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The molecular diagnostics segment is the fastest growing segment within the global IVD market. The global market is estimated to be $8,760 million in 2019. Infectious diseases diagnostics represent the largest segment within the market, accounting for more than half of the global molecular diagnostics market. The global market is forecasted to grow at a compound average growth rate (CAGR) of 8.1% to reach $12,955 million in 2024. Major segments that are expected to drive the growth are infectious diseases, cancer, and transplant diagnostics. These are all broken out and forecasted in Kalorama’s The World Molecular Diagnostics Market, 8th Edition. The discovery of the structure of DNA in 1953 is one of the earliest scientific advancements that facilitated the development of molecular methods as diagnostic tools, even though it took more than 4 decades for the first tests to get commercialized. The pioneers in the molecular diagnostics field include Roche Diagnostics, Gen-Probe, and Becton Dickinson. The main focus of the initial molecular diagnostics products were infectious diseases such as HIV, Chlamydia Trachomatis/Neisseria Gonorrhoea (CT/NG), and TB. Some of the initial molecular diagnostics products include Roche’s PCR test for HIV and CT/NG, Gen Probe’s tests for TB and CT/NG based on transcription mediated amplification (TMA) method, and Becton Dickinson’s CT/NG test based on branched chain DNA 0 2 4 6 8 10 12 14 8.7 12.9 2019 2024 This White Paper is derived from Kalorama Information’s market research reports: For more information, visit: www.kaloramainformation.com (bDNA) signal amplification technology. Focus on infectious diseases was maintained even during the early years of the last decade by companies that ventured into the molecular diagnostics sector, and commercial molecular assays were introduced for hepatitis and respiratory diseases. The blood banking sector became one of the key application areas during this period, since the high sensitivity offered by molecular diagnostics brought significant value for donor blood screening for pathogens of high concern. Currently, the use of molecular diagnostics methods is not limited to infectious diseases. Other disease segments where molecular assays have high demand include inherited diseases, coagulation, transplant medicine, prenatal and postnatal screening, and cancer. Molecular Diagnostics Market Facts Kalorama Information made the following findings about the market in its report: • Fast Growth: The global market is forecasted to grow at a compound average growth rate (CAGR) of 8.1% to reach $12,955 million in 2024. • Microbiology leads: Infectious diseases diagnostics represents the largest market within the market, accounting for more than half of the global molecular diagnostics market. • Watch Reimbursements: Even though the demand for molecular diagnostic tests is growing at a high single-digit growth rate in spite of affordability concerns, reimbursement has been a major factor for this segment. This is particularly true in the case of tests for supporting drug decisions. • IT is Central: The molecular diagnostics market is evolving with the effective integration of information technology (IT), including various bioinformatics platforms, cloud computing, and big data analysis methods. From data sharing to developing well-curated gene variations to integration of clinical insights for better outcomes, to development of automated sample-toinsight systems, only improved information technology will enable the realization of these concepts. • Watch NGS: Though a small segment now, we are right on the cusp of next-generation sequencing becoming an essential part of clinical decision making. Clinical usage is behind many installations and consumable purchases and has been touted by the major sequencing providers. NOW PUBLISHED – KALORAMA INFORMATION’S World Market for Molecular Diagnostics, 8 TH Edition This White Paper is derived from Kalorama Information’s market research reports: For more information, visit: www.kaloramainformation.com The first-generation molecular testing methods were time consuming and labor intensive, which included techniques such as the Southern Blot, DNA probes, capillary electrophoresis and pulsed field gel electrophoresis. The sector has seen significant advancements and most popular molecular technologies used for developing molecular diagnostic tests include nucleic acid amplification technologies (NAATs) including polymerase chain reaction (PCR) and other NAAT methods, sequencing, mass spectroscopy, microarrays, and biochips. Currently, molecular diagnostics is one of the fast-growing segments in the clinical diagnostics market. The field has witnessed innovation in multiple levels during the past two decades, leading to increasing significance in the clinical diagnostics sector. “Infectious diseases diagnostics account for more than half of the global molecular diagnostics market.” A majority of the molecular tests that are CE-marked and FDA-approved are based on new genetic markers that are validated for clinical utility. Innovations in biomedical engineering have enabled automation of many steps including sample preparation steps, reducing the labor and time for testing. Emerging Trends Influencing the Market Landscape Molecular diagnostics is a fast evolving and dynamic field and is the fastest growing segment within the in vitro diagnostics (IVD) market. Molecular diagnostics have become indispensable tools in clinical medicine that touch all aspects of healthcare including treatment decisions in terms of identifying antimicrobial resistant (AMR) infections at the earliest, companion diagnostics assisting in the evaluation of suitability of various cancer treatment options, pharmacokinetics or patient metabolism of drugs for HIV, psychiatric conditions or blood thinners; cancer prognosis and therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions. Rather than replacing other major IVD modalities such as immunodiagnostics, the molecular diagnostics market has expanded by meeting clinical needs unmet or never envisioned with other major testing disciplines. As they become more affordable, displacement of other diagnostics such as immunodiagnostics has also occurred owing to the high sensitivity and unique insights molecular diagnostic methods offer. Certain IVD segments have been or are in the course of being remade worldwide through the application of molecular methods including blood screening, POC diagnostics, cytogenetics, and tissue typing. Some of the key market trends of the industry that are influencing the market landscape in a big way are as below: This White Paper is derived from Kalorama Information’s market research reports: For more information, visit: www.kaloramainformation.com Democratization of Molecular Testing with Sample-to-Result and POC Systems Opposing trends of centralization and decentralization are expected to reshape the molecular diagnostic market landscape. While democratization of molecular tests is becoming a reality with advancements in automation and information technology, the opposite trend is also strong, as many tests are moving from local clinical labs to large reference labs due to the economies of scales that can be achieved. Advancements in automation and information technologies (IT) have created a new level of optimism in the molecular diagnostics markets as evident from the research investments, university spin-offs, mergers, and acquisitions in the segment. The holy grail for molecular testing is the ability to load an untreated sample onto a cartridge or cassette, push start and then come back when the test has been completed. The “sample-to-result” table-top systems fast entering the market represent an important milestone towards achieving this goal. Some of the leading global companies focusing on offering such table-top systems include Cepheid, Spartan, Qiagen, Hologic, GenMark, and Enigma. The investments by such leading companies and government agencies who partner with them are pushing the existing limits of automation and IT, facilitating fast advancement towards near-patient and point-of-care diagnostics solutions. Table-top systems are considered the prerequisite technology advancement to providing molecular testing in small laboratories and resource-limited test sites anywhere in the world. The market is moving beyond these systems and the next generation of sample-to-result molecular test instruments is focusing on bringing genetic medicine to a much broader audience. The commercialization of these platforms and tests are the next major development towards democratization of molecular diagnostics as they have the potential to improve the quality of healthcare by improving the affordability and accessibility to advanced diagnostic solutions even in remote areas where challenges of skilled manpower and infrastructure are acute. Government investments into academic research and initiatives to support startup companies in the field are also driving the growth of the molecular diagnostics sector. This White Paper is derived from Kalorama Information’s market research reports: For more information, visit: www.kaloramainformation.com Major Companies in the Market The following companies participate in the market segments of molecular testing. Full profiles, notices of product launches and mergers, as well as market assessments are included in Kalorama’s World Market for Molecular Diagnostics, 8 th Edition. • Abbott Diagnostics • Advanced Cell Diagnostics (Biotechne) • Agilent Technologies • Amoy Diagnostics • Applied Spectral Imaging • Becton, Dickinson & Co. (BD) • Beijing Genomics Institute (BGI) • Berry Genomics • bioMérieux • Bio-Rad Laboratories • CareDx, Inc. • Danaher (Cepheid and Leica Biosystems) • Eiken Chemical • GenMark Diagnostics • Genotypic Technology Pvt. Ltd. • Grifols, S.A. • Illumina • Immucor, Inc. • Meridian Bioscience, Inc. • Molbio Diagnostics Pvt. Ltd. • PerkinElmer, Inc. • QIAGEN N.V. • Quidel Corporation • Roche Diagnostics • Thermo Fisher Scientific, Inc. • Vela Diagnostics

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