Metastatic Non-Small Cell Lung Cancer Market

• Metastatic NSCLC market size has seen a revolutionary change in the last decade owing to the increase in incident cases of NSCLC, continuous uptake of approved therapies, mainly immune checkpoint inhibitors, expected entry of potential premium price emerging therapies, and increasing awareness of mutations like KRAS, BRAF, c-Met, and others. The total market size of metastatic NSCLC is estimated to be ~USD 21 billion in the 7MM in 2023.
• The real-world treatment trend depicts a drastic shift toward targeted and immunotherapies (from only systemic therapies in the past), which is expected to contribute the most now.
• The existing NSCLC treatment is mainly dominated by checkpoint inhibitors such as KEYTRUDA and OPDIVO. Regarding EGFR-positive NSCLC market size, we expect third-generation EGFRs such as AstraZeneca’s TAGRISSO to dominate.
• Amgen’s LUMAKRAS was approved in 2021 for NSCLC patients harboring KRASG12C mutation.
• ADCs are a class of oncology medications that are among the most rapidly expanding. Despite the outstanding patient responses that conventional ADCs have produced, they have only been tested on patients with the highest target expression levels and a narrow number of targets. Although only one ADC is approved for NSCLC, and it is only for a limited subgroup (HER2m NSCLC), companies are attempting to target a larger NSCLC population, particularly in areas where KEYTRUDA is the market leader. Among the upcoming therapies in the 7MM, Dato-DXd is expected to capture a significant market size of patients expressing PD-L1.
• As per DelveInsight’s analysis, the total incident cases of NSCLC in the 7MM were approximately 531,800 cases in 2023; these cases are estimated to increase by 2034.
• Various types of mutations are commonly observed in NSCLC. There is mounting evidence that substantial molecular and clinical heterogeneity exists within oncogenic driver-defined subgroups of NSCLC. The most frequent biomarkers are EGFR in Japan and KRAS in the US and Europe.
• EGFR exon 19 deletions and Exon 21 L858R substitution (sensitizing mutations) account for approximately 80% of EGFR mutations in NSCLC.
• The most frequent KRAS variant observed in NSCLC is G12C. In the United States, KRASG12C is present in ~37% of NSCLC cases.
• The total market size of NSCLC in the United States is estimated to be ~USD 12,600 million by 2023. Among the total market, PDL1, EGFR, ALK, and KRAS seem to have maximum therapies, thus contributing to a significant market size.
• In the US, in 2023, there were approximately 115,000 metastatic cases of NSCLC (De novo advanced/metastatic patients and recurrent patients from early stages).
• Among EU4 countries, Germany accounted for the highest number of NSCLC cases in 2023, whereas Spain accounted for the lowest cases in 2023.

DelveInsight's “Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of top oncogenic drivers/biomarkers in Non-small Cell Lung Cancer (such as EGFR, c-MET, ROS1, KRAS, ALK, BRAF, PD-L1, etc.), historical and forecasted epidemiology as well as the Non-small Cell Lung Cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Metastatic NSCLC market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Non-small Cell Lung Cancer market size from 2020 to 2034. The report also covers current Non-small Cell Lung Cancer treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

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

Study Period: 2020–2034

Metastatic Non-small Cell Lung Cancer Treatment Market

Metastatic Non-small Cell Lung Cancer Overview and Diagnosis

Non-small Cell Lung Cancer is the most common type of lung cancer, accounting for 81% of all lung cancer diagnoses. Early diagnosis offers the best prognosis for Non-Small Cell Lung Cancer. However, Non-Small Cell Lung Cancer and other lung cancers can be difficult to diagnose because these cancers often have symptoms mistaken for common illnesses or the effects of long-term smoking. Because of this, 80% of people diagnosed with Non-Small Cell Lung Cancer have already progressed to advanced stages, making it more difficult to treat. If lung cancer is suspected, the physician will recommend imaging tests (CT, PET, or MRI scans) to identify abnormalities in and around the lungs. The physician may also examine a sample of mucus under the microscope.

If these initial tests identify cancer, a lung biopsy can be conducted. A bronchoscopy can also be recommended, allowing the physician to visualize and remove tissue. If lung cancer is confirmed, genetic testing can be done on the lung tissue to identify details about the cancer that can help inform treatment.

Further details related to country-based variations in diagnosis are provided in the report...

Metastatic Non-small Cell Lung Cancer Treatment

Treatment options and recommendations depend on several factors, including the type and stage of cancer, possible side effects, and the patient’s preferences and overall health. The most common treatments for non-small cell lung cancer are:

• Surgery
• Radiotherapy
• Chemotherapy
• Chemotherapy with radiotherapy (chemoradiotherapy)
• Immunotherapy
• Targeted cancer drugs

Note: Detailed updates are provided in the final report...

World Conference on Lung Cancer (WCLC) 2023 Key Updates

• Bristol Myers Squibb demonstrated the results of the TRIDENT-1 Phase I/II trial of repotrectinib for patients with ROS1-positive NSCLC.
• Daiichi Sankyo presented the HERTHENA-Lung01 Phase II trial of patritumab deruxtecan for EGFR-mutated NSCLC patients.
• ArriVent Biopharma presented FAVOUR Phase Ib results of furmonertinib for patients with NSCLC EGFR exon 20 insertion mutation.
• Mirati Therapeutics presented data from Phase I/Ib cohort and Phase II Cohort A of the KRYSTAL-1 study evaluating adagrasib in patients with NSCLC harboring a KRASG12C mutation.
• Amgen announced data from the CodeBreaK 101 clinical trial Phase Ib study evaluating LUMAKRAS (sotorasib) with carboplatin and pemetrexed in patients with KRAS G12C-mutated advanced NSCLC.
• Janssen Pharmaceuticals announced follow-up results from the Phase Ib/II CHRYSALIS-2 study of RYBREVANT (amivantamab-vmjw), targeting EGFR and MET, with lazertinib, an EGFR TKI, plus platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory NSCLC and EGFR mutations.
• As per AstraZeneca, subgroup analysis of the POSEIDON Phase III trial demonstrated that >2x patients derived long-term clinical benefit when treated with IMFINZI plus IMJUDO plus chemotherapy vs. chemotherapy alone. Phase III FLAURA2 trial of TAGRISSO plus CTx demonstrated a statistically significant, clinically meaningful improvement in PFS vs. TAGRISSO monotherapy. Interim data from TROPION-Lung04 provided encouraging efficacy and safety signals for both doublet and triplet regimens and set the stage for Phase III trials TROPION-Lung07, TROPION Lung08, and AVANZAR.

Metastatic Non-small Cell Lung Cancer Epidemiology

The Metastatic Non-small Cell Lung Cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of Non-small Cell Lung Cancer, total incident cases of Non-small Cell Lung Cancer by histology, total cases of Non-small Cell Lung Cancer by stages, total incident cases of Non-small Cell Lung Cancer by genetic mutation/biomarkers, total treated cases of Non-small Cell Lung Cancer by line of therapies in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the US, in 2023, there were approximately 202,600 new cases of lung cancer (~114,300 in men and ~88,400 in women About 10–15% of all lung cancers are SCLC, and about 80–85% are Non-Small Cell Lung Cancer.
• The three main histological subtypes of Non-Small Cell Lung Cancer are Adenocarcinoma, Squamous cell carcinoma, and large cell (undifferentiated) carcinoma. In the United States, approximately 57% of all lung cancers are adenocarcinomas.
• Among the age-specific contribution, age =65 years are affected more by NSCLC than age <65 years. In 2023, there were ~138,700 cases of NSCLC in age =65 years in the United States.
• In 2023, the total incident cases of NTRK metastatic NSCLC in the United States was around 445.
• In biomarker specific specific cases, most number of cases is from PD-L1 followed by KRAS, EGFR. On the other hand, NTRK accounted for least number of cases whereas, BRAF and MET accounted for approximately 5% and 4% cases, respectively.
• The two main subtypes of KRAS NSCLC are KRAS G12C, and KRAS non-G12C (G12V, G12D, G13D, G12R, and others). In the United States, ~22,300 cases comprised of KRAS G12C, and ~38,400 cases comprised of KRAS non-G12C in 2023.

Metastatic Non-small Cell Lung Cancer Recent Developments

• In September 2025, Eli Lilly announced that the U.S. FDA granted Breakthrough Therapy designation to olomorasib, combined with KEYTRUDA (pembrolizumab), for first-line treatment of unresectable advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation and PD-L1 expression ≥ 50%. Olomorasib is a selective second-generation KRAS G12C inhibitor showing early CNS activity.
• In September 2025, Boehringer Ingelheim announced that the U.S. FDA granted Breakthrough Therapy Designation to HERNEXEOS® (zongertinib tablets) for first-line treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase activating mutations.
• In August 2025, the FDA approved Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received prior systemic therapy, under accelerated approval.
• In August 2025, SystImmune and Bristol Myers Squibb announced that the FDA granted Breakthrough Therapy Designation to izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations after progression on EGFR TKI and platinum-based chemotherapy.
• In July 2025, DualityBio announced that the FDA granted Fast Track Designation to its next-generation HER3-targeting antibody-drug conjugate, DB-1310, for treating advanced or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) in patients with specific EGFR mutations after progression on prior targeted therapy and chemotherapy.
• In July 2025, Dizal announced FDA approval of ZEGFROVY® (sunvozertinib) to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, whose disease progressed after platinum-based chemotherapy.
• In June 2025, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
• In March 2025, Johnson & Johnson announced that new data from its oncology pipeline, including overall survival results from the Phase 3 MARIPOSA study, will be presented at the 2025 European Lung Cancer Congress. The study evaluates RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) versus osimertinib in first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations.
• In February 2025, the FDA granted Fast Track designation to IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, for treating patients with unresectable, locally advanced, or metastatic squamous NSCLC that has progressed after anti–PD-(L)1 therapy and platinum-based chemotherapy.

Metastatic Non-small Cell Lung Cancer Drug Chapters

The drug chapter segment of the Non-small Cell Lung Cancer report encloses a detailed analysis of Non-small Cell Lung Cancer marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Non-small Cell Lung Cancer pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Metastatic NSCLC Marketed Drugs

KEYTRUDA (pembrolizumab): Merck

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. The drug is mainly used for advanced cancers that have spread to other body parts or are not responding to other treatments.

In January 2023, Merck announced that the US FDA had approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a single agent for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with Stage IB (T2a =4 cm), II, or IIIA NSCLC.

KEYTRUDA is under review in the EU as monotherapy for the first-line treatment of patients with Stage III NSCLC who are not candidates for surgical resection, definitive chemoradiation, or metastatic NSCLC and whose tumors express PD-L1 (TPS =1%) with no EGFR or ALK genomic tumor aberrations based on results from the Phase III KEYNOTE-042 trial.

LIBTAYO (cemiplimab-rwlc): Regeneron Pharmaceuticals

LIBTAYO (cemiplimab) is a prescription medicine used to treat adults with a type of lung cancer called NSCLC. Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), a negative regulator of T-cell function. By blocking PD-1, cemiplimab enhances T-cell-mediated antitumor responses. It may be combined with chemotherapy containing platinum medicine as the first treatment when the lung cancer has not spread outside the chest (locally advanced lung cancer).

In November 2022, Regeneron Pharmaceuticals announced that the US FDA approved the PD-1 inhibitor LIBTAYO in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC with no EGFR, ALK or ROS1 aberrations.

In March 2023, Regeneron Pharmaceuticals announced that the European Commission (EC) approved LIBTAYO in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC with =1% PD-L1 expression. This includes patients with no EGFR, ALK, or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

Metastatic NSCLC Emerging Drugs

Telisotuzumab Vedotin (Teliso-V): AbbVie

Teliso-V is an investigational antibody–drug conjugate targeting c-Met, a receptor tyrosine kinase overexpressed in tumors, including Non-small Cell Lung Cancer. Teliso-V has the potential to become an important new treatment option in non-small cell lung cancer, with an anticipated approval in 2L+ NSCLC in 2024. In January 2022, AbbVie announced that the FDA granted Breakthrough Therapy Designation to investigational telisotuzumab vedotin for the treatment of patients with advanced/metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. In May 2022, AbbVie initiated a Phase III clinical trial to evaluate Teliso-V versus docetaxel for the treatment of patients with previously treated c-Met overexpressing, epidermal growth factor receptor wild type, and advanced/metastatic non-squamous NSCLC.

Datopotamab deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo

Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of the most advanced programs in AstraZeneca’s ADC scientific platform and one of the three leading ADCs in the oncology pipeline of Daiichi Sankyo. In January 2023, a Phase III clinical trial, combined with immune checkpoint inhibitors for the first-line treatment for Non-Small Cell Lung Cancer without actionable genomic alterations, PD-L1 <50% (trial name: TROPION-Lung07), was initiated. No TROP2-directed therapies are currently approved for treating Non-Small Cell Lung Cancer patients. AstraZeneca and Daiichi Sankyo are interrogating Dato-DXd in 1L non-driver mutation patients with TROPION-Lung08 (trying to knock off the Keynote-024 regimen) and with TROPION-Lung07 (trying to dethrone Keynote-189 regimen, the most important indication for Merck’s KEYRTUDA), as well as covering 2L and 3L patients with TROPION-Lung01.

Note: Detailed emerging therapies assessment will be provided in the final report...

Drug Class Insights

The existing Non-small Cell Lung Cancer treatment is mainly dominated by targeted therapies for mutations such as EGFR-sensitizing mutations, EGFR exon 20 insertions, ALK fusions, ROS1 fusions, BRAFV600E mutation, MET exon 14 skipping mutations, RET fusions, and KRASG12C mutation.

Epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements are well-known genetic abnormalities that drive the development of Non-small Cell Lung Cancer. The use of tyrosine kinase inhibitors (TKIs) as a treatment approach has shown better results in terms of patient outcomes when compared to chemotherapy.

EGFR mutations are frequently observed, EGFR exon 19 deletions and EGFR exon 21 L858R mutations. The FDA has approved various tyrosine kinase inhibitors (TKIs) to treat these mutations, with TAGRISSO (osimertinib) considered the standard treatment. GILOTRIF (afatinib) is approved for patients with other EGFR sensitivity mutations like S768I, L861Q, and G719X. However, approximately 8–10% of EGFR mutations involve exon 20 insertions, which do not respond to treatments targeting exon 19 or 21 alterations, including osimertinib. Currently, two targeted therapies, RYBREVANT (amivantamab) and EXKIVITY (mobocertinib), are approved for this particular mutation but only as a second-line option following platinum-based chemotherapy. Later EXKIVITY were withdrawn from the market. These mutations represent an area of unmet medical need in Non-small Cell Lung Cancer. While treatment with EGFR TKIs effectively eliminates most cancer cells, a small population of drug-tolerant cells may persist. These cells can remain inactive and undetectable for extended periods but eventually resume growth and spread to other body parts.

Moving onto ALK rearrangements, which are present in around 5% of Non-Small-Cell Lung Cancer cases, primarily in adenocarcinomas, represent a distinct molecular subtype of lung cancer. The first ALK inhibitor approved for treatment was crizotinib, and subsequently, several other ALK inhibitors have received approval, including ceritinib, alectinib, brigatinib, and lorlatinib. A direct comparison among all the ALK TKIs is still lacking, but researchers are actively developing new ALK TKIs to overcome resistance to the currently available ones. This suggests the possibility of a sequential treatment strategy involving different ALK TKIs in this specific disease.

While tumors with ROS1 rearrangements, known as ROS1-positive tumors, are not common, the similarities between ROS1 and ALK receptors, as well as the similarities between ROS1-positive and ALK-positive Non-small Cell Lung Cancer, have led to the repurposing of ALK inhibitors for the treatment of ROS1-positive disease. XALKORI (crizotinib), already approved for treating patients with ALK fusions, became the first drug specifically indicated for patients with ROS1-positive Non-small Cell Lung Cancer in 2016.

In treating patients with BRAF V600E mutations, the combination of dabrafenib and trametinib is approved. However, it is worth noting that BRAF mutations are relatively uncommon in Non-small Cell Lung Cancer compared to other cancers such as melanoma.

Even though numerous MET inhibitors with different mechanisms of action have failed to demonstrate significant effectiveness in clinical trials, the FDA has approved MET inhibitors like TABRECTA (capmatinib) and TEPMETKO (tepotinib) for treating patients with advanced Non-small Cell Lung Cancer that have MET exon 14 skipping mutations.

When treating RET alterations, Pralsetinib and selpercatinib have received approval. It is important to note that RET fusions, also called RET gene rearrangements, are distinct from RET mutations as they do not involve changes in the gene itself.

TRK inhibitors have demonstrated promising effectiveness and good tolerability in patients with solid tumors carrying NTRK fusions, regardless of the tumor's histology. The first-generation TRK inhibitors, such as larotrectinib and entrectinib, are recommended as the initial treatment for patients with locally advanced or metastatic Non-Small Cell Lung Cancer who have confirmed NTRK fusion. However, resistance to TRK inhibitors can eventually emerge due to various mechanisms, either directly targeting the TRK protein or through other indirect means. Interestingly, NTRK fusion has been identified as a potential resistance mechanism to EGFR-TKIs, suggesting that combining EGFR-TKIs with TRK inhibitors could be a potential treatment option for patients experiencing EGFR-TKI resistance mediated by NTRK fusion.

Considering that HER2 has emerged as a notable targetable oncogenic driver, lung cancer is particularly interesting due to the significant occurrence of mutations in the tyrosine kinase domain of the HER2 gene. In August 2022, ENHERTU (fam-trastuzumab deruxtecan-nxki) received approval to treat Non-Small Cell Lung Cancer patients with an activating HER2 mutation.

Targeting KRAS represents a significant advancement in oncology in recent times. KRAS is the most frequently mutated oncogene in human cancer, with the highest occurrence in non-small-cell lung, colorectal, and pancreatic cancer. In lung cancer, the most prevalent KRAS mutation is G12C. In the past, KRAS was considered "undruggable" due to the absence of conventional drug-binding sites. However, the approval of KRAS G12C inhibitors, such as sotorasib and adagrasib, for treating locally advanced or metastatic Non-Small Cell Lung Cancer has revolutionized the approach to treating cancers with KRAS G12C mutations. Numerous other KRAS players such as Gritstone Bio and Elicio Therapeutics, are evaluating their respective Pan-KRAS Vaccines in Phase I/II along with Immuneering Corporation with its KRASG12S in early-stage trial.

Targeted therapies targeting NRG1 alterations have also entered early clinical studies. Currently, there are no approved treatments specifically targeting NRG1-positive cancer. However, zenocutuzumab presents promising potential as a new standard of care. Below is a glimpse of US FDA-approved therapies for NSCLC.

Metastatic Non-small Cell Lung Cancer Market Outlook

As more targetable mutations are discovered, and new targeted drugs are developed, patients and oncologists will have an expanding array of treatment options. Given the rapid pace of drug approvals, it is important to pause and ensure sufficient data supports the use of specific agents in the appropriate treatment settings, including adjuvant, consolidation, first-line, or subsequent therapy.

Previously, molecular-based treatments were limited to advanced-stage Non-small Cell Lung Cancer. However, recent findings have demonstrated their efficacy in early-stage and locally advanced disease. New studies have explored therapies targeting a wider range of oncogenes, aiming to overcome drug resistance and provide treatment options for patients previously excluded from clinical trials for advanced-stage lung cancer. The emerging data from these ongoing trials are expected to influence future treatment guidelines and foster the adoption of personalized medicine. As a result, a continuous evolution of the treatment landscape is anticipated, ultimately leading to improved survival rates and enhanced quality of life for lung cancer patients.

PD-L1 Expression

With more than 500,000 cases in the 7MM region, lung cancer is one of the leading causes of death worldwide. This condition is often diagnosed when the patient reaches the advanced, inoperable, or metastatic stage, adversely affecting their quality of life.

Till the last decade, chemotherapy was used as the standard of care in the advanced and metastatic stages until the first ICI ‘KEYTRUDA (pembrolizumab)’ got approved in 2015 as a second-line treatment option for such advanced patients; a similar path was followed by TECENTRIQ (atezolizumab) who entered the market in 2016. These therapies entered the first-line domain after 2016 and expanded their labels by expanding the targetable pool. Recently, in 2020, OPDIVO (nivolumab) + ipilimumab was approved as a 1L treatment for patients with metastatic NSCLC.

EGFR Mutation

The treatment of EGFR-mutant NSCLC has been transformed by the development of targeted therapies in the last two decades; however, choosing the best therapy after EGFR TKIs fail is still a challenge. There are five EGFR tyrosine kinase inhibitors (TKIs) approved for first-line treatment of advanced NSCLC with common EGFR-sensitizing mutations (e.g., EGFR exon 19 deletions or exon 21 mutations [L858R]): erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib. These drugs have different efficacy and safety profiles and are classified as first- (e.g., erlotinib, gefitinib), second- (e.g., afatinib, dacomitinib), or third-generation (e.g., osimertinib) TKIs. Afatinib and osimertinib, which are second- and third-generation TKIs, respectively, have shown prolonged activity against some rare EGFR mutations (e.g., T790M [osimertinib], G719X, L861Q, or S768I [afatinib and osimertinib]).

Key players, such as AstraZeneca, Bristol Myers Squibb, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda, Eli Lilly, Immutep, Sanofi, GlaxoSmithKline, and others, are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products to treat Non-Small Cell Lung Cancer.

• The total market size of PD-L1 expressing NSCLC is estimated to be ~USD 20 billion by 2034 in the 7MM, followed by EGFR and KRAS.
• The total market size in the US for EGFR mNSCLC was estimated to be nearly USD 4,000 million in 2023, which is expected to increase due to the launch of emerging therapies and label expansion of current therapies.
• Alectinib is a common second ALK TKI used after crizotinib progression in 1st line of treatment. In 2023, Alectinib captured ~60% market share of the ALK market in the US.
• Lorlatinib is a third-generation ALK inhibitor that generated ~USD 250 million in 2023 in the 7MM.
• PD-L1 therapies are mainly utilized in patients without genetic drivers. Merck’s KEYTRUDA is generally considered the ‘gold standard’ of care in 1L NSCLC when combined with platinum-chemotherapy, regardless of PD-1 status.
• ENHERTU's uptake in HER2m NSCLC is strong, but ROZLYTREK and GAVRETO in RET-fusion are performing below sales expectations.

Metastatic Non-small Cell Lung Cancer Recent Developments

• In January 2025, the FDA accepted and granted priority review to the BLA for Dato-DXd for adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have previously received systemic therapies, including EGFR-targeted treatments. This BLA is supported by findings from the phase 2 TROPION-Lung05 trial, phase 3 TROPION-Lung01 trial, and phase 1 TROPION-PanTumor01 trial.
• In January 2025, the FDA granted fast track designation to BBO-8520 for adult patients with previously treated KRAS G12C-mutated metastatic NSCLC. BBO-8520 is an investigational oral agent being evaluated in an open-label, multicenter, first-in-human phase 1 study for the treatment of KRAS G12C-mutated NSCLC and colorectal cancer (CRC).
• In December 2024, Xcovery Holdings, Inc., an oncology-focused pharmaceutical company, announced FDA approval of ensartinib (Ensacove) for treating ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Metastatic Non-small Cell Lung Cancer Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

By overcoming the resistance from first and second-generation EGFR inhibitors and better efficacy in terms of overall response and progression-free survival, TAGRISSO become the market leader in the EGFR NSCLC market with fast uptake.

Lorlatinib is a third-generation ALK inhibitor. It showed higher potency and selectivity for ALK mutation, better penetration into the brain, and broader activity against different resistance mutations compared to the previous generation ALK inhibitor. Its uptake is fast compared to alectinib. However, by 2034, the highest market size will be captured by alectinib.

Further detailed analysis of emerging therapies drug uptake in the report...

Metastatic Non-small Cell Lung Cancer Activities

The report provides insights into Metastatic NSCLC clinical trials within Phase III and II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Non-Small Cell Lung Cancer emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists, Pulmonologists and Professors, Chief of the Thoracic Service at the Memorial Sloan Kettering Cancer Center, and Others.

DelveInsight’s analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 18+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas, UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Non-Small Cell Lung Cancer market trends.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Market Access and Reimbursement

The cost of treating Non-Small Cell Lung Cancer has shown significant increases over time, irrespective of the stage of the disease. According to real-world findings, this is particularly true for younger patients treated in the outpatient setting. Although first-generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries for other registered therapies—even for ALK inhibitors and checkpoint inhibitors in first-line—there were apparent gaps in availability and/or reimbursement.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Metastatic NSCLC Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Non-Small Cell Lung Cancer, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the Non-Small Cell Lung Cancer market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Non-Small Cell Lung Cancer market.

Metastatic Non-Small Cell Lung Cancer Report Insights

• Metastatic NSCLC Patient Population
• Metastatic NSCLC Therapeutic Approaches
• Metastatic NSCLC Pipeline Analysis
• Metastatic NSCLC Market Size and Trends
• Existing and future Market Opportunity

Metastatic Non-Small Cell Lung Cancer Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Non-Small Cell Lung Cancer Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Metastatic NSCLC Drugs Uptake
• Key Metastatic NSCLC Market Forecast Assumptions

Metastatic Non-Small Cell Lung Cancer Report Assessment

• Current Metastatic NSCLC Treatment Practices
• Metastatic NSCLC Unmet Needs
• Metastatic NSCLC Pipeline Product Profiles
• Metastatic NSCLC Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the historical and forecasted Non-Small Cell Lung Cancer patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What was the Non-Small Cell Lung Cancer total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
• How will different NSCLC target classes affect the treatment paradigm of Non-Small Cell Lung Cancer?
• What will be the impact of KEYTRUDA’s expected patent expiry?
• How will KEYTRUDA compete with other therapies in the first- and second lines?
• Which class is going to be the largest contributor in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• Although multiple expert guidelines recommend testing for targetable mutations prior to therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for treating Non-Small Cell Lung Cancer?
• How many companies are developing therapies to treat Non-Small Cell Lung Cancer?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy Metastatic NSCLC Market Report

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Non-Small Cell Lung Cancer Market.
• 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
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

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• Novel Insights Into The Non-Small Cell Lung Cancer Market
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• Latest DelveInsight Blogs

Related Infographics of the Report

• BRAF Non-Small Cell Lung Cancer (BRAF+ NSCLC) Market
• ALK Non-Small Cell Lung Cancer (ALK+ NSCLC) Market
• c-MET Non-Small Cell Lung Cancer (c-MET+ NSCLC) Market
• EGFR Non-Small Cell Lung Cancer (EGFR+ NSCLC) Market
• PD-L1Non-Small Cell Lung Cancer (PD-L1+ NSCLC) Market