Metastatic Non-Small Cell Lung Cancer - Market Insight, Epidemiology and Market Forecast -2032

Metastatic Non-Small Cell Lung Cancer - Market Insight, Epidemiology and Market Forecast -2032



Key Highlights

NSCLC market size has seen a revolutionary change in the last decade owing to the increase in incident case of NSCLC, continuous uptake of approved therapies mainly immune checkpoint inhibitors, expected entry of potential premium price emerging therapies and increasing awareness of mutations like KRAS, BRAF, c-Met and others. The total market size of metastatic NSCLC is estimated to be ~USD 45 billion by 2032 in the 7MM.

The real-world treatment trend depicts a drastic shift towards targeted and immunotherapies (from only systemic therapies in the past), which is expected to contribute the most now.

The existing NSCLC treatment is mainly dominated by Checkpoint-inhibitors such as KEYTRUDA, and OPDIVO. As far as EGFR- positive NSCLC market size is concerned, we expect third-generation EGFRs such as AstraZeneca’s TAGRISSO to dominate.

Amgen’s LUMAKRAS was approved in 2021 for NSCLC patients harbouring KRASG12C mutation. It is expected to reach approximately USD 1,300 million by the end of the forecast period.

ADCs are a class of oncology medications that are among the most rapidly expanding. Despite the outstanding patient responses that conventional ADCs have produced, they have only been tested on patients who have the highest levels of target expression and a narrow number of targets. Although there is only one ADC approved for NSCLC, and it is only for a limited subgroup (HER2m NSCLC), companies are attempting to target a larger NSCLC population, particularly in areas where KEYTRUDA is the market leader. Targeting the non-actionable genomic aberration NSCLC market are DATO-Dxd and TRODELVY. Among the upcoming therapies in the 7MM, Dato-DXd is expected to capture a significant market size of the patients expressing PD-L1.

As per DelveInsight’s analysis, the total incident cases of NSCLC in the 7MM were approximately 527,000 cases in the year 2022, these cases are estimated to increase by the year 2032.

The most common alterations seen in Non–Small Cell Lung Cancer is EGFR and KRAS mutations. EGFR mutations occur in exon 19—that's a deletion—as well as L858R exon 21.

DelveInsight's “Metastatic Non-small Cell Lung Cancer – Market Insights, Epidemiology and Market Forecast – 2032” report delivers an in-depth understanding of top oncogenic drivers/biomarker in Non-small Cell Lung Cancer (such as EGFR, c-MET, ROS1, KRAS, ALK, BRAF, PD-L1, etc), historical and forecasted epidemiology as well as the Non-small Cell Lung Cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Metastatic NSCLC market report provides real world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Non-small Cell Lung Cancer market size from 2019 to 2032. The report also covers current Non-small Cell Lung Cancer treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

The United States

EU4 (Germany, France, Italy, and Spain) and the United Kingdom

Japan

Study Period: 2019–2032

Non-small Cell Lung Cancer Understanding and Treatment Algorithm

Non-small Cell Lung Cancer Overview and Diagnosis

Non-small Cell Lung Cancer is the most common type of lung cancer, accounting for 81% of all lung cancer diagnoses. Early diagnosis offers the best prognosis for Non–Small Cell Lung Cancer. But, Non–Small Cell Lung Cancer 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. Because of this, 80 percent of people diagnosed with Non–Small Cell Lung Cancer 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 your lungs. The physician may also take a sample of mucus for examination under the microscope.

If these initial tests identify cancer, a lung biopsy can be conducted. A bronchoscopy can also be recommended, which allows the physician to not only visualize but also 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.

Further details related to country-based variations in diagnosis are provided in the report

Non-small Cell Lung Cancer 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 non-small cell lung cancer are:

Surgery

Radiotherapy

Chemotherapy

Chemotherapy with radiotherapy (chemoradiotherapy)

Immunotherapy

Targeted cancer drugs

Clinical and Registrational Updates in 2023

NDA acceptance of repotrectinib, for the treatment of patients with ROS1-positive locally advanced or metastatic NSCLC. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 2023.

In January 2023, Daiichi Sankyo initiated the TROPION-Lung07 Phase III trial to evaluate datopotamab deruxtecan in combination with pembrolizumab in patients with previously untreated metastatic non-small cell lung cancer.

In January 2023, the EMA validated the ENHERTU Type II variation application for the treatment of HER2 mutant metastatic non-small cell lung cancer.

American Society of Clinical Oncology (ASCO) 2023 Key Updates

Dizal Pharmaceuticals’ Sunvozertinib shines in a groundbreaking WU-KONG6 trial, unveiling remarkable antitumor effectiveness and exceptional safety in previously treated NSCLC with EGFR Exon20 insertions.

Updated TROPION-Lung02 results revealed Daiichi Sankyo and AstraZeneca's datopotamab deruxtecan continued success in triggering promising and persistent responses across diverse NSCLC cancer patients.

AstraZeneca’s rilvegostomig, a TIGIT and PD-1 bispecific, offers hope for advanced PD-L1+ NSCLC after prior treatment resistance.

Kelun Pharma’s TROP2-targeting ADC, SKB264 exhibited manageable safety and promising antitumor activity in advanced or metastatic NSCLC, with enhanced response in EGFR mutant subtype.

Amgen’s Sotorasib provides a consistent benefit over docetaxel in the majority of key prespecified molecularly defined subsets pretreated KRAS G12C–mutated NSCLC patients enrolled in the Phase III CodeBreaK 200 trial.

Combining pembrolizumab with pemetrexed and platinum-based chemotherapy showed a slight numerical improvement in progression-free survival and overall survival compared to chemotherapy plus placebo. However, this improvement did not reach statistical significance in patients with TKI-resistant, EGFR-mutated, metastatic nonsquamous non-small cell lung cancer.

In the Phase III ADAURA trial, adjuvant treatment with AstraZeneca’s osimertinib demonstrated a significant improvement in overall survival compared to placebo for patients with resected, EGFR-mutated, stage IB to IIIA non-small cell lung cancer.

Non-small Cell Lung Cancer Epidemiology

The Non-small Cell Lung Cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of Non-small Cell Lung Cancer, total incident cases of Non-small Cell Lung Cancer by histology, total cases of Non-small Cell Lung Cancer by stages, total incident cases of Non-small Cell Lung Cancer by genetic mutation/biomarkers, total treated cases of Non-small Cell Lung Cancer by line of therapies in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2019 to 2032.

In the US for 2022, there are approximately 200,000 new cases of lung cancer (~113,000 in men and ~88,000 in women). The society also reported that most lung cancer statistics include both small cell lung cancer and non-small cell lung cancer. About 10% to 15% of all lung cancers are SCLC, and about 80% to 85% are Non–Small Cell Lung Cancer.

The most frequent biomarkers are EGFR, and KRAS.

The three main histological subtypes of Non–Small Cell Lung Cancer are Adenocarcinoma, Squamous cell carcinoma, and large cell (undifferentiated) carcinoma. In the United States approximately 57% of all lung cancers are adenocarcinomas. About 25-30% of all lung cancers are Squamous cell carcinoma. Large cell (undifferentiated) carcinoma makes up around 2% of all lung cancers.

In 2022, there were ~115,000 metastatic NSCLC cases in the United States.

Non-small Cell Lung Cancer Drug Chapters

The drug chapter segment of the Non-small Cell Lung Cancer report encloses a detailed analysis of Non-small Cell Lung Cancer marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives on the Non-small Cell Lung Cancer 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 an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. FDA’s approval in January 2023, marked the fifth indication for KEYTRUDA in non-small cell lung cancer and the first indication for KEYTRUDA in patients with resected stage IB (T2a =4 cm), II, or IIIA disease following adjuvant chemotherapy. With this approval, KEYTRUDA is the only immunotherapy with an approved option for Non–Small Cell Lung Cancer regardless of PD-L1 expression in both the adjuvant and metastatic settings. Six years ago, KEYTRUDA was the first anti-PD-1 therapy approved for the first-line treatment of metastatic non-small cell lung cancer and has changed the way metastatic disease is treated. The approval of KEYTRUDA is unfavorable for TECENTRIQ, which was the first immunotherapy to receive approval in the adjuvant setting for non-small cell lung cancer patients who underwent surgery in October 2021. KEYTRUDA's approval is more extensive compared to TECENTRIQ's approval, as it encompasses a wider range of cancer stages and PD-L1 statuses. TECENTRIQ has specifically approved for PD-L1-positive patients with stages 2 to 3A lung cancer, whereas KEYTRUDA's approval covers a broader range.

LIBTAYO (cemiplimab-rwlc): Regeneron Pharmaceuticals

LIBTAYO is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells and was invented using Regeneron's proprietary VelocImmune technology. In November 2022, Regeneron Pharmaceuticals announced that the US FDA has approved the PD-1 inhibitor LIBTAYO in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations. This second FDA approval for cemiplimab-rwlc in advanced non-small cell lung cancer greatly broadens the scope in which a cemiplimab-rwlc-based regimen can be prescribed to encompass a wide range of patients, either as a single agent in those with PD-L1 =50% or now in combination with chemotherapy irrespective of PD-L1 expression or tumor histology. LIBTAYO, alongside KEYTRUDA, is the only other PD-1/L1 inhibitor that can be used in combination with chemotherapy for first-line treatment of non-small cell lung cancer in the United States, irrespective of PD-L1 levels or histology. This approval complements the previous approval of LIBTAYO as a monotherapy for patients with high expression of PD-L1. However, having a similar indication to KEYTRUDA does not automatically imply that LIBTAYO will divide the market equally with the leading PD-1 inhibitor from Merck.

Note: Detailed current therapies assessment will be provided in the full report of Non-small Cell Lung Cancer

Emerging Drugs

Telisotuzumab Vedotin (Teliso-V): AbbVie

Teliso-V is an investigational antibody-drug conjugate targeting c-Met, a receptor tyrosine kinase that is 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+ Non–Small Cell Lung Cancer 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, advanced/metastatic non-squamous non-small cell lung cancer.

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 in combination 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 the treatment of patients with Non–Small Cell Lung Cancer. 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 all comer 2L and 3L patients in with TROPION-Lung01.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

The existing Non-small Cell Lung Cancer 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.

Epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements are well-known genetic abnormalities that drive the development of Non-small Cell Lung Cancer. The use of tyrosine kinase inhibitors (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 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. Currently, two targeted therapies, RYBREVANT (amivantamab) and EXKIVITY (mobocertinib) are approved for this particular mutation but only as a second-line option following platinum-based chemotherapy. These mutations represent an area of unmet medical need in Non-small Cell Lung Cancer. While treatment with EGFR TKIs effectively eliminates the majority of 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 parts of the body.

Moving onto ALK rearrangements, which are present in around 5% of Non-Small-Cell Lung Cancer cases, primarily in adenocarcinomas, and represent a distinct molecular subtype of lung cancer. 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.

While tumors with ROS1 rearrangements, known as ROS1-positive tumors, are not common, the similarities between ROS1 and ALK receptors, as well as the similarities between ROS1-positive and ALK-positive Non-small Cell Lung Cancer, have led to the repurposing of ALK inhibitors for the treatment of ROS1-positive disease. XALKORI (crizotinib), which is already approved for treating patients with ALK fusions, became the first drug specifically indicated for patients with ROS1-positive Non-small Cell Lung Cancer in 2016.

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 Non-small Cell Lung Cancer compared to other cancers such as melanoma.

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 Non-small Cell Lung Cancer that have MET exon 14 skipping mutations.

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.

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 Non-Small Cell Lung Cancer 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. Interestingly, 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.

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 Non-Small Cell Lung Cancer patients with an activating HER2 mutation.

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, colorectal cancer, and pancreatic cancer. In lung cancer, the most prevalent KRAS mutation is G12C. In the past, KRAS was considered ""undruggable"" due to the absence of conventional drug-binding sites. However, the approval of KRAS G12C inhibitors, such as sotorasib and adagrasib, for the treatment of locally advanced or metastatic Non-Small Cell Lung Cancer, has revolutionized the approach to treating cancers with KRAS G12C mutations. Currently, numerous other KRAS players such as Gritstone Bio and Elicio Therapeutics, both are evaluating their respective Pan-KRAS Vaccines in Phase I/II along with Immuneering Corporation with its KRASG12S in early stage trial.

Targeted therapies targeting NRG1 alterations have also entered early clinical studies. Currently, there are no approved treatments specifically targeting NRG1-positive cancer. However, zenocutuzumab presents promising potential as a new standard of care. Below is a glimpse of US FDA approved therapies for NSCLC

Non–Small Cell Lung Cancer Market Outlook

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 that there is sufficient data supporting 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 as well. New studies have explored therapies that target a wider range of oncogenes, aiming to overcome drug resistance and provide treatment options for patients who were 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.

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 for the treatment of Non–Small Cell Lung Cancer.

The total market size of PD-L1 expressing NSCLC is estimated to be ~USD 20 billion by 2032 in the 7MM followed by EGFR and KRAS.

Non–Small Cell Lung Cancer Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019–2032, which depends on the competitive landscape, safety, and efficacy data along with 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.

Further detailed analysis of emerging therapies drug uptake in the report…

Non–Small Cell Lung Cancer Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. 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 Non–Small Cell Lung Cancer 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 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.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In 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 Non–Small Cell Lung Cancer has shown significant increases over time, irrespective of the stage of the disease. This is particularly true for younger patients treated in the outpatient setting, according to real-world findings. 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.

Scope of the Report

The report covers a segment of key events, an executive summary, descriptive overview of Non–Small Cell Lung Cancer, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.

Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression along with treatment guidelines.

Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.

A detailed review of the Non–Small Cell Lung Cancer market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.

The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Non–Small Cell Lung Cancer market.

Non–Small Cell Lung Cancer Report Insights

Patient Population

Therapeutic Approaches

Non–Small Cell Lung Cancer Pipeline Analysis

Non–Small Cell Lung Cancer Market Size and Trends

Existing and future Market Opportunity

Non–Small Cell Lung Cancer Report Key Strengths

Ten Years Forecast

7MM Coverage

Non–Small Cell Lung Cancer Epidemiology Segmentation

Key Cross Competition

Conjoint analysis

Drugs Uptake and Key Market Forecast Assumptions

Non–Small Cell Lung Cancer Report Assessment

Current Treatment Practices

Unmet Needs

Pipeline Product Profiles

Market Attractiveness

Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

What is the historical and forecasted Non–Small Cell Lung Cancer patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?

What was the Non–Small Cell Lung Cancer total market size, the market size by therapies, market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?

How will different NSCLC target class affect the treatment paradigm of Non–Small Cell Lung Cancer?

What will be the impact of KEYTRUDA’s expected patent expiry?

How will KEYTRUDA compete with other therapies in the first- and second lines?

Which class is going to be the largest contributor in 2032?

What are the pricing variations among different geographies for approved and off-label therapies?

How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Although multiple expert guidelines recommend testing for targetable mutations prior to therapy initiation, why do barriers to testing remain high?

What are the current and emerging options for the treatment of Non–Small Cell Lung Cancer?

How many companies are developing therapies for the treatment of Non–Small Cell Lung Cancer?

What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?

Patient acceptability in terms of preferred treatment options as per real-world scenarios?

What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Non–Small Cell Lung Cancer Market.

Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years

Understand the existing market opportunity in varying geographies and the growth potential over the coming years.

Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.

Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.

To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.

Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy


1. Key Insights
2. Report Introduction
3. Dermatomyositis Market Overview at a Glance
3.1. Market Share (%) Distribution of Dermatomyositis in 2019
3.2. Market Share (%) Distribution of Dermatomyositis in 2032
4. Methodology of Dermatomyositis Epidemiology and Market
5. Executive Summary of Dermatomyositis
6. Key Events
7. Disease Background and Overview
7.1. Introduction to Dermatomyositis
7.2. Types of Dermatomyositis
7.3. Signs and Symptoms
7.4. Clinical Manifestation of Dermatomyositis
7.5. Causes
7.6. Complications
7.7. Pathophysiology
7.8. Diagnosis
7.8.1. Diagnostic Criteria
7.8.1.1. Bohan and Peter’s Classification Criteria for Polymyositis and Dermatomyositis
7.8.2. The Myositis Association: Diagnostic Criteria for Dermatomyositis
7.8.3. Diagnostic Criteria for Polymyositis and Dermatomyositis
7.8.4. Differential Diagnosis
7.8.5. Diagnostic Guidelines
7.8.5.1. The European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile IIM
7.8.5.2. Clinical Practice Guidance for Juvenile Dermatomyositis (JDM) 2018: Japan
7.8.5.3. Single Hub and Access Point for Pediatric Rheumatology in Europe (SHARE): Consensus-based Recommendations for the Management of Juvenile Dermatomyositis
7.8.6. Diagnostic Algorithm
7.9. Treatment
7.9.1. Treatment Guidelines
7.9.1.1. Single Hub and Access Point for Pediatric Rheumatology in Europe (SHARE): Consensus-based Recommendations for the Management of JDM
7.9.1.2. Clinical Practice Guidelines for JDM 2018: Japan
7.9.1.3. British Society for Rheumatology Guideline on Management of Pediatric, Adolescent, and Adult Patients With Idiopathic Inflammatory Myopathy
7.9.1.4. Japanese Society of Rheumatology
7.9.2. Treatment Algorithm
8. Patient Journey
9. Epidemiology and Patient Population
9.1. Key Findings
9.2. Assumptions and Rationale: The 7MM
9.2.1. Total Diagnosed Prevalent Cases of Dermatomyositis
9.2.1.1. Diagnosed Prevalent Cases of Juvenile Dermatomyositis
9.2.1.2. Diagnosed Prevalent Cases of Adult Dermatomyositis
9.2.2. Age-specific Diagnosed Prevalent Cases of Dermatomyositis
9.2.3. Gender-specific Diagnosed Prevalent Cases of Dermatomyositis
9.2.4. Severity-specific Diagnosed Prevalent Cases of Dermatomyositis
9.2.5. Chronicity-specific Diagnosed Prevalent Cases of Dermatomyositis
9.2.6. Comorbidity-specific Diagnosed Prevalent Cases of Dermatomyositis
9.3. Total Diagnosed Prevalent Cases of Dermatomyositis in the 7MM
9.4. The US
9.4.1. Total Diagnosed Prevalent Cases of Dermatomyositis in the US
9.4.2. Age-specific Diagnosed Prevalent Cases of Dermatomyositis in the US
9.4.3. Gender-specific Diagnosed Prevalent Cases of Dermatomyositis in the US
9.4.4. Severity-specific Diagnosed Prevalent Cases of Dermatomyositis in the US
9.4.5. Chronicity-specific Diagnosed Prevalent Cases of Dermatomyositis in the US
9.4.6. Comorbidity-specific Diagnosed Prevalent Cases of Dermatomyositis in the US
9.5. EU4 and the UK
9.5.1. Total Diagnosed Prevalent Cases of Dermatomyositis in EU4 and the UK
9.5.2. Age-specific Diagnosed Prevalent Cases of Dermatomyositis in EU4 and the UK
9.5.3. Gender-specific Diagnosed Prevalent Cases of Dermatomyositis in EU4 and the UK
9.5.4. Severity-specific Diagnosed Prevalent Cases of Dermatomyositis in EU4 and the UK
9.5.5. Chronicity-specific Diagnosed Prevalent Cases of Dermatomyositis in EU4 and the UK
9.5.6. Comorbidity-specific Diagnosed Prevalent Cases of Dermatomyositis in EU4 and the UK
9.6. Japan
9.6.1. Total Diagnosed Prevalent Cases of Dermatomyositis in Japan
9.6.2. Age-specific Diagnosed Prevalent Cases of Dermatomyositis in Japan
9.6.3. Gender-specific Diagnosed Prevalent Cases of Dermatomyositis in Japan
9.6.4. Severity-specific Diagnosed Prevalent Cases of Dermatomyositis in Japan
9.6.5. Chronicity-specific Diagnosed Prevalent Cases of Dermatomyositis in Japan
9.6.6. Comorbidity-specific Diagnosed Prevalent Cases of Dermatomyositis in Japan
10. Marketed Drugs
10.1. Key Cross Competition
10.1.1. OCTAGAM 10% (immunoglobulin): Octapharma
10.1.2. Drug Description
10.1.3. Regulatory Milestones
10.1.4. Clinical Development
10.1.5. Clinical Trial Information
10.1.6. Safety and Efficacy
10.1.7. Product Profile
11. Emerging Drugs
11.1. Key Cross Competition
11.2. Brepocitinib (PF-06700841): Priovant Therapeutics/Pfizer
11.2.1. Drug Description
11.2.2. Other Developmental Activity
11.2.3. Clinical Development
11.2.4. Clinical Trials Information
11.2.5. Safety and Efficacy
11.2.6. Product Profile
11.2.7. Analysts’ Views
11.3. ULTOMIRIS (ravulizumab/ALXN1210): AstraZeneca
11.3.1. Drug Description
11.3.2. Other Developmental Activity
11.3.3. Clinical Development
11.3.4. Clinical Trials Information
11.3.5. Product Profile
11.3.6. Analysts’ Views
11.4. Efgartigimod: Argenx
11.4.1. Drug Description
11.4.2. Clinical Development
11.4.3. Clinical Trials Information
11.4.4. Product Profile
11.4.5. Analysts’ Views
11.5. PF-06823859 (anti-beta interferon): Pfizer
11.5.1. Drug Description
11.5.2. Other Developmental Activity
11.5.3. Clinical Development
11.5.4. Clinical Trials Information
11.5.5. Safety and Efficacy
11.5.6. Product Profile
11.5.7. Analysts’ Views
11.6. HIZENTRA (IgPro20): CSL Behring
11.6.1. Drug Description
11.6.2. Other Development Activity
11.6.3. Clinical Development
11.6.4. Clinical Trials Information
11.6.5. Product Profile
11.6.6. Analysts’ Views
11.7. JNJ-80202135 (nipocalimab): Janssen (Johnson & Johnson)
11.7.1. Drug Description
11.7.2. Other Developmental Activity
11.7.3. Clinical Development
11.7.4. Clinical Trials Information
11.7.5. Safety and Efficacy
11.7.6. Product Profile
11.7.7. Analysts’ Views
11.8. M-5049 (enpatoran): Merck
11.8.1. Drug Description
11.8.2. Clinical Development
11.8.3. Clinical Trials Information
11.8.4. Safety and Efficacy
11.8.5. Product Profile
11.9. VIB7734/MEDI7734 (daxdilimab): Horizon Therapeutics
11.9.1. Drug Description
11.9.2. Other Development Activity
11.9.3. Clinical Development
11.9.4. Clinical Trials Information
11.9.5. Product Profile
11.10. KZR-616 (zetomipzomib): Kezar Life Sciences/Onyx therapeutics
11.10.1. Drug Description
11.10.2. Other Development Activity
11.10.3. Clinical Development
11.10.4. Clinical Trials Information
11.10.5. Safety and Efficacy
11.10.6. Product Profile
11.11. PF1801 (froniglutide): Immunoforge
11.11.1. Drug Description
11.11.2. Other Developmental Activity
11.11.3. Clinical Development
11.11.4. Clinical Trials Information
11.11.5. Product Profile
11.12. GLPG3667: Galapagos NV
11.12.1. Drug Description
11.12.2. Clinical Development
11.12.3. Clinical Trials Information
11.12.4. Product Profile
11.13. BEGESAND/BEGEDINA (begelomab): Adienne Pharma & Biotech
11.13.1. Drug Description
11.13.2. Other Developmental Activity
11.13.3. Clinical Development
11.13.4. Clinical Trials Information
11.13.5. Product Profile
12. Dermatomyositis: Market Analysis
12.1. Key Findings
12.2. Key Market Forecast Assumptions
12.3. Market Outlook
12.4. Conjoint Analysis
12.5. Total Market Size of Dermatomyositis in the 7MM
12.6. Total Market Size of Dermatomyositis by Therapies in the 7MM
12.7. Market Size of Dermatomyositis in the US
12.7.1. Total Market Size of Dermatomyositis in the US
12.7.2. The Market Size of Dermatomyositis by Therapies in the US
12.8. Market Size of Dermatomyositis in EU4 and the UK
12.8.1. Total Market Size of Dermatomyositis in EU4 and the UK
12.8.2. The Market Size of Dermatomyositis by Therapies in EU4 and the UK
12.9. Market Size of Dermatomyositis in Japan
12.9.1. Total Market Size of Dermatomyositis in Japan
12.9.2. The Market Size of Dermatomyositis by Therapies in Japan
13. Key Opinion Leaders’ Views
14. SWOT Analysis
15. Unmet Needs
16. Market Access and Reimbursement
16.1. The United States
16.1.1. Center for Medicare & Medicaid Services (CMS)
16.2. EU4 and the UK
16.2.1. Germany
16.2.2. France
16.2.3. Italy
16.2.4. Spain
16.2.5. The United Kingdom
16.3. Japan
16.3.1. MHLW
17. Appendix
17.1. Bibliography
17.2. Acronyms and Abbreviations
17.3. Report Methodology
18. DelveInsight Capabilities
19. Disclaimer
20. About Delvinsight

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