The ROS-1 NSCLC current market is mainly dominated by tyrosine kinase inhibitors such as XALKORI at present and is anticipated to be dominated by Repotrectinib, Taletrectinib, and NVL-520 by 2034. Additionally, the market for ROS1 inhibitors is expected to grow significantly in the coming years. This is due to the increasing biomarker testing rates, the increasing number of patients who are being diagnosed with different types of cancers, the growing awareness of ROS1 mutations, and entry of next-generation emerging ROS1 TKIs with superior CNS penetration and broader coverage of ROS1 resistance mutations than first-generation TKIs.
LAS VEGAS, Nov. 5, 2024 /PRNewswire/ -- DelveInsight's ROS1 Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging ROS1 inhibitors, market share of individual therapies, and current and forecasted ROS1 inhibitors market size from 2020 to 2034, segmented into the 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Key Takeaways from the ROS1 Inhibitors Market Report
- As per DelveInsight's analysis, the ROS-1 inhibitor market size in the 7MM for ROS-1 Non-small cell lung cancer (NSCLC) was estimated to be nearly USD 290 million in 2023, in which the US accounted for the maximum share of the total market.
- In the US, the highest revenue was captured by XALKORI (crizotinib), which is anticipated to decline owing to the entry of next-generation ROS-1 targeting therapies by 2034.
- Leading ROS1 inhibitor companies such as AnHeart Therapeutics, Nuvalent, and others are developing novel ROS1 inhibitors that can be available in the ROS1 inhibitors market in the coming years.
- Some of the key ROS1 inhibitors in the pipeline include Taletrectinib, NVL-520, and others.
- In March 2024, China's second National Medical Products Administration (NMPA) accepted taletrectinib's new drug application (NDA) and granted Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have been previously treated with ROS1 tyrosine kinase inhibitors (TKIs).
- In February 2024, NVL-520 received the Breakthrough Therapy Designation from the Food and Drug Administration (FDA).
Discover which therapies are expected to grab the ROS1 inhibitors market share @ ROS1 Inhibitors Market Report
ROS1 Inhibitors Market Dynamics
The market dynamics for ROS1 inhibitors are shaped by several key factors, including the growing incidence of NSCLC, advancements in precision medicine, and the competitive landscape of pharmaceutical innovation. The prevalence of ROS1 gene rearrangements in NSCLC, although rare (occurring in about 1-2% of cases), has spurred significant interest among pharmaceutical companies in developing therapies that can effectively target this genetic anomaly. As a result, the market is seeing increased investment in R&D activities aimed at enhancing the efficacy and safety profiles of ROS1 inhibitors.
One of the major drivers of the ROS1 inhibitors market is the growing adoption of personalized medicine approaches in oncology. As molecular diagnostics become more sophisticated and widely available, more patients with NSCLC are being identified as candidates for ROS1-targeted therapies. This has led to an increased demand for these inhibitors, as they offer a more tailored and potentially more effective treatment option compared to traditional chemotherapy. Moreover, the approval of several ROS1 inhibitors by regulatory bodies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) has further fueled market growth, providing oncologists with a broader arsenal of treatment options.
The competitive landscape of the ROS1 inhibitors market is characterized by both established pharmaceutical giants and smaller biotech firms vying to capture market share. Companies like Pfizer, with its drug XALKORI (crizotinib), were early entrants in this space and have set a high standard for subsequent therapies.
Choosing between XALKORI, ROZLYTREK, and AUGTYRO-the recommended first-line treatments approved by the FDA-requires taking into account factors including systemic and CNS efficacy, tolerability, and access to therapy. Notably, ROS1 TKI resistance always arises, reducing the therapeutic effectiveness of these medications and causing disease recurrence. Numerous next-generation ROS1 TKIs are currently in the pipeline, which cover a wider range of ROS1 resistance mutations and have better CNS penetration than first-generation TKIs, as well as other therapeutic approaches to treat TKI resistance. These advancements have been made possible by understanding of the molecular mechanisms of resistance. Newer entrants are challenging dominance of current TKIs. This competition is expected to drive innovation and potentially lead to the development of more effective treatments with fewer side effects.
Another important aspect of the ROS1 inhibitors market dynamics is the pricing and reimbursement landscape. As with many targeted therapies, the high cost of ROS1 inhibitors poses a challenge for healthcare systems, particularly in countries with limited healthcare budgets. Reimbursement policies can significantly impact the adoption of these therapies, making it crucial for pharmaceutical companies to engage with healthcare payers to ensure that patients have access to these potentially life-saving treatments. Additionally, the emergence of biosimilars and generics could play a role in making ROS1 inhibitors more affordable and accessible, further influencing market dynamics.
ROS1 Inhibitors Treatment Market
The ROS1 inhibitor shows exceptional effectiveness in treating NSCLC, including both well-established therapies with regulatory approval and new treatments in development. ROS1 inhibitors have transformed the management of NSCLC, becoming a critical therapeutic strategy.
The current market for ROS-1 NSCLC is primarily led by TKIs like XALKORI. XALKORI functions as a TKIs, targeting the ALK or ROS1 kinases, which activate the ALK or ROS1 gene. This action prevents the oncogenic fusion proteins from triggering gene expression. Additionally, approved treatments like ROZLYTREK (entrectinib) and ZYKADIA (ceritinib) have shown remarkable success in ROS1-positive NSCLC, with indications extending across various stages of the disease.
ROZLYTREK, an oral prescription medication developed by Genentech, is designed for adults with NSCLC that has metastasized and is linked to an abnormal ROS1 gene. Additionally, it is prescribed for adults and children aged one month and older with solid tumors caused by specific abnormal NTRK genes, especially when the cancer has spread, or surgery could lead to severe complications. This treatment is used when there are no satisfactory alternative options, or when the cancer persists or spreads despite other treatments.
In August 2019, the FDA granted accelerated approval to ROZLYTREK for adults and pediatric patients aged 12 years and older with solid tumors that have an NTRK gene fusion without a known resistance mutation, that are metastatic, or where surgical removal is likely to cause significant complications, and have either progressed after treatment or have no other satisfactory standard therapy options. Additionally, ROZLYTREK was approved for adults with metastatic ROS1-positive NSCLC. The drug is also being explored for its potential in treating other cancers, including breast and colorectal cancer.
Learn more about the FDA-approved ROS1 inhibitors @ ROS1 Inhibitors Drugs
Key Emerging ROS1 Inhibitors and Companies
Several key players, including Genentech, Pfizer, Novartis, Bristol Mayer Squibb, AnHeart Therapeutics, and others, are involved in developing drugs for ROS1 inhibitors for various indications such as NSCLC, breast cancer, renal cell carcinoma, and others.
Taletrectinib is an oral, potent, brain-penetrant, and selective next-generation ROS1 inhibitor, considered a potential best-in-class treatment. It is currently being evaluated in a Phase II interventional study for ROS1-positive NSCLC in both TKI-naïve patients and those previously treated with TKIs. Developed by AnHeart Therapeutics, taletrectinib received Breakthrough Therapy Designation from the FDA in March 2024.
In 2023, China's NMPA accepted its first NDA and granted Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC previously treated with ROS1 TKIs. In March 2024, a second NDA was accepted by the NMPA for first-line treatment of ROS1-positive lung cancer. Additionally, in 2021, Innovent and AnHeart Therapeutics, a subsidiary of Nuvation Bio, entered an exclusive licensing agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Zidesamtinib is a new brain-penetrant inhibitor specifically designed to target ROS1, aimed at addressing the challenges of treating tumors driven by ROS1 mutations that have become resistant to existing ROS1 inhibitors. This includes tumors with the common G2032R "solvent front" resistance mutation. The drug also avoids inhibiting the closely related TRK family and is intended to treat brain metastases. Currently, in Phase II trials, it is being studied as NVL-520 for its high selectivity in patients with advanced NSCLC and other solid tumors (ARROS-1). This drug is being developed by Nuvalent, and in February 2024, NVL-520 received Breakthrough Therapy Designation from the FDA.
The anticipated launch of these emerging therapies are poised to transform the ROS1 inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the ROS1 inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about ROS1 inhibitors clinical trials, visit @ ROS1 Inhibitors Treatment Drugs
ROS1 Inhibitors Overview
Receptor Tyrosine Kinase (ROS1) is a crucial transmembrane receptor protein that governs various cellular processes, including apoptosis, survival, differentiation, proliferation, cell migration, and transformation. It plays a significant role in several malignancies, such as glioblastoma, colorectal cancer, gastric adenocarcinoma, inflammatory myofibroblastic tumor, ovarian cancer, angiosarcoma, and non-small cell lung cancer. A ROS1 inhibitor is a compound that blocks the activity of the abnormal ROS1 fusion protein found in certain cancer cells. By inhibiting this protein, ROS1 inhibitors may help prevent the growth and spread of cancer cells.
These inhibitors are a form of targeted therapy, with all ROS1 inhibitors being multi-kinase inhibitors capable of inhibiting Anaplastic Lymphoma Kinase (ALK), Mesenchymal Epithelial Transition (MET), and other kinases, in addition to ROS1. ROS1 kinase inhibitors specifically target the kinase domain of ROS1. Conventional kinases are classified into DFG-in (active, type I) and DFG-out (inactive, type II) based on their domain conformation. For patients with stage four ROS1-positive lung cancer, a ROS1 TKI or ROS1 inhibitor is recommended.
ROS1 Inhibitors Epidemiology Segmentation
ROS1 oncogenic fusions are observed in 1-2% of NSCLC patients. It is estimated that there are more than 4,000 newly diagnosed patients with ROS1-positive NSCLC in the United States each year. The ROS1 inhibitors market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
- Total Cases of Selected Indications for ROS1 Inhibitor
- Total Eligible Patient Pool of Selected Indication for ROS1 Inhibitor
- Total Treatable Cases in Selected Indication for ROS1 Inhibitor
ROS1 Inhibitors Report Metrics | Details |
Study Period | 2020-2034 |
ROS1 Inhibitors Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key ROS1 Inhibitors Companies | AnHeart Therapeutics, Nuvalent, Bristol Myers Squibb, Genentech, Pfizer, and others |
Key ROS1 Inhibitors | Taletrectinib, NVL-520, AUGTYRO, ROZLYTREK, XALKORI, and others |
Scope of the ROS1 Inhibitors Market Report
- ROS1 Inhibitors Therapeutic Assessment: ROS1 Inhibitors current marketed and emerging therapies
- ROS1 Inhibitors Market Dynamics: Conjoint Analysis of Emerging ROS1 Inhibitors Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, ROS1 Inhibitors Market Access and Reimbursement
Discover more about ROS1 inhibitors in development @ ROS1 Inhibitors Clinical Trials
Table of Contents
1 | Key Insights |
2 | Report Introduction |
3 | Executive Summary of ROS1 Inhibitor |
4 | Key Events |
5 | Epidemiology Market Forecast Methodology |
6 | ROS1 Inhibitor Market Overview at a Glance in the 7MM |
6.1. | Market Share (%) Distribution by Therapies in 2023 |
6.2. | Market Share (%) Distribution by Therapies in 2034 |
6.3. | Market Share (%) Distribution by Indications in 2023 |
6.4. | Market Share (%) Distribution by Indications in 2034 |
7 | ROS1 Inhibitor: Background and Overview |
7.1. | Introduction |
7.2. | Potential of ROS1 Inhibitors in Different Indications |
7.3. | Clinical Applications of ROS1 Inhibitors |
8 | Target Patient Pool |
8.1. | Assumptions and Rationale |
8.2. | Key Findings |
8.2. | Total Cases of Selected Indication for ROS1 Inhibitors in the 7MM |
8.3. | Total Eligible Patient Pool of Selected Indication for ROS1 Inhibitors in the 7MM |
8.4. | Total Treatable Cases in Selected Indication for ROS1 Inhibitors in the 7MM |
9 | Marketed Therapies |
9.1. | Key Competitors |
9.2. | ROZLYTREK (entrectinib): Genentech |
9.2.1. | Product Description |
9.2.2. | Regulatory milestones |
9.2.3. | Other developmental activities |
9.2.4. | Clinical development |
9.2.5. | Safety and efficacy |
9.3. | XALKORI (crizotinib): Pfizer |
9.3.1. | Product Description |
9.3.2. | Regulatory milestones |
9.3.3. | Other developmental activities |
9.3.4. | Clinical development |
9.3.5. | Safety and efficacy |
List to be continued in the report | |
10 | Emerging Therapies |
10.1. | Key Competitors |
10.2. | Taletrectinib: AnHeart Therapeutics |
10.2.1. | Product Description |
10.2.2. | Other developmental activities |
10.2.3. | Clinical development |
10.2.4. | Safety and efficacy |
10.3. | NVL-520: Nuvalent |
10.3.1. | Product Description |
10.3.2. | Other developmental activities |
10.3.3. | Clinical development |
10.3.4. | Safety and efficacy |
List to be continued in the report | |
11 | ROS1 Inhibitors: Seven Major Market Analysis |
11.1. | Key Findings |
11.2. | Market Outlook |
11.3. | Conjoint Analysis |
11.4. | Key Market Forecast Assumptions |
11.4.1. | Cost Assumptions and Rebates |
11.4.2. | Pricing Trends |
11.4.3. | Analogue Assessment |
11.4.4. | Launch Year and Therapy Uptakes |
11.5. | Total Market Sizes of ROS1 Inhibitors in the 7MM |
11.6. | The United States |
11.6.1. | Market Size of ROS1 Inhibitors by Indications in the United States |
11.6.2. | Market Size of ROS1 Inhibitors by Therapies in the United States |
11.7. | EU4 and the UK |
11.7.1. | Market Size of ROS1 Inhibitors by Indications in EU4 and the UK |
11.7.2. | Market Size of ROS1 Inhibitors by Therapies in EU4 and the UK |
11.8. | Japan |
11.8.1 | Market Size of ROS1 Inhibitor by Indications in Japan |
11.8.2. | Market Size of ROS1 Inhibitors by Therapies in Japan |
12 | SWOT Analysis |
13 | KOL Views |
14 | Unmet Needs |
15 | Market Access and Reimbursement |
16 | Appendix |
16.1. | Bibliography |
16.2. | Report Methodology |
17 | DelveInsight Capabilities |
18 | Disclaimer |
19 | About DelveInsight |
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