Product Code: PM3097
The global biologics safety testing market size is expected to reach USD 11,949.49 million by 2032, according to a 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 into current 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 undergo extensive 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 to increased 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 to expand country's capacity for producing biologics.
The increasing trend towards personalized medicine and targeted therapies has led to the development of biologics tailored to specific patient populations, increasing the demand for biologics safety testing. The global biologics market is growing rapidly, which is expected to continue 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 to give 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 to the growing use of biologics drugs due to growing prevalence of the chronic diseases.
Vaccine development segment is expected to grow at a high CAGR during the forecast period. The rising demand for the vaccines due to COVID-19 and other diseases is bolstering market growth.
Endotoxin test segment accounted for the largest market share in 2022 due to an increase in demand for innovative medical equipment, medicinal medicines, and biologics to perform many tests.
North America is the largest market due to the presence of many small and large players in the region.
Key players include Charles River Laboratories, Thermo Fisher Scientific, SGS and Bioservice Scientific Laboratories.
Polaris Market Research has segmented the Biologics Safety Testing market report according to test 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
Table of Contents
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
3. Research Methodology
- 3.1. Overview
- 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