More than 130 medical devices were approved by the FDA since January 2018, while several are currently being evaluated across more than 9,500 (active) clinical trials, worldwide. Even though technical innovation has enabled the development of a variety of versatile medical devices, product approval, given stringent regulatory standards, is still a concern.
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The USD 820 million (by 2030) financial opportunity within the contract regulatory affairs-management services market for medical devices has been analyzed across the following segments:
- Medical Device Class
- Class I
- Class II
- Class III
- Therapeutic Area
- Cardiovascular Disorders
- CNS Disorders
- Metabolic Disorders
- Oncological Disorders
- Ophthalmological Disease
- Orthopedic Disorders
- Pain Disorders
- Respiratory Disorders
- Others
- Type of Regulatory Affairs Service
- Pharmacies GAP-Analysis
- Pharmacies Legal Representation
- Pharmacies Notified Body Selection
- Product Labelling-related Services
- Product Registration and Clinical Trial Applications
- Regulatory Document Submissions
- Regulatory Writing and Publishing
- Risk Management-related Services
- Technical Dossier Set-up
- Vigilance & Medical Device Report
- Key Geographical Regions
- North America
- Europe
- Asia-Pacific and Rest of the World
The Contract Regulatory Affairs-Management Market for Medical Devices, 2019-2030 report features the following companies, which we identified to be key players in this domain:
- CTI Clinical Trial and Consulting Services
- CROMSOURCE
- ICON
- Intertek
- Medpace
- MIC Medical
- North American Science Associates (NAMSA)
- Parexel
- PharmaLex
- Premier Research
- Société Générale de Surveillance (SGS)
- Underwriters Laboratory (UL)
Table of Contents
- Preface
2. Executive Summary
Introduction
- Role of Regulatory Affairs in Medical Device Supply Chain
- Regulatory and Reimbursement Landscape for Medical Devices
- Competitive Landscape
- Company Profiles
- Competitive Benchmarking
- Guide to Regulatory Outsourcing Models
- Medical Device Regulatory Affairs: Key Performance Indicators
- Market Forecast
- Conclusion
- Survey Insights
- Executive Insights
- Appendix 1: Tabulated Data
- Appendix 2: List of Companies and Organizations
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Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
Outsourcing has become a popular trend among biopharmaceutical developers, allowing them to leverage the expertise / larger production capacities of CMOs / CDMOs and achieve significant cost and time related advantages Roots Analysis is pleased to announce the publication of its recent study, titled, “Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030.” The report features an extensive study on the contract service providers within the biopharmaceutical industry.
The study features in-depth analysis, highlighting the capabilities of a diverse set of biopharmaceutical CMOs and CDMOs.
Amongst other elements, the report includes:A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring a comprehensive list of active CMOs and detailed analysis of the manufacturing service providers based on a number of parameters.Elaborate profiles of key players that have a diverse range of capabilities for the development, manufacturing, and packaging of biologics.A detailed discussion on the key enablers in this domain, including certain niche product classes, which are likely to have a significant impact on the growth of the contract services market.A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs.A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.A discussion on challenges related to in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource.An analysis of the recent collaborations (signed since 2013) focused on the contract manufacturing of biologics.A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2013-2018, along with the geographical distribution of this activity.An in-depth analysis of more than 490 grants that have been awarded to research institutes engaged in next generation immune checkpoint therapy-related projects.An analysis on the recent trends within biopharmaceutical contract manufacturing industry, highlighting various facility and capability expansions.A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders.A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders.A discussion on affiliated trends, key drivers, and challenges, under a comprehensive SWOT framework.A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CMO services to medical device developers.A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)Commonly Outsourced Business OperationsActive Pharmaceutical Ingredients (API)Finished Dosage Formulations (FDF)Types of Expression SystemMammalianMicrobialOthersCompany SizeSmallMid-SizedLarge and Very LargeScale of OperationPreclinicalClinicalCommercialKey Geographical Region North AmericaEuropeAsia-PacificRest of the World The report also features detailed transcripts of discussions held with the following experts:Astrid Brammer, Senior Manager Business Development, Richter-Helm Mathias Schmidt (Chief Executive Officer, ArmaGen)Birgit Schwab, Senior Manager Strategic Marketing, Rentschler BiotechnologieChristian Bailly, Director of CDMO, Pierre FabreClaire Otjes, Assistant Marketing Manager, Batavia BiosciencesDavid C Cunningham, Director Corporate Development, Goodwin BiotechnologyDietmar Katinger, Chief Executive Officer, Polymun ScientificDenis Angioletti, Chief Commercial Officer, Cerbios-PharmaJeffrey Hung, Chief Commercial Officer, Vigene BiosciencesKevin Daley, Director Pharmaceuticals, NovasepMark Wright, Site Head, Grangemouth, Piramal HealthcareNicolas Grandchamp, R Leader, GEG TechRaquel Fortunato, Chief Executive Officer, GenIbet BiopharmaceuticalsSebastian Schuck, Head of Business Development, Wacker BiotechStephen Taylor, Senior Vice President Commercial, FUJIFILM Diosynth BiotechnologiesTatjana Buchholz, Marketing Manager, PlasmidFactory and Marco Schmeer, Project Manager, PlasmidFactoryTim Oldham, Chief Executive Officer, Cell Therapies To request for sample report - https://www.rootsanalysis.com/reports/view_document/biopharmaceutical-contract-manufacturing-market/250.html Key companies covered in the report3P BiopharmaceuticalsAbzenaAlbany Molecular ResearchBioVectraBioXcellence (Boehringer Ingelheim)CelonicCharles River LaboratoriesChemPartnerCobra BiologicsCordenPharmaCytovance BiologicsGE HealthcareGoodwin BiotechnologyGrand River Aseptic ManufacturingIDT BiologikaKBI BioPharmaKemwell BiopharmaLFB BiomanufacturingMeridian Life SciencePatheonPfizer CentreOnePX'TherapeuticsSamsung BioLogicsSanofi, CEPiAThermo Fisher ScientificVetter Pharma International For more information please click on the following link:Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030 Other Recent OfferingsCell Therapy Manufacturing Market (3rd Edition), 2019-2030Antibody Contract Manufacturing Market, 2020-2030China Biopharmaceutical Contract Manufacturing Market, 2020-2030Peptide Therapeutics: Contract API Manufacturing Market, 2020-2030 About Roots AnalysisRoots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry.
The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector.
If you’d like help with your growing business needs, get in touch at [email protected] Contact InformationRoots Analysis Private LimitedGaurav Chaudhary+1 (415) 800 [email protected] - https://www.facebook.com/RootsAnalysis
Therefore, the use of technology can save time and money, while providing a far better understanding of the relationships between different formulations and processes parameters.Key Drivers, Restraints, and Opportunities of AI in Pharma and Biotech MarketAdoption of artificial intelligence (AI) in the drug discovery market in developing regions such as APAC is increasing, thanks to the expansion of pharmaceutical industries by collaborating with other industries and rise in demand to reduce drug discovery time.
Furthermore, the expansion of biotechnology industries is estimated to offer significant opportunities for the market.An estimated 50% of U.S. citizens are affected by at least one chronic condition; consequently, the pharmaceutical segment of the healthcare industry is projected to be positively impacted by the expected trend of AI adoption.All top 10 so-called giant pharma companies (namely Novartis, Roche, Pfizer, Merck, AstraZeneca, GlaxoSmithKline, Sanofi, Abbvie, Bristol-Myers Squibb, and Johnson & Johnson) have either expressly collaborated with or acquired AI technologies to take advantage of the opportunities AI brings to the table.
Industry leaders are presently focused on the development of more efficient methods, and machine learning is emerging as a possible solution.The current machine learning initiatives of the top five pharmaceutical and biotechnology companies reveal trends within the following areas:Digital coaching solutions – Utilization of web-based technologies to simulate one-on-one coaching sessions so that all patients can have the benefit of a uniquely devised medication program.For instance: Johnson & Johnson’s Patient Athlete programPersonalized medicine – Personalized medicine, also called precision medicine, maybe a medical model that separates people into different groups—with medical decisions, practices, interventions, and/or products being tailored to the individual patient supported their predicted response or risk of disease.For instance.
Unlike other applications within healthcare facilities, drug discovery seems to own a clearer path to adoption.Recently, robots became more collaborative with humans and are more easily trained by moving them through the desired task.
Over time, it seems likely that an equivalent improvement in intelligence that we have seen in other areas of AI would be incorporated into physical robots.Surgical robots initially approved in the U.S. in 2000, provided ‘superpowers’ to surgeons, improving their ability to examine, create precise and minimally invasive incisions, and stitch wounds.
Common surgical procedures using robotic surgery include gynecologic surgery, prostate surgery, and head and neck surgery.Pre Book Ai In Pharma And Biotech Market Report – https://www.transparencymarketresearch.com/checkout.php?rep_id=79399=S North America to Capture Major Share of Global Market of AI in Pharma & BiotechNorth America is expected to account for a major share of the global market of AI in Pharma and Biotech due to the high prevalence of chronic diseases among the population.
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