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治療用タンパク質:バイオシミラー、バイオベター、バイオスーペリア

Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors

発行 La Merie Publishing 商品コード 146105
出版日 ページ情報 英文 301 Pages
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治療用タンパク質:バイオシミラー、バイオベター、バイオスーペリア Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors
出版日: 2013年05月01日 ページ情報: 英文 301 Pages
概要

売上総額500億米ドルを超える治療用タンパク質は、確立された治療価値と経済的魅力を備えた医薬品のひとつとなっています。ブランド薬が特許の保護を失い、法規制当局がより良いガイダンスを提示するにつれ、バイオシミラーや次世代薬剤の開発が製薬会社やバイオテクノロジー企業、およびテクノロジーに注力する企業にとって魅力ある目標となっています。

当レポートでは、現在のバイオシミラー、バイオベター、バイオスーペリア治療用タンパク質の研究開発動向を分析し、非タンパク質製品と認可薬剤の概要、および競合企業のプロジェクト内容をまとめ、概略以下の構成でお届けします。

第1章 赤血球生成促進剤 (ESA)

  • 規制市場における第1世代のエポエチン
  • 規制市場における第2世代のエポエチン
  • 規制市場におけるエポエチンバイオシミラー
  • 規制市場におけるダーベポエチンバイオシミラー
  • 規制市場における次世代生物学的赤血球生成促進剤(ESA)
  • 次世代小分子赤血球生成促進剤
  • 規制緩和市場における第1世代のEPO
  • 規制緩和市場におけるダーベポエチンバイオシミラー
  • 規制緩和市場における次世代生物学的ESA

第2章 G-CSF、GM-CSF

  • 規制市場における第1世代のブランドG-CSF製品
  • 規制市場における第1世代のバイオシミラーG-CSF製品
  • 規制市場における次世代G-CSF製品と使用
  • 規制市場における次世代バイオシミラーG-CSF製品と使用
  • 非規制市場における第1世代のG-CSF製品
  • 非規制市場における次世代G-CSF製品
  • 規制市場における第1世代および次世代のGM-CSF製品
  • 非規制市場における第1世代および次世代のGM-CSF製品

第3章 血小板産生促進剤(TPO-IL-11)

  • TPO-Rアクチベータ
  • IL-11アクチベータ
  • 小分子TPO作動薬

第4章 インターフェロン

  • インターフェロン・アルファ
  • コンセンサス・インターフェロン
  • インターフェロン・ベータ
  • インターフェロン・ガンマ
  • その他

第5章 インスリン

  • 規制市場におけるRecヒトインスリンの売上
  • 規制市場におけるRhuインスリン 他

第6章 凝固因子

  • 凝固因子
  • フィブリノゲン
  • その他

第7章 ヒト成長ホルモン

  • 第1世代:規制市場におけるソマトロピン
  • 第1世代:規制市場におけるバイオシミラーソマトロピン
  • 第2世代:規制市場におけるSR処方における注入型ソマトロピン 他

第8章 FSH、hCG、LH−生殖補助技術のための治療用タンパク質

  • FSH含有製品
  • 組み換えメノトロピン 他

第9章 血栓溶解剤・線維素溶解剤

  • 第1世代の線維素溶解剤 他

第10章 酵素置換促進治療

  • ゴーシェ病
  • ファブリー病
  • ポンペ病 他

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目次
Product Code: LMCA0009

The new Competitive Intelligence Report ‘Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors of May 2013’ provides a competitor analysis in the product portfolios and development pipelines of ten major classes of therapeutic proteins and their biosimilar and biobetter/biosuperior versions in regulated and less regulated markets:

  • Erythropoietin (EPO) & Erythropoiesis Stimulating Agents (ESA)
  • G-CSF & GM-CSF
  • Thrombopoietin & Thrombopoiesis Stimulating Agents
  • Interferon
  • Insulin
  • Coagulation Factors
  • Human Growth Hormone (hGH)
  • FSH, hCG and LH: Therapeutic Proteins for Assisted Reproductive Technology (ART)
  • Thrombolytics & Fibrinolytics
  • Enzyme Replacement Therapies

Territories covered are the major pharmaceutical markets North America, Europe and Japan, as well as South Korea, India, China and other countries in Latin America, Africa and Australasia.

With more than US$ 50 bln in sales, therapeutic proteins represent a major category of pharmaceutical products with established therapeutic value and high economic attractiveness. As more and more of the branded products are running out of patent protection and regulatory agencies are providing better guidance, development of biosimilar versions as well as of improved next generation versions are a highly attractive goal for pharmaceutical and biotechnology as well as technology focused companies.

This report includes a compilation of current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins as well as non-protein based competitor products and an overview of approved products in regulated and less regulated markets.

Competitor projects are listed in a tabular format providing Information on:

  • Drug Codes,
  • Target / Mechanism of Action,
  • Class of Compound,
  • Company,
  • Product Category,
  • Indication,
  • R&D Stage and
  • additional comments with a hyperlink leading to the source of information.

About Competitor Analysis Series:

The Competitor Analysis Series delivers NO-FRILLS, but concise information about the pipeline of R&D projects for targets, diseases, technologies and companies at low prices. The information is provided in a tabular format and fully referenced.

SAMPLE

Next generation biologic Eythropoiesis Stimulating Agents (ESA)
in regulated markets - IV

Table of Contents

1). Erythropoiesis Stimulating Agents (ESA)

  • First generation epoetins in regulated markets
  • Second generation epoetins in regulated markets
  • Epoetin biosimilars in regulated markets
  • Darbepoetin biosimilars in regulated markets
  • Next generation biologic Eythropoiesis Stimulating Agents (ESA) in regulated markets
  • Next generation small molecule Erythropoiesis Stimulating Agents
  • First generation EPO in less regulated markets (Latin America; Africa; Asia; RoW)
  • Darbepoietin biosimilars in less regulated markets
  • Next generation biologic ESAs in less regulated markets

2). G-CSF and GM-CSF

  • 2012 Sales of Branded G-CSF Products in Regulated Markets
  • 1st Generation Branded G-CSF Products in Regulated Markets
  • Biosimilar 1st Generation G-CSF Products in Regulated Markets
  • Next Generation Branded G-CSF Products in Regulated Markets
  • Biosimilar Next Generation G-CSF Products in Regulated Markets
  • 1st Generation G-CSF Products in Non-Regulated Markets: India
  • 1st Generation G-CSF Products in Non-Regulated Markets: China & Taiwan
  • 1st Generation G-CSF Products in Non-Regulated Markets - Korea
  • 1st Generation G-CSF Products in Non-Regulated Markets - Latin America
  • 1st Generation G-CSF Products in Non-Regulated Markets: Other Territories
  • Next Generation G-CSF Products in Non-Regulated Markets
  • 1st and Next Generation GM-CSF Products in Regulated Markets
  • 1st and Next Generation GM-CSF Products in Non-Regulated Markets

3). Thrombopoiesis-Stimulating Agents (TPO; IL-11)

  • Thrombopoietin receptor (TPO-R) activators
  • Interleukin-11 (IL-11) receptor activators
  • Small molecule TPO-R Agonists
  • Corporate TPO/IL-11 Receptor Agonist Product Portfolios and R&D Pipelines

4). Interferon

  • a). INTERFERON alpha
  • Interferon alpha sales 2012 of branded products in regulated markets
  • 1st generation Interferon alpha-2a in regulated markets
  • 1st generation Interferon alpha-2a in non-regulated markets
  • Next generation Interferon alpha-2a in regulated markets
  • Next generation Interferon alpha-2a in non-regulated markets and biosimilars
  • 1st generation Interferon alpha-2b in regulated markets
  • 1st generation Interferon alpha-2b in non-regulated markets and biosimilars
  • Next generation Interferon alpha-2b in regulated markets
  • Next generation Interferon alpha-2b in non-regulated markets and biosimilars
  • Other Interferon alpha sub-types
  • Interferon alpha with not specified sub-type - 1/2
  • Purified natural human interferon alpha
  • b). Consensus INTERFERONs
  • c). INTERFERON beta
  • Interferon beta sales 2012 of branded products in regulated markets
  • 1st generation Interferon beta-1a in regulated markets
  • 1st generation Interferon beta-1a in non-regulated markets and biosimilars
  • 1st generation Interferon beta-1b in regulated markets
  • 1st generation Interferon beta-1b in non-regulated markets and biosimilars
  • 1st generation Interferon beta with not disclosed sub-type
  • Next generation Interferon beta in regulated markets
  • Purified natural human interferon beta
  • d). INTERFERON gamma
  • e). Other INTERFERONs

5). Insulin

  • 2012 Sales of branded recombinant human insulins in regulated markets
  • 2012 Sales of branded short-acting recombinant human insulin analogs in regulated markets
  • 2012 Sales of branded long-acting recombinant human insulin analogs in regulated markets
  • Rhu insulin (2nd generation) in regulated markets
  • Biosimilar rhu insulin (2nd generation) in regulated markets
  • Rhu insulin analogs (3rd generation) in regulated markets
  • Biosimilar rhu insulin analogs (3rd generation) in regulated markets
  • Ultra-long acting rhu insulin formulations and insulin analogs (4th generation)
  • Ultra-fast acting rhu insulin formulations and insulin analogs (4th generation)
  • Combinations of modern basal and prandial insulin & analogs (4th generation)
  • Combinations of insulin & GLP-1 agonist (4th generation)
  • Other combinations with insulin
  • Oral and Transbuccal Insulins (5th generation)
  • Inhaled and transdermal insulin
  • Novel approaches for insulin therapy
  • Rhu insulin (2nd generation) in non-regulated markets: India
  • Rhu insulin (2nd generation) in non-regulated markets: China
  • Rhu insulin (2nd generation) in non-regulated markets: Other Territories
  • Modern insulin analogs (3rd generation) in non-regulated markets

6). Coagulation Factors

  • Sales of Recombinant Coagulation Factors for Hemophilia in 2012
  • Coagulation Factor VIII
  • Coagulation Factor IX
  • Coagulation Factor VII
  • Coagulation Factors for Willebrand Disease
  • Fibrinogen
  • Factors XI, X and XIII
  • Alternative Procoagulants & Adjuncts
  • Human Plasma-Derived Prothrombin Complex Concentrates
  • Gene Therapy of Hemophilia
  • Topical Human Plasma-Derived Fibrinogen and Thrombin Products
  • Topical Plasma-Derived Thrombin Products
  • Topical Recombinant Human Factor II (Prothrombin)
  • Alternative Topical Hemostats

7). Human Growth Hormone (hGH)

  • 2012 Sales of Branded Somatropin Products in Regulated Markets
  • 2012 Sales of Selected Somatropin Products in Non-Regulated Markets
  • 1st Generation: Somatropin in Regulated Markets
  • 1st Generation: Biosimilar Somatropin in Regulated Markets
  • 2nd Generation: Injectable Somatropin in Slow-release Formulation in Regulated Markets
  • 2nd Generation: Injectable Long-acting Somatropin in Regulated Markets
  • 2nd Generation: Injection-Free Somatropin in Regulated Markets
  • 1st Generation: Somatropin Products in Non-Regulated Markets
  • 2nd Generation: Injectable Long-Acting Somatropin Products in Non-Regulated Markets

8). FSH, hCG and LH - Assisted Reproductive Technology (ART)

  • Urinary FSH-Containing Products: Menotropins
  • Recombinant Menotropins
  • 1st Generation Purified Human Urinary FSH
  • 2nd Generation Recombinant Human FSH
  • Biosimilar Recombinant Human FSH
  • 2nd Generation Rhu FSH in Non-Regulated Markets
  • 3rd Generation Rhu FSH
  • Purified Urinary Human Choriogonadotropin (hCG)
  • Recombinant Human Choriogonadotropin (rhCG)
  • Recombinant Human Luteinizing Hormone (rhLH)
  • hCG Receptor Agonist

9). Thrombolytics & Fibrinolytics

  • Non-fibrin selective (1st generation) Fibrinolytics
  • Fibrin selective wild-type t-PA-based Fibrinolytics
  • Fibrin selective engineered t-PA-based Fibrinolytics
  • Non-t-PA-based Fibrinolytics
  • Plasmin-based Fibrinolytics
  • Adjunctive therapy to Fibrinolytics
  • Biosimilar Thrombolytics and Fibrinolytics in Non-Regulated Markets

10). Enzyme Replacement Therapies

  • Gaucher Disease
  • Fabry Disease
  • Pompé Disease
  • Hunter Disease (MPS II)
  • Niemann Pick Diseases
  • Mucopolysaccharidosis I (MPS I)
  • San Filippo Syndrome (MPS IIIA)
  • Morquio Syndrome (MPS IVA)
  • Mucopolysaccharidosis VI (MPS VI)
  • Tay-Sachs Disease
  • Chronic Deficiency of Adenosine Deaminase
  • Phenylketonuria / Hyperphenylalaninemia
  • Other Enzyme Replacement Therapies
  • Exocrine Pancreatic Insufficiency: Porcine-Derived ERT
  • Exocrine Pancreatic Insufficiency: Recombinant ERT
  • Others
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