表紙:アジアの特殊ジェネリック医薬品市場を促進するインドと中国の規制およびインフラの改革
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アジアの特殊ジェネリック医薬品市場を促進するインドと中国の規制およびインフラの改革

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

出版日: | 発行: Frost & Sullivan | ページ情報: 英文 39 Pages | 納期: 即日から翌営業日

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アジアの特殊ジェネリック医薬品市場を促進するインドと中国の規制およびインフラの改革
出版日: 2021年02月19日
発行: Frost & Sullivan
ページ情報: 英文 39 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

当レポートでは、アジアの特殊ジェネリック医薬品市場について調査分析し、成長機会、主要国のバイオ医薬品環境、重要なR&D、規制、成長に影響を与えるインフラの改革に焦点を当てて、体系的な情報を提供しています。

目次

戦略的必須事項

エグゼクティブサマリー - 特殊ジェネリック医薬品市場

成長機会分析 - 特殊ジェネリック医薬品市場

  • 特殊ジェネリック医薬品市場の分析範囲
  • 特殊ジェネリック医薬品市場セグメンテーション
  • 米国における新薬承認申請規制経路 - 特殊ジェネリック医薬品市場
  • 戦略的パートナーシップに対する潜在的バイオ医薬品企業 - 特殊ジェネリック医薬品市場
  • 特殊ジェネリック医薬品市場の成長促進要因
  • 特殊ジェネリック医薬品市場の成長抑制要因
  • 医薬品支出全体における特殊医薬品のシェア - 特殊ジェネリック医薬品市場
  • 主要国の市場の魅力 - 特殊ジェネリック医薬品市場
  • アジアの主要国におけるバイオ医薬品市場情勢 - 特殊ジェネリック医薬品市場
  • ASEANの主要国におけるバイオ医薬品市場情勢 - 特殊ジェネリック医薬品市場
  • バイオ医薬品業界の準備(インドと中国)- 特殊ジェネリック医薬品市場
  • バイオ医薬品業界の準備(シンガポールと香港)- 特殊ジェネリック医薬品市場
  • バイオ医薬品業界の準備(新興のASEAN諸国)- 特殊ジェネリック医薬品市場

成長機会分野 - 特殊ジェネリック医薬品市場

  • 成長機会1:ニッチな腫瘍の適応に関する専門知識を身に付ける中小企業
  • ケーススタディ - ニッチな腫瘍の適応、希少疾患の薬剤開発は、高いアンメットニーズ
  • 成長機会2:複雑な疾患に対するウェアラブル・長時間作用型の併用製品
  • ケーススタディ - 革新的な薬剤とデバイスの組み合わせによる、患者治療の改善と医療費の削減
  • 成長機会3:505(b)(2) 経路を活用するための韓国企業の戦略的コラボレーション
  • ケーススタディ - 韓国企業は世界の市場にフォーカス、専門的なジェネリック医薬品の機能を活用する必要がある
  • 別紙のリスト
  • 免責事項
目次
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