F. Hoffmann-La Roche Ltd.

DUBLIN--( BUSINESS WIRE )--The "Australia Non-Invasive Prenatal Testing (NIPT) Market: Focus on Technology, Method, Application, and End User - Forecast, 2024-2033" report has been added to ResearchAndMarkets.com's offering. The Australia non-invasive prenatal testing (NIPT) market, initially valued at $40.0 million in 2023, is set for substantial growth, projected to surge to $110.7 million by 2033, marking a remarkable compound annual growth rate (CAGR) of 10.71% over the period from 2024 to 2033. The base year considered for the calculation of the market size is 2023. A historical year analysis has been done for the period FY2019-FY2022. The market size has been estimated for FY2023 and projected for the period FY2024-FY2033. The Australia non-invasive prenatal testing (NIPT) market shows promising growth, driven by increasing awareness, rising maternal age, and advanced diagnostic technologies. Expanding healthcare access and a preference for non-invasive methods contribute to demand, with potential growth through innovation and competitive pricing strategies. Industrial Impacts The Australia non-invasive prenatal testing (NIPT) market is set for steady growth, driven by broader advancements in diagnostic testing and healthcare services. As healthcare systems evolve, there is a growing emphasis on non-invasive, cost-effective diagnostic solutions, particularly in prenatal care. Technological advancements and the increasing focus on precision medicine are enhancing the accuracy and accessibility of genetic screenings. The expansion of diagnostic capabilities and a rising demand for safer, more reliable testing methods are likely to propel the adoption of non-invasive prenatal testing (NIPT). Increasing maternal age and growing awareness of genetic conditions further contribute to the demand for non-invasive prenatal testing (NIPT). The Australia healthcare system's ongoing improvements, including funding for advanced medical technologies, provide a conducive environment for market growth. Moreover, policy reforms and healthcare initiatives aimed at expanding access to genetic testing in both urban and rural settings are expected to boost market penetration. NGS Technology Segment to Dominate the Australia Non-Invasive Prenatal Testing (NIPT) Market (by Technology) Based on technology, the Australia non-invasive prenatal testing (NIPT) market was led by the NGS technology segment, which held a 54.75% share in 2023. next-generation sequencing (NGS) offers highly accurate, non-invasive genetic screening using a simple maternal blood sample. This technology enables the detection of chromosomal abnormalities, such as trisomies 13, 18, and 21, by analyzing cell-free DNA (cfDNA) fragments from the mother's blood. Non-invasive prenatal testing (NIPT) using NGS works by identifying specific genetic markers within the cfDNA to assess the risk of chromosomal abnormalities in the fetus. The test provides early results, typically within 5-7 days, allowing parents to make informed decisions early in their pregnancy. For instance, Illumina, Inc.'s VeriSeq NIPT Solution v2 is a next-generation sequencing-based non-invasive prenatal testing (NIPT) with approximately 99.9% sensitivity. It is a streamlined, accessible solution that offers clinicians reliable results and enables sample reporting in about 26 hours. cfDNA Segment to Dominate the Australia Non-Invasive Prenatal Testing (NIPT) Market (by Method) Based on the method, the Australia non-invasive prenatal testing (NIPT) testing market was led by the cfDNA method segment, which held an 87.25% share in 2023. Cell-free DNA (cfDNA) testing is a widely used method in Australia's non-invasive prenatal testing (NIPT) market, allowing for the detection of fetal chromosomal abnormalities by analyzing small fragments of fetal DNA in maternal blood. This method offers high accuracy and minimal risk compared to invasive techniques such as amniocentesis. For instance, F. Hoffmann-La Roche Ltd. offers Harmony Test, a prominent offering that utilizes cfDNA technology to screen trisomies 13, 18, and 21 with proven clinical precision. Similarly, Victorian Clinical Genetics Services Limited provides the percept NIPT, leveraging cfDNA to ensure effective early detection of chromosomal anomalies. Healius Limited (Genetic Diagnostics) expands the cfDNA-based offerings with its Generation NIPT, Generation 46, and Generation Plus, which cater to diverse testing needs, including comprehensive assessments for microdeletions and rare genetic conditions. These examples highlight the integral role of cfDNA methods in Australia's non-invasive prenatal testing (NIPT) advancements. Trisomy Detection Segment to Dominate the Australia Non-Invasive Prenatal Testing (NIPT) Market (by Application) Based on application, the Australia non-invasive prenatal testing (NIPT) testing market was led by the trisomy detection application segment, which held a 56.50% share in 2023. Trisomy detection is one of the primary applications of non-invasive prenatal testing (NIPT), focusing on identifying chromosomal abnormalities such as Trisomy 21 (Down Syndrome), Trisomy 18 (Edwards Syndrome), and Trisomy 13 (Patau Syndrome). These conditions occur when there are three copies of a chromosome instead of the normal two, leading to fetal developmental and health complications. For instance, tests offered by Sonic Healthcare, F. Hoffmann-La Roche Ltd., and Healius Limited, among others, namely, percept NIPT, Harmony, and Generation NIPT, offer a highly accurate and reliable method for detecting these trisomies by analyzing cell-free fetal DNA (cffDNA) present in maternal blood. Australia non-invasive prenatal testing (NIPT) market was led by the hospital and clinics segment, which held a 72.25% share in 2023. The dominance of hospitals in the Australia non-invasive prenatal testing (NIPT) market is underscored by their pivotal role in providing comprehensive healthcare services and incorporating non-invasive prenatal testing (NIPT) into their services to enhance the range of prenatal diagnostics offered to expectant parents. This segment involves the utilization of non-invasive prenatal testing (NIPT) technologies within hospital facilities, allowing for efficient and accurate screening of genetic abnormalities in the fetus. Hospitals may also exist in the private sector, owned by for-profit or nonprofit organizations. In the case of private hospitals, funding is sourced from patients' direct payments for medical services, insurance coverage, government support through national health insurance initiatives, or financial assistance from foreign embassies. How can this report add value to an organization? Product/Innovation Strategy: The Australia non-invasive prenatal testing (NIPT) market has been extensively segmented based on various categories, such as technology, method, application, and end user. This can help readers understand which segments account for the largest share and which are well-positioned to grow in the coming years. Growth/Marketing Strategy: Mergers, acquisitions, and product launches accounted for the minimal number of key developments, i.e., nearly 30.61% of the total developments in the Australia non-invasive prenatal testing (NIPT) market were between January 2019 and September 2024. Competitive Strategy: The Australia non-invasive prenatal testing (NIPT) market has numerous established players with product portfolios. Key players in the Australia non-invasive prenatal testing (NIPT) market analyzed and profiled in the study involve established players offering products for Australia non-invasive prenatal testing (NIPT). Key Market Players and Competition Synopsis Victorian Clinical Genetics Services Limited Healius Limited F. Hoffmann-La Roche Ltd Illumina, Inc. Novacyt BGI Genomics Natera, Inc. Monash IVF Group Virtus Health Sonic Healthcare Limited PathWest Laboratory Medicine Key Attributes: Report Attribute Details No. of Pages 70 Forecast Period 2024 - 2033 Estimated Market Value (USD) in 2024 $44.3 Million Forecasted Market Value (USD) by 2033 $110.7 Million Compound Annual Growth Rate 10.7% Regions Covered Australia Key Topics Covered: Executive Summary Scope and Definition 1 Markets 1.1 Market Outlook 1.2 Key Findings 1.3 Australia Market Scenario 1.3.1 Realistic Scenario 1.3.2 Optimistic Scenario 1.3.3 Pessimistic Scenario 1.4 Industry Outlook 1.4.1 Trends 1.4.1.1 Expanding Application of Non-Invasive Prenatal Testing (NIPT) Products 1.4.2 Regulatory Landscape 1.4.3 Product Benchmarking 1.5 Business Dynamics 1.5.1 Impact Analysis 1.5.2 Business Drivers 1.5.2.1 High Incidence of Genetic Disorders 1.5.2.2 Rising Maternal Age 1.5.2.3 Rising Adoption of Non-Invasive Prenatal Testing 1.5.3 Business Restraints 1.5.3.1 Lack of Awareness Regarding Non-Invasive Prenatal Testing (NIPT) 1.5.4 Business Opportunities 1.5.4.1 Expansion of NIPT Accessibility and Coverage 2 Australia Non-Invasive Prenatal Testing (NIPT) Market, Test Volume 2.1 Test Volume 3 Australia Non-Invasive Prenatal Testing (NIPT) Market, by Technology 3.1 Opportunity Assessment 3.2 Growth-Share Matrix 3.2.1 NGS 3.2.2 PCR 3.2.3 Others 4 Australia Non-Invasive Prenatal Testing (NIPT) Market, by Method 4.1 Opportunity Assessment 4.2 Growth-Share Matrix 4.2.1 cfDNA 4.2.2 FCMB 5 Australia Non-Invasive Prenatal Testing (NIPT) Market, by Application 5.1 Opportunity Assessment 5.2 Growth-Share Matrix 5.2.1 Trisomy Detection 5.2.2 Microdeletion Detection 5.2.3 Sex Chromosome Aneuploidy Detection 5.2.4 Others 6 Australia Non-Invasive Prenatal Testing (NIPT) Market, by End User 6.1 Opportunity Assessment 6.2 Growth-Share Matrix 6.2.1 Hospital and Clinics 6.2.2 Diagnostic Laboratories 6.2.3 Others 7 Company Profiles 7.1 Overview 7.2 Top Products/Service 7.3 Top Competitors 7.4 Key Personnel 7.5 Analyst View 8 Research Methodology For more information about this report visit https://www.researchandmarkets.com/r/tbu1p1 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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LONDON, Jan. 14, 2025 /PRNewswire/ -- Kinomica Ltd., a developer of diagnostics for precision oncology, today announced the appointment of Roche Diagnostics' former Global Head of Strategy and Business Development, Dr Michele Pedrocchi as its new Chair of the Board of Directors. With his more than 30 years of successful track record in Life Science and in-vitro Diagnostics and as a former member of the Executive Committee at Roche Diagnostics, Michele has extensive experience and understanding of the growth drivers of a business, including commercial execution and innovation of business models and products. His industry impacting achievements include an instrumental role in establishing polymerase chain reaction (PCR) as a routine diagnostics methodology in Europe and his pioneering role in introducing patient selection for targeted oncology treatments through Companion Diagnostics (CDx), as well as venturing into digital health solutions. Tim Fell, Chief Executive Officer of Kinomica, said: "As an international executive who has brought ground-breaking diagnostic solutions into routine clinical practice, Michele's experience and guidance will be invaluable as Kinomica seeks to do the same with phosphoproteomic diagnostics for therapy selection." Michele Pedrocchi, new Chair of the Board of Directors of Kinomica, commented: "I am thrilled to be taking on this role as Kinomica has great potential for contributing in a fundamental way to truly precision medicine. This world-class team of scientists has made impressive inroads on the promise of phosphoproteomics to guide cancer treatment. Making this proprietary approach and insights widely available is our declared goal." The new Chair appointment follows a financing round led by Mercia Ventures with additional participation from BGF, Longwall Ventures and other existing investors, that sees the company's Board of Directors further strengthen with the appointments of Dr Robert Hornby and Joanna Smart as investor directors for Mercia Ventures and BGF respectively. About Kinomica Kinomica is a developer of precision oncology diagnostics. The company has developed KScan®, a phosphoproteomic diagnostic platform to help clinicians better realize the full potential of precision medicine by predicting which of the drugs currently approved to treat a disease a particular patient will respond best to, thereby aiding clinical decision making. Learn more at and follow us on LinkedIn. Logo - SOURCE Kinomica Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US.3 TUCSON, Ariz., Jan. 13, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its highly-sensitive in-situ hybridisation (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail.4 The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection, thus facilitating faster access to treatment.4 This announcement follows the assay's CE Mark approval in June 2024. Continue Reading VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail B-cell lymphoma is a type of cancer that typically develops in the lymphatic system. It accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases.3 NHL is one of the most common forms of cancer in the US, accounting for about 4% of all cancer cases,5 and causing more than 80,000 deaths each year.5 In the early stages of NHL, patients may experience symptoms like swelling of the lymph nodes, fever, fatigue, loss of appetite or a red rash. "Accurately differentiating lymphoma from an infection is critical in ensuring accurate and timely diagnosis, especially as the symptoms can appear similar," said Jill German, Head of Pathology Lab at Roche Diagnostics. "With this new test, clinicians can have confidence in their diagnosis, while the test reduces the need for multiple samples and time consuming follow up tests, giving patients certainty sooner, and enabling faster access to the right treatment." With increased sensitivity, the new VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail enables assessment across the more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide. The test can assess small biopsies and formalin-fixed tissue, reducing the need for a fresh tissue sample, which may not be available especially if lymphoma was not originally suspected. These test properties preserve tissue, may result in fewer additional patient biopsies and make interpretation quicker and easier for the pathologist, helping facilitate a faster diagnosis and access to treatment for patients. This first-of-its-kind assay is a significant addition to Roche's industry-leading hematopathology portfolio, which includes more than 65 biomarkers. About the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay is a qualitative assay that is used to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed paraffin embedded (FFPE) human hematolymphoid specimens by in situ hybridization (ISH). The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms. The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is indicated for use when a biopsy of lymph node or bone marrow (core biopsy and clot section) indicates inconclusive results. It enables the assessment of both markers in the context of one another on a single slide as an aid in differentiating between a reactive process or B-cell lymphoma and plasma cell neoplasms. This is not a standalone test, and results should be evaluated by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests. This product is intended for in vitro diagnostic (IVD) use.4 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References 1Rimsza LM, et al. Kappa and lambda light chain mRNA in situ hybridization compared to flow cytometry and immunohistochemistry in B cell lymphomas. Diagn Pathol. 2014;9:144. 2F. Hoffmann-La Roche Ltd. Conjoint Market Research. [Survey; Cited 2024 April 4]. Data on File. 3American Cancer Society. Types of B-cell Lymphoma. [Internet; Cited 3 December 2024]. Available at: . 4F. Hoffmann-La Roche Ltd. VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. [Method Sheet; cited 2025 January 10]. Data on file. 5American Cancer Society. Key Statistics for Non-Hodgkin Lymphoma [Internet; Cited 3 December 2024]. Available at: (NHL),11%2C780%20males%20and%208%2C360%20females). Roche Media Relations Jo Lynn Garing, +1 317-363-7286 SOURCE Roche WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED