Product Code: MCDB329K
Chronic Diseases, Biomarkers and the FDA
Biomarkers are a key medical product development tool capable of facilitating development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treatments by reducing the time and cost of clinical trials while maintaining patient protections. FDA encourages the integration of biomarkers in medical product development and approval, to facilitate the monitoring of FDA-regulated products, and their appropriate use in clinical practice. Biomarkers promise to reduce stagnation and foster innovation in the development of new medical products. A biomarker can be used as the basis for creating a routine diagnostic test for clinical use, after it has been approved as an in-vitro diagnostic. A biomarker can also be used to develop a companion diagnostic test that enables better decision-making on the use of a therapy that is tailored to the patient.
What You Will Learn:
- What companies are active in the microneedle diagnostics segments, what distinguishes their technology, and what is their market presence?
- What are the identified and verified chronic disease biomarkers, and what are their properties ?
- What are the major factors that are influencing interest in chronic disease biomarkers?
- What are the design factors, material selection issues, technologies, and market development issues for microneedles capable of capturing and identifying chronic disease biomarkers?
- What are the important therapeutic markets for microneedle measurable chronic disease biomarkers? What is their market potential?
- What are the significant economic, technology, and regulatory factors affecting the market for diagnostic microneedles?
Table of Contents
- Executive Summary
- Microneedle Measurable Chronic Disease Biomarkers
- Executive Summary
- Point-of-Care Diagnostics Market Dynamics
- Biomarkers and their Potential in Clinical Medicine
- Microneedles for Detecting and Measuring Biomarkers
- Microneedle Product Categories
- Solid Microneedles
- Hollow Microneedles
- Coated Microneedles
- Dissolving Microneedles
- Stretched Needles
- Carbon Nanotubes
- Ion Etching
- C-MEMS
- Specialty Microneedles
- Phase Transition
- Microprocessor-based Devices
- Composite Microneedles
- Light-responsive Microneedles
- Flexible Arrays
- Microneedle Arrays & Array Geometries
- Array Architectures
- Microneedles & Microfluidics
- Wearable Microneedles
- The Role of Interstitial Fluid
- Microneedle Diagnostics - Design Factors
- Analyte Capture
- Sample Acquisition
- Biofluid Absorption
- Electrochemical Sensing Methods
- Optical Sensing Methods
- Chronic Disease Associated Biomarkers
- Biomarker Detection
- Microneedle Fabrication
- Micromolding
- Microforming
- Micromachining
- Structured Films
- Emerging Fabrication Methods
- 3D Printing
- Electrospun Arrays
- Two-Photon Polymerization (2PP)
- Magnetization-induced Self-assembly
- Additive Fabrication Methods
- Stereolithography
- Fused Deposition Modelling
- Digital Light Processing
- Selective Laser Sintering
- Selective Laser Melting
- Inkjet Printing
- Surface Modification
- Diagnostic Microneedle Device Analysis
- Micro Transdermal Interface Platform (MicroTIPs)
- Mindera Health
- Scibase (Nevisense)
- Seventh Sense Biosystems
- Sysmex
- Chronic Disease Biomarkers
- Opportunities Extend Across Numerous Therapeutic Areas
- Anesthesiology
- Cardiology
- Endocrinology
- Gastroenterology
- Gynecology
- Hematology
- Inborn Errors of Metabolism
- Infectious Diseases
- Neurology
- Oncology
- Rheumatology
- Microneedle Biomarker Diagnostics
- Key Therapeutic Sectors
- Glucose
- Immune Factors
- Electrolytes/Potassium
- Biomarker-enabled Diagnostics
- Company Profiles
- Market Participant Profiles