Small Cell Lung Cancer – Opportunity Analysis and Forecasts to 2029

The small cell lung cancer (SCLC) market has experienced moderate growth since 2016, and is expected to increase further, from $698m in 2019 to $2.4bn in 2029 across the eight major markets (8MM*) at a compound annual growth rate of 12.9%. Growth will be driven by the anticipated launch of 10 pipeline agents and greater market access across the 8MM for premium priced agents. This report notes that the main barriers for market growth include the absence of predictive biomarkers leading to a lack of targeted approaches in the treatment paradigm.

Adam Pearson, PhD, Oncology and Hematology Analyst at GlobalData, comments: “SCLC is a disease area characterized by high levels of unmet need and an area of great opportunity for R&D. Compared to the introduction of targeted approaches in other areas of oncology, SCLC is a market still dominated by generic chemotherapies. Key opinion leaders (KOLs) indicate that the limited understanding of the underlying SCLC biology has resulted in a lack of effective targeted approaches.”

Significant unmet needs are expected to remain in the SCLC market, which present considerable commercial opportunities. KOLs interviewed by GlobalData have indicated that more innovation will be required to tackle this problem.

Pearson continues: “The Food and Drug Administration (FDA) approval of Roche’s Tecentriq in 2019 marked the first FDA-approved immunotherapy for patients with ES-SCLC and represented a positive innovation for patients, despite the marginal absolute benefit in overall survival. Tecentriq, in combination with chemotherapy, gained first-mover advantage in SCLC and future additional revenue streams may derive from its combination with tiragolumab, contingent on demonstrable efficacy in an ongoing phase III trial. Roche’s Tecentriq is therefore forecast to retain its position as market leader in SCLC over the forecast period and will benefit from the lack of effective alternatives in this disease area.

“In the relapsed/refractory setting, the recently approved branded chemotherapy, Zepzelca (lurbinectedin), is expected to be widely adopted, in part due to the market withdrawal of Opdivo and Keytruda in later lines.”

Ten novel pipeline agents are forecast to enter the market in the period to 2029. The majority of these are being developed in China and approximately half are domestically developed Chinese immune checkpoint inhibitors.

Pearson adds: “The last decade has seen an acceleration of Chinese capabilities for drug commercialization and has resulted in the development of domestic brands. This has been most evident in the development of immune-checkpoint inhibitors (ICI), positioned to be approved across multiple oncology indications. However, the introduction of Chinese checkpoint inhibitors into the SCLC treatment paradigm is more likely to have commercial, rather than clinical implications. KOLs note that new checkpoint inhibitors are unlikely to demonstrate improved efficacy over existing international ICI brands, however the introduction of multiple significantly discounted ICIs may provide pricing pressures for established ICI brands.”

*8MM = US, France, Germany, Italy, Spain, UK, Canada and Australia

Scope

  • Overview of SCLC including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline SCLC market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting SCLC therapeutics sales in the 8MM.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs (Phase III).
  • Analysis of the current and future market competition in the global SCLC market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

KEY QUESTIONS ANSWERED

  • 10 late-stage pipeline agents are going to enter the SCLC market from 2019 onwards. Will the impact will these agents have on the market? Which of these drugs will have the highest peak sales, and why?
  • What are the current unmet needs in SCLC, which pipeline agents are positioned to counter these unmet needs? What are the opportunities for R&D?
  • What is the market outlook in the 8MM from 2019-2029? Considering major patent expiries, launch of new premium priced agents and expected label expansions.
  • What are the main corporate trends? Who are the current and future players?

Key Highlights

Lung cancer remains a leading cause of cancer-related death worldwide and is a huge global health burden. Small cell lung cancer constitutes approximately 10-15% of all lung cancers and is a subtype characterized by aggressive disease and a lack of therapeutic options, resulting in poor clinical outcomes for patients. The approval and introduction of immune checkpoint inhibitors in combination with chemotherapy in the ES-SCLC setting has finally introduced a novel therapeutic approach in an indication dominated by the use of generic chemotherapy for decades. Despite a marginal (but significant) improvement in clinical outcomes for patients, the introduction of IO represents a welcome change in the treatment paradigm. Other catalysts of significance include the market withdrawal of Opdivo and Keytruda from the indication and the recent introduction of Zepzelca and Cosela into the treatment paradigm. Despite the introduction of new market entrants, significant opportunity exists across several patient subsets and multiple lines of therapy for R&D. GlobalData anticipates 10 pipeline agents to be launched across the 8MM (the majority in China) over the forecast period 2019-2029. The SCLC market is forecast to grow to $2.4B by 2029, at a Compound Annual Growth Rate (CAGR) of 12.9%.

This report covers opportunities for various marketed agents and pipeline agents in development across the 8MM, clinical and commercial assessments for agents in late-stage clinical development, R&D strategies, and innovative approaches in development for SCLC. This edition provides an update to the previous sales forecast for marketed and pipeline agents and highlights expected market dynamics by country and class of therapy across the forecast period, 2019-2029.

  • The main drivers of growth include the anticipated approval and launch of 10 pipeline therapies (the majority being launched in China) and greater market access across the 8MM for premium priced agents
  • The main barriers to growth in the 8MM include an absence of predictive biomarkers leading to a lack of targeted approaches in the treatment paradigm
  • A Shift in the treatment paradigm from the use of inexpensive generic chemotherapies to a mixture of chemotherapy/IO, which are associated with higher costs
  • The most important unmet needs in the SCLC market include: Limited understanding of underlying SCLC biology, a lack of effective treatments as a result, especially in the relapsed / refractory setting

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 SCLC therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SCLC 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 SCLC 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

Roche

Astrazeneca

PharmaMar

G1 Therapeutics

Chia Tai Tianqing Pharmaceutical Group Co

EpicentRx

Jiangsu Chia-Tai Tianqing Pharmaceutical

Shanghai Henlius Biotech Inc

Jiangsu HengRui Medicine

Advenchen Laboratories

Innovent Biologics

Beigene

Shanghai Junshi Biosciences

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Small Cell Lung Cancer: Executive Summary

2.1 The Global SCLC Market Is Expected to Grow at a

12.9% CAGR to $2.4B During 2019-2029

2.2 The Development of Immune Checkpoint Inhibitors in the Late-Stage Pipeline and a Focus on Innovative Approaches and Targets in Early-Stage Development

2.3 A Lack of Effective Targeted Treatment Options Underlied by the Limited Understanding of SCLC Disease Pathology

2.4 Multiple Late-Stage Candidates Consist of Chinese Domestic Immune Checkpoint Inhibitors or Dual Checkpoint Inhibition

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification or Staging Systems

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 Used

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for SCLC, 2019-2029

5.5.1 Diagnosed Incident Cases of SCLC

5.5.2 Sex-Specific Diagnosed Incident Cases of SCLC

5.5.3 Age-Specific Diagnosed Incident Cases of SCLC

5.5.4 Diagnosed Incident Cases of SCLC by Stage at Diagnosis

5.5.5 Five-Year Diagnosed Prevalent Cases of SCLC

5.5.6 Diagnosed Incident Cases of SLFN11-Positive SCLC

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 COVID-19 Impact

5.6.3 Limitations of Analysis

5.6.4 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Lack of Diagnostic Tools for Early Detection of Small Cell Lung Cancer

7.3 More Effective Therapies to Improve Overall Survival

7.4 Lack of Treatment Options for Relapsed/Refractory Relapse Disease

7.5 Discovery of Predictive Biomarkers and Understanding of the Underlying Biology of Small Cell Lung Cancer

7.6 Lack of Effective Therapies to Address Patients with Brain Metastasis

8 R&D Strategies

8.1 Overview

8.2 The Development of Checkpoint Inhibitors and Incorporation Into the Treatment Paradigm Across Multiple Lines of Therapy

8.3 Dual Checkpoint Blockade to Potentiate Efficacy and Overcome Resistance to ICI Treatment

8.4 The Development of Agents for Novel Targets in SCLC

8.5 Clinical Trials Design

8.5.1 Use of Overall Survival, Progression-Free Survival to Gain Front-Line Approvals and Overall Response Rate for Later Lines

8.5.2 An Absence of Biomarker-Driven Clinical Trial Design

8.5.3 The Clinical Trial Design for Chinese Domestic ICIs Is Consistent with Western Trials

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Early-Stage Approaches

9.3 Other Drugs in Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

10.4.4 Urban China

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

List of Tables

Table 1: SCLC: Key Metrics in the 8MM

Table 2: AJCC TNM Classification System for Small Cell Lung Cancer

Table 3: AJCC TNM Staging System for Small Cell Lung Cancer

Table 4: Risk Factors and Comorbidities for SCLC

Table 5: Treatment Guidelines for SCLC

Table 6: Leading Treatments for SCLC, 2021

Table 7: Overview of Key Pivotal Phase II/III Trials in SCLC

Table 8: Innovative Early-Stage Approaches for Small Cell Lung Cancer, 2021

Table 9: Drugs in Development for Small Cell Lung Cancer, 2021

Table 10: Clinical Benchmarking of Key Marketed and Pipeline Products

Table 11: Commercial Benchmark of Key Pipeline Drugs – SCLC

Table 12: Key Events Impacting Sales for SCLC, 2019-2029

Table 13: SCLC Market – Global Drivers and Barriers, 2019-2029

Table 14: Key Historical and Projected Launch Dates for SCLC

Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

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

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Tecentriq and Zepzelca, in the Relapsed/Refractory Setting

Figure 3: 8MM, Diagnosed Incidence of SCLC, Men, Ages ≥18 Years, 2009-2029

Figure 4: 8MM, Diagnosed Incidence of SCLC, Women, Ages ≥18 Years, 2009-2029

Figure 5: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of SCLC

Figure 6: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of SCLC by Stage at Diagnosis

Figure 7: 8MM, Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of SCLC

Figure 8: 8MM, Sources Used to Forecast the SLFN11 Biomarker of SCLC

Figure 9: 8MM, Diagnosed Incident Cases of SCLC, Both Sexes, Ages ≥18 Years, N, 2019

Figure 10: 8MM, Diagnosed Incident Cases of SCLC, by Sex, Ages ≥18 Years, N, 2019

Figure 11: 8MM, Diagnosed Incident Cases of SCLC by Age, Both Sexes, N, 2019

Figure 12: 8MM, Diagnosed Incident Cases of SCLC by Stage at Diagnosis, Ages ≥18 Years, Both Sexes, N, 2019

Figure 13: 8MM, Five-Year Diagnosed Prevalent Cases of SCLC, Ages ≥18 Years, Both Sexes, N, 2019

Figure 14: 8MM, Diagnosed Incident Cases of SLFN11-Positive SCLC, Ages ≥18 Years, Both Sexes, N, 2019 and 2029

Figure 15: Generalized Treatment Algorithm for SCLC Patients

Figure 16: Unmet Needs and Opportunities in Small Cell Lung Cancer

Figure 17: Overview of the Development Pipeline in Small Cell Lung Cancer

Figure 18: Key Phase III Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for Small Cell Lung Cancer in the 8MM During the Forecast Period

Figure 19: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), Tecentriq and Zepzelca in the Relapsed/Refractory Setting

Figure 20: Global (8MM) Sales Forecast by Country for SCLC in 2019 and 2029

Figure 21: Global Sales Forecast by Class for SCLC in 2019 and 2029

Figure 22: Sales Forecast by Class for SCLC in the US in 2019 and 2029

Figure 23: Sales Forecast by Class for SCLC in the 5EU in 2019 and 2029

Figure 24: Sales Forecast by Class for SCLC in Japan in 2019 and 2029

Figure 25: Sales Forecast by Class for SCLC in China in 2019 and 2029

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