Anaplastic Lymphoma Kinase Non-Small-Cell Lung Cancer - Epidemiology Forecast - 2034

Key Highlights:

• ALK NSCLC is a distinct molecular subtype of lung cancer defined by ALK gene rearrangements that drive tumor growth and survival. This subgroup exhibits unique biological and clinical characteristics compared to other NSCLC forms, highlighting the critical role of molecular testing in accurate disease classification and patient stratification.
• In 2024, DelveInsight estimated approximately 200,000 incident cases of NSCLC in the US, reflecting its dominant share of lung cancer and the critical need for molecular characterization.
• In 2024, DelveInsight estimated that in the 7MM approximately 26,000 patients were considered as eligible patient pool for ALK NSCLC, underscoring the significant clinical and commercial opportunity, the growing role of biomarker-driven patient identification, and the expanding adoption of targeted therapeutic approaches in this molecularly defined segment.
• In EU4 and the UK, total incident cases of NSCLC by ALK biomarker positive were approximately 8,000 in 2024, with numbers projected to rise further by 2034, reflecting an increasing disease burden across this subgroup.
• In 2024, DelveInsight estimated approximately 6,000 patients in Japan as the total eligible patient pool for ALK NSCLC, underscoring the importance of this molecular subgroup in the region's lung cancer landscape.
• ALK NSCLC remains challenging due to the diversity of fusion variants, the complexity of accurate biomarker identification, and its frequent association with CNS involvement, with diagnostic variability further complicating precise disease characterization and timely classification.

DelveInsight's "ALK NSCLC - Epidemiology Forecast - 2034" report delivers an in-depth understanding of ALK NSCLC, historical and forecasted epidemiology trends in the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding

ALK NSCLC Overview

ALK NSCLC is a distinct molecular subtype of lung cancer characterized by chromosomal rearrangements involving the ALK gene. This alteration drives oncogenic signaling pathways that promote tumor cell proliferation, survival, and metastasis. ALK NSCLC typically occurs in younger patients, non-smokers, or light smokers, and accounts for approximately 3-7% of all NSCLC cases.

The causes of ALK NSCLC are rooted in genetic alterations rather than environmental exposures. The most common abnormality is the EML4-ALK fusion, though multiple other fusion partners (e.g., KIF5B, TFG, and STRN) have been identified. These fusions result from chromosomal translocations that lead to constitutive activation of ALK tyrosine kinase signaling. Unlike smoking-associated NSCLC, where carcinogen exposure plays a central role, ALK-positive disease arises predominantly from these molecular changes, with additional modifying influences from host genetic susceptibility and tumor microenvironment interactions.

Clinically, ALK NSCLC often presents with non-specific pulmonary symptoms such as persistent cough, dyspnea, chest pain, or hemoptysis. Extra pulmonary symptoms like weight loss and fatigue are also common. Patients may develop advanced disease at diagnosis due to the aggressive nature of this subtype, with frequent metastases to the brain, liver, and bones. Compared to EGFR-mutated or KRAS-driven NSCLC, ALK-positive tumors are more likely to cause CNS involvement early in the disease course. Radiologically, these tumors often appear as peripheral or central lung masses, sometimes with associated lymphadenopathy.

ALK NSCLC Diagnosis

Diagnosis of ALK NSCLC relies on a combination of histopathologic evaluation, molecular testing, and imaging. Tissue biopsy establishes the NSCLC diagnosis, after which molecular assays confirm ALK rearrangements. Immunohistochemistry (IHC) detects ALK protein overexpression, Fluorescence in Situ Hybridization (FISH) visualizes ALK gene translocations, and Next-Generation Sequencing (NGS) provides comprehensive genomic characterization, identifying fusion variants. Reverse Transcription Polymerase Chain Reaction (RT-PCR) can detect ALK fusion transcripts with high sensitivity, while liquid biopsy through circulating tumor DNA (ctDNA) analysis offers a non-invasive alternative when tissue is limited. Imaging with Computed Tomography (CT), Positron Emission Tomography (PET), and Magnetic Resonance Imaging (MRI) helps assess tumor distribution and metastatic spread, particularly to the CNS.

Several other molecularly defined subtypes can mimic ALK NSCLC, making differential diagnosis essential. EGFR-mutated NSCLC commonly arises in non-smokers with adenocarcinoma histology but involves EGFR exon alterations instead of ALK fusions. ROS1-rearranged tumors share clinicopathologic features with ALK NSCLC yet are driven by distinct fusion events. RET and NTRK fusions present with similar morphologic and radiologic patterns, requiring molecular profiling for confirmation. KRAS, MET exon 14 skipping, HER2, and BRAF alterations also define alternative oncogenic subsets that may overlap in presentation. Broad molecular testing ensures accurate classification of ALK-driven tumors among these differentials.

ALK NSCLC Epidemiology

The ALK NSCLC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of NSCLC, total eligible patient pool for ALK NSCLC, total incident cases of NSCLC by ALK biomarker positive, and total treated cases of ALK NSCLC in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• In 2024, DelveInsight estimated approximately 210,000 incident cases of NSCLC in EU4 and the UK, underscoring the substantial disease burden in these regions and their critical role in shaping the clinical and therapeutic landscape of lung cancer.
• In 2024, DelveInsight estimated approximately 10,000 patients in the US comprising the total eligible patient pool for ALK NSCLC, emphasizing the significance of this subgroup in driving precision medicine uptake and targeted therapy adoption.
• Among EU4 and the UK, Germany reported the highest number of patients eligible for ALK NSCLC with approximately 2,700 patients, followed by the UK with nearly 2,200 patients, while Spain had the lowest pool with approximately 1,300 patients in 2024. This distribution emphasizes the variability of ALK NSCLC incidence within Europe and its relevance in advancing precision medicine approaches.
• In 2024, DelveInsight estimated approximately 4,400 total incident cases of NSCLC with positive ALK biomarker in Japan, highlighting the role of biomarker testing in identifying this clinically significant subgroup within the broader NSCLC population.

KOL Views

DelveInsight's analysts collaborated with over 50 key opinion leaders (KOLs), conducting in-depth interviews with more than 30 experts across the 7MM. To keep pace with evolving epidemiology trends, the team gathered first-hand insights from KOLs and subject matter experts (SMEs) through primary research, addressing data limitations and reinforcing findings from secondary research. These professionals offered valuable input on the ALK NSCLC landscape, highlighting patient behavior trends, and challenges in access to care. Contributors included experts from renowned institutions such as the Dana-Farber Cancer Institute, US; American Lung Association, US; University Hospital Heidelberg, Germany; Comprehensive Cancer Center, France; University of Parma, Italy; La Paz University Hospital, Spain; Royal Marsden Hospital, UK; Showa University, Japan; and Tokyo Medical University, Japan; among others.

According to US KOLs, "ALK NSCLC represents a small yet clinically critical subset of lung cancer, where limited awareness and variability in molecular testing practices contribute to delayed detection of ALK rearrangements, ultimately impacting patient outcomes and highlighting the need for consistent biomarker-driven diagnosis."

According to European KOLs, "ALK NSCLC demonstrates aggressive disease biology, often presenting with early CNS involvement and rapid progression, underscoring its serious clinical nature and the necessity of precise molecular profiling to distinguish it from other oncogenic drivers."

According to Japanese KOLs, "The growing burden of ALK NSCLC, particularly within younger non-smoking populations, reflects its unique epidemiologic pattern, while the heterogeneity of fusion variants poses significant challenges for accurate identification and comprehensive disease monitoring."

Scope of the Report:

• The report covers a segment of executive summary, descriptive overview of ALK NSCLC, explaining its causes, signs and symptoms, and currently available diagnostic algorithms and guidelines.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of incidence rate, disease progression, and diagnosis guidelines.
• The report provides an edge for understanding trends, expert insights/KOL views, and patient journeys in the 7MM.
• A detailed review of current challenges in establishing the diagnosis.

ALK NSCLC Report Insights

• Patient Population
• Country-wise Epidemiology Distribution
• Total Incident Cases of NSCLC
• Total Eligible Patient Pool for ALK NSCLC
• Total Incident Cases of NSCLC by ALK Biomarker Positive
• Total Treated Cases of ALK NSCLC

ALK NSCLC Report Key Strengths

• 10 years Forecast
• The 7MM Coverage

Key Questions:

Epidemiology Insights

• What are the disease risk, burden, and unmet needs of ALK NSCLC?
• What is the historical ALK NSCLC patient population in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• Out of the above-mentioned countries, which country would have the highest incident population of ALK NSCLC during the forecast period (2025-2034)?
• What would be the forecasted patient population of ALK NSCLC at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to ALK NSCLC?
• At what Compound annual growth rate (CAGR) the population is expected to grow across the 7MM during the forecast period (2025-2034)?

ALK NSCLC to Buy

• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To analyze epidemiological trends of ALK NSCLC across different regions and assess how these patterns may evolve in the coming years.
• Detailed insights on various factors hampering disease diagnosis and other existing diagnostic challenges.
• To understand the perspective of key opinion leaders (KOL) around the current challenges with establishing the diagnosis options.

Frequently Asked Questions:

1. What is the forecast period covered in the report?

The ALK NSCLC epidemiology report for the 7MM covers the forecast period from 2025 to 2034, providing a projection of epidemiology dynamics and trends during this timeframe.

2. Out of all EU4 countries and the UK, which country had the highest incident cases of ALK NSCLC cases in 2024?

The highest cases of ALK NSCLC were found in Germany among EU4 and the UK in 2024.

3. How is epidemiological data collected and analyzed for forecasting purposes?

Epidemiological data is collected through surveys, health records, and other sources. It is then analyzed to calculate incidence rates, identify trends, and project future disease burdens using mathematical models.

4. Out of all 7MM countries, which country had the highest total eligible patient pool for ALK NSCLC in 2024?

The highest cases of ALK NSCLC were found in the US among the 7MM in 2024.