말단비대증 : 시장 인사이트, 역학, 시장 예측(-2034년)

Key Highlights:

• According to the estimates, the Acromegaly market size in the 7MM is ~USD 1,300 million in 2023.
• In 2023, among all the therapies, the highest Acromegaly market revenue was generated by somatostatin, i.e., ~USD 300 million, followed by growth hormone antagonist, i.e., ~USD 90 million in EU4 and the UK.
• The highest Acromegaly market was accounted by US which was ~ 55% of 7MM.
• Acromegaly is a rare hormonal disorder characterized by excessive production of growth hormone (GH) in the pituitary gland, a small gland located at the base of the brain. This overproduction of GH is most commonly caused by a non-cancerous tumor, known as an adenoma, in the pituitary gland. The condition primarily affects adults between the ages of 30 and 50, but it can develop at any age.
• Acromegaly primarily manifests as progressive tissue enlargement, notably altering facial features, hands, and feet. This includes enlargement of the nose, lips, tongue, ears, and a protruding jaw, along with swelling and enlargement of the hands and feet due to tissue and bone overgrowth.
• Acromegaly not only alters physical appearance but also impacts internal organs like the heart and lungs, potentially resulting in cardiovascular and respiratory complications. Additionally, joint pain, arthritis, and carpal tunnel syndrome often accompany the condition.
• Diagnosis is established through blood tests to measure GH and insulin-like growth factor 1 (IGF-1) levels, typically elevated in individuals with acromegaly. Imaging tests, like MRI or CT scans, locate pituitary tumors and determine their size.
• In 2023, the total diagnosed prevalent cases of acromegaly were ~60,000 cases in the 7MM.
• Treatment options for acromegaly include surgical removal of the pituitary tumor, radiation therapy, and medications to control GH production. If diagnosed and treated early, some symptoms may improve or reverse, but certain physical changes may remain permanent if the condition has been present for an extended period.
• Few therapies are being investigated for the treatment of acromegaly. Some key Acromegaly companies involved in the development are Crinetics Pharmaceuticals (Paltusotine) and Camurus AB (CAM2029).
• Females were found to be slightly more affected by this condition than males and accounted for around 14,000 cases of acromegaly in 2023.
• Regular follow-up with healthcare professionals is crucial for monitoring hormone levels and managing potential complications. Acromegaly requires long-term care to improve the quality of life and prevent further health problems associated with excessive growth hormone.

Acromegaly Market Report Summary

• The Acromegaly market report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The Acromegaly market report also encompasses a comprehensive analysis of the Acromegaly market, providing an in-depth examination of its historical and projected market size (2020 - 2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The Acromegaly market report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Acromegaly market.

Acromegaly Market

Various key Acromegaly companies are leading the treatment landscape, such as Crinetics Pharmaceuticals, Camurus AB, Amryt Pharma/Chiasma, Recordati/ Novartis Pharmaceuticals and others. The details of the country-wise and therapy-wise market size have been provided below.

• The total Acromegaly market size in the United States was ~USD 700 million in 2023.
• In 2023, among all the therapies in the United States, the largest Acromegaly market size was generated by somatostatin, i.e., ~USD 500 million, followed by growth hormone antagonist, i.e., ~USD 160 million.
• In the 7MM, among all the emerging therapies, paltusotine is expected to generate the largest Acromegaly market size by 2034.
• Among EU4 countries and the UK, the UK contributed the highest Acromegaly market size of acromegaly, i.e. approximately 30% of the total Acromegaly market size in EU4 and the UK.

Acromegaly Drug Chapters

The section dedicated to drugs in the Acromegaly market report provides an in-depth evaluation of late-stage pipeline drugs (Phase III) related to Acromegaly.

The drug chapters section provides valuable information on various aspects related to clinical trials of Acromegaly, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Acromegaly

Marketed Acromegaly Therapies

MYCAPSSA (octreotide acetate): Amryt Pharma/Chiasma

MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. It reduces the production of GH by binding to receptors on specialized cells in the pituitary gland. Being administrated orally, these capsules can serve as an alternative to the current standard-of-care injection therapy available for people living with acromegaly today.

Octreotide exerts pharmacologic actions similar to the natural hormone somatostatin but is a more potent inhibitor of GH, glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin-releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits the release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, and pancreatic polypeptide.

SIGNIFOR LAR (pasireotide): Recordati/Novartis Pharmaceuticals

SIGNIFOR LAR (pasireotide) was developed by Novartis Pharmaceuticals as an injectable suspension. It is a long-acting release form of pasireotide pamoate, as a powder to be suspended in the provided diluent immediately before intramuscular injection. SIGNIFOR LAR is a somatostatin analog that consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D, L-lactide-co-glycolide) acids (PLGA), and it is available in a vial containing the sterile pasireotide pamoate.

The recommended initial dose of SIGNIFOR LAR for the treatment of acromegaly is 40 mg, administered by intramuscular injection once every 4 weeks (every 28 days). The dose may be increased to a maximum of 60 mg for patients who have not normalized growth hormone (GH) and/or age and sex-adjusted insulin-like growth factor-1 (IGF-1) levels after 3 months of treatment with SIGNIFOR LAR at 40 mg and who tolerate this dose.

Emerging Acromegaly Therapies

Paltusotine (CRN 00808): Crinetics Pharmaceuticals

Paltusotine (CRN 00808), developed by Crinetics Pharmaceuticals, is an oral, selective, nonpeptide, somatostatin receptor type 2 (SST2) agonist, with potential growth hormone (GH) secretion-inhibiting and antineoplastic activities. It is designed to reduce excess GH secretion from benign pituitary tumors and normalize IGF-1 levels in patients with acromegaly.

Currently, the company is conducting a Phase III development program for paltusotine in acromegaly which includes the PATHFNDR-1 trial and the PATHFNDR-2 trial. Enrollment in PATHFNDR-1 was completed in 2022, while the PATHFNDR-2 study, it is still ongoing. The company plans to seek regulatory approval for paltusotine for the treatment of acromegaly in the United States with an anticipated submission of a New Drug Application, or NDA, in 2024.

CAM2029 (octreotide subcutaneous depot): Camurus AB

CAM2029 is a ready-to-use, long-acting subcutaneous injection depot based on the active substance octreotide formulated with Camurus' proprietary Fluid Crystal injection depot technology. It is provided as a prefilled syringe, thus not requiring reconstitution or conditioning before administration. Due to the superior ease of handling and administration, CAM2029 can conveniently be administered by patients. It was developed for the treatment of acromegaly and neuroendocrine tumors. This drug offers the potential for enhanced treatment efficacy in patients for whom current treatments provide suboptimal treatment effects.

It is currently being investigated in a Phase III trial (NCT04125836) for the treatment of acromegaly.

Acromegaly Market Outlook

The current treatment options include surgery, medicines, and radiation therapy. The treatment goals are to control tumor size, return GH and IGF-I levels to normal, improve symptoms, and manage related health problems. Currently, three types (Somatostatin analogs, dopamine agonists, growth hormone-receptor antagonists) of medicines are used to treat acromegaly. However, they do not provide a cure for the disease. The medicines may be used alone or in combination with each other. The third treatment option is radiation therapy (stereotactic and conventional), which uses high-energy x-rays or particle waves to kill tumor cells. This type of treatment may be recommended if surgery is not possible or fails to remove all tumor tissue, and medicines are not an option.

Many new molecules with novel mechanisms, like Somatostatin receptor type 2 (SST2) agonists, Somatostatin receptor agonists among others, are being developed for the treatment of Acromegaly by key players like Crinetics Pharmaceuticals, Camurus AB, Amryt Pharma/Chiasma, Recordati/ Novartis Pharmaceuticals among others.

In conclusion, despite the lack of appropriate treatment in the current treatment landscape, many potential therapies with novel mechanisms are expected to enter the market, resolving a dire unmet need and leading to significant improvement in the treatment outcome of Acromegaly patients. Hence, with the upcoming availability of new treatment options and increasing healthcare spending across the 7MM, the treatment scenario is expected to experience significant growth during the forecast period (2024-2034).

Acromegaly Understanding and Treatment

Acromegaly Overview

Acromegaly is a rare, slowly progressive, acquired disorder that affects adults. The pituitary gland produces too much growth hormone (GH). The pituitary gland is a small gland located near the base of the skull that stores several hormones and releases them into the bloodstream as needed by the body. These hormones regulate many different bodily functions. In most patients, acromegaly is caused by the growth of a benign tumor (adenoma) arising from the pituitary gland. Common signs and symptoms of acromegaly are enlarged hands and feet. Overall, acromegaly signs and symptoms tend to vary from one person to another and may include any of the following: enlarged hands and feet, enlarged facial features, including the facial bones, lips, nose, and tongue, coarse, oily, thickened skin, excessive sweating and body odor.

Acromegaly Diagnosis

Screening is recommended for all patients presenting with clinical features of acromegaly such as mass tumor effects, systemic effects of GH/IGF-1 excess, cardiovascular and metabolic features, respiratory and bone/joint manifestations, and/or other endocrine consequences. However, screening may also be considered in patients with several medical conditions associated with acromegaly, such as type 2 diabetes mellitus, carpal tunnel syndrome, debilitating arthritis, hypertension, and sleep apnea. Biochemical screening is the first step for an acromegaly diagnosis. Endocrine Society guidelines and experts' consensus recommend using age- and sex-adjusted IGF-1 levels in combination with GH nadir during an oral glucose tolerance test (OGTT) to diagnose and rule out acromegaly. Measuring serum IGF-1 is usually the initial screening test.

Doctors most often diagnose acromegaly by ordering two blood tests - IGF test and Oral glucose tolerance test that help to determine that the body is making too much GH.

Acromegaly Treatment

Treatment goals in acromegaly include symptom relief, tumor control with the maintenance of pituitary function, biochemical normalization of GH/IGF-1, and reversal of the excess morbidity and mortality associated with the disorder. Current modalities of treatment available include surgery, medical therapy, and radiotherapy. Treatment is complex, and more than one modality is frequently required to achieve treatment goals. In a pregnant patient with acromegaly due to a microadenoma, the clinician should discontinue medical management, and these patients can just be closely monitored. The same applies to those with macroadenomas not affecting the optic chiasm with close monitoring of visual fields.

Acromegaly Epidemiology

The Acromegaly epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases, Tumor Origin-specific, Gender-specific Cases, Tumor Size-specific Cases of Acromegaly in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2023, US accounted for the highest diagnosed prevalent cases in the 7MM, with around 27,000 cases followed by Japan where cases were ~9,000 cases of acromegaly.
• In the United States, as per the gender-specific cases of acromegaly, there were ~13,000 and ~14,000 in males and females, respectively, in 2023.
• In the US, tumor size-specific cases of acromegaly were ~75% and ~25% for macroadenomas and microadenomas, respectively, in 2023, which are likely to increase.
• In EU4 and the UK, tumor origin-specific cases of acromegaly were ~20,300 and ~1,060 for pituitary and non-pituitary tumors, respectively, in 2023.

Acromegaly KOL Views

To stay abreast of the latest trends in the Acromegaly market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of Acromegaly, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the University of Bordeaux, Stanford University, University of Colorado School of Medicine, University of Genova etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Acromegaly market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for Acromegaly important primary endpoints are proportion of patients with a mean GH level less than 2.5 µg/L and normal IGF-1 levels at Week 24, dose-adjusted proportion of patients who maintain their biochemical response is evaluated.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, a final weightage score is decided, based on which the emerging therapies are ranked.

Acromegaly Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The Acromegaly market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Acromegaly Market Report Insights

• Acromegaly Patient Population
• Acromegaly Therapeutic Approaches
• Acromegaly Market Size
• Acromegaly Market Trends
• Existing Acromegaly Market Opportunity

Acromegaly Market Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Acromegaly Epidemiology Segmentation
• Key Cross Competition

Acromegaly Market Report Assessment

• Current Acromegaly Treatment Practices
• Reimbursements
• Acromegaly Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Acromegaly management recommendations?
• Would research and development advances pave the way for future tests and therapies for Acromegaly?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Acromegaly?
• What kind of uptake will the new therapies witness in coming years in Acromegaly patients?

Table of Contents

1 Key Insights

2 Report Introduction

3 Acromegaly Market Overview at a Glance

• 3.1 Market Share (%) Distribution of Acromegaly by therapies in 2020
• 3.2 Market Share (%) Distribution of Acromegaly by therapies in 2034

4 Executive Summary of Acromegaly

5 Key events

6 Disease Background and Overview

• 6.1 Introduction
• 6.2 Causes for Acromegaly
• 6.3 Risk Factors of Acromegaly
• 6.4 Signs and Symptoms of Acromegaly
• 6.5 Biomarkers of Acromegaly
• 6.6 Clinical Manifestations of Acromegaly
  • 6.6.1 Osteoarticular Manifestations
  • 6.6.2 Cardiovascular Manifestations
  • 6.6.3 Respiratory Manifestations
  • 6.6.4 Endocrinological and Other Manifestations
  • 6.6.5 Gastrointestinal Manifestations
• 6.7. Gen tic Background for Acromegaly
  • 6.7.1 Familial Isolated Pituitary Adenoma
  • 6.7.2 AIP (Aryl Hydrocarbon Receptor Interacting Protein)
  • 6.7.3 Multiple Endocrine Neoplasia Types 1 and 4 (MEN1 and MEN4)
  • 6.7.4 Carney Complex
  • 6.7.5 McCune-Albright Syndrome
  • 6.7.6 GH excess in Neurofibromatosis Type 1
  • 6.7.7 Somatic Changes in Somatotropinomas
• 6.8 Pathophysiology of Acromegaly
• 6.9 Complications
  • 6.9.1 Bone Complications from Acromegaly
  • 6.9.2 Soft Tissue Complications from Acromegaly
  • 6.9.3 Pituitary Hormone Deficiencies
  • 6.9.4 Sleep Apnea
  • 6.9.5 Heart Problems
  • 6.9.6 Diabetes
  • 6.9.7 Colon Polyps
• 6.10 Diagnosis and Screening
  • 6.10.1 Blood tests
  • 6.10.2 Imaging tests
  • 6.10.3 Differential Diagnosis
  • 6.10.4 Diagnostic Algorithm
• 6.11 Treatment
  • 6.11.1 Surgical Therapy
  • 6.11.2 Medical Agents
  • 6.11.3 Radiotherapy
  • 6.11.4 Management of Acromegaly in Pregnancy
  • 6.11.5 Treatment Algorithm
• 6.12 Treatment Guidelines
  • 6.12.1 Pituitary Society Acromegaly Management Guidelines
  • 6.12.2 Acromegaly Consensus Group Guidelines 2020
  • 6.12.3 An Endocrine Society Clinical Practice Guideline 2014
  • 6.12.4 American Association of Clinical Endocrinologists Medical Guidelines (AACE)

7 Methodology

8 Acromegaly Epidemiology and Patient Population

• 8.1 Key Findings
• 8.2 Assumptions and Rationale
• 8.3 Total Diagnosed Prevalent Cases of Acromegaly in the 7MM
• 8.4 The United States
  • 8.4.1 Total Diagnosed Prevalent Cases of Acromegaly in the United States
  • 8.4.2 Tumor Origin-specific Cases of Acromegaly in the United States
  • 8.4.3 Gender-specific Cases of Acromegaly in the United States
  • 8.4.4 Tumor Size-specific Cases of Acromegaly in the United States
• 8.5 EU4 and the UK
  • 8.5.1 Total Diagnosed Prevalent Cases of Acromegaly in EU4 and the UK
  • 8.5.2 Tumor Origin-specific Cases of Acromegaly in EU4 and the UK
  • 8.5.3 Gender-specific Cases of Acromegaly in EU4 and the UK
  • 8.5.4 Tumor Size-specific Cases of Acromegaly in EU4 and the UK
• 8.6 Japan
  • 8.6.1 Total Diagnosed Prevalent Cases of Acromegaly in Japan
  • 8.6.2 Tumor Origin-specific Cases of Acromegaly in Japan
  • 8.6.3 Gender-specific Cases of Acromegaly in Japan
  • 8.6.4 Tumor Size-specific Cases of Acromegaly in Japan

9 Acromegaly Patient Journey

10 Acromegaly Marketed Therapies

• 10.1 Key Cross
• 10.2 MYCAPSSA (octreotide acetate): Amryt Pharma/Chiasma
  • 10.2.1 Product Description
  • 10.2.2 Regulatory Milestones
  • 10.2.3 Other Developmental Activities
  • 10.2.4 Safety and Efficacy
• 10.3 SIGNIFOR LAR (pasireotide): Recordati/Novartis Pharmaceuticals
  • 10.3.1 Product Description
  • 10.3.2 Regulatory Milestones
  • 10.3.3 Other Developmental Activities
  • 10.3.4 Safety and Efficacy
• 10.4 BYNFEZIA PEN (octreotide acetate): Sun Pharma
  • 10.4.1 Product Description
  • 10.4.2 Regulatory Milestones
  • 10.4.3 Other Developmental Activities

11 Emerging Acromegaly Therapies

• 11.1 Key Cross
• 11.2 Paltusotine (CRN 00808): Crinetics Pharmaceuticals
  • 11.2.1 Product Description
  • 11.2.2 Other Developmental Activities
  • 11.2.3 Clinical Developmental Activities
  • 11.2.4 Safety and Efficacy
• 11.3 CAM2029 (octreotide subcutaneous depot): Camurus AB
  • 11.3.1 Product Description
  • 11.3.2 Other Developmental Activities
  • 11.3.3 Clinical Developmental Activities
  • 11.3.4 Safety and Efficacy

12 Acromegaly Market: Seven Major Market Analysis

• 12.1 Key Findings
• 12.2 Acromegaly Market Outlook
• 12.3 Key Acromegaly Market Forecast Assumptions
• 12.4 Conjoint Analysis
• 12.5 Total Market Size of Acromegaly in the 7MM
• 12.6 Market Size of Acromegaly by Therapies in the 7MM
• 12.7 The United States Acromegaly Market Size
  • 12.7.1 Total Market Size of Acromegaly in the United States
  • 12.7.2 Market Size of Acromegaly by Therapies in the United States
• 12.8 EU4 and the UK Acromegaly Market Size
  • 12.8.1 Total Market Size of Acromegaly in EU4 and the UK
  • 12.8.2 Market Size of Acromegaly by Therapies in EU4 and the UK
• 12.9 Japan Acromegaly Market Size
  • 12.9.1 Total Market Size of Acromegaly in Japan
  • 12.9.2 Market Size of Acromegaly by Therapies in Japan

13 Acromegaly KOL Views

14 Acromegaly SWOT Analysis

15 Acromegaly Unmet Needs

16 Acromegaly Market Access and Reimbursement

• 16.1 The United States
  • 16.1.1 Centers for Medicare & Medicaid Services (CMS)
• 16.2 EU4 and the UK
  • 16.2.1 Germany
  • 16.2.2 France
  • 16.2.3 Italy
  • 16.2.4 Spain
  • 16.2.5 United Kingdom
• 16.3 Japan
  • 16.3.1 MHLW
• 16.4 MYCAPSSA (octreotide acetate)
• 16.5 SIGNIFOR LAR (pasireotide)
• 16.6 Somatuline
• 16.7 Somavert (pegvisomant)

17 Appendix

• 17.1 Bibliography
• 17.2 Report Methodology

18 DelveInsight Capabilities

19 Disclaimer

20 About DelveInsight