TAGRISSO Sets the Stage for Market Leadership in Oncology with Strong Growth Prospects | DelveInsight

TAGRISSO has become a standard treatment due to its strong efficacy in both first-line and adjuvant settings. The growing prevalence of EGFR mutations, a rise in lung cancer diagnoses, and broader approvals for early-stage treatment all contribute to its promising growth potential.

LAS VEGAS  , March 11, 2025 /PRNewswire/ -- DelveInsight's "TAGRISSO Market Size, Forecast, and Market Insight Report" highlights the details around TAGRISSO, a kinase inhibitor of the EGFR, which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately nine-fold lower concentrations than wild-type. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TAGRISSO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

AstraZeneca's TAGRISSO (osimertinib) Overview

TAGRISSO is a prescription medication for adults with non-small cell lung cancer (NSCLC) that carries specific EGFR gene mutations. It is used to help prevent cancer recurrence after surgical tumor removal, as a first-line treatment for metastatic NSCLC, or for patients whose cancer has spread and no longer responds to prior EGFR TKI therapy.  

As a kinase inhibitor, TAGRISSO irreversibly targets specific mutant forms of EGFR (T790M, L858R, and exon 19 deletions) with significantly higher selectivity than the wild-type EGFR. After oral administration, two active metabolites (AZ7550 and AZ5104) circulate at around 10% of the parent drug and exhibit similar inhibitory effects as osimertinib. In vitro studies also show that osimertinib inhibits HER2, HER3, HER4, ACK1, and BLK at clinically relevant levels.  

The recommended TAGRISSO dosage is 80 mg once daily, taken with or without food, and continued until disease progression or unacceptable toxicity occurs.

Learn more about TAGRISSO projected market size for EGFR mNSCLC @ TAGRISSO Market Potential 

EGFR is a protein that plays a crucial role in cell growth. When mutations occur in the EGFR gene, they can lead to excessive cell growth, potentially causing cancer. These mutations can take various forms, including deletions, insertions, and point mutations. Among the most common EGFR mutations detected in test results are the EGFR exon 19 deletion and the EGFR L858R point mutation.  

In non-small cell lung cancer, targeted therapies primarily focus on EGFR-sensitizing mutations and EGFR exon 20 insertions. The most frequently observed EGFR mutations include exon 19 deletions and exon 21 L858R mutations. To address these, the FDA has approved several tyrosine kinase inhibitors (TKIs).  

In 2023, the EGFR-mutated NSCLC market across the 7MM was valued at approximately USD 4 billion. The NSCLC treatment landscape is becoming increasingly biomarker-driven, with EGFR emerging as one of the most lucrative targets. TAGRISSO remains the leading therapy in this segment, maintaining a strong market presence. However, resistance to EGFR TKIs, particularly after TAGRISSO treatment, is a growing challenge. Developing treatments for patients who experience resistance remains one of the most pressing unmet needs in this space.

Discover more about the EGFR mNSCLC market in detail @ EGFR Metastatic Non-small Cell Lung Cancer Market Report

Emerging Competitors of TAGRISSO

The promising candidates in EGFR NSCLC pipeline include Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Zipalertinib (Cullinan Oncology/Taiho Pharma), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Savolitinib (AstraZeneca/Hutchison MediPharma), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), BNT327/PM8002 (Biotheus/BioNTech), Zanidatamab (Jazz Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sasanlimab (Pfizer), Pamvatamig (MCLA-129) (Merus), REQORSA (quaratusugene ozeplasmid) (Genprex), PT-112 (Promontory Therapeutics), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), Carotuximab (ENV-105) (Kairos Pharma), and others.

To know more about the number of competing drugs in development, visit @ TAGRISSO Market Positioning Compared to Other Drugs

Key Milestones of TAGRISSO 

• In December 2024, TAGRISSO was approved in Europe for patients with unresectable EGFR-mutated lung cancer based on the results of the LAURA Phase III study.
• In September 2024, TAGRISSO was approved in the US for patients with unresectable stage III EGFR-mutated lung cancer based on LAURA Phase III trial results.
• In July 2024, TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, was approved in Europe for the first-line treatment of adult patients with advanced EGFR-mutated NSCLC whose tumors have exon 19 deletions or exon 21 (L858R) mutations. Approval was based on the results from the Phase III FLAURA2 study.
• In June 2024, TAGRISSO in combination with chemotherapy was approved in Japan as a first-line treatment for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results.
• In June 2024, TAGRISSO was granted priority review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer. TAGRISSO was also recently granted BTD by the FDA in this setting.
• In February 2024, TAGRISSO in combination with chemotherapy was approved in the US for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results.
• In October 2023, TAGRISSO plus chemotherapy was granted priority review in the US for patients with EGFR-mutated advanced lung cancer based on FLAURA2 Phase III trial results.
• In August 2022, TAGRISSO was approved in Japan for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the positive results from the global ADAURA Phase III trial.
• In May 2021, TAGRISSO was approved in Europe for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial.
• In December 2020, TAGRISSO was approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial.
• In October 2020, TAGRISSO granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the data from the ADAURA Phase III trial.
• In July 2020, TAGRISSO was granted BTD in the US for the adjuvant treatment of patients with Stage IB–IIIA EGFR-mutated lung cancer based on unprecedented results from the Phase III ADAURA trial.
• In August 2018, the MHLW approved TAGRISSO for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive NSCLC
• In June 2018, the EC granted marketing authorization for TAGRISSO as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.
• In April 2018, the US FDA approved TAGRISSO for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
• In April 2018, Molecular Partners and AstraZeneca announced a clinical collaboration for MP0250 in EGFR-mutated NSCLC with osimertinib. Under the collaboration, AstraZeneca will supply osimertinib for the clinical study.
• In April 2017, the EC granted full marketing authorization for TAGRISSO for treating adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
• In March 2017, the US FDA granted full approval for TAGRISSO for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. TAGRISSO was granted accelerated approval for this indication in November 2015 based on tumor response rate and duration of response.
• In 2017, TAGRISSO was granted BTD and priority review by the US FDA for the first-line treatment of patients with metastatic NSCLC.
• In March 2016, the MHLW approved TAGRISSO for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR-TKI.
• In January 2016, AstraZeneca and Incyte Corporation announced a clinical trial collaboration to evaluate the efficacy and safety of INCB39110 in combination with osimertinib.
• In September 2014, the US FDA granted ODD to TAGRISSO for treating EGFR mutation-positive NSCLC.
• In April 2014, TAGRISSO received BTD from the US FDA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy.
• In November 2013, TAGRISSO was granted FTD for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy.

Discover how TAGRISSO is shaping the EGFR NSCLC treatment landscape @ TAGRISSO NSCLC

TAGRISSO Market Dynamics

TAGRISSO, developed by AstraZeneca, is a third-generation EGFR TKI that has become a key player in the treatment of NSCLC with EGFR mutations. Since its approval, TAGRISSO has gained significant traction due to its efficacy in treating both first-line and post-resistance settings, particularly in patients with the T790M resistance mutation. The drug's ability to penetrate the blood-brain barrier and show strong efficacy against brain metastases has further strengthened its market positioning, leading to widespread adoption among oncologists.  

A major driver of TAGRISSO's market dynamics is its dominance as the preferred first-line treatment for EGFR-mutated NSCLC. This shift from earlier-generation TKIs has been supported by clinical data demonstrating superior progression-free survival (PFS) and overall survival (OS) benefits. The expansion of TAGRISSO's indications, including its approval in the adjuvant setting for early-stage EGFR-mutated NSCLC, has further broadened its market reach. Additionally, AstraZeneca has aggressively pursued global regulatory approvals, ensuring market access across multiple geographies, particularly in high-prevalence regions such as East Asia, where EGFR mutations are more common.  

However, TAGRISSO faces growing challenges, including the emergence of resistance mechanisms such as MET amplification and C797S mutations, which limit long-term efficacy. To counteract this, AstraZeneca is exploring combination strategies with MET inhibitors and other targeted therapies. Furthermore, increasing competition from next-generation EGFR TKIs, such as those under development by companies like Takeda and Johnson & Johnson, poses a potential threat. Pricing and reimbursement pressures, particularly in cost-sensitive markets, also impact its commercial strategy, necessitating a balance between pricing optimization and maintaining accessibility.  

Despite these challenges, TAGRISSO remains a blockbuster drug with robust revenue growth, driven by strong clinical performance and strategic lifecycle management. Ongoing clinical trials evaluating its use in earlier disease stages and in combination therapies could further extend its market leadership. With its strong foothold in the EGFR-mutated NSCLC landscape, TAGRISSO is expected to remain a key driver of AstraZeneca's oncology portfolio in the foreseeable future.

Dive deeper to get more insight into TAGRISSO's strengths & weaknesses relative to competitors @ TAGRISSO Market Drug Report

Table of Contents

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