Acromegaly Market Analysis 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

The Acromegaly market size in the 7MM (US, EU4, UK, and Japan) was approximately USD 1.3 billion in 2023, with the US contributing ~55% of the total market share. Among therapies, somatostatin analogs led the market with ~USD 300 million, followed by growth hormone antagonists at ~USD 90 million in EU4 and the UK.
Acromegaly is a rare hormonal disorder caused by excessive growth hormone (GH) production, typically due to a non-cancerous pituitary adenoma. It commonly affects adults aged 30-50 and results in progressive tissue enlargement, altering facial features (enlarged nose, lips, jaw), hands, feet, and sometimes internal organs, leading to cardiovascular and respiratory complications, joint pain, and arthritis.

In 2023, diagnosed prevalent cases reached ~60,000 across the 7MM, with females slightly more affected (~14,000 cases). Diagnosis involves elevated GH and IGF-1 levels confirmed by MRI/CT scans. Treatment includes surgery, radiation therapy, and medications to control GH production. Early intervention can reverse some symptoms, though long-standing physical changes may be permanent. Key pipeline therapies include Paltusotine (Crinetics Pharmaceuticals) and CAM2029 (Camurus AB). Long-term follow-up is essential for managing hormone levels and related complications.

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(Albany, USA) DelveInsight's "Acromegaly Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Acromegaly, historical and forecasted epidemiology as well as the Acromegaly market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Acromegaly market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Acromegaly market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Acromegaly treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Acromegaly market.

Some facts of the Acromegaly Market Report are:
• According to DelveInsight, Acromegaly market size is expected to grow at a decent CAGR by 2034.
• The Acromegaly market size was valued ~USD 1,300 million in 2023 and is to grow with a significant CAGR during the study period (2020-2034)
• Leading Acromegaly companies working in the market are Amolyt Pharma, Amryt Pharma Plc, Antisense Therapeutics Ltd, Aquestive Therapeutics Inc, ASCIL Biopharm, Camurus AB, Crinetics Pharmaceuticals Inc, Daewoong Pharmaceutical Co Ltd, Debiopharm International SA, DexTech Medical AB, Enesi Pharma Ltd, Foresee Pharmaceuticals Co Ltd, GeneScience Pharmaceuticals Co Ltd, Genevant Sciences Ltd, GlyTech Inc, Ionis Pharmaceuticals Inc, Italfarmaco SpA, OPKO Health Inc, Pharmathen Global BV, Rani Therapeutics LLC, Strongbridge Biopharma plc., and others.
• Key Acromegaly Therapies expected to launch in the market are Paltusotine (CRN 00808), CAM-2029 (octreotide subcutaneous depot), and many others.
• In March 2025, Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine disorder characterized by consistently elevated levels of growth hormone. The MAA will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). Additionally, the EMA on February 27, 2025 granted paltusotine Orphan Drug Designation (ODD) for the treatment of acromegaly.
• In January 2025, MAR002 is a promising first-in-class antibody targeting the growth hormone receptor (GHR), being developed for the treatment of acromegaly. Acromegaly is a serious, life-threatening condition primarily driven by insulin resistance, lipotoxicity, and cardiovascular issues. Current treatments for acromegaly often fail to provide optimal disease management. In the U.S., it is estimated that over 30,000 individuals are affected by acromegaly.
• In December 2024, Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. If approved, paltusotine will be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for adults living with acromegaly.
• In October 2024, Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly.
• On March 2024, Crinetics Pharmaceuticals announced results of a Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)
• On April 2024, Camurus AB announced results of a Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
• On September 2023, Pfizer announced results of a non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)
• The Acromegaly market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Acromegaly pipeline products will significantly revolutionize the Acromegaly market dynamics.
• In 2023, the United States had the highest number of diagnosed prevalent cases of acromegaly in the 7MM, with approximately 27,000 cases, followed by Japan with around 9,000 cases.
• In the United States, gender-specific cases of acromegaly in 2023 were approximately 13,000 in males and around 14,000 in females.
• In the US, tumor size-specific cases of acromegaly in 2023 were approximately 75% for macroadenomas and 25% for microadenomas, with numbers expected to rise.
• In the EU4 and the UK, tumor origin-specific cases of acromegaly in 2023 included approximately 20,300 cases from pituitary tumors and around 1,060 cases from non-pituitary tumors.
• In September 2024, Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today revealed that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist being developed for the proposed treatment and long-term maintenance therapy of acromegaly.
• In July 2024, Swedish pharmaceutical company Camurus announced positive outcomes from the Phase III ACROINNOVA 2 study, which evaluated the efficacy and safety of octreotide subcutaneous (SC) depot (CAM2029) in patients with acromegaly.
• In 2023, the total acromegaly market size in the United States was approximately USD 700 million.
• In 2023, somatostatin therapies generated the largest market size among all acromegaly treatments in the United States, reaching around USD 500 million, followed by growth hormone antagonists at approximately USD 160 million.
• In 2023, somatostatin therapies generated the highest revenue among all treatments in the EU4 and the UK, totaling approximately USD 300 million, followed by growth hormone antagonists at around USD 90 million.
• In the EU4 countries and the UK, the UK accounted for the largest share of the acromegaly market, contributing around 30% of the total market size in these regions.

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Acromegaly Overview
Acromegaly is a rare hormonal disorder caused by the excessive secretion of growth hormone (GH), most often due to a non-cancerous pituitary adenoma. The condition typically affects adults aged 30-50 and develops gradually, leading to progressive tissue overgrowth. This results in enlarged facial features-such as the nose, lips, tongue, and jaw-as well as swelling in the hands and feet. Internal organs like the heart and lungs may also be affected, increasing the risk of cardiovascular and respiratory complications, along with joint pain, arthritis, and carpal tunnel syndrome.
Diagnosis relies on elevated GH and insulin-like growth factor 1 (IGF-1) levels and imaging tests like MRI or CT scans to identify pituitary tumors. Treatment options include surgery, radiation therapy, and medications to reduce GH production. While early intervention can reverse some symptoms, prolonged disease may cause permanent physical changes, requiring long-term management and regular follow-ups.

Acromegaly Market Outlook
The Acromegaly treatment landscape is driven by leading companies such as Crinetics Pharmaceuticals, Camurus AB, Amryt Pharma/Chiasma, and Recordati/Novartis Pharmaceuticals.

In 2023, the United States dominated the market with a value of approximately USD 700 million, accounting for the largest share in the 7MM. Within the US, somatostatin analogs led with ~USD 500 million, followed by growth hormone antagonists at ~USD 160 million.

Across the EU4 and the UK, the UK contributed the highest share-about 30% of the regional market size.

Current treatment approaches for acromegaly include surgery, medications, and radiation therapy, aiming to reduce tumor size, normalize GH and IGF-I levels, relieve symptoms, and manage related health issues. Medications-primarily somatostatin analogs, dopamine agonists, and growth hormone-receptor antagonists-help control the disease but are not curative and are often used alone or in combination. Radiation therapy (stereotactic or conventional) is typically considered when surgery is not feasible or fails to eliminate all tumor tissue.

The pipeline is robust, with novel agents such as somatostatin receptor type 2 (SST2) agonists and other somatostatin receptor agonists being developed by leading companies including Crinetics Pharmaceuticals, Camurus AB, Amryt Pharma/Chiasma, and Recordati/Novartis.

Despite limitations in current therapies, these emerging treatments are expected to address significant unmet needs, improve patient outcomes, and drive substantial market growth across the 7MM from 2024 to 2034.

Acromegaly Epidemiology
In 2023, the United States recorded the highest diagnosed prevalent cases of acromegaly in the 7MM, with approximately 27,000 cases, followed by Japan with around 9,000 cases. In the US, the gender distribution was nearly balanced, with about 13,000 males and 14,000 females affected. Regarding tumor size, approximately 75% of US cases were macroadenomas and 25% were microadenomas, a trend expected to rise. In the EU4 and the UK, there were around 20,300 pituitary tumor cases and about 1,060 non-pituitary tumor cases in 2023, highlighting regional variations in disease presentation.

Acromegaly Epidemiology Segmentation
• Total Diagnosed Prevalent Cases
• Tumor Origin-specific
• Gender-specific Cases
• Tumor Size-specific Cases of Acromegaly

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Acromegaly Drugs Uptake
• Paltusotine (CRN 00808) by Crinetics Pharmaceuticals is an oral, selective SST2 agonist designed to reduce excess growth hormone (GH) secretion and normalize IGF-1 levels in acromegaly patients. It is in Phase III trials (PATHFNDR-1 completed in 2022; PATHFNDR-2 ongoing), with an NDA submission in the US planned for 2024.

• CAM2029 (octreotide subcutaneous depot) by Camurus AB is a ready-to-use, long-acting subcutaneous injection using Fluid Crystal depot technology, eliminating the need for reconstitution. Developed for acromegaly and neuroendocrine tumors, it enables convenient self-administration and potentially improved treatment outcomes. CAM2029 is currently in a Phase III trial (NCT04125836) for acromegaly.

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Acromegaly Therapeutics Assessment

Major key companies are working proactively in the Acromegaly Therapeutics market to develop novel therapies which will drive the Acromegaly treatment markets in the upcoming years are Amolyt Pharma, Amryt Pharma Plc, Antisense Therapeutics Ltd, Aquestive Therapeutics Inc, ASCIL Biopharm, Camurus AB, Crinetics Pharmaceuticals Inc, Daewoong Pharmaceutical Co Ltd, Debiopharm International SA, DexTech Medical AB, Enesi Pharma Ltd, Foresee Pharmaceuticals Co Ltd, GeneScience Pharmaceuticals Co Ltd, Genevant Sciences Ltd, GlyTech Inc, Ionis Pharmaceuticals Inc, Italfarmaco SpA, OPKO Health Inc, Pharmathen Global BV, Rani Therapeutics LLC, Strongbridge Biopharma plc., and others.

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