Leading Pipeline Agents

6.3 Product Profile: Recorlev

6.4 Product Profile: Relacorilant

6.5 Product Profile: SPI-62

6.6 Pipeline Products – Review Designations

6.7 Cushing’s Syndrome: Clinical Trials Overview, Phase II/III

7 R&D Strategies

7.1 Trends in Clinical Trial Design in Cushing’s Syndrome

7.2 Trends in Deal-Making in Cushing’s Syndrome

8 Market Outlook

8.1 Cushing’s Syndrome Sales Forecast

8.2 Cushing’s Syndrome Market Forecast

8.3 Market Drivers and Barriers

9 Appendix

9.1 Primary Research: KOL Information

9.2 About the Authors

10 Contact Us

List of Figures

Figure 1: Summary of Key Findings

Frequently Asked Questions

The total Cushing’s syndrome market value was $121.4 million in 2020.

The sales in Cushing’s syndrome are expected to grow at a CAGR of more than 10% during 2020-2030.

Key drugs for Cushing’s syndrome include Signifor/Signifor LAR, Korlym, Isturisa, Metopirone, Lysodren, and Ketoconazole (branded and -generic).

Key therapies for Cushing’s syndrome include Steroidogenesis Inhibitor, GR-II Antagonist, and SPI-62.


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