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Market Research Report

Acromegaly and Gigantism - Global Drug Forecast and Market Analysis to 2029

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Acromegaly and Gigantism - Global Drug Forecast and Market Analysis to 2029
Published: November 15, 2020 Content info: 225 Pages
Description

Acromegaly and gigantism are rare disorders of the pituitary gland characterized by the hypersecretion of growth hormone (GH). This GH excess is often a result of a benign GH-secreting pituitary adenoma. Rarely, tumors in other organs can secrete growth hormone-releasing hormone (GHRH), leading to elevation in GH levels in the serum. This triggers the release of anti-apoptotic and mitogenic peptide hormone, insulin-like growth factor 1 (IGF-1). While both acromegaly and gigantism are complications of uncontrolled GH levels, the presentation of the two hormonal diseases is very different. GH excess beginning in adulthood is known as acromegaly and is characterized by an insidious onset and a delayed diagnosis, whereas GH excess beginning during childhood is known as gigantism and is characterized by a dramatic acceleration of growth, leading to an unusually tall stature.

Symptoms of acromegaly and gigantism include the development of abnormally large hands and feet, an enlarged tongue, hyperhidrosis, joint pain, tiredness, and headaches. Surgery to remove the pituitary tumor is often offered to patients with acromegaly or gigantism. Pharmacotherapeutic approaches may be employed to increase the efficacy of surgery, or as a monotherapeutic strategy in cases where surgical procedures are not appropriate for the patient. Somatostatin is a cyclic polypeptide hormone that inhibits the secretion of a number of hormones, including that of GH. First-line pharmaceutical products used to treat acromegaly and gigantism are typically somatostatin analogs (SSAs) because the natural version of the hormone has a very short half-life and cannot bring about sustained suppression of GH.

In 1988, Novartis' Sandostatin, became the first SSA to be approved by the FDA. The therapy, which is injected up to four times daily marked the advent of a new effort by drug developers to produce products that are administered less frequently. Since then, the SSA drug class has expanded to include therapies such as Novartis' Sandostatin LAR (long-acting repeatable) Depot (octreotide acetate for injectable suspension), Novartis' Signifor LAR (pasireotide), and Ipsen's Somatuline (lanreotide acetate) Depot which are all injected on a monthly basis. Although SSAs dominate the treatment landscape, Pfizer's GH inhibitor Somavert (pegvisomant) and dopamine agonists, bromocriptine mesylate and cabergoline have also penetrated the market and are used in combination with first-line drugs.

The seven pharmaceutical markets (7MM) covered in this report and forecast model are the US, France, Germany, Italy, Spain, the UK, and Canada. GlobalData estimates that drug sales for acromegaly and gigantism in 2019 were approximately $1.4B across the 7MM. Over the 10-year forecast period, the market is expected to reach $2.2B in 2029, increasing at a CAGR of 4.4%. Growth in the market will be driven by the launch of longer-acting somatostatin analogs, oral therapies, and growth hormone receptor inhibitors, which are used in combination with first-line drugs to provide an effective treatment option for patients with intractable disease.

Key Highlights

  • The acromegaly and gigantism market was worth $1.4B in 2019. The market is expected to grow at a CAGR of 4.4% from 2019 to 2029, reaching a global value of $2.2B. GlobalData projects that the marketed for acromegaly and gigantism will experience growth driven by the launch of oral therapies, injectable somatostatin analogs that are administered less frequently than the market-leading product, which is Novartis' Sandostatin LAR Depot.
  • Low disease awareness and delayed diagnosis is the most significant unmet need in this therapy area. Lack of physician and patient education means that a large percentage of patients treat the symptoms of these conditions without being able to address the cause of the endocrinological abnormalities for many years. Additionally, more patients are expected to undergo surgery which effectively cures the disease in patients whose pituitary tumors can be successfully excised. Market exclusivity for major brands such as Novartis' Signifor (pasireotide) and Ipsen's Somatuline Depot (lanreotide acetate), will also be lost during the forecast window, which will allow competitor drug developers to consider producing generic formulations of these market-dominating somatostatin analogs.
  • No drugs are being specifically developed for gigantism which means that some pipeline agents will not benefit from being used to treat pediatric patients. Oral therapies such as Chiasma's Mycapssa (octreotide acetate) and Crinetics' paltusotine are expected to be used to treat younger patients who may not be candidates for surgery or intramuscular injections. For this reason, and the fact that both of these drugs will launch in multiple markets, Mycapssa and paltusotine are expected to become some of the top-selling therapeutics that will enter the acromegaly market between 2019 and 2029. Growth in the market will be driven by the launch of growth hormone receptor inhibitors. Only one marketed drug (Pfizer's Somavert/pegvisomant) targets this signaling pathway. Although Pfizer's Somavert is highly effective in inducing biochemical control of acromegaly, the high cost of therapy has led some regulatory bodies to restrict its use, denying a subset of patients from access to this treatment option. Antisense Therapeutics' atesidorsen sodium, and Ionis Pharma's IONIS-GHRLRx are growth hormone receptor inhibitors that are expected to be injected less frequently than Pfizer's Somavert. Furthermore, these drug candidates represent a new molecule type entering the market within the forecast window, as no antisense therapies are currently available for the management of acromegaly and gigantism.
  • A disadvantage of the market-leading drug, Sandostatin LAR, is that this therapy is injected via the intramuscular route of administration which is associated with pain and discomfort. Furthermore, patients typically receive injections in a clinical setting which is can be inconvenient for individuals who do not live within easy reach of their healthcare provider.
  • Drug developers are also focusing on producing self-administrable therapies that can increase patients' compliance. These therapeutics will reduce the need for patients to attend frequent hospital appointments in order to receive treatment.
  • The top selling drug to enter the market in the forecast period will be Camurus' octreotide LA, which is expected to become the first long-acting subcutaneously administrable formulation of octreotide. The largest pharmacotherapy market for acromegaly and gigantism in 2019 was the US, which made up 75% of sales in the base year of the forecast window. The dominance of this market will continue, as most patients with acromegaly in the 7MM are diagnosed and treated in the US. In 2029, the US will generate $1.6B.

Key Questions Answered

  • What were the key treatments for acromegaly and gigantism 2019?
  • When will the late stage pipeline products launch in each of the 7MM?
  • What are the major clinical and environmental unmet needs in the acromegaly and gigantism market?
  • What are the key opportunities for pharmaceutical companies developing drug candidates for acromegaly and gigantism?

Scope

  • Overview of acromegaly and gigantism, including epidemiology, etiology, pathophysiology, symptoms, diagnosis of the diseases, and treatment strategies.
  • Annualized acromegaly and gigantism therapeutics market revenue and sales forecast, including discussion of treatment usage patterns in individual patient populations.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the acromegaly and gigantism market.
  • Pipeline analysis: comprehensive assessment of emerging trends, molecule types represented in the pipeline, and drug delivery systems being developed by pharmaceutical companies. All drug candidates at Phase II and Phase III stages of development are extensively profiled.
  • Analysis of the current and future market competition, and an insightful review of the key market drivers, opportunities, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

  • The report will enable you to -
  • 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 acromegaly and gigantism therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global acromegaly and gigantism therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for strategic consolidations, investments and strategic partnerships.
Table of Contents
Product Code: GDHC207PIDR

Table of Contents

1 Table of Contents

  • 1.1 List of Tables
  • 1.2 List of Figures

2 Acromegaly and Gigantism: Executive Summary

  • 2.1 Steady Growth Expected in the Acromegaly and Gigantism Market from 2019-2029
  • 2.2 Pharmaceutical Companies Are Focused on Developing Self-Administrable, Convenient Therapies
  • 2.3 Polypharmacy Will Become Increasingly Common in the Management of Patients With Intractable Disease
  • 2.4 Lack of Disease Awareness Causing Delays in Diagnosis Is a Globally Prevalent Unmet Need
  • 2.5 Oral Therapies and Long-Acting Injectable Somatostatin Receptor Agonists Will Become Top-Selling New Market Entrants in 2029
  • 2.6 What Do Physicians Think?

3 Introduction

  • 3.1 Catalyst
  • 3.2 Related Reports

4 Disease Overview

  • 4.1 Etiology and Pathophysiology
    • 4.1.1 Etiology
    • 4.1.2 Pathophysiology
  • 4.2 Classification or Staging Systems
  • 4.3 Prognosis and Quality of Life

5 Epidemiology

  • 5.1 Disease Background
  • 5.2 Risk Factors and Comorbidities
  • 5.3 Global and Historical Trends
  • 5.4 Forecast Methodology
    • 5.4.1 Sources
    • 5.4.2 Forecast Assumptions and Methods
    • 5.4.3 Diagnosed Prevalent Cases of Acromegaly and Gigantism
    • 5.4.4 Diagnosed Prevalent Cases of Acromegaly and Gigantism with Macroadenoma
    • 5.4.5 Diagnosed Prevalent Cases of Acromegaly and Gigantism with Diabetes
    • 5.4.6 Diagnosed Prevalent Cases of Acromegaly and Gigantism with Cardiovascular Disease
    • 5.4.7 Diagnosed Prevalent Cases of Acromegaly and Gigantism with Hypertension
  • 5.5 Epidemiological Forecast for Acromegaly, 2019-2029
    • 5.5.1 Diagnosed Prevalent Cases of Acromegaly
    • 5.5.2 Sex-Specific Diagnosed Prevalent Cases of Acromegaly
    • 5.5.3 Age-Specific Diagnosed Prevalent Cases of Acromegaly
    • 5.5.4 Diagnosed Prevalent Cases of Acromegaly with Macroadenoma
    • 5.5.5 Diagnosed Prevalent Cases of Acromegaly with Comorbidities
    • 5.5.6 Diagnosed Prevalent Cases of Gigantism
    • 5.5.7 Sex-Specific Diagnosed Prevalent Cases of Gigantism
    • 5.5.8 Age-Specific Diagnosed Prevalent Cases of Gigantism
    • 5.5.9 Diagnosed Prevalent Cases of Gigantism with Macroadenoma
    • 5.5.10 Diagnosed Prevalent Cases of Gigantism with Comorbidities
  • 5.6 Discussion
    • 5.6.1 Epidemiological Forecast Insight
    • 5.6.2 Limitations of Analysis
    • 5.6.3 Strengths of Analysis

6 Disease Management

  • 6.1 Overview
  • 6.2 Diagnosis
  • 6.3 Treatment
    • 6.3.1 Treatment Guidelines
    • 6.3.2 Non-pharmacotherapeutic Treatment Options
    • 6.3.3 Pharmacotherapy
  • 6.4 US
  • 6.5 5EU
  • 6.6 Canada

7 Competitive Assessment

  • 7.1 Overview

8 Unmet Needs and Opportunity Assessment

  • 8.1 Overview
  • 8.2 Increasing Disease Awareness Among Patients and Physicians
  • 8.3 Greater Control Over Treatment-Related Costs Blocking Access to Essential Therapies
  • 8.4 Improving the Efficacy and Side-Effect Profiles of Pharmaceutical Products
  • 8.5 Making Drug Administration More Manageable for Patients

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Somatostatin Receptor Agonists
  • 9.3 Antisense Therapy Growth Hormone Receptor Inhibitors
  • 9.4 Early-Stage Pipeline Products

10 Current and Future Players

11 Market Outlook

  • 11.1 Global Markets
    • 11.1.1 Forecast
    • 11.1.2 Drivers and Barriers - Global Issues
  • 11.2 US
    • 11.2.1 Forecast
    • 11.2.2 Key Events
    • 11.2.3 Drivers and Barriers
  • 11.3 5EU
    • 11.3.1 Forecast
    • 11.3.2 Key Events
    • 11.3.3 Drivers and Barriers
  • 11.4 Canada
    • 11.4.1 Forecast
    • 11.4.2 Key Events
    • 11.4.3 Drivers and Barriers

12 Appendix

List of Tables

List of Tables

  • Table 1: Acromegaly and Gigantism: Key Metrics in the 7MM
  • Table 2: Metabolic Effects of GH, IGF-1, and Acromegaly
  • Table 3: Signs and Symptoms of Acromegaly and Gigantism
  • Table 4: Risk Factors and Comorbidities for Acromegaly and Gigantism
  • Table 5: Global Consensus Criteria for the Diagnosis and Cure of Acromegaly
  • Table 6: Commonly Used Treatment Guidelines for Acromegaly
  • Table 7: Acromegaly and Gigantism Disease Management - US
  • Table 8: Acromegaly and Gigantism Disease Management - 5EU
  • Table 9: Acromegaly and Gigantism Disease Management - Canada
  • Table 10: Marketed Therapies for Acromegaly and Gigantism Across the 7MM.
  • Table 11: Examples of Primary and Secondary Endpoints in Clinical Trials for Marketed Drugs
  • Table 12: Comparison of Therapeutic Classes in Development for Acromegaly and Gigantism, 2019-2029
  • Table 13: Early-Stage Pipeline Agents for Acromegaly, 2020
  • Table 14: Novartis' Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 15: Ipsen's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 16: Sun Pharma's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 17: Pfizer's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 18: Chiasma's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 19: Antisense Therapeutics' Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 20: Crinetics' Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 21: Ionis Pharma's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 22: Camurus' Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 23: Strongbridge Biopharma's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 24: Enesi Pharma's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 25: Italfarmaco's Acromegaly and Gigantism Portfolio Assessment, 2020
  • Table 26: Acromegaly and Gigantism Market - Global Drivers and Barriers, 2019-2029
  • Table 27: Key Events Impacting Sales for Acromegaly and Gigantism in the US, 2019-2029
  • Table 28: Acromegaly and Gigantism Market - Drivers and Barriers in the US, 2019-2029
  • Table 29: Key Events Impacting Sales for Acromegaly and Gigantism in the 5EU, 2019-2029
  • Table 30: Acromegaly and Gigantism Market - Drivers and Barriers in the 5EU, 2019-2029
  • Table 31: Key Events Impacting Sales for Acromegaly and Gigantism in Canada, 2019-2029
  • Table 32: Acromegaly and Gigantism Market - Drivers and Barriers in Canada, 2019-2029
  • Table 33: Key Historical and Projected Launch Dates for Acromegaly and Gigantism
  • Table 34: Key Historical and Projected Patent Expiry Dates for Acromegaly and Gigantism
  • Table 35: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

List of Figures

  • Figure 1: Global Sales Forecast by Country for Acromegaly and Gigantism in 2019 and 2029
  • Figure 2: Analysis of the Company Portfolio Gap in Acromegaly and Gigantism During the Forecast Period
  • Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for Acromegaly/Gigantism During the Forecast Period
  • Figure 4: Regulation of the Growth Hormone Axis
  • Figure 5: 7MM, Diagnosed Prevalence of Acromegaly (%), Men and Women, Ages ≥15 Years, 2019
  • Figure 6: 7MM, Diagnosed Prevalence of Gigantism (%), Men and Women, All Ages, 2019
  • Figure 7: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of Acromegaly
  • Figure 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Gigantism
  • Figure 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Acromegaly and Gigantism with Macroadenoma
  • Figure 10: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Acromegaly and Gigantism with Diabetes
  • Figure 11: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Acromegaly and Gigantism with Cardiovascular Disease
  • Figure 12: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Acromegaly and Gigantism with Hypertension
  • Figure 13: 7MM, Diagnosed Prevalent Cases of Acromegaly, Both Sexes, Ages ≥15 Years, N, 2019
  • Figure 14: 7MM, Diagnosed Prevalent Cases of Acromegaly by Sex, Ages ≥15 Years, N, 2019
  • Figure 15: 7MM, Diagnosed Prevalent Cases of Acromegaly by Age, Both Sexes, N, 2019
  • Figure 16: 7MM, Diagnosed Prevalent Cases of Acromegaly with Macroadenoma, Both Sexes, Ages ≥15 Years, N, 2019
  • Figure 17: 7MM, Diagnosed Prevalent Cases of Acromegaly with Comorbidities, Both Sexes, Ages ≥15 Years, N, 2019
  • Figure 18: 7MM, Diagnosed Prevalent Cases of Gigantism, Both Sexes, All Ages, N, 2019
  • Figure 19: 7MM, Diagnosed Prevalent Cases of Gigantism, by Sex, All Ages, N, 2019
  • Figure 20: 7MM, Diagnosed Prevalent Cases of Gigantism by Age, Both Sexes, N, 2019
  • Figure 21: 7MM, Diagnosed Prevalent Cases of Gigantism with Macroadenoma, Both Sexes, All Ages, N, 2019
  • Figure 22: 7MM, Diagnosed Prevalent Cases of Gigantism with Comorbidities, Both Sexes, All Ages, N, 2019
  • Figure 23: Unmet Needs and Opportunities in Acromegaly and Gigantism
  • Figure 24: Overview of the Development Pipeline in Acromegaly and Gigantism
  • Figure 25: Ongoing Phase II/III Trials for the Pipeline Agents that GlobalData Expects to Be Licensed for Acromegaly and Gigantism in the 7MM, 2019-2029
  • Figure 26: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for Acromegaly/Gigantism During the Forecast Period
  • Figure 27: Company Portfolio Gap Analysis in Acromegaly and Gigantism, 2019-2029
  • Figure 28: Clinical Trials for Acromegaly and Gigantism in the 7MM by Trial Status
  • Figure 29: Global (7MM) Sales Forecast by Country for Acromegaly and Gigantism in 2019 and 2029
  • Figure 30: Global (7MM) Sales Forecast by Therapeutic Class for Acromegaly and Gigantism in 2019 and 2029
  • Figure 31: Global (7MM) Sales Forecast by Individual Drug for Acromegaly and Gigantism in 2019 and 2029
  • Figure 32: Acromegaly and Gigantism Sales in the US by Drug, 2019 and 2029
  • Figure 33: Acromegaly and Gigantism Sales in the 5EU by Drug, 2019 and 2029
  • Figure 34: Acromegaly and Gigantism Sales in Canada by Drug, 2019 and 2029
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