The ALK inhibitors market is projected to expand in the near future. This growth is driven by the rising number of cancer diagnoses, heightened awareness of ALK inhibitors, and the increasing number of these inhibitors undergoing clinical trials and seeking approval from various companies.
LAS VEGAS, Aug. 30, 2024 /PRNewswire/ — DelveInsight’s ALK Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging ALK inhibitors, market share of individual therapies, and current and forecasted ALK inhibitors market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Key Takeaways from the ALK Inhibitors Market Report
- At present, ALECENSA (alectinib) and ALUNBRIG (brigatinib) are the preferred first-line Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs). ALECENSA is widely used compared to ALUNBRIG and dominates the ALK-positive NSCLC market. Prior to the entry of ALECENSA and ALUNBRIG, XALKORI (crizotinib) was the first-line treatment choice in ALK-positive NSCLC.
- ALECENSA is the best-selling ALK inhibitor, with global sales of USD 1.65 billion in 2023.
- Leading companies in the ALK inhibitor space are Pfizer, Takeda, Nuvalent, Hoffmann-La Roche, Xcovery Holdings, and others.
- Some of the key ALK inhibitors in the pipeline include Ensartinib, NVL-655, and others.
- In June 2024, a small study of ALK-positive anaplastic large cell lymphoma (ALK+ ALCL) concluded the induced high response rate of 93% of ALUNBRIG made brentuximab vedotin fail.
- In May 2024, the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK TKIs.
- Based on the results of the Phase III ALINA study, ALECENSA was approved in April 2024 for the treatment of ALK-positive early-stage NSCLC. For ALK-positive early stage NSCLC, ALECENSA is the first adjuvant therapy. With this approval, an increase in sales is expected.
- In March 2024, Xcovery Holdings received an acceptance of a New Drug Application (NDA) from the US FDA for Bemena (ensartinib) to treat ALK-positive NSCLC.
- In February 2024, Nuvalent initiated the Phase II Portion of ALKOVE-1 Clinical Trial for Patients with ALK-Positive NSCLC and other Solid Tumors.
Discover which therapies are expected to grab the ALK inhibitors market share @ ALK Inhibitors Market Report
ALK Inhibitors Market Dynamics
The market dynamics for ALK inhibitors have been evolving rapidly, driven by significant advances in cancer treatment and the growing prevalence of ALK-positive cancers, particularly NSCLC. One of the primary drivers of the ALK inhibitors market is the increasing incidence of ALK-positive NSCLC. As the understanding of cancer genomics improves, more patients are being tested for specific genetic mutations, including ALK rearrangements, leading to a rise in the identification of patients who can benefit from ALK-targeted therapies. This trend is supported by advancements in diagnostic technologies, which enable more precise and rapid detection of ALK mutations, thus facilitating timely and appropriate treatment.
The competitive landscape of the ALK inhibitors market is characterized by the presence of several key players in the market. For instance, drugs like XALKORI, ZYKADIA, ALECENSA, ALUNBRIG, LORBRENA, and others have already been approved and are widely used in clinical practice. These medications vary in terms of their efficacy, safety profiles, and ability to penetrate the blood-brain barrier, offering clinicians multiple options to tailor treatment to individual patient needs.
Ever since the first ALK inhibitor, XALKORI, hit the US market in 2011, the field ALK-positive NSCLC has grown more competitive. For advanced ALK-positive NSCLC patients who have progressed on XALKORI, Novartis’ ZYKADIA (ceritinib) received regulatory nod in 2014, and then ALECENSA in 2015, ALUNBRIG in 2017, and LORBRENA in 2018.
For earlier lines of treatment, these drugs have obtained regulatory approval. In advanced ALK-positive NSCLC, for example, ZYKADIA and ALECENSA were approved as first-line treatments in 2017. ALUNBRIG and LORBRENA received regulatory nods in 2020 and 2021, respectively.
Despite the significant progress, challenges remain in the ALK inhibitors market. Drug resistance is a major issue, as many patients eventually develop resistance to first-line ALK inhibitors, necessitating the development of next-generation therapies. Additionally, the high cost of these targeted treatments poses a barrier to access for some patients, particularly in low- and middle-income countries. Efforts to address these challenges include ongoing research into resistance mechanisms and the development of more affordable therapeutic options.
Looking forward, the ALK inhibitors market is poised for continued growth, driven by ongoing innovation and an increasing emphasis on personalized medicine. As new drugs are developed and approved, and as combination therapies and novel treatment strategies are explored, the outlook for patients with ALK-positive cancers is expected to improve. Moreover, collaborations between pharmaceutical companies, research institutions, and healthcare providers will be crucial in overcoming existing barriers and ensuring that the benefits of ALK inhibitors reach a broader patient population.
Learn more about the FDA-approved ALK inhibitors @ ALK Inhibitors Drugs
Key Emerging ALK Inhibitors and Companies
Companies, including Nuvalent, Xcovery Holdings, and others, are involved in developing ALK inhibitors for indications such as NSCLC, ALCL, and others.
Ensartinib shows great potential as a leading treatment for ALK-positive NSCLC. In a Phase I/II trial, it demonstrated promising clinical activity in patients with this condition. Additionally, a single-arm Phase II trial involving 156 Chinese patients who had previously been treated with crizotinib has been completed. Following this, a New Drug Application was filed in China. In March 2024, the FDA accepted the NDA, marking a significant milestone for Xcovery in its efforts to introduce ensartinib as a new first-line therapeutic option.
NVL-655 is a novel ALK-selective inhibitor that can penetrate the brain, addressing several shortcomings of current treatments. It remains effective in tumors resistant to first, second, and third-generation ALK inhibitors, including those with the G1202R mutation or compound mutations. NVL-655 has been designed to improve brain penetrance, offering better treatment options for patients with brain metastases. Its selectivity for ALK helps minimize central nervous system (CNS) side effects related to off-target inhibition of the TRK family, potentially leading to more durable responses in patients with ALK-mutant variants. The ALKOVE-1 Phase I/II clinical trial of NVL-655 for advanced ALK-positive NSCLC and other solid tumors is currently enrolling participants. In May 2024, the FDA granted BTD to NVL-655 for treating patients with locally advanced or metastatic ALK-positive NSCLC who have previously been treated with two or more ALK TKIs.
The anticipated launch of these emerging therapies are poised to transform the ALK 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 ALK inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about ALK inhibitors clinical trials, visit @ ALK Inhibitors Treatment Drugs
ALK Inhibitors Overview
ALK inhibitors are a class of targeted cancer therapies designed to block the activity of ALK, a protein that can become abnormally active in certain cancers. Mutations or rearrangements involving the ALK gene can lead to uncontrolled cell growth and cancer development. ALK inhibitors work by specifically targeting and inhibiting the activity of the ALK protein, thereby slowing or stopping the progression of the cancer. These inhibitors have shown significant efficacy, particularly in non-small cell lung cancer patients with ALK gene rearrangements.
The development of ALK inhibitors has marked a significant advancement in personalized cancer therapy. Patients with ALK-positive cancers often experience substantial clinical benefits, including tumor shrinkage and extended progression-free survival. However, resistance to ALK inhibitors can develop over time due to additional mutations in the ALK gene or activation of alternative signaling pathways.
ALK Inhibitors Epidemiology Segmentation
The total number of incident cases of ALK-positive NSCLC in the US was 10,130 in 2023. Biomarker testing of ALK mutation is recommended in the 7MM, and the biomarker testing rate is higher in the US compared to EU4 and the UK, and Japan. The ALK inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Incident Cases of Selected Indication for ALK Inhibitors
- Total Eligible Patient Pool of Selected Indication for ALK Inhibitors
- Total Treated Cases in Selected Indication for ALK Inhibitors
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ALK Inhibitors Report Metrics |
Details |
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Study Period |
2020–2034 |
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ALK Inhibitors Report Coverage |
7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
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Key Companies |
Pfizer, Novartis, Takeda, Nuvalent, Hoffmann-La Roche, Genentech, Chugai Laboratories, Xcovery Holdings, TargetRx, and others |
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Key ALK Inhibitors |
XALKORI, ALECENSA, ZYKADIA, ALUNBRIG, LORBRENA, Ensartinib, NVL-655, and others |
Scope of the ALK Inhibitors Market Report
- ALK Inhibitors Therapeutic Assessment: ALK Inhibitors current marketed and emerging therapies
- ALK Inhibitors Market Dynamics: Conjoint Analysis of Emerging ALK Inhibitors Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, ALK Inhibitors Market Access and Reimbursement
Discover more about ALK inhibitors in development @ ALK Inhibitors Clinical Trials
Table of Contents
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1 |
Key Insights |
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2 |
Report Introduction |
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3 |
Executive Summary of ALK Inhibitor |
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4 |
Key Events |
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5 |
Epidemiology Market Forecast Methodology |
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6 |
ALK Inhibitor Market Overview at a Glance in the 7MM |
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6.1. |
Market Share (%) Distribution by Therapies in 2023 |
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6.2. |
Market Share (%) Distribution by Therapies in 2034 |
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6.3. |
Market Share (%) Distribution by Indications in 2023 |
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6.4. |
Market Share (%) Distribution by Indications in 2034 |
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7 |
ALK Inhibitor: Background and Overview |
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7.1. |
Introduction |
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7.2. |
The Potential of ALK Inhibitors in Different Indications |
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7.3. |
Clinical Applications of ALK Inhibitors |
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8 |
Target Patient Pool |
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8.1. |
Assumptions and Rationale |
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8.2. |
Key Findings |
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8.3 |
Total Cases of Selected Indication for ALK Inhibitor in the 7MM |
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8.4. |
Total Eligible Patient Pool of Selected Indication for ALK Inhibitor in the 7MM |
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8.5. |
Total Treatable Cases in Selected Indication for ALK Inhibitor in the 7MM |
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9 |
Marketed Therapies |
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9.1. |
Key Competitors |
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9.2. |
ALECENSA (alectinib): Genentech/Hoffmann-La Roche/Chugai Laboratories |
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9.2.1. |
Product Description |
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9.2.2. |
Regulatory milestones |
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9.2.3. |
Other developmental activities |
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9.2.4. |
Clinical development |
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9.2.5. |
Safety and efficacy |
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9.3. |
XALKORI (crizotinib): Pfizer |
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9.3.1. |
Product Description |
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9.3.2. |
Regulatory milestones |
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9.3.3. |
Other developmental activities |
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9.3.4. |
Clinical development |
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9.3.5. |
Safety and efficacy |
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List to be continued in the report |
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10 |
Emerging Therapies |
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10.1. |
Key Competitors |
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10.2. |
Ensartinib: Xcovery Holdings |
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10.2.1. |
Product Description |
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10.2.2. |
Other developmental activities |
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10.2.3. |
Clinical development |
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10.2.4. |
Safety and efficacy |
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10.3. |
NVL-655: Nuvalent |
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10.3.1. |
Product Description |
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10.3.2. |
Other developmental activities |
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10.3.3. |
Clinical development |
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10.3.4. |
Safety and efficacy |
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List to be continued in the report |
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11 |
ALK Inhibitor: Seven Major Market Analysis |
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11.1. |
Key Findings |
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11.2. |
Market Outlook |
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11.3. |
Conjoint Analysis |
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11.4. |
Key Market Forecast Assumptions |
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11.4.1. |
Cost Assumptions and Rebates |
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11.4.2. |
Pricing Trends |
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11.4.3. |
Analogue Assessment |
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11.4.4. |
Launch Year and Therapy Uptakes |
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11.5. |
Total Market Size of ALK Inhibitors in the 7MM |
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11.6. |
The United States |
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11.6.1. |
Market Size of ALK Inhibitors by Indications in the United States |
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11.6.2. |
Market Size of ALK Inhibitors by Therapies in the United States |
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11.7. |
EU4 and the UK |
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11.7.1. |
Market Size of ALK Inhibitors by Indications in EU4 and the UK |
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11.7.2. |
Market Size of ALK Inhibitors by Therapies in EU4 and the UK |
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11.8. |
Japan |
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11.8.1. |
Market Size of ALK Inhibitor by Indications in Japan |
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11.8.2. |
Market Size of ALK Inhibitors by Therapies in Japan |
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12 |
SWOT Analysis |
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13 |
KOL Views |
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14 |
Unmet Needs |
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15 |
Market Access and Reimbursement |
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16 |
Appendix |
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16.1. |
Bibliography |
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16.2. |
Report Methodology |
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17 |
DelveInsight Capabilities |
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18 |
Disclaimer |
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19 |
About DelveInsight |
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