Biosimilars and Follow-On Biologics Market Report 2024-2034
상품코드:1484115
리서치사:Visiongain
발행일:2024년 05월
페이지 정보:영문 391 Pages
라이선스 & 가격 (부가세 별도)
한글목차
세계의 바이오시밀러/팔로우 온 바이오로직스 시장 규모는 2034년까지 CAGR 14.8%로 성장할 것으로 예측되고 있습니다.
만성질환 치료제의 수요 증가 :
당뇨병, 류마티스 관절염, 각종 암과 같은 만성질환이 점점 더 증가하고 있으며, 효과적인 장기 치료의 필요성이 높아지고 있습니다. 이러한 급증은 고령화, 생활습관병 증가, 조기 발견 및 장기 치료를 가능하게 하는 의학의 발전 등 다양한 요인에 의해 촉진되고 있습니다.
질병의 메커니즘에 대한 이해가 깊어짐에 따라 바이오의약품은 의료 혁신의 최전선에 서서 이전에는 치료할 수 없었던 질환을 앓고 있는 환자들에게 희망을 가져다주고 있습니다. 또한 만성질환의 적극적인 관리를 옹호하는 의료계의 인식과 발전적인 정책은 바이오의약품에 대한 수요 증가에 더욱 기여하고 있습니다.
바이오시밀러 승인에 유리한 규제 정책 :
세계 규제 당국은 바이오시밀러가 품질, 안전성, 유효성에 대한 엄격한 기준을 충족하도록 보장하고, 바이오시밀러 승인을 위한 명확하고 투명한 경로를 확립하는 것이 중요하다는 것을 인식하고 있습니다.
유리한 규제 정책의 중요한 요소 중 하나는 바이오시밀러의 고유한 특성에 맞는 특정 가이드라인과 프레임워크를 수립하는 것입니다. 비교적 쉽게 복제할 수 있는 저분자 의약품과 달리, 바이오로직스는 살아있는 세포 내에서 생산되는 거대하고 복잡한 분자이기 때문에 개발 및 특성 평가가 더 어렵습니다. 규제 경로에서는 바이오시밀러 제조업체가 레퍼런스 바이오의약품의 기존 임상 데이터에 의존할 수 있도록 허용하고 있으며, 승인 절차가 빨라지는 반면, 유사성과 안전성을 입증하기 위해서는 견고한 비교 분석 연구와 임상시험이 필요합니다. 이 가이드라인은 명확한 기대치와 요구 사항을 제시함으로써 제조업체가 규제 프로세스를 보다 효율적이고 효과적으로 진행할 수 있도록 하여 바이오시밀러 개발 및 승인을 가속화할 수 있도록 돕습니다.
세계의 바이오시밀러/팔로우 온 바이오로직스 시장을 조사했으며, 시장 개요, 시장 성장에 대한 영향요인 및 시장 기회의 분석, 시장 규모의 추이·예측, 각종 구분·지역/주요 국가별의 상세 분석, 경쟁 구도, 주요 기업의 개요 등을 정리하여 전해드립니다.
목차
제1장 리포트의 개요
제2장 주요 요약
제3장 시장 개요
주요 조사 결과
시장 역학
시장 촉진요인
시장 억제요인
시장 기회
COVID-19의 영향 분석
바이오시밀러 매출 : 지역별
바이오시밀러 최신 승인 예정
최신 바이오시밀러 제품 거래
승인 바이오시밀러 리스트
최근 발매된 바이오시밀러 리스트
Porter's Five Forces 분석
PEST 분석
제4장 바이오시밀러/팔로우 온 바이오로직스 시장 분석 : 제품 유형별
주요 조사 결과
시장 매력 지수
시장 규모의 추이·예측
재조합 비당화 단백질
제품 유형별
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
인간성장호르몬
과립구집락자극인자(필그라스팀)
인슐린
인터페론
재조합 당화 단백질
제품 유형별
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
에리스로포이에틴
모노클로널 항체
Follitropin
저분자량 헤파린
제5장 바이오시밀러/팔로우 온 바이오로직스 시장 분석 : 용도별
주요 조사 결과
시장 매력 지수
시장 규모의 추이·예측
혈액
유형별
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
호중구감소증
빈혈
기타
종양
유형별
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
폐암
뇌종양
유방암
자궁경부암
대장암
백혈병
기타
자가면역질환
유형별
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
관절염
염증성장질환
건선
기타
성장호르몬 결핍증
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
당뇨병
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
기타
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
제6장 바이오시밀러/팔로우 온 바이오로직스 시장 분석 : 기술별
주요 조사 결과
시장 매력 지수
시장 규모의 추이·예측
재조합 DNA(rDNA) 기술
모노클로널 항체(MAb) 기술
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
제7장 바이오시밀러/팔로우 온 바이오로직스 시장 분석 : 제조업체별
주요 조사 결과
시장 매력 지수
시장 규모의 추이·예측
수탁 연구·수탁제조 서비스
사내
시장 규모의 추이·예측 : 지역별
시장 점유율 : 지역별
제8장 바이오시밀러/팔로우 온 바이오로직스 시장 분석 : 지역별
주요 조사 결과
시장 규모의 추이·예측
제9장 북미의 바이오시밀러/팔로우 온 바이오로직스 시장 분석
제10장 유럽의 바이오시밀러/팔로우 온 바이오로직스 시장 분석
제11장 아시아태평양의 바이오시밀러/팔로우 온 바이오로직스 시장 분석
제12장 라틴아메리카의 바이오시밀러/팔로우 온 바이오로직스 시장 분석
제13장 중동 및 아프리카의 바이오시밀러/팔로우 온 바이오로직스 시장 분석
제14장 기업 개요
경쟁 구도
전략적 전망
Amgen Inc.
Apotex(Apobiologix)
Biocad
Biocon Biologics Ltd.
Bio-Thera Solutions
Coherus Biosciences
Dr. Reddy's Laboratories
Fresenius Kabi(Fresenius SE &Co. KGaA)
Intas Pharma
Pfizer
Reliance Life Sciences
Samsung Bioepis(Samsung Biologics)
Sandoz Group AG
Teva Pharmaceuticals Industries Ltd.
제15장 결론·제안
Visiongain에 의한 결론
참여 기업에 대한 제안
KSA
영문 목차
영문목차
The global Biosimilars and Follow-on Biologics market is projected to grow at a CAGR of 14.8% by 2034
The Biosimilars and Follow-on Biologics Market Report 2024-2034: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.
Increasing Demand of Drugs For Treating Chronic Conditions
The increasing demand for drugs stems from their remarkable efficacy in treating a wide array of chronic and complex diseases, ranging from cancer to autoimmune disorders and beyond. Chronic conditions such as diabetes, rheumatoid arthritis, and various forms of cancer are becoming increasingly prevalent, driving up the need for effective long-term treatments. This surge is propelled by various factors, including the aging population, the prevalence of lifestyle-related ailments, and advancements in medical science enabling earlier detection and prolonged treatment.
As our understanding of disease mechanisms deepens, biologics continue to be at the forefront of medical innovation, offering hope for patients with previously untreatable conditions. Additionally, heightened awareness and evolving healthcare policies advocating proactive management of chronic illnesses further contribute to the increasing demand for these drugs.
Favourable regulatory policies for approval of biosimilars
Regulatory agencies around the world have recognized the importance of establishing clear and transparent pathways for the approval of biosimilars, ensuring that these products meet stringent standards of quality, safety, and efficacy.
One of the key elements of favourable regulatory policies is the establishment of specific guidelines and frameworks tailored to the unique characteristics of biosimilars. Unlike small molecule drugs, which can be replicated with relative ease, biologics are large, complex molecules produced in living cells, making their development and characterization more challenging. Regulatory pathways allow biosimilar manufacturers to rely on existing clinical data for reference biologics, expediting the approval process while still requiring robust comparative analytical and clinical studies to demonstrate similarity and safety. By providing clear expectations and requirements, these guidelines enable manufacturers to navigate the regulatory process more efficiently and effectively, accelerating the development and approval of biosimilars.
Moreover, favourable regulatory policies include provisions to expedite the review and approval of biosimilar products, fostering competition and expanding patient access to affordable treatments. Regulatory agencies may employ mechanisms such as abbreviated pathways or priority review designations to streamline the approval process for biosimilars, particularly for products targeting diseases with significant unmet medical needs. These expedited pathways help bring biosimilar products to market more quickly, encouraging innovation and investment in the biosimilars space.
What Questions Should You Ask before Buying a Market Research Report?
How is the Biosimilars and Follow-on Biologics Market evolving?
What is driving and restraining the Biosimilars and Follow-on Biologics Market?
How will each Biosimilars and Follow-on Biologics submarket segment grow over the forecast period and how much revenue will these submarkets account for in 2034?
How will the market shares for each Biosimilars and Follow-on Biologics submarket develop from 2024 to 2034?
What will be the main driver for the overall market from 2024 to 2034?
Will leading Biosimilars and Follow-on Biologics Markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
How will the market shares of the national markets change by 2034 and which geographical region will lead the market in 2034?
Who are the leading players and what are their prospects over the forecast period?
What are the Biosimilars and Follow-on Biologics projects for these leading companies?
How will the industry evolve during the period between 2024 and 2034? What are the implications of Biosimilars and
Follow-on Biologics projects taking place now and over the next 10 years?
Is there a greater need for product commercialisation to further scale the Biosimilars and Follow-on Biologics Market?
Where is the Biosimilars and Follow-on Biologics Market heading and how can you ensure you are at the forefront of the market?
What are the best investment options for new product and service lines?
What are the key prospects for moving companies into a new growth path and C-suite?
You need to discover how this will impact the Biosimilars and Follow-on Biologics market today, and over the next 10 years:
Our 391-page report provides 156 tables and 200 charts/graphs exclusively to you.
The report highlights key lucrative areas in the industry so you can them - NOW.
It contains in-depth analysis of global, regional and national sales and growth.
It highlights for you the key successful trends, changes and revenue projections made by your competitors.
This report tells you TODAY how the Biosimilars and Follow-on Biologics Market will develop in the next 10 years, and in line with the variations in COVID-19 economic recession and bounce. This market is more critical now than at any point over the last 10 years.
Forecasts to 2034 and other analyses reveal commercial prospects
In addition to revenue forecasting to 2034, our new study provides you with recent results, growth rates, and market shares.
You will find original analyses, with business outlooks and developments.
Discover qualitative analyses (including market dynamics, drivers, opportunities, restraints and challenges), cost structure, impact of rising Biosimilars and Follow-on Biologics prices and recent developments.
This report includes data analysis and invaluable insight into how COVID-19 will affect the industry and your company. Four COVID-19 recovery patterns and their impact, namely, "V", "L", "W" and "U" are discussed in this report.
In addition to the revenue predictions for the overall world market and segments, you will also find revenue forecasts for four regional and 27 leading national markets:
North America
U.S.
Canada
Europe
Germany
UK
France
Spain
Italy
Russia
Poland
Belgium
Rest of Europe
Asia Pacific
China
Japan
India
Australia
South Korea
Singapore
Taiwan
Rest of Asia Pacific
Latin America
Brazil
Mexico
Argentina
Colombia
Rest of Latin America
MEA
GCC
South Africa
Rest of MEA
The report also includes profiles and for some of the leading companies in the Biosimilars and Follow-on Biologics Market, 2024 to 2034, with a focus on this segment of these companies' operations.
Leading companies profiled in the report
Amgen Inc.
Apotex (Apobiologix)
Biocad
Biocon Biologics Ltd.
Bio-Thera Solutions
Coherus Biosciences
Dr. Reddy's Laboratories
Fresenius Kabi (Fresenius SE & Co. KGaA)
Intas Pharma
Pfizer
Reliance Life Sciences
Samsung Bioepis (Samsung Biologics)
Sandoz Group AG
Teva Pharmaceuticals Industries Ltd.
Overall world revenue for Biosimilars and Follow-on Biologics Market, 2024 to 2034 in terms of value the market will surpass US$33,000 million in 2024, our work calculates. We predict strong revenue growth through to 2034. Our work identifies which organizations hold the greatest potential. Discover their capabilities, progress, and commercial prospects, helping you stay ahead.
How will the Biosimilars and Follow-on Biologics Market, 2024 to 2034 report help you?
In summary, our 390+ page report provides you with the following knowledge:
Revenue forecasts to 2034 for Biosimilars and Follow-on Biologics Market, 2024 to 2034, with forecasts for product type, application, technology and manufacturer each forecast at a global and regional level - discover the industry's prospects, finding the most lucrative places for investments and revenues.
Revenue forecasts to 2034 for five regional and 28 key national markets - See forecasts for the Biosimilars and Follow-on Biologics Market, 2024 to 2034 market in North America, Europe, Asia-Pacific, Latin America, and MEA. Also forecasted is the market in the US, Canada, Mexico, Brazil, Argentina, Germany, France, UK, Spain, Italy, Russia, Poland, Belgium, China, India, Japan, Australia, South Korea, Singapore, Taiwan, GCC, and South Africa among other prominent economies.
Prospects for established firms and those seeking to enter the market - including company profiles for 14 of the major companies involved in the Biosimilars and Follow-on Biologics Market, 2024 to 2034.
Find quantitative and qualitative analyses with independent predictions. Receive information that only our report contains, staying informed with invaluable business intelligence.
Information found nowhere else
With our new report, you are less likely to fall behind in knowledge or miss out on opportunities. See how our work could benefit your research, analyses, and decisions. Visiongain's study is for everybody needing commercial analyses for the Biosimilars and Follow-on Biologics Market, 2024 to 2034, market-leading companies. You will find data, trends and predictions.
Table of Contents
1 Report Overview
1.1 Objectives of the Study
1.2 Introduction to Biosimilars and Follow-On Biologics Market
1.3 What This Report Delivers
1.4 Why You Should Read This Report
1.5 Key Questions Answered by This Analytical Report
1.6 Who is This Report for?
1.7 Methodology
1.7.1 Market Definitions
1.7.2 Market Evaluation & Forecasting Methodology
1.7.3 Data Validation
1.7.3.1 Primary Research
1.7.3.2 Secondary Research
1.8 Frequently Asked Questions (FAQs)
1.9 Associated Visiongain Reports
1.10 About Visiongain
2 Executive Summary
3 Market Overview
3.1 Key Findings
3.2 Market Dynamics
3.2.1 Market Driving Factors
3.2.1.1 Expiration of Patents for Original Biologics in the recent years
3.2.1.2 Increasing Incidence of Chronic Diseases
3.2.1.3 Established Clear Guidelines for the Approval of Biosimilars
3.2.2 Market Restraining Factors
3.2.2.1 High Development Costs of follow-on biologics
3.2.2.2 Lack of Interchangeability Between Biosimilars and Their Reference Biologics
3.2.2.3 Intellectual Property Issues and Other Legal Challenges
3.2.3 Market Opportunities
3.2.3.1 Development of Biosimilar Versions of Monoclonal Antibodies
3.2.3.2 Growing Demand for Affordable Biologics in Emerging Markets
3.2.3.3 Expanding the Portfolio of Biosimilars for Rare Diseases
3.3 COVID-19 Impact Analysis
3.4 Biosimilars Revenue by Region
3.4.1 Worldwide
3.4.2 United States
3.4.3 Japan
3.5 Biosimilars Latest Expected Approvals
3.5.1 United States
3.5.2 Europe
3.6 Latest Biosimilar Product Deals
3.7 List of Approved Biosimilars
3.8 List of Recently Launched Biosimilars
3.9 Porter's Five Forces Analysis
3.9.1 Bargaining Power of Suppliers
3.9.2 Bargaining Power of Buyers
3.9.3 Competitive Rivalry
3.9.4 Threat of Substitutes
3.9.5 Threat of New Entrants
3.10 PEST Analysis
4 Biosimilars and Follow-On Biologics Market Analysis by Product Type
4.1 Key Findings
4.2 Product Type Segment: Market Attractiveness Index
4.3 Biosimilars and Follow-On Biologics Market Size Estimation and Forecast by Product Type
4.4 Recombinant Non-Glycosylated Proteins
4.4.1 Recombinant Non-Glycosylated Proteins Market by Product Type
4.4.2 Market Size by Region, 2024-2034 (US$ Million)
4.4.3 Market Share by Region, 2024 & 2034 (%)
4.4.4 Human Growth Hormone
4.4.4.1 Market Size by Region, 2024-2034 (US$ Million)
