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Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity
The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. New York, USA, July 22, 2025 (GLOBE NEWSWIRE) -- Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. DelveInsight's Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging melanoma drugs, market share of individual therapies, and current and forecasted Melanoma 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 Melanoma Market Report According to DelveInsight's analysis, the total melanoma market size is expected to grow positively by 2034. The United States accounts for the largest market size of melanoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. In 2024, the total number of incident cases of melanoma was approximately 105K in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around 20% of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. Prominent companies, including Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others, are actively working on innovative melanoma drugs. Some of the key melanoma therapies in the pipeline include Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. In May 2025, Immatics announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that would assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. Discover which melanoma medications are expected to grab the market share @ Melanoma Market Report Melanoma Overview Melanoma is a type of skin cancer that originates in melanocytes, the pigment-producing cells responsible for giving skin its color. While it is less common than other skin cancers, melanoma is significantly more aggressive and has a higher risk of spreading to other parts of the body if not detected early. It can occur anywhere on the body but is most frequently found on areas exposed to the sun, such as the back, legs, arms, and face. The primary cause of melanoma is ultraviolet radiation from sunlight or artificial sources like tanning beds, which can damage the DNA in skin cells. Individuals with fair skin, a history of sunburns, a large number of moles, or a family history of melanoma are at higher risk. Genetic mutations, such as in the BRAF gene, also play a significant role in the development of melanoma in certain cases. Symptoms of melanoma often begin with changes in the appearance of a mole or pigmented area. Warning signs include asymmetry, irregular borders, color variation, a diameter larger than 6 mm, and evolving shape or size, summarized by the ABCDE rule. Itching, bleeding, or the appearance of a new mole can also be concerning signs. Diagnosis typically involves a thorough skin examination followed by a biopsy of any suspicious lesion. If melanoma is confirmed, further tests such as sentinel lymph node biopsy, imaging scans (CT, MRI, or PET), and blood work may be conducted to determine the stage and whether the cancer has spread. Early diagnosis is critical, as it significantly improves the prognosis and expands treatment Epidemiology Segmentation The melanoma epidemiology section provides insights into the historical and current melanoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The melanoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Melanoma Stage-specific Incident Cases of Melanoma Mutation-specific Incident Cases of Melanoma Line-wise Treated Cases of Melanoma Download the report to understand which factors are driving melanoma epidemiology trends @ Melanoma Treatment Algorithm Melanoma Treatment Market There remains a substantial unmet need for effective treatment options in melanoma patients who are resistant to, unsuitable for, or unresponsive to standard therapies like checkpoint inhibitors or BRAF/MEK-targeted treatments. The FDA has approved several therapies for melanoma, including AMTAGVI (lifileucel, Iovance Biotherapeutics), OPDUALAG (nivolumab + relatlimab, Bristol Myers Squibb), KEYTRUDA (pembrolizumab, Merck), OPDIVO (nivolumab, BMS), KIMMTRAK (tebentafusp-tebn, Immunocore), YERVOY (ipilimumab, BMS), TECENTRIQ (atezolizumab, Roche), among others. AMTAGVI, from Iovance Biotherapeutics, became the first FDA-approved, personalized, one-time T cell therapy in February 2024. It is intended for adults with unresectable or metastatic melanoma who have previously been treated with PD-1 inhibitors, and for those with BRAF V600 mutations, after BRAF inhibitor ± MEK inhibitor therapy. That same year, Iovance submitted a Marketing Authorization Application (MAA) for lifileucel to the EMA in June (validated in August) and to the UK's MHRA in October. In June 2025, Iovance announced that the final results from the Phase II C-144-01 trial of AMTAGVI in advanced melanoma patients were published in the Journal of Clinical Oncology and presented at the 2025 ASCO Annual Meeting. Bristol Myers Squibb's OPDUALAG combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor, and is indicated for the treatment of unresectable or metastatic melanoma. The FDA approved it in March 2022 for adults and children aged 12 and above. However, in February 2025, BMS reported that the Phase III RELATIVITY-098 trial did not achieve its primary endpoint of recurrence-free survival (RFS) in the adjuvant setting for completely resected stage III–IV melanoma, although the safety profile remained consistent with existing data on the combination. KEYTRUDA and OPDIVO both demonstrate strong efficacy in treating melanoma, though OPDIVO has gained greater commercial traction through effective combination regimens and broader clinical use. Despite metastatic melanoma often being incurable, the emergence of advanced treatments such as immune checkpoint inhibitors and targeted therapies has markedly improved survival and quality of life, signaling a significant evolution in the standard of care. Learn more about the melanoma treatment options @ Melanoma Treatment Guidelines Melanoma Emerging Drugs and Companies Some of the products in the pipeline include Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), RP1 (vusolimogene oderparepvec) plus nivolumab (Replimune and BMS), APG-115 (Ascentage Pharma), Naporafenib (ERAS-254) (Erasca), KB707 (Krystal Biotech), Darovasertib (IDE196) (IDEAYA Biosciences and Novartis), HBI-8000 (HUYA Bioscience and BMS), Fianlimab (Regeneron Pharmaceuticals), and others. IMA203 is a TCR T-cell therapy that targets the Preferentially Expressed Antigen in Melanoma (PRAME). It's designed to identify an intracellular PRAME-derived peptide displayed on the surface of cells by HLA-A*02:01, triggering a strong and specific anti-tumor immune response. Encouraging Phase Ib results, along with PRAME's high expression rate in melanoma (~90–95%), support IMA203's therapeutic promise. The therapy is currently under investigation in the SUPRAME Phase III trial (NCT06743126) for previously treated advanced or metastatic cutaneous melanoma, and its Phase Ib expansion now includes uveal melanoma. According to the company's 2024 Annual Report, interim analysis for IMA203 is expected in Q1 2026, with final Phase III results in Q4 2026. A Biologics License Application (BLA) submission is planned for Q1 2027, aiming for a market launch in Q3 2027. RP1 is a herpes simplex virus-based therapy modified with a fusogenic protein (GALV-GP R) and GM-CSF to enhance tumor cell destruction, increase immunogenic cell death, and promote a systemic anti-tumor immune response. The FDA has awarded Breakthrough Therapy Designation (BTD) for RP1 in combination with nivolumab for adults with advanced melanoma that has progressed after anti-PD1 treatment. In June 2025, Replimune shared updated results from the IGNYTE study (RP1 + nivolumab in anti-PD1-refractory melanoma) at the 2025 ASCO Annual Meeting. Darovasertib (IDE196) is a potent, selective PKC inhibitor in clinical development. PKC lies downstream of the GNAQ and GNA11 pathways. Darovasertib is currently in a Phase III trial for primary non-metastatic uveal melanoma, a Phase II/III (DAR-UM-2) study for HLA-A2-negative metastatic uveal melanoma (MUM), and other Phase II trials in ocular melanoma. The company expects results from the pivotal DAR-UM-2 trial in first-line HLA-A2-negative MUM by late 2025. In March 2025, the FDA granted BTD to darovasertib for neoadjuvant treatment of primary uveal melanoma patients recommended for enucleation. The anticipated launch of these emerging melanoma therapies are poised to transform the Melanoma market landscape in the coming years. As these cutting-edge melanoma therapies continue to mature and gain regulatory approval, they are expected to reshape the melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for melanoma, visit @ Melanoma Management Melanoma Market Dynamics The melanoma market dynamics are anticipated to change in the coming years. Drugs like OPDIVO and KEYTRUDA, particularly in combination with ipilimumab, have significantly improved overall survival and achieved durable response rates (~30–40%) in metastatic melanoma; however, the limited long-term efficacy in many patients highlights the urgent need for effective second-line therapies and continued innovation. With nearly 50% of melanoma patients harboring BRAF mutations, targeted therapy has become a viable option, while molecular profiling enables patient stratification even in refractory settings for clinical trials and off-label interventions. Moreover, targeting underrepresented melanoma subtypes such as uveal, mucosal, and acral presents opportunities for market expansion and accelerated regulatory pathways, given the high unmet need and paucity of existing therapies. Furthermore, many potential therapies are being investigated for the treatment of melanoma, and it is safe to predict that the treatment space will significantly impact the melanoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the melanoma market in the 7MM. However, several factors may impede the growth of the melanoma market. Moreover, melanoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the melanoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the melanoma market growth. Melanoma Report Metrics Details Study Period 2020–2034 Melanoma Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Melanoma Companies Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others Key Melanoma Therapies Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others Scope of the Melanoma Market Report Melanoma Therapeutic Assessment: Melanoma current marketed and emerging therapies Melanoma Market Dynamics: Conjoint Analysis of Emerging Melanoma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Melanoma Market Access and Reimbursement Discover more about melanoma drugs in development @ Melanoma Clinical Trials Table of Contents 1. Melanoma Market Key Insights 2. Melanoma Market Report Introduction 3. Melanoma Market Overview at a Glance 4. Melanoma Market Executive Summary 5. Disease Background and Overview 6. Melanoma Treatment and Management 7. Melanoma Epidemiology and Patient Population 8. Patient Journey 9. Melanoma Marketed Drugs 10. Melanoma Emerging Drugs 11. Seven Major Melanoma Market Analysis 12. Melanoma Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Melanoma Pipeline Melanoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key melanoma companies, including IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics, among others. Ocular Melanoma Market Ocular Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ocular melanoma companies, including Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others. Uveal Melanoma Market Uveal Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key uveal melanoma companies, including Novartis Pharmaceuticals, Foghorn Therapeutics, TriSalus Life Sciences, Inc., Bristol Myers Squibb, Array BioPharma, Ono Pharmaceutical, AstraZeneca, Roche, IDEAYA Biosciences, Merck & Co, GlaxoSmithKline, Janssen, among others. Metastatic Melanoma Market Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic melanoma companies, including Cancer Insight LLC, Elios Therapeutics LLC, Evaxion Biotech A/S, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, InxMed (Shanghai) Co. Ltd., Aivita Biomedical Inc., Hoffmann-La Roche, Idera Pharmaceuticals, Iovance Biotherapeutics Inc., Eisai Inc., Biocad, Myrexis Inc., Pain Therapeutics, Altor BioScience, among others. Refractory Metastatic Melanoma Market Refractory Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key refractory metastatic melanoma companies, including BioNTech SE, Y-mAbs Therapeutics, Seagen Inc., among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. 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Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity
New York, USA, July 22, 2025 (GLOBE NEWSWIRE) — Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. DelveInsight's Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging melanoma drugs, market share of individual therapies, and current and forecasted Melanoma 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 Melanoma Market Report According to DelveInsight's analysis, the total melanoma market size is expected to grow positively by 2034. The United States accounts for the largest market size of melanoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. In 2024, the total number of incident cases of melanoma was approximately 105K in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around 20% of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. Prominent companies, including Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others, are actively working on innovative melanoma drugs. and others, are actively working on innovative melanoma drugs. Some of the key melanoma therapies in the pipeline include Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab , and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. , and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. In May 2025, Immatics announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that would assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. Discover which melanoma medications are expected to grab the market share @ Melanoma Market Report Melanoma Overview Melanoma is a type of skin cancer that originates in melanocytes, the pigment-producing cells responsible for giving skin its color. While it is less common than other skin cancers, melanoma is significantly more aggressive and has a higher risk of spreading to other parts of the body if not detected early. It can occur anywhere on the body but is most frequently found on areas exposed to the sun, such as the back, legs, arms, and face. The primary cause of melanoma is ultraviolet radiation from sunlight or artificial sources like tanning beds, which can damage the DNA in skin cells. Individuals with fair skin, a history of sunburns, a large number of moles, or a family history of melanoma are at higher risk. Genetic mutations, such as in the BRAF gene, also play a significant role in the development of melanoma in certain cases. Symptoms of melanoma often begin with changes in the appearance of a mole or pigmented area. Warning signs include asymmetry, irregular borders, color variation, a diameter larger than 6 mm, and evolving shape or size, summarized by the ABCDE rule. Itching, bleeding, or the appearance of a new mole can also be concerning signs. Diagnosis typically involves a thorough skin examination followed by a biopsy of any suspicious lesion. If melanoma is confirmed, further tests such as sentinel lymph node biopsy, imaging scans (CT, MRI, or PET), and blood work may be conducted to determine the stage and whether the cancer has spread. Early diagnosis is critical, as it significantly improves the prognosis and expands treatment options. Melanoma Epidemiology Segmentation The melanoma epidemiology section provides insights into the historical and current melanoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The melanoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Melanoma Stage-specific Incident Cases of Melanoma Mutation-specific Incident Cases of Melanoma Line-wise Treated Cases of Melanoma Download the report to understand which factors are driving melanoma epidemiology trends @ Melanoma Treatment Algorithm Melanoma Treatment Market There remains a substantial unmet need for effective treatment options in melanoma patients who are resistant to, unsuitable for, or unresponsive to standard therapies like checkpoint inhibitors or BRAF/MEK-targeted treatments. The FDA has approved several therapies for melanoma, including AMTAGVI (lifileucel, Iovance Biotherapeutics), OPDUALAG (nivolumab + relatlimab, Bristol Myers Squibb), KEYTRUDA (pembrolizumab, Merck), OPDIVO (nivolumab, BMS), KIMMTRAK (tebentafusp-tebn, Immunocore), YERVOY (ipilimumab, BMS), TECENTRIQ (atezolizumab, Roche), among others. AMTAGVI, from Iovance Biotherapeutics, became the first FDA-approved, personalized, one-time T cell therapy in February 2024. It is intended for adults with unresectable or metastatic melanoma who have previously been treated with PD-1 inhibitors, and for those with BRAF V600 mutations, after BRAF inhibitor ± MEK inhibitor therapy. That same year, Iovance submitted a Marketing Authorization Application (MAA) for lifileucel to the EMA in June (validated in August) and to the UK's MHRA in October. In June 2025, Iovance announced that the final results from the Phase II C-144-01 trial of AMTAGVI in advanced melanoma patients were published in the Journal of Clinical Oncology and presented at the 2025 ASCO Annual Meeting. Bristol Myers Squibb's OPDUALAG combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor, and is indicated for the treatment of unresectable or metastatic melanoma. The FDA approved it in March 2022 for adults and children aged 12 and above. However, in February 2025, BMS reported that the Phase III RELATIVITY-098 trial did not achieve its primary endpoint of recurrence-free survival (RFS) in the adjuvant setting for completely resected stage III–IV melanoma, although the safety profile remained consistent with existing data on the combination. KEYTRUDA and OPDIVO both demonstrate strong efficacy in treating melanoma, though OPDIVO has gained greater commercial traction through effective combination regimens and broader clinical use. Despite metastatic melanoma often being incurable, the emergence of advanced treatments such as immune checkpoint inhibitors and targeted therapies has markedly improved survival and quality of life, signaling a significant evolution in the standard of care. Learn more about the melanoma treatment options @ Melanoma Treatment Guidelines Melanoma Emerging Drugs and Companies Some of the products in the pipeline include Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), RP1 (vusolimogene oderparepvec) plus nivolumab (Replimune and BMS), APG-115 (Ascentage Pharma), Naporafenib (ERAS-254) (Erasca), KB707 (Krystal Biotech), Darovasertib (IDE196) (IDEAYA Biosciences and Novartis), HBI-8000 (HUYA Bioscience and BMS), Fianlimab (Regeneron Pharmaceuticals), and others. IMA203 is a TCR T-cell therapy that targets the Preferentially Expressed Antigen in Melanoma (PRAME). It's designed to identify an intracellular PRAME-derived peptide displayed on the surface of cells by HLA-A*02:01, triggering a strong and specific anti-tumor immune response. Encouraging Phase Ib results, along with PRAME's high expression rate in melanoma (~90–95%), support IMA203's therapeutic promise. The therapy is currently under investigation in the SUPRAME Phase III trial (NCT06743126) for previously treated advanced or metastatic cutaneous melanoma, and its Phase Ib expansion now includes uveal melanoma. According to the company's 2024 Annual Report, interim analysis for IMA203 is expected in Q1 2026, with final Phase III results in Q4 2026. A Biologics License Application (BLA) submission is planned for Q1 2027, aiming for a market launch in Q3 2027. RP1 is a herpes simplex virus-based therapy modified with a fusogenic protein (GALV-GP R) and GM-CSF to enhance tumor cell destruction, increase immunogenic cell death, and promote a systemic anti-tumor immune response. The FDA has awarded Breakthrough Therapy Designation (BTD) for RP1 in combination with nivolumab for adults with advanced melanoma that has progressed after anti-PD1 treatment. In June 2025, Replimune shared updated results from the IGNYTE study (RP1 + nivolumab in anti-PD1-refractory melanoma) at the 2025 ASCO Annual Meeting. Darovasertib (IDE196) is a potent, selective PKC inhibitor in clinical development. PKC lies downstream of the GNAQ and GNA11 pathways. Darovasertib is currently in a Phase III trial for primary non-metastatic uveal melanoma, a Phase II/III (DAR-UM-2) study for HLA-A2-negative metastatic uveal melanoma (MUM), and other Phase II trials in ocular melanoma. The company expects results from the pivotal DAR-UM-2 trial in first-line HLA-A2-negative MUM by late 2025. In March 2025, the FDA granted BTD to darovasertib for neoadjuvant treatment of primary uveal melanoma patients recommended for enucleation. The anticipated launch of these emerging melanoma therapies are poised to transform the Melanoma market landscape in the coming years. As these cutting-edge melanoma therapies continue to mature and gain regulatory approval, they are expected to reshape the melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for melanoma, visit @ Melanoma Management Melanoma Market Dynamics The melanoma market dynamics are anticipated to change in the coming years. Drugs like OPDIVO and KEYTRUDA, particularly in combination with ipilimumab, have significantly improved overall survival and achieved durable response rates (~30–40%) in metastatic melanoma; however, the limited long-term efficacy in many patients highlights the urgent need for effective second-line therapies and continued innovation. With nearly 50% of melanoma patients harboring BRAF mutations, targeted therapy has become a viable option, while molecular profiling enables patient stratification even in refractory settings for clinical trials and off-label interventions. Moreover, targeting underrepresented melanoma subtypes such as uveal, mucosal, and acral presents opportunities for market expansion and accelerated regulatory pathways, given the high unmet need and paucity of existing therapies. Furthermore, many potential therapies are being investigated for the treatment of melanoma, and it is safe to predict that the treatment space will significantly impact the melanoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the melanoma market in the 7MM. However, several factors may impede the growth of the melanoma market. Moreover, melanoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the melanoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the melanoma market growth. Melanoma Report Metrics Details Study Period 2020–2034 Melanoma Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Melanoma Companies Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others Key Melanoma Therapies Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others Scope of the Melanoma Market Report Melanoma Therapeutic Assessment: Melanoma current marketed and emerging therapies Melanoma current marketed and emerging therapies Melanoma Market Dynamics: Conjoint Analysis of Emerging Melanoma Drugs Conjoint Analysis of Emerging Melanoma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Melanoma Market Access and Reimbursement Discover more about melanoma drugs in development @ Melanoma Clinical Trials Table of Contents 1. Melanoma Market Key Insights 2. Melanoma Market Report Introduction 3. Melanoma Market Overview at a Glance 4. Melanoma Market Executive Summary 5. Disease Background and Overview 6. Melanoma Treatment and Management 7. Melanoma Epidemiology and Patient Population 8. Patient Journey 9. Melanoma Marketed Drugs 10. Melanoma Emerging Drugs 11. Seven Major Melanoma Market Analysis 12. Melanoma Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Melanoma Pipeline Melanoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key melanoma companies, including IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics, among others. Ocular Melanoma Market Ocular Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ocular melanoma companies, including Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others. 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Ltd., Aivita Biomedical Inc., Hoffmann-La Roche, Idera Pharmaceuticals, Iovance Biotherapeutics Inc., Eisai Inc., Biocad, Myrexis Inc., Pain Therapeutics, Altor BioScience, among others. Refractory Metastatic Melanoma Market Refractory Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key refractory metastatic melanoma companies, including BioNTech SE, Y-mAbs Therapeutics, Seagen Inc., among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. 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21-07-2025
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- Globe and Mail
Glioma Pipeline Appears Promising With 180+ Leading Biotech and Pharma Companies Driving Innovation in the Therapeutics Segment
DelveInsight's, ' Glioma Pipeline Insight, 2025 ' report provides comprehensive insights about 180+ companies and 200+ pipeline drugs in Glioma pipeline landscape. It covers the Glioma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Glioma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Glioma Pipeline. Dive into DelveInsight's comprehensive report today! @ Glioma Pipeline Outlook Key Takeaways from the Glioma Pipeline Report In July 2025, Eli Lilly and Company announced a study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. In July 2025, Istari Oncology Inc. announced a Phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. The objective of this study is to investigate the safety and efficacy (anti-tumor response and survival) of lerapolturev in recurrent WHO grade IV malignant glioma. In July 2025, Incyte Corporation conducted a study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal. In July 2025, Nuvation Bio Inc. organized a 2-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. DelveInsight's Glioma pipeline report depicts a robust space with 180+ active players working to develop 200+ pipeline therapies for Glioma treatment. The leading Glioma Companies such as CellabMED, Oblato, BioMed Valley Discoveries, PharmAbcine, I-Mab Biopharma, Chimerix, Medicenna Therapeutics, Daiichi Sankyo, Eli Lilly and Company, Candel Therapeutics, AstraZeneca, Aveta Biomics, Angiochem, Arog Pharmaceuticals, Boehringer Ingelheim, BioMimetix, Bexion Pharmaceuticals, CANbridge Life Sciences, Crimson Biopharma, Epitopoietic Research Corporation, Stemgen and others. Promising Glioma Pipeline Therapies such as DS-1001b, Nimotuzumab, Radiotherapy, AP23573, BLZ-100, LY2157299, Temozolomide, Safusidenib, ONC201, PLB1001, YYB-103, and others. Stay ahead with the most recent pipeline outlook for Glioma. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Glioma Treatment Drugs Glioma Emerging Drugs Profile AV-GBM-1: Aivita Biomedical, Inc. AV-GBM-1 is an innovative immunotherapy developed by AIVITA Biomedical, Inc., specifically targeting glioblastoma (GBM), one of the most aggressive forms of brain cancer. This treatment utilizes autologous dendritic cells that are loaded with autologous tumor neoantigens derived from tumor-initiating cells. The therapy is administered through a series of subcutaneous injections and aims to enhance the immune response against the patient's unique cancer profile. Currently, the drug is in phase III stage of its clinical trial for the treatment of Glioma. DB 107: Denovo BioPharma Denovo BioPharma's DB107 is an investigational gene therapy designed to treat high-grade gliomas, including glioblastoma (GBM), a particularly aggressive form of brain cancer. The therapy utilizes a novel biomarker-guided approach, leveraging the Denovo Genomic Marker 7 (DGM7) to identify patients who are likely to benefit from the treatment. Currently, the drug is in phase II stage of its clinical trial for the treatment of Glioma. MDNA55: Medicenna Therapeutics, Inc. MDNA55 is a therapeutic for recurrent glioblastoma multiforme (rGBM), a uniformly fatal form of brain cancer. By using a highly specific IL-4 Superkine as the vehicle to deliver a potent bacterial toxin to the tumor cells, MDNA55 has the potential to purge bulk tumors and disrupt their supporting networks, while reactivating the immune system to tackle cancer. MDNA55 is designed to be a molecular trojan horse. It is a genetic fusion of two molecules: a circularly permuted IL-4 Superkine and the catalytic domain of the pseudomonas exotoxin A. Genetic fusion allows MDNA55 to harness the selectivity of the Superkine for cancers that overexpress the target IL-4 receptor (IL-4R) and deliver the cell-killing toxin directly into the tumor, its microenvironment and cancer stem cells. Since the IL-4 receptor is not found in a healthy brain and the exotoxin is only active in the cancer cell cytoplasm, this helps ensure that healthy cells are unaffected. When MDNA55 binds the target IL-4R, it is swallowed inside the tumor cell through a process called endocytosis. Once inside the tumor, proteases cleave the drug and activate the catalytic domain of the exotoxin to begin the process of apoptosis (cell death) involving a protein called elongation factor-2. Currently, the drug is in phase II stage of its clinical trial for the treatment of Glioma. Abemaciclib: Eli Lilly and Company Abemaciclib is an antitumor agent and dual inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6) that are involved in the cell cycle and promotion of cancer cell growth in case of unregulated activity. It is either given alone in patients who has undergone endocrine therapy and chemotherapy after the metastasis of cancer, or in combination with Fulvestrant. Following oral treatment in patients with HR-positive, HER2-negative breast cancer, abemaciclib demonstrated increased progression-free survival rates and objective response rates. Abemaciclib has been used in trials studying the treatment of melanoma, lymphoma, neoplasm, solid tumor, and glioblastoma. NMS-03305293: Nerviano Medical Sciences NMS-293 is a second generation PARP inhibitor that differentiates from other approved or advanced molecules in its unique selectivity for PARP1 vs. PARP2 enzymes and low DNA trapping activity, both features potentially linked to lower hematological toxicity and higher potential for combination with DNA damaging agents in a wide range of tumors, covering high unmet medical needs. It also has a superior ability to penetrate the blood-brain barrier, a very important feature supporting its utilization in CNS tumors and brain metastases. The drug has shown high anti-tumor activity as single agent in BRCA mutated preclinical tumor models and synergy and tolerability in combination with chemotherapy. Based on the findings, NMS-293 is currently in clinical developmental Phase II in combination with temozolomide in recurrent glioblastoma. CAN-3110: Candel Therapeutics CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase I investigator-sponsored clinical trial in patients with recurrent HGG. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Glioma. MB-101: Mustang Bio MB-101 is an IL13Rα2-targeted CAR T cell therapy developed by Mustang Bio, aimed at treating recurrent glioblastoma (GBM) and high-grade gliomas. Currently, the drug is in Phase I stage of clinical trial for the treatment of Glioma. The Glioma Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Glioma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Glioma Treatment. Glioma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Glioma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Glioma market Explore groundbreaking therapies and clinical trials in the Glioma Pipeline. Access DelveInsight's detailed report now! @ New Glioma Drugs Glioma Companies CellabMED, Oblato, BioMed Valley Discoveries, PharmAbcine, I-Mab Biopharma, Chimerix, Medicenna Therapeutics, Daiichi Sankyo, Eli Lilly and Company, Candel Therapeutics, AstraZeneca, Aveta Biomics, Angiochem, Arog Pharmaceuticals, Boehringer Ingelheim, BioMimetix, Bexion Pharmaceuticals, CANbridge Life Sciences, Crimson Biopharma, Epitopoietic Research Corporation, Stemgen and others. Glioma Pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Oral Parenteral Subcutaneous Topical Transdermal Glioma Products have been categorized under various Molecule types, such as Oligonucleotide Peptide Small molecule Unveil the future of Glioma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Glioma Market Drivers and Barriers Scope of the Glioma Pipeline Report Coverage- Global Glioma Companies- CellabMED, Oblato, BioMed Valley Discoveries, PharmAbcine, I-Mab Biopharma, Chimerix, Medicenna Therapeutics, Daiichi Sankyo, Eli Lilly and Company, Candel Therapeutics, AstraZeneca, Aveta Biomics, Angiochem, Arog Pharmaceuticals, Boehringer Ingelheim, BioMimetix, Bexion Pharmaceuticals, CANbridge Life Sciences, Crimson Biopharma, Epitopoietic Research Corporation, Stemgen and others. Glioma Pipeline Therapies- DS-1001b, Nimotuzumab, Radiotherapy, AP23573, BLZ-100, LY2157299, Temozolomide, Safusidenib, ONC201, PLB1001, YYB-103, and others. Glioma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Glioma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Glioma Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Glioma Companies, Key Products and Unmet Needs Table of Contents Introduction Executive Summary Glioma Disease: Overview Pipeline Therapeutics Therapeutic Assessment Glioma Disease– DelveInsight's Analytical Perspective Late Stage Products (Phase III) AV-GBM-1: Aivita Biomedical, Inc. Drug profiles in the detailed report….. Mid Stage Products (Phase II) DB 107: Denovo BioPharma Drug profiles in the detailed report….. Early Stage Products (Phase I) MB-101: Mustang Bio Preclinical Stage Products Drug Name: Company Name Drug profiles in the detailed report….. Inactive Products Glioma Disease Key Companies Glioma Disease Key Products Glioma Disease- Unmet Needs Glioma Disease- Market Drivers and Barriers Glioma Disease- Future Perspectives and Conclusion Glioma Disease Analyst Views Glioma Disease Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
