Biologics Safety Testing Market Share, Size, Trends, Industry Analysis Report, By Product & Service (Consumable, Instrument, Services); By Application; By Test Type; By Region; Segment Forecast, 2023-2032

Biologics Safety Testing Market Share, Size, Trends, Industry Analysis Report, By Product & Service (Consumable, Instrument, Services); By Application; By Test Type; By Region; Segment Forecast, 2023-2032

The global biologics safety testing market size is expected treach USD 11,949.49 million by 2032, according ta new study by Polaris Market Research. The report “Biologics Safety Testing Market Share, Size, Trends, Industry Analysis Report, By Product & Service (Consumable, Instrument, Services); By Application; By Test Type; By Region; Segment Forecast, 2023-2032” gives a detailed insight intcurrent market dynamics and provides analysis on future market growth.

The market for biologics safety testing requires stringent regulatory requirements, and agencies like (EMA) and the (FDA) demand that biologics undergextensive effectiveness and safety testing before receiving marketing authorization, positively influencing the market growth. The FDA has issued guidelines for various processes in biologics development like administrative guidelines, adverse effects, product derivation guidelines, application submission guidelines, clinical trials guidelines, CMC and GMP guidelines, Devices guidelines, and Labeling and Promotion guidelines.

New biologics are being developed due tincreased investment in R&D in the pharmaceutical and healthcare sectors, which has augmented market growth. For instance, in December 2022, Global pharma companies GSK, Takeda, and Sanofi announced their collaboration with the agency for the National University of Singapore; Nanyang Technological University, & the Singapore Institute of Technology texpand country's capacity for producing biologics.

The increasing trend towards personalized medicine and targeted therapies has led tthe development of biologics tailored tspecific patient populations, increasing the demand for biologics safety testing. The global biologics market is growing rapidly, which is expected tcontinue in the coming years, augmenting biologics safety testing. In November 2022, Abzena launched a new biologics testing facility in California. The facility enables stricter control over schedules and a thorough review of each integrated program tgive appropriate biosafety data de-risking and their partners' activities and assist with regulatory filings.

Biologics Safety Testing Market Report Highlights

Consumables segment is leading the global market owing tthe growing use of biologics drugs due tgrowing prevalence of the chronic diseases.

Vaccine development segment is expected tgrow at a high CAGR during the forecast period. The rising demand for the vaccines due tCovid-19 and other diseases is bolstering market growth.

Endotoxin test segment accounted for the largest market share in 2022 due tan increase in demand for innovative medical equipment, medicinal medicines, and biologics tperform many tests.

North America is the largest market due tthe presence of many small and large players in the region.

Key players include Charles River Laboratories, ThermFisher Scientific, SGS and Bioservice Scientific Laboratories.

Polaris Market Research has segmented the Biologics Safety Testing market report according ttest type, product & services, application, and region:

Biologics Safety Testing, Test Type Outlook (Revenue - USD Million, 2019 - 2032)

Endotoxin Test

Sterility Test

Mycoplasma Tests

Bioburden Tests

Residual Host-cell Proteins and DNA Detection Tests

Virus safety Test

Others

Biologics Safety Testing, Product & Services Outlook (Revenue - USD Million, 2019 - 2032)

Consumables

Instrument

Services

Biologics Safety Testing, Application Outlook (Revenue - USD Million, 2019 - 2032)

Vaccine Development & Manufacturing

Monoclonal Antibodies Development & Manufacturing

Cellular & Gene Therapy

Blood & Blood related Products Development and Manufacturing

Others

Biologics Safety Testing, Regional Outlook (Revenue - USD Million, 2019 - 2032)

North America

U.S.

Canada

Europe

Germany

UK

France

Italy

Spain

Russia

Netherlands

Asia Pacific

China

India

Japan

South Korea

Indonesia

Malaysia

Latin America

Argentina

Brazil

Mexico

Middle East & Africa

UAE

Saudi Arabia

Israel

South Africa


1. Introduction
1.1. Report Description
1.1.1. Objectives of the Study
1.1.2. Market Scope
1.1.3. Assumptions
1.2. Stakeholders
2. Executive Summary
2.1. Market Highlights
3. Research Methodology
3.1. Overview
3.1.1. Data Mining
3.2. Data Sources
3.2.1. Primary Sources
3.2.2. Secondary Sources
4. Global Biologics Safety Testing Market Insights
4.1. Biologics Safety Testing Market – Product & Services Snapshot
4.2. Biologics Safety Testing Market Dynamics
4.2.1. Drivers and Opportunities
4.2.1.1. Development of new and advanced instruments for biologics testing
4.2.1.2. Increasing investment in research and development in the pharmaceutical and biotechnology industries
4.2.2. Restraints and Challenges
4.2.2.1. High cost of biologics
4.3. Porter’s Five Forces Analysis
4.3.1. Bargaining Power of Suppliers (Moderate)
4.3.2. Threats of New Entrants: (Low)
4.3.3. Bargaining Power of Buyers (Moderate)
4.3.4. Threat of Substitute (Moderate)
4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. Biologics Safety Testing Market Product & Services Trends
4.6. Value Chain Analysis
4.7. COVID-19 Impact Analysis
5. Global Biologics Safety Testing Market, by Test Type
5.1. Key Findings
5.2. Introduction
5.2.1. Global Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
5.3. Endotoxin Test
5.3.1. Global Biologics Safety Testing Market, by Endotoxin Test, by Region, 2019-2032 (USD Million)
5.4. Sterility Test
5.4.1. Global Biologics Safety Testing Market, by Sterility Test, by Region, 2019-2032 (USD Million)
5.5. Mycoplasma Tests
5.5.1. Global Biologics Safety Testing Market, by Mycoplasma Tests, by Region, 2019-2032 (USD Million)
5.6. Bioburden Tests
5.6.1. Global Biologics Safety Testing Market, by Bioburden Tests, by Region, 2019-2032 (USD Million)
5.7. Residual Host-cell Proteins & DNA Detection Tests
5.7.1. Global Biologics Safety Testing Market, by Residual Host-cell Proteins & DNA Detection Tests, by Region, 2019-2032 (USD Million)
5.8. Virus safety Test
5.8.1. Global Biologics Safety Testing Market, by Virus safety Test, by Region, 2019-2032 (USD Million)
5.9. Others
5.9.1. Global Biologics Safety Testing Market, by Others, by Region, 2019-2032 (USD Million)
6. Global Biologics Safety Testing Market, by Application
6.1. Key Findings
6.2. Introduction
6.2.1. Global Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
6.3. Vaccine Development and Manufacturing
6.3.1. Global Biologics Safety Testing Market, by Vaccine Development and Manufacturing, by Region, 2019-2032 (USD Million)
6.4. Monoclonal Antibodies Development and Manufacturing
6.4.1. Global Biologics Safety Testing Market, by Monoclonal Antibodies Development and Manufacturing, by Region, 2019-2032 (USD Million)
6.5. Cellular & Gene Therapy Products Development and Manufacturing
6.5.1. Global Biologics Safety Testing Market, by Cellular & Gene Therapy Products Development and Manufacturing, by Region, 2019-2032 (USD Million)
6.6. Blood and Blood Products Development and Manufacturing
6.6.1. Global Biologics Safety Testing Market, by Blood and Blood Products Development and Manufacturing, by Region, 2019-2032 (USD Million)
6.7. Other Application
6.7.1. Global Biologics Safety Testing Market, by Other Application, by Region, 2019-2032 (USD Million)
7. Global Biologics Safety Testing Market, by Product & Services
7.1. Key Findings
7.2. Introduction
7.2.1. Global Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
7.3. Consumables
7.3.1. Global Biologics Safety Testing Market, by Consumables, By Region, 2019-2032 (USD Million)
7.4. Instrument
7.4.1. Global Biologics Safety Testing Market, by Instrument, By Region, 2019-2032 (USD Million)
7.5. Services
7.5.1. Global Biologics Safety Testing Market, by Services, By Region, 2019-2032 (USD Million)
8. Global Biologics Safety Testing Market, by Geography
8.1. Key findings
8.2. Introduction
8.2.1. Biologics Safety Testing Market Assessment, By Geography, 2019-2032 (USD Million)
8.3. Biologics Safety Testing Market – North America
8.3.1. North America: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.3.2. North America: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.3.3. North America: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.3.4. Biologics Safety Testing Market – U.S.
8.3.4.1. U.S.: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.3.4.2. U.S.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.3.4.3. U.S.: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.3.5. Biologics Safety Testing Market – Canada
8.3.5.1. Canada: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.3.5.2. Canada.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.3.5.3. Canada: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4. Biologics Safety Testing Market – Europe
8.4.1. Europe: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.2. Europe.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.3. Europe: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4.4. Biologics Safety Testing Market – UK
8.4.4.1. UK: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.4.2. UK.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.4.3. UK: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4.5. Biologics Safety Testing Market – France
8.4.5.1. France: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.5.2. France.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.5.3. France: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4.6. Biologics Safety Testing Market – Germany
8.4.6.1. Germany: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.6.2. Germany.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.6.3. Germany: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4.7. Biologics Safety Testing Market – Italy
8.4.7.1. Italy: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.7.2. Italy.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.7.3. Italy: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4.8. Biologics Safety Testing Market – Spain
8.4.8.1. Spain: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.8.2. Spain.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.8.3. Spain: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4.9. Biologics Safety Testing Market – Netherlands
8.4.9.1. Netherlands: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.9.2. Netherlands.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.9.3. Netherlands: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.4.10. Biologics Safety Testing Market – Russia
8.4.10.1. Russia: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.4.10.2. Russia.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.4.10.3. Russia: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.5. Biologics Safety Testing Market – Asia Pacific
8.5.1. Asia Pacific: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.5.2. Asia Pacific.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.5.3. Asia Pacific: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.5.4. Biologics Safety Testing Market – China
8.5.4.1. China: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.5.4.2. China.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.5.4.3. China: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.5.5. Biologics Safety Testing Market – India
8.5.5.1. India: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.5.5.2. India.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.5.5.3. India: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.5.6. Biologics Safety Testing Market – Malaysia
8.5.6.1. Malaysia: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.5.6.2. Malaysia.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.5.6.3. Malaysia: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.5.7. Biologics Safety Testing Market – Japan
8.5.7.1. Japan: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.5.7.2. Japan.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.5.7.3. Japan: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.5.8. Biologics Safety Testing Market – Indonesia
8.5.8.1. Indonesia: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.5.8.2. Indonesia.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.5.8.3. Indonesia: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.5.9. Biologics Safety Testing Market – South Korea
8.5.9.1. South Korea: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.5.9.2. South Korea.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.5.9.3. South Korea: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.6. Biologics Safety Testing Market – Middle East & Africa
8.6.1. Middle East & Africa: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.6.2. Middle East & Africa.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.6.3. Middle East & Africa: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.6.4. Biologics Safety Testing Market – Saudi Arabia
8.6.4.1. Saudi Arabia: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.6.4.2. Saudi Arabia.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.6.4.3. Saudi Arabia: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.6.5. Biologics Safety Testing Market – UAE
8.6.5.1. UAE: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.6.5.2. UAE.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.6.5.3. UAE: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.6.6. Biologics Safety Testing Market – Israel
8.6.6.1. Israel: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.6.6.2. Israel.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.6.6.3. Israel: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.6.7. Biologics Safety Testing Market – South Africa
8.6.7.1. South Africa: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.6.7.2. South Africa.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.6.7.3. South Africa: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.7. Biologics Safety Testing Market – Latin America
8.7.1. Latin America: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.7.2. Latin America.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.7.3. Latin America: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.7.4. Biologics Safety Testing Market – Mexico
8.7.4.1. Mexico: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.7.4.2. Mexico.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.7.4.3. Mexico: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.7.5. Biologics Safety Testing Market – Brazil
8.7.5.1. Brazil: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.7.5.2. Brazil.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.7.5.3. Brazil: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
8.7.6. Biologics Safety Testing Market – Argentina
8.7.6.1. Argentina: Biologics Safety Testing Market, by Test Type, 2019-2032 (USD Million)
8.7.6.2. Argentina.: Biologics Safety Testing Market, by Product & Services, 2019-2032 (USD Million)
8.7.6.3. Argentina: Biologics Safety Testing Market, by Application, 2019-2032 (USD Million)
9. Competitive Landscape
9.1. Expansion and Acquisition Analysis
9.1.1. Expansion
9.1.2. Acquisitions
9.2. Partnerships/Collaborations/Agreements/Exhibitions
10. Company Profiles
10.1. Avance Biosciences
10.1.1. Company Overview
10.1.2. Financial Performance
10.1.3. Product Benchmarking
10.1.4. Recent Development
10.2. Charles River Laboratories
10.2.1. Company Overview
10.2.2. Financial Performance
10.2.3. Product Benchmarking
10.2.4. Recent Development
10.3. Thermo Fisher Scientific
10.3.1. Company Overview
10.3.2. Financial Performance
10.3.3. Product Benchmarking
10.3.4. Recent Development
10.4. Merck
10.4.1. Company Overview
10.4.2. Financial Performance
10.4.3. Product Benchmarking
10.4.4. Recent Development
10.5. Creative Biogene
10.5.1. Company Overview
10.5.2. Financial Performance
10.5.3. Product Benchmarking
10.5.4. Recent Development
10.6. Eurofins Scientific
10.6.1. Company Overview
10.6.2. Financial Performance
10.6.3. Product Benchmarking
10.6.4. Recent Development
10.7. Lonza Group
10.7.1. Company Overview
10.7.2. Financial Performance
10.7.3. Product Benchmarking
10.7.4. Recent Development
10.8. Maravai LifeSciences
10.8.1. Company Overview
10.8.2. Financial Performance
10.8.3. Product Benchmarking
10.8.4. Recent Development
10.9. WuXi AppTec
10.9.1. Company Overview
10.9.2. Financial Performance
10.9.3. Product Benchmarking
10.9.4. Recent Development
10.10. Pace Analytical Services
10.10.1. Company Overview
10.10.2. Financial Performance
10.10.3. Product Benchmarking
10.10.4. Recent Development
10.11. Eurofins Scientific
10.11.1. Company Overview
10.11.2. Financial Performance
10.11.3. Product Benchmarking
10.11.4. Recent Development

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