바이오시밀러 수탁 제조 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측, 제품별, 기술별, 용도별, 지역별 부문, 경쟁(2020-2030년)
Biosimilar Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product, By Technology, By Application, By Region and Competition, 2020-2030F
상품코드:1796887
리서치사:TechSci Research
발행일:2025년 08월
페이지 정보:영문 185 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
세계의 바이오시밀러 수탁 제조 시장 규모는 2024년 93억 7,000만 달러로 평가되었고 예측 기간 중 CAGR은 16.59%를 나타낼 전망이며, 2030년에는 235억 4,000만 달러에 달할 것으로 예상됩니다.
세계의 바이오시밀러 수탁 제조 시장은 다양한 만성 질환의 유병률이 증가함에 따라 큰 성장을 이루고 있습니다. 게다가 저가로 적당한 치료가 가능한 암 바이오시밀러 증가나 세계에서 비용 효율적인 헬스케어 시스템의 도입이 진행되고 있는 것도 바이오시밀러 수탁제조 수요를 높이고 있습니다. 또한, 다양한 유형의 만성 질환을 앓고 있는 노인 인구가 세계적으로 증가하고 있는 것도 바이오시밀러 수탁 제조 수요를 더욱 증가시킬 것으로 예측됩니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
93억 7,000만 달러
시장 규모 : 2030년
235억 4,000만 달러
CAGR : 2025-2030년
16.59%
급성장 부문
종양학
최대 시장
북미
시장 성장 촉진요인
생물 제제의 특허 만료에 의한 바이오시밀러 개발 촉진
시장의 과제
바이오시밀러 제조의 복잡성과 비용 상승
주요 시장 동향
바이오시밀러 제조에서 단일 사용 바이오프로세싱 기술의 상승
목차
제1장 개요
시장의 정의
시장 범위
대상 시장
조사 대상 연도
주요 시장 세분화
제2장 조사 방법
제3장 주요 요약
제4장 고객의 목소리
제5장 세계의 바이오시밀러 수탁 제조 시장 전망
시장 규모와 예측
금액별
시장 점유율·예측
제품별(재조합 비당화 단백질, 재조합 당화 단백질)
기술별(포유류, 비포유류)
용도별(종양학, 혈액 질환, 성장 호르몬 결핍, 만성 및 자가 면역 질환, 류마티스 관절염 등)
지역별
기업별(2024년)
시장 맵
제품별
기술별
용도별
지역별
제6장 북미의 바이오시밀러 수탁 제조 시장 전망
시장 규모와 예측
시장 점유율·예측
북미 : 국가별 분석
미국
캐나다
멕시코
제7장 유럽의 바이오시밀러 수탁 제조 시장 전망
시장 규모와 예측
시장 점유율·예측
유럽 : 국가별 분석
프랑스
독일
영국
이탈리아
스페인
제8장 아시아태평양의 바이오시밀러 수탁 제조 시장 전망
시장 규모와 예측
시장 점유율과 예측
아시아태평양 : 국가별 분석
중국
인도
일본
한국
호주
제9장 남미의 바이오시밀러 수탁 제조 시장 전망
시장 규모와 예측
시장 점유율·예측
남미 : 국가별 분석
브라질
아르헨티나
콜롬비아
제10장 중동 및 아프리카의 바이오시밀러 수탁 제조 시장 전망
시장 규모와 예측
시장 점유율·예측
중동 및 아프리카 : 국가별 분석
남아프리카
사우디아라비아
아랍에미리트(UAE)
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향과 발전
합병과 인수
제품 출시
최근 동향
제13장 Porter's Five Forces 분석
업계 내 경쟁
신규 진입의 가능성
공급자의 힘
고객의 힘
대체품의 위협/서비스
제14장 경쟁 구도
Catalent, Inc.
Boehringer Ingelheim GmbH
Alcami Corporation, Inc.
Almac Group
Lonza Group AG
Biocon Limited
Avid Bioservice, Inc.
Rentschler Biopharma SE
Fujifilm Kyowa Kirin Biologics Co., Ltd.
WuXi Biologics, Inc.
제15장 전략적 제안
제16장 기업 소개와 면책사항
KTH
영문 목차
영문목차
Global Biosimilar Contract Manufacturing Market was valued at USD 9.37 billion in 2024 and is expected to reach USD 23.54 billion by 2030 with a CAGR of 16.59% during the forecast period. The global market for Biosimilar Contract Manufacturing is experiencing significant growth, driven by the growing prevalence of various chronic diseases. Additionally, increasing availability of cancer biosimilars with lowered prices and affordable treatment, along with the growing adoption of cost-effective healthcare systems across the globe, have increased the demand for biosimilar contract manufacturing. Additionally, the growing geriatric population across the globe, susceptible to different kinds of chronic diseases, is further expected to increase the demand for biosimilar contract manufacturing.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 9.37 Billion
Market Size 2030
USD 23.54 Billion
CAGR 2025-2030
16.59%
Fastest Growing Segment
Oncology
Largest Market
North America
Key Market Drivers
Patent Expiry of Biologics Encouraging Biosimilar Development
The expiration of patents on many blockbusters biologic drugs has created a significant opportunity for biosimilar development, directly driving the demand for contract manufacturing organizations (CMOs) that specialize in biosimilar production. Biologics such as trastuzumab, bevacizumab, and adalimumab have either lost or are nearing the expiration of their exclusivity periods in multiple regions including the U.S., Europe, and parts of Asia. This opens the door for biosimilar manufacturers to introduce more cost-effective alternatives.
CMOs play a pivotal role in facilitating this transition by providing the infrastructure, expertise, and regulatory guidance required to bring these complex products to market efficiently. According to the U.S. Food and Drug Administration (FDA), as of 2024, over 40 biosimilars have been approved in the United States, a marked increase compared to just 11 approvals five years earlier. The European Medicines Agency (EMA) also reports steady growth in biosimilar approvals since its first authorization in 2006, reflecting a regulatory climate conducive to biosimilar uptake. The challenge of producing biologics-due to their complexity, the need for sterile environments, and sophisticated analytical testing-makes contract manufacturing a strategic choice for many biosimilar developers. Rather than investing in costly facilities and process development, pharmaceutical companies are increasingly outsourcing CMOs that already possess these capabilities, thus speeding up time-to-market and reducing capital expenditure.
Key Market Challenges
High Complexity and Cost of Biosimilar Manufacturing
Despite their economic appeal, biosimilars are biologically complex molecules that require sophisticated manufacturing infrastructure, highly skilled personnel, and rigorous quality control systems. Developing biosimilars involves extensive comparative analytical studies and process validation steps to ensure therapeutic equivalence to the original biologic, which significantly increases development time and cost. Even with outsourcing to CMOs, the cost of manufacturing biosimilars can be prohibitively high, particularly for smaller biotech firms or those targeting niche therapeutic areas. Governments such as the U.S. FDA and EMA require a comprehensive dossier of quality, safety, and efficacy data before approving a biosimilar, further increasing regulatory and financial burdens.
Moreover, CMOs must make substantial upfront investments in specialized bioreactors, cell culture facilities, and cleanroom environments to accommodate biosimilar projects. These capital-intensive requirements limit the number of CMOs equipped to handle large-scale biosimilar contracts, creating a bottleneck in supply and potentially slowing market growth.
Key Market Trends
Rise of Single-Use Bioprocessing Technologies in Biosimilar Manufacturing
One of the most prominent trends reshaping the biosimilar contract manufacturing landscape is the widespread adoption of single-use bioprocessing technologies. Single-use systems-comprising disposable bioreactors, mixing systems, and filtration units-offer significant advantages over traditional stainless-steel equipment, including reduced contamination risk, lower cleaning validation costs, and faster turnaround times between batches.
These benefits are particularly relevant in the biosimilar space, where cost efficiency and speed to market are critical. CMOs are increasingly incorporating single-use technologies to enhance their operational flexibility and meet the unique production needs of multiple clients simultaneously. According to the U.S. Department of Commerce, biopharmaceutical manufacturers who adopt single-use systems report a 30-50% reduction in production costs, making this approach especially attractive for biosimilar developers operating on tight margins.
Furthermore, these technologies support small and medium-sized batches, aligning well with the growing trend of personalized medicine and targeted biosimilars. The ability to quickly scale up or down based on demand also makes contract manufacturing more agile and responsive to fluctuating market needs.
Key Market Players
Catalent, Inc.
Boehringer Ingelheim GmbH
Alcami Corporation, Inc.
Almac Group
Lonza Group AG
Biocon Limited
Avid Bioservice, Inc.
Rentschler Biopharma SE
Fujifilm Kyowa Kirin Biologics Co., Ltd.
WuXi Biologics, Inc.
Report Scope:
In this report, the Global Biosimilar Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Biosimilar Contract Manufacturing Market, By Product:
Recombinant Non-glycosylated Proteins
Recombinant Glycosylated Proteins
Biosimilar Contract Manufacturing Market, By Technology:
Mammalian
Non-Mammalian
Biosimilar Contract Manufacturing Market, By Application:
Oncology
Blood Disorders
Growth Hormonal Deficiency
Chronic & Autoimmune Disorders
Rheumatoid Arthritis
Others
Biosimilar Contract Manufacturing Market, By Region:
North America
United States
Mexico
Canada
Europe
France
Germany
United Kingdom
Italy
Spain
Asia-Pacific
China
India
South Korea
Japan
Australia
South America
Brazil
Argentina
Colombia
Middle East and Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the Global Biosimilar Contract Manufacturing Market.
Available Customizations:
Global Biosimilar Contract Manufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Service Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Biosimilar Contract Manufacturing Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins)
