Non-Small Cell Lung Cancer – Global Drug Forecast and Market Analysis to 2029

Non-small cell lung cancer (NSCLC) is currently the most common cancer in the world and is the leading cause of cancer mortality in men and women. Of total lung cancer incident cases, approximately 85% are the NSCLC subtype. NSCLC patients are usually diagnosed in the later stages of the disease, resulting in a poor prognosis. Since the last global market forecast (2015–2025), there have been significant changes in the treatment of patients with advanced disease, particularly in the metastatic setting. Although NSCLC is still not considered curable, physicians are enthusiastic about the progress being made in this field. New agents provide more durable responses, as demonstrated by improvements in progression-free survival and overall survival. Progress is demonstrated by the introduction of checkpoint inhibitors into the first-line setting and multiple next-generation targeted therapeutics which have dramatically improved patient outcomes. These recent successes will be further built upon during the forecast period. Personalized medicine will become more precise, with the development of agents targeting niche molecular aberrations, currently underserved by available treatments. Furthermore, novel agents will allow targeting of new actionable mutations. The strategic use of these targeted agents and immuno-oncology (IO)-based therapies in effective combinatorial regimens in the neoadjuvant and adjuvant settings for specific patient populations is also expected to transform the treatment landscape over the forecast period.

GlobalData is expecting the entry of the introduction of 29 novel entrants over the forecast period of 2019-2029. In this report, GlobalData has weighed the clinical and commercial potential of each NSCLC therapy to forecast market growth and identify new commercial opportunities.

KEY QUESTIONS ANSWERED

• 29 late-stage pipeline agents are going to enter the NSCLC 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 NSCLC, 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?

Scope

Overview of NSCLC including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Topline NSCLC 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 NSCLC 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 NSCLC 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

The main drivers of growth include the anticipated approval and launch of 29 pipeline therapies, in addition to label expansions of currently marketed therapies across the 8MM during the forecast period.

The main barriers to growth in the 8MM include the patent expiry of major brands and the high price of premium priced therapeutics entering the market.

Among the late-stage pipeline products and marketed agents, Checkpoint inhibitors and EGFR inhibitors are expected to generate the greatest revenues over the forecast period.

The most important unmet needs in the NSCLC market include: Comprehensive molecular testing, novel approaches to primary and acquired resistance and an improvement in curative therapeutic options

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 NSCLC therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global NSCLC 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 NSCLC 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

Boehringer Ingelheim

CTTQ Pharma

GlaxoSmithKline

Pfizer

Roche

Astrazeneca

Novartis

Eli Lilly

Jiangsu Simcere Pharmaceutical Co

Jiangsu Hengrui Medicine Co

Merck & Co

EMD Serono

Exelixis

Sun Pharma

Shanghai Sunway Biotech Co

Beta Pharma

Bristol Myers Squibb

Takeda

Bayer and Loxo Oncology

Hansoh Pharmaceutical Group Company

Blueprint Medicines Corporation

 Celgene

Jiangsu Hansoh Pharmaceutical Co

Yuhan Corporation

ACEA Therapeutics

Amgen

Johnson and Johnson

Regeneron Pharmaceuticals and Sanofi Genzyme

C-Stone Pharna

Inventis Bio

Xcovery

Eisai and SFJ Pharmaceuticals

OSE Immunotherapeutics

Turning Point Therapeutics

Innovent Biologics

Mirati Therapeutics

Beigene

Shanghai Junshi Biosciences

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 NSCLC: Executive Summary

2.1 The NSCLC Market Will Expand to $32.9B in 2029

2.2 Targeting Large Patient Populations in the First Line, with a Focus on Establishing New Actionable Mutations and Label Expansions for Premium Products into Earlier Lines

2.3 Opportunities Remain for Tackling Primary and Acquired Resistance to Targeted and IO Based Therapies

2.4 First-in-Class Approvals for Novel Actionable Mutations and Targeting Resistance

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

5.4.3 Diagnosed Incident Cases of NSCLC

5.4.4 Diagnosed Incident Cases of NSCLC by Stage at Diagnosis

5.4.5 Diagnosed Incident Cases of NSCLC by Histological Types

5.4.6 Mutations Among Diagnosed Incident Cases of Non-Squamous Cell Carcinoma and Squamous Cell Carcinoma

5.4.7 Five-Year Diagnosed Prevalent Cases of NSCLC

5.5 Epidemiological Forecast for NSCLC, 2019–2029

5.5.1 Diagnosed Incident Cases of NSCLC

5.5.2 Sex-Specific Diagnosed Incident Cases of NSCLC

5.5.3 Age-Specific Diagnosed Incident Cases of NSCLC

5.5.4 Diagnosed Incident Cases of NSCLC by Stage at Diagnosis

5.5.5 Diagnosed Incident Cases of NSCLC by Histological Type

5.5.6 Diagnosed Incident Cases of Non-Squamous Cell Carcinoma by Mutations: Genomic Biomarkers, EGFR and KRAS Mutations

5.5.7 Diagnosed Incident Cases of Squamous Cell Carcinoma by Mutations

5.5.8 Five-Year Diagnosed Prevalent Cases of NSCLC

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 COVID-19 Impact

5.6.3 Limitations of the Analysis

5.6.4 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis and Treatment Overview

6.2 US

6.3 5EU

6.4 Japan

6.5 China

7 Competitive Assessment

7.1 Overview

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Increased Education, Application, and Refinement of Comprehensive Molecular Testing

8.3 Primary and Acquired Resistance to Immunotherapy

8.4 Personalized Approaches to Tackling Resistance

8.5 Improving Curative Options and Patient Outcomes for Those Without Actionable Mutations

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Merck & Co.

10.4 AstraZeneca

10.5 Roche

10.6 Eli Lilly

10.7 BMS

10.8 Pfizer

10.9 Boehringer Ingelheim

10.10 Novartis

10.11 Future players

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 5EU

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 Japan

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 US

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

11.5 China

11.5.1 Forecast

11.5.2 Key Events

11.5.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for This Report

12.4.1 KOLs

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: NSCLC: Key Metrics in the 8MM

Table 2: Histologies and Subtypes in NSCLC

Table 3: TNM descriptors used in the AJCC/IASLC Lung Cancer Staging System

Table 4: Overview of the AJCC/IASLC staging system for NSCLC.

Table 5: Risk Factors and Comorbidities for NSCLC

Table 6: 8MM, Diagnosed Incident Cases of NSCLC by Stage at Diagnosis, Ages ≥18 Years, Both Sexes, N, 2019

Table 7: 8MM, Diagnosed Incident Cases of Non-Squamous Cell Carcinoma by Immunotherapy and Genomic Biomarkers, Ages ≥18 Years, Both Sexes, N, 2019

Table 8: 8MM, Diagnosed Incident Cases of Squamous Cell Carcinoma by Mutations, Ages ≥18 Years, Both Sexes, N, 2019

Table 9: Biomarker Testing Rates (%) in Nonsquamous NSCLC in 2019

Table 10: Treatment Guidelines for NSCLC in the 8MM

Table 11: Country Profile – US

Table 12: Country Profile – 5EU

Table 13: Country Profile – Japan

Table 14: Country Profile – China

Table 15: Leading Treatments for NSCLC, 2019

Table 16: Merck’s NSCLC Portfolio Assessment, 2019

Table 17: AstraZeneca’s NSCLC Portfolio Assessment, 2019

Table 18: Roche’s NSCLC Portfolio Assessment, 2019

Table 19: Eli Lilly’s NSCLC Portfolio Assessment, 2019

Table 20: BMS’s NSCLC Portfolio Assessment, 2019

Table 21: Pfizer’s NSCLC Portfolio Assessment, 2019

Table 22: Boehringer Ingelheim’s NSCLC Portfolio Assessment, 2019

Table 23: Novartis’ NSCLC Portfolio Assessment, 2019

Table 24: Future players in NSCLC Portfolio Assessment, 2019

Table 25: NSCLC Market – Global Drivers and Barriers, 2019–2029

Table 26: Key Events Impacting Sales for NSCLC in the 5EU, 2019–2029

Table 27: NSCLC Market – Drivers and Barriers in the 5EU, 2019–2029

Table 28: Key Events Impacting Sales for NSCLC in Japan, 2019–2029

Table 29: NSCLC Market – Global Drivers and Barriers in Japan, 2019–2029

Table 30: Key Events Impacting Sales for NSCLC in the US, 2019–2029

Table 31: NSCLC Market – Drivers and Barriers in the US, 2019–2029

Table 32: Key Events Impacting Sales for NSCLC in China, 2019–2029

Table 33: NSCLC Market – Global Drivers and Barriers in China, 2019–2029

Table 34: Key Historical and Projected Launch Dates for NSCLC

Table 35: Key Historical and Projected Patent Expiry Dates for NSCLC

Table 36: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

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

Figure 2: Analysis of the Company Portfolio Gap in NSCLC During the Forecast Period

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

Figure 4: 8MM, Diagnosed Incidence of NSCLC, Men, Ages ≥18 Years, 2009–2029

Figure 5: 8MM, Diagnosed Incidence of NSCLC, Women, Ages ≥18 Years, 2009–2029

Figure 6: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of NSCLC

Figure 7: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of NSCLC by Stage at Diagnosis

Figure 8: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of NSCLC by Histology Types

Figure 9: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Non-Squamous Cell Carcinoma and Squamous Cell Carcinoma by PD-L1, TMB, EGFR, KRAS, BRAF V600E, and MET Exon 14 Mutations

Figure 10: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Non-Squamous Cell Carcinoma Exon 18, Exon 19, Exon 20, Exon 21, KRAS G12C, KRAS G12D, KRAS G12V, ALK, BRAF, ROS1, RET, NTRK1, and HER2 Mutations

Figure 11: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Squamous Cell Carcinoma by FGFR1, PIK3CA, DDR2, PTEN, ALK, ROS1, BRAF, and RET Mutations

Figure 12: 8MM, Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of NSCLC

Figure 13: 8MM, Diagnosed Incident Cases of NSCLC, Both Sexes, Ages ≥18 Years, N, 2019

Figure 14: 8MM, Diagnosed Incident Cases of NSCLC, by Sex, Ages ≥18 Years, N, 2019

Figure 15: 8MM, Diagnosed Incident Cases of NSCLC by Age, Both Sexes, N, 2019

Figure 16: 8MM, Diagnosed Incident Cases of NSCLC by Histological Type, Ages ≥18 Years, Both Sexes, N, 2019

Figure 17: 8MM, Five-Year Diagnosed Prevalent Cases of NSCLC, Ages ≥18 Years, Both Sexes, N, 2019

Figure 18: An Overview of the Treatment Algorithm in Non-invasive and Invasive NSCLC

Figure 19: The Current Paradigm for Biomarker-Driven Treatment in NSCLC

Figure 20: Unmet Needs and Opportunities in Non-small Cell Lung Cancer

Figure 21: Overview of the Development Pipeline in NSCLC

Figure 22: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects to be Licensed for NSCLC 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 NSCLC During the Forecast Period

Figure 24: Analysis of the Company Portfolio Gap in NSCLC During the Forecast Period

Figure 25: Global (8MM) Sales Forecast by Country for NSCLC in 2019 and 2029

Figure 26: Sales Forecast by Class for NSCLC in the 5EU in 2019 and 2029

Figure 27: Sales Forecast by Class for NSCLC in Japan in 2019 and 2029

Figure 28: Sales Forecast by Class for NSCLC in the US in 2019 and 2029

Figure 29: Sales Forecast by Class for NSCLC in China in 2019 and 2029

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