Type 1 Diabetes – Global Drug Forecast and Market Analysis to 2029

Type 1 Diabetes (T1D), is an autoimmune disease that permanently destroys beta cells of the pancreatic islet, which means that the body can no longer produce insulin. Insulin is the hormone that is needed for the transport of glucose from blood into cells, and without it the body is driven into a hyperglycemic state. Left untreated, this leads to death. There is no cure for T1D, and it is managed as a chronic condition through injections of exogenous insulin. There are other types of diabetes such as Type 2 Diabetes (developed resistance to insulin), gestational diabetes, latent autoimmune diabetes in adults, and diabetes that occurs as a symptom of other diseases. This report focuses on T1D.

It is expected that 15 therapeutics will launch in the Type 1 Diabetes (T1D) market in the eight major markets (8MM*) before 2030. They include Adocia’s BioChaperone Insulin lispro, an ultra-fast prandial insulin; Zealand Pharma’s dasiglucagon, a liquid-stable glucagon to manage hypoglycemia for use in a bihormonal pump; and Provention Bio’s teplizumab, the first preventative therapeutic for T1D. Despite this robust pipeline, there are still considerably high unmet needs within the space, all of which relate to the lack of a disease-modifying therapeutic that combats the autoimmune-mediated attack of beta cells in T1D patients.

GlobalData’s recent report reveals that over the next 10 years, the T1D pipeline is set to deliver innovative therapies that aim to improve disease management. These include novel second-generation insulin analogs, adjunct therapies, and the first disease-modifying therapeutics for T1D.

Samisha Khangaonkar, Pharma Analyst at GlobalData, comments: “Therapeutics that focus on the preservation of the remaining beta cells are becoming more critical for the long-term management of T1D. T1D patients with residual beta cell function require smaller doses of insulin, which can improve side effects and compliance. While many of these disease-modifying therapeutics are far from a cure for T1D, their effects may still have a significant impact on the long-term prognosis for T1D patients.”

Advances in insulin therapies such as the development of insulin analogs, novel/targeted approaches to administration, continuous glucose monitoring (CGM), and novel pens and devices for administration have all contributed to the improved treatment of T1D patients. However, even with these advances, the majority of T1D patients do not achieve the glycemic targets set by national and international guidelines. As such, the overall quality of life of a T1D patient has not improved, and the life expectancy is still 10–15 years less than the healthy population.

Khangaonkar continues: “It is disappointing that hypoglycemia and weight gain are still risks associated with all insulin therapies, and the threat of hypoglycemia as a consequence of poor glycemic control poses a major barrier to optimizing glycemic control in T1D patients.

“The need for a treatment that lowers blood glucose to the target levels without causing hypoglycemic events or weight gain is still one of the largest unmet needs in T1D treatment. Increased compliance and targeted patient education are additional unmet needs that have significant impacts on patient care, and are aspects of treatment often overlooked by drug developers.”

*8MM (US, France, Germany, Italy, Spain, UK, Japan, and Canada)

Scope

  • Overview of T1D including epidemiology, disease etiology and management.
  • Topline T1D 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, Japan and Canada 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 angina pectoris therapeutics market. Insightful review of the key industry drivers, restraints and challenges.

KEY QUESTIONS ANSWERED

Despite the existence of numerous well-established treatment options in the T1D space, a few-yet significant-unmet needs remain.

– Which unmet needs are the most pressing in the 8MM?

– Where should pharmaceutical companies focus drug development efforts in order to become a significant player in the space?

Novel insulins continue to be developed, and the first disease-modifying therapeutics may 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 T1D market has been dominated by three main companies since the discovery of insulin 100 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?

Key Highlights

The diagnosed prevalence of T1D is expected to increase over the 10-year forecast period due changing population demographics, and an increased understanding of risk factors and environmental factors that may trigger the onset of T1D.

The potential launch of 5 disease-modifying therapeutics will increase the number of patients who, at diagnosis, can prolong their endogenous insulin secretion to improve disease management. 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 device integration into the treatment and management of T1D will impact the therapeutics that find success in the market. The drive toward closed-loops systems, like an artificial pancreas, places a great need for ultra-fast insulins to launch in the market, and prompts more collaboration between across the industry.

Despite the variety of insulins currently available to T1D patients, there is still room for improvement within the treatment space. The most recognizable is the need for novel treatment options for refractory patients.

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 T1D therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global T1D 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 T1D therapeutics market from 2019-2029.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

Novo Nordisk

Eli Lilly

Sanofi

Biocon/Viatris

Mannkind Corporation

J&J

Diasome

Adocia

Diamyd Medical

Zealand Pharma

AstraZeneca

Lexicon Therapeutics

vTv Therapeutics

Provention Bio

Dompe Farmaceuti

PolTreg

CellTrans

Table of Contents

| Contents

| List of Tables

| List of Figures

| About GlobalData

1 Type 1 Diabetes: Executive Summary

1.1 The Type 1 Diabetes Market Will Grow to $24B by 2029

1.2 T1D Veteran Players Use Various Strategies to Defend Insulin Franchises from Biosimilar Erosion, While New Players Invest in the Disease-Modifying Space

1.3 Current and Future Therapies Leave Significant Unmet Needs in the Market

1.4 The Rise of Pump Usage and Increased Market Entry of Ultra-Rapid-Acting Insulin Formulations May Improve the T1D Treatment Landscape

1.5 Opportunity Remains for Beta Cell Regenerative Therapies

1.6 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

3.1.3 Biomarkers for Monitoring the Islet Autoreactivity of Type 1 Diabetes

4 Epidemiology

4.1 Disease Background

4.2 Risk Factors and Comorbidities

4.3 Global and Historical Trends

4.4 Forecast Methodology

4.4.1 Sources

4.4.2 Forecast Assumptions and Methods

4.4.3 Diagnosed Prevalent Cases of T1D

4.4.4 Diagnosed Prevalent Cases of T1D by Body Mass Index

4.4.5 Diagnosed Prevalent Cases of T1D with Brittle Diabetes

4.4.6 Diagnosed Prevalent Cases of T1D Experienced with Diabetic Ketoacidosis Event

4.4.7 Diagnosed Prevalent Cases of T1D Who Experienced Hypoglycemia Events

4.4.8 Diagnosed Prevalent Cases of T1D Who Are Eligible for Pancreas and/or Islet Transplantation

4.4.9 Diagnosed Prevalent Cases of T1D Who Require/Will Undergo a Kidney Transplant or Have Already Received a Kidney Transplant

4.4.10 Total Prevalent Cases of T1D

4.5 Epidemiological Forecast for T1D (2019–2029)

4.5.1 Diagnosed Prevalent Cases of T1D

4.5.2 Age-Specific Diagnosed Prevalent Cases of T1D

4.5.3 Sex-Specific Diagnosed Prevalent Cases of T1D

4.5.4 Diagnosed Prevalent Cases of T1D by BMI

4.5.5 Diagnosed Prevalent Cases of T1D with Brittle Diabetes and Diabetic Ketoacidosis Event

4.5.6 Diagnosed Prevalent Cases of T1D Who Have Experienced Hypoglycemia Events

4.5.7 T1D Diagnosed Patients Who Are Eligible for Pancreas and/or Islet Transplantation and Who Require/Will Undergo a Kidney Transplant OR Have Already Received a Kidney Transplant

4.5.8 Total Prevalent Cases of T1D

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 US Disease Management

5.3 5EU Disease Management

5.4 Japan Disease Management

5.5 Canada Disease Management

5.6 KOL Insights on Disease Management

6 Competitive Assessment

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Disease-Modifying Therapies – Preservation of Beta Cells

7.3 Hypoglycemia Avoidance and Managing Glycemic Control

7.4 Obesity, Weight Management, and Control of Associated Metabolic Syndrome

7.5 Improving Compliance and Reducing the Burden of Insulin Therapies

7.6 Type 1 Diabetes Patient Care and Education

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 Players

11.1 Overview

11.2 Deal-Making Trends

11.3 Sanofi Portfolio Assessment, 2021

11.4 Eli Lilly Portfolio Assessment, 2021

11.5 Novo Nordisk Portfolio Assessment, 2021

11.6 Johnson and Johnson Portfolio Assessment, 2021

11.7 Lexicon Pharmaceuticals Portfolio Assessment, 2021

11.8 AstraZeneca, 2021

11.9 Mannkind Corporation, 2021

11.10 Diasome Pharmaceuticals Portfolio Assessment, 2021

11.11 Adocia Portfolio Assessment, 2021

11.12 Biocon Portfolio Assessment, 2021

11.13 Diamyd Medical Portfolio Assessment, 2021

11.14 Zealand Pharma Portfolio Assessment, 2021

11.15 vTv Therapeutics Portfolio Assessment, 2021

11.16 Provention Bio Portfolio Assessment, 2021

11.17 Dompé Farmaceuti Portfolio Assessment, 2021

11.18 PolTreg Portfolio Assessment, 2021

11.19 CellTrans Portfolio Assessment, 2021

12 Market Outlook

12.1 Global Markets

12.1.1 Forecast

12.1.2 Drivers and Barriers – Global Issues

12.2 US

12.2.1 Forecast

12.2.2 Key Events

12.2.3 Drivers and Barriers

12.3 5EU

12.3.1 Forecast

12.3.2 Key Events

12.3.3 Drivers and Barriers

12.4 Japan

12.4.1 Forecast

12.4.2 Key Events

12.4.3 Drivers and Barriers

12.5 Canada

12.5.1 Forecast

12.5.2 Key Events

12.5.3 Drivers and Barriers

13 Appendix

13.1 Bibliography

13.2 Abbreviations

13.3 Methodology

13.3.1 Forecasting Methodology

13.4 Primary Research – KOLs and Payers Interviewed for This Report

13.4.1 KOLs

13.4.2 Payers

13.5 Primary Research – Prescriber Survey

13.6 About the Authors

13.6.1 Analyst

13.6.2 Associate Therapy Area Director

13.6.3 Therapy Area Director

13.6.4 Epidemiologist

13.6.5 Managing Epidemiologists

13.6.6 Global Director of Therapy Analysis and Epidemiology

13.6.7 Global Head and EVP of Healthcare Operations and Strategy

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List of Tables

Table 1: Type 1 Diabetes: Key Metrics in the 8MM

Table 2: Symptoms of T1D

Table 3: Risk Factors and Comorbidities for T1D

Table 4: Diagnostic Tests and Typical Criteria for Diagnosing T1D

Table 5: Treatment Guidelines for Type 1 Diabetes

Table 6: A Sample of Education Campaigns in Type 1 Diabetes

Table 7: A Sample of Head-to-Head Trials in Type 1 Diabetes

Table 8: Sanofi Portfolio Assessment, 2021

Table 9: Eli Lilly Portfolio Assessment, 2021

Table 10: Novo Nordisk Portfolio Assessment, 2021

Table 11: J&J Portfolio Assessment, 2021

Table 12: Provention Bio Portfolio Assessment, 2021

Table 13: AstraZeneca, 2021

Table 14: PolTreg Portfolio Assessment, 2021

Table 15: Diasome Portfolio Assessment, 2021

Table 16: Adocia Portfolio Assessment, 2021

Table 17: Biocon Portfolio Assessment, 2021

Table 18: Diamyd Medical Portfolio Assessment, 2021

Table 19: Zealand Portfolio Assessment, 2021

Table 20: vTv Therapeutics Portfolio Assessment, 2021

Table 21: Provention Bio Portfolio Assessment, 2021

Table 22: Dompé Farmaceuti Portfolio Assessment, 2021

Table 23: PolTreg Portfolio Assessment, 2021

Table 24: CellTrans Portfolio Assessment, 2021

Table 25: Type 1 Diabetes Market – Global Drivers and Barriers, 2019–2029

Table 26: Key Events Impacting Sales for Type 1 Diabetes in the US, 2019–2029

Table 27: Type 1 Diabetes – Drivers and Barriers in the US, 2019–2029

Table 28: Key Events Impacting Sales for Type 1 Diabetes in the 5EU, 2019–2029

Table 29: Type 1 Diabetes Market – Drivers and Barriers in the 5EU, 2019–2029

Table 30: Key Events Impacting Sales for Type 1 Diabetes in Japan, 2019–2029

Table 31: Type 1 Diabetes Market – Drivers and Barriers in Japan, 2019–2029

Table 32: Key Events Impacting Sales for Type 1 Diabetes in Canada, 2019–2029

Table 33: Type 1 Diabetes Market – Drivers and Barriers in Canada, 2019–2029

Table 34: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for T1D in 2019 and 2029

Figure 2: Analysis of the Company Portfolio Gap in Type 1 Diabetes During the Forecast Period

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Type 1 Diabetes During the Forecast Period

Figure 4: Etiology of T1D

Figure 5: Pathophysiology of T1D

Figure 6: 8MM, Diagnosed Prevalence (%) of T1D, Men, All Ages, 2009–2029

Figure 7: 8MM, Diagnosed Prevalence (%) of T1D, Women, All Ages, 2009–2029

Figure 8: 8MM, Sources Used and Not Used, Diagnosed Prevalent Cases of T1D

Figure 9: 8MM, Sources Used, Diagnosed Prevalent Cases of T1D by BMI, Brittle Diabetes, Diabetic Ketoacidosis Event, and Hypoglycemia Events

Figure 10: 8MM, Sources Used, Total Prevalent Cases of T1D

Figure 11: 8MM, Diagnosed Prevalent Cases of T1D, All Ages, Both Sexes, N, 2019

Figure 12: 8MM, Age-Specific Diagnosed Prevalent Cases of T1D, Both Sexes, N, 2019

Figure 13: 8MM, Sex-Specific Diagnosed Prevalent Cases of T1D, All Ages, N, 2019

Figure 14: 8MM, Diagnosed Prevalent Cases of T1D by BMI, All Ages, N, 2019

Figure 15: 8MM, Diagnosed Prevalent Cases of T1D with Brittle Diabetes and Diabetic Ketoacidosis Events, All Ages, N, 2019

Figure 16: 8MM, Diagnosed Prevalent Cases of T1D Who Have Experienced Hypoglycemia Events, All Ages, N, 2019

Figure 17: 8MM, T1D Diagnosed Patients Who Are Eligible for Pancreas and/or Islet Transplantation and Who Require/Will Undergo a Kidney Transplant or Have Already Received a Kidney Transplant, All Ages, N, 2019

Figure 18: 8MM, Total Prevalent Cases of T1D, All Ages, Both Sexes, N, 2019

Figure 19: Disease Management Flow Chart

Figure 20: Unmet Needs and Opportunities in Type 1 Diabetes

Figure 21: Overview of the Development Pipeline in Type 1 Diabetes

Figure 22: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for T1D in the 8MM During the Forecast Period

Figure 23: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of T1D During the Forecast Period

Figure 24: Competitive Assessment of the Marketed and Pipeline Human Insulins and Pre-Mix Insulins

Figure 25: Competitive Assessment of the Marketed and Pipeline Rapid-Acting Insulin Analogs

Figure 26: Competitive Assessment of the Marketed and Pipeline Basal Insulin Analogs

Figure 27: Competitive Assessment of the Marketed and Pipeline Adjunct Therapeutics

Figure 28: Competitive Assessment of the Disease-Modifying Therapeutics

Figure 29: Analysis of the Company Portfolio Gap in T1D During the Forecast Period

Figure 30: Global (8MM) Sales Forecast by Country for T1D, 2019 and 2029

Figure 31: Sales Forecast by Class for Type 1 Diabetes in the US, 2019 and 2029

Figure 32: Sales Forecast by Class for Type 1 Diabetes in the 5EU in 2019 and 2029

Figure 33: Sales Forecast by Class for Type 1 Diabetes in Japan in 2019 and 2029

Figure 34: Sales Forecast by Class for Type 1 Diabetes in Canada in 2019 and 2029

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