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市場調查報告書

美國Biosimilar市場:劑量、價格、臨床Pipeline展望

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

出版商 KuicK Research 商品編碼 822039
出版日期 內容資訊 英文 300 Pages
商品交期: 最快1-2個工作天內
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美國Biosimilar市場:劑量、價格、臨床Pipeline展望 US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025
出版日期: 2019年04月12日內容資訊: 英文 300 Pages
簡介

本報告分析美國國內Biosimilar市場,彙整市場基本結構和特性、技術開發歷史和背景、相關法規動向、主要Pipeline產品 (共28種) 和其臨床試驗情況、未來市場成長、技術開發方向,並提供主要企業簡介和業績展望等情報。

第1章 Biosimilar市場概要

  • Biosimilar歷史和發展
  • 全球Biosimilar市場:發展趨勢

第2章 Biosimilar背後的工程

  • 從零開始的設計
  • Biosimilar開發
    • 品質
    • 非臨床評估
    • 臨床評估

第3章 Biosimilar作用

第4章 Biosimilar相關技術創新

  • 表現系統的改善
  • 提升效價以減少容量需求
  • 分析技術
  • 設計品質

第5章 Biosimilar和學名藥:不同?還是相同?

第6章 美國Biosimilar市場的誕生

  • 市場概要
  • 美國Biosimilar市場:Pipeline產品概要

第7章 Biosimilar開發和市場相關之FDA規範及條例

  • 核准所需資料
  • 簡化核准手續的需求
  • Biosimilar使用者費用
  • Biosimilar行動計畫

第8章 2025年前專利到期的生物製劑

第9章 FDA (美國食品藥物管理局) 核准Biosimilar

第10章 美國市場 - 已核准上市Biosimilar:臨床試驗趨勢、價格、劑量

  • Retacrit (epoetin alfa-epbx)
  • Zarxio (filgrastim-sndz)
  • Nivestym (filgrastim-aafi)
  • Granix (tbo-filgrastim)
  • Inflectra (infliximab-dyyb)
  • Renflexis (infliximab-abda)
  • Fulphila (pegfilgrastim-jmdb)
  • Udenyca (pegfilgrastim-cbqv)

第11章 美國市場 - 已核准未上市Biosimilar

  • Trazimera (trastuzumab-qyyp)
  • Amjevita (adalimumab-atto)
  • Cyltezo (adalimumab-adbm)
  • Hyrimoz (adalimumab-adaz)
  • Mvasi (bevacizumab-awwb)
  • Erelzi (etanercept-szzs)
  • Ixifi (infliximab-qbtx)
  • Truxima (rituximab-abbs)
  • Ogivri (trastuzumab-dkst)
  • Herzuma (trastuzumab-pkrb)
  • Ontruzant (trastuzumab-dttb)

第12章 嘗試降低價格

  • 促進市場競爭
  • 縮短排他期間
  • 互換性
  • 外插法
  • 目標成為有成本效益的醫療改革

第13章 支付醫療費用者:美國Biosimilar市場招待人

第14章 美國Biosimilar市場動態

  • 市場推動因素
  • 跨越阻礙

第15章 美國Biosimilar市場:PEST分析

第16章 美國Biosimilar市場:未來展望

第17章 美國市場 - Biosimilar臨床試驗Pipeline:按企業、按症狀、按階段

  • 研究
  • 臨床前
  • 臨床
  • Phase-I
  • 預註冊
  • 已註冊

第18章 美國市場 - 已上市Biosimilar臨床分析 (按企業、按症狀)

  • Adalimumab (Humira & Raheara)
  • Insulin Glargine Biosimilar (Abasaglar、Abasria、Basaglar)
  • Somatropin Biosimilar (Omnitrope、PrOmnitrope)
  • Insulin Lispro Biosimilar (Admelog、Insulin lispro Sanofi)
  • Trenonacog Alfa (IXINITY)
  • Pegfilgrastim Biosimilar - Biocon/Mylan
  • Infliximab Biosimilar (Flixabi & RENFLEXIS)
  • Bevacizumab Biosimilar (Mvasi)
  • Desvenlafaxine - Extended Release - Alembic

第19章 臨床試驗延期中的Biosimilar、Pipeline產品:按企業、按症狀、按階段

  • 未報告動向
  • 中止
  • 延期中

第20章 競爭環境

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

"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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