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(Albany, US), November 11, 2026 – DelveInsight’s ‘Acromegaly Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of acromegaly, historical and forecasted epidemiology, as well as the acromegaly market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Acromegaly Market Report

• In July 2026, Camurus announced that the US FDA accepted the NDA resubmission for CAM2029, an investigational long-acting octreotide subcutaneous depot for treating acromegaly.

• In January 2026, Camurus announced that the US FDA had accepted for review the resubmitted NDA for CAM2029, an octreotide extended-release injection, for the treatment of patients with acromegaly, with a PDUFA target action date of June 10, 2026.

• In January 2026, Marea announced positive Phase I topline results for MAR002 in acromegaly, highlighting potential for best-in-class efficacy and a favorable dosing profile.

• In December 2025, Debiopharm announced that the first patient had been randomized in the Phase III (OXTEND-03) clinical trial for adults with acromegaly who are currently maintained on somatostatin analogs.

• In February 2026, Crinetics Pharmaceuticals announced that the CHMP of the EMA had adopted a positive opinion recommending the marketing authorization of PALSONIFY (paltusotine) for adult patients with acromegaly.

• According to DelveInsight’s analysis, the acromegaly market size in the 7MM was approximately USD 1,300 million in 2025, and it is projected to grow at a CAGR of ~1.5% during 2026-2036.

• Among the 7MM, the United States accounted for the largest share of the acromegaly market in 2025, while among the EU4 and the UK, the UK held the largest market share, followed by Germany, with Spain accounting for the smallest share.

• According to DelveInsight’s estimates, the total diagnosed prevalent cases of acromegaly in the 7MM were approximately 59,000 in 2025.

• In the United States, the total diagnosed prevalent cases of acromegaly were estimated at approximately 27,500 in 2025 and are projected to increase by 2036, driven by improved detection and greater disease awareness.

• Surgery remains the standard of care and first-line treatment, but a substantial proportion of patients require adjunctive medical therapy and/or radiotherapy due to incomplete tumor resection or persistent biochemical activity.

• Limitations in current management, including incomplete biochemical control, treatment burden, and the lack of highly sensitive biomarkers, highlight the need for improved diagnostic tools and more effective, patient-friendly therapies.

• The leading Acromegaly companies include Debiopharm International SA, AstraZeneca, Marea Therapeutics, Crinetics, Camurus, Chiesi, and others.

• Promising Acromegaly therapies include Paltusotine (PALSONIFY), CAM2029 (OCZYESA), Octreotide (MYCAPSSA), Debio 4126, ALXN2420, MAR002, and others.

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Acromegaly Overview

Acromegaly is a rare endocrine disorder characterized by chronic overproduction of growth hormone (GH), most commonly caused by a benign pituitary adenoma arising from somatotroph cells. Excess GH leads to elevated insulin-like growth factor 1 (IGF-1) levels, resulting in progressive somatic overgrowth, metabolic dysfunction, and multisystem complications. The disease typically develops insidiously in adults, leading to delayed diagnosis due to gradual symptom progression. Diagnosis primarily involves biochemical confirmation followed by imaging studies. The initial step includes measurement of serum IGF-1 levels, which serve as a sensitive screening marker, followed by a growth hormone suppression test (oral glucose tolerance test, OGTT), where failure of GH suppression confirms the diagnosis. Once biochemical evidence is established, pituitary MRI is performed to localize and characterize the adenoma. Additional evaluation may include assessment of pituitary function and screening for associated comorbidities, while genetic testing may be considered in selected cases, particularly in younger patients or those with a family history suggestive of hereditary syndromes.

Acromegaly Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalent Cases of Acromegaly

• Tumor Origin-specific Diagnosed Prevalent Cases of Acromegaly

• Gender-specific Diagnosed Prevalent Cases of Acromegaly

• Tumor Size-specific Diagnosed Prevalent Cases of Acromegaly

• Total Treated Cases of Acromegaly

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Acromegaly Epidemiology Key Findings

• According to DelveInsight’s estimates, the total number of diagnosed prevalent cases of acromegaly in the 7MM was approximately 59,000 in 2025.

• In the United States, acromegaly has an estimated incidence of ~2–11 new cases per million annually, with approximately 20,000–45,000 prevalent cases, though the true burden is likely underestimated due to underdiagnosis.

• In the United States, ~95% of cases are attributed to pituitary adenomas, while only ~5% arise from non-pituitary sources, underscoring the dominant role of pituitary-origin disease.

• Acromegaly demonstrates a slight female predominance (~51% vs. ~49% in males), with most patients diagnosed in their 40s to 50s, reflecting the slow and progressive nature of the disease.

• Among the EU4 and the UK, Germany had the highest number of diagnosed prevalent cases, while Spain had the least.

• Based on tumor size, acromegaly is classified into microadenoma and macroadenoma, which are key determinants of disease severity and treatment strategy.

Approved Therapies for Acromegaly

• Paltusotine (PALSONIFY): Crinetics

PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. It offers a first-line, non-injectable alternative to traditional somatostatin analogs, with clinical data showing rapid normalization or lowering of IGF-1 levels and reduction in acromegaly-related symptoms in a substantial proportion of patients.

• CAM2029 (OCZYESA): Camurus

OCZYESA is a ready-to-use, long-acting subcutaneous injection depot based on octreotide, formulated with Camurus’ proprietary Fluid Crystal injection depot technology. It is designed for self-administration via a pre-filled autoinjector pen, enabling convenient at-home dosing.

Acromegaly Pipeline Analysis

• Debio 4126: Debiopharm International SA

Debio 4126 is an innovative, long-acting octreotide designed for intramuscular administration every three months. Early clinical data and robust pharmacokinetic modeling have demonstrated sustained octreotide release, consistent inhibition of IGF-1, and a safety profile comparable to marketed somatostatin analogues (SSAs), supporting the initiation of the Phase III trial.

• ALXN2420: AstraZeneca

ALXN2420 is a novel small-peptide antagonist of the GHR being developed as an add-on therapy to SSAs to further suppress and normalize IGF-1 levels. In vivo administration of ALXN2420 led to a robust reduction in IGF-1 levels, and when combined with an SSA, it demonstrated an additive effect on IGF-1 reduction.

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Acromegaly Market Outlook

The acromegaly treatment landscape is well-established but continues to evolve, with management centered on a multimodal approach involving surgery, pharmacotherapy, and radiotherapy. Somatostatin receptor ligands (SRLs) remain the cornerstone of pharmacologic management, which keeps the US somatostatin analogs market central to the overall acromegaly market. Despite these options, limitations such as incomplete response, injectable burden, and tolerability issues highlight the need for improved therapies. The pipeline is increasingly focused on next-generation somatostatin analogs, oral therapies, and novel receptor-targeting approaches, reflecting a shift toward improved convenience and efficacy and a gradual transition toward more patient-centric and mechanism-driven therapies. Advancements in diagnostic practices, therapeutic innovation, and disease awareness are expected to support steady growth in the gigantism drugs market and the wider acromegaly market over the forecast period, with increasing emphasis on sustained biochemical control and improved long-term outcomes.

Acromegaly Market Drivers

• Rising disease recognition and diagnosis, driven by greater clinical awareness and widespread use of MRI for pituitary adenomas

• Advancements in targeted medical therapies, including somatostatin receptor ligands, growth hormone receptor antagonists, and dopamine agonists

• Long-acting formulations and newer agents improving treatment adherence and disease control

• Emerging competitive pipeline featuring novel mechanisms such as Debio 4126, ALXN2420, and MAR002

• Introduction of oral and long-acting agents addressing the limitations of traditional injectable therapies

Acromegaly Market Barriers

• Incomplete biochemical control with existing therapies

• Burden of long-term treatment and monitoring

• Delayed diagnosis and disease recognition

• Treatment-related limitations and tolerability issues

• Lack of highly sensitive biomarkers

Acromegaly Treatment Landscape

The treatment of acromegaly is primarily centered on transsphenoidal surgical resection of the pituitary adenoma, which remains the first-line and potentially curative option for localized disease. In patients with persistent or inoperable disease, medical therapy is the mainstay, including somatostatin receptor ligands (SRLs), growth hormone receptor antagonists (e.g., pegvisomant), and dopamine agonists, aimed at normalizing GH and IGF-1 levels. For patients who are refractory to surgery and medical therapy, radiotherapy (conventional or stereotactic radiosurgery) may be considered as an adjunctive treatment. Overall management is tailored based on tumor characteristics, biochemical control, and patient-specific factors, with a goal of reducing morbidity and long-term complications.

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Scope of the Acromegaly Market Report

• Coverage- 7MM

• Study Period- 2022-2036

• Forecast Period- 2026-2036

• Acromegaly Companies- Debiopharm International SA, AstraZeneca, Marea Therapeutics, Crinetics, Camurus, Chiesi, and others.

• Acromegaly Therapies- Paltusotine (PALSONIFY), CAM2029 (OCZYESA), Octreotide (MYCAPSSA), Debio 4126, ALXN2420, MAR002, and others.

• Acromegaly Market Dynamics: Acromegaly market drivers and market barriers

• Acromegaly Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis

• Acromegaly Unmet Needs, KOL Views, Reimbursement

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. Epidemiology and Market Forecast Methodology of Acromegaly

6. Acromegaly Market Overview at a Glance

7. Disease Background and Overview of Acromegaly

8. Treatment and Management

9. Epidemiology and Patient Population of Acromegaly

10. Patient Journey of Acromegaly

11. Marketed Therapies

12. Emerging Therapies

13. Acromegaly: Seven Major Market Analysis

14. Unmet Needs of Acromegaly

15. SWOT Analysis of Acromegaly

16. KOL Views of Acromegaly

17. Market Access and Reimbursement of Acromegaly

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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