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Yahoo
15 hours ago
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Pacific Edge Ltd (PFGTF) (FY 2025) Earnings Call Highlights: Navigating Revenue Challenges and ...
Operating Revenue: $21.8 million for FY25, down 8.6% from the prior year. Cash and Cash Equivalents: $22.6 million as of March 31, 2025. Average Sales Price (ASP): Increased to $594 from $584 in the previous year. Operating Expenses: Down 7.3% year-over-year. Research Costs: Increased by 21% year-over-year. Sales and Marketing Costs: Reduced by 31% year-over-year. Non-Medicare Revenues: Represent 57% of US volumes. Tests Per Sales FTE: Increased, indicating improved efficiency. Cash Burn: Largely flat half-on-half. Capital Raise: Announced $20 million on ASX and NZX platforms. Warning! GuruFocus has detected 7 Warning Signs with PFGTF. Release Date: May 29, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Pacific Edge Ltd (PFGTF) has achieved inclusion in the AUA's microhematuria guideline, marking a significant strategic milestone for the company. Non-Medicare revenues have increased and now represent 57% of US volumes, indicating a successful diversification of revenue sources. The company has established a higher draft CMS pricing for Triage Plus at $1,018 per test, which is an improvement over the previous $760 per test. Pacific Edge Ltd (PFGTF) has a strong relationship with Kaiser Permanente, contributing to growth in US commercial volumes. The company is focused on innovation and product development, including the development of IVD kits for international markets. There has been an 11% reduction in the number of global tests operated, impacting operating revenue. The company faces challenges with Medicare coverage, including an adverse Local Coverage Determination that has affected revenue. Operating revenue for the financial year '25 was down 8.6% compared to the prior year. The reduction in the US sales force has impacted revenue, with a significant reduction in sales and marketing costs by 31% year-on-year. There is uncertainty regarding the timeline for Medicare recoverage, which could impact future financial performance. Q: Could you quantify the impact on US commercial test volumes post coverage loss? Was it down 20% or more? A: Peter Meintjes, Chief Executive Officer: We haven't published that figure, but we estimate the reduction to be less than 20%. Q: With 40% of revenue coming from Medicare, should we expect a decline due to the payer mix shift? A: Peter Meintjes, Chief Executive Officer: We anticipate a greater percentage of commercially insured or private payers in our mix going forward, especially for Triage, which skews younger than the Medicare population. Q: Can you provide an update on the cost base and how it might change? A: Peter Meintjes, Chief Executive Officer: The cost base is expected to remain about the same. We will continue to look for ways to reduce unnecessary costs, but you can model it as being roughly the same. Q: Is there still room for growth with Kaiser, particularly in Southern California? A: Peter Meintjes, Chief Executive Officer: Yes, there is room to grow. We have seen steady growth since the EMR integration, and there are still doctors not using it on all their patients. The finance department at Kaiser is recognizing savings, which is a positive sign. Q: How are urologists responding to the guideline inclusion of Triage, and what are the ordering patterns post-announcement? A: Peter Meintjes, Chief Executive Officer: Feedback has been overwhelmingly positive, especially from new users and existing Detect users transitioning to Triage. The guideline inclusion has been well-received, and we expect to grow volume soon. Q: How should we think about research costs in FY26 and beyond? A: Peter Meintjes, Chief Executive Officer: We don't foresee an increase in research costs. We have a series of trials planned, but we expect costs to remain stable. Q: If CMS coverage is achieved, is the current capital raise sufficient to reach breakeven? A: Peter Meintjes, Chief Executive Officer: It depends on how quickly we achieve recoverage and other variables like the success of our commercial payer strategy and sales force efficiency. If recoverage is quick, the chances of having sufficient capital increase. Q: Will the clinical guidelines impact the legal liability for users of Cxbladder? A: Peter Meintjes, Chief Executive Officer: The inclusion in guidelines reduces legal exposure for physicians using Cxbladder, as it aligns with recommended practices. However, stronger language in future guidelines could further mitigate liability. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
4 days ago
- Business
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Collaborations for Change: AUA and Pfizer Select Recipients for $1.5 Million Grant Program to Improve Advanced Prostate Cancer Care
BALTIMORE, May 29, 2025 (GLOBE NEWSWIRE) -- The American Urological Association (AUA) is excited to announce it has selected seven grant winners to split $1.5 million as part of a collaborative initiative with Pfizer External Research & Grants (ER&G) which is aimed to improve the quality of care for individuals with advanced prostate cancer. Following a joint Request for Proposals (RFP), 23 grant proposals were received from urology and urologic oncology institutions and organizations nationwide. After a rigorous review process, seven innovative projects were awarded grant funding, totaling $1.5 million on behalf of the Pfizer-Astellas Alliance. 'The AUA is proud to once again collaborate with Pfizer in supporting forward-thinking research and education in advanced prostate cancer,' said Mark Gonzalgo, MD, PhD, MBA, chair of education at the AUA. 'This grant initiative continues to foster groundbreaking strategies that address unmet needs in care delivery—from earlier diagnosis to individualized treatment approaches. We commend this year's grant recipients for their commitment to improving outcomes and elevating the standard of care for patients navigating this challenging disease.' Congratulations to the following selected applications: 'Addressing Genomic Disparities in Prostate Cancer: A Quality Improvement Initiative for Equitable Access to Germline and Somatic Testing' – Rohan Garje, MD, Miami Cancer Institute 'Advanced Prostate Cancer Collaboration Advances Rural Equity' – Charles Shelton, MD, The Outer Banks Hospital 'AI-Enhanced Quality Improvement to Optimize Genetic Testing in Advanced Prostate Cancer' – Kenneth Nepple, MD, University of Iowa 'Bridging Gaps in Advanced Prostate Cancer Care: A Quality Improvement Initiative in the Bronx' – Christopher Jakubowski, MD, Montefiore Medical Center 'Boosting Precision: Enhancing Germline and Somatic Testing in Advanced Prostate Cancer' – Guru Sonpavde, MD, AdventHealth Foundation Central Florida 'A Clinical Trial to Address Physician- and Patient-based Barriers to NGS Testing' – Catherine Marshall, MD, MPH, Johns Hopkins University 'Implementing MyNavigator Platform in a High Volume, Rural Advanced Prostate Cancer Practice to Optimize Performance of Multidisciplinary Care Team, Improve Patient Symptom Monitoring, and Collect Real World Data: A Quality Improvement Initiative' – Timothy Richardson, MD, Avident Health, LLC *Pending executed agreements About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 26,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy. CONTACT: Corey Del Bianco American Urological Association 443-689-4033 cdelbianco@
Yahoo
21-05-2025
- Business
- Yahoo
Prostate Cancer Diagnostics Solution Market Trends, Challenges and Future Outlook
Prostate Cancer Diagnostics Solution Market Overview 2025-2034 Luton, Bedfordshire, United Kingdom, May 21, 2025 (GLOBE NEWSWIRE) -- Global Prostate Cancer Diagnostics Solution Market The global prostate cancer diagnostics solution market is undergoing a significant transformation, propelled by technological advances, improved patient awareness, and increased healthcare spending. In 2024, the market size is valued at approximately USD 4.18 billion, and it is forecast to reach USD 10.84 billion by 2034, reflecting a strong CAGR of 10%. This growth is primarily fueled by the increasing incidence of prostate cancer globally, driven in part by an aging population, better screening coverage, and enhancements in molecular and imaging-based diagnostics. Get a Sample PDF Brochure: Prostate cancer remains one of the most prevalent malignancies among men, especially in North America and Europe. While early detection significantly improves prognosis, traditional diagnostic methods such as PSA screening and manual biopsies face criticism for low specificity and overdiagnosis. In response, the market is witnessing a shift toward precision diagnostics using biomarkers, genetic assays, and advanced imaging systems. Market Growth Drivers The market is influenced by several factors. First, the growing awareness around early screening programs, especially in developed nations, has led to a significant uptick in test volumes. Public health campaigns and evolving guidelines from organizations like the American Urological Association (AUA) and European Association of Urology (EAU) encourage age-appropriate prostate screening. Secondly, technology has improved both the sensitivity and specificity of diagnostic tools. Multiparametric MRI, PSMA-based imaging, liquid biopsy, and AI-assisted pathology have reduced false positives and enabled targeted biopsies. Healthcare providers are increasingly integrating prostate-specific biomarkers such as PCA3, 4Kscore, SelectMDx, and PHI (Prostate Health Index) into diagnostic workflows. Molecular diagnostics and genomic profiling are also gaining traction for risk stratification and treatment planning. For instance, gene expression panels help differentiate between indolent and aggressive tumors, enabling clinicians to tailor active surveillance or treatment strategies. Emerging markets in Asia-Pacific, Latin America, and the Middle East are also contributing to market expansion. Improved healthcare infrastructure, greater access to insurance, and the establishment of private diagnostic centers have expanded access to prostate cancer testing beyond urban centers. Governments in countries like China, India, and Brazil are prioritizing cancer screening under national health plans, further accelerating adoption. Challenges and Constraints Despite promising growth, the prostate cancer diagnostics market faces several challenges. Overdiagnosis and overtreatment remain concerns, particularly in cases where low-risk tumors are detected. Invasive diagnostic procedures, such as transrectal ultrasound (TRUS)-guided biopsies, are associated with discomfort, infection risk, and high costs. Moreover, the accessibility of advanced imaging and molecular testing remains limited in low-income regions. Regulatory barriers also affect product adoption. Diagnostic test developers must navigate complex approval processes, such as FDA clearance and CE marking, which can delay commercialization. Furthermore, reimbursement coverage for newer tests varies significantly across markets, limiting patient access to cutting-edge solutions in some areas. Browse full Report - Market Segmentation By Product Type Imaging continues to dominate the market owing to its role in tumor localization and staging. This includes multiparametric MRI and PSMA-PET, which are essential for visualizing high-risk tumors. Biomarkers, on the other hand, are rapidly gaining popularity, especially with non-invasive urine and blood-based tests that offer high specificity. Biopsy devices remain essential, particularly for confirmatory diagnosis. The prostate cancer diagnostics market is segmented into imaging, biomarkers, and biopsy devices. Product Type 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Imaging 40% 4.34 9.5% Biomarkers 35% 3.79 10.2% Biopsy Devices 25% 2.71 10.8% By Application Screening forms the foundation of prostate cancer prevention strategies, accounting for the largest market share. Diagnosis is growing steadily with the adoption of precision-guided biopsy methods. Monitoring applications are increasingly important in active surveillance models and recurrence tracking. Applications include screening, diagnosis, and monitoring. Application 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Screening 45% 4.88 9.8% Diagnosis 35% 3.79 10.1% Monitoring 20% 2.17 10.5% By End User Hospitals are the largest end users due to their integrated imaging, pathology, and urology departments. Diagnostic laboratories follow closely, with specialized labs offering advanced biomarker panels and gene sequencing. Research institutes contribute to market development through clinical trials and new test validation. End users encompass hospitals, diagnostic laboratories, and research institutes. End User 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Hospitals 50% 5.42 9.9% Diagnostic Labs 35% 3.79 10.2% Research Institutes 15% 1.63 10.4% By Technology Immunohistochemistry techniques remain widely used due to their cost-effectiveness and accessibility. Molecular diagnostics are growing rapidly, especially with NGS and PCR-based tests enabling more accurate diagnosis. Imaging techniques continue to evolve, with AI-assisted MRI and PSMA scans reshaping early detection. Technologies include immunohistochemistry, molecular diagnostics, and imaging techniques. Technology 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Immunohistochemistry 40% 4.34 9.5% Molecular Diagnostics 35% 3.79 10.2% Imaging Techniques 25% 2.71 10.8% By Distribution Channel Direct sales dominate the market as most products are sold directly to hospitals and diagnostic centers. Distributors play a key role in reaching secondary markets and mid-sized labs. Online sales are growing quickly, particularly for biomarker kits and reagent supplies, driven by digital procurement platforms. Distribution channels comprise direct sales, distributors, and online sales. Distribution Channel 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Direct Sales 50% 5.42 9.9% Distributors 30% 3.25 10.3% Online Sales 20% 2.17 10.5% Recent Developments EDX Medical Group has developed an AI-driven prostate cancer supertest that measures over 100 biomarkers using blood and urine samples, achieving 96% accuracy. This test is expected to revolutionize early detection and personalized treatment plans . Telix Pharmaceuticals received FDA approval for Gozellix, a prostate cancer screening agent designed for PET scanning of PSMA-positive lesions, offering a longer shelf life and enhanced clinical utility . Key Players Abbott Laboratories Siemens Healthineers Roche Diagnostics Hologic, Inc. Myriad Genetics, Inc. OPKO Health, Inc. Genomic Health (Exact Sciences Corporation) MDxHealth Beckman Coulter, Inc. Thermo Fisher Scientific Inc. Market Outlook In the next decade, the prostate cancer diagnostics market is expected to continue evolving toward non-invasive, high-accuracy, and personalized testing paradigms. AI integration will play a pivotal role in radiology and pathology, helping clinicians interpret results faster and more accurately. The convergence of imaging, molecular diagnostics, and clinical decision support tools is paving the way for comprehensive, data-driven diagnostic ecosystems. Industry players are likely to invest in integrated diagnostic platforms, point-of-care testing innovations, and strategic collaborations with research institutions. Startups and biotech firms are actively exploring liquid biopsy techniques and next-generation sequencing (NGS) for early detection and risk profiling. At the same time, healthcare systems are adopting risk-based screening models to optimize resources and minimize overtreatment. With increased emphasis on preventive care and patient-centered medicine, prostate cancer diagnostics are poised to become more accessible, reliable, and cost-effective worldwide. Stakeholders that prioritize innovation, regulatory agility, and affordability are expected to capture significant market share in this rapidly expanding field. This report is also available in the following languages : Japanese (前立腺がん診断ソリューション市場), Korean (전립선암 진단 솔루션 시장), Chinese (前列腺癌诊断解决方案市场), French (Marché des solutions de diagnostic du cancer de la prostate), German (Markt für Prostatakrebsdiagnostiklösungen), and Italian (Mercato delle soluzioni diagnostiche per il cancro alla prostata), etc. Download Full PDF Sample Copy of Market Report @ Related reports – Handheld Acoustic Camera Market The global handheld acoustic camera market is valued at approximately $120 million, reflecting a growing interest in innovative sound visualization technologies. The market is projected to reach around $250 million by 2034, driven by advancements in sensor technology, increased demand from various sectors, and rising awareness of sound management in industrial applications. Fully Automatic Autoclave Market The global fully automatic autoclave market is valued at approximately $1.2 billion in 2024, with a projected growth trajectory that anticipates a market value of around $2.0 billion by 2034. This represents a robust Compound Annual Growth Rate (CAGR) of 6.1% during the forecast period from 2025 to 2034. Veterinary Diagnostic Kits Market The global veterinary diagnostic kits market is valued at approximately $3.2 billion in 2024 and is projected to reach around $5.4 billion by 2034. This growth reflects a Compound Annual Growth Rate (CAGR) of 5.5% during the forecast period from 2025 to 2034. Poultry Disease Diagnostic Kit Market The global poultry disease diagnostic kit market is valued at approximately $920 million in 2024, reflecting a robust growth trajectory driven by increasing poultry production and a rising focus on animal health. By 2034, the market is projected to reach around $1.8 billion, representing significant expansion fueled by advancements in diagnostic technologies and increased awareness of poultry disease management. GIST Mutation Detection Kit Market The global market for GIST (Gastrointestinal Stromal Tumors) mutation detection kits is valued at approximately $405 million. This market is projected to grow to around $700 million by 2034, reflecting an estimated compound annual growth rate (CAGR) of 6.0%. HPV Genotyping Detection Kit Market The global HPV genotyping detection kit market is poised for significant growth, with an estimated market value of approximately USD 2.5 billion in 2024. This market is projected to expand to around USD 5.3 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of approximately 8% during the forecast period of 2025–2034. Virus DNA Extraction Kit Market The global market for virus DNA extraction kits is valued at approximately $1.2 billion in 2024, driven by increasing research activities in genomics and molecular diagnostics. The market is projected to reach about $2.3 billion by 2034, reflecting a robust growth trajectory. This translates to a Compound Annual Growth Rate (CAGR) of around 7.1% during the forecast period from 2025 to 2034. SARS-CoV-2 IgM and IgG Antibody Test Kit(Colloidal Gold Method) Market The global market for SARS-CoV-2 IgM and IgG antibody test kits, particularly those utilizing the colloidal gold method, is valued at approximately $1.2 billion. This market is projected to expand significantly, achieving a value of around $2.8 billion by 2034, driven by increasing demand for rapid and accurate COVID-19 testing solutions. The Compound Annual Growth Rate (CAGR) for this forecast period is estimated at 8.5%. SARS-CoV-2 Antigen Test Kit Market The global market for SARS-CoV-2 antigen test kits is projected to reach approximately $4.5 billion in 2024, fueled by continued demand for rapid testing solutions amidst ongoing public health considerations. Over the forecast period from 2025 to 2034, the market is expected to expand significantly, with a projected market value of around $7 billion by 2034. This trajectory indicates a Compound Annual Growth Rate (CAGR) of approximately 5.5%, driven by enhanced manufacturing capabilities, technological advancements, and the growing emphasis on home testing solutions. Plasma Autoclave Market The global plasma autoclave market is valued at approximately $500 million in 2024, with expectations to reach around $900 million by 2034. This growth trajectory reflects a robust compound annual growth rate (CAGR) of approximately 6% from 2025 to 2034. Alkaline Bicarbonate Hemodialysis Concentrate Market The global alkaline bicarbonate hemodialysis concentrate market is valued at approximately $2.8 billion. The market is poised for significant growth, with a projected value of around $4.5 billion by 2034, reflecting a compound annual growth rate (CAGR) of 5.0% during the forecast period of 2025–2034. Dental Coloring Liquid Market The global dental coloring liquid market is valued at approximately $540 million in 2024, with an anticipated growth trajectory that will see it reach around $1.1 billion by 2034. The expected Compound Annual Growth Rate (CAGR) during the forecast period, from 2025 to 2034, is projected to be about 7.3%. Dental Polishing Paste Market The global dental polishing paste market is projected to reach approximately $335 million in 2024, with a steady growth trajectory anticipated over the next decade. By 2034, the market value is expected to expand to around $520 million, reflecting a compound annual growth rate (CAGR) of approximately 4.4% during the forecast period of 2025–2034. Dental Acid Etching Agent Market The global dental acid etching agent market is projected to reach a value of approximately $350 million in 2024, driven by the rising demand for cosmetic dentistry and advancements in dental materials. During the forecast period from 2025 to 2034, the market is anticipated to grow at a CAGR of 6.5%, driven by increasing dental care awareness, technological innovations, and the growing prevalence of dental disorders. Root Canal Lubricant Market The global root canal lubricant market is valued at approximately $180 million in 2024, with projections indicating a robust growth trajectory, reaching an estimated $300 million by 2034. This reflects a Compound Annual Growth Rate (CAGR) of around 5.1% over the forecast period from 2025 to 2034. Laryngeal and Tracheal Stents Market The global laryngeal and tracheal stents market is valued at approximately $450 million. Projections indicate significant growth, with an estimated market value of $1.1 billion by 2034, signaling a robust expansion driven by advancements in medical technology and increasing prevalence of respiratory conditions. Pharmaceutical Grade Medium Chain Triglyceride (MCT) Market The global pharmaceutical-grade medium chain triglyceride (MCT) market is valued at approximately $550 million, fueled by rising health awareness and the increasing use of MCT in dietary supplements and clinical nutrition. The market is projected to grow significantly, reaching an estimated value of $1.2 billion by 2034, reflecting a robust compound annual growth rate (CAGR) of 8.1% over the forecast period from 2025 to 2034. Hydroxyethyl Starch API Market The global Hydroxyethyl Starch (HES) API market is estimated at approximately USD 675 million in 2024, with a projected value reaching around USD 1.1 billion by 2034. This growth reflects a robust compound annual growth rate (CAGR) of about 5.1% for the period from 2025 to 2034. Pet Wellness Exams Market The global pet wellness exams market is expected to reach a value of approximately $3.5 billion in 2024, driven by increasing pet ownership and a growing emphasis on preventive healthcare. The projected market value is estimated to rise to around $5.8 billion by 2034, reflecting a robust demand for wellness services in the pet care sector. Enteric Pathogen Test Kits Market The global market for enteric pathogen test kits is valued at approximately $1.2 billion in 2024, driven by heightened consumer awareness regarding food safety and stringent regulatory frameworks. The market is projected to reach around $2.3 billion by 2034, reflecting robust growth opportunities in both emerging and established markets. CONTACT: Contact Data Irfan Tamboli (Head of Sales) Phone: + 1704 266 3234 Email: sales@ in to access your portfolio
Yahoo
21-05-2025
- Business
- Yahoo
Prostate Cancer Diagnostics Solution Market Trends, Challenges and Future Outlook
Prostate Cancer Diagnostics Solution Market Overview 2025-2034 Luton, Bedfordshire, United Kingdom, May 21, 2025 (GLOBE NEWSWIRE) -- Global Prostate Cancer Diagnostics Solution Market The global prostate cancer diagnostics solution market is undergoing a significant transformation, propelled by technological advances, improved patient awareness, and increased healthcare spending. In 2024, the market size is valued at approximately USD 4.18 billion, and it is forecast to reach USD 10.84 billion by 2034, reflecting a strong CAGR of 10%. This growth is primarily fueled by the increasing incidence of prostate cancer globally, driven in part by an aging population, better screening coverage, and enhancements in molecular and imaging-based diagnostics. Get a Sample PDF Brochure: Prostate cancer remains one of the most prevalent malignancies among men, especially in North America and Europe. While early detection significantly improves prognosis, traditional diagnostic methods such as PSA screening and manual biopsies face criticism for low specificity and overdiagnosis. In response, the market is witnessing a shift toward precision diagnostics using biomarkers, genetic assays, and advanced imaging systems. Market Growth Drivers The market is influenced by several factors. First, the growing awareness around early screening programs, especially in developed nations, has led to a significant uptick in test volumes. Public health campaigns and evolving guidelines from organizations like the American Urological Association (AUA) and European Association of Urology (EAU) encourage age-appropriate prostate screening. Secondly, technology has improved both the sensitivity and specificity of diagnostic tools. Multiparametric MRI, PSMA-based imaging, liquid biopsy, and AI-assisted pathology have reduced false positives and enabled targeted biopsies. Healthcare providers are increasingly integrating prostate-specific biomarkers such as PCA3, 4Kscore, SelectMDx, and PHI (Prostate Health Index) into diagnostic workflows. Molecular diagnostics and genomic profiling are also gaining traction for risk stratification and treatment planning. For instance, gene expression panels help differentiate between indolent and aggressive tumors, enabling clinicians to tailor active surveillance or treatment strategies. Emerging markets in Asia-Pacific, Latin America, and the Middle East are also contributing to market expansion. Improved healthcare infrastructure, greater access to insurance, and the establishment of private diagnostic centers have expanded access to prostate cancer testing beyond urban centers. Governments in countries like China, India, and Brazil are prioritizing cancer screening under national health plans, further accelerating adoption. Challenges and Constraints Despite promising growth, the prostate cancer diagnostics market faces several challenges. Overdiagnosis and overtreatment remain concerns, particularly in cases where low-risk tumors are detected. Invasive diagnostic procedures, such as transrectal ultrasound (TRUS)-guided biopsies, are associated with discomfort, infection risk, and high costs. Moreover, the accessibility of advanced imaging and molecular testing remains limited in low-income regions. Regulatory barriers also affect product adoption. Diagnostic test developers must navigate complex approval processes, such as FDA clearance and CE marking, which can delay commercialization. Furthermore, reimbursement coverage for newer tests varies significantly across markets, limiting patient access to cutting-edge solutions in some areas. Browse full Report - Market Segmentation By Product Type Imaging continues to dominate the market owing to its role in tumor localization and staging. This includes multiparametric MRI and PSMA-PET, which are essential for visualizing high-risk tumors. Biomarkers, on the other hand, are rapidly gaining popularity, especially with non-invasive urine and blood-based tests that offer high specificity. Biopsy devices remain essential, particularly for confirmatory diagnosis. The prostate cancer diagnostics market is segmented into imaging, biomarkers, and biopsy devices. Product Type 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Imaging 40% 4.34 9.5% Biomarkers 35% 3.79 10.2% Biopsy Devices 25% 2.71 10.8% By Application Screening forms the foundation of prostate cancer prevention strategies, accounting for the largest market share. Diagnosis is growing steadily with the adoption of precision-guided biopsy methods. Monitoring applications are increasingly important in active surveillance models and recurrence tracking. Applications include screening, diagnosis, and monitoring. Application 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Screening 45% 4.88 9.8% Diagnosis 35% 3.79 10.1% Monitoring 20% 2.17 10.5% By End User Hospitals are the largest end users due to their integrated imaging, pathology, and urology departments. Diagnostic laboratories follow closely, with specialized labs offering advanced biomarker panels and gene sequencing. Research institutes contribute to market development through clinical trials and new test validation. End users encompass hospitals, diagnostic laboratories, and research institutes. End User 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Hospitals 50% 5.42 9.9% Diagnostic Labs 35% 3.79 10.2% Research Institutes 15% 1.63 10.4% By Technology Immunohistochemistry techniques remain widely used due to their cost-effectiveness and accessibility. Molecular diagnostics are growing rapidly, especially with NGS and PCR-based tests enabling more accurate diagnosis. Imaging techniques continue to evolve, with AI-assisted MRI and PSMA scans reshaping early detection. Technologies include immunohistochemistry, molecular diagnostics, and imaging techniques. Technology 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Immunohistochemistry 40% 4.34 9.5% Molecular Diagnostics 35% 3.79 10.2% Imaging Techniques 25% 2.71 10.8% By Distribution Channel Direct sales dominate the market as most products are sold directly to hospitals and diagnostic centers. Distributors play a key role in reaching secondary markets and mid-sized labs. Online sales are growing quickly, particularly for biomarker kits and reagent supplies, driven by digital procurement platforms. Distribution channels comprise direct sales, distributors, and online sales. Distribution Channel 2024 Market Share (%) 2034 Market Value (USD Billion) CAGR (2025–2034) Direct Sales 50% 5.42 9.9% Distributors 30% 3.25 10.3% Online Sales 20% 2.17 10.5% Recent Developments EDX Medical Group has developed an AI-driven prostate cancer supertest that measures over 100 biomarkers using blood and urine samples, achieving 96% accuracy. This test is expected to revolutionize early detection and personalized treatment plans . Telix Pharmaceuticals received FDA approval for Gozellix, a prostate cancer screening agent designed for PET scanning of PSMA-positive lesions, offering a longer shelf life and enhanced clinical utility . Key Players Abbott Laboratories Siemens Healthineers Roche Diagnostics Hologic, Inc. Myriad Genetics, Inc. OPKO Health, Inc. Genomic Health (Exact Sciences Corporation) MDxHealth Beckman Coulter, Inc. Thermo Fisher Scientific Inc. Market Outlook In the next decade, the prostate cancer diagnostics market is expected to continue evolving toward non-invasive, high-accuracy, and personalized testing paradigms. AI integration will play a pivotal role in radiology and pathology, helping clinicians interpret results faster and more accurately. The convergence of imaging, molecular diagnostics, and clinical decision support tools is paving the way for comprehensive, data-driven diagnostic ecosystems. Industry players are likely to invest in integrated diagnostic platforms, point-of-care testing innovations, and strategic collaborations with research institutions. Startups and biotech firms are actively exploring liquid biopsy techniques and next-generation sequencing (NGS) for early detection and risk profiling. At the same time, healthcare systems are adopting risk-based screening models to optimize resources and minimize overtreatment. With increased emphasis on preventive care and patient-centered medicine, prostate cancer diagnostics are poised to become more accessible, reliable, and cost-effective worldwide. Stakeholders that prioritize innovation, regulatory agility, and affordability are expected to capture significant market share in this rapidly expanding field. This report is also available in the following languages : Japanese (前立腺がん診断ソリューション市場), Korean (전립선암 진단 솔루션 시장), Chinese (前列腺癌诊断解决方案市场), French (Marché des solutions de diagnostic du cancer de la prostate), German (Markt für Prostatakrebsdiagnostiklösungen), and Italian (Mercato delle soluzioni diagnostiche per il cancro alla prostata), etc. Download Full PDF Sample Copy of Market Report @ Related reports – Handheld Acoustic Camera Market The global handheld acoustic camera market is valued at approximately $120 million, reflecting a growing interest in innovative sound visualization technologies. The market is projected to reach around $250 million by 2034, driven by advancements in sensor technology, increased demand from various sectors, and rising awareness of sound management in industrial applications. Fully Automatic Autoclave Market The global fully automatic autoclave market is valued at approximately $1.2 billion in 2024, with a projected growth trajectory that anticipates a market value of around $2.0 billion by 2034. This represents a robust Compound Annual Growth Rate (CAGR) of 6.1% during the forecast period from 2025 to 2034. Veterinary Diagnostic Kits Market The global veterinary diagnostic kits market is valued at approximately $3.2 billion in 2024 and is projected to reach around $5.4 billion by 2034. This growth reflects a Compound Annual Growth Rate (CAGR) of 5.5% during the forecast period from 2025 to 2034. Poultry Disease Diagnostic Kit Market The global poultry disease diagnostic kit market is valued at approximately $920 million in 2024, reflecting a robust growth trajectory driven by increasing poultry production and a rising focus on animal health. By 2034, the market is projected to reach around $1.8 billion, representing significant expansion fueled by advancements in diagnostic technologies and increased awareness of poultry disease management. GIST Mutation Detection Kit Market The global market for GIST (Gastrointestinal Stromal Tumors) mutation detection kits is valued at approximately $405 million. This market is projected to grow to around $700 million by 2034, reflecting an estimated compound annual growth rate (CAGR) of 6.0%. HPV Genotyping Detection Kit Market The global HPV genotyping detection kit market is poised for significant growth, with an estimated market value of approximately USD 2.5 billion in 2024. This market is projected to expand to around USD 5.3 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of approximately 8% during the forecast period of 2025–2034. Virus DNA Extraction Kit Market The global market for virus DNA extraction kits is valued at approximately $1.2 billion in 2024, driven by increasing research activities in genomics and molecular diagnostics. The market is projected to reach about $2.3 billion by 2034, reflecting a robust growth trajectory. This translates to a Compound Annual Growth Rate (CAGR) of around 7.1% during the forecast period from 2025 to 2034. SARS-CoV-2 IgM and IgG Antibody Test Kit(Colloidal Gold Method) Market The global market for SARS-CoV-2 IgM and IgG antibody test kits, particularly those utilizing the colloidal gold method, is valued at approximately $1.2 billion. This market is projected to expand significantly, achieving a value of around $2.8 billion by 2034, driven by increasing demand for rapid and accurate COVID-19 testing solutions. The Compound Annual Growth Rate (CAGR) for this forecast period is estimated at 8.5%. SARS-CoV-2 Antigen Test Kit Market The global market for SARS-CoV-2 antigen test kits is projected to reach approximately $4.5 billion in 2024, fueled by continued demand for rapid testing solutions amidst ongoing public health considerations. Over the forecast period from 2025 to 2034, the market is expected to expand significantly, with a projected market value of around $7 billion by 2034. This trajectory indicates a Compound Annual Growth Rate (CAGR) of approximately 5.5%, driven by enhanced manufacturing capabilities, technological advancements, and the growing emphasis on home testing solutions. Plasma Autoclave Market The global plasma autoclave market is valued at approximately $500 million in 2024, with expectations to reach around $900 million by 2034. This growth trajectory reflects a robust compound annual growth rate (CAGR) of approximately 6% from 2025 to 2034. Alkaline Bicarbonate Hemodialysis Concentrate Market The global alkaline bicarbonate hemodialysis concentrate market is valued at approximately $2.8 billion. The market is poised for significant growth, with a projected value of around $4.5 billion by 2034, reflecting a compound annual growth rate (CAGR) of 5.0% during the forecast period of 2025–2034. Dental Coloring Liquid Market The global dental coloring liquid market is valued at approximately $540 million in 2024, with an anticipated growth trajectory that will see it reach around $1.1 billion by 2034. The expected Compound Annual Growth Rate (CAGR) during the forecast period, from 2025 to 2034, is projected to be about 7.3%. Dental Polishing Paste Market The global dental polishing paste market is projected to reach approximately $335 million in 2024, with a steady growth trajectory anticipated over the next decade. By 2034, the market value is expected to expand to around $520 million, reflecting a compound annual growth rate (CAGR) of approximately 4.4% during the forecast period of 2025–2034. Dental Acid Etching Agent Market The global dental acid etching agent market is projected to reach a value of approximately $350 million in 2024, driven by the rising demand for cosmetic dentistry and advancements in dental materials. During the forecast period from 2025 to 2034, the market is anticipated to grow at a CAGR of 6.5%, driven by increasing dental care awareness, technological innovations, and the growing prevalence of dental disorders. Root Canal Lubricant Market The global root canal lubricant market is valued at approximately $180 million in 2024, with projections indicating a robust growth trajectory, reaching an estimated $300 million by 2034. This reflects a Compound Annual Growth Rate (CAGR) of around 5.1% over the forecast period from 2025 to 2034. Laryngeal and Tracheal Stents Market The global laryngeal and tracheal stents market is valued at approximately $450 million. Projections indicate significant growth, with an estimated market value of $1.1 billion by 2034, signaling a robust expansion driven by advancements in medical technology and increasing prevalence of respiratory conditions. Pharmaceutical Grade Medium Chain Triglyceride (MCT) Market The global pharmaceutical-grade medium chain triglyceride (MCT) market is valued at approximately $550 million, fueled by rising health awareness and the increasing use of MCT in dietary supplements and clinical nutrition. The market is projected to grow significantly, reaching an estimated value of $1.2 billion by 2034, reflecting a robust compound annual growth rate (CAGR) of 8.1% over the forecast period from 2025 to 2034. Hydroxyethyl Starch API Market The global Hydroxyethyl Starch (HES) API market is estimated at approximately USD 675 million in 2024, with a projected value reaching around USD 1.1 billion by 2034. This growth reflects a robust compound annual growth rate (CAGR) of about 5.1% for the period from 2025 to 2034. Pet Wellness Exams Market The global pet wellness exams market is expected to reach a value of approximately $3.5 billion in 2024, driven by increasing pet ownership and a growing emphasis on preventive healthcare. The projected market value is estimated to rise to around $5.8 billion by 2034, reflecting a robust demand for wellness services in the pet care sector. Enteric Pathogen Test Kits Market The global market for enteric pathogen test kits is valued at approximately $1.2 billion in 2024, driven by heightened consumer awareness regarding food safety and stringent regulatory frameworks. The market is projected to reach around $2.3 billion by 2034, reflecting robust growth opportunities in both emerging and established markets. CONTACT: Contact Data Irfan Tamboli (Head of Sales) Phone: + 1704 266 3234 Email: sales@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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16-05-2025
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Edap TMS SA (EDAP) Q1 2025 Earnings Call Highlights: Record Focal One Placements Amid Revenue ...
HIFU Revenue: 6.2 million, up 6.8% from 5.8 million in Q1 2024. Total Worldwide Revenue: 13.6 million, a decrease of 9.1% from 14.9 million in Q1 2024. Gross Profit: 5.7 million, down from 6.4 million in Q1 2024. Gross Profit Margin: 42%, compared to 42.8% in Q1 2024. Operating Expenses: 11.7 million, up from 11.2 million in Q1 2024. Operating Loss: 6 million, compared to 4.8 million in Q1 2024. Net Loss: 7.1 million or 0.19 per diluted share, compared to 4.5 million or 0.12 per diluted share in Q1 2024. Cash and Cash Equivalents: 22.8 million at the end of Q1 2025, down from 29.8 million at the end of Q4 2024. Inventory: 18 million at the end of Q1 2025, down from 18.5 million at the end of Q4 2024. Warning! GuruFocus has detected 3 Warning Signs with EDAP. Release Date: May 15, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Edap TMS SA (NASDAQ:EDAP) placed a record nine Focal One systems in the first quarter of 2025, marking the highest number of placements for any first quarter period in the company's history. Focal One received CE mark approval for the treatment of posterior deep infiltrating endometriosis, expanding its potential market in Europe. The company launched the new Focal One I robotic HIFU system at the 2025 AUA meeting, showcasing advancements in their technology. Positive results from the FARP randomized controlled trial were presented, supporting the efficacy of robotic focal therapy for prostate cancer. The world's first remote transatlantic Focal One robotic HIFU procedure was conducted, highlighting the system's innovative capabilities and potential for remote operations. Total worldwide revenue decreased by 9.1% compared to the same period in 2024, primarily due to declines in non-core ESWL and distribution divisions. Operating loss increased to 6 million in the first quarter of 2025, compared to 4.8 million in the first quarter of 2024. Net loss for the first quarter of 2025 was 7.1 million, a significant increase from the 4.5 million net loss in the year-ago period. The company is experiencing longer and more challenging review and procedure approvals, particularly for patients enrolled in Medicare Advantage plans. A 10% tariff impact is forecasted for goods transferred from France to the US in the second quarter, potentially affecting costs and profitability. Q: Ryan, you mentioned changing trends in the payer landscape with longer and more challenging reviews and procedure approvals. Can you elaborate on this? Is it specific to Medicare Advantage, or is it broader? A: The trends are specific to Medicare Advantage Plan patients. Approximately 54% of patients on Medicare opt for a Medicare Advantage plan. We are working closely with consulting firms to navigate this process, and while there are some denials, we are seeing progress with appeals and approvals. Q: Are the challenges with payer approvals continuing into Q2, and are you able to get procedures approved despite delays? A: There is always a risk of denials, but we are making notable progress with appeals. We work closely with institutions and consulting partners, and we win the majority of appeals. Q: Ken, you've maintained your HIFU sales growth guidance of 16% to 25%. What assumptions are incorporated at the low and high ends of this range? Are you expecting an acceleration in procedure growth? A: The capital equipment environment is lumpy, but we have factored in procedure growth in our forecast. We remain confident in achieving the 16% to 25% HIFU revenue growth range for the year. Q: With the CE mark approval for endometriosis, what are your next steps for marketing Focal One in Europe, and what are your plans for the US? A: We are embarking on a controlled market entry in CE countries, working with initial hospitals to expand clinical development efforts. In the US, we are tracking data from phase two and three studies to use in future FDA interactions, while focusing on the controlled launch phase in Europe. Q: Can you provide more details on the strategic focus and recent achievements of Edap TMS? A: We are focused on becoming the global leader in focal therapy. Recent achievements include record placements of Focal One systems, CE mark approval for endometriosis treatment, and the launch of the new Focal One I robotic HIFU system. These milestones reflect our strategic focus and growing demand for Focal One. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
