PUBLISHER: DelveInsight | PRODUCT CODE: 1652667
PUBLISHER: DelveInsight | PRODUCT CODE: 1652667
DelveInsight's "Non-small Cell Lung Cancer (NSCLC) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of top oncogenic drivers/biomarkers in NSCLC (such as EGFR, c-MET, ROS1, KRAS, ALK, HER2, BRAF, RET fusion, NRG1 fusion, NTRK1/2/3 gene fusion, PD-L1, etc.), historical and forecasted epidemiology as well as the NSCLC market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
NSCLC market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM NSCLC market size from 2020 to 2034. The report also covers current NSCLC treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
NSCLC Overview and Diagnosis
NSCLC is the most common type of lung cancer, accounting for 81% of all lung cancer diagnoses. Early diagnosis offers the best prognosis for NSCLC. However, NSCLC 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 NSCLC 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.
NSCLC 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 NSCLC are:
The NSCLC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of NSCLC, gender-specific cases of NSCLC, age-specific cases of NSCLC, total incident cases of NSCLC by histology, total cases of NSCLC by stages, total incident cases of NSCLC by genetic mutation/biomarkers, Line wise Treated Cases of Metastatic NSCLC in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the NSCLC report encloses a detailed analysis of NSCLC marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the NSCLC pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.
Marketed Drugs
KEYTRUDA (pembrolizumab): Merck
KEYTRUDA is a PD-1-blocking antibody. It is mainly used for advanced cancers that have spread to other body parts or are not responding to other treatments. In some cancers, it is only given to patients whose tumors produce high protein levels known as PD-L1. KEYTRUDA was first approved in October 2015 by the US FDA as a monotherapy for metastatic NSCLC. Later, the labels were expanded in 2016, 2017, 2018, and in 2023. In October 2023, the FDA approved KEYTRUDA platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent KEYTRUDA as post-surgical adjuvant treatment for resectable (tumors =4 cm or node positive) NSCLC. The drug has also received approvals in EU4 and the UK (August 2016) and Japan (December 2016), where the labels were expanded as well. Recently in September 2024, Merck announced that the MHLW has approved new indications for KEYTRUDA in combination with chemotherapy as a neoadjuvant treatment. Earlier in March 2024, Merck announced that the EC has approved KEYTRUDA in combination with platinum-containing chemotherapy as neoadjuvant treatment
In December 2024, Merck announced that it is discontinuing the Phase III KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with NSCLC, based on the recommendation of an independent Data Monitoring Committee (DMC).
TECENTRIQ (atezolizumab): Genentech/Roche
TECENTRIQ is a PD-L1-blocking antibody. It is an Fc-engineered, humanized, non-glycosylated IgG1 kappa immunoglobulin with a calculated molecular mass of 145 kDa. According to Roche's recent product development portfolio published in October 2024, the company anticipates submitting a filing for TECENTRIQ in the periadjuvant treatment of NSCLC in 2025.
TECENTRIQ was initially approved by the US FDA for the treatment of people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities in October 2016. Later, the company expanded the label in 2018, 2019, 2020, 2021, and 2024. The drug was also approved in the EU (September 2017) and in Japan (April 2018) for the treatment of NSCLC. Recently, in September 2024, the US FDA approved TECENTRIQ and HYBREZA (hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for SC, under the skin injection for patients in the US.
Emerging Drugs
Telisotuzumab vedotin: 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. In December 2024, Daiichi Sankyo announced Dato-DXd has been granted BTD in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
Drug Class Insights
The existing NSCLC 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.
EGFR mutations and ALK rearrangements are well-known genetic abnormalities that drive the development of NSCLC. The use of 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 TKIs to treat these mutations, with TAGRISSO considered the standard treatment. GILOTRIF 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, three targeted therapies, RYBREVANT, TAGRISSO and EXKIVITY, are approved for EGFR. Later EXKIVITY were withdrawn from the market. These mutations represent an area of unmet medical need in NSCLC. 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.
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.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, 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.
NSCLC Activities
The report provides insights into therapeutic candidates in 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 NSCLC 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.
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 NSCLC 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.