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市場調查報告書

藥事未核准檢驗 (LTD) 及FDA認證檢驗的價格分析

Price Point Analysis for Laboratory Developed Tests (LDTs) and FDA Regulated Tests

出版商 Frost & Sullivan 商品編碼 371843
出版日期 內容資訊 英文 52 Pages
商品交期: 最快1-2個工作天內
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藥事未核准檢驗 (LTD) 及FDA認證檢驗的價格分析 Price Point Analysis for Laboratory Developed Tests (LDTs) and FDA Regulated Tests
出版日期: 2016年09月06日 內容資訊: 英文 52 Pages
簡介

本報告提供各種疾病的藥事未核准檢驗 (以下LTD) 及FDA (美國食品藥物管理局) 認證檢驗相關分析,各疾病、各標準、 目的 (風險評估,篩檢,診斷,分期、預後,治療方法選擇,治療監測等) ,檢查數量、市場收益額、平均單價預測。

摘要整理

自體免疫疾病

  • 麩質過敏症專用的LDT試劑
  • 克隆氏症專用的LDT試劑
  • 類風濕性關節炎專用的LDT試劑
  • 狼瘡專用的LDT試劑
  • 發炎性腸道疾病 (IBD)、大腸躁鬱症 (IBS) 專用的LDT試劑
  • 生物標記的指南

心臟疾病

  • 心臟疾病專用的LDT/FDA試劑

腫瘤

  • 前列腺癌症
  • 乳癌
  • 結腸癌症專用的LDT試劑/CLIA適用免除試劑
  • 肺癌的LDT/FDA試劑
  • 婦產科癌症 (卵巢) 專用的LDT/FDA試劑
  • 婦產科癌症 (子宮頸部) 專用的LDT/FDA試劑
  • 生物標記的指南
  • 胃癌/GIST (胃腸道基質腫瘤) 專用的LDT/FDA試劑

其他領域

  • 女性維他命D檢驗
  • 女性產前診斷
  • 女性妊娠、荷爾蒙檢驗
  • 訂單數量多的毒素檢驗
  • 訂單數量多的遺傳基因檢驗
  • 訂單數量多的傳染病檢查

關於Frost&Sullivan

目錄
Product Code: 9AB9-55

Discover the Perfect Assay Price Point to Remain Competitive

The main objective of this research is to estimate test volumes and unit prices for a wide variety of LDTs (genetic) and a few high volume FDA tests for selective therapeutic areas. The tests are categorized by their intended uses across the diagnostic spectrum (risk assessment, screening, diagnosis, staging and prognosis, therapy selection, therapy monitoring). A selective list of therapeutic areas covered in this research include: autoimmune diseases, cancers (breast, colorectal, prostrate, lung, gastric, cervical, and ovarian), toxicology, cardiology, women's health (vitamin D, prenatal, pregnancy and hormone), and infectious disease testing (TB, hepatitis A/B/C, cytomegalovirus). The base year used for analysis is 2015.

Table of Contents

1. PRICE POINT ANALYSIS FOR LABORATORY DEVELOPED TESTS (LDTS) AND FDA REGULATED TESTS

Executive Summary

  • Research Scope
  • Executive Summary
  • Executive Summary (continued)
  • Executive Summary (continued)
  • Research Objectives
  • Abbreviations

Autoimmune Diseases

  • Celiac Disease Specific LDT Assays
  • Chron's Disease Specific LDT Assays
  • Rheumatoid Arthritis Specific LDT Assays
  • Lupus Specific LDT Assays
  • LupusSpecific LDT Assays (continued)
  • IBD and IBS Specific LDT Assays
  • Biomarker Guidelines

Cardiology

  • Cardiac Disease Specific LDTs and FDA Assays
  • Cardiac Disease Specific LDTs and FDA Assays (continued)

Oncology

  • Prostate Cancer Specific LDT Assays
  • Prostate Cancer Specific LDT Assays (continued)
  • Breast Cancer Specific LDT Assays
  • Breast Cancer Specific LDT Assays (continued)
  • Breast Cancer Specific LDT Assays (continued)
  • Colon Cancer Specific LDT and CLIA Waived Assays
  • Colon Cancer Specific LDT and CLIA Waived Assays (continued)
  • Colon Cancer Specific LDT and CLIA Waived Assays (continued)
  • Lung Cancer Specific LDT and FDA Assays
  • Lung Cancer Specific LDT and FDA Assays (continued)
  • Gynecologic Cancers (Ovarian)Specific LDT and FDA Assays
  • Gynecologic Cancers (Cervical)Specific LDT and FDA Assays
  • Biomarker Guidelines
  • Gastric Cancer/GIST Specific LDT and FDA Assays

Other Areas

  • Women's Health Vitamin D Tests
  • Women's Health Prenatal Tests
  • Women's Health Pregnancy and Hormone Tests
  • Toxicology Popularly Ordered Tests
  • Infectious Diseases Popularly Ordered Genetic Tests
  • Infectious Diseases Popularly Ordered Tests
  • Legal Disclaimer

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