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바이오시밀러 시장 분석 및 예측(-2034년) : 유형, 제품, 용도, 최종 사용자, 기술, 프로세스, 구성 요소, 단계, 서비스, 디바이스
Biosimilars Market Analysis and Forecast to 2034: Type, Product, Application, End User, Technology, Process, Component, Stage, Services, Device
상품코드 : 1762088
리서치사 : Global Insight Services
발행일 : 2025년 07월
페이지 정보 : 영문 390 Pages
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한글목차

바이오시밀러 시장은 2024년 240억 달러에서 2034년까지는 1,177억 달러로 확대되며 약 17.3%의 연평균 복합 성장률(CAGR)을 나타낼 전망입니다. 시장에는 이미 승인된 기준 제품과 유사성이 높고, 안전성과 효능에 임상적으로 의미가 있는 차이가 없는 생물학적 제제가 포함되어 있습니다. 비용 효율적, 저렴한 의료 솔루션에 대한 수요가 증가하고 있습니다.

업계 개요

바이오시밀러 시장은 세계의 관세, 지정학적 긴장, 진화하는 공급망 역학 등 복잡한 정세를 극복하고 있습니다. 영향을 완화하고 외국제 생물제제에 대한 의존을 줄이고 있습니다. 한편, 미국과 중국의 마찰 속에서 지정학적 취약성에 직면하고 있습니다. 세계적으로 보면, 바이오시밀러 시장은 생물제제를 대체하는 비용 대비 효과적인 대체품과 고령화에 의해 활황을 보이고 있습니다. 역동적인 공급망과 전략적 제휴를 조건으로 시장은 크게 확대될 전망입니다.

시장 세분화
유형 재조합 당화 단백질, 재조합 비당화 단백질, 펩타이드
제품 단클론항체, 인슐린, 에리스로포이에틴, 과립구집략자극인자, 인간성장호르몬, 인터페론, 불임호르몬
용도 종양학, 만성 질환, 자가 면역 질환, 혈액 질환, 전염병, 성장 호르몬 결핍
최종 사용자 병원, 클리닉, 연구 기관, 제약 회사, 생명 공학 회사
기술 재조합 DNA 기술, 단일클론항체 기술, 단백질 시퀀싱, 생물정보학
프로세스 업스트림 처리, 다운스트림 처리
구성 요소 원료의약품(API), 완제품 제형
단계 임상시험, 전임상연구, 상업화
서비스 계약 제조, 계약 연구, 규제 컨설팅
장치 생물반응기, 크로마토그래피 시스템

시장 개요 :

바이오시밀러 시장은 주로 비용효과가 높은 생물학적 제제에 대한 요구 증가와 선발생물 제제의 특허 만료에 힘입어 견조한 확대를 계속하고 있습니다. 견인 암 영역의 바이오시밀러는 상당한 비용 절감과 동등한 효과를 제공하기 위해 건강 공급자와 지불자에게 매우 매력적입니다. 시밀러의 채용을 뒷받침하고 있습니다. 자가면역질환이나 당뇨병 등의 새로운 하위 부문은 이러한 질환의 이환율이 상승해, 의사나 환자의 사이에서 바이오시밀러가 받아들여지고 있기 때문에 대폭적인 성장이 전망되고 있습니다. 특히 자가면역질환 분야는 단일클론항체의 기술 혁신과 차세대 바이오시밀러의 개발로부터 혜택을 받을 것으로 예상되며, 이로써 환자의 예후 개선과 치료 선택의 확대가 기대되어 시장 역학에 큰 영향을 미칩니다.

충돌 개요 :

바이오시밀러 시장은 역동적인 시장 점유율 분포가 특징이며, 암 이환율 증가와 비용 효율적인 대체 치료에 대한 수요로부터 암 영역이 돌출한 리더로서 대두하고 있습니다. 면역분야는 자가면역질환의 이환율이 증가하고 이에 따른 치료 옵션의 필요성에 따라 약간의 차이가 있습니다. 지역별로는 유럽이 확립된 규제 프레임워크과 높은 보급률에 의해 시장의 주도적 지위를 유지하고 있는 한편, 아시아태평양은 의료비 증가와 정부의 지원책에 뒷받침되어 강력한 성장을 이루고 있습니다. 업계의 주요 기업은 이 급성장 시장에서 더 큰 점유율을 얻기 위해 전략적 제휴 및 제품 상시를 통해 적극적으로 포트폴리오를 강화하고 있습니다. 바이오시밀러 시장 경쟁 구도는 특히 엄격한 승인 프로세스가 제품의 안전성과 효능을 보장하는 유럽 및 북미와 같은 지역에서 규제의 영향으로 크게 형성됩니다. Amgen, Sandoz, Pfizer 등의 기업들이 최전선에 서서 광범위한 조사 능력과 전략적 제휴를 활용하여 경쟁 우위를 획득하고 있습니다. 앞으로는 몇 가지 큰 히트 생물 제제의 특허가 끊어져 의료 종사자와 환자 사이에 바이오시밀러가 받아들여지고 있는 것이 추풍이 되어 시장은 크게 성장할 전망입니다. 그러나 지적재산권 분쟁과 시장 진입 장벽과 같은 과제는 여전히 남아 있습니다. 그러나 생명공학의 진보와 지속적인 규제 당국의 지원으로 시장 확대의 호기가 생길 것으로 기대되고 있습니다.

주요 동향 및 촉진요인 :

바이오시밀러 시장은 블록버스터 생물제제의 특허 만료으로 인해 시장이 바이오시밀러 경쟁에 개방되어 강력한 성장을 이루고 있습니다. 바이오시밀러의 채택을 적극적으로 추진하고 있습니다. 기술혁신을 촉진하고 바이오시밀러 의약품 파이프라인의 충실로 이어지고 있습니다. 또한 의료 종사자와 환자 사이에서 바이오시밀러의 인지도와 수용도가 높아지고 있는 것도 시장 수요를 촉진하고 있습니다.

억제요인과 도전 :

바이오시밀러 시장에는 몇 가지 중요한 억제요인과 과제가 있습니다. 많은 기업의 경제적 부담이 늘어나고 있습니다. 또한 바이오시밀러의 처방에 대한 의사의 인식과 신뢰가 현저히 부족하고, 이것이 바이오시밀러의 채용을 방해하고 있습니다. 게다가 상시후의 바이오시밀러의 안전성과 유효성을 감시하기 위한 견고한 약물감시 시스템의 필요성은 물류와 재정상의 과제가 되고 있습니다. 티가 정착하고 있기 때문에 바이오시밀러는 비용면에서 유리하다고 해도 시장 점유율을 확대하는 것이 곤란합니다.

목차

제1장 바이오시밀러 시장 개요

제2장 주요 요약

제3장 시장에 관한 중요 인사이트

제4장 바이오시밀러 시장 전망

제5장 바이오시밀러 시장 전략

제6장 바이오시밀러 시장 규모

제7장 바이오시밀러 시장 : 유형별

제8장 바이오시밀러 시장 : 제품별

제9장 바이오시밀러 시장 : 용도별

제10장 바이오시밀러 시장 : 최종 사용자별

제11장 바이오시밀러 시장 : 기술별

제12장 바이오시밀러 시장 : 프로세스별

제13장 바이오시밀러 시장 : 구성 요소별

제14장 바이오시밀러 시장 : 단계별

제15장 바이오시밀러 시장 : 서비스별

제16장 바이오시밀러 시장 : 디바이스별

제17장 바이오시밀러 시장 : 지역별

제18장 경쟁 구도

제19장 기업 프로파일

KTH
영문 목차

영문목차

Biosimilars Market is anticipated to expand from $24.0 billion in 2024 to $117.7 billion by 2034, growing at a CAGR of approximately 17.3%. Biosimilars Market encompasses biologic medical products highly similar to already approved reference products, offering no clinically meaningful differences in safety or efficacy. This market is driven by patent expirations of biologics, cost-effectiveness, and increasing demand for affordable healthcare solutions. Regulatory frameworks in various regions are evolving to support biosimilar approvals, fostering innovation and competition. The market is poised for significant growth as healthcare systems seek to balance cost pressures with the need for advanced therapeutic options.

Industry Overview:

The biosimilars market is navigating a complex landscape of global tariffs, geopolitical tensions, and evolving supply chain dynamics. Japan and South Korea are strategically enhancing their biosimilar capabilities, leveraging innovation to mitigate tariff impacts and reduce dependency on foreign biologics. China's focus on self-reliance is intensifying, with state-backed initiatives fostering a robust domestic biosimilars sector. Taiwan, while pivotal in biopharmaceutical manufacturing, faces geopolitical vulnerabilities amidst US-China frictions. Globally, the biosimilars market is buoyant, driven by cost-effective alternatives to biologics and an aging population. By 2035, the market is poised for significant expansion, contingent on resilient supply chains and strategic alliances. Middle East conflicts, while primarily affecting energy prices, indirectly influence biosimilar production costs and distribution logistics worldwide.

Market Segmentation
TypeRecombinant Glycosylated Proteins, Recombinant Non-Glycosylated Proteins, Peptides
ProductMonoclonal Antibodies, Insulin, Erythropoietin, Granulocyte Colony-Stimulating Factor, Human Growth Hormone, Interferons, Fertility Hormones
ApplicationOncology, Chronic Diseases, Autoimmune Diseases, Blood Disorders, Infectious Diseases, Growth Hormone Deficiency
End UserHospitals, Clinics, Research Institutes, Pharmaceutical Companies, Biotechnology Firms
TechnologyRecombinant DNA Technology, Monoclonal Antibody Technology, Protein Sequencing, Bioinformatics
ProcessUpstream Processing, Downstream Processing
ComponentActive Pharmaceutical Ingredients (API), Finished Dosage Formulations
StageClinical Trials, Preclinical Studies, Commercialization
ServicesContract Manufacturing, Contract Research, Regulatory Consulting
DeviceBioreactors, Chromatography Systems

Market Overview:

The Biosimilars Market is experiencing robust expansion, primarily fueled by the rising need for cost-effective biologic therapies and the expiration of patents for original biologics. The oncology segment leads the market, driven by the increasing prevalence of cancer and the high cost of reference biologics. Biosimilars in oncology offer significant cost savings and comparable efficacy, making them highly attractive to healthcare providers and payers. Furthermore, advancements in biologic drug development and manufacturing technologies enhance their adoption. Emerging sub-segments, such as autoimmune diseases and diabetes, are poised for substantial growth due to the rising incidence of these conditions and the growing acceptance of biosimilars among physicians and patients. The autoimmune segment, in particular, is expected to benefit from ongoing innovations in monoclonal antibodies and the development of next-generation biosimilars, which promise improved patient outcomes and expanded therapeutic options, thereby significantly impacting market dynamics.

Geographical Overview:

The biosimilars market is witnessing remarkable growth, with regional dynamics playing a pivotal role. In North America, the market is expanding due to a robust regulatory framework and increasing healthcare expenditure. The United States, a key player, is driving growth through strategic collaborations and a focus on reducing healthcare costs. Europe stands as a leader in the biosimilars market, propelled by supportive government policies and a strong emphasis on cost-effective healthcare solutions. The region's well-established pharmaceutical industry and high acceptance rates among healthcare professionals further contribute to its dominance. Germany and the United Kingdom are at the forefront. In Asia Pacific, the biosimilars market is experiencing rapid expansion. This growth is driven by a surge in chronic diseases and an aging population. Countries like China and India are investing heavily in biosimilar development and manufacturing. Their large patient pools and increasing healthcare access further bolster market potential. Latin America is an emerging market for biosimilars, with growing awareness and acceptance among healthcare providers. Brazil and Mexico are leading the way, focusing on regulatory improvements and cost-saving initiatives. The region's potential is significant, given its evolving healthcare landscape. The Middle East & Africa region is gradually recognizing the benefits of biosimilars. The market here is driven by the need to improve healthcare affordability and accessibility. Countries like Saudi Arabia and South Africa are making strides in adopting biosimilars to enhance healthcare outcomes and economic efficiency.

Competition Overview:

The biosimilars market is characterized by a dynamic distribution of market share, with the oncology segment emerging as a prominent leader due to the increasing prevalence of cancer and the demand for cost-effective treatment alternatives. The immunology segment follows closely, driven by the rising incidence of autoimmune diseases and the subsequent need for affordable therapeutic options. Geographically, Europe maintains a leadership position in the market due to its well-established regulatory framework and high adoption rates, while the Asia-Pacific region is witnessing robust growth fueled by increasing healthcare expenditure and supportive government initiatives. Key industry players are actively enhancing their portfolios through strategic collaborations and product launches to capture a larger share of this burgeoning market. The competitive landscape of the biosimilars market is shaped significantly by regulatory influences, particularly in regions like Europe and North America, where stringent approval processes ensure product safety and efficacy. Companies such as Amgen, Sandoz, and Pfizer are at the forefront, leveraging their extensive research capabilities and strategic alliances to gain competitive advantage. Looking ahead, the market is poised for substantial growth, driven by the expiration of patents for several blockbuster biologics and the increasing acceptance of biosimilars among healthcare providers and patients. However, challenges such as intellectual property disputes and market entry barriers persist. Nonetheless, advancements in biotechnology and ongoing regulatory support are expected to create lucrative opportunities for market expansion.

Recent Developments:

The biosimilars market has experienced notable developments in recent months. Amgen announced a strategic partnership with a leading European pharmaceutical company to co-develop and commercialize a new biosimilar targeting autoimmune diseases, aiming to expand their presence in the European market. In regulatory news, the U.S. FDA approved a groundbreaking biosimilar for treating cancer, marking a significant milestone in oncology therapeutics and potentially reducing treatment costs. Pfizer and Biocon Biologics entered a joint venture to enhance their biosimilars portfolio, focusing on emerging markets in Asia and Africa, which are projected to see substantial growth in demand. Market analysts reported a surge in biosimilars adoption in the European Union, driven by favorable regulatory policies and increased physician acceptance, which is expected to boost market growth. Lastly, a prominent South Korean biosimilar manufacturer announced a major investment to expand its production facilities, aiming to meet the growing global demand for cost-effective biologic treatments. These developments underscore the dynamic nature of the biosimilars market, highlighting opportunities for growth and innovation.

Key Companies:

Alvotech, Coherus Bio Sciences, Amgen, Samsung Bioepis, Celltrion, Biocon, Sandoz, Mylan, Fresenius Kabi, Stada Arzneimittel, Dr Reddy's Laboratories, Lupin, Hikma Pharmaceuticals, Apotex, Teva Pharmaceutical Industries, Zydus Cadila, Torrent Pharmaceuticals, Cadila Healthcare, Alkem Laboratories, Gedeon Richter

Key Trends and Drivers:

The biosimilars market is experiencing robust growth, propelled by the expiration of patents for blockbuster biologics, which opens the market to biosimilar competition. This trend is further driven by the increasing prevalence of chronic diseases, which necessitates cost-effective treatment options. Governments and healthcare providers are actively promoting the adoption of biosimilars to reduce healthcare expenditure. Technological advancements in the development and manufacturing of biosimilars are enhancing product quality and reducing time-to-market. This progress is crucial in gaining regulatory approval and fostering market acceptance. Additionally, the growing investment in research and development by key pharmaceutical companies is fueling innovation, leading to a broader pipeline of biosimilar products. The market is also witnessing increased collaborations and partnerships among pharmaceutical companies to leverage expertise and share resources. This trend is accelerating the development and commercialization of biosimilars, thus expanding market reach. Moreover, the rising awareness and acceptance of biosimilars among healthcare professionals and patients are driving market demand. As biosimilars continue to gain traction, opportunities abound in emerging markets where healthcare infrastructure is rapidly evolving, presenting significant growth potential for industry players.

Restraints and Challenges:

The biosimilars market encounters several significant restraints and challenges. A primary challenge is the regulatory complexity and variability across regions, which can delay approvals and increase costs. This complexity often necessitates extensive clinical trials, adding to the financial burden on manufacturers. Furthermore, there is a notable lack of physician awareness and confidence in prescribing biosimilars, which hampers their adoption. Intellectual property disputes, including patent litigations, can also obstruct market entry and expansion. Additionally, the need for robust pharmacovigilance systems to monitor biosimilar safety and efficacy post-launch poses logistical and financial challenges. Lastly, the entrenched brand loyalty to original biologics makes it difficult for biosimilars to gain market share, despite their cost advantages. These factors collectively impede the swift growth and broader acceptance of biosimilars in the healthcare market.

Research Scope:

Our research scope provides comprehensive market data, insights, and analysis across a variety of critical areas. We cover Local Market Analysis, assessing consumer demographics, purchasing behaviors, and market size within specific regions to identify growth opportunities. Our Local Competition Review offers a detailed evaluation of competitors, including their strengths, weaknesses, and market positioning. We also conduct Local Regulatory Reviews to ensure businesses comply with relevant laws and regulations. Industry Analysis provides an in-depth look at market dynamics, key players, and trends. Additionally, we offer Cross-Segmental Analysis to identify synergies between different market segments, as well as Production-Consumption and Demand-Supply Analysis to optimize supply chain efficiency. Our Import-Export Analysis helps businesses navigate global trade environments by evaluating trade flows and policies. These insights empower clients to make informed strategic decisions, mitigate risks, and capitalize on market opportunities.

TABLE OF CONTENTS

1: Biosimilars Market Overview

2: Executive Summary

3: Premium Insights on the Market

4: Biosimilars Market Outlook

5: Biosimilars Market Strategy

6: Biosimilars Market Size

7: Biosimilars Market, by Type

8: Biosimilars Market, by Product

9: Biosimilars Market, by Application

10: Biosimilars Market, by End User

11: Biosimilars Market, by Technology

12: Biosimilars Market, by Process

13: Biosimilars Market, by Component

14: Biosimilars Market, by Stage

15: Biosimilars Market, by Services

16: Biosimilars Market, by Device

17: Biosimilars Market, by Region

18: Competitive Landscape

19: Company Profiles

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