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.
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?
- 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?
- 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
2 Introduction
3 Disease Overview
4 Epidemiology
5 Disease Management
6 Competitive Assessment
7 Unmet Needs and Opportunity Assessment
8 R&D Strategies
9 Pipeline Assessment
10 Pipeline Valuation Analysis
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Novo Nordisk
- Eli Lilly
- Zealand Pharma
- Xeris Pharmaceuticals
- Eiger Biopharmaceuticals
- Fresenius Kabi
- Amphastar Pharmaceuticals
- Fuji Pharma
- Kaigen Pharma