株式会社グローバルインフォメーション
TEL: 044-952-0102
市場調査レポート

ジェネリック&特殊医薬品企業における革新的ドラッグデリバリーシステムの機会

Innovative Drug Delivery Systems Opportunities for Generic & Specialty Pharmaceutical Companies

発行 MP Advisors 商品コード 296610
出版日 ページ情報 英文 91 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=115.27円で換算しております。
Back to Top
ジェネリック&特殊医薬品企業における革新的ドラッグデリバリーシステムの機会 Innovative Drug Delivery Systems Opportunities for Generic & Specialty Pharmaceutical Companies
出版日: 2014年02月25日 ページ情報: 英文 91 Pages
概要

経口ドラッグデリバリー市場は全ドラッグデリバリー市場で52%以上の市場シェアを占め、最大分野となっています。現在の市場額は490億米ドルですが、今後はCAGR11%で成長し、2016年までに900億米ドル以上に達すると予測されています。経口ドラッグデリバリー市場は主に、注射剤しかない医薬品の経口薬・経口製剤の放出制御製剤を可能にする新技術によって促進される見込みです。世界の注射剤ドラッグデリバリー市場額は、2015年までに290億米ドルに達すると予測されています。

当レポートでは、主に製薬企業・特殊製薬企業の経口・注射製剤の新しいドラッグデリバリーシステムにフォーカスして調査し、付加価値製剤の形成に含まれるさまざまな製剤技術、製薬アプリケーションおよび特殊技術のメリットを分析しており、多様な特許製剤技術の議論を含め、概略下記の構成でお届けいたします。

第1章 世界のジェネリック医薬品ビジネス:現況・将来の機会

第2章 近年の契約に基づいた先進ドラッグデリバリーシステムにおける治療フォーカス・動向

第3章 特許失効の影響・ジェネリック医薬品企業の戦略:スーパージェネリック医薬品

第4章 製剤における溶解度と透過性の関係

第5章 水不溶性医薬品・経口ペプチドデリバリーのための製剤アプローチ

第6章 FDAの505 (b)(2)アプリケーションに対するガイドラインおよび開発のメリット

第7章 505 (b)(2)開発で許可される変更のタイプとそのメリット

第8章 505 (b)(2)開発の臨床データ要件における規制の課題と安全性の研究

第9章 経口・注射製剤における100以上の製剤設計の議論による医薬品企業75社以上の製剤技術の分析、アプリケーションおよびメリット

第10章 議論された特殊医薬品企業の後期段階パイプライン開発

第11章 議論された製剤特許技術

目次
Product Code: TC14022402

The oral drug delivery market remains the largest slice of the overall drug delivery market, with more than 52% of the market share. It is presently valued at $49 billion and is expected to reach over $90 billion by 2016, at a CAGR of 11%. The growth in the oral drug delivery market shall be driven primarily by newer technologies enabling controlled release formulations of oral drugs and oral formulations of injectable only drugs. Global injectable drug delivery market is expected to be worth $29b by 2015.

Novel drug delivery systems (NDDS) offers many more advantages, which include improved therapy by increasing the efficacy and duration of drug activity, increased patient compliance through decreased dosing frequency and convenient routes of administration and improved targeting for a specific site to reduce unwanted side effects. The challenge for both drug and drug delivery companies is to deliver both existing and emerging drug technologies in a manner that improves the benefits to the patients.

The generic market with reference to innovative molecule (NCE) has become very competitive as several companies have already filed the ANDA for the potential generic drugs in the near term. The study of novel drug delivery companies and their formulation technologies will provide the potential value added opportunity in the generic field in terms of patient's compliance or bioavailability enhancement. It will also provide enhanced life cycle for the drugs under patent coverage (life cycle extension).

This comprehensive report on novel drug delivery system focused mainly on oral and injectable formulations for the pharma and specialty companies. This report enumerates the various formulation technology involved in making value added formulations, pharmaceutical applications and advantages of the specific technology. Wherever available, the marketed drugs using the similar technology as the proof of validation and the status of additional pipeline have also been discussed. The discussed proprietary formulations technologies includes Colal, Glide SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen, Oradur, EnteriCare and Saber.

This report will be helpful for the pharma companies exploring novel opportunities for their growth by in-licensing the formulation technology or value added pipeline drugs available/being studied in the market.

Table of Contents

  • 1. Global Generic Business - Present Status and Future Opportunities
  • 2. Therapeutic focus and Trends in Advanced drug Delivery System based on recent deals
  • 3. Patent expiry impact and generic companies strategies -Super generics
  • 4. The relationship between solubility and permeability in formulations
  • 5. Formulation approach for water -insoluble drugs and oral peptide delivery
  • 6. FDA guidelines for 505 (b)(2) applications and advantage of development
  • 7. Types of changes allowed in 505 (b)(2) development and its advantage
  • 8. Regulatory challenges in clinical data requirement in 505(b)(2) development and safety studies
  • 9. Analysis, Application and Advantages of formulations technologies for more than 75 pharma companies with over 100 formulation technologies in oral and injectable formulations discussed
  • 10. Late stage pipeline development for discussed specialty Pharma companies
  • 11. The discussed formulations proprietary technologies includes Colal, Glide SDI, Arestat, GeoClock, GeoMatrix, FlashTab, Lock Tab, Medusa, Eligen, Oradur, EnteriCare and Saber

Key Charts and Tables

  • Chart -1 : Global revenue of Advanced Drug Delivery Systems by region, 2009-16 ($millions)
  • Chart-2 : Utilization of generic medicines within the unprotected markets
  • Chart - 3 : Generic spending per capita (US$) in 2011 and 2016
  • Chart - 4 : Trends in Drug Delivery Deals - stages of development in 2012
  • Chart - 5 : The current trends in Drug Delivery Deals By technology - 2012
  • Chart - 6 : Oral Drug Delivery Market, Marketed Oral Small Molecules by Therapy Area, %, 2011
  • Chart -7 : Relationship between solubility and GI permeability
  • Chart - 8 : Solubility and GI Permeability -Biopharmaceutical Classification Scheme (BCS)
  • Chart - 9 : FDA approval statistics for 505(b)(2) pathway -1996-2011
  • Table -1 : Formulation approaches for Water-Insoluble drugs
  • Table -2 : Ingredients Used for Oral Delivery of Peptides
  • Table -3 : Potential Regulatory Pathways for Drug Products Under Development
  • Table -4 : Time and Cost Comparison-ANDA vs 505(b)(2)

Company Name

  • Glide Pharma
  • Caretek Medical Ltd .
  • Arecor Ltd
  • Critical Pharmaceuticals
  • IotaNano
  • MedPharm Ltd
  • Q Chip Ltd
  • XstalBio Ltd
  • Skye Pharma
  • Ethypharm
  • Flamel Technologies
  • InSiteVision
  • Durect
  • Depomed
  • Impax Laboratories
  • Banner Caps
  • Medincell .
  • Pacira Pharmaceuticals.
  • InnoCore Pharmaceuticals.
  • Chiasma Pharma.
  • D-Pharm
  • Emisphere Technologies .
  • ALZA Corporation
  • Antares Pharma
  • Camurus ...
  • Xspray Microparticles AB
  • Octoplus
  • Sigmoid Pharma Ltd
  • EmulTech
  • Corium International
  • Endo Pharmaceuticals
  • Zogenix
  • Star Pharma
  • QLT Inc
  • Bend Research
  • Bind Biosciences
  • Apricus Bio
  • Merrion Pharmaceuticals
  • Aptalis
  • Grunenthal GmbH
  • Alkermes
  • InnerCap Technologies Inc
  • Scolr Pharma
  • Catalent
  • SPI Pharma
  • CIMA Drug Delivery Technologies
  • Skinvisible pharmaceuticals
  • SEPS Pharma
  • Unigene Laboratories
  • Kurve Technology
  • Egalet Ltd
  • ThioMatrix
  • NAL Pharma
  • GL Pharmatech
  • Dexcel Pharma
  • Plx Pharma
  • Cosmo Pharmaceuticals
  • Cambrex Corporations
  • Supernus Pharmaceuticals
  • Tris Pharma
  • Orexo
  • Cipher Pharma
  • Aegis Therapeutics
  • Alpex Pharma
  • IntelGenx Corp
  • MonoSol Rx
  • Purdue Pharma
  • Patheon Inc
  • URL Pharma
  • Xenoport
  • Novartis
  • Pfizer
  • Echo Pharmaceuticals
  • Pozen Inc.
  • Osmotica Pharmaceuticals
  • KV Pharmaceuticals
  • Veloxis Pharma
Back to Top