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市場調查報告書

非專利注射劑

Generic injectables

出版商 Greystone Research Associates 商品編碼 358326
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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非專利注射劑 Generic injectables
出版日期: 2016年05月24日 內容資訊: 英文
簡介

本報告提供非專利注射劑的市場調查,注射劑及非專利注射劑概要及經濟學,產品製造相關考察,影響市場成長因素分析,各藥物類別及治療層級的市場趨勢,專利、專賣銷售權等的影響,訴訟相關趨勢,ANDA申請策略的重要性,主要供應商的市場上存在感與產品的地位等分析彙整。

摘要整理

市場機會

  • 注射劑的經濟學
  • 注射劑的成長
  • 需求推進因素
  • 競爭環境

非專利注射劑:成長因素

  • 專利和壟斷銷售權
  • 訴訟和FTF (First-to-File) ANDA策略
  • ANDA的買賣

非專利注射劑:產品相關的考察

  • 供給狀態的容器
  • 冷凍乾燥/再製作
  • 製劑因素

非專利注射劑的市場分析

各類藥物分析

  • 腎上腺素促效劑
  • 骨形成促進藥
  • 抗生素
  • 麻醉劑
  • 心律不整治療劑
  • 抗凝固劑
  • 抗痙攣藥
  • 制吐藥
  • 消炎劑
  • 降壓劑
  • 腫瘤用藥
  • 抗病毒藥物
  • 骨吸收抑製藥
  • 利尿劑
  • 葉酸葉酸代謝物
  • 生長激素抑制劑
  • 肌肉鬆弛劑
  • 麻醉劑止痛藥
  • 神經傳達物質
  • 類鴉片物質拮抗劑
  • 鎮壓藥
  • 血管擴張藥

各治療層級分析

  • 抗感染疾病
  • 心臟、循環系統
  • 血液
  • 神經
  • 疼痛管理
  • 其他主要級
    • 市場因素
    • 法律規章上的課題
    • 訴訟上的課題
    • ANDA申請策略的發展
    • CMO所扮演的角色
    • 醫療的經濟學
    • 企業分析
目錄
Product Code: GJT574K

The generic injectable drug segment is a rapidly evolving and highly competitive market that lacks a true data compass to assist decision makers in mapping strategies for success in this segment. Attempting to determine the optimal time to file an ANDA application is a process that can be worth significant profits for first-to-filers. But it is a process that is marked by little in the way of analytical decision support and in which litigation has become a staple defensive mechanism for both the filer and the branded drug owner. There are 235 distinct APIs for which there is at least one approved generic injectable ANDA. These 235 APIs account for 1,167 approved ANDAs. Including all approved doses, the current universe of generic injectables consists of 1,699 unique injectable products. These products are currently marketed and supplied by slightly less than one hundred companies. Competition among the various drug and therapeutic classes is uneven, with the top ten segments accounting for a disproportionate level of activity and revenue. Understanding the underlying factors affecting business performance is key to attaining financial targets.

Generic Injectables - What You Will Learn

  • Provides detailed analysis of generic drugs supplied as injectables and assesses key market segments, market dynamics and potential product opportunities
  • Presents the competitive picture for generic injectables in two dozen drug classes
  • Evaluates the importance of ANDA filing strategies and indirect ANDA acquisition on participant growth prospects
  • Analyzes the impact of patents, exclusivity and litigation on participant market sector prospects
  • Assesses the market presence and product position of the top twenty-four generic injectables suppliers
  • Evaluates the impact of economic, technology, and regulatory factors

Table of Contents

Executive Summary

The Market Opportunity

  • The Economics of Injectable Drugs
  • Growth in Injectables
  • Demand Drivers
  • Competitive Landscape

Generic Injectables - Growth Factors

  • Patents and Exclusivity
  • Litigation and First-to-File ANDA Strategies
  • Buying and Selling ANDAs

Generic Injectables - Product Considerations

  • As-supplied Container
  • Lyophilization/Reconstitution
  • Formulation Factors

Generic Injectables Market Analysis

Drug Class Analysis

  • Adrenergic AgentsAnabolic
  • AgentsAntibioticsAnestheticsAntiarrhythmicsAnticoagulantsAnticonvulsantsAntiemeticsAnti-inflammatory
  • Antihypertensives
  • Antineoplastics
  • Antivirals
  • Bone Resorption
  • InhibitorsDiureticsFolic Acid
  • MetabolitesGrowth
  • HormoneInhibitorsMuscle
  • RelaxantsNarcotic
  • AnalgesicsNeurotransmitterOpioid
  • Antagonist
  • Sedative
  • Vasodilators

Therapeutic Class Analysis

  • Anti-infectives
  • Cardiology
  • Hematology
  • Neurology
  • Pain Management
  • Other Key Classes
  • Market Factors
  • Regulatory Issues
  • Litigation Issues
  • Evolving ANDA Filing Strategies
  • The Role of CMOs
  • Healthcare Economics
  • Company Analysis
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