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Hepatocellular Carcinoma FDA Approvals, Clinical Trials, Emerging Drugs and Companies

Hepatocellular Carcinoma FDA Approvals, Clinical Trials, Emerging Drugs and Companies

Globe and Mail29-01-2025

DelveInsight's, 'Hepatocellular Carcinoma Pipeline Insight' report provides comprehensive insights about 90+ companies and 95+ pipeline drugs in Hepatocellular Carcinoma pipeline landscape. It covers the Hepatocellular Carcinoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hepatocellular Carcinoma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Hepatocellular Carcinoma Treatment Landscape. Click here to read more @ Hepatocellular Carcinoma Pipeline Outlook
Key Takeaways from the Hepatocellular Carcinoma Pipeline Report
In January 2025:- Hoffmann-La Roche:- This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.
In January 2025:- Polaris Group:- A Randomized, Double-Blind, Multi-Center Study of ADI-PEG 20 Versus Placebo in Subjects with High Arginine Level and Unresectable Hepatocellular Carcinoma. Efficacy will be determined by overall survival, progression free survival, pharmacodynamics (peripheral blood arginine and citrulline levels) and immunogenicity (antibodies to ADI-PEG 20).
In January 2025:- AstraZeneca:- A Phase I/II Open-Label Study to Evaluate the Safety, Cellular Kinetics and Efficacy of AZD5851, a Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against GPC3 in Adult Participants With Advanced/Recurrent Hepatocellular Carcinoma: ATHENA. This first-time in human, single-arm, open-label multicentre Phase I/II study will evaluate the safety, tolerability, antitumour activity, cellular kinetics, pharmacodynamics, and immunogenicity of AZD5851 in adult participants with GPC3+ advanced/recurrent HCC, where at least one line of prior therapy has failed/or was intolerable, or participant/investigator decision.
DelveInsight's Hepatocellular Carcinoma pipeline report depicts a robust space with 90+ active players working to develop 95+ pipeline therapies for Hepatocellular Carcinoma treatment.
The leading Hepatocellular Carcinoma Companies such as Can-Fite BioPharma, Sinocelltech, AVEO Oncology, Oxford BioTherapeutics, Beijing SyngenTech, Surface Oncology, Novartis Oncology, Array BioPharma, Taizhou Hanzhong Pharmaceuticals, Akeso Biopharma, Shanghai Henlius Biotech, Chugai Pharmaceutical, CStone Pharmaceuticals, Shenogen Pharma, GlaxoSmithKline, Tarus Therapeutics, Tvardi Therapeutics, Virogin Biotech, Yiviva, Chia Tai Tianqing Pharmaceutical Group, Antengene Corporation, Iterion Therapeutics, Sumitomo Pharma, SillaJen Biotherapeutics, SCG Cell Therapy, Guangdong ProCapZoom Biosciences, Eutilex, Polaris Pharmaceuticals, OriCell Therapeutics, and others
Promising Hepatocellular Carcinoma Therapies such as Pembrolizumab, Tislelizumab, HLX53 (1000mg), Atezolizumab, Bevacizumab, Tiragolumab, Nivolumab and others
Discover groundbreaking developments in Hepatocellular Carcinoma therapies! Gain in-depth knowledge of key Hepatocellular Carcinoma clinical trials, emerging drugs, and market opportunities @ Hepatocellular Carcinoma Clinical Trials Assessment
Hepatocellular Carcinoma Emerging Drugs
• Namodenoson: Can-Fite BioPharma
Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5'- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR). The drug had been out-licensed to Chong Kun Dang (CKD) Pharmaceutical in Korea and to CMS in China.for the treatment of Liver Cancer and NASH. A Phase I/II study in hepatocellular carcinoma (HCC) successfully met its primary and secondary endpoints demonstrating initial indications for efficacy of Namodenoson. A global Phase II study treating patients with Namodenoson as a second-line therapy has recently been concluded.
• SRF388: Surface Oncology
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. IL-27 is an immunosuppressive cytokine involved in resolving T cell mediated inflammation. Recent data points to IL-27 as a master regulator of the expression of co-inhibitory receptors expressed on CD4+ and CD8+ T cells. Elevated levels of IL-27 transcripts and mRNA gene signatures are found in cancer and are associated with poor prognoses. Surface Oncology has identified particular tumor types where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors.
• Porustobart: Harbour BioMed
Porustobart (HBM4003) is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from mice. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, porustobart has demonstrated significantly improved depletion specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combo-therapy.
• Fisogatinib: CStone Pharmaceuticals
Fisogatinib is an orally available, potent, irreversible inhibitor of FGFR4. Fisogatinib was specifically designed to inhibit FGFR4 with exquisite selectivity, thereby sparing the paralogs FGFR1, FGFR2 and FGFR3 and preventing potential adverse effects. Preclinical data has validated FGFR4 as an oncogenic driver for a subset of patients with advanced HCC. The US Food and Drug Administration has granted orphan drug designation to fisogatinib for the treatment of HCC. Fisogatinib is being investigated in the Phase I/II stage of its development for the treatment of patients with FGFR4-activated HCC.
• STP705: Sirnaomics
STP705 is composed of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA respectively and formulated in nanoparticles with a proprietary Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA has demonstrated the ability to inhibit the expression of their target mRNA and combining the two siRNAs produces a synergistic effect that diminishes pro-fibrogenic, pro-inflammatory, and pro-tumorigenic factors. Sirnaomics has completed several pre-clinical studies that demonstrate that inhibition of TGF-β1 and COX-2 and is expected to result in the inhibition of tumor growth and provide an alternative approach for the treatment of various liver cancers. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with numerous oncology targets.
Stay informed about the Hepatocellular Carcinoma pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Hepatocellular Carcinoma Unmet Needs
Hepatocellular Carcinoma Companies
Can-Fite BioPharma, Sinocelltech, AVEO Oncology, Oxford BioTherapeutics, Beijing SyngenTech, Surface Oncology, Novartis Oncology, Array BioPharma, Taizhou Hanzhong Pharmaceuticals, Akeso Biopharma, Shanghai Henlius Biotech, Chugai Pharmaceutical, CStone Pharmaceuticals, Shenogen Pharma, GlaxoSmithKline, Tarus Therapeutics, Tvardi Therapeutics, Virogin Biotech, Yiviva, Chia Tai Tianqing Pharmaceutical Group, Antengene Corporation, Iterion Therapeutics, Sumitomo Pharma, SillaJen Biotherapeutics, SCG Cell Therapy, Guangdong ProCapZoom Biosciences, Eutilex, Polaris Pharmaceuticals, OriCell Therapeutics, and others.
Hepatocellular Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
Hepatocellular Carcinoma Products have been categorized under various Molecule types such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
Transform your understanding of the Hepatocellular Carcinoma Pipeline! See the latest progress in drug development and clinical research @ Hepatocellular Carcinoma Market Drivers and Barriers, and Future Perspectives
Scope of the Hepatocellular Carcinoma Pipeline Report
Coverage- Global
Hepatocellular Carcinoma Companies- Can-Fite BioPharma, Sinocelltech, AVEO Oncology, Oxford BioTherapeutics, Beijing SyngenTech, Surface Oncology, Novartis Oncology, Array BioPharma, Taizhou Hanzhong Pharmaceuticals, Akeso Biopharma, Shanghai Henlius Biotech, Chugai Pharmaceutical, CStone Pharmaceuticals, Shenogen Pharma, GlaxoSmithKline, Tarus Therapeutics, Tvardi Therapeutics, Virogin Biotech, Yiviva, Chia Tai Tianqing Pharmaceutical Group, Antengene Corporation, Iterion Therapeutics, Sumitomo Pharma, SillaJen Biotherapeutics, SCG Cell Therapy, Guangdong ProCapZoom Biosciences, Eutilex, Polaris Pharmaceuticals, OriCell Therapeutics, and others
Hepatocellular Carcinoma Therapies- Pembrolizumab, Tislelizumab, HLX53 (1000mg), Atezolizumab, Bevacizumab, Tiragolumab, Nivolumab and others
Hepatocellular Carcinoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Hepatocellular Carcinoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Table of Content
1. Introduction
2. Executive Summary
3. Hepatocellular Carcinoma: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Hepatocellular Carcinoma- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Namodenoson: Can-Fite BioPharma
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. SRF388: Surface Oncology
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. STP705: Sirnaomics
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Hepatocellular Carcinoma Key Companies
21. Hepatocellular Carcinoma Key Products
22. Hepatocellular Carcinoma- Unmet Needs
23. Hepatocellular Carcinoma- Market Drivers and Barriers
24. Hepatocellular Carcinoma- Future Perspectives and Conclusion
25. Hepatocellular Carcinoma Analyst Views
26. Hepatocellular Carcinoma Key Companies
27. 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: 9650213330
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/report-store/microscopy-device-market

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Health Canada Authorizes PiaSky® (crovalimab for injection) As the First Monthly (Every Four Weeks) Subcutaneous Treatment for People With Paroxysmal Nocturnal Hemoglobinuria (PNH) Français
Health Canada Authorizes PiaSky® (crovalimab for injection) As the First Monthly (Every Four Weeks) Subcutaneous Treatment for People With Paroxysmal Nocturnal Hemoglobinuria (PNH) Français

Cision Canada

timea day ago

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Health Canada Authorizes PiaSky® (crovalimab for injection) As the First Monthly (Every Four Weeks) Subcutaneous Treatment for People With Paroxysmal Nocturnal Hemoglobinuria (PNH) Français

PiaSky® is the first monthly (every four weeks) subcutaneous treatment for PNH in Canada with the option to self-administer following adequate training (1) PiaSky® (crovalimab for injection) has the potential to help reduce treatment burden for people with PNH in Canada and their caregivers (2, 3) MISSISSAUGA, ON, June 11, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has authorized PiaSky® (crovalimab for injection) as the first monthly (every four weeks) subcutaneous therapy indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and adolescents 13 years of age and older with a body weight of at least 40 kg. (1) "We are pleased to offer PiaSky as a new option to the treatment landscape for Canadians living with PNH," said Brigitte Nolet, President and CEO, Roche Pharma Canada. 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(7) Complement component 5 (C5) inhibitors – treatments that block part of the complement system cascade – have been shown to be effective in treating PNH. (4, 5, 6, 8) "The approval of crovalimab, a novel C5 inhibitor, provides further freedom of choice for patients with PNH receiving terminal complement blockade," said Dr. Christopher Patriquin, Chair of the Canadian PNH Network and Assistant Professor of Medicine and Clinician Investigator at the University of Toronto. "Blocking C5 directly was the first approved strategy for treating such patients, and this new drug will allow them another option. They can now choose to get the disease-controlling treatment in small-volume, subcutaneous doses every 4 weeks, and even, in appropriate cases, self-administer them, instead of the other available C5 inhibitors which are given intravenously." 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(5, 6, 11, 12) About PiaSky ® [crovalimab for injection] PiaSky is a novel recycling monoclonal antibody that inhibits the complement protein C5 and is designed to block the complement system. (1, 10) It is recycled within the bloodstream, allowing the medicine to bind and inhibit the C5 protein multiple times and to act longer in the body with a small volume of medicine. (1, 13) Individuals will have the option to self-administer PiaSky following an initial intravenous (IV) infusion and weekly subcutaneous (SC) loading doses in the first month of treatment, in appropriate cases following adequate training. (1) PiaSky's flexibility of administration may help to reduce treatment burden and disruption to the lives of people with PNH and their caregivers. (2, 3) About the COMMODORE 2 study The COMMODORE 2 study is a Phase III, randomised, open-label study evaluating the efficacy and safety of PiaSky® (crovalimab for injection) versus eculizumab in people with paroxysmal nocturnal hemoglobinuria who have not been treated previously with C5 inhibitors. The study's co-primary efficacy endpoints measure transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). The adults enrolled in the study were randomised in a 2:1 ratio to be treated with either subcutaneous (SC) PiaSky every four weeks or intravenous eculizumab every two weeks. The participants who were less than 18 years old were included in a non-randomised treatment arm and were treated with SC PiaSky every four weeks. (9, 10) About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec. PiaSky Product Monograph, June 4, 2025 Roth A, Nishimura JI, Nagy Z, Gaal-Weisinger J, Panse J, Yoon SS, et al. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria. Blood. 2020;135(12):912–20. Sampei Z, Haraya K, Gan SW, Muraoka M, Hayasaka A, Fukuzawa T, et al. Beyond Recycling Antibodies: Crovalimab's Molecular Design Enables Four-Weekly Subcutaneous Injections for PNH Treatment. Int J Mol Sci. 2024;25(21). Shah N, Bhatt H. Paroxysmal nocturnal hemoglobinuria. StatPearls. Treasure Island (FL) 2022. Schrezenmeier H, Roth A, Araten DJ, Kanakura Y, Larratt L, Shammo JM, et al. Baseline clinical characteristics and disease burden in patients with paroxysmal nocturnal hemoglobinuria (PNH): updated analysis from the International PNH Registry. Ann Hematol. 2020;99(7):1505–14. Patriquin CJ, Kiss T, Caplan S, Chin-Yee I, Grewal K, Grossman J, et al. How we treat paroxysmal nocturnal hemoglobinuria: a consensus statement of the Canadian PNH Network and review of the national registry. Eur J Haematol. 2019;102(1):36–52. Hill A, Platts PJ, Smith A, Richards SJ, Cullen MJ, Hill QA, et al. The incidence and prevalence of paroxysmal nocturnal hemoglobinuria (PNH) and survival of patients in Yorkshire. Blood. 2006;108:985. Hillmen P, Young NS, Schubert J, Brodsky RA, Socie G, Muus P, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355(12):1233–43. COMMODORE 2 (NCT04434092). [Internet; cited June 2025] Available at: Roth A, He G, Tong H, Lin Z, Wang X, Chai-Adisaksopha C, et al. Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition. Am J Hematol. 2024;99(9):1768-77. Oliver MP, C. Paroxysmal Nocturnal Hemoglobinuria: Current Management, Unmet Needs, and Recommendations. J Blood Med. 2023:613-28. Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106(12):3699–709. Fukuzawa T, et al. Long lasting neutralisation of C5 by SKY59, a novel recycling antibody, is a potential therapy for complement-mediated diseases. Sci Rep. 2017;7(1):1080. SOURCE Hoffmann-La Roche Limited (Roche Canada)

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Facial Lines Market Set for Significant Transformation by 2032, Forecasts DelveInsight

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Chronic Insomnia Market Growth Projections 2023-2032: DelveInsight Analysis
Chronic Insomnia Market Growth Projections 2023-2032: DelveInsight Analysis

Globe and Mail

time02-06-2025

  • Globe and Mail

Chronic Insomnia Market Growth Projections 2023-2032: DelveInsight Analysis

The Key Chronic Insomnia Companies in the market include - Janssen Research & Development, Takeda, and others. The Chronic Insomnia market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Chronic Insomnia pipeline products will significantly revolutionize the Chronic Insomnia market dynamics. DelveInsight's 'Chronic Insomnia Market Insights, Epidemiology, and Market Forecast-2032″ report offers an in-depth understanding of the Chronic Insomnia, historical and forecasted epidemiology as well as the Chronic Insomnia market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan. 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Chronic Insomnia Epidemiology Segmentation: The Chronic Insomnia market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalence of Chronic Insomnia Prevalent Cases of Chronic Insomnia by severity Gender-specific Prevalence of Chronic Insomnia Diagnosed Cases of Episodic and Chronic Chronic Insomnia Download the report to understand which factors are driving Chronic Insomnia epidemiology trends @ Chronic Insomnia Epidemiology Forecast Chronic Insomnia Drugs Uptake and Pipeline Development Activities The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Chronic Insomnia market or expected to get launched during the study period. The analysis covers Chronic Insomnia market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share. The report also covers the Chronic Insomnia Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies. Chronic Insomnia Therapies and Key Companies Discover more about therapies set to grab major Chronic Insomnia market share @ Chronic Insomnia Treatment Market Chronic Insomnia Market Drivers Increasing Prevalence Personalization of therapies Chronic Insomnia Market Barriers Issues with diagnosis and poor knowledge Use of off-label drugs High economic burden Scope of the Chronic Insomnia Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Chronic Insomnia Companies: Janssen Research & Development, Takeda, and others Key Chronic Insomnia Therapies: Seltorexant, Ramelteon and zolpidem, and others Chronic Insomnia Therapeutic Assessment: Chronic Insomnia current marketed and Chronic Insomnia emerging therapies Chronic Insomnia Market Dynamics: Chronic Insomnia market drivers and Chronic Insomnia market barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Chronic Insomnia Unmet Needs, KOL's views, Analyst's views, Chronic Insomnia Market Access and Reimbursement Table of Contents 1. Chronic Insomnia Market Report Introduction 2. Executive Summary for Chronic Insomnia 3. SWOT analysis of Chronic Insomnia 4. Chronic Insomnia Patient Share (%) Overview at a Glance 5. Chronic Insomnia Market Overview at a Glance 6. Chronic Insomnia Disease Background and Overview 7. Chronic Insomnia Epidemiology and Patient Population 8. Country-Specific Patient Population of Chronic Insomnia 9. Chronic Insomnia Current Treatment and Medical Practices 10. Chronic Insomnia Unmet Needs 11. Chronic Insomnia Emerging Therapies 12. Chronic Insomnia Market Outlook 13. Country-Wise Chronic Insomnia Market Analysis (2019–2032) 14. Chronic Insomnia Market Access and Reimbursement of Therapies 15. Chronic Insomnia Market Drivers 16. Chronic Insomnia Market Barriers 17. Chronic Insomnia Appendix 18. Chronic Insomnia Report Methodology 19. DelveInsight Capabilities 20. Disclaimer 21. About DelveInsight About DelveInsight DelveInsight is a leading Healthcare 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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:

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