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Hypoglycemia - Global Drug Forecast and Market Analysis to 2030

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    Report

  • 124 Pages
  • November 2021
  • Region: Global
  • GlobalData
  • ID: 5505109
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Hypoglycemia, or low blood sugar, is primarily observed in diabetic patients who are receiving insulin therapy. In other instances, such as life-threatening illness conditions, end-stage liver disease, sepsis, malnourishment, or renal failure, glucose use can exceed glucose consumption, glycogenolysis, and glyconeogenesis. This can result in hypoglycemia. Hypoglycemia is primarily treated through the consumption of glucose, however in diabetic patients on insulin, hypoglycemia can suddenly become severe with neuroglycopenic symptoms including a of consciousness. In these instances, a rescue intervention of glucagon or IV glucose is administered. This report will focus on diabetic hypoglycemia, and post-bariatric surgery hypoglycemia (PBH). There is currently no approved treatment for PBH.

The launch of the novel formulations of glucaon therapeutics will be the main drivers of growth over the forecast period, with the first liquid-stable glugaons expected to launch during the forecast period in addition to increased uptake of nasal glucagon, Baqsimi. Other major drivers for the hypoglycemia market include the increased T1D diagnosed prevalence, and the uptake of novel glucagon formulations will drive therapy usage over hospital treatment. Based on the epidemiological analysis by The publisher, the diagnosed incident cases of severe hypoglycemia attributed to T1D will grow by 4.7% over the next decade, from 17,359 cases in 2020 to 18,180 cases in 2030, at an Annual Growth Rate (AGR) of 0.5% per year in the seven major pharmaceutical markets (7MM) covered in this report, the US, 5EU (France, Germany, Italy, Spain, and UK), and Japan. The diagnosed incident cases of severe hypoglycemia attributed to T2D will grow by 1.4% over the next decade, from 173,085 cases in 2020 to 175,530 cases in 2030 at an AGR of 0.1% in the 7MM. The diagnosed incident cases of PBH will grow by 18.7% over the next decade, from 50,227 cases in 2020 to 59,627 cases in 2030 at an AGR of 1.7% in the 7MM.

The publisher projects the therapeutic market for hypoglycemia within the 7MM will grow from $423.5M in 2020 at a compound annual growth rate (CAGR) of 4.8% to $657.1M by 2030. In particular, The publisher expects the US market will contribute the most to the hyoglycemia market’s growth, contributing $399.8M sales in 2020 (94% of the hypoglycemia market) and $577.1M in 2030 (85.5% of the hypoglycemia market)

The consensus among interviewed physicians regarding the current treatment landscape of hypoglycemia is that there are sufficient treatments to address severe hypoglycemia, and there are few unmet needs for hypoglycemia that can be addressed therapeutically. Key Opinion Leaders (KOLs) interviewed by The publisher highlighted the importance of preventing severe hypoglycemia through blood glucose monitoring and insulin management. The primary unmet need is that there are no adequate treatments for non-diabetic hypoglycemia. Other unmet needs include the lack of affordable treatments, the lack of convenient treatments, and the prevalence of hypoglycemia unawareness. The publisher’s research suggests that the future level of attainment of these unmet needs will be medium-high, and there is not much of an of opportunity for drug developers to enter the severe hypoglycemia market, but there is opportunity to address the non-diabetic hypoglycemia market.

Key Highlights

  • The diagnosed incidence of hypoglycemia and severe hypoglycemia is expected to increase over the 10-year forecast period due to the increasing prevalence of both T1D and T2D.
  • The increased uptake of Baqsimi and liquid-stable glucagons will increase the number of patients who can treat their hypoglycemia outside of a hospital setting and improve overall quality of life. These drugs are expected to have a high annual cost of therapy (ACOT), a factor that will contribute to notable profitability.
  • The increasing trend of glucose monitoring in the treatment and management of insulin-dependent diabetic patients will impact the therapeutics that find success in the market. Increased monitoring will allow patients to catch hypoglycemia before it becomes severe. For T1D, the drive toward closed-loop pump systems, like an artificial pancreas, provides an opportunity for dual-hormonal pumps to use glucagon to actively manage hypoglycemia.
  • Severe hypoglycemia is adequately treated, and there is little room for new entrants. The launch of the first liquid-stable and inhalable glucagons has made rescue treatment easier. The most recognizable needs the larger market must address are that that that insulins are still causing hypoglycemia and non-diabetic hypoglycemia need targeted treatments.

KEY QUESTIONS ANSWERED

Treatment for severe hypoglycemia is well-established, but a few - yet significant - unmet needs remain.
  • Which unmet needs are the most pressing in the 7MM?
  • Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space?
Novel glucagon formulations continue to be developed, and the first PBH treatment will emerge over the forecast period.
  • What are the most promising late-stage candidates and how much they expected to generate over the forecast period?
  • What do KOLs say about their clinical and commercial positioning?
The hypoglycemia market has been dominated by two main companies since the first glucagon therapy 60 years ago, though more recently new players have started to emerge.
  • Which have been historically the companies leading the way?
  • What new companies are emerging in the space?

Scope

  • Overview of hypoglycemia including epidemiology, disease etiology and management.
  • Topline hypoglycemia drugs market revenue (including off-label adjunct therapeutics used for metabolic benefits), annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.
  • Key topics covered include assessment of current and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5EU, and Japan over the 10-year forecast period.
  • Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global hypoglycemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges.

Reasons to Buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global hypoglycemia therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global hypoglycemia market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global hypoglycemia therapeutics market from 2020-2030.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Hypoglycemia: Executive Summary
1.1 The Hypoglycemia Market Will Grow to 675.1M by 2030
1.2 New Hypoglycemia Players Are Focusing on Increasing Ease-of-Use and Integration with Technologies
1.3 There Are Few Unmet Needs for Hypoglycemia That Can Be Addressed Therapeutically
1.4 Pipeline Therapies and Device Integration Could Greatly Impact the Incidence of Severe Events
1.5 What Do Physicians Think?
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or Staging Systems
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global and Historical Trends
4.3.1 Diagnosed Incidence of Hypoglycemia Attributed to Type 1 Diabetes
4.3.2 Diagnosed Incidence of Hypoglycemia Attributed to Type 2 Diabetes
4.4 7MM Forecast Methodology
4.4.1 Sources
4.4.2 Sources Not Used
4.4.3 Forecast Assumptions and Methods
4.4.4 Diagnosed Incident Cases of Type 1 Diabetes
4.4.5 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 Diabetes
4.4.6 Diagnosed Incident Cases of Type 2 Diabetes
4.4.7 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 2 Diabetes
4.4.8 Diagnosed Incident Cases of Non-Diabetic Hypoglycemia
4.4.9 Diagnosed Incident Cases of Hypoglycemia in Bariatric Surgery Population
4.5 Epidemiological Forecast for Hypoglycemia (2020-2030)
4.5.1 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 Diabetes
4.5.2 Age-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 Diabetes
4.5.3 Sex-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 Diabetes
4.5.4 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 Diabetes by Severity
4.5.5 Hospitalized Severe Incident Cases of Hypoglycemia Attributed to Type 1 Diabetes
4.5.6 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 2 Diabetes
4.5.7 Age-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to Type 2 Diabetes
4.5.8 Sex-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to Type 2 Diabetes
4.5.9 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 2 Diabetes by Severity
4.5.10 Hospitalized Severe Incident Cases of Hypoglycemia Attributed to Type 2 Diabetes
4.5.11 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 and Type 2 Diabetes
4.5.12 Age-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 and Type 2 Diabetes
4.5.13 Sex-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 and Type 2 Diabetes
4.5.14 Diagnosed Incident Cases of Hypoglycemia Attributed to Type 1 and Type 2 Diabetes by Severity
4.5.15 Hospitalized Severe Incident Cases of Hypoglycemia Attributed to Type 1 and Type 2 Diabetes
4.5.16 Diagnosed Incident Cases of Non-Diabetic Hypoglycemia
4.5.17 Diagnosed Incident Cases of Hypoglycemia in the Bariatric Surgery Population
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 COVID-19 Impact
4.6.3 Limitations of the Analysis
4.6.4 Strengths of the Analysis
5 Disease Management
5.1 Diagnosis and Treatment Overview
5.2 Patient Hypoglycemia Self-Management Practices Across the 7MM
5.3 Severe Hypoglycemia Treatment Practices Across the 7MM
5.3.1 Hospitalization Across the 7MM Markets
5.4 Non-diabetic Hypoglycemia Management Across the 7MM
6 Competitive Assessment
6.1 Overview
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Treatments for Non-diabetic Hypoglycemia
7.3 Severe Hypoglycemia Prevention
7.4 Ease of Glucagon Administration
7.5 Glucagon Cost
7.6 Hypoglycemia Awareness
8 R&D Strategies
8.1 Overview
8.2 Clinical Trials Design
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
10 Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive Assessment
11 Current and Future Players12 Market Outlook13 Appendix
List of Tables
Table 1: Hypoglycemia: Key Metrics in the 7MM
Table 2: Symptoms of Hypoglycemia
Table 3: Levels of Hypoglycemia
Table 4: Risk Factors and Comorbidities for Hypoglycemia
Table 5: Treatment Guidelines for Hypoglycemia
Table 6: Eli Lilly Hypoglycemia Portfolio Assessment, 2021
Table 7: Novo Nordisk Hypoglycemia Portfolio Assessment, 2021
Table 8: Amphastar Hypoglycemia Portfolio Assessment, 2021
Table 9: Zealand Pharma’s Hypoglycemia Portfolio Assessment, 2021
Table 10: Xeris Hypoglycemia Portfolio Assessment, 2021
Table 11: Eiger Hypoglycemia Portfolio Assessment, 2021
Table 12: Hypoglycemia Market - Global Drivers and Barriers, 2020-2030
Table 13: Key Events Impacting Sales for Hypoglycemia in the US, 2020-2030
Table 14: Hypoglycemia Market - Drivers and Barriers in the US, 2020-2030
Table 15: Key Events Impacting Sales for Hypoglycemia in the 5EU, 2020-2030
Table 16: Hypoglycemia - Drivers and Barriers in the 5EU, 2020-2030
Table 17: Key Events Impacting Sales for Hypoglycemia in Japan, 2020-2030
Table 18: Hypoglycemia Market - Drivers and Barriers in Japan, 2020-2030
Table 19: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for Hypoglycemia in 2020 and 2030
Figure 2: Analysis of the Company Portfolio Gap in Hypoglycemia During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that The Publisher Expects to Be Licensed for the Treatment of Hypoglycemia During the Forecast Period
Figure 4: Etiology of Common Types of Inborn Hypoglycemia
Figure 5: Pathophysiology of Hypoglycemia
Figure 6: 7MM, Diagnosed Incidence of Hypoglycemia Attributed to Type 1 Diabetes, Men and Women, All Ages, 2010-2030 (Cases per 100,000 Population)
Figure 7: 7MM, Diagnosed Incidence of Hypoglycemia Attributed to Type 2 Diabetes, Men and Women, All Ages, 2010-2030 (Cases per 100,000 Population)
Figure 8: Sources Used for Diagnosed Incident Cases of T1D
Figure 9: Sources Used for Diagnosed Incident Cases of T2D
Figure 10: Sources Used for Diagnosed Incident Cases of Non-Severe, Severe, and All Hypoglycemia
Figure 11: Sources Used for Diagnosed Incident Cases of Hospitalized Hypoglycemia
Figure 12: Sources Used for Diagnosed Incident Cases of Non-Diabetic Hypoglycemia
Figure 13: Sources Used for Diagnosed Incident Cases of Bariatric Surgeries
Figure 14: Sources Used for Diagnosed Incident Cases of Hypoglycemia Among the Bariatric Surgery Population
Figure 15: Diagnosed Incident Cases of Hypoglycemia Attributed to T1D, 7MM, Men and Women, All Ages, 2020
Figure 16: 7MM, Age-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to T1D, Men and Women, 2020 (N)
Figure 17: 7MM, Sex-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to T1D, All Ages, 2020 (N)
Figure 18: 7MM, Diagnosed Incident Cases of Hypoglycemia Attributed to T1D by Severity, Men and Women, All Ages, 2020 (N)
Figure 19: 7MM, Hospitalized Severe Incident Cases of Hypoglycemia Attributed to TID, Men and Women, All Ages, 2020 (N)
Figure 20: Diagnosed Incident Cases of Hypoglycemia Attributed to T2D, 7MM, Men and Women, All Ages, 2020
Figure 21: 7MM, Age-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to T2D, Men and Women, 2020 (N)
Figure 22: 7MM, Sex-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to T2D, All Ages, 2020 (N)
Figure 23: 7MM, Diagnosed Incident Cases of Hypoglycemia Attributed to T2D by Severity, Men and Women, All Ages, 2020 (N)
Figure 24: 7MM, Hospitalized Severe Incident Cases of Hypoglycemia Attributed to T2D, Men and Women, All Ages, 2020 (N)
Figure 25: Diagnosed Incident Cases of Hypoglycemia Attributed to T1D and T2D, 7MM, Men and Women, All Ages, 2020
Figure 26: 7MM, Age-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to T1D and T2D, Men and Women, 2020 (N)
Figure 27: 7MM, Sex-Specific Diagnosed Incident Cases of Hypoglycemia Attributed to T1D and T2D, All Ages, 2020 (N)
Figure 28: 7MM, Diagnosed Incident Cases of Hypoglycemia Attributed to T1D and T2D by Severity, Men and Women, All Ages, 2020 (N)
Figure 29: 7MM, Hospitalized Severe Incident Cases of Hypoglycemia Attributed to T1D and T2D, Men and Women, All Ages, 2020 (N)
Figure 30: 7MM, Diagnosed Incident Cases of Non-Diabetic Hypoglycemia, Men and Women, All Ages, 2020 (N)
Figure 31: Diagnosed Incident Cases of Hypoglycemia in the Bariatric Surgery Population, 7MM, Men and Women, All Ages, 2020
Figure 32: Unmet Needs and Opportunities in Hypoglycemia
Figure 33: Overview of the Development Pipeline in Hypoglycemia
Figure 34: Key Late-Stage Trials for the Promising Pipeline Agents that The Publisher Expects to Be Licensed for Hypoglycemia in the 7MM During the Forecast Period
Figure 35: Competitive Assessment of the Late-Stage Pipeline Agents that The Publisher Expects to Be Licensed for the Treatment of Hypoglycemia During the Forecast Period
Figure 36: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked for Severe Hypoglycemia Rescue
Figure 37: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked for PBH
Figure 38: Analysis of the Company Portfolio Gap in Hypoglycemia During the Forecast Period
Figure 39: Global (7MM) Sales Forecast by Country for Hypoglycemia in 2020 and 2030
Figure 40: Sales Forecast by Class for Hypoglycemia in the US in 2020 and 2030
Figure 41: Sales Forecast by Class for Hypoglycemia in the 5EU in 2020 and 2030
Figure 42: Sales Forecast by Class for Hypoglycemia in Japan in 2020 and 2030

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Novo Nordisk
  • Eli Lilly
  • Zealand Pharma
  • Xeris Pharmaceuticals
  • Eiger Biopharmaceuticals
  • Fresenius Kabi
  • Amphastar Pharmaceuticals
  • Fuji Pharma
  • Kaigen Pharma