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미국의 바이오시밀러 시장 : 투여량, 가격, 임상 파이프라인 전망

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

리서치사 KuicK Research
발행일 2019년 04월 상품 코드 822039
페이지 정보 영문 300 Pages
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미국의 바이오시밀러 시장 : 투여량, 가격, 임상 파이프라인 전망 US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025
발행일 : 2019년 04월 페이지 정보 : 영문 300 Pages

미국의 바이오시밀러(Biosimilars) 시장을 분석했으며, 시장의 기본 구조와 특성, 기술 개발 경위와 배경, 관련 규제 동향, 주요 파이프라인 제품(총 28종)과 임상시험 상황, 향후 시장 성장 및 기술 개발 방향성, 주요 기업 개요와 실적 전망 등의 정보를 정리하여 전해드립니다.

제1장 바이오시밀러 시장 개요

  • 바이오시밀러의 연혁과 발전
  • 세계의 바이오시밀러 시장 : 발전 동향

제2장 바이오시밀러의 공학적 배경

  • 제로에서의 설계
  • 바이오시밀러 개발
    • 품질
    • 비임상평가
    • 임상평가

제3장 바이오시밀러의 작용

제4장 바이오시밀러 관련 기술 혁신

  • 발현계의 개량
  • 용량 요건을 경감하기 위한 가격 인상
  • 분석 기술
  • 설계별 품질

제5장 바이오시밀러와 제네릭 의약품 : 다른가, 같은가?

제6장 미국의 바이오시밀러 시장 탄생

  • 시장 개요
  • 미국의 바이오시밀러 시장 : 파이프라인 제품 개요

제7장 바이오시밀러 개발 및 시장에 관한 FDA의 규칙과 규제

  • 인증에 필요한 데이터
  • 간략한 승인절차 요구
  • 바이오시밀러의 사용자 요금
  • 바이오시밀러 행동 플랜

제8장 2025년까지 특허가 만료되는 생물학적 제제

제9장 FDA 인증 바이오시밀러

제10장 미국 시장 - 인증/출시된 바이오시밀러 : 임상시험 동향, 가격, 투여량

  • 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)

제11장 미국 시장 - 인증/비출시 바이오시밀러

  • 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)

제12장 가격 인하 시도

  • 시장 경쟁 촉진
  • 독점기간 단축
  • 호환성
  • 외부 삽입법
  • 비용 효율적인 의료를 목표로 한 개혁

제13장 의료비 지불자 : 미국 바이오시밀러 시장의 안내 역할

제14장 미국의 바이오시밀러 시장 역학

  • 시장 성장 촉진요인
  • 극복해야 할 과제

제15장 미국의 바이오시밀러 시장 : PEST 분석

제16장 미국의 바이오시밀러 시장 : 향후 전망

제17장 미국 시장 - 바이오시밀러 임상시험 파이프라인 : 기업별, 증상별, 상(단계)별

  • 연구
  • 전임상
  • 임상시험
  • 제I상
  • 등록전
  • 등록완료

제18장 미국 시장 - 출시된 바이오시밀러의 임상 분석(기업별, 증상별)

  • 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

제19장 임상시험이 연기된 바이오시밀러 파이프라인 제품 : 기업별, 증상별, 상(相)별

  • 보고 없음
  • 중단
  • 연기

제20장 경쟁 환경

  • Alembic
  • Allergan
  • Aptevo Therapeutics
  • Biocon
  • Celltrion
  • Eli Lilly
  • MedImmune
  • Pfizer
  • Polpharma
  • Samsung Bioepis
  • Sandoz
  • Sanofi
  • Teva
LSH 19.04.26

"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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