HER2+ Non Small Cell Lung Cancer Market Insight, Epidemiology and Market Forecast - 2036

Key Highlights

• The HER2+ NSCLC Market (Mutant, Overexpression, and Amplification) in the 7MM was USD ~850 million in 2023 and is expected to increase to USD ~3,110 million by 2036, at a CAGR of 13.2%.
• NSCLC comprises approximately 80- 85% of all lung cancer diagnoses, with HER2+ gene mutation found in approximately 1-4% of NSCLC cases. Additionally, HER2+ amplification and overexpression are observed in about 2-5% and 2-30% of NSCLC cases, respectively, in the US.
• Currently, the regimen of HER2-mutant NSCLC treatment involves the use of Chemotherapy, Targeted therapy, Immunotherapy, Laser therapy, Photodynamic therapy, Radiation therapy, Surgery, and some other options.
• ENHERTU (trastuzumab deruxtecan) stands as the only FDA approved therapy for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2+ (ERBB2) mutations and who have received prior systemic therapy. The drug received accelerated approval in August 2022, however, its approval is limited to later-line settings, leaving significant unmet needs in first-line treatment.
• Recently, novel, more selective, oral HER2+ TKIs have been developed to improve outcomes in NSCLC with HER2+ mutations, looking to challenge ENHERTU’S dominance
• Potential drugs in the HER2+ NSCLC Pipeline include Pyrotinib (Jiangsu HengRui Medicine), Zongertinib (Boehringer Ingelheim), BAY 2927088 (Bayer), FWD1509 (Forward Pharmaceuticals), ORIC-114 (ORIC Pharmaceuticals), IAM1363 (Iambic Therapeutics), Firmonertinib (ArriVent BioPharma), XMT-2056 (Mersana Therapeutics/ GSK), and others in different stages of clinical development. The launch of these therapies would significantly impact the HER2+ NSCLC market during the forecast period (2026-2036).
• Boehringer's zongertinib and Bayer's BAY2927088 are neck and neck in a race to become the first targeted small molecule approved for HER2+-mutated NSCLC.
• The HER2+ NSCLC Market Dynamics are anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, and incremental healthcare spending across the world. However, the poor prognosis, late diagnosis, and lack of effective biomarkers of HER2+ NSCLC, particularly with brain metastases, underscores a significant unmet need for more effective treatments.

Key Factors Driving HER2+ Non Small Cell Lung Cancer Market

HER2+ Non Small Cell Lung Cancer Rising Prevalence

HER2+ mutations occur in approximately 1-4% of NSCLC cases, with amplification and overexpression seen in 2-5% and 2-30% of cases respectively in the US. NSCLC accounts for roughly 80-85% of all lung cancer diagnoses, and the growing identification of HER2+ subtypes is increasing the need for targeted therapies.

HER2+ Non Small Cell Lung Cancer Current Treatment Landscape

Treatment options for HER2+ NSCLC include chemotherapy, targeted therapy, immunotherapy, surgery, radiation, laser therapy, and photodynamic therapy. ENHERTU (trastuzumab deruxtecan) is currently the only FDA-approved therapy for unresectable or metastatic HER2+ NSCLC in later-line settings, leaving room for expansion in earlier lines of treatment.

HER2+ Non Small Cell Lung Cancer Market Drivers

The HER2+ NSCLC market is expected to expand due to improved diagnostic approaches, increased awareness of HER2 mutations, and rising healthcare investments. Novel oral HER2 tyrosine kinase inhibitors (TKIs) are in development, aiming to improve patient outcomes and broaden treatment options.

HER2+ Non Small Cell Lung Cancer Clinical Trials and Competitive Landscape

The pipeline features multiple candidates in different stages of development, including Pyrotinib (Jiangsu HengRui Medicine), Zongertinib (Boehringer Ingelheim), BAY 2927088 (Bayer), FWD1509 (Forward Pharmaceuticals), ORIC-114 (ORIC Pharmaceuticals), IAM1363 (Iambic Therapeutics), Firmonertinib (ArriVent BioPharma), and XMT-2056 (Mersana Therapeutics/GSK). Zongertinib and BAY2927088 are leading in clinical trials as potential first targeted small-molecule therapies for HER2+-mutated NSCLC, reflecting a highly competitive landscape.

The "HER2+ NSCLC Market Insight, Epidemiology, and Market Forecast - 2036" report delivers an in-depth understanding of HER2+ NSCLC, historical and forecasted epidemiology as well as the HER2+ NSCLC market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The HER2+ NSCLC Treatment Market report provides current treatment practices, emerging drugs, HER2+ NSCLC market share of individual therapies, and current and forecasted HER2+ NSCLC market size from 2022 to 2036, segmented by seven major markets. The report also covers current HER2+ NSCLC treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

HER2+ NSCLC Treatment Market: Understanding and Algorithm

HER2+ (also called ERBB2) is a receptor tyrosine kinase encoded by the ERBB2 proto-oncogene located on chromosome 17’s long arm (17q21). It belongs to the EGFR/ErbB receptor family, which includes HER1/EGFR, HER2+, HER3, and HER4. Unlike the other family members, HER2+ has no identified ligand. Instead, it becomes active when it forms homodimers or pairs with another HER receptor that has already bound a ligand, leading to cross-phosphorylation and activation of its tyrosine kinase domain.

In non-small cell lung cancers (NSCLCs), three major forms of HER2+ dysregulation are recognized: gene mutations, gene amplification, and protein overexpression. These alterations arise through distinct biological mechanisms and result in different clinical effects. They influence tumor behavior, patient outcomes, and therapeutic decision-making in NSCLC. Symptoms associated with HER2-positive NSCLC may include chronic coughing, chest discomfort, shortness of breath, wheezing, decreased appetite, weight loss, and fatigue.

HER2+ NSCLC Diagnosis

• The diagnosis and staging of NSCLC are often done at the same time. The tests and procedures used in the diagnosis of NSCLC includes:
• Physical exam and history
• Laboratory tests
• Chest X-ray
• CT scan (CAT scan)
• Sputum cytology
• Thoracentesis
• Biopsy
• Fine-needle Aspiration (FNA) biopsy of the lung
• Bronchoscopy
• Thoracoscopy
• Lymph node biopsy:
• The specific diagnosis of HER2+ NSCLC, which is used to confirm the mutation type, is as follows:
• FISH for HER2+ amplifications
• Immunohistochemical staining for HER2+ overexpression
• Next-generation Sequencing (NGS) for mutation

HER2+ NSCLC Treatment

Outcomes from conventional treatments for HER2-positive NSCLC remain poor, except in cases where the cancer is highly localized. Newly diagnosed individuals with HER2-positive NSCLC are therefore good candidates for clinical trials investigating novel therapeutic strategies. Although several treatment modalities exist, management typically relies on standard options such as surgery, radiation therapy, chemotherapy, targeted therapy, immunotherapy, laser therapy, photodynamic therapy, cryosurgery, electrocautery, and watchful waiting.

ENHERTU is currently the only therapy approved by the U.S. Food and Drug Administration for HER2-positive NSCLC. It was authorized in August 2022 in the United States for patients with HER2-mutant NSCLC who have previously received systemic treatment. This approval has markedly reshaped treatment options for individuals with pretreated HER2-mutant NSCLC.

HER2+ Non-small Cell Lung Cancer Epidemiology

The HER2+ NSCLC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total incident cases of NSCLC, gender-specific cases of NSCLC, age-specific cases of NSCLC, total incident cases of NSCLC by histology, total incident cases of NSCLC by stage, and total incident cases of advanced HER2+ NSCLC (mutation, overexpression and amplification) in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2022 to 2036.

• In 2023, the total HER2+ NSCLC Incident Cases in 7MM was ~531,800, out of which the contribution of the US was ~38%.
• Among EU4 and the UK, Germany accounted for the highest number of HER2+ NSCLC cases whereas Spain accounted for the lowest number of cases in 2023.
• In the US total diagnosed cases of NSCLC by stage were observed to be ~59,400, ~16,900, ~26,700, ~11,200, and ~88,300 cases of stage I, stage II, stage IIIA, stage IIIB, and stage IV, respectively, in 2023.
• In 2023, total incident cases of advanced HER2+ NSCLC according to HER2+ gene mutation, HER2+ gene overexpression, and HER2+ gene amplification were ~6,000, ~32,400, and ~8,100 respectively in the US.

HER2+ NSCLC Drug Chapters

HER2+ NSCLC Marketed Drugs

• ENHERTU (trastuzumab deruxtecan): Daiichi Sankyo and AstraZeneca

ENHERTU (trastuzumab deruxtecan) is an antibody-drug conjugate targeting HER2 that delivers a topoisomerase inhibitor. It is approved for adults with unresectable or metastatic NSCLC harboring activating HER2 (ERBB2) mutations, confirmed using a test authorized by the US FDA, and who have previously undergone systemic treatment.

The therapy first earned approval from the US FDA in August 2022 for adults with previously treated HER2-mutant metastatic NSCLC, granted via the accelerated approval pathway based on objective response rate and duration of response. Ongoing approval will depend on additional evidence confirming clinical benefit in subsequent studies. In August 2023, Japan’s MHLW also authorized the drug for HER2-positive NSCLC, followed by regulatory clearance in Europe the next month. The company is now working to expand ENHERTU’s use into the first-line setting through a Phase III trial, with topline results anticipated in 2025, leveraging its established performance in second-line treatment.To be continued in the report….

HER2+ NSCLC Emerging Drugs

• Zongertinib (BI-1810631): Boehringer Ingelheim

Zongertinib (BI 1810631) is an experimental, orally administered HER2-selective TKI being developed for the treatment of HER2-mutated non-small cell lung cancer (NSCLC). The therapy received FDA Fast Track status in 2023, followed in 2024 by Breakthrough Therapy Designation from both the U.S. FDA and China’s CDE for adults with advanced NSCLC harboring activating HER2 mutations who have previously undergone systemic treatment.

The company is currently testing the drug in the Phase III Beamion LUNG-2 study as a first-line option for patients with unresectable, locally advanced, or metastatic non-squamous NSCLC with HER2 tyrosine kinase domain mutations. Additionally, the Phase I Beamion LUNG-1 trial is assessing zongertinib as a standalone therapy in individuals whose NSCLC carries HER2 mutations. In September 2024, the company announced favorable findings from the Phase Ib primary analysis of Cohort 1 in Beamion LUNG-1.

• BAY 2927088: Bayer

BAY 2927088 is an orally administered small-molecule tyrosine kinase inhibitor designed to strongly target mutant HER2+, including HER2+ exon 20 insertions and point mutations, as well as EGFR, while showing strong selectivity for mutant over wild-type EGFR. In February 2024, it was granted Breakthrough Therapy designation for use in adults with unresectable or metastatic NSCLC harboring activating HER2+ (ERBB2) mutations who have previously undergone systemic treatment.

The drug is currently being studied in the Phase III SOHO-02 trial as a first-line treatment for patients with locally advanced or metastatic NSCLC with HER2-activating mutations. Based on the company’s Q2 2024 update, submission of BAY 2927088 for second-line treatment of HER2-mutated NSCLC is expected in 2025.

HER2+ NSCLC Drugs Market Insights

• Tyrosine kinase inhibitors (TKIs)

Tyrosine kinase inhibitors (TKIs) are targeted treatments that work by blocking tyrosine kinases - enzymes essential for signaling pathways that control how cells grow, divide, and survive. Currently, there are few approved TKIs for treating HER2-mutant NSCLC. Although HER2-directed therapies are well established in breast cancer, their application in lung cancer is beginning to attract interest.

Several next-generation TKIs are under investigation for HER2-mutant NSCLC, including Zongertinib from Boehringer Ingelheim, BAY 2927088 from Bayer, IAM1363 from Iambic Therapeutics, Firmonertinib from ArriVent BioPharma, and NVL-330 from Nuvalent. Early evidence suggests that these emerging TKIs may also demonstrate activity in patients with brain metastases.

• Antibody drug conjugate (ADC)

At present, only one antibody-drug conjugate is authorized for treating HER2-positive NSCLC. The therapy generating the most attention in HER2-mutated NSCLC is ENHERTU, developed by Daiichi Sankyo and AstraZeneca. It’s worth remembering that ADCs function as a more targeted form of chemotherapy, so side effects are anticipated. Careful monitoring is especially important in lung cancer patients, as conditions like interstitial lung disease (ILD) or pneumonitis may occur.

HER2+ NSCLC Market Outlook

HER2+ alterations are recognized as key oncogenic drivers in NSCLC. In recent years, meaningful progress has been made in characterizing HER2-driven disease and understanding how various classes of HER2-targeted therapies perform. At present, platinum-based chemotherapy - with or without immunotherapy - remains the recommended first-line option for patients with advanced or metastatic HER2+ NSCLC. Historically, standard treatments such as chemotherapy, immunotherapy, checkpoint inhibitors, and targeted cellular approaches have achieved a median progression-free survival of only about four months, highlighting the urgent need for more effective therapeutic strategies.

ENHERTU (T-DXd) received approval from the U.S. Food and Drug Administration in August 2022 for patients with HER2-mutant NSCLC previously treated with systemic therapy, marking a major shift in the management of pretreated disease. The therapy was subsequently approved by Japan’s MHLW in August 2023 and gained authorization in Europe in the following month.

The treatment landscape for HER2+ NSCLC is rapidly advancing as ongoing research continues to illuminate the genetic drivers of these tumors. Several emerging agents - such as Pyrotinib from Jiangsu Hengrui Medicine, Zongertinib from Boehringer Ingelheim, and BAY2927088 developed by Bayer - are drawing significant interest. These next-generation HER2-targeted TKIs reflect a shift toward more precise and potent treatment approaches.

The development pipeline also includes additional candidates such as FWD1509 from Forward Pharma, IAM1363 from Iambic Therapeutics, ORIC-114 from ORIC Pharmaceuticals, and Firmonertinib from ArriVent BioPharma, all at varying clinical stages. Together, these emerging therapies are driving innovation and increasing competition in the HER2+ NSCLC field. In addition, combination strategies are under investigation to further improve the effectiveness of HER2-directed treatments.

• Among the 7MM, the US accounted for the largest market size of HER2+ NSCLC i.e., USD ~540 million in 2023.
• Among EU4 and the UK, Germany captured the maximum market size in 2023, followed by France in the same year.
• In 2023, among the therapies for HER2+ NSCLC, the highest revenue was generated by Checkpoint inhibitors ± Chemotherapy, i.e., USD ~480 million in the US.

Recent Developments in the HER2+ NSCLC Treatment Market Landscape

• In September 2024, AstraZeneca presented the first data of the ENHERTU monotherapy cohort for second or later-line treatment at WCLC from the Phase Ib clinical trial for HER2+ positive nonsquamous NSCLC (DESTINY-Lung03), building on data from the DESTINY-Lung01 Phase II trial.
• In September 2024, Boehringer Ingelheim reports positive results from a Phase Ib primary analysis of Cohort 1 of the Beamion LUNG-1 trial evaluating zongertinib in pretreated patients with advanced NSCLC with activating HER2+ mutations.
• In August 2024, Bayer announced that the first patient had been enrolled in the global Phase III SOHO-02 trial, an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced NSCLC, whose tumors have activating HER2+ mutations.
• In June 2024, Bayer presented the safety and clinical activity of BAY 2927088 from a Phase I/II trial expansion cohort in patients with HER2+-mutant NSCLC at the 2024 ASCO annual meeting.

To be continued in the report….

HER2+ NSCLC Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2022-2036. The landscape of HER2+ NSCLC treatment has experienced an uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing treatment care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Boehringer's zongertinib and Bayer's BAY2927088 (both are oral agents) have had differing development histories, but they are now neck and neck in a race to become the first targeted small molecule approved for HER2+-mutated NSCLC. Experts agrees that zongertinib has better tolerability than BAY 2927088. It is important to highlight that we do not see much of future for pyrotinib since zongertinib and BAY2927088 have shown nearly 70% ORR in the Phase I/II trials.

HER2+ NSCLC Pipeline Development Activities

The HER2+ NSCLC therapeutics market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key HER2+ NSCLC Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The HER2+ NSCLC therapeutics market report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for HER2+ NSCLC emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair Department of Critical Care Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or HER2+ NSCLC Market Trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the HER2+ NSCLC unmet needs.

The analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Versailles Saint Quentin University, France; Fred Hutchinson Cancer Center, US; Lung Clinic Grosshansdorf, Germany; Sylvester Comprehensive Cancer Center, US; University Hospital Münster, Münster, Germany; Johns Hopkins University School of Medicine, US; Massachusetts General Hospital, US; Nagasaki University, Japan; Vall d’Hebron University Hospital, Spain; Georgetown University, US, etc., were contacted. Their opinion helps understand and validate HER2+ NSCLC epidemiology and market trends.

HER2+ NSCLC Therapeutics Market: Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving HER2+ NSCLC Treatment Market Landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial’s primary and secondary outcome measures are evaluated. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

HER2+ NSCLC Therapeutics Market Access and Reimbursement

ENHERTU: Patient Savings Program

Eligible patients may pay as little as USD 0 per ENHERTU prescription. The annual benefit can be used for the cost of the drug itself and may also cover up to USD 100 in infusion costs per administration. There are no income requirements to participate in the program. Patients who are residents of Massachusetts or Rhode Island are not eligible for infusion assistance.

Key eligibility criteria:

• Patients are eligible for the program if they meet all of the following criteria:
• The patient may be eligible for this offer if they are insured by commercial insurance and their insurance does not cover the full cost of their prescription.

Patients who are enrolled in a state or federally funded prescription insurance program are not eligible for this offer. This includes patients enrolled in Medicare Part B, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD) programs or TRICARE, and patients who are Medicare-eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees. Suppose the patient is enrolled in a state or federally funded prescription insurance program. In that case, they may not use this program even if they elect to be processed as an uninsured (cash-paying) patient. This offer is not insurance and is restricted to residents of the United States and Puerto Rico.

HER2+ NSCLC Treatment Market Report Scope

• The HER2+ NSCLC therapeutics market report covers a descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into HER2+ NSCLC epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for HER2+ NSCLC is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the HER2+ NSCLC therapeutics market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The HER2+ NSCLC therapeutics market report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM HER2+ NSCLC market.

HER2+ NSCLC Treatment Market Report Insights

• Patient-based HER2+ NSCLC Market Forecasting
• Therapeutic Approaches
• HER2+ NSCLC Pipeline Drugs Analysis
• HER2+ NSCLC Market Size and Trends
• HER2+ NSCLC Drugs Market Opportunities
• Impact of Upcoming Therapies

HER2+ NSCLC Treatment Market Report Key Strengths

• 11 Years HER2+ NSCLC Market Forecast
• 7MM Coverage
• HER2+ NSCLC Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed HER2+ NSCLC Drugs Market
• HER2+ NSCLC Drugs Uptake

HER2+ NSCLC Treatment Market Report Assessment

• Current HER2+ NSCLC Treatment Market Practices
• HER2+ NSCLC Unmet Needs
• HER2+ NSCLC Pipeline Drugs Profiles
• HER2+ NSCLC Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the HER2+ NSCLC drugs market share (%) distribution in 2022 and what it would look like in 2036?
• What would be the HER2+ NSCLC treatment market size as well as market size by therapies across the 7MM during the study period (2022-2036)?
• Which country will have the largest HER2+ NSCLC market size during the study period (2022-2036)?
• What are the disease risks, burdens, and unmet needs of HER2+ NSCLC?
• What is the historical HER2+ NSCLC patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What is the distribution of HER2+ mutation, overexpression, and amplification in NSCLC?
• What will be the growth opportunities across the 7MM concerning the patient population of HER2+ NSCLC?
• How many emerging therapies are in the mid-stage and late stage of development for the HER2+ NSCLC treatment?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to HER2+ NSCLC therapies?
• What are the recent novel therapies, targets, HER2+ NSCLC mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the clinical studies going on for HER2+ NSCLC and their status?
• What are the key designations that have been granted for the HER2+ NSCLC emerging therapies?

Reasons to Buy

• The HER2+ NSCLC therapeutics market report will help in developing business strategies by understanding trends shaping and driving HER2+ NSCLC drugs market.
• To understand the future market competition in the HER2+ NSCLC drugs market and Insightful review of the SWOT analysis of HER2+ NSCLC.
• Organize sales and marketing efforts by identifying the best opportunities for HER2+ NSCLC in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the HER2+ NSCLC drugs market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the HER2+ NSCLC drugs market.
• To understand the future market competition in the HER2+ NSCLC drugs market.

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