바이오시밀러 검사 서비스 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측 : 서비스 유형별, 분자 유형별, 치료 분야별, 최종사용자별, 지역별, 경쟁별(2020-2030년)
Biosimilar Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service Type, By Molecule Type, By Therapeutic Area, By End User, By Region and Competition, 2020-2030F
상품코드:1770829
리서치사:TechSci Research
발행일:2025년 07월
페이지 정보:영문 181 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
바이오시밀러 검사 서비스 세계 시장은 2024년에 15억 3,000만 달러로 평가되었으며, 2030년에는 30억 3,000만 달러에 달하고, CAGR 12.04%로 성장할 것으로 예측됩니다.
이러한 성장의 배경에는 특히 많은 고수익 생물학적 제제의 특허가 만료됨에 따라 생물학적 제제를 대체할 수 있는 비용 효율적인 대체품에 대한 수요가 증가하고 있는 것이 주요 요인으로 작용하고 있습니다. 제약사들은 경쟁 우위를 확보하고 보다 저렴한 치료 옵션을 제공하기 위해 바이오시밀러 개발에 대한 투자를 늘리고 있습니다. 이러한 바이오시밀러 개발의 급증으로 규제 적합성, 안전성, 유효성을 보장하기 위한 전문 검사 서비스의 필요성이 증가하고 있습니다. 미국 FDA와 유럽의약품청(EMA) 등 규제 당국은 바이오시밀러 의약품의 승인을 위해 광범위한 분석시험, 비임상시험, 임상시험을 요구하고 있습니다. 이에 따라 의약품 개발 수탁기관(CRO) 및 바이오의약품 서비스 제공업체는 특성시험, 생물학적 분석시험, 약동학적/약력학적 분석 등의 서비스를 통해 바이오시밀러 제조업체를 지원하는 데 있어 매우 중요한 역할을 하고 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
15억 3,000만 달러
시장 규모 : 2030년
30억 3,000만 달러
CAGR : 2025-2030년
12.04%
급성장 부문
자가면역질환
최대 시장
북미
시장 촉진요인
만성질환 및 자가면역질환의 유병률 상승
주요 시장 과제
바이오시밀러 개발 및 시험의 복잡성과 높은 비용 부담
주요 시장 동향
바이오시밀러 특성 분석에 첨단 분석 기술 도입 증가
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 소리
제5장 세계의 바이오시밀러 검사 서비스 시장 전망
시장 규모 및 예측
금액별
시장 점유율과 예측
서비스 유형별(분석 시험, 임상 검사)
분자 유형별(단클론항체, 재조합 호르몬, 인슐린, 인터페론, 효소, 기타)
치료 분야별(종양학, 자가면역질환, 당뇨병, 감염증, 신경학, 기타)
최종사용자별(제약·바이오테크놀러지 기업, 개발 조사위원회탁기관, 학술조사기관, 기타)
기업별(2024)
지역별
시장 맵
제6장 북미의 바이오시밀러 검사 서비스 시장 전망
시장 규모 및 예측
시장 점유율과 예측
북미 : 국가별 분석
미국
멕시코
캐나다
제7장 유럽의 바이오시밀러 검사 서비스 시장 전망
시장 규모 및 예측
시장 점유율과 예측
유럽 : 국가별 분석
프랑스
독일
영국
이탈리아
스페인
제8장 아시아태평양의 바이오시밀러 검사 서비스 시장 전망
시장 규모 및 예측
시장 점유율과 예측
아시아태평양 : 국가별 분석
중국
인도
한국
일본
호주
제9장 남미의 바이오시밀러 검사 서비스 시장 전망
시장 규모 및 예측
시장 점유율과 예측
남미 : 국가별 분석
브라질
아르헨티나
콜롬비아
제10장 중동 및 아프리카의 바이오시밀러 검사 서비스 시장 전망
시장 규모 및 예측
시장 점유율과 예측
중동 및 아프리카 : 국가별 분석
남아프리카공화국
사우디아라비아
아랍에미리트
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향과 발전
인수합병
제품 출시
최근 동향
제13장 혼란 : 분쟁, 팬데믹, 무역장벽
제14장 Porter's Five Forces 분석
업계내 경쟁
신규 참여의 가능성
공급업체의 능력
고객의 능력
대체품의 위협
제15장 경쟁 구도
Thermo Fisher Scientific Inc.
Charles River Laboratories, Inc.
SGS S.A.
Eurofins Scientific Limited
Intertek Group plc
Element Materials Technology
Pacific BioLabs, Inc.
Sartorius AG
WuXi AppTec
Syngene International Ltd.
제16장 전략적 제안
제17장 조사 회사 소개 및 면책사항
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영문 목차
영문목차
The Global Biosimilar Testing Services Market was valued at USD 1.53 Billion in 2024 and is projected to reach USD 3.03 Billion by 2030, growing at a CAGR of 12.04%. This growth is driven by rising demand for cost-effective alternatives to biologic drugs, particularly as patents for many high-revenue biologics expire. Pharmaceutical companies are increasingly investing in biosimilar development to gain competitive advantage and offer more affordable treatment options. This surge in biosimilar development has amplified the need for specialized testing services to ensure regulatory compliance, safety, and efficacy. Regulatory authorities such as the U.S. FDA and EMA require extensive analytical, non-clinical, and clinical testing for biosimilar approval. As a result, contract research organizations (CROs) and biopharmaceutical service providers play a pivotal role in supporting biosimilar manufacturers with services such as characterization studies, bioanalytical testing, and pharmacokinetic/pharmacodynamic analysis.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 1.53 Billion
Market Size 2030
USD 3.03 Billion
CAGR 2025-2030
12.04%
Fastest Growing Segment
Autoimmune Diseases
Largest Market
North America
Key Market Drivers
Rising Prevalence of Chronic and Autoimmune Diseases
The increasing incidence of chronic and autoimmune diseases is a key factor driving growth in the Global Biosimilar Testing Services Market, as it boosts demand for affordable biologic therapies. Chronic noncommunicable diseases (NCDs) continue to be a major global health concern. According to the World Health Organization (WHO), NCDs were responsible for approximately 43 million deaths in 2021-about 75% of all non-pandemic-related fatalities. Cardiovascular diseases led with 19 million deaths, followed by cancers (10 million), chronic respiratory illnesses (4 million), and diabetes-related complications (over 2 million). The high burden of these diseases has intensified the need for biosimilars as cost-effective alternatives, thereby increasing the demand for comprehensive testing services to ensure therapeutic equivalence and safety.
Key Market Challenges
High Complexity and Cost of Biosimilar Development and Testing
The intricate nature and high cost of biosimilar development and testing remain major challenges in the Global Biosimilar Testing Services Market. Unlike small-molecule generics, biosimilars are complex biologics produced using living systems, requiring advanced analytical and functional characterization to establish similarity with reference products. Technologies such as mass spectrometry, chromatography, capillary electrophoresis, and NMR spectroscopy are essential for detailed analysis, significantly raising development expenses. Biosimilar developers must also conduct robust comparability assessments, potency tests, immunogenicity evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials to comply with rigorous regulations set by bodies like the U.S. FDA, EMA, and PMDA. These multifaceted regulatory demands lead to prolonged development timelines and substantial financial investment, posing barriers especially for small and mid-sized firms.
Key Market Trends
Increasing Adoption of Advanced Analytical Techniques for Biosimilar Characterization
A prominent trend in the Global Biosimilar Testing Services Market is the growing reliance on advanced analytical tools for biosimilar characterization. To meet regulatory expectations set by agencies such as the U.S. FDA, EMA, and PMDA, biosimilar developers must demonstrate structural and functional equivalence to originator biologics. Traditional methods often lack the sensitivity to detect subtle molecular differences, prompting increased use of high-resolution mass spectrometry (HRMS), nuclear magnetic resonance (NMR) spectroscopy, capillary electrophoresis (CE), and surface plasmon resonance (SPR). These technologies enable comprehensive assessments of purity, potency, and immunogenicity.
With biologics like monoclonal antibodies, fusion proteins, and recombinant hormones growing more complex, the need for precise testing of attributes such as glycosylation patterns, post-translational modifications, and aggregation is intensifying. Complementary techniques like high-performance liquid chromatography (HPLC) and size-exclusion chromatography (SEC) are widely employed to analyze stability and degradation pathways. The integration of automation and high-throughput screening platforms is also enhancing reproducibility and reducing testing variability, ultimately improving testing efficiency and quality.
Key Market Players
Thermo Fisher Scientific Inc.
Charles River Laboratories, Inc.
SGS S.A.
Eurofins Scientific Limited
Intertek Group plc
Element Materials Technology
Pacific BioLabs, Inc.
Sartorius AG
WuXi AppTec
Syngene International Ltd.
Report Scope:
In this report, the Global Biosimilar Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Biosimilar Testing Services Market, By Service Type:
Analytical Testing
Clinical Testing
Biosimilar Testing Services Market, By Molecule Type:
Monoclonal Antibodies
Recombinant Hormones
Insulin
Interferons
Enzymes
Others
Biosimilar Testing Services Market, By Therapeutic Area:
Oncology
Autoimmune Diseases
Diabetes
Infectious Diseases
Neurology
Others
Biosimilar Testing Services Market, By End User:
Pharmaceutical & Biotechnology Companies
Contract Research Organizations
Academic & Research Institutes
Others
Biosimilar Testing Services Market, By Region:
North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia-Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Biosimilar Testing Services Market.
Available Customizations:
Global Biosimilar Testing Services 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. Product 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, and Trends
4. Voice of Customer
5. Global Biosimilar Testing Services Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Service Type (Analytical Testing, Clinical Testing)
5.2.2. By Molecule Type (Monoclonal Antibodies, Recombinant Hormones, Insulin, Interferons, Enzymes, Others)
5.2.3. By Therapeutic Area (Oncology, Autoimmune Diseases, Diabetes, Infectious Diseases, Neurology, Others)
5.2.4. By End User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic & Research Institutes, Others)
5.2.5. By Company (2024)
5.2.6. By Region
5.3. Market Map
6. North America Biosimilar Testing Services Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Service Type
6.2.2. By Molecule Type
6.2.3. By Therapeutic Area
6.2.4. By End User
6.2.5. By Country
6.3. North America: Country Analysis
6.3.1. United States Biosimilar Testing Services Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Service Type
6.3.1.2.2. By Molecule Type
6.3.1.2.3. By Therapeutic Area
6.3.1.2.4. By End User
6.3.2. Mexico Biosimilar Testing Services Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Service Type
6.3.2.2.2. By Molecule Type
6.3.2.2.3. By Therapeutic Area
6.3.2.2.4. By End User
6.3.3. Canada Biosimilar Testing Services Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Service Type
6.3.3.2.2. By Molecule Type
6.3.3.2.3. By Therapeutic Area
6.3.3.2.4. By End User
7. Europe Biosimilar Testing Services Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Service Type
7.2.2. By Molecule Type
7.2.3. By Therapeutic Area
7.2.4. By End User
7.2.5. By Country
7.3. Europe: Country Analysis
7.3.1. France Biosimilar Testing Services Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Service Type
7.3.1.2.2. By Molecule Type
7.3.1.2.3. By Therapeutic Area
7.3.1.2.4. By End User
7.3.2. Germany Biosimilar Testing Services Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Service Type
7.3.2.2.2. By Molecule Type
7.3.2.2.3. By Therapeutic Area
7.3.2.2.4. By End User
7.3.3. United Kingdom Biosimilar Testing Services Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Service Type
7.3.3.2.2. By Molecule Type
7.3.3.2.3. By Therapeutic Area
7.3.3.2.4. By End User
7.3.4. Italy Biosimilar Testing Services Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Service Type
7.3.4.2.2. By Molecule Type
7.3.4.2.3. By Therapeutic Area
7.3.4.2.4. By End User
7.3.5. Spain Biosimilar Testing Services Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Service Type
7.3.5.2.2. By Molecule Type
7.3.5.2.3. By Therapeutic Area
7.3.5.2.4. By End User
8. Asia-Pacific Biosimilar Testing Services Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Service Type
8.2.2. By Molecule Type
8.2.3. By Therapeutic Area
8.2.4. By End User
8.2.5. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Biosimilar Testing Services Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Service Type
8.3.1.2.2. By Molecule Type
8.3.1.2.3. By Therapeutic Area
8.3.1.2.4. By End User
8.3.2. India Biosimilar Testing Services Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Service Type
8.3.2.2.2. By Molecule Type
8.3.2.2.3. By Therapeutic Area
8.3.2.2.4. By End User
8.3.3. South Korea Biosimilar Testing Services Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Service Type
8.3.3.2.2. By Molecule Type
8.3.3.2.3. By Therapeutic Area
8.3.3.2.4. By End User
8.3.4. Japan Biosimilar Testing Services Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Service Type
8.3.4.2.2. By Molecule Type
8.3.4.2.3. By Therapeutic Area
8.3.4.2.4. By End User
8.3.5. Australia Biosimilar Testing Services Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Service Type
8.3.5.2.2. By Molecule Type
8.3.5.2.3. By Therapeutic Area
8.3.5.2.4. By End User
9. South America Biosimilar Testing Services Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Service Type
9.2.2. By Molecule Type
9.2.3. By Therapeutic Area
9.2.4. By End User
9.2.5. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Biosimilar Testing Services Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Service Type
9.3.1.2.2. By Molecule Type
9.3.1.2.3. By Therapeutic Area
9.3.1.2.4. By End User
9.3.2. Argentina Biosimilar Testing Services Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Service Type
9.3.2.2.2. By Molecule Type
9.3.2.2.3. By Therapeutic Area
9.3.2.2.4. By End User
9.3.3. Colombia Biosimilar Testing Services Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Service Type
9.3.3.2.2. By Molecule Type
9.3.3.2.3. By Therapeutic Area
9.3.3.2.4. By End User
10. Middle East and Africa Biosimilar Testing Services Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Service Type
10.2.2. By Molecule Type
10.2.3. By Therapeutic Area
10.2.4. By End User
10.2.5. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Biosimilar Testing Services Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Service Type
10.3.1.2.2. By Molecule Type
10.3.1.2.3. By Therapeutic Area
10.3.1.2.4. By End User
10.3.2. Saudi Arabia Biosimilar Testing Services Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Service Type
10.3.2.2.2. By Molecule Type
10.3.2.2.3. By Therapeutic Area
10.3.2.2.4. By End User
10.3.3. UAE Biosimilar Testing Services Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Service Type
10.3.3.2.2. By Molecule Type
10.3.3.2.3. By Therapeutic Area
10.3.3.2.4. By End User
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments
13. Disruptions: Conflicts, Pandemics and Trade Barriers
