Metastatic Non-small Cell Lung Cancer Market Forecast Analysis and with Focus on its Immune/Molecular Biomarker Types: PD-L1, EGFR, KRAS, ALK, BRAF, MET, ROS-1, HER2, RET fusion, and NTRK1/2/3 Gene fusion | DelveInsight

The metastatic non-small cell lung cancer market size is expected to witness a revolutionary change in the coming decade owing to the increase in incident cases of NSCLC, continuous uptake of approved therapies, expected entry of potential premium price emerging therapies, and increasing awareness of mutations like KRAS, HER2, c-Met, and others. 

LAS VEGAS, Nov. 28, 2023 /PRNewswire/ -- DelveInsight's Metastatic Non-small Cell Lung Cancer Market Insights report includes a comprehensive understanding of current country-specific treatment practices, metastatic non-small cell lung cancer upcoming therapies, market share of mNSCLC individual approved & emerging therapies, and current and forecasted mNSCLC market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Germany, France, Italy, Spain), the United Kingdom, and Japan].

Metastatic Non-small Cell Lung Cancer Market Report Key Takeaways

• The metastatic non-small cell lung cancer market is anticipated to grow at a significant CAGR of 9.4% by 2032.
• The highest market size is expected from the, followed by PDL1 NSCLC segment is expected to contribute the highest to market size followed by EGFR and KRAS by 2032 in the 7MM.
• As per DelveInsight's analysis, the total incident cases of NSCLC in the 7MM were approximately 500K cases in the year 2022 and is expected to reach approximately 600K cases in the year 2032.
• 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-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 ~40% of NSCLC cases.
• The focus of most trials in NSCLC in recent years has been in the metastatic setting as monotherapy or in combination with chemotherapy and other targeted agents.
• Key NSCLC companies, such as Cstone/Pfizer, BeiGene, EQRx International, Hansoh Pharmaceutical, Daiichi Sankyo, AstraZeneca, Gilead Sciences, AbbVie, Sanofi, Novartis, Taiho Pharmaceutical, Cullinan Oncology, Arrivent Biopharma, Bristol-Myers-Squibb, Xcovery, OSE Immunotherapeutics, Jiangsu HengRui Medicine, Merck, GlaxoSmithKline, Arcus Biosciences, Gilead Sciences, Shanghai Henlius Biotech, Incyte, Macrogenics, Akeso Biopharma, OncoC4/BioNtech, Roche, Regeneron Pharmaceuticals, Revolution Medicines, AnHeart Therapeutics, Innovent Biologics, NeoTX Therapeutics, Alethia Biotherapeutics, Immutep, Iovance Biotherapeutics, Candel Therapeutics, Helsinn Healthcare, Ellipses Pharma, Kelun-Biotech, Dizal Pharmaceutical, RedCloud Bio, J Ints Bio, Blueprint Medicines Corporation, Forward Pharmaceuticals, Mirati Therapeutics, Amgen, SignalChem, Verastem, Haihe Biopharma, Ribon Therapeutics, PDC*line Pharma, and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for NSCLC treatment.
• Before the approval of the first drug LUMAKRAS (licensed for KRAS G12C mutant NSCLC), KRAS mutations were historically thought to be undruggable. Despite only treating less than half of the KRAS mutation, Amgen's LUMKRAS and Mirati's KRAZATI are predicted to generate approximately USD 3.0 billion in 7MM sales in 2032. The EMA panel's rejection of Mirati's KRAZATI is one recent development that stunned many experts in the field.

Dive deeper for rich insights into the Metastatic NSCLC Market Outlook

Metastatic Non-small Cell Lung Cancer: Overview and Treatment

NSCLC is the most common type of lung cancer, accounting for 80-85% 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, often, these cancers have symptoms that are mistaken for common illnesses or the effects of long-term smoking. NSCLC 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, chemoradiotherapy, immunotherapy, and targeted cancer drugs.

Metastatic NSCLC refers to advanced stages of cancer that have spread to other regions of the body. There is no cure for cancer once it has spread. Treatment is frequently aimed at extending a person's life and increasing their quality of life.

Key Analysis of the Various NSCLC Biomarkers 

Recently, DelveInsight launched the epidemiology-based metastatic non-small cell lung cancer market report covering the detailed analysis of mNSCLC genetic mutations/biomarkers for the study period 2019–2032 in the 7MM. The most frequent biomarkers are EGFR, ALK, PD-L1, ROS1, BRAF, MET, KRAS, RET, HER2, and NTRK. Let's deep dive into the assessment of these biomarkers individually

PD-L1

The total incident cases of PD-L1 genetic mutations were ~263K cases in 2022 in 7MM and these cases are further expected to rise by 2032. Assessment of the PD-L1 biomarker through immunohistochemistry or other techniques helps oncologists determine whether a patient is a candidate for immune checkpoint inhibitor therapies, which have revolutionized the treatment landscape for mNSCLC. This biomarker has transformed personalized medicine in lung cancer by guiding treatment decisions and improving patient outcomes.

With the rising incidence and launch of emerging therapies, the PD-1 NSCLC market will show significant growth in the coming years. Front-line NSCLC represents a large market, currently only being dominated by anti-PD1 drugs and anti-PD-1 + CTx combination, leaving a significant opportunity for therapy beyond anti-PD1 to deliver higher clinical benefit. 

"The PD-1 mNSCLC market is estimated to rise to USD 20 billion in the 7MM by 2032." DelveInsight.

mNSCLC Late-Stage Pipeline Therapies Targeting PD-L1 Mutations and Companies

• Tislelizumab: BeiGene
• Datopotamab Deruxtecan: Daiichi SankyoTRODELVY: Gilead Sciences
• Ceralasertib: AstraZeneca
• Ociperlimab + Tislelizumab: BeiGene
• Zimberelimab + Domvanalimab: Gilead Sciences/Arcus Biosciences
• Vibostolimab + KEYTRUDA: MERck
• Tiragolumab: Hoffmann-La Roche
• Eftilagimod alpha: Immutep
• HLX10 + CTx: Shanghai Henlius Biotech

For more insights into the PD-L1 mNSCLC market landscape, visit PD-L1 mNSCLC Market Outlook

EGFR

Epidermal growth factor receptor (EGFR) mutations are well-known genetic abnormalities that drive the development of NSCLC. As per the assessment done by DelveInsight, total incident cases of EGFR genetic mutations were ~115K cases in 2022 and these cases are further expected to rise by 2032 in the 7MM.

The rapid development of EGFR-TKIs has revolutionized the treatment patterns of EGFR-mutated NSCLC, which improved the survival and quality of life of this population. 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% to 10% of EGFR mutations involve exon 20 insertions, which do not respond to treatments targeting exon 19 or 21 alterations, including osimertinib.

In recent years, EGFR has become one of the lucrative NSCLC biomarkers, with TAGRISSO being the market leader. The drug approval for the exon 20 insertion subgroup of EGFR represents the most current EGFR advancement. In the market for exon 20 insertion EGFR mutant NSCLC, RYBREVANT has a competitive advantage over EXKIVITY since it has demonstrated superior effectiveness and safety. In addition, in combination with lazertinib to compete with TAGRISSO, RYBREVANT is also broadening its focus to target the larger EGFR mutant NSCLC market. Takeda said in October 2023 that it would voluntarily remove EXKIVITY from the United States after failing to meet the primary endpoint in a late-stage study.

Late-Stage and Mid-Stage Pipeline Therapies Targeting EGFR Mutations and Companies

• Patritumab Deruxtecan (Her3-DXd): Daiichi Sankyo
• Ivonescimab + CTx: Summit Therapeutics/Akeso
• Zipalertinib (TAS6417): CULLINAN ONCOLOGY/Taiho Oncology
• Sunvozertinib (DZD9008): Dizal Pharmaceutical
• Aumolertinib ± CTx: EQRx International/Hansoh Pharmaceutical

For a deeper understanding of the EGFR mNSCLC market landscape, explore the EGFR mNSCLC Market Outlook

KRAS

Targeting KRAS represents a significant advancement in the field of oncology in recent times. KRAS is the most frequently mutated oncogene in human cancer, with the highest occurrence in non-small-cell lung cancer, followed by colorectal cancer, and pancreatic cancer. In lung cancer, the most prevalent KRAS mutation is G12C. As per DelveInsight analysis, total incident cases of KRAS genetic mutations were  ~130K cases in 2022 and these cases are further expected to rise by 2032.

The most common and mostly unexplored biomarker in NSCLC is KRAS. Only the KRAS G12C subtype is targeted by the presently approved KRAS inhibitors (LUMAKRAS & KRAZATI). Patients with less common KRAS mutations are still unaddressed. So far, no drug has been authorized for non-G12C KRAS patients. There is an opportunity for pan-KRAS inhibitors for broader KRAS mutation coverage. Currently, 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 trials.

Late-Stage Pipeline Therapies Targeting KRAS Mutations and Companies

• Garsorasib (D-1553): InventisBio
• Glecirasib (JAB-21822): Jacobio
• RMC-4630: Revolution medicine
• SLATE-KRAS/v: Gritstone bio
• LY3537982: Eli Lilly

ALK

ALK rearrangements are present in around 5% of NSCLC cases, primarily in adenocarcinomas, and represent a distinct molecular subtype of lung cancer. As per DelveInsight analysis, total incident cases of ALK genetic mutations were ~25K cases in 2022 and these cases are further expected to rise by 2032. 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.

Late-Stage and Mid-Stage  Pipeline Therapies Targeting ALK Mutations and Companies

• X-396 (Ensartinib): Xcovery Holding Company
• NVL-655: Nuvalent

and others

For a comprehensive view of the ALK-mNSCLC market, check out the ALK-mNSCLC Market Outlook

BRAF

BRAF is a gene that encodes a protein involved in cell signaling pathways. In a subset of NSCLC patients, mutations in the BRAF gene have been identified as a critical driver of the disease. These mutations can lead to uncontrolled cell growth and division, contributing to the development and progression of NSCLC. As per DelveInsight analysis, total incident cases of BRAF genetic mutations were ~21K cases in 2022 and these cases are further expected to rise by 2032. 

The discovery of BRAF mutations as a biomarker in NSCLC has opened new avenues for targeted therapies, as drugs specifically designed to inhibit BRAF-mutated proteins have shown promise in clinical trials. Identifying and targeting the BRAF biomarker in NSCLC is a significant step forward in the quest for more effective and personalized treatments for this challenging form of lung cancer. In the treatment of 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 NSCLC compared to other cancers such as melanoma.

Early and Mid-Stage Pipeline Therapies Targeting BRAF Mutations and Companies

• VS-6766: Verastem

 and others

If you're looking for further information on the BRAF-mutated mNSCLC market landscape, please visit the BRAF-mutated mNSCLC Market Outlook

MET

One significant biomarker in NSCLC is MET, a receptor tyrosine kinase that plays a pivotal role in cell growth, survival, and metastasis. MET biomarker testing is essential for identifying NSCLC patients who may benefit from targeted therapies like MET inhibitors or combination treatments. As per DelveInsight analysis, total incident cases of MET genetic mutations were ~30K cases in 2022 and these cases are further expected to rise by 2032.

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 NSCLC that have MET exon 14 skipping mutations. 

Early and Mid-Stage Pipeline Therapies Targeting MET Mutations and Companies

• Telisotuzumab Vedotin: AbbVie
• REGN5093: Regeneron Pharmaceuticals
• MYTX-011: Mythic Therapeutics
• REGN5093-M114: Regeneron Pharmaceuticals

 and others

For a more comprehensive overview of the c-MET mutated mNSCLC market, make sure to visit the c-MET Mutated mNSCLC Market Outlook

ROS-1

ROS1 stands out as a key driver mutation in a subset of NSCLC cases. ROS1 gene rearrangements are relatively rare, occurring in about 1-2% of NSCLC patients, but they hold great significance in the context of personalized treatment. As per DelveInsight analysis, total incident cases of ROS1 genetic mutations were ~11K cases in 2022 and these cases are further expected to rise by 2032.

In ROS1-rearranged NSCLC, first-line treatment with crizotinib or entrectinib and subsequent treatment with lorlatinib at disease progression leads to similar results in patients with metastatic disease. ROZLYTREK (entrectinib) was approved in Japan as an oral selective inhibitor of TRKA/B/C, ROS1, and ALK tyrosine kinases for treating advanced or recurrent adult and pediatric solid tumors with positive NTRK fusion. Then, ROZLYTREK soon received approval for this indication by the FDA in August 2019. Lorlatinib is a third-generation ROS1 TKI with improved CNS activity due to high CSF fluid concentrations through the reduction of P-glycoprotein-mediated efflux. In the emerging pipeline, Turning Point Therapeutics, in collaboration with Zai Lab, is currently developing repotrectinib, a next-generation TKI known for its efficient ability to cross the blood-brain barrier.

Early and Mid-Stage Pipeline Therapies Targeting ROS1 Mutations and Companies

• Taletrectinib (DS-6051b; AB-106): AnHeart Therapeutics/Innovent Biologics/Daiichi Sankyo
• Repotrectinib (TPX-0005): BMS/Turning Point Therapeutics/Zai Lab
• NVL-520: Nuvalent

and others

RET Fusion

RET (Rearranged during Transfection) is a gene that, when mutated or altered, can drive the growth and spread of NSCLC. Identifying the RET biomarker through advanced genetic testing is crucial as it enables oncologists to tailor treatment plans, such as RET inhibitors, to specifically target the underlying genetic abnormalities driving the cancer's progression. As per DelveInsight analysis, total incident cases of RET fusion genetic mutations were ~9K cases in 2022 and these cases are further expected to rise by 2032.

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

Early and Mid-Stage Pipeline Therapies Targeting RET Fusion Mutations and Companies

• Vepafestinib: Helsinn Healthcare
• EP0031: Ellipses Pharma/Kelun-Biotech

 others

NTRK1/2/3 Gene Fusion

The NTRK fusion biomarker has emerged as a significant player in the realm of targeted therapy. NTRK, which stands for Neurotrophic Tyrosine Receptor Kinase, is a family of genes that encode for proteins essential in nerve cell development. When fusion events occur, leading to the abnormal activation of NTRK genes, it can result in uncontrolled cell growth and contribute to the development of NSCLC. As per DelveInsight analysis, total incident cases of NTRK fusion genetic mutations were  1.1K cases in 2022 and these cases are further expected to rise by 2032.

Currently, 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 NSCLC 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. 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. 

Early and Mid-Stage Pipeline Therapies Targeting NTRK Fusion Mutations and Companies

• Repotrectinib: Turning Point Therapeutics/Zai Lab

and others

HER2

NSCLC is a complex and heterogeneous disease, and the identification of specific biomarkers has become crucial in tailoring targeted therapies for patients. One such biomarker of growing significance in NSCLC is HER2, which stands for Human Epidermal Growth Factor Receptor 2. While HER2 alterations have historically been associated with breast cancer, recent research has revealed their presence in a subset of NSCLC cases as well. HER2-positive NSCLC represents a distinct molecular subtype, characterized by genetic alterations or overexpression of the HER2 gene. As per DelveInsight analysis, total incident cases of HER2 genetic mutations were  ~11K cases in 2022 and these cases are further expected to rise by 2032.

Considering that HER2 has emerged as a notable targetable oncogenic driver and lung cancer is of particular interest 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 for the treatment of NSCLC patients with an activating HER2 mutation.

Late and Mid-Stage Pipeline Therapies Targeting HER2 Mutations and Companies

• ENHERTU: AstraZeneca and Daiichi Sankyo
• Pyrotinib: Jiangsu HengRui Medicine
• Sunvozertinib (DZD9008): Dizal Pharmaceuticals
• BI-1810631: Boehringer Ingelheim, and others

To delve into the HER2+ mNSCLC market landscape in more detail, access the HER2+ mNSCLC Market Outlook

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