Severe Asthma in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033

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This new set to update and replace the previous asthma market analysis publication, Asthma: Global Drug Forecast and Market Analysis to 2029 (December 2020, GDHC208PIDR), which covered the forecast period 2019–29. This new publication covers the severe asthma market over the forecast period of 2023-33.

GlobalData estimated the total severe asthma market to be valued at $5.1 billion across the 8MM, with the US accounting for 80.4% of the market. The five major European markets (5EU) (France, Germany, Italy, Spain, and UK) accounted for 16.2% of the global severe asthma market in 2023 with an estimated value of $825.1 million. Japan’s severe asthma market was estimated to be $30.6 million in 2023, accounting for 0.6% of the market. China’s severe asthma market was estimated to be $58.4 million in 2023, accounting for 1.1% of the market.
Major drivers of growth in the PsO market over the forecast period include –
• Increased adoption of biologics: The expansion of biologic therapies, including [Dupixent (dupilumab), Fasenra (benralizumab), Tezspire (tezepelumab)], will contribute to market growth despite their high costs. These therapies provide targeted treatment for Type 2 inflammation-driven asthma and are increasingly prescribed due to their effectiveness in reducing exacerbations.
• Expansion of market access and reimbursement policies: Improved insurance coverage and reimbursement policies for biologics in key markets, particularly in the US and 5EU, will facilitate wider adoption and drive revenue growth.
• Rising prevalence and increased diagnosis rates: The number of diagnosed severe asthma patients is expected to grow as awareness improves and healthcare systems implement better screening and management strategies.
• Introduction of novel therapies: The pipeline for severe asthma includes next-generation biologics with more convenient dosing schedules targeting novel inflammatory pathways (such as depemokimab, lunsekimig, AZD-8630) which may further drive market expansion.

The major barriers of growth in the PsO market during the forecast period include –
• High cost of biologics and access limitations: The high price of biologics continues to be a significant barrier, particularly in regions with stringent reimbursement policies. Cost-effectiveness assessments and payer constraints may limit broader adoption.
• Limited treatment options for non-Type 2 asthma: While targeted biologics have transformed the treatment landscape for Type 2 severe asthma, effective options for non-Type 2 (neutrophilic or mixed-inflammatory) asthma remain limited, presenting an ongoing unmet need.
• Patent expirations and biosimilar competition: Several leading biologics are expected to face patent expirations during the forecast period, potentially leading to increased competition from biosimilars and downward pressure on pricing.
• Patient adherence challenges: Some patients with severe asthma may struggle with adherence to biologic therapies due to factors such as administration method, dosing frequency, or accessibility, impacting long-term treatment outcomes.

Scope

Overview of Severe Asthma, including epidemiology, symptoms, diagnosis, and disease management.

Annualized severe asthma therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2023 to 2033.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the severe asthma therapeutics market.

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for severe asthma treatment. The most promising candidates in late-stage development are profiled.

Analysis of the current and future market competition in the global severe asthma therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

• In 2023, GlobalData estimated that the global severe asthma market reached $5.1 billion across the 8MM, and expects the severe asthma market to grow at a strong Compound Annual Growth Rate of 7.1%, reaching sales of $10.1 billion by 2033.

Major drivers of the severe market growth over the forecast period are the:

• The expansion of biologic therapies, including Dupixent (dupilumab), Fasenra (benralizumab), and Tezspire (tezepelumab).

• Rising prevalence and increased diagnosis rates of severe asthma.

• Introduction of novel severe asthma therapies.

Reasons to Buy

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 8MM severe asthma therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 8MM severe asthma therapeutics 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.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Teva
AstraZeneca
GSK
Theravance Biopharma
Novartis
Sanofi/Regeneron
Connect Biopharma
Chiesi
Areteia Therapeutics
Mundi Pharma

Table of Contents

List of Contents

List of Tables

List of Figures

1 Severe Asthma: Executive Summary

1.1 The severe asthma market will show steady growth during the forecast period, reaching sales of $10.1 billion in 2033

1.2 GSK, AstraZeneca, and Sanofi/Regeneron continue competing for first place in 2033

1.3 High unmet needs in the severe asthma market

1.4 Late-stage severe asthma pipeline therapies targeting specific populations

1.5 What do physicians think?

2 Introduction

2.1 Catalyst

2.2 Related reports

2.3 Upcoming related 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

4.4 Forecast methodology

4.4.1 Sources

4.4.2 Forecast assumptions and methods

4.4.3 Forecast assumptions and methods: 12-month diagnosed prevalent cases of asthma – 8MM

4.4.4 Forecast assumptions and methods: lifetime diagnosed prevalent cases of asthma – 8MM

4.4.5 Forecast assumptions and methods: 12-month diagnosed prevalent cases of severe asthma.

4.4.6 Forecast assumptions and methods: lifetime diagnosed prevalent cases of asthma – 8MM

4.4.7 Forecast assumptions and methods: 12-month diagnosed prevalent cases of severe asthma by inflammatory subtypes

4.4.8 Forecast assumptions and methods: 12-month diagnosed prevalent cases of severe asthma by inflammatory subtypes.

4.5 Epidemiological forecast for asthma and severe asthma

4.5.1 12-month diagnosed prevalent cases of asthma

4.5.2 Age-specific 12-month diagnosed prevalent cases of asthma

4.5.3 Sex-specific 12-month diagnosed prevalent cases of asthma

4.5.4 Lifetime diagnosed prevalent cases of asthma

4.5.5 Age-specific lifetime diagnosed prevalent cases of asthma

4.5.6 Sex-specific lifetime diagnosed prevalent cases of asthma

4.5.7 12-month diagnosed prevalent cases of severe asthma

4.5.8 Age-specific 12-month diagnosed prevalent cases of severe asthma

4.5.9 Sex-specific 12-month diagnosed prevalent cases of severe asthma

4.5.10 Lifetime diagnosed prevalent cases of severe asthma

4.5.11 Age-specific lifetime diagnosed prevalent cases of severe asthma

4.5.12 Sex-specific lifetime diagnosed prevalent cases of severe asthma

4.5.13 12-month diagnosed prevalence of severe asthma by inflammatory subtypes

4.5.14 Lifetime diagnosed prevalence of severe asthma by inflammatory subtypes

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

5.1.1 Diagnosis

5.1.2 Treatment guidelines and clinical practice

5.2 KOL insights on disease management

5.2.1 US

5.2.2 5EU

5.2.3 Japan

5.2.4 China

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Effective treatment for T2-low asthma

7.3 High cost of therapy

7.4 Low patient compliance

7.5 Long-term safety and efficacy of biologics

8 R&D Strategies

8.1 Overview

8.1.1 R&D targeting novel inflammatory pathways for T2-low asthma

8.1.2 Improving patient compliance through delivery innovation

8.2 Clinical trials design

8.2.1 Primary endpoints in severe asthma trials

8.2.2 Patient populations in clinical trials

8.2.3 Comparator regimens and trial duration

8.2.4 Innovations in Trial Design and Future Directions

9 Pipeline Assessment

9.1 Overview

9.1.1 Eosinophil modulator

9.1.2 Anti-IL-5/5Rα

9.1.3 Anti-IL4Rα

9.1.4 Anti-TSLP

9.1.5 Anti-TSLP/IL-13 bispecific

9.1.6 ICS/LABA/LAMA fixed-dose combinations

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

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 China

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 interviewed for this report

13.4.1 Key opinion leaders

13.5 Primary research – prescriber survey

13.6 About the authors

13.6.1 Analyst

13.6.2 Therapy Area Director

13.6.3 Epidemiologist

13.6.4 Managing Epidemiologist

13.6.5 Vice President of Disease Intelligence and Epidemiology

13.6.6 Global Head of Pharma Research, Analysis, and Competitive Intelligence

About GlobalData

Contact Us

Table

Table 1: Severe asthma: key metrics in the 8MM

Table 2: Asthma Classification and Staging Systems: Criteria and Descriptions

Table 3: Global Initiative for Asthma treatment stages

Table 4: Risk factors and comorbidities for severe asthma

Table 5: Treatment guidelines for severe asthma

Table 6: Country profile – US

Table 7: Country profile – 5EU

Table 8: Country profile – Japan

Table 9: Country profile – China

Table 10: Top 10 deals by value, 2019–24

Table 11: Severe asthma market – global drivers and barriers, 2023–33

Table 12: Key events impacting sales for severe asthma in the US, 2023–33

Table 13: Severe asthma market – drivers and barriers in the US, 2023–33

Table 14: Key events impacting sales for severe asthma in the 5EU, 2023–33

Table 15: Severe asthma market – drivers and barriers in the 5EU, 2023–33

Table 16: Key events impacting sales for severe asthma in Japan, 2023–33

Table 17: Severe asthma market – drivers and barriers in Japan, 2023–33

Table 18: Key events impacting sales for severe asthma in China, 2023–33

Table 19: Severe asthma – drivers and barriers in China, 2023–33

Table 20: High-prescribing physicians (non-KOLs) surveyed, by country

Figures

Figure 1: Global sales forecast by country for severe asthma in 2023 and 2033

Figure 2: Analysis of the company portfolio gap in severe asthma during 2023–33

Figure 3: Competitive assessment of the late-stage pipeline agents that GlobalData expects to be licensed for the treatment of severe asthma during 2023–33

Figure 4: Pathophysiology of asthma

Figure 5: Key pathways targeted by drugs in severe asthma

Figure 6: 8MM, 12-month diagnosed prevalence of asthma, both sexes, %, all ages, 2013–33

Figure 7: 8MM, lifetime diagnosed prevalence of asthma, both sexes, %, all ages, 2013–33

Figure 8: 8MM, lifetime diagnosed prevalence of severe asthma, both sexes, %, all ages, 2013–33

Figure 9: 8MM, sources used and not used to forecast the 12-month diagnosed prevalent cases of asthma

Figure 10: 8MM, sources used to forecast the lifetime diagnosed prevalent cases of asthma

Figure 11: 8MM, sources used and not used to forecast the 12-month diagnosed prevalent cases of severe asthma

Figure 12: 8MM, sources used to forecast the lifetime diagnosed prevalent cases of severe asthma

Figure 13: 8MM, 12-month diagnosed prevalent cases of asthma, N, both sexes, all ages, 2023

Figure 14: 8MM, 12-month diagnosed prevalent cases of asthma by age, N, both sexes, 2023

Figure 15: 8MM, 12-month diagnosed prevalent cases of asthma by sex, N, all ages, 2023

Figure 16: 8MM, lifetime diagnosed prevalent cases of asthma, N, both sexes, all ages, 2023

Figure 17: 8MM, lifetime diagnosed prevalent cases of asthma by age, N, both sexes, 2023

Figure 18: 8MM, lifetime diagnosed prevalent cases of asthma by sex, N, all ages, 2023

Figure 19: 8MM, 12-month diagnosed prevalent cases of severe asthma, N, both sexes, all ages, 2023

Figure 20: 8MM, 12-month diagnosed prevalent cases of severe asthma by age, N, both sexes, 2023

Figure 21: 8MM, 12-month diagnosed prevalent cases of asthma by sex, N, all ages, 2023

Figure 22: 8MM, lifetime diagnosed prevalent cases of severe asthma, N, both sexes, all ages, 2023

Figure 23: 8MM, lifetime diagnosed prevalent cases of severe asthma by age, N, both sexes, 2023

Figure 24: 8MM, lifetime diagnosed prevalent cases of severe asthma by sex, N, all ages, 2023

Figure 25: 8MM, 12-month diagnosed prevalent cases of severe asthma by inflammatory subtypes, N, both sexes, ages ≥20 years, 2023

Figure 26: 8MM, lifetime diagnosed prevalent cases of severe asthma by inflammatory subtypes, N, both sexes, ages ≥20 years, 2023

Figure 27: Unmet needs and opportunities in severe asthma

Figure 28: Overview of the development pipeline in severe asthma

Figure 29: Key late-stage trials for the promising pipeline agents that GlobalData expects be licensed for severe asthma in the 8MM during 2023–33

Figure 30:Competitive assessment of the marketed and pipeline drugs benchmarked against the standard of care, Xolair

Figure 31:Competitive assessment of the marketed and pipeline drugs benchmarked against the standard of care, Formodual

Figure 32: Analysis of the company portfolio gap in severe asthma during 2023–33

Figure 33: Global (8MM) sales forecast by country for severe asthma in 2023 and 2033

Figure 34: Sales forecast by class for severe asthma in the US in 2023 and 2033

Figure 35: Sales forecast by class for severe asthma in the 5EU in 2023 and 2033

Figure 36: Sales forecast by class for severe asthma in Japan in 2023 and 2033

Figure 37: Sales forecast by class for severe asthma in China in 2023 and 2033

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