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Biologics Safety Testing Market Trends and Forecast

The future of the global biologics safety testing market looks promising with opportunities in vaccine development and manufacturing, monoclonal antibodies development and manufacturing, cellular & gene therapy product development and manufacturing, and blood and blood product development and manufacturing. The global biologics safety testing market is expected to reach an estimated $8.2 billion by 2028 with a CAGR of 12.8% from 2023 to 2028. The major drivers for this market are increasing pharmaceutical and biotechnology industry, rising concerns over cell culture contamination, and growing R&D investment in life science segment.
Biologics Safety Testing Market by Type, Product & Services, and Application
 
A more than 150-page report is developed to help in your business decisions. A sample figure with some insights is shown below. 
Biologics Safety Testing Market by Segments

Biologics Safety Testing Market by Segment

The study includes trends and forecast for the global biologics safety testing market by type, product & services, application, and region, as follows:

Biologics Safety Testing Market by Type [Value ($B) Shipment Analysis from 2017 to 2028]:

  • Endotoxin Test
  • Sterility Test
  • Mycoplasma Tests
  • Bioburden Tests
  • Residual Host-cell Proteins & DNA Detection Tests
  • Virus safety Test
  • Others

Biologics Safety Testing Market by Product & Services [Value ($B) Shipment Analysis from 2017 to 2028]:

  • Consumables
  • Instrument
  • Services

Biologics Safety Testing Market by Application [Value ($B) Shipment Analysis from 2017 to 2028]:

  • Vaccine Development and Manufacturing
  • Monoclonal Antibodies Development and Manufacturing
  • Cellular & Gene Therapy Product Development and Manufacturing
  • Blood and Blood Product Development and Manufacturing
  • Others

Biologics Safety Testing Market by Region [Value ($B) Shipment Analysis from 2017 to 2028]:

  • North America
  • Europe
  • Asia Pacific
  • The Rest of the World

List of Biologics Safety Testing Companies

Companies in the market compete on the basis of type quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies, biologics safety testing companies cater to increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduced production costs, and expand their customer base. Some of the biologics safety testing companies profiled in this report includes- 
 

Biologics Safety Testing Market Insights

  • Lucintel forecasts that residual host-cell proteins & DNA detection tests are expected to witness the highest growth over the forecast period as it enables the biopharmaceutical manufacturers to demonstrate the safety and purity of their products before the regulatory authorities by testing for residual host cell proteins and DNA.
  • Vaccine development and manufacturing is expected to witness the highest growth over the forecast period due to increasing number of infectious diseases and growing necessity of biologics safety testing for quality assurance.
  • North America is expected to remain the largest region over the forecast period due to increasing investment in R&D in the biopharmaceutical industry, growing number of biological products and novel drugs, and rising awareness among population towards product safety.

Features of the Biologics Safety Testing Market

  • Market Size Estimates: Biologics safety testing market size estimation in terms of value ($B)
  • Trend and Forecast Analysis: Market trends (2017-2022) and forecast (2023-2028) by various segments and regions.
  • Segmentation Analysis: Biologics safety testing market size by various segments, such as type, product & services, application, and region
  • Regional Analysis: Biologics safety testing market breakdown by North America, Europe, Asia Pacific, and the Rest of the World.
  • Growth Opportunities: Analysis on growth opportunities in different types, product & services, applications, and regions for the biologics safety testing market.
  • Strategic Analysis: This includes M&A, new type development, and competitive landscape for the biologics safety testing market.
  • Analysis of competitive intensity of the industry based on Porter’s Five Forces model.

FAQ

Q1. What is the biologics safety testing market size?
Answer: The global biologics safety testing market is expected to reach an estimated $8.2 billion by 2028.
Q2. What is the growth forecast for biologics safety testing market?
Answer: The global biologics safety testing market is expected to grow with a CAGR of 12.8% from 2023 to 2028.
Q3. What are the major drivers influencing the growth of the biologics safety testing market?
Answer: The major drivers for this market are increasing pharmaceutical and biotechnology industry, rising concerns over cell culture contamination, and growing R&D investment in life science segment.
Q4. What are the major segments for biologics safety testing market?
Answer: The future of the biologics safety testing market looks promising with opportunities in vaccine development and manufacturing, monoclonal antibodies development and manufacturing, cellular & gene therapy product development and manufacturing, and blood and blood product development and manufacturing.
Q5. Who are the key biologics safety testing companies?
Answer: Some of the key biologics safety testing companies is as follows:
  • Charles River Laboratories
  • Lonza
  • Thermo Fisher Scientific
  • Merck KGaA
  • F. Hoffmann-La Roche
 
Q6. Which biologics safety testing segment will be the largest in future?
Answer: Lucintel forecasts that residual host-cell proteins & DNA detection tests are expected to witness the highest growth over the forecast period as it enables the biopharmaceutical manufacturers to demonstrate the safety and purity of their products before the regulatory authorities by testing for residual host cell proteins and DNA.
Q7. In biologics safety testing market, which region is expected to be the largest in next 5 years?
Answer: North America is expected to remain the largest region over the forecast period due to increasing investment in R&D in the biopharmaceutical industry, growing number of biological products and novel drugs, and rising awareness among population towards product safety.
Q8. Do we receive customization in this report?
Answer: Yes, Lucintel provides 10% Customization Without any Additional Cost.

This report answers following 11 key questions

Q.1. What are some of the most promising, high-growth opportunities for the biologics safety testing market by type (endotoxin test, sterility test, mycoplasma tests, bioburden tests, residual host-cell proteins & DNA detection tests, virus safety test, and others), product & service (consumables, instrument, and services), application (vaccine development and manufacturing, monoclonal antibodies development and manufacturing, cellular & gene therapy product development and manufacturing, blood and blood product development and manufacturing, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
Q.2. Which segments will grow at a faster pace and why?
Q.3. Which region will grow at a faster pace and why?
Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
Q.5. What are the business risks and competitive threats in this market?
Q.6. What are the emerging trends in this market and the reasons behind them?
Q.7. What are some of the changing demands of customers in the market?
Q.8. What are the new developments in the market? Which companies are leading these developments?
Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or type substitution?
Q.11.  What M&A activity has occurred in the last five years and what has its impact been on the industry?
 
For any questions related to biologics safety testing market or related biologics safety testing companies, biologics safety testing market size, biologics safety testing market share, biologics safety testing analysis, write Lucintel analyst at email: helpdesk@lucintel.com we will be glad to get back to you soon.
 
Table of Contents
 
1. Executive Summary
 
2. Global Biologics Safety Testing Market: Market Dynamics
2.1: Introduction, Background, and Classifications
2.2: Supply Chain
2.3: Industry Drivers and Challenges
 
3. Market Trends and Forecast Analysis from 2017 to 2028
3.1: Macroeconomic Trends (2017-2022) and Forecast (2023-2028)
3.2: Global Biologics Safety Testing Market Trends (2017-2022) and Forecast (2023-2028)
3.3: Global Biologics Safety Testing Market by Type
3.3.1: Endotoxin Test
3.3.2: Sterility Test
3.3.3: Mycoplasma Tests
3.3.4: Bioburden Tests
3.3.5: Residual Host-cell Proteins & DNA Detection Tests
3.3.6: Virus safety Test
3.3.7: Others
3.4: Global Biologics Safety Testing Market by Product and Services
3.4.1: Consumables
3.4.2: Instrument
3.4.3: Services
3.5: Global Biologics Safety Testing Market by Application
3.5.1: Vaccine Development and Manufacturing
3.5.2: Monoclonal Antibodies Development and Manufacturing
3.5.3: Cellular & Gene Therapy Product Development and Manufacturing
3.5.4: Blood and Blood Product Development and Manufacturing
3.5.5: Others
 
4. Market Trends and Forecast Analysis by Region from 2017 to 2028
4.1: Global Biologics Safety Testing Market by Region
4.2: North American Biologics Safety Testing Market
4.2.1: North American Biologics Safety Testing Market by Type: Endotoxin Test, Sterility Test, Mycoplasma Tests, Bioburden Tests, Residual Host-Cell Proteins & DNA Detection Tests, Virus Safety Test, and Others
4.2.2: North American Biologics Safety Testing Market by Application: Vaccine Development and Manufacturing, Monoclonal Antibodies Development and Manufacturing, Cellular & Gene Therapy Product Development and Manufacturing, Blood and Blood Product Development and Manufacturing, and Others
4.3: European Biologics Safety Testing Market
4.3.1: European Biologics Safety Testing Market by Type: Endotoxin Test, Sterility Test, Mycoplasma Tests, Bioburden Tests, Residual Host-Cell Proteins & DNA Detection Tests, Virus Safety Test, and Others
4.3.2: European Biologics Safety Testing Market by Application: Vaccine Development and Manufacturing, Monoclonal Antibodies Development and Manufacturing, Cellular & Gene Therapy Product Development and Manufacturing, Blood and Blood Product Development and Manufacturing, and Others
4.4: APAC Biologics Safety Testing Market 
4.4.1: APAC Biologics Safety Testing Market by Type: Endotoxin Test, Sterility Test, Mycoplasma Tests, Bioburden Tests, Residual Host-Cell Proteins & DNA Detection Tests, Virus Safety Test, and Others
4.4.2: APAC Biologics Safety Testing Market by Application: Vaccine Development and Manufacturing, Monoclonal Antibodies Development and Manufacturing, Cellular & Gene Therapy Product Development and Manufacturing, Blood and Blood Product Development and Manufacturing, and Others
4.5: ROW Biologics Safety Testing Market 
4.5.1: ROW Biologics Safety Testing Market by Type: Endotoxin Test, Sterility Test, Mycoplasma Tests, Bioburden Tests, Residual Host-Cell Proteins & DNA Detection Tests, Virus Safety Test, and Others
4.5.2: ROW Biologics Safety Testing Market by Application: Vaccine Development and Manufacturing, Monoclonal Antibodies Development and Manufacturing, Cellular & Gene Therapy Product Development and Manufacturing, Blood and Blood Product Development and Manufacturing, and Others
 
5. Competitor Analysis
5.1: Type Portfolio Analysis
5.2: Operational Integration
5.3: Porter’s Five Forces Analysis
 
6. Growth Opportunities and Strategic Analysis
6.1: Growth Opportunity Analysis
6.1.1: Growth Opportunities for the Global Biologics Safety Testing Market by Type 
6.1.2: Growth Opportunities for the Global Biologics Safety Testing Market by Product and Services 
6.1.3: Growth Opportunities for the Global Biologics Safety Testing Market by Application 
6.1.4: Growth Opportunities for the Global Biologics Safety Testing Market by Region 
6.2: Emerging Trends in the Global Biologics Safety Testing Market 
6.3: Strategic Analysis
6.3.1: New Product Development
6.3.2: Capacity Expansion of the Global Biologics Safety Testing Market 
6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Biologics Safety Testing Market 
6.3.4: Certification and Licensing
 
7. Company Profiles of Leading Players
7.1: Charles River Laboratories 
7.2: Lonza
7.3: Thermo Fisher Scientific
7.4: Merck KGaA
7.11: F.Hoffman La Roche
 
.

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Lucintel has been in the business of market research and management consulting since 2000 and has published over 1000 market intelligence reports in various markets / applications and served over 1,000 clients worldwide. This study is a culmination of four months of full-time effort performed by Lucintel's analyst team. The analysts used the following sources for the creation and completion of this valuable report:
  • In-depth interviews of the major players in this market
  • Detailed secondary research from competitors’ financial statements and published data 
  • Extensive searches of published works, market, and database information pertaining to industry news, company press releases, and customer intentions
  • A compilation of the experiences, judgments, and insights of Lucintel’s professionals, who have analyzed and tracked this market over the years.
Extensive research and interviews are conducted across the supply chain of this market to estimate market share, market size, trends, drivers, challenges, and forecasts. Below is a brief summary of the primary interviews that were conducted by job function for this report.
 
Thus, Lucintel compiles vast amounts of data from numerous sources, validates the integrity of that data, and performs a comprehensive analysis. Lucintel then organizes the data, its findings, and insights into a concise report designed to support the strategic decision-making process. The figure below is a graphical representation of Lucintel’s research process. 
 

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