본 보고서에서는 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본에서의 DLL3 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 "Delta-like Ligand 3 (DLL3)-targeted Therapies - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the DLL3-targeted therapies, historical and competitive landscape as well as its market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The DLL3-targeted therapies' market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted DLL3-targeted therapies' 7MM market size from 2020 to 2034. The report also covers current DLL3-targeted therapies' treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
Delta-like Ligand 3 (DLL3)-targeted Therapies Overview
DLL3 is an atypical ligand of the Notch signaling pathway that, when overexpressed, contributes to the growth, migration, and invasiveness of SCLC cells. It also plays a role in driving the development of metastatic and treatment-resistant features in NECs, promoting both tumor cell proliferation and resistance to platinum-based chemotherapy. In normal cells, DLL3 expression is low and primarily localized to the Golgi apparatus and cytoplasmic vesicles. This restricted localization is maintained by the transmembrane domain and adjacent sequences in the DLL3 protein, which act as retention signals. However, in SCLC, DLL3 is significantly overexpressed and mislocalized to the cell surface, a feature present in up to 85% of human SCLC tumors. Although the precise mechanisms responsible for this overexpression and abnormal trafficking in malignant cells remain unclear, its distinct expression pattern makes DLL3 a notable marker and potential therapeutic target in SCLC.
In addition to SCLC, DLL3 is also broadly expressed in various other NECs, including certain molecular subtypes of pulmonary Large Cell NEC (LCNEC), as well as NECs of the gastroenteropancreatic system, bladder, prostate, and cervix. Elevated DLL3 expression in these malignancies has been associated with more advanced stages of disease and reduced overall survival, indicating a link between DLL3 levels and poor clinical prognosis.
Delta-like Ligand 3 (DLL3)-targeted Therapies' Market Overview
The differential expression and localization profiles of DLL3 in normal and tumor cells render DLL3 an attractive, tumor-selective therapeutic target. DLL3-targeted therapies include Antibody-drug Conjugates (ADCs), bispecific antibodies, cell therapies, antibody radionuclide conjugates, and photoabsorber conjugates. These diverse platforms reflect innovative strategies to exploit DLL3 as a therapeutic target.
The epidemiology chapter of DLL3-targeted therapies' in the report provides historical as well as forecasted epidemiology segmented as total cases in selected indications for DLL3-targeted therapies, total eligible patient pool in selected indications for DLL3-targeted therapies, and total treated cases in selected indications for DLL3-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 list is indicative and not exhaustive...
The drug chapter segment of the DLL3-targeted therapies report encloses a detailed analysis of approved DLL3-targeted therapies, late-, mid-, and early-stage DLL3-targeted therapies. It also helps understand the clinical trial details of DLL3-targeted therapies, 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 Delta-like Ligand 3 (DLL3)-targeted Therapies
IMDELLTRA (tarlatamab-dlle): Amgen
IMDELLTRA is a first-in-class immunotherapy engineered by Amgen researchers that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.
In May 2024, the US FDA approved IMDELLTRA for the treatment of adult patients with Extensive-stage SCLC (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies.
Emerging Delta-like Ligand 3 (DLL3)-targeted Therapies
Peluntamig (PT217): Phanes Therapeutics
Peluntamig (PT217), a first-in-class native IgG-like bispecific antibody targeting DLL3 and CD47, is being developed for the treatment of patients with SCLC and NEC, including Neuroendocrine Prostate Cancer (NEPC). The FDA has already granted peluntamig two Orphan Drug Designations (ODDs) for the treatment of SCLC and NEC, as well as two Fast Track Designations (FTDs) for the treatment of ES-SCLC with disease progression following treatment with platinum chemotherapy with or without a checkpoint inhibitor, and metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC), respectively. Currently, the therapy is in Phase I/II SKYBRIDGE trial (NCT05652686) for SCLC and NEC.
MK-6070/ HPN328-4001/ DS3280: Merck/ Daiichi Sankyo
MK-6070 is an investigational DLL3-directed tri-specific T-cell engager currently being evaluated in a Phase I/II clinical trial as a monotherapy in certain patients with advanced cancers associated with expression of DLL3 and in combination with atezolizumab in certain patients with SCLC. The US FDA granted ODD to MK-6070 for the treatment of SCLC in March 2022. In March 2024, Merck announced the completion of the acquisition of Harpoon Therapeutics.
In August 2024, Daiichi Sankyo and Merck, expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody-drug conjugates to include Merck's MK-6070. The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070. The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in certain patients with SCLC, as well as other potential combinations.
While ES-SCLC remains the primary focus, ongoing research is exploring DLL3-targeted therapies in other neuroendocrine cancers, including large cell neuroendocrine carcinoma, neuroendocrine prostate cancer, gastroenteropancreatic neuroendocrine tumors, and others. This expansion is expected to drive further market growth and diversify therapeutic applications.
Several key players, including Phanes Therapeutics, Merck, Abdera Therapeutics, and others, are involved in developing drugs for DLL3-targeted therapies. Overall, this is an exciting new class with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of DLL3-targeted therapies and define their role in autoimmune indications.
The launch of IMDELLTRA, the first DLL3-targeted therapy, has garnered widespread attention and marked a major milestone in DLL3-directed treatment, generating around USD 115 million in revenue in 2024 in the US. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients. This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved BiTE molecule. IMDELLTRA offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them.
This section focuses on the uptake rate of potential approved and emerging DLL3-targeted therapies expected to be launched in the market during 2025-2034.
Delta-like Ligand 3 (DLL3)-targeted Therapies Pipeline Development Activities
The report provides insights into different therapeutic candidates. 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 DLL3-targeted therapies' market growth over the forecast period.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for DLL3-targeted 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 DLL3-targeted therapies' 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 Emory University and others.
Their opinion helps understand and validate current and emerging therapy treatment patterns or DLL3-targeted therapies' 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. 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 treatment landscape.
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, Continuing Medical Education (CME) program, 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.
Key Updates on Delta-like Ligand 3 (DLL3)-targeted Therapies
The abstract list is not exhaustive, will be provided in the final report