(Albany, US), October 30, 2026 – DelveInsight’s ‘Anaplastic Lymphoma Kinase Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034’ report delivers an in-depth understanding of ALK positive metastatic non small cell lung cancer, historical and forecasted epidemiology, as well as the ALK metastatic NSCLC market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Key Takeaways from the ALK Metastatic NSCLC Market Report
The total ALK+ NSCLC incidence in the US was approximately 10,130 cases in 2023, and the number of cases is projected to increase during the forecast period owing to the rise in biomarker testing rates.
The total ALK metastatic NSCLC market size in the 7MM was approximately USD 1,526 million in 2023, of which the US accounted for nearly USD 915 million.
In 2023, alectinib captured approximately 60% of the ALK market in the US, and ALECENSA is much more widely used than ALUNBRIG and dominates the ALK market.
Lorlatinib generated approximately USD 250 million in the 7MM in 2023.
The total number of ALK NSCLC cases in EU4 and the UK was estimated at nearly 10,400 in 2023, with Germany accounting for the highest patient share.
According to five-year follow-up data from the CROWN study, 60% of participants in the LORBRENA group were alive without disease progression, compared with just 8% in the XALKORI group.
There are not many ALK metastatic NSCLC companies currently targeting this segment, and the ALK metastatic NSCLC pipeline is not very robust.
The leading ALK metastatic NSCLC companies include Roche, Pfizer, Takeda Pharmaceuticals, Xcovery, Nuvalent, and others.
Promising ALK NSCLC drugs include Alectinib, Brigatinib, Lorlatinib, Ensartinib, NVL-655, and others.
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ALK Metastatic NSCLC Overview
ALK refers to anaplastic lymphoma kinase, initially identified in lymphoma but predominantly associated with non-small cell lung cancer. The ALK gene is present during embryonic development and forms the gastrointestinal and nervous systems. It becomes inactive in utero, but in some individuals, it can re-activate and fuse with another gene, resulting in an ALK fusion or ALK rearrangement that can lead to cancer. When ALK fuses with another gene and causes lung cancer, the patient is considered to have ALK+ metastatic NSCLC (ALK-positive). The most common fusion partner is EML4, and multiple fusions exist within EML4 based on the specific site where ALK joins the gene. Currently, the recommended treatment approach is generally uniform for most ALK-positive patients, irrespective of the precise type of ALK rearrangement.
To determine whether lung cancer is ALK-positive, testing of the tumor tissue or blood is required, employing methods such as FISH analysis, immunohistochemistry, next-generation sequencing (comprehensive biomarker testing), and liquid biopsy.
ALK Metastatic NSCLC Epidemiology Segmentation in the 7MM
Total Incident Cases of NSCLC
Gender-specific Cases of NSCLC
Age-specific Cases of NSCLC
Total Incident Cases of NSCLC by Histology
Total Incident Cases of NSCLC by Stage
Total Cases of NSCLC by Genetic Mutations/Biomarkers
Download the report to understand which factors are driving ALK+ NSCLC Incidence trends @ ALK NSCLC Epidemiology
ALK Metastatic NSCLC Epidemiology Key Findings
About 10–15% of all lung cancers are SCLC, and about 80–85% are NSCLC. In the 7MM, approximately 524,000 NSCLC incident cases were present in 2023.
ALK rearrangements are present in around 5% of NSCLC cases, primarily in adenocarcinomas, representing a distinct molecular subtype of lung cancer.
Biomarker testing for ALK mutation is recommended in the 7MM, and the biomarker testing rate is higher in the US compared to EU4, the UK, and Japan.
In 2023, there were nearly 10,000 cases of ALK NSCLC in the US, and these are projected to increase during the forecast period owing to the increase in biomarker testing rate.
Approved Therapies for ALK Metastatic NSCLC
Before 2011, patients with advanced NSCLC who were ALK-positive had few therapy choices, and the usual course of treatment included chemotherapy. The discovery of the ALK driver mutation significantly changed how this malignancy is treated, owing to the entry of targeted drugs for this subset. At present, ALECENSA and ALUNBRIG are the preferred first-line ALK TKIs. Before their entry, XALKORI was the first-line treatment choice in ALK patients.
ALECENSA (alectinib), Genentech/Hoffmann-La Roche/Chugai Laboratories
A highly selective, central nervous system-active oral medicine used to treat people with NSCLC whose tumors are identified as ALK-positive. It inhibits ALK and RET proteins by preventing their phosphorylation, thereby inhibiting the growth and survival of cancer cells. The US FDA approval was based on the Phase III ALEX study in previously untreated ALK-positive metastatic NSCLC and two Phase II studies, NP28761 and NP28673, in patients who progressed on or were intolerant to crizotinib. NCCN recommends ALECENSA for the first-line treatment of ALK NSCLC.
ALUNBRIG (brigatinib), Takeda Pharmaceuticals
A kinase inhibitor indicated for adult patients with ALK-positive metastatic NSCLC. The ALUNBRIG MoA involves in vitro activity at clinically achievable concentrations against multiple kinases, including ALK, ROS1, IGF-1R, and FLT3, as well as EGFR deletion and point mutations. Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signaling proteins STAT3, AKT, ERK1/2, and S6 in vitro and in vivo, and demonstrated dose-dependent inhibition of EML4-ALK positive NSCLC xenograft growth in mice. In the Phase III ALTA-3 study, the median progression-free survival was 19.3 months with brigatinib and 19.2 months with alectinib.
ALK Metastatic NSCLC Pipeline Analysis
Ensartinib: Xcovery
Ensartinib is a potential best-in-class compound for the first-line treatment of ALK-positive NSCLC. It has shown promising clinical activity in a Phase I/II trial, and a single-arm Phase II trial as second-line treatment in 156 Chinese patients previously treated with crizotinib has been completed, with a New Drug Application filed in China. A global first-line Phase III registration trial versus crizotinib is ongoing, and in March 2024, the FDA accepted the NDA for ensartinib.
NVL-655: Nuvalent
NVL-655 is a novel brain-penetrant ALK-selective inhibitor that remains active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including those with the solvent front G1202R mutation or compound mutations such as G1202R/L1196M, G1202R/G1269A, and G1202R/L1198F. ALK-selectivity is emphasized to minimize CNS adverse events related to off-target inhibition of the TRK family. In February 2024, Nuvalent initiated the Phase II portion of the ALKOVE-1 clinical trial, and in May 2024, the FDA granted breakthrough therapy designation (BTD) to NVL-655 for patients with locally advanced or metastatic ALK-positive NSCLC previously treated with two or more ALK TKIs.
Discover more about therapies set to grab Major ALK Metastatic NSCLC Market Share @ ALK NSCLC Drugs Market Drivers and Barriers
ALK Metastatic NSCLC Market Outlook
The ALK metastatic NSCLC market is constantly evolving, with targeted therapies being actively developed as the understanding of the disease improves. Historically, ALK-positive metastatic NSCLC was treated with chemotherapy alone and was associated with low 5-year survival rates. XALKORI (crizotinib), the first-generation ALK inhibitor, was the first drug approved for ALK-mutated NSCLC in 2011, but it was limited by low brain penetration and susceptibility to resistance. In 2017, the FDA approved ZYKADIA (ceritinib), the first-to-market second-generation TKI, though concerns around gastrointestinal toxicity and dosing issues were noted. ALUNBRIG was approved by the FDA in 2020 as a first-line option based on the ALTA-1L trial, and LORBRENA/LORVIQUA (lorlatinib), a third-generation ALK inhibitor, was approved in 2021 as a first-line therapy based on the CROWN trial. Fourth-generation NVL-655 is designed to remain active in tumors resistant to first-, second-, and third-generation ALK inhibitors.
The ALK market space has become stagnant, with only a few players developing therapies for ALK-mutated NSCLC. Emerging assets such as ensartinib and NVL-655 may offer advantages over existing ALK NSCLC drugs, such as improved potency, selectivity, and safety. However, they face a competitive market with several approved drugs with proven efficacy and survival benefits, and the ALK market needs more innovation and differentiation to attract new players and patients.
ALK Metastatic NSCLC Treatment Landscape
Treatment options and recommendations for ALK-positive metastatic non-small cell lung cancer (NSCLC) depend on several factors, including cancer type and stage, potential treatment-related side effects, the patient’s overall health, and individual preferences. Although direct comparative studies evaluating all available ALK tyrosine kinase inhibitors (TKIs) remain limited, ongoing research focuses on developing next-generation ALK TKIs to overcome resistance to existing therapies. These developments highlight the potential for sequential treatment strategies involving different ALK inhibitors. Molecular and biomarker-directed treatment approaches for advanced or metastatic ALK-positive NSCLC include alectinib, brigatinib, ceritinib, crizotinib, and lorlatinib as first-line treatment options, while subsequent-line therapies include alectinib, brigatinib, ceritinib, and lorlatinib.
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Scope of the ALK Metastatic NSCLC Market Report
Coverage- 7MM
Study Period- 2020-2034
Forecast Period- 2024-2034
ALK Metastatic NSCLC Companies- Roche, Pfizer, Takeda Pharmaceuticals, Xcovery, Nuvalent, and others.
ALK Metastatic NSCLC Therapies- Alectinib, Brigatinib, Lorlatinib, Ensartinib, NVL-655, and others.
ALK Metastatic NSCLC Market Segmentation- By Region and By Therapies
ALK Metastatic NSCLC Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis
ALK Metastatic NSCLC Unmet Needs, KOL Views, Reimbursement
Table of Contents
Key Insights
Report Introduction
Key Highlights
Executive Summary
ALK mNSCLC Market Overview at a Glance
Key Events
Epidemiology and Market Forecast Methodology
Disease Background and Overview
Diagnosis of NSCLC
Current Treatment Practices: NSCLC
Treatment Guidelines and Recommendations for Non-small Cell Lung Cancer (NSCLC)
Epidemiology and Patient Population
Patient Journey
Key Endpoints in NSCLC
Marketed Drugs
Emerging Drugs
ALK mNSCLC: The 7MM Analysis
Unmet Needs
SWOT Analysis
KOL Views
Market Access and Reimbursement
Appendix
DelveInsight Capabilities
Disclaimer
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