본 보고서에서는 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본에서의 미분화 림프종 키나아제(ALK) 표적 치료제 시장을 조사했으며, 시장 배경, 시장 동향, 기존약 및 신흥약의 개요, 경쟁 구도, 시장 점유율, 환자수, 시장 규모 추이와 예측, 미충족 의료 수요, 시장 접근과 상환 동향 등을 정리했습니다.
DelveInsight's "Anaplastic Lymphoma Kinase (ALK) Targeted Therapies - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the ALK targeted therapies, historical and competitive landscape as well as the ALK Targeted Therapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The ALK targeted therapies market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM ALK targeted therapies market size from 2020 to 2034. The report also covers current ALK targeted therapies treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
Anaplastic Lymphoma Kinase (ALK) Targeted Therapies Understanding
The ALK receptor is a membrane-bound tyrosine kinase. The ALK gene is present during embryonic development and forms the gastrointestinal and nervous systems. It becomes inactive in utero, but in some individuals, it can re-activate and undergo fusion (joining) with another gene, resulting in an ALK fusion or ALK rearrangement that can lead to cancer. When ALK fuses with another gene and causes lung cancer, the patient is considered ALK-positive. ALK can fuse with various genes, with the most common fusion partner being EML4. Even within EML4, multiple fusions exist based on the specific site where ALK joins the gene. Currently, the recommended treatment approach is generally uniform for most ALK-positive patients, irrespective of the precise type of ALK rearrangement they may have. The pathogenesis of several cancers is closely related to aberrant forms of ALK or aberrant ALK expression, including ALK fusion proteins, ALK-activated point mutations, and ALK amplification. ALK inhibitors are the blockers of the activity of ALK, which help control cell growth. Blocking these proteins may help keep cancer cells from growing and spreading. Many ALK inhibitors are approved, including LORBRENA, ALUNBRIG, ALECENSA, ZYKADIA, and XALKORI.
The ALK inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of selected indication for ALK targeted therapies, total eligible patient pool of selected indication for ALK targeted therapies, and total treated cases in selected indication for ALK targeted therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the ALK targeted therapies reports encloses a detailed analysis of ALK targeted marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the ALK inhibitor's clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Marketed Drugs
ALECENSA: Genentech/Hoffmann-La Roche/Chugai Laboratories
ALECENSA (alectinib) is a highly selective, central nervous system-active oral medicine used to treat people with NSCLC whose tumors are identified as ALK-positive. ALECENSA is a tyrosine kinase inhibitor that targets ALK fusion proteins, preventing signaling within cancer cells to inhibit their growth and survival. It is an oral medicine created at Chugai Kamakura Research Laboratories. The US patents of ALECENSA for NSCLC will expire in 2030, 2031, 2032, and 2035.
The US FDA approved ALECENSA in April 2024 based on the results of the Phase III ALEX study of ALECENSA in people with ALK-positive metastatic NSCLC who had not received prior treatment and the results of two Phase II studies, NP28761 and NP28673, of ALECENSA in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib. NCCN recommends ALECENSA for the first-line treatment of ALK NSCLC.
XALKORI: Pfizer
XALKORI (crizotinib) is an oral prescription medicine used to treat people with NSCLC that has spread to other parts of the body and is caused by a defect in either ALK or ROS1.
In January 2021, the FDA approved crizotinib for pediatric patients 1 year of age and older and young adults with relapsed or refractory systemic ALCL that is ALK-positive. In July 2022, the FDA approved crizotinib for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory ALK-positive myofibroblastic tumors (IMT). The safety and efficacy of crizotinib were evaluated from trial ADVL0912.
Emerging Drugs
Sacituzumab Tirumotecan (MK-2870/SKB264): Merck and Kelun-Biotech
Sacituzumab tirumotecan is an investigational ADC that consists of three components-a TROP2-targeting monoclonal antibody, sacituzumab, a cytotoxic payload from the topoisomerase 1 inhibitor class, and a novel, irreversible but hydrolyzable linker, which joins the monoclonal antibody and the cytotoxic payload leveraging proprietary linker conjugation technology. Sacituzumab tirumotecan was developed by Kelun-Biotech. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture, and commercialize sacituzumab tirumotecan in all territories outside of Greater China. As of June 30, 2024, MSD has initiated 10 ongoing Phase III global clinical studies of sacituzumab tirumotecan as a monotherapy or in combination with pembrolizumab or other agents for NSCLC, breast cancer, gastric cancer, endometrial cancer, and cervical cancer.
Neladalkib (NVL-655): Nuvalent
Neladalkib is a novel brain-penetrant ALK-selective inhibitor that overcomes several limitations observed with currently available therapies. Neladalkib remains active in tumors that have developed resistance to first, second, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations. Neladalkib has been optimized for brain penetrance to improve treatment options for patients with brain metastases. ALK-selectivity is emphasized to minimize CNS adverse events related to off-target inhibition of the structurally related tropomyosin receptor kinase (TRK) family and potentially drive more durable responses for patients with ALK-mutant variants. The ALKOVE-1 Phase I/II clinical trial of neladalkib for patients with advanced ALK-positive NSCLC and other solid tumors is enrolling. In May 2024, the FDA granted breakthrough therapy designation (BTD) to neladalkib for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).
Many of these companies are conducting trials in collaboration with universities and research centers as well. Some companies are even expanding the labels of the approved products for other indications.
Drug Class Insights
ALK rearrangements are present in around 5% of NSCLC cases, primarily in adenocarcinomas, representing a distinct molecular subtype of lung cancer. The first ALK inhibitor approved for treatment was XALKORI (crizotinib), and subsequently, several other ALK inhibitors have received approval, including ZYKADIA (ceritinib), ALECENSA (alectinib), ALUNBRIG (brigatinib), and LORBRENA (lorlatinib). A direct comparison among all the ALK Tyrosine Kinase Inhibitors (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.
First generation ALK inhibitor: XALKORI was the first generation ALK inhibitor it showed better results than chemotherapy. XALKORI also had some limitations, such as its low penetration into the brain, which increased the risk of brain metastases, and its susceptibility to resistance, which reduced its effectiveness over time due to this second-generation ALK inhibitor emerging in the market and first was approved in 2017.
Second-generation ALK inhibitors: Such as ceritinib, alectinib, brigatinib, and others, effectively treat patients with ALK-positive NSCLC who have developed resistance to first-generation ALK inhibitors. These drugs showed higher potency and selectivity for ALK mutation, better penetration into the brain, and broader activity against different resistance mutations. They also had different safety profiles and side effects.
Third-generation ALK inhibitor: LORBRENA/LORVIQUA (lorlatinib) was approved in 2021 as third generation ALK inhibitor for the treatment of ALK-positive mNSCLC based on results from the CROWN trial in first-line setting. It showed higher potency and selectivity for ALK mutation, better penetration into the brain, and broader activity against different resistance mutations.
Fourth-generation ALK inhibitor: Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors. Neladalkib is currently being investigated in clinical trials for treating patients with ALK-positive NSCLC who have developed resistance to second-generation ALK inhibitors.
The market for ALK targeted therapies is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancers, the growing awareness of ALK inhibitors, and the increasing number of ALK inhibitors that are under clinical trials and filed for approval by various companies.
ALK inhibitors demonstrate the highest efficacy in treating ALK-positive NSCLC, whether these are established therapies with regulatory approval or emerging treatments. ALK inhibitors have revolutionized the management of non-small cell lung cancer, representing a pivotal therapeutic approach. Established treatments such as ALECENSA (alectinib), XALKORI (crizotinib), LORBRENA (lorlatinib), and many other drugs have demonstrated significant efficacy in NSCLC, with expanded indications spanning various disease stages. The advent of novel agents like ceritinib has introduced innovative pharmacological strategies to enhance treatment efficacy. Additionally, experimental drugs like sacituzumab tirumotecan and NVL-655 offer potential efficacy for curing ALK-positive NSCLC, melanoma, and other indications. With ongoing clinical trials and regulatory advancements, the market outlook for ALK inhibitors is promising, fostering continued innovation and progress in ALK-positive NSCLC therapeutics. This evolution holds the potential to improve patient outcomes and redefine standards of care in ALK-positive NSCLC management globally.
Several key players, including Pfizer, Xcovery Holdings, Nuvalent, Hoffman-Roche, and others, are involved in developing drugs for ALK inhibitors for various indications such as NSCLC, ALCL, melanoma, and others. Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of ALK inhibitors and define their role in the therapy of cancer.
Anaplastic Lymphoma Kinase (ALK) Targeted Therapies Uptake
At present, ALECENSA and ALUNBRIG are the preferred first-line ALK TKIs. ALECENSA is much more widely used compared to ALUNBRIG and dominates the ALK market. Prior to the entry of ALECENSA and ALUNBRIG, XALKORI was the first-line treatment choice in ALK patients. In 2024, ALECENSA became the first ALK inhibitor to receive approval for use in the adjuvant treatment of ALK-positive NSCLC. This marks a significant advancement in the treatment of this patient population, as it opens up new opportunities for early-stage intervention in ALK-positive NSCLC. However, the adjuvant segment for ALK-positive NSCLC remains a largely underserved and unmet market. Currently, no other companies are specifically targeting this setting, despite the clear need for effective adjuvant therapies to reduce recurrence and improve survival outcomes in patients who are treated after initial surgery or chemotherapy. This leaves ALECENSA with a first-mover advantage, potentially solidifying its position in a market with limited competition. In 2024, ALECENSA generated nearly USD 140 million revenue whereas, XALKORI and ALUNBRIG generated USD 2 million and USD 6 million for the first line of ALK NSCLC, respectively. The sales of XALKORI have been observed to be declining due to the fact of its patent expiration in 2025 and coming years.
This section focuses on the uptake rate of potential approved and emerging ALK inhibitors expected to be launched in the market during 2025-2034.
Anaplastic Lymphoma Kinase (ALK) Targeted Therapies Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
The presence of numerous drugs under different stages is expected to generate immense opportunity for ALK inhibitors market growth over the forecast period.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for ALK inhibitor therapies.
KOL Views
To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on ALK inhibitors' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.
DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins Sidney Kimmel Cancer Center, Michigan University, and others.
Their opinions help understand and validate current and emerging therapy treatment patterns or ALK inhibitor market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the 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.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
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. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.
In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.
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.
The abstract list is not exhaustive, will be provided in the final report
Key Updates on ALK Targeted Therapies
6.1.. Market Share (%) Distribution by Therapies in 2024
6.2.. Market Share (%) Distribution by Therapies in 2034
6.3.. Market Share (%) Distribution by Indications in 2024
6.4.. Market Share (%) Distribution by Indications in 2034
7.1.. Introduction
7.2.. The Potential of ALK Inhibitors in Different Indications
7.3.. Clinical Applications of ALK Inhibitors
8.1.. Assumptions and Rationale
8.2.. Key Findings
8.2.. Total Cases of Selected Indication for ALK Targeted Therapies in the 7MM
8.3.. Total Eligible Patient Pool of Selected Indication for ALK Targeted Therapies in the 7MM
8.4.. Total Treatable Cases in Selected Indication for ALK Targeted Therapies in the 7MM
9.1.. Key Competitors
9.2.. ALECENSA (alectinib): Genentech/Hoffmann-La Roche/Chugai Laboratories
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
9.2.6.. Analyst Views
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
10.1.. Key Competitors
10.2.. Sacituzumab Tirumotecan (MK-2870/SKB264): Merck and Kelun-Biotech
10.2.1.. Product Description
10.2.2.. Other developmental activities
10.2.3.. Clinical development
10.2.4.. Safety and efficacy
10.3.. Neladalkib (NVL-655): Nuvalent
10.3.1.. Product Description
10.3.2.. Other developmental activities
10.3.3.. Clinical development
10.3.4.. Safety and efficacy
11.1.. Key Findings
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 ALK Targeted Therapies in the 7MM
11.6.. The United States
11.6.1.. Market Size of ALK Targeted Therapies by Indication in the United States
11.6.2.. Market Size of ALK Targeted Therapies by Therapies in the United States
11.7.. EU4 and the UK
11.7.1.. Market Size of ALK Targeted Therapies by Indications in EU4 and the UK
11.7.2.. Market Size of ALK Targeted Therapies by Therapies in EU4 and the UK
11.8.. Japan
11.8.1.. Market Size of ALK Targeted Therapies by Indications in Japan
11.8.2.. Market Size of ALK Targeted Therapies by Therapies in Japan
16.1.. Bibliography
16.2.. Report Methodology