시장보고서

상품코드

1555687

생물학적 제제 안전성 시험 시장 : 제품 유형별, 시험 방법별, 시험 유형별, 최종 사용자별, 국가별, 지역별 - 산업 분석, 시장 규모, 시장 점유율, 예측(2024-2032년)

Biologics Safety Testing Market, By Product Type, By Test Method, By Test Type, By End-User, By Country, and By Region - Industry Analysis, Market Size, Market Share & Forecast from 2024-2032

발행일: 2024년 08월 | 리서치사:

AnalystView Market Insights | 페이지 정보: 영문 345 Pages | 배송안내 : 2-3일 (영업일 기준)

샘플 요청 목록에 추가

※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

보고서 하이라이트

생물학적 제제 안전성 시험 시장 규모는 2023년 38억 7,643만 달러로 2024년부터 2032년까지 복합 연간 성장률(CAGR) 11.2%로 확대될 전망입니다.

생물학적 제제 안전성 시험 시장 : 시장 역학

질병 치료에서 생물 로직 채택 확대는 종합적인 안전성 테스트 솔루션 수요를 촉진할 전망입니다

질병 치료에 바이오 로직 채택 확대는 종합적인 안전성 테스트 솔루션의 필요성을 크게 뒷받침하고 있습니다. 바이오로직이 암, 자가면역질환, 희소질환 등의 치료법에 계속 혁명을 일으키는 중, 그 안전성과 유효성을 확보하는 것이 가장 중요한 과제가 되고 있습니다. 예를 들어, FDA는 생물학적 제제 승인의 급증을 보고하고 있으며, 생물학적 제제는 현재 신약 승인 전체의 거의 30%를 차지하고 있습니다. 세계보건기구(WHO)와 같은 조직은 오염을 방지하고 환자의 안전을 보장하기 위해 엄격한 안전성 시험 프로토콜의 중요성을 강조합니다. 시장에 진입하는 바이오시밀러 증가는 이들 제품이 기준 바이오로직과 동일한 엄격한 기준을 충족해야 하기 때문에 견고한 안전성 시험의 필요성을 강조합니다.

생물학적 제제 안전성 시험 시장 : 주요 인사이트력

우리 리서치 애널리스트의 분석에 따르면 시장은 예측 기간 동안에 약 11.2%의 복합 연간 성장률(CAGR)로 매년 성장할 것으로 추정됩니다.

제품 유형별로 키트 및 시약은 2023년에 가장 큰 시장 점유율을 보여줄 것으로 예상됩니다.

검사법의 세분화에 근거하여, 2023년에는 신속 검사가 주요 유형이었습니다.

검사 유형별로는 2023년에는 엔도톡신 검사가 주요 유형으로

지역별로는 북미가 2023년 수익으로 이끌었습니다.

생물학적 제제 안전성 시험 시장 : 세분화 분석 :

생물학적 제제 안전성 시험 시장은 제품 유형, 테스트 방법, 테스트 유형, 최종 사용자 및 지역에 따라 세분화됩니다.

시장은 제품 유형에 따라 네 가지 범주로 나뉩니다. 장비, 키트 및 시약, 서비스, 소프트웨어입니다. 키트 & 시약은 검사 과정에서 필수적인 역할을 하기 때문에 우선순위가 가장 높고 중요한 기능을 가진 장비가 됩니다. 다음으로 우선 순위가 낮은 것은 소프트웨어로 데이터 관리를 지원합니다.

시장은 검사 방법에 따라 세 가지 범주로 나뉩니다. 전통적 검사법, 신속 검사법, 체외 검사법입니다. 신속검사는 신속하게 결과를 내는 효율이 우수하며, 정밀하고 관리된 환경을 제공하는 체외검사가 이어집니다. 전통적인 검사는 우선 순위가 가장 낮고 종종 시간이 오래 걸리고 선진적이지 않습니다.

생물학적 제제 안전성 시험 시장 : 지리적 인사이트

북미는 주요 바이오 의약품 기업의 존재, 첨단 건강 관리 인프라, FDA와 같은 기관에 의해 확립된 엄격한 규제 프레임 워크에 의해 지원되고 시장을 독점하고 있습니다. 유럽은 독일, 영국, 프랑스 등의 국가들이 견고한 제약 부문과 유럽 의약품청(EMA)이 정하는 엄격한 안전 기준의 준수에 의해 주도하고 있습니다. 아시아태평양에서는 특히 중국, 일본, 인도 등 국가에서 바이오 의약 연구에 대한 투자 증가, 의료 지출 증가, 바이오 시밀러의 상승이 추풍으로 시장이 급속히 확대되고 있습니다. 일본의 PMDA나 중국의 NMPA 등 이 지역의 규제 상황의 진전도 시장 성장에 기여하고 있습니다. 한편 라틴아메리카와 중동 및 아프리카는 다른 지역에 비해 속도가 느린 것, 헬스 케어 인프라 개선과 생물학적 제제 안전성 시험의 인지도 향상에 견인되어 완만한 시장 개척을 볼 수 있습니다.

생물학적 제제 안전성 시험 시장 : 경쟁 구도:

Thermo Fisher Scientific, Merck KGaA 및 Charles River Laboratories와 같은 주요 기업은 무균 시험, 엔도톡신 시험 및 마이코플라스마 검출을 포함한 종합적인 안전성 테스트 서비스 및 제품을 제공하며 시장을 독점하고 있습니다. 이 업계의 선두 주자들은 연구 능력을 강화하고 포트폴리오를 확대하기 위해 지속적으로 연구 개발에 투자하고 있습니다. 또한 Saltrius AG와 Lonza Group과 같은 기업들은 시장에서의 입지를 강화하고 새로운 기술에 접근하기 위해 중소기업 인수와 파트너십 형성에 주력하고 있습니다. 경쟁 구도은 특히 아시아태평양의 신규 기업 진입에 의해 특징 지어집니다. 아시아태평양에서는 현지 기업들이 비용면에서 우세하고 성장하는 바이오 의약품 시장을 활용하고 있습니다. 규제 요건이 강화되고 생물학적 수요가 증가함에 따라 경쟁이 더욱 심화되고 안전성 시험법의 진보가 촉진되고 각 회사는 품질과 혁신성에 의한 차별화를 촉구할 것으로 예상됩니다.

소개
북미
- 개요
- 북미의 주요 제조업체
- 미국
- 캐나다
유럽
- 개요
- 유럽의 주요 제조업체
- 독일
- 이탈리아
- 영국
- 프랑스
- 러시아
- 네덜란드
- 스웨덴
- 폴란드
- 기타
아시아태평양(APAC)
- 개요
- 아시아태평양의 주요 제조업체
- 인도
- 중국
- 일본
- 한국
- 호주
- 태국
- 인도네시아
- 필리핀
- 기타
라틴아메리카
- 개요
- 라틴아메리카의 주요 제조업체
- 브라질
- 멕시코
- 아르헨티나
- 콜롬비아
- 기타
중동 및 아프리카
- 개요
- 중동 및 아프리카의 주요 제조업체
- 사우디아라비아
- 아랍에미리트(UAE)
- 이스라엘
- 터키
- 알제리
- 이집트
- 기타

제12장 주요 벤더 분석 - 생물학적 제제 안전성 시험 업계

경쟁 대시보드
기업 프로파일
- BioOutsource Ltd.(Sartorius)
- Cambrex Corporation
- Charles River Biopharmaceutical Services
- Charles River Laboratories International, Inc.
- Cytovance Biologics Inc.
- Eurofins Lancaster Laboratories
- Eurofins Scientific SE
- InvivoGen
- Lonza Group Ltd.
- Merck KGaA
- Pace Analytical Services, LLC
- Sartorius AG
- SGS SA
- Thermo Fisher Scientific Inc.
- Toxikon Corporation
- WuXi AppTec
- Others

제13장 애널리스트의 전방위 전망

BJH 24.10.11

REPORT HIGHLIGHT

Biologics Safety Testing Market size was valued at USD 3,876.43 Million in 2023, expanding at a CAGR of 11.2% from 2024 to 2032.

The Biologics Safety Testing Market, essential for ensuring the safety and efficacy of biologic products, encompasses various assays and protocols to detect contaminants and ensure compliance with regulatory standards. The increasing adoption of biologics in disease treatment, advancements in cell culture technology, and stringent regulatory frameworks are contributing to the expansion of this market. However, the high costs associated with safety testing procedures and the complexity of biological products pose significant challenges. Despite these challenges, the market presents opportunities in the form of technological advancements in testing methods and the rising demand for biosimilars. Notably, the biologics sector accounts for over 40% of the pharmaceutical pipeline, highlighting the growing need for comprehensive safety testing solutions.

Biologics Safety Testing Market- Market Dynamics

Growing Adoption of Biologics in Disease Treatment Fuels Demand for Comprehensive Safety Testing Solutions

The rising adoption of biologics in disease treatment is significantly driving the need for comprehensive safety testing solutions. As biologics continue to revolutionize therapies for conditions like cancer, autoimmune disorders, and rare diseases, ensuring their safety and efficacy has become paramount. For instance, the FDA has reported a surge in biologic drug approvals, with biologics now representing nearly 30% of all new drug approvals. Organizations like the World Health Organization (WHO) have emphasized the importance of rigorous safety testing protocols to prevent contamination and ensure patient safety. The increasing number of biosimilars entering the market also underscores the need for robust safety testing, as these products must meet the same stringent standards as their reference biologics.

Biologics Safety Testing Market- Key Insights

As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 11.2% over the forecast period (2024-2032)

Based on product type segmentation, Kits & Reagents was predicted to show maximum market share in the year 2023

Based on Test Method segmentation, Rapid Tests were the leading type in 2023

Based on Test Type segmentation, Endotoxin Testing was the leading type in 2023

Based on region, North America was the leading revenue generator in 2023

Biologics Safety Testing Market- Segmentation Analysis:

The Global Biologics Safety Testing Market is segmented based on Product Type, Test Method, Test Type, End-User, and Region.

The market is divided into four categories based on product type: Instruments, Kits & Reagents, Services, and Software. Kits & Reagents hold the highest priority due to their essential role in testing processes, followed by Instruments for their critical function. Services come next, offering specialized expertise, while Software holds the lowest priority, supporting data management.

The market is divided into three categories based on Test Methods: Traditional Tests, Rapid Tests, and In Vitro Tests. Rapid Tests are prioritized for their efficiency in delivering quick results, followed by In Vitro Tests, which offer precise and controlled environments. Traditional Tests hold the lowest priority, often being time-consuming and less advanced.

Biologics Safety Testing Market- Geographical Insights

North America dominates the market, supported by the presence of major biopharmaceutical companies, advanced healthcare infrastructure, and stringent regulatory frameworks established by agencies like the FDA. Europe follows closely, with countries like Germany, the UK, and France leading due to their robust pharmaceutical sectors and adherence to strict safety standards set by the European Medicines Agency (EMA). In Asia-Pacific, the market is rapidly expanding, fueled by increasing investments in biopharmaceutical research, growing healthcare expenditure, and the rise of biosimilars, particularly in countries like China, Japan, and India. The region's evolving regulatory landscape, such as Japan's PMDA and China's NMPA, is also contributing to market growth. Meanwhile, Latin America and the Middle East & Africa are witnessing gradual market development, driven by improving healthcare infrastructure and rising awareness of biologics safety testing, albeit at a slower pace compared to other regions.

Biologics Safety Testing Market- Competitive Landscape:

Leading companies like Thermo Fisher Scientific, Merck KGaA, and Charles River Laboratories dominate the market, offering a comprehensive range of safety testing services and products, including sterility testing, endotoxin testing, and mycoplasma detection. These industry giants continually invest in R&D to enhance their testing capabilities and expand their portfolios. Additionally, companies like Sartorius AG and Lonza Group are focusing on acquiring smaller firms and forming partnerships to strengthen their market position and access emerging technologies. The competitive landscape is also marked by the entry of new players, particularly in the Asia-Pacific region, where local companies are leveraging cost advantages and growing biopharmaceutical markets. As regulatory requirements tighten and the demand for biologics increases, the competition is expected to further intensify, driving advancements in safety testing methods and pushing companies to differentiate themselves through quality and innovation.

Recent Developments:

In December 2022, WuXi Biologics launched a new biosafety testing center in Shanghai, enhancing its capabilities in the biopharmaceutical sector. This facility aims to support the development of safer and more effective therapies for global health challenges.

In July 2024, SGS North America expanded its biologics testing capabilities at Lincolnshire Center of Excellence, enhancing instrumentation and expertise. This facility supports biopharmaceutical companies in drug development, ensuring compliance with regulatory guidelines and accelerating market entry for biologics products.

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

GLOBAL BIOLOGICS SAFETY TESTING MARKET KEY PLAYERS- DETAILED COMPETITIVE INSIGHTS

BioOutsource Ltd. (Sartorius)
Cambrex Corporation
Charles River Biopharmaceutical Services
Charles River Laboratories International, Inc.
Cytovance Biologics Inc.
Eurofins Lancaster Laboratories
Eurofins Scientific SE
InvivoGen
Lonza Group Ltd.
Merck KGaA
Pace Analytical Services, LLC
Sartorius AG
SGS S.A.
Thermo Fisher Scientific Inc.
Toxikon Corporation
WuXi AppTec
Others

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT TYPE- MARKET ANALYSIS, 2019 - 2032

Instruments
Kits & Reagents
Services
Software

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY TEST METHOD- MARKET ANALYSIS, 2019 - 2032

Traditional Tests
Rapid Tests
In Vitro Tests

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE- MARKET ANALYSIS, 2019 - 2032

Sterility Testing
Endotoxin Testing
Mycoplasma Testing
Bioburden Testing
Residual Host Contaminant Detection

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY END-USER- MARKET ANALYSIS, 2019 - 2032

Pharmaceutical & Biotechnology Companies
Contract Research Organizations (CROs)
Academic & Research Institutes
Regulatory Bodies

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY REGION- MARKET ANALYSIS, 2019 - 2032

North America
The U.S.
Canada
Europe
Germany
France
Italy
Spain
United Kingdom
Russia
Netherlands
Sweden
Poland
Rest of Europe
Asia Pacific
India
China
South Korea
Japan
Australia
Thailand
Indonesia
Philippines
Rest of APAC
Latin America
Brazil
Mexico
Argentina
Colombia
Rest of LATAM
The Middle East and Africa
Saudi Arabia
United Arab Emirates
Israel
Turkey
Algeria
Egypt
Rest of MEA

1. Biologics Safety Testing Market Overview

1.1. Study Scope
1.2. Market Estimation Years

2. Executive Summary

2.1. Market Snippet
- 2.1.1. Biologics Safety Testing Market Snippet by Product Type
- 2.1.2. Biologics Safety Testing Market Snippet by Test Method
- 2.1.3. Biologics Safety Testing Market Snippet by Test Type
- 2.1.4. Biologics Safety Testing Market Snippet by End-User
- 2.1.5. Biologics Safety Testing Market Snippet by Country
- 2.1.6. Biologics Safety Testing Market Snippet by Region
2.2. Competitive Insights

3. Biologics Safety Testing Key Market Trends

3.1. Biologics Safety Testing Market Drivers
- 3.1.1. Impact Analysis of Market Drivers
3.2. Biologics Safety Testing Market Restraints
- 3.2.1. Impact Analysis of Market Restraints
3.3. Biologics Safety Testing Market Opportunities
3.4. Biologics Safety Testing Market Future Trends

4. Biologics Safety Testing Industry Study

4.1. PEST Analysis
4.2. Porter's Five Forces Analysis
4.3. Growth Prospect Mapping
4.4. Regulatory Framework Analysis

5. Biologics Safety Testing Market: COVID-19 Impact Analysis

5.1. Pre-COVID-19 Impact Analysis
5.2. Post-COVID-19 Impact Analysis
- 5.2.1. Top Performing Segments
- 5.2.2. Marginal Growth Segments
- 5.2.3. Top Looser Segments
- 5.2.4. Marginal Loss Segments

6. Biologics Safety Testing Market Landscape

6.1. Biologics Safety Testing Market Share Analysis, 2023
6.2. Breakdown Data, by Key Manufacturer
- 6.2.1. Established Players' Analysis
- 6.2.2. Emerging Players' Analysis

7. Biologics Safety Testing Market - By Product Type

7.1. Overview
- 7.1.1. Segment Share Analysis, By Product Type, 2023 & 2032 (%)
- 7.1.2. Instruments
- 7.1.3. Kits & Reagents
- 7.1.4. Services
- 7.1.5. Software

8. Biologics Safety Testing Market - By Test Method

8.1. Overview
- 8.1.1. Segment Share Analysis, By Test Method, 2023 & 2032 (%)
- 8.1.2. Traditional Tests
- 8.1.3. Rapid Tests
- 8.1.4. In Vitro Tests

9. Biologics Safety Testing Market - By Test Type

9.1. Overview
- 9.1.1. Segment Share Analysis, By Test Type, 2023 & 2032 (%)
- 9.1.2. Sterility Testing
- 9.1.3. Endotoxin Testing
- 9.1.4. Mycoplasma Testing
- 9.1.5. Bioburden Testing
- 9.1.6. Residual Host Contaminant Detection

10. Biologics Safety Testing Market - By End-User

10.1. Overview
- 10.1.1. Segment Share Analysis, By End-User, 2023 & 2032 (%)
- 10.1.2. Pharmaceutical & Biotechnology Companies
- 10.1.3. Contract Research Organizations (CROs)
- 10.1.4. Academic & Research Institutes
- 10.1.5. Regulatory Bodies

11. Biologics Safety Testing Market- By Geography

11.1. Introduction
- 11.1.1. Segment Share Analysis, By Geography, 2023 & 2032 (%)
11.2. North America
- 11.2.1. Overview
- 11.2.2. Biologics Safety Testing Key Manufacturers in North America
- 11.2.3. North America Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
- 11.2.4. North America Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
- 11.2.5. North America Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
- 11.2.6. North America Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
- 11.2.7. North America Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.2.8. U.S.
  - 11.2.8.1. Overview
  - 11.2.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.2.8.3. U.S. Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.2.8.4. U.S. Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.2.8.5. U.S. Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.2.8.6. U.S. Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.2.9. Canada
  - 11.2.9.1. Overview
  - 11.2.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.2.9.3. Canada Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.2.9.4. Canada Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.2.9.5. Canada Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.2.9.6. Canada Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
11.3. Europe
- 11.3.1. Overview
- 11.3.2. Biologics Safety Testing Key Manufacturers in Europe
- 11.3.3. Europe Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
- 11.3.4. Europe Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
- 11.3.5. Europe Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
- 11.3.6. Europe Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
- 11.3.7. Europe Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.8. Germany
  - 11.3.8.1. Overview
  - 11.3.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.8.3. Germany Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.8.4. Germany Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.8.5. Germany Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.8.6. Germany Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.9. Italy
  - 11.3.9.1. Overview
  - 11.3.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.9.3. Italy Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.9.4. Italy Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.9.5. Italy Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.9.6. Italy Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.10. United Kingdom
  - 11.3.10.1. Overview
  - 11.3.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.10.3. United Kingdom Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.10.4. United Kingdom Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.10.5. United Kingdom Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.10.6. United Kingdom Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.11. France
  - 11.3.11.1. Overview
  - 11.3.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.11.3. France Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.11.4. France Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.11.5. France Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.11.6. France Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.12. Russia
  - 11.3.12.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.12.2. Russia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.12.3. Russia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.12.4. Russia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.12.5. Russia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.13. Netherlands
  - 11.3.13.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.13.2. Netherlands Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.13.3. Netherlands Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.13.4. Netherlands Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.13.5. Netherlands Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.14. Sweden
  - 11.3.14.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.14.2. Sweden Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.14.3. Sweden Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.14.4. Sweden Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.14.5. Sweden Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.15. Poland
  - 11.3.15.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.15.2. Poland Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.15.3. Poland Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.15.4. Poland Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.15.5. Poland Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.3.16. Rest of Europe
  - 11.3.16.1. Overview
  - 11.3.16.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.3.16.3. Rest of the Europe Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.3.16.4. Rest of the Europe Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.3.16.5. Rest of the Europe Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.3.16.6. Rest of the Europe Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
11.4. Asia Pacific (APAC)
- 11.4.1. Overview
- 11.4.2. Biologics Safety Testing Key Manufacturers in Asia Pacific
- 11.4.3. Asia Pacific Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
- 11.4.4. Asia Pacific Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
- 11.4.5. Asia Pacific Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
- 11.4.6. Asia Pacific Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
- 11.4.7. Asia Pacific Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.8. India
  - 11.4.8.1. Overview
  - 11.4.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.8.3. India Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.8.4. India Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.8.5. India Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.8.6. India Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.9. China
  - 11.4.9.1. Overview
  - 11.4.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.9.3. China Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.9.4. China Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.9.5. China Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.9.6. China Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.10. Japan
  - 11.4.10.1. Overview
  - 11.4.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.10.3. Japan Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.10.4. Japan Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.10.5. Japan Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.10.6. Japan Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.11. South Korea
  - 11.4.11.1. Overview
  - 11.4.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.11.3. South Korea Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.11.4. South Korea Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.11.5. South Korea Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.11.6. South Korea Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.12. Australia
  - 11.4.12.1. Overview
  - 11.4.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.12.3. Australia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.12.4. Australia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.12.5. Australia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.12.6. Australia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.13. Thailand
  - 11.4.13.1. Overview
  - 11.4.13.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.13.3. Thailand Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.13.4. Thailand Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.13.5. Thailand Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.13.6. Thailand Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.14. Indonesia
  - 11.4.14.1. Overview
  - 11.4.14.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.14.3. Indonesia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.14.4. Indonesia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.14.5. Indonesia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.14.6. Indonesia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.15. Philippines
  - 11.4.15.1. Overview
  - 11.4.15.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.15.3. Philippines Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.15.4. Philippines Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.15.5. Philippines Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.15.6. Philippines Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.4.16. Rest of APAC
  - 11.4.16.1. Overview
  - 11.4.16.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.4.16.3. Rest of APAC Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.4.16.4. Rest of APAC Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.4.16.5. Rest of APAC Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.4.16.6. Rest of APAC Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
11.5. Latin America
- 11.5.1. Overview
- 11.5.2. Biologics Safety Testing Key Manufacturers in Latin America
- 11.5.3. Latin America Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
- 11.5.4. Latin America Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
- 11.5.5. Latin America Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
- 11.5.6. Latin America Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
- 11.5.7. Latin America Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.5.8. Brazil
  - 11.5.8.1. Overview
  - 11.5.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.5.8.3. Brazil Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.5.8.4. Brazil Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.5.8.5. Brazil Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.5.8.6. Brazil Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.5.9. Mexico
  - 11.5.9.1. Overview
  - 11.5.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.5.9.3. Mexico Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.5.9.4. Mexico Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.5.9.5. Mexico Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.5.9.6. Mexico Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.5.10. Argentina
  - 11.5.10.1. Overview
  - 11.5.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.5.10.3. Argentina Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.5.10.4. Argentina Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.5.10.5. Argentina Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.5.10.6. Argentina Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.5.11. Colombia
  - 11.5.11.1. Overview
  - 11.5.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.5.11.3. Colombia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.5.11.4. Colombia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.5.11.5. Colombia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.5.11.6. Colombia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.5.12. Rest of LATAM
  - 11.5.12.1. Overview
  - 11.5.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.5.12.3. Rest of LATAM Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.5.12.4. Rest of LATAM Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.5.12.5. Rest of LATAM Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.5.12.6. Rest of LATAM Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
11.6. Middle East and Africa
- 11.6.1. Overview
- 11.6.2. Biologics Safety Testing Key Manufacturers in Middle East and Africa
- 11.6.3. Middle East and Africa Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
- 11.6.4. Middle East and Africa Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
- 11.6.5. Middle East and Africa Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
- 11.6.6. Middle East and Africa Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
- 11.6.7. Middle East and Africa Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.6.8. Saudi Arabia
  - 11.6.8.1. Overview
  - 11.6.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.6.8.3. Saudi Arabia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.6.8.4. Saudi Arabia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.6.8.5. Saudi Arabia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.6.8.6. Saudi Arabia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.6.9. United Arab Emirates
  - 11.6.9.1. Overview
  - 11.6.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.6.9.3. United Arab Emirates Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.6.9.4. United Arab Emirates Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.6.9.5. United Arab Emirates Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.6.9.6. United Arab Emirates Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.6.10. Israel
  - 11.6.10.1. Overview
  - 11.6.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.6.10.3. Israel Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.6.10.4. Israel Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.6.10.5. Israel Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.6.10.6. Israel Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.6.11. Turkey
  - 11.6.11.1. Overview
  - 11.6.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.6.11.3. Turkey Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.6.11.4. Turkey Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.6.11.5. Turkey Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.6.11.6. Turkey Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.6.12. Algeria
  - 11.6.12.1. Overview
  - 11.6.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.6.12.3. Algeria Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.6.12.4. Algeria Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.6.12.5. Algeria Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.6.12.6. Algeria Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.6.13. Egypt
  - 11.6.13.1. Overview
  - 11.6.13.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.6.13.3. Egypt Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.6.13.4. Egypt Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.6.13.5. Egypt Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.6.13.6. Egypt Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
- 11.6.14. Rest of MEA
  - 11.6.14.1. Overview
  - 11.6.14.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
  - 11.6.14.3. Rest of MEA Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
  - 11.6.14.4. Rest of MEA Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
  - 11.6.14.5. Rest of MEA Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
  - 11.6.14.6. Rest of MEA Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)

12. Key Vendor Analysis- Biologics Safety Testing Industry

12.1. Competitive Dashboard
12.2. Company Profiles
- 12.2.1. BioOutsource Ltd. (Sartorius)
- 12.2.2. Cambrex Corporation
- 12.2.3. Charles River Biopharmaceutical Services
- 12.2.4. Charles River Laboratories International, Inc.
- 12.2.5. Cytovance Biologics Inc.
- 12.2.6. Eurofins Lancaster Laboratories
- 12.2.7. Eurofins Scientific SE
- 12.2.8. InvivoGen
- 12.2.9. Lonza Group Ltd.
- 12.2.10. Merck KGaA
- 12.2.11. Pace Analytical Services, LLC
- 12.2.12. Sartorius AG
- 12.2.13. SGS S.A.
- 12.2.14. Thermo Fisher Scientific Inc.
- 12.2.15. Toxikon Corporation
- 12.2.16. WuXi AppTec
- 12.2.17. Others

13. 360 Degree Analyst View

14. Appendix

14.1. Research Methodology
14.2. References
14.3. Abbreviations
14.4. Disclaimer
14.5. Contact Us