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anaplastic lymphoma kinase non small cell lung cancer epidemiology forecast

Anaplastic Lymphoma Kinase Non-Small-Cell Lung Cancer Epidemiology Forecast – 2036

Published Date : 2026

Pages : 87

Region : United States, Japan, EU4 & UK

Summary
TOC Table of Content
LOT
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anaplastic lymphoma kinase non small cell lung cancer epidemiology forecast

ALK NSCLC Insights and Trends

According to DelveInsight’s analysis, the total incident cases of ALK NSCLC were approximately 10,100 in the United States in 2025.
ALK-positive NSCLC is a genetically defined subset of lung cancer characterized by rearrangements in the ALK gene that drive uncontrolled tumor growth. It is most commonly seen in younger patients.
Current clinical guidelines recommend that all patients with advanced non-squamous NSCLC (and selected squamous cases) undergo broad molecular profiling at diagnosis or progression, including mandatory ALK testing.
A key challenge in ALK-positive NSCLC is disease relapse, particularly in the brain, as CNS metastases are common and can occur even when systemic disease is controlled. While newer ALK inhibitors offer better CNS penetration, long-term disease control remains limited, and resistance continues to emerge over time.

Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer (ALK NSCLC) Epidemiology Forecast in the US

2025 Incident of ALK NSCLC: ~25,500
2036 Projected ALK NSCLC Incident Cases: ~27,600
ALK NSCLC Growth Rate (2026–2036): ~0.5% CAGR

DelveInsight's ‘ALK NSCLC – Epidemiology Forecast – 2036’ report delivers an in-depth understanding of the gastroparesis, historical and forecasted epidemiology, in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Study Period	2022–2036
Historical Year	2022–2025
Forecast Period	2026–2036
Base Year	2026
Geographies Covered	North America : The US; Europe: Germany, France, Italy, and Spain and the UK; Asia-Pacific: Japan
ALK NSCLC Epidemiology CAGR (Forecast period)	~0.5% (2026–2036)
ALK NSCLC Epidemiology Segmentation Analysis	Patient Burden Assessment Total Incident Cases of NSCLC Gender-specific Incident Cases of NSCLC Age-specific Incident Cases of NSCLC Stage-specific Incident Cases of NSCLC Treated Cases of ALK NSCLC

Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer (ALK NSCLC) Understanding and Diagnosis Algorithm

ALK NSCLC Overview

ALK-positive non-small cell lung cancer (ALK NSCLC) is a distinct molecular subtype of lung cancer characterized by rearrangements in the anaplastic lymphoma kinase (ALK) gene, most commonly the EML4-ALK fusion. It is more frequently observed in younger patients, non-smokers, or light smokers with adenocarcinoma histology. This subtype is clinically significant because it is highly responsive to targeted therapies, which have transformed prognosis compared to conventional chemotherapy. The disease often shows a tendency to spready early to the central nervous system (CNS), making effective brain-penetrant therapies especially important.

Further details are provided in the report.

ALK NSCLC Diagnosis

The diagnosis of ALK NSCLC relies on molecular testing to identify ALK gene rearrangements. Patients with advanced non-squamous NSCLC are routinely tested using techniques such as immunohistochemistry, fluorescence in situ hybridization, or next-generation sequencing (NGS), with NGS increasingly preferred due to its ability to detect multiple genomic alterations simultaneously. Accurate and early identification of ALK status is critical, as it directly guides treatment decisions. Imaging studies, including MRI of the brain, are also commonly performed given the high incidence of CNS metastases in this patient population.

Further details are provided in the report.

Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer (ALK NSCLC) Epidemiology

Key Findings from ALK NSCLC Epidemiological Analysis and Forecast

Among the 7MM, the US accounted for the highest number of incident cases of NSCLC with ~10,000 cases in 2025.
NSCLC shows a higher incidence in males, accounting for 56% of cases, compared to 44% in females.
Among the age groups, the highest age-specific cases accounted for 65+ years in 2025 with more than 65% of the total cases.
In the US, out of all the stages, the highest stage-specific cases accounted for stage IV, followed by stage I in 2025. While the least stage-specific cases were observed in stage IIIB.
Among EU4 and the UK, Germany accounted for the highest incident cases of ALK NSCLC, followed by Uk, and the least cases were accounted for by Spain in the year 2025.

Scope of the Report

The report covers a segment of a descriptive overview of gastroparesis, explaining their causes, signs and symptoms, and pathogenesis.
Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression.

Report Insights

ALK NSCLC Patient Population Forecast

Report Key Strengths

Epidemiology‑based (Epi‑based) Bottom‑up Forecasting
11-year Forecast
Patient Burden Trends (by geography)

FAQs

What are the disease risks, burdens, and unmet needs of gastroparesis? What will be the growth opportunities across the 7MM concerning the patient population with gastroparesis?
What is the historical and forecasted gastroparesis patient pool in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?

Reasons to Buy

Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
To understand key opinion leaders’ perspectives around the diagnostic challenges to overcome barriers in the future.
Detailed insights on various factors hampering disease diagnosis and other existing diagnostic challenges.

1 Key Insights

2 Report Introduction

3 Executive Summary

4 Epidemiology Methodology of ALK NSCLC

5 ALK NSCLC Epidemiology Overview at a Glance

5.1 Patient Share (%) Distribution by Country in 2025 in the 7MM

5.2 Patient Share (%) Distribution by Country in 2036 in the 7MM

6 Disease Background And Overview of ALK NSCLC

6.1 Introduction

6.2 Causes

6.3 Signs And Symptoms

6.4 Diagnosis

6.4.1 Differential Diagnosis

6.4.2 Diagnostic Algorithm

6.4.3 Diagnostic Guidelines

6.4.3.1 NCCN Guidelines for Diagnosis of ALK NSCLC

7 Epidemiology and Patient Population of ALK NSCLC

7.1 Key Findings

7.2 Assumption and Rationale

7.3 Total Incident Cases of ALK NSCLC in the 7MM

7.4 The United States

7.4.1 Total Incident Cases of NSCLC in the United States

7.4.2 Gender-specific Incident Cases of NSCLC in the United States

7.4.3 Age-specific Incident Cases of NSCLC in the United States

7.4.4 Stage-specific Incident Cases of NSCLC in the United States

7.4.5 Treated Cases of ALK NSCLC in the United States

7.5 EU4 and the UK

7.5.1 Total Incident Cases of NSCLC in EU4 and the UK

7.5.2 Gender-specific Incident Cases of NSCLC in EU4 and the UK

7.5.3 Age-specific Incident Cases of NSCLC in EU4 and the UK

7.5.4 Stage-specific Incident Cases of NSCLC in EU4 and the UK

7.5.5 Treated Cases of ALK NSCLC in EU4 and the UK

7.6 Japan

7.6.1 Total Incident Cases of NSCLC in Japan

7.6.2 Gender-specific Incident Cases of NSCLC in Japan

7.6.3 Age-specific Incident Cases of NSCLC in Japan

7.6.4 Stage-specific Incident Cases of NSCLC in Japan

7.6.5 Treated Cases of ALK NSCLC in Japan

8 Appendix

8.1 Bibliography

8.2 Report Methodology

9 DelveInsight Capabilities

10. Disclaimer

11 About DelveInsight

List of Tables:

List of Table

Table 1: Summary of ALK NSCLC Epidemiology (2022–2036)

Table 3: Total Eligible Patient Pool for ALK NSCLC in the 7MM (2022-2036)

Table 4: Total Incident Cases of NSCLC in the US (2022–2036)

Table 5: Total Eligible Patient Pool for ALK NSCLC in the US (2022–2036)

Table 6: Total Incident Cases of NSCLC by ALK biomarker Positive in the US (2022–2036)

Table 7: Total Treated Cases of ALK NSCLC in the US (2022–2036)

Table 8: Total Incident Cases of NSCLC in EU4 and the UK (2022–2036)

Table 9: Total Eligible Patient Pool for ALK NSCLC in EU4 and the UK (2022–2036)

Table 10: Total Incident Cases of NSCLC by ALK biomarker Positive in EU4 and the UK (2022–2036)

Table 11: Total Treated Cases of ALK NSCLC in EU4 and the UK (2022–2036)

Table 12: Total Incident Cases of NSCLC in Japan (2022–2036)

Table 13: Total Eligible Patient Pool for ALK NSCLC in Japan (2022–2036)

Table 14: Total Incident Cases of NSCLC by ALK Biomarker Positive in Japan (2022–2036)

Table 15: Total Treated Cases of ALK NSCLC in Japan (2022–2036)

List of Figures:

List of Figures

Figure 1: Types of ALK NSCLC

Figure 2: Common Risk Factors

Figure 3: Diagnostic Algorithm

Figure 4: Total Eligible Patient Pool for ALK NSCLC in the 7MM (2022-2036)

Figure 5: Total Incident Cases of NSCLC in the US (2022–2036)

Figure 6: Total Eligible Patient Pool for ALK NSCLC in the US (2022–2036)

Figure 7: Total Incident Cases of NSCLC by ALK biomarker Positive in the US (2022–2036)

Figure 8: Total Treated Cases of ALK NSCLC in the US (2022–2036)

Figure 9: Total Incident Cases of NSCLC in EU4 and the UK (2022–2036)

Figure 10: Total Eligible Patient Pool for ALK NSCLC in EU4 and the UK (2022–2036)

Figure 11: Total Incident Cases of NSCLC by ALK biomarker Positive in EU4 and the UK (2022–2036)

Figure 12: Total Treated Cases of ALK NSCLC in EU4 and the UK (2022–2036)

Figure 13: Total Incident Cases of NSCLC in Japan (2022–2036)

Figure 14: Total Eligible Patient Pool for ALK NSCLC in Japan (2022–2036)

Figure 15: Total Incident Cases of NSCLC by ALK Biomarker Positive in Japan (2022–2036)

Figure 16: Total Treated Cases of ALK NSCLC in Japan (2022–2036)

Figure 20: Patient Journey

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