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Global Biologics Safety Testing Market By Product (Kits & Reagents, Services, and Instruments), By Test Type (Endotoxin Test, Sterility Test, Cell Line Authentication and Characterization Test, Residual Host Contaminant Detection Test, Adventitious Agent Detection Tests, Bioburden Test, and Other Test), By Application (vaccine & therapeutics development, blood, and cellular and gene therapy, tissue and tissue-Related product testing, blood -related product testing and stem cell research), and By Region (North America, Europe, Asia Pacific, South America, and the Middle East & Africa)-Global Forecast to 2027.
Global Biologics Safety Testing Market Overview:
Biologics is a product that is derived from humans, animals, or microorganisms by using biotechnology. Biologics drugs are referred to as biologic response modifiers and consist of vaccines, blood & blood components, tissues, genes, allergens, and recombinant proteins. Biologics are advanced prescription drugs used to treat numerous diseases such as cancer, Crohn’s disease, rheumatoid arthritis, and other auto-immune diseases. Biological safety testing is essential for new products launching in the market. It is performed to ensure the non-contamination of vaccines & biopharmaceuticals and safety quality norms. Biological safety testing is an essential step in pharmaceutical industries to identify and assess undesirable or even harmful effects for humans and protect patients; drugs must obtain official approval before they can be placed on the market.
Global Biologics Safety Testing Market Insights
The global biologics safety testing market size was valued at USD 3.04 billion in 2019 and projected to reach USD 7.14 billion by 2027, growing at a CAGR of 12.12% during the forecast period, 2020-2027. The major factors are the growing pharmaceutical and biotechnology companies and the growing number of new products or drug launches. Additionally, the rising prevalence of chronic diseases and increasing R&D investments in the life science sector will spur the global biologics safety testing industry in the future periods. Furthermore, the rising number of government initiatives to promote biological safety testing products and the presence of regulatory authorities to enforce significant safety standards are expected to witness remarkable growth of biologics safety testing. The rising rate of microbial contamination and bioburden while manufacturing biologics are expected to propel the demand for biologics safety testing in coming years.
Moreover, the upsurge in demand for innovative product launches and rising pharmaceutical outsourcing is positively impacting the biologics safety testing industry. Furthermore, the rapid expansion in customer base, rise in the extensive R&D activities at the academic and industrial level, and growing usage of biomedical applications are fueling the demand for the biologics safety testing market. The increasing demand to develop therapeutically advanced drugs on a large scale, emerging markets, and increasing pharmaceutical outsourcing will bolster biologics safety testing market share. In addition, the rising rate of the geriatric population and increasing healthcare demands in the developing world propelling the growth of the biologics safety testing market across the globe.
Growth Driver
Biological safety testing is performed to get assure the safety quality and non-contamination of vaccines and biopharmaceuticals. Pharmaceuticals companies outsource their various functions, such as manufacturing, clinical trial management, and portions of drug discovery, to CROs to reduce operational costs. Moreover, to enhance drug safety and shortens drug development time pharmaceutical industry is outsourcing its biologics for testing. However, restrictions are often challenging to achieve. Also, the lack of skilled professionals for handling the biologics safety testing instruments will be a restraint to the growth of the biologics safety testing market.
Product Segmental Analysis
The global biologics safety testing market is segregated into kits & reagents, services, and instruments based on the product.
The kits & reagents segment is estimated to the highest growth over the analysis timeframe due to the repetitive purchase of kits and rising adoption of kit-based testing.
The instruments will grow significantly due to the rise in the adoption of biologics safety testing and technological advancement related to biologics safety testing.
Test Type Segmental Analysis
Based on the test type, the global biologics safety testing market is categorized into endotoxin test, sterility test, cell line authentication, bioburden test, and characterization test, residual host contaminant detection test, adventitious agent detection tests, and another test. The endotoxin test segment held for a significant market share in 2019 and will gain maximum market revenue by 2027. It is attributable to the increasing use in vaccine testing, gene therapy, drug development, cell therapy, and monoclonal antibody testing, rise in prevalence of diseases, and increase in the number of drug launches.
The sterility test segment is poised to witness significant growth over the forecast period. It is used in medical devices, pharmaceuticals, preparations & tissue materials and highly adapted for sterile testing in human & veterinary products.
Application Segmental Analysis
Based on the Application, the global biologics safety testing market is classified into vaccine & therapeutics development, blood & blood-related product testing, cellular & gene therapy, tissue & tissue-related product testing, and stem cell research. The vaccine & therapeutics development are expected to be the highest revenue share for biologics safety testing during the forecast period. The segment’s hike is attributed to the growing prevalence of diseases, rising pharmaceutical & biotechnology company investments in vaccine development, and increasing initiatives for immunization—moreover, the increasing demands of therapeutics to prevent infectious diseases.
The gene therapy will witness a lucrative growth rate in the estimated period due to the high risk of contamination with residual DNA and helps in treating a wide range of diseases, such as cancer, diabetes, heart disease, hemophilia, and AIDS.
Region Segmental Analysis
By geography, the global biologics safety testing market is segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa. North America is estimated to project considerable growth over 2020-2026. It is owing to advents in technology, the presence of leading industry players offering innovative products, and increasing healthcare expenditure. Moreover, the rising research in the field of cancer drives market growth. The Asia Pacific will have a prominent share of the biologics safety testing market by 2027. Due to the rising demand for new drugs & vaccines, it was continually improving healthcare infrastructure in the region and mounting health care expenditures in developing countries such as India and China.
Competitor Analysis
Companies such as Sartorius AG, Merck KGaA, Thermo Fisher Scientific Inc, Charles River Laboratories, Lonza Group LTD, SGS SA, Cytovance Biologics, Inc, Pace Toxikon Corporation, Analytical Services Inc, and WuXiApptec are the key players in the global biologics safety testing market.
Key Stakeholders
- Market research and consulting firms
- Industry associations
- Global biologics safety testing instruments manufacturing firm
- Research organizations and consulting companies
- Organizations, associations, and alliances related to biologics safety testing
- Regulatory bodies
- Suppliers
- Retailers
The objective of the research
- Market modeling starts with identifying a target market where historical data exists. A Market can include prediction problems, economic factors, analyzing customer behavior, and identifying new patterns from past events, which helps our client to have deep dive into the market.
- Product analysis involves examining product features, costs, availability, quality, and other aspects. Product analysis is conducted to understand potential buyers and measure competition in the market.
- Market Trend and Economic Factors Analysis helps assess potential changes to an economy’s inflation rate, taxes, interest rates, exchange rates, trading regulations, and excise duties that can or have a major effect on the target market.
- Market Segmental Analysis defines an in-depth scenario of the target market by grouping consumers into naturally existing created segments of consumers who share similar product preferences or characteristics.
- The geographical mapping approach helps our clients to understand national or international markets because different consumers in different regions have different needs, wants, and cultural characteristics that can specifically target.
Market Modelling
By Product
- Kits & Reagents
- Services
- Instruments
By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
By Region
- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
Report Content
- Research Strategic Development
- Market Modelling
- Product Analysis
- Market Trend and Economic Factors Analysis
- Market Segmental Analysis
- Geographical Mapping
- Country Wise Segregation
- Research Methodology
- Identification of Target Market
- Data Acquisition
- Refining of Data/ Data Transformations
- Data Validation through Primary Techniques
- Exploratory Data Analysis
- Graphical Techniques/Analysis
- Quantitative Techniques/Analysis
- Visual Result/Presentation
- Executive Summary
- Market Insights
- Supply Chain Analysis
- Economic Factor Analysis
- Drivers
- Trends
- Opportunities
- Challenges
- Technological Landscape
- Competitors & Product Analysis
- Regulatory Framework
- Company market share analysis, 2019
- Porter’s Five forces analysis
- New Investment Analysis
- PESTEL Analysis
- Global Biologics Safety Testing Market Overview
- Market Size & Forecast,2016-2027
- Demand
- By Value (USD Million)
- Consumption
- Demand
- Market Share & Forecast, 2016-2027
- By Product
- Kits & Reagents
- Services
- Instruments
- By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
- By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
- By Region
- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
- By Product
- Market Size & Forecast,2016-2027
- North America Biologics Safety Testing Market Overview
- North America Biologics Safety Testing Market Size & Forecast, 2016-2027
- Demand
- By Value (USD Million)
- Consumption
- Demand
- North America Biologics Safety Testing Market Share & Forecast,2016-2027
- By Product
- Kits & Reagents
- Services
- Instruments
- By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
- By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
- By Country
- US
- Canada
- Mexico
- Price-Point Analysis
- Manufacturer & Distributor List (Top 5)
- Company Market Share (Top 3-5)
- Economic Impact Study on North America Biologics Safety Testing Market
- By Product
- North America Biologics Safety Testing Market Size & Forecast, 2016-2027
- Europe Biologics Safety Testing Market Overview
- Europe Biologics Safety Testing Market Size & Forecast, 2016-2027
- Demand
- By Value (USD Million)
- Consumption
- Demand
- Europe Biologics Safety Testing Market Share & Forecast,2016-2027
- By Product
- Kits & Reagents
- Services
- Instruments
- By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
- By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
- By Country
- Germany
- UK
- France
- Italy
- Rest of Europe
- Price-Point Analysis
- Manufacturer & Distributor List (Top 5)
- Company Market Share (Top 3-5)
- Economic Impact Study on Europe Biologics Safety Testing Market
- By Product
- Europe Biologics Safety Testing Market Size & Forecast, 2016-2027
- Asia Pacific Biologics Safety Testing Market Overview
- Asia Pacific Biologics Safety Testing Market Size & Forecast, 2016-2027
- Demand
- By Value (USD Million)
- Consumption
- Demand
- Asia Pacific Biologics Safety Testing Market Share & Forecast, 2016-2027
- By Product
- Kits & Reagents
- Services
- Instruments
- By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
- By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
- By Country
- China
- India
- Japan
- Australia
- Rest of Asia Pacific
- Price-Point Analysis
- Manufacturer & Distributor List (Top 5)
- Company Market Share (Top 3-5)
- Economic Impact Study on Asia Pacific Biologics Safety Testing Market
- By Product
- Asia Pacific Biologics Safety Testing Market Size & Forecast, 2016-2027
- South America Biologics Safety Testing Market Overview
- South America Biologics Safety Testing Market Size & Forecast, 2016-2027
- Demand
- By Value (USD Million)
- Consumption
- Demand
- South America Biologics Safety Testing Market Share & Forecast,2016-2027
- By Product
- Kits & Reagents
- Services
- Instruments
- By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
- By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
- By Country
- Brazil
- Argentina
- Rest of South America
- Price-Point Analysis
- Manufacturer & Distributor List (Top 5)
- Company Market Share (Top 3-5)
- Economic Impact Study on South America Biologics Safety Testing Market
- By Product
- South America Biologics Safety Testing Market Size & Forecast, 2016-2027
- Middle East & Africa Biologics Safety Testing Market Overview
- Middle East & Africa Biologics Safety Testing Market Size & Forecast, 2016-2027
- Demand
- By Value (USD Million)
- Consumption
- Demand
- Middle East & Biologics Safety Testing Market Share & Forecast, 2016-2027
- By Product
- Kits & Reagents
- Services
- Instruments
- By Test Type
- Endotoxin Test
- Sterility Test
- Cell Line Authentication and Characterization Test
- Bioburden Test
- Residual Host Contaminant Detection Test
- Adventitious Agent Detection Tests
- Other Test
- By Application
- Vaccine & Therapeutics Development
- Blood and Blood-Related Product Testing
- Cellular and Gene Therapy
- Tissue and Tissue-Related Product Testing
- Stem Cell Research
- By Country
- Saudi Arabia
- UAE
- South Africa
- Rest of Middle East & Africa
- Price-Point Analysis
- Manufacturer & Distributor List (Top 5)
- Company Market Share (Top 3-5)
- Economic Impact Study on Middle East & Africa Biologics Safety Testing Market
- By Product
- Middle East & Africa Biologics Safety Testing Market Size & Forecast, 2016-2027
- Competitor Analysis
- Company Description
- Financial Analysis
- Key Products
- Key Management Personnel
- Contact Address
- SWOT Analysis
- Company Profile
- Merck KGaA
- Sartorius AG
- Thermo Fisher Scientific Inc
- Charles River Laboratories
- Lonza Group LTD
- SGS SA
- Cytovance Biologics Inc
- Pace Toxikon Corporation
- Analytical Services Inc
- WuXiApptec
