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市場調査レポート

米国のバイオシミラー市場:投与量・価格・臨床パイプラインの展望

US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025

発行 KuicK Research 商品コード 822039
出版日 ページ情報 英文 300 Pages
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米国のバイオシミラー市場:投与量・価格・臨床パイプラインの展望 US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025
出版日: 2019年04月12日 ページ情報: 英文 300 Pages
概要

当レポートでは、米国国内のバイオシミラー市場について分析し、市場の基本構造や特性、技術開発の経緯や背景事情、関連規制の動き、主なパイプライン製品 (全28種) とその治験状況、今後の市場成長・技術開発の方向性、主要企業のプロファイルと業績見通し、といった情報を取りまとめてお届けいたします。

第1章 バイオシミラー市場の概要

  • バイオシミラーの沿革と発展
  • 世界のバイオシミラー市場:発展動向

第2章 バイオシミラーの工学的背景

  • ゼロからの設計
  • バイオシミラーの開発
    • 品質
    • 非臨床評価
    • 臨床評価

第3章 バイオシミラーの作用

第4章 バイオシミラー関連の技術革新

  • 発現系の改良
  • 容量要件を軽減するための力価引き上げ
  • 分析技術
  • 設計ごとの品質

第5章 バイオシミラーとジェネリック医薬品:違うのか、同じなのか?

第6章 米国のバイオシミラー市場の誕生

  • 市場概要
  • 米国のバイオシミラー市場:パイプライン製品の概要

第7章 バイオシミラーの開発・市場に関する、FDAの規則・規制

  • 認証に必要なデータ
  • 簡略承認手続のニーズ
  • バイオシミラーのユーザー料金
  • バイオシミラーのアクションプラン

第8章 2025年までに特許満了となる生物製剤

第9章 FDA (連邦食品医薬品局) 認証済みのバイオシミラー

第10章 米国市場 - 認証・上市済みバイオシミラー:治験動向、価格、投与量

  • Retacrit (エポエチンアルファ - epbx)
  • Zarxio (フィルグラスチム - sndz)
  • Nivestym (フィルグラスチム - aafi)
  • Granix (tbo - フィルグラスチム)
  • Inflectra (インフリキシマブ - dyyb)
  • Renflexis (インフリキシマブ - abda)
  • Fulphila (ペグフィルグラスチム - jmdb)
  • Udenyca (ペグフィルグラスチム - cbqv)

第11章 米国市場 - 認証済み・非上市のバイオシミラー

  • Trazimera (トラスツズマブ - qyyp)
  • Amjevita (アダリムマブ - atto)
  • Cyltezo (アダリムマブ - adbm)
  • Hyrimoz (アダリムマブ - adaz)
  • Mvasi (ベバシズマブ - awwb)
  • Erelzi (エタネルセプト - szzs)
  • Ixifi (インフリキシマブ - qbtx)
  • Truxima (リツキシマブ - abbs)
  • Ogivri (トラスツズマブ - dkst)
  • Herzuma (トラスツズマブ - pkrb)
  • Ontruzant (トラスツズマブ - dttb)

第12章 価格引き下げの試み

  • 市場競争の促進
  • 独占期間の短縮
  • 互換性
  • 外挿法
  • コスト効率的な医療を目指した改革

第13章 医療費支払者:米国のバイオシミラー市場の案内役

第14章 米国のバイオシミラー市場のダイナミクス

  • 市場促進要因
  • 超えるべき課題

第15章 米国のバイオシミラー市場:PEST分析

第16章 米国のバイオシミラー市場:将来展望

第17章 米国市場 - バイオシミラーの治験パイプライン:企業別、症状別、相 (フェーズ) 別

  • 研究
  • 前臨床
  • 治験
  • 第I相
  • 登録前
  • 登録済み

第18章 米国市場 - 上市済みバイオシミラーの臨床面での分析 (企業別・症状別)

  • アダリムマブ (Humira & Raheara)
  • インスリングラルギンのバイオシミラー (Abasaglar、Abasria、Basaglar)
  • ソマトロピンのバイオシミラー (Omnitrope、PrOmnitrope)
  • インスリンリスプロのバイオシミラー (Admelog、Insulin lispro Sanofi)
  • トレノナコグアルファ (IXINITY)
  • ペグフィルグラスチムのバイオシミラー - Biocon/Mylan
  • インフリキシマブのバイオシミラー (Flixabi & RENFLEXIS)
  • ベバシズマブのバイオシミラー (Mvasi)
  • 徐放性デスベンラファキシン - Alembic

第19章 治験延期中のバイオシミラー・パイプライン製品:企業別・症状別・相別

  • 何の動向も報告されなかったもの
  • 中断
  • 延期中

第20章 競争環境

  • Alembic
  • Allergan
  • Aptevo Therapeutics
  • Biocon
  • Celltrion
  • Eli Lilly
  • MedImmune
  • Pfizer
  • Polpharma
  • Samsung Bioepis
  • Sandoz
  • Sanofi
  • Teva
目次

"US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025" Report Highlights:

  • US Biosimilar Market Current Scenario
  • US Biosimilars Clinical Pipeline by Company, Indication & Phase: 28 Biosimilars
  • Marketed Biosimilars Clinical Insight by Company & Indication: 9 Biosimilars
  • Biosimilars Market Opportunity: US$ 5 Billion
  • FDA Rules & Regulations For Biosimilars Development & Market
  • Approved & Marketed Biosimilars: Clinical Insight, Price & Dosage

"US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025" report gives comprehensive insight on clinical and non-clinical issues involved in the development of biosimilars market in US. Report highlights the ongoing market trends and initiatives undertaken by various stake holders to advance the approval and commercialization of biosimilars in the US pharmaceutical market.

Biosimilars have started gaining attention worldwide as they are cheaper but equally effective than their original product. Biosimilars cost lesser than biologics as they take less time to develop and go through only four stages of testing - analytical, non-clinical, clinical pharmacology and clinical studies. Biosimilars are not similar or same as generic drugs due to difference in their physiochemical properties.

Globally they are at different stages of progression with respect to adoption of biosimilars in main stream pharmaceutical market. Although European market is the most mature market in comparison to US market but it is catching up to speed. Total of 19 biosimilars have been approved by FDA since 2014, but only 9 biosimilars have been able to make it to the market as of 2019. The most recent approved biosimilar is Trazimera of Pfizer (March 11, 2019).

Most successful biosimilar in the US market has been Sandoz's Zarxio. It captured more market than Inflectra. Biosimilars market has a bright future. The market has the potential to grow faster if some of the issues like interchangeability status, extrapolation, shortening exclusivity period etc. are solved. In addition, market competition needs to be promoted.

Currently, US biosimilars market is at the interim state. With most of the biologic products going off patent by 2025 and increasing rate of patients suffering from chronic diseases. The biosimilars market has a huge opportunity to spread it swings in the US drug market. With few reforms and education to the stakeholders this goal is achievable. The US biosimilar market will continue to evolve and grow exponentially but with small degree of uncertainty. The regulatory authorities need to form a more concrete framework to keep these grey areas of the biosimilar market in check. This, accompanied with education of physicians/patients to speed market uptake, new development and commercial paradigms can provide the proper platform for developing new commercially successful biosimilars.

Table of Contents

1. Overview Of Biosimilars Market

  • 1.1 History & Evolution Of Biosimilars
  • 1.2 Global Biosimilars Market: Flourishing

2. Engineering Behind Biosimilars

  • 2.1 Designing From Scratch
  • 2.2 Developing Biosimilars
    • 2.2.1 Quality
    • 2.2.2 Nonclinical Evaluation
    • 2.2.3 Clinical Evaluation

3. Working of Biosimilars

4. Technical Innovations In Biosimilars

  • 4.1 Improved Expression Systems
  • 4.2 Higher Titers To Reduce Capacity Requirements
  • 4.3 Analytical Technology
  • 4.4 Quality By Design

5. Biosimilars & Generics : Different Or Same?

6. Budding US Biosimilar Market

  • 6.1 Market Overview
  • 6.2 US Biosimilar Pipeline Overview

7. FDA Rules & Regulations For Biosimilars Development & Market

  • 7.1 Data Required For Approval
  • 7.2 Need For Abbreviated Approval Pathway
  • 7.3 Biosimilar User Fees
  • 7.4 Biosimilars Action Plan

8. Biologics Coming Off Patent by 2025

9. FDA Approved Biosimilars

10. US - Approved & Marketed Biosimilars: Clinical, Price & Dosage

  • 10.1 Retacrit (epoetin alfa-epbx)
  • 10.2 Zarxio (filgrastim-sndz)
  • 10.3 Nivestym (filgrastim-aafi)
  • 10.4 Granix (tbo-filgrastim)
  • 10.5 Inflectra (infliximab-dyyb)
  • 10.6 Renflexis (infliximab-abda)
  • 10.7 Fulphila (pegfilgrastim-jmdb)
  • 10.8 Udenyca (pegfilgrastim-cbqv)

11. US - Approved Not Marketed Biosimilars

  • 11.1 Trazimera (trastuzumab-qyyp)
  • 11.2 Amjevita (adalimumab-atto)
  • 11.3 Cyltezo (adalimumab-adbm)
  • 11.4 Hyrimoz (adalimumab-adaz)
  • 11.5 Mvasi (bevacizumab-awwb)
  • 11.6 Erelzi (etanercept-szzs)
  • 11.7 Ixifi (infliximab-qbtx)
  • 11.8 Truxima (rituximab-abbs)
  • 11.9 Ogivri (trastuzumab-dkst)
  • 11.10 Herzuma (trastuzumab-pkrb)
  • 11.12 Ontruzant (trastuzumab-dttb)

12. Tackling the High Price

  • 12.1 Promote Competition
  • 12.2 Shortening Exclusivity Period
  • 12.3 Interchangeability
  • 12.4 Extrapolation
  • 12.5 Reforms for Cost Effective Drug

13. Payers: Concierge to US Biosimilar Market

14. US Biosimilar Market Dynamics

  • 14.1 Market Drivers
  • 14.2 Hurdles To Cross

15. US Biosimilar Market PEST Analysis

16. US Biosimilar Market Future Prospects

17. US - Biosimilars Clinical Pipeline by Company, Indication & Phase

  • 17.1 Research
  • 17.2 Preclinical
  • 17.3 Clinical
  • 17.4 Phase-I
  • 17.5 Preregistration
  • 17.6 Registered

18. US - Marketed Biosimilars Clinical Insight by Company & Indication

  • 18.1 Adalimumab (Humira & Raheara)
  • 18.2 Insulin Glargine Biosimilar (Abasaglar, Abasria & Basaglar)
  • 18.3 Somatropin Biosimilar (Omnitrope & PrOmnitrope)
  • 18.4 Insulin Lispro Biosimilar (Admelog & Insulin lispro Sanofi)
  • 18.5 Trenonacog Alfa (IXINITY)
  • 18.6 Pegfilgrastim Biosimilar - Biocon/Mylan
  • 18.7 Infliximab Biosimilar (Flixabi & RENFLEXIS)
  • 18.8 Bevacizumab Biosimilar (Mvasi)
  • 18.9 Desvenlafaxine - Extended Release - Alembic

19. Suspended Biosimilars in Clinical Pipeline by Company, Indication & Phase

  • 19.1 No Development Reported
  • 19.2 Discontinued
  • 19.3 Suspended

20. Competitve Landscape

  • 20.1 Alembic
  • 20.2 Allergan
  • 20.3 Aptevo Therapeutics
  • 20.4 Biocon
  • 20.5 Celltrion
  • 20.6 Eli Lilly
  • 20.7 MedImmune
  • 20.8 Pfizer
  • 20.9 Polpharma
  • 20.10 Samsung Bioepis
  • 20.11 Sandoz
  • 20.12 Sanofi
  • 20.13 Teva

List of Figures

  • Figure 1-1: Geographic Division Of Biosimilar Market
  • Figure 1-2: Global - Biosimilars Market Share (%), 2018
  • Figure 2-1: Sources Of Variation Between Biosimilar Productions
  • Figure 2-2: Phases Of Biosimilar Development
  • Figure 2-3: Stages Of Comparability Exercise
  • Figure 2-4: New Drug Development: Cost & Time Comparison
  • Figure 3-1: Working Of Biosimilar On Active Rheumatoid Arthritis
  • Figure 4-1: Technology Needed For Cost Effectiveness Of Biosimilars
  • Figure 6-1: US - Filgrastim Market Share (%), 2018
  • Figure 6-2: US - Infliximab Market Share (%), 2018
  • Figure 6-3: US - Biosimilar Clinical Pipeline By Phase (%), 2019 till 2025
  • Figure 6-4: US - Biosimilar Clinical Pipeline By Phase (Number), 2019 till 2025
  • Figure 6-5: US - Biosimilar Discontinued in Clinical Pipeline By Phase (%),2019 till 2025
  • Figure 6-6: US - Biosimilar Discontinued in Clinical Pipeline By Phase (Number), 2019 till 2025
  • Figure 10-1: FDA Approved Biosimilars: Marketed
  • Figure 10-2: US - Cost Of 10 ml Retacrit In Different Concentration (US$), March'2019
  • Figure 10-3: US - Price Comparison In Different Concentration Of Zarxio & Neupogen (US$)
  • Figure 10-4: US - Cost Of Zarxio In Concentration - 300mgc/0.5 ml & 480mgc/0.8 ml (US$)
  • Figure 10-5: Wholesale Acquisition Cost Of Zarxio, Neupogen & Nivestym - 480mcg/ 0.8 ml (US$)
  • Figure 10-6: US - Cost Of Nivestym In Different Concentration (300mcg/0.5ml, 480mgc/0.8ml) (US$)
  • Figure 10-7: US - Cost Of 300 mcg Syringe & Vial Of Granix (US$)
  • Figure 10-8: US - Cost Of 480 mcg Syringe & Vial Of Granix (US$)
  • Figure 10-9: US - Cost Of Inflectra & Remicade For Injection dyyb 100 mg Powder (US$)
  • Figure 10-10: Global - Sale Of Inflectra & Remicade In 2017 (US$ Billions)
  • Figure 10-11: US - Sale Of Inflectra & Remicade In 2018 (US$ Billions)
  • Figure 10-12: US - Cost Difference Between Renflexis & Remicade (US$)
  • Figure 10-13: US - Cost Difference Between Renflexis & Inflectra (US$)
  • Figure 10-14: US - US - WAC Of Udenyca & Neulasta (US$)
  • Figure 10-15: US - WAC Of Udenyca & Neulasta (US$)
  • Figure 10-16: US - Cost Difference Between Udenyca, Fulphila, Neulasta For 6mg/0.6mL (US$)
  • Figure 11-1: US - Market Share Of Amjevita & Humira By 2032 (%)
  • Figure 11-2: US - WAC of Mvasi & Avastin (US$)
  • Figure 13-1: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (US$ Million), 2018 - 2025
  • Figure 13-2: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (US$ Million), 2018
  • Figure 13-3: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (%), 2018
  • Figure 13-4: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (US$ Million), 2025
  • Figure 13-5: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (%), 2025
  • Figure 13-6: Payers Strategies On Handling Biosimilars.
  • Figure 13-7: US - Health Care Expenditure By Out of Pocket & Health Insurance (US$ Million), 2018
  • Figure 13-8: US - Health Care Expenditure By Out of Pocket & Health Insurance (%), 2018
  • Figure 13-9: US - Health Care Expenditure By Out of Pocket & Health Insurance (US$ Million), 2025
  • Figure 13-10: US - Health Care Expenditure By Out of Pocket & Health Insurance (US$ Million), 2025
  • Figure 14-1: Main Therapeutics Areas Of Biosimilar Development (%), 2016
  • Figure 14-2: US - Share of generic and innovator products in small molecule and large molecule market (%)
  • Figure 15-1:PEST Analysis Of The Biosimilar Market
  • Figure 16-1: US - Biosimilar Market Opportunity(US$ Billion), 2019 - 2025
  • Figure 16-2: Global - GDP Expenditure On Healthcare (%), 2017
  • Figure 16-3: US - Savings by Biosimilar Molecule Class

List of Tables

  • Table 5-1: Difference Between Generics & Biosimilars
  • Table 8-1: US - Coming Off Patent Biologicals: Humanized Antibody
  • Table 8-2: US - Coming Off Patent Biologicals: Not Humanized Antibody
  • Table 8-3: US - Coming Off Patent Biologicals: Not Antibodies
  • Table 9-1: List Of All The FDA Approved Biosimilars
  • Table 10-1: US - Recommended Dosing of Retacrit For Patients With Chronic Kidney Disease (CKD)
  • Table 10-2: US - Recommended Dosing Of Retacrit For Zidovudine-Treated Patients With HIV Infection
  • Table 10-3: US - Recommended Dosing Of Retacrit For Patients Undergoing Cancer Chemotherapy
  • Table 10-4: US - Recommended Dosing Of Retacrit For Patients Undergoing Elective, Non-Cardiac, Non-Vascular Surgery
  • Table 10-5: US - Recommended Dosage Of Zarxio For Cancer Patients Receiving Myelosuppressive Chemotherapy Or Induction &/or Consolidation Chemotherapy For AML
  • Table 10-6: US - Recommended Dosage Of Zarxio For Cancer Patients Undergoing Bone Marrow Transplantation
  • Table 10-7: US - Recommended Dosage Of Zarxio For Cancer Patients Undergoing Autologous PBPC Collection & Therapy
  • Table 10-8: US - Recommended Dosage Of Zarxio For Patients With Severe Chronic Neutropenia
  • Table 10-9: US - Recommended Dosage Of Nivestym For Cancer Patients Receiving Myelosuppressive Chemotherapy Or Induction &/Or Consolidation Chemotherapy For AML
  • Table 10-10: US - Recommended Dosage Of Nivestym For Cancer Patients Undergoing Bone Marrow Transplantation
  • Table 10-11: US - Recommended Dosage Of Nivestym For Cancer Patients Undergoing Autologous PBPC Collection & Therapy
  • Table 10-12: US - Recommended Dosage Of Nivestym For Patients & Severe Chronic Neutropenia
  • Table 10-13: Indications For Inflectra
  • Table 10-14: US - Recommended dosage Of Inflectra For Different Indications
  • Table 10-15: Indications of Renflexis
  • Table 10-16: US - Recommended Dosage Of Renflexis In Different Diseases
  • Table 10-17: US - Recommended Dosage of Fulphila For Different Indications
  • Table 10-18: US - Recommended Dosage of Udenyca For Different Indications
  • Table 11-1: US - Recommended Dosage Of Trazimera For Different Indications
  • Table 11-2: Indications of Amjevita
  • Table 11-3: US - Recommended Dosage Of Amjevita For Different Indications
  • Table 11-4: Indications of Cyltezo
  • Table 11-5: --US - Recommended Dosage Of Cyltezo For Different Indications
  • Table 11-6: Indications of Hyrimoz
  • Table 11-7: US - Recommended Dosage Of Hyrimoz For Different Indications
  • Table 11-8: Indications of Mvasi
  • Table 11-9: US - Recommended Dosage Of Mvasi For Different Indications
  • Table 11-10: US - Recommended Dosage Of Erelzi For Different Indications
  • Table 11-11: Indications of Ixifi
  • Table 11-12: US - Recommended Dosage Of Ixifi For Different Indications
  • Table 11-13: US - Recommended Dosage Of Ogivri For Different Indications
  • Table 11-14: US - Recommended Dosage Of Herzuma For Different Indications
  • Table 11-15: US - Recommended Dosage Of Ontruzant For Different Indications
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