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PMC's FDA Report Shows Continued Progress for Personalized Medicine
PMC's FDA Report Shows Continued Progress for Personalized Medicine

Associated Press

time19-05-2025

  • Health
  • Associated Press

PMC's FDA Report Shows Continued Progress for Personalized Medicine

Washington, D.C., May 19, 2025 (GLOBE NEWSWIRE) -- The Personalized Medicine Coalition (PMC) has released a new report documenting the U.S. Food and Drug Administration's approval last year of 18 new personalized medicines. The agency also approved six new gene and cell-based therapies for rare genetic diseases and some cancers and approved or cleared new or expanded indications for 11 diagnostic testing systems. 'The new personalized medicine approvals and policy developments at the FDA in 2024 helps demonstrate that scientific innovation continues to move the health system away from one-size-fits-all, trial-and-error medicine, toward the utilization of molecular information to improve patient outcomes and make clinical care more efficient,' says PMC President Daryl Pritchard. The annual report, Personalized Medicine at FDA: The Scope & Significance of Progress in 2024, also highlighted several regulatory developments in the field of personalized medicine. Other 2024 achievements include: • expanded indications for previously authorized personalized therapies, including the first ever for an approved gene therapy treatment • safety label changes for certain cancer treatments based on pharmacogenomic (PGx)-based biomarker testing • release of a draft guidance document on Diversity Action Plans to improve enrollment of participants from underrepresented populations in clinical studies • establishment of the Center for Drug Evaluation and Research (CDER) Artificial Intelligence (AI) Council to provide oversight, coordination and consolidation of CDER activities around AI use • creation of the CDER Center for Real-World Evidence Innovation to coordinate, advance and promote the use of real-world evidence in regulatory decision-making • establishment of the Rare Disease Innovation Hub to enhance collaboration across the FDA for rare disease product development 'The newly approved products, and these important regulatory milestones, will help innovators and clinicians provide safer and more efficacious treatments and prevention regimens based on the principles of patient-centered care,' the report reads. The scope of breakthroughs underscored the acceleration of the personalized medicine field. The 2024 approval of 18 personalized medicines – meaning the label references specific biological markers – represent approximately 38 percent of all newly approved therapeutic molecular entities. Treatment areas include: cancer, Alzheimer's disease, cystic fibrosis, Niemann-Pick disease and alopecia. Personalized medicines now account for at least a quarter of drug approvals for each of the last 10 years. That's a notable increase from a decade ago when such treatments made up less than 10 percent of new therapies that were approved. 'We can't take progress for granted, however,' says Pritchard. 'The FDA should continue to promote policies and practices that push forward the field so we can realize the true potential of personalized medicine.' ### About the Personalized Medicine Coalition: The Personalized Medicine Coalition is a nonprofit education and advocacy organization comprised of more than 200 institutions from across the health care spectrum, including innovators, scientists, patients, providers and payers. PMC works closely with business executives, clinicians, lawmakers and government agency officials to promote the understanding and adoption of personalized medicine concepts, services and products. For more information, please visit Kayla Brown Personalized Medicine Coalition [email protected]

Computational Biology Market to Generate $9.52 Billion in Revenues in 2025; Forecast to Reach $22.47 Billion by 2029 - Analysis of the Key Drivers, Top Segments, Regional Shifts, Leading Players & More
Computational Biology Market to Generate $9.52 Billion in Revenues in 2025; Forecast to Reach $22.47 Billion by 2029 - Analysis of the Key Drivers, Top Segments, Regional Shifts, Leading Players & More

Yahoo

time13-02-2025

  • Business
  • Yahoo

Computational Biology Market to Generate $9.52 Billion in Revenues in 2025; Forecast to Reach $22.47 Billion by 2029 - Analysis of the Key Drivers, Top Segments, Regional Shifts, Leading Players & More

Certara L.P., Chemical Computing Group, Compugen, Genedata AG, and Insilico Biotechnology AG Lead the Industry Computational Biology Market Dublin, Feb. 13, 2025 (GLOBE NEWSWIRE) -- The "Computational Biology Market Report 2025" has been added to computational biology market size has grown rapidly in recent years. It will grow from $8.09 billion in 2024 to $9.52 billion in 2025 at a compound annual growth rate (CAGR) of 17.6%. The growth in the historic period can be attributed to multi-omics integration, personalized medicine and precision healthcare, genomic sequencing revolution, handling biological big data. The computational biology market size is expected to see exponential growth in the next few years. It will grow to $22.47 billion in 2029 at a compound annual growth rate (CAGR) of 23.9%. The growth in the forecast period can be attributed to cloud computing and high-performance computing (HPC), quantitative and predictive biology adoption, collaborative interdisciplinary research, advancements in bioinformatics and computational tools. Major trends in the forecast period include advancements in data science and bioinformatics, genomic sequencing technologies, machine learning and ai in bioinformatics, drug discovery and development, personalized medicine and precision funding has been the major driver in the computational biology market. For instance, in April 2023, according to National Cancer Institute (NCI), a US-based government agency, in the fiscal year 2021, the NCI had a total budget of $6. 4 billion, which included $195 million in funding from the CURES Act. This represented a 1.6% increase, equivalent to $99. 3 million, compared to the preceding fiscal year. Therefore, government funding is driving the computational biology market increasing demand for personalized medicine is expected to propel the growth of computational biology going forward. For instance, in 2022, according to the Personalized Medicine Coalition, a US-based professional membership organization, the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) approved 37 new molecular entities (NMEs) in 2022. Out of the 35 therapeutic NMEs, approximately 34%, which amounts to 12 of them, are classified as personalized medicines by the Personalized Medicine Coalition (PMC). Therefore, the increasing demand for personalized medicine is driving the growth of the computational biology companies operating in the computational biology market are developing new solutions for proteomics research to gain a competitive edge in the market. For instance, in May 2023, Biognosys AG, a Switzerland-based biotechnology company launched Spectronaut 18 and unveiled significant scientific and technological enhancements for its exclusive proteomics research software and offerings. Spectronaut 18 offers high throughput and efficiency in data-independent acquisition (DIA) proteomics analysis. The company's TrueDiscovery platform accelerates biomarker discovery in fields like oncology and neuroscience by providing unparalleled depth and sensitivity in proteomics. TrueTarget enables high-resolution drug target identification and deconvolution, and Biognosys' iRT Kit, recommended for real-time system suitability monitoring, is now supported in combination with Bruker ProteoScape companies operating in the computational biology market are developing advanced biosimulation solutions to gain a competitive edge in the market. For instance, in June 2022, Certara, a US-based software development company launched new versions of its Immunogenicity (IG), Immuno-oncology (IO), and Vaccine Simulators to enhance the predictability of novel biologic therapies in drug development. These simulators are built on quantitative systems pharmacology (QSP) and use computational modeling and experimental data to understand drug interactions with biological systems and disease processes. They assist in creating virtual patients, conducting computer-based trials, and predicting drug behavior in patients, streamlining the drug development process and minimizing risks. Certara's IG Simulator assesses immunogenicity in various biologic therapies, the IO Simulator optimizes cancer therapy combinations, and the Vaccine Simulator determines vaccine dosing strategies. North America was the largest region in the computational biology market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the computational biology market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the computational biology market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Canada, Spain. Report Scope Markets Covered:1) By Services: In-house; Contract2) By Tools: Databases; Infrastructure (Hardware); Analysis Software and Services3) By Application: Cellular and Biological Simulation; Drug Discovery and Disease Modelling; Clinical Trials4) By End Users: Research; Pharmaceutical Industry; Commercial ApplicationsSubsegments:1) By In-house: Data Analysis; Software Development; Research And Development2) By Contract: Outsourced Bioinformatics; Collaborative Research; Data Management ServicesKey Companies Profiled: Certara L.P.; Chemical Computing Group Inc.; Compugen Ltd.; Genedata AG; Insilico Biotechnology AGTime Series: Five years historic and ten years Ratios of market size and growth to related markets, GDP proportions, expenditure per Segmentation: Country and regional historic and forecast data, market share of competitors, market Attributes Report Attribute Details No. of Pages 200 Forecast Period 2025-2029 Estimated Market Value (USD) in 2025 $9.52 Billion Forecasted Market Value (USD) by 2029 $22.47 Billion Compound Annual Growth Rate 23.9% Regions Covered Global Companies Featured in this Computational Biology Market Report Certara L.P. Chemical Computing Group Inc. Compugen Ltd. Genedata AG Insilico Biotechnology AG Dassault Systemes SE Instem PLC Rosa & Co. LLC Simulation Plus Inc. Nimbus Discovery LLC Rhenovia Pharma SAS Leadscope Inc. DNAnexus Altaris Capital Partner Genialis Inc. Inari Agriculture Inc. BC Platforms Ventus Therapeutics Monte Rosa Therapeutics Schrodinger Inc. Strand Life Sciences Entos Pharmaceuticals Numerate Inc. Insitro Recursion Pharmaceuticals Atomwise Relay Therapeutics Exscientia For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Computational Biology Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio

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