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市場調查報告書
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994957

印度和中國的監管和基礎設施改革,以促進亞洲特種仿製藥市場

Regulatory and Infrastructure Reforms in India and China Catalyzing the Asian Specialty Generics Market

出版日期: | 出版商: Frost & Sullivan | 英文 39 Pages | 商品交期: 最快1-2個工作天內

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  • 全貌
  • 簡介
  • 目錄
簡介

本報告是對亞洲仿製藥市場的系統研究和分析,重點關注增長機會,關鍵國家的生物製藥環境,關鍵的研發,法規以及影響增長的基礎設施改革,並提供了信息。

目錄

戰略要求

執行摘要-特殊仿製藥市場

增長機會分析-特殊藥品市場

  • 特種仿製藥市場分析範圍
  • 特殊仿製藥市場細分
  • 美國特殊仿製藥市場中的新藥應用監管途徑
  • 可能建立戰略夥伴關係的生物製藥公司-特殊仿製藥市場
  • 促進特殊仿製藥市場增長的因素
  • 抑制特殊仿製藥市場增長的因素
  • 特種藥物在整體藥物支出中的份額-特種仿製藥市場
  • 主要國家的市場吸引力-特殊仿製藥市場
  • 亞洲主要國家/地區的生物製藥市場情況-特殊仿製藥市場
  • 東盟主要國家/地區生物製藥市場狀況-特殊仿製藥市場
  • 生物製藥行業準備工作(印度和中國)-特殊仿製藥市場
  • 生物製藥行業準備工作(新加坡和香港)-特殊仿製藥市場
  • 為生物製藥業做準備(新興的東盟國家)-特殊仿製藥市場

增長機會區域-特殊藥品市場

  • 增長機會1:在利基腫瘤適應方面具有專門知識的中小企業
  • 案例研究-生態位腫瘤的適應症,罕見疾病的藥物開發,未滿足的高需求
  • 增長機會2:用於複雜疾病的可穿戴,長效組合產品
  • 案例研究-通過創新的藥物和設備組合改善患者護理並降低醫療成本
  • 增長機會3:505(b)(2)韓國公司利用路線的戰略合作
  • 案例研究-韓國公司需要專注於全球市場並利用專用仿製藥的功能
  • 附件清單
  • 免責聲明
目錄
Product Code: PBA0-52

High Unmet Needs in Niche Oncology Indications will Drive Future Growth Potential

Frost & Sullivan's Transformational Health team provides critical insights into the Asian specialty generics market with this research service, highlighting growth opportunities, selected countries' biopharmaceutical environment, and significant R&D, regulatory, and infrastructure reforms influencing its growth. The report examines similarities and contrasts between various Asian countries in specialty generics R&D, manufacturing, adoption, and access.

Specialty generics do not have a commonly accepted definition, often used interchangeably as complex generics. Specialty pharmaceuticals are often large, injectable, protein-based molecules produced through a biotechnology process. But they may also be small molecules produced through traditional pharmaceutical manufacturing methods.

Specialty generics offer lucrative market opportunities to Asian drug manufacturers to increase profit margins by developing innovative, value-added alternatives of existing drugs to offset traditional generics' shrinking margins in developed countries. The focus on improving the R&D landscape, especially for biologics, will attract global biopharmaceuticals to Asia due to the inherent advantage of a large patient pool and low-cost development and manufacturing.

This report reviews drivers propelling specialty generics adoption in these countries. For example, the rising prevalence of chronic diseases such as diabetes and cancer, where specialty drugs primarily drive treatment, will drive the demand for economic and easy-to-administer generic formulations to improve access. Self?administered medications using new drug delivery systems such as nasal sprays, autoinjectors, pen injectors, prefilled syringes, and needle-free injectors offer convenience that will drive the specialty generics demand. Specialty generics development provides competitive differentiation to companies compared to traditional generics. Compared to the 505(b)(1) pathway for new drug approval (NDA), the 505(b)(2) pathway in the US offers faster approval, lower risk, and market exclusivity from 3 to 7 years in some instances when coupled with the correct development and regulatory strategies.

Research Highlights:

The report highlights biopharmaceutical industry dynamics in selected countries. China is the most attractive site due to its strong focus on developing R&D infrastructure and capabilities specifically for biologics. India is the most lucrative location for low-cost manufacturing. Generics participants in India are increasingly focusing on developing innovative products, although the country lags in macroeconomic indicators due to low healthcare spending. Singapore and Hong Kong have a conducive macroeconomic and biopharma environment, followed by Thailand. While the market is nascent, there are signs that strong growth and new regulatory and infrastructure reforms are ahead, and this report will outline and provide commentary regarding those signs.

Table of Contents

Strategic Imperatives

  • Why is it Increasingly Difficult to Grow?
  • The Strategic Imperative 8™
  • The Impact of the Top Three Strategic Imperatives on the Asian Specialty Generics Market
  • Growth Opportunities Fuel the Growth Pipeline Engine™

Executive Summary-Specialty Generics Market

  • Executive Summary-Specialty Generics Market
  • Key Growth Opportunities-The Asian Specialty Generics Market

Growth Opportunity Analysis-Specialty Generics Market

  • Specialty Generics Market Scope of Analysis
  • Specialty Generics Market Segmentation
  • New Drug Application Regulatory Pathways in the US-Specialty Generics Market
  • Potential Regional Biopharma Players for Strategic Partnerships-Specialty Generics Market
  • Potential Regional Biopharma Players for Strategic Partnerships-Specialty Generics Market (continued)
  • Growth Drivers for the Specialty Generics Market
  • Growth Restraints for the Specialty Generics Market
  • Specialty Drugs Share in Overall Drugs Spending-Specialty Generics Market
  • Selected Countries' Market Attractiveness-Specialty Generics Market
  • Biopharmaceutical Market Landscape in Selected Asian Countries-Specialty Generics Market
  • Biopharmaceutical Market Landscape in Selected ASEAN Countries-Specialty Generics Market
  • Biopharmaceutical Industry Readiness (India and China)-Specialty Generics Market
  • Biopharmaceutical Industry Readiness (Singapore and Hong Kong)-Specialty Generics Market
  • Biopharmaceutical Industry Readiness (Emerging ASEAN Countries)-Specialty Generics Market

Growth Opportunity Universe-Specialty Generics Market

  • Growth Opportunity 1: Small and Mid-Sized Players Developing Expertise in Niche Oncology Indications
  • Growth Opportunity 1: Small and Mid-Sized Players Developing Expertise in Niche Oncology Indications (continued)
  • Case Study-Developing Drugs for Niche Oncology Indications and Orphan Diseases with High Unmet Needs
  • Growth Opportunity 2: Wearable, Long-Acting Combination Products for Complex Diseases
  • Growth Opportunity 2: Wearable, Long-Acting Combination Products for Complex Diseases (continued)
  • Case Study-Improving Patient Care and Reducing Healthcare Costs Through Innovative Drug-device Combinations
  • Growth Opportunity 3: Korean Companies' Strategic Collaborations for Leveraging the 505(b)(2) Pathway
  • Growth Opportunity 3: Korean Companies' Strategic Collaborations for Leveraging the 505(b)(2) Pathway (continued)
  • Case Study-Korean Companies Should Focus on Global Markets and Leverage Their Specialty Generics Capabilities
  • List of Exhibits
  • Legal Disclaimer