The EGFR non-small cell lung cancer (EGFR + NSCLC) market is estimated to be valued at USD 4.31 Bn in 2024 and is expected to reach USD 7.27 Bn by 2031, growing at a compound annual growth rate (CAGR) of 7.7% from 2024 to 2031. The increasing prevalence of lung cancer across the world and rising focus on targeted therapies to treat NSCLC are fueling the growth of this market.

Market Driver - Increasing Incidence of NSCLC Cases with EGFR Mutations

The occurrence of non-small cell lung cancer (NSCLC) cases harboring epidermal growth factor receptor (EGFR) mutations has witnessed a marked rise over the past decade. Statistics show lung cancer is now the most commonly diagnosed cancer as well as the leading cause of cancer death among both men and women in the United States. This genomic alteration is known to drive tumor growth and disease progression in NSCLC patients.

Large epidemiological studies have found the incidence of EGFR mutations to vary between regions and ethnicities. For instance, East Asian countries like Japan, China and South Korea report mutation rates as high as 40-50% in their lung cancer patient pool compared to rates below 10% observed in Caucasian populations. Even within the United States, a higher prevalence of 15-20% is seen among Asian-American NSCLC cases.

A majority of EGFR mutations occur in exons 18 to 21 of the gene which encodes the tyrosine kinase domain of EGFR. Widespread screening combined with growing NSCLC patient volumes has significantly raised the base number of new EGFR mutation-positive diagnoses every year. Rising incidence trend of targetable EGFR mutant NSCLC presents a sizable opportunity for pharmaceutical innovations in this space.

Market Driver - Strong Clinical Advancements in EGFR Inhibitors

The EGFR-TKI class of targeted therapies has emerged as the standard-of-care first-line treatment option for advanced or metastatic NSCLC patients with activating EGFR mutations. Compared to chemotherapy, EGFR-TKIs delivered higher response rates, longer progression-free survival and an improved safety profile and quality of life for patients.

Continued R&D in this field has led to second and third-generation compounds with enhanced efficacy. Osimertinib is a potent, irreversible EGFR-TKI targeting the T790M resistance mutation and was the first drug to demonstrate a progression-free and overall survival benefit over platinum-based chemotherapy in the second-line setting.

In addition to late-stage trials in specialized populations and adjuvant/neoadjuvant use, biomarker-driven studies are optimizing patient selection. Companion diagnostics play a defining role to guide genetic screening and ensure only mutation-positive patients receive EGFR-TKI therapy. Continued scientific progress establishing robust evidence-based treatment pathways from early to late disease has improved outcomes for EGFR mutant NSCLC to the level of a chronic disease for selected patient subsets. This has reinforced the central role of EGFR inhibitors in modern precision oncology practice.

Market Challenge - High Costs Associated with Targeted Therapies

One of the major challenges faced in the EGFR + NSCLC market is the high costs associated with targeted therapies. EGFR inhibitors like gefitinib, erlotinib, and afatinib which are used as first-line treatments for EGFR mutated NSCLC have significantly high costs. For instance, the average wholesale price of erlotinib is approximately $7,000 per month in the United States. The high costs of these targeted drugs pose affordability challenges for a majority of patients, especially in developing countries where the incidence and mortality rates of lung cancer are rising rapidly.

Additionally, the costs put a huge strain on public and private health insurance budgets. While targeted therapies have improved clinical outcomes compared to chemotherapy, the expense involved limits their widespread accessibility and adoption. Drug developers will need to explore strategies to make these life-saving drugs more affordable without compromising on their efficacy.

Market Opportunity - Expanding Research on Combination Therapies

One of the key opportunities in the EGFR + NSCLC market is expanding research on combination therapies, such as EGFR inhibitors with immunotherapy. As monotherapy resistance develops in a majority of patients within a year of treatment initiation, combining EGFR inhibitors with immunotherapies holds promise to potentially delay or prevent resistance development.

Ongoing clinical trials are evaluating the safety and efficacy of combining EGFR inhibitors like osimertinib and gefitinib with immune checkpoint inhibitors like pembrolizumab. Positive results from such studies could establish EGFR inhibitor plus immunotherapy combinations as an important new standard of care.

This will significantly expand the addressable patient pool and market potential for drug developers. Greater research efforts to understand combination therapy mechanisms and biomarkers of response can optimize outcomes for NSCLC patients.

EGFR mutations are common in NSCLC, occurring in 10-15% of cases. Treatment approaches vary depending on disease stage and line of therapy. For early-stage EGFR+ NSCLC, surgical resection is the standard first-line treatment.

In metastatic or advanced settings, first-line EGFR TKI therapy is preferred. Two of the most commonly prescribed first-generation TKIs are Tarceva (erlotinib) and Iressa (gefitinib). These oral medications target the EGFR mutation and have shown superior progression-free survival over platinum-based chemotherapy.

Upon disease progression, prescribers often consider second-generation EGFR TKIs like Tagrisso (osimertinib). Tagrisso selectively targets both common EGFR mutations as well as the resistant T790M mutation, making it an important second-line option. It has significantly improved outcomes versus platinum chemotherapy in this setting.

For patients with the T790M mutation who progress on Tagrisso, third-generation TKIs such as Dotorza (dorvotinib) may be explored in clinical trials, though these newer agents have not yet received FDA approval. Beyond the third line, chemo-immunotherapy combinations like Keytruda (pembrolizumab) plus platinum doublet chemotherapy become preferred when patients are still sufficiently fit.

Overall treatment selection is influenced by mutation status, performance status, organ dysfunction, prior treatment history, and availability of clinical trial options.

EGFR + NSCLC can be treated based on the stage of cancer. For stage I-IIIA disease, surgery is the standard first-line treatment with the goal of removing the tumor. For patients whose cancer has spread to distant areas (stage IV), systemic therapy is preferred.

First-line treatment options for stage IV include tyrosine kinase inhibitors (TKIs) such as gefitinib (Iressa), erlotinib (Tarceva), or afatinib (Gilotrif). These oral drugs target the EGFR mutation that is driving cancer growth and have proven effective with response rates around 65-75%. They are preferred over chemotherapy as they provide similar efficacy with fewer side effects. Among the TKIs, afatinib is preferred due to its ability to target both activated and resistant EGFR mutations.

For patients who progress on first-line TKI treatment, second-line options include chemo drugs like pemetrexed (Alimta) or docetaxel. Some may benefit from switching to a different TKI like osimertinib (Tagrisso) which is able to overcome common resistance mutations. For those who progress on second-line chemotherapy or TKI, third-line treatment choices consist of chemotherapy, clinical trials, or best supportive care depending on performance status and tumor burden. The goal at this stage is to improve quality of life by controlling cancer progression.

Roche's acquisition of Genentech in 2009 was a strategic move to gain access to Genentech's biomarker testing capabilities and FDA-approved EGFR inhibitor Tarceva (erlotinib). This acquisition positioned Roche as the leading player in the EGFR + NSCLC market. Tarceva was the first FDA-approved EGFR TKI therapy and dominated the EGFR non-small cell lung cancer (EGFR + NSCLC) market until 2015. By acquiring Genentech, Roche combined drug development and diagnostic capabilities that helped drive personalized treatment of EGFR+ patients.

AstraZeneca's Tagrisso (osimertinib) has been a major breakthrough in the EGFR non-small cell lung cancer (EGFR + NSCLC) market. Launched in 2015, Tagrisso is specifically designed to treat EGFR T790M mutation which causes resistance to earlier generation EGFR TKIs. Within 2 years of launch, Tagrisso captured over 50% share of the third-generation EGFR TKI market, demonstrating its best-in-class efficacy and strong clinical data. AstraZeneca adopted a targeted launch strategy, educating physicians about T790M mutation and the benefits of Tagrisso.

PFE/Merck's Tagrisso faced latest entry challenges but it adopted a two-pronged strategy - an 'umbrella' trial studying Tagrisso for all EGFR+ populations and providing comprehensive access programs. This helped communicate Tagrisso's broader utility and overcome access barriers. Between 2017-2019, Tagrisso's market share doubled to over 30% in the overall EGFR TKI market, demonstrating the success of PFE/Merck's strategy.

Insights, By Treatment: New Targeted Therapies Driving Growth of EGFR-TKI Inhibitors

In terms of treatment, EGFR-TKI inhibitors account for approximately 63.4% share of the EGFR non-small cell lung cancer (EGFR + NSCLC) market in 2024, owning to the benefits offered by these new targeted therapies over standard chemotherapy. EGFR-TKI inhibitors like afatinib, erlotinib and gefitinib directly target mutations in the Epidermal Growth Factor Receptor (EGFR), a key driver of cancer cell proliferation in NSCLC tumors. By blocking the action of EGFR, these new drugs are able to halt cancer growth more effectively with lesser side-effects compared to traditional chemotherapies which affect both cancerous as well as healthy rapidly dividing cells.

The superior clinical efficacy demonstrated by EGFR-TKI inhibitors in improving progression-free survival as well as overall survival rates among NSCLC patients with activating EGFR mutations has made them the standard of care as first-line treatment for this specific patient subgroup.

Additionally, these oral drugs offer the benefit of easy administration and better quality of life to patients compared to lengthier intravenous chemotherapy regimens. With increasing awareness and adoption among patients and physicians, the usage of EGFR-TKI inhibitors is growing at a faster pace, driving its share in the overall NSCLC treatment market.

Insights, By Stages of the Disease: Early Detection Fueling Dominance of Early-Stage NSCLC

In terms of stages of the disease, early-stage NSCLC is projected to hold 58.7% share of the EGFR non-small cell lung cancer (EGFR + NSCLC) market in 2024. This can be attributed to growing awareness programs that encourage regular lung screenings as well as advancements in diagnostic techniques that allow for earlier detection of NSCLC tumors. Technologies such as low-dose CT scans provide radiologists the ability to catch even tiny cancerous lesions in their initial stages before they metastasize to other organs.

 Once NSCLC is identified at an early localized stage while still confined to the lungs, treatment options such as surgery to remove the tumor hold higher chances of cure with fewer complications and longer survival outcomes for patients. The benefits of early detection in catching NSCLC at the curable early stage is driving higher treatment rates within this segment compared to advanced metastatic disease.

Insights, By Therapy Approvals: Efficacy Data catapulting Frontline Usage of First-line Treatments

In terms of therapy approvals, first-line treatments contribute the highest share of the EGFR non-small cell lung cancer (EGFR + NSCLC) market owing to the survival advantages conferred by these options when used upfront for newly diagnosed NSCLC patients. Landmark clinical trials have provided robust evidence establishing EGFR-TKI inhibitors and immune checkpoint inhibitors as preferred first-line therapy protocols for specific molecular subclasses of NSCLC.

By delivering superior overall response rates and progression free survival benefits compared to chemotherapy alone, these new targeted and immune-oncology based combination regimens have become coveted treatments prescribed in the frontline setting to maximize patient outcomes.

Further research validating the use of immunotherapy, chemo-immunotherapy and novel combinations in earlier treatment lines is propelling higher consumption of first-line approved therapies in the NSCLC market.

• EGFR mutations are present in approximately 10-15% of NSCLC cases, with a higher prevalence in Asian populations, making Asia-Pacific a significant growth region for EGFR-targeted treatments.
• Unmet Needs: The development of therapies to address resistance mutations such as C797S is crucial in the NSCLC treatment landscape.
• EGFR Inhibitors Impact: EGFR inhibitors remain the first-line treatment for EGFR-mutant NSCLC but have limited efficacy against specific mutations, such as exon 20 insertions.

The major players operating in the EGFR non-small cell lung cancer (EGFR + NSCLC) market include AstraZeneca, Janssen Pharmaceuticals, Pfizer, Roche, Novartis, Cullinan Oncology, Bridge Biotherapeutics, ORIC Pharmaceuticals, BeiGene, Dizal Pharmaceuticals, Merck & Co., and Bristol-Myers Squibb.

• In March 2024, AstraZeneca expanded its clinical trials for TAGRISSO (osimertinib) in combination with chemotherapy. The trial, known as FLAURA2, demonstrated a significant improvement in progression-free survival (PFS) in patients with advanced-stage EGFR-mutated non-small cell lung cancer (NSCLC). The combination of TAGRISSO and chemotherapy showed better outcomes compared to TAGRISSO alone, potentially enhancing survival rates for patients with more aggressive forms of NSCLC​.
• In September 2023, Janssen Pharmaceuticals reported positive results from the Phase 3 MARIPOSA trial. The trial evaluated the combination of amivantamab (RYBREVANT®) and lazertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC). The study demonstrated a significant improvement in progression-free survival (PFS) compared to osimertinib, the current standard of care. Specifically, the combination therapy reduced the risk of disease progression or death by 30%, with a median PFS of 23.7 months for amivantamab and lazertinib, compared to 16.6 months for osimertinib​.
• In August 2023, ORIC-114 announced that it is currently undergoing Phase I clinical trials, and significant findings indicate that the drug demonstrates promising CNS activity. Specifically, ORIC-114, a brain-penetrant EGFR and HER2 inhibitor, has shown notable activity against brain metastases in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 mutations. The trial revealed both systemic and intracranial responses, including the first reported confirmed complete response in a patient with untreated brain metastases​. This highlights its potential in addressing CNS metastasis, a significant challenge in NSCLC treatments.
• In July 2023, BBT-176, developed by Bridge Biotherapeutics, demonstrated promising efficacy in its Phase I trials for treating non-small cell lung cancer (NSCLC) with EGFR mutations. The drug specifically targets the complex EGFR mutations (including C797S mutations) that arise after resistance develops to third-generation EGFR inhibitors like osimertinib. In the interim results from the study reported significant tumor shrinkage in patients with advanced NSCLC. For instance, one patient from the 320 mg dosing cohort experienced a 30.3% reduction in tumor size, while another from the 480 mg cohort saw a 26.3% reduction.
• In January 2022, Zipalertinib (Cullinan Oncology) announced that the FDA granted breakthrough therapy designation for Zipalertinib (also known as CLN-081), specifically for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had already undergone prior platinum-based chemotherapy.

• By Treatment
  • EGFR-TKI Inhibitors
  • Immunotherapy
• By Stages of the Disease
  • Early-stage NSCLC
  • Metastatic NSCLC
• By Therapy Approvals
  • First-line Treatments
  • Second-line Treatments