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Microneedle Measurable Chronic Disease Biomarkers

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  • 138 Pages
  • June 2022
  • Region: Global
  • Greystone Associates
  • ID: 5599594
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.

Biomarkers are biochemical molecules that indicate how the human body may react to certain active pharmaceutical ingredients (APIs) or different types of environmental factors. A simple but well-known example of the role of biomarkers in patient health and well-being would be food allergies. By identifying biomarkers in human physiology and understanding their role in drug therapy, allergies and immune reactions, caregivers are better able to help patients avoid drug side effects and to determine when a particular drug will produce the desired therapeutic effect for a given patient. 

The FDA has assembled a database titled Table of Pharmacogenomic Biomarkers in Drug Labeling. This information resource illustrates identified relationships between drugs and biomarkers. Knowing which patients exhibit certain types of biomarkers is therefore desirable. Researchers and investigators are interested in finding ways to identify, measure and quantify biomarkers in ways that are non-invasive, or at least minimally invasive to minimize any discomfort to the patient. 

Microneedles are one of the ways being explored to sample, measure and quantify biomarkers for specific diseases. Using microneedles to collect biomarkers in the interstitial fluid (ISF) can be an inexpensive and rapid method for assessing the role of biomarkers in therapeutics and disease management.

This report covers these areas and describes the current state of technology. 

Microneedle Measurable Chronic Disease Biomarkers - 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
  • 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