Biologics Safety Testing Market by Product & Service (Consumables, Instrument, Services), Application (Vaccine, Monoclonal Antibodies, Blood products, Cell & Gene Therapy Products), Test Type (Endotoxin, Myoplasm, Sterility Test) - Global Forecast to 2026
[185 Pages Report] The global biologics safety testing market is projected to reach USD 6.2 billion by 2026 from USD 3.4 billion in 2021, at a CAGR of 12.4% during the forecast period. The growth of the global biologics safety testing market is driven by factors such as the growth in the biologics and biosimilars markets, growing concerns over cell culture contamination, and rising biopharmaceuticals R&D activities and investments. In addition, emerging markets and increasing biopharmaceutical outsourcing are expected to provide significant growth opportunities for players in the Biologics safety testing market.
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Covid-19 Impact On The Global Biologics Saftey Testing Market
COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 has moved from a regional crisis to a global pandemic. The World Health Organization (WHO) officially declared the outbreak of COVID-19 a pandemic. A mix of established pharmaceutical and biopharmaceutical companies, along with the players of the Biologics safety testing market, have stepped forward to contribute to worldwide research efforts by providing biologics safety testing for developing safety test kits and testing for treatments and vaccines manufacturing that target the infection caused by the novel Coronavirus. Some examples are as follows:
- As vaccine manufacturing is expected to increase due to the growing number of COVID-19 cases, biologics safety testing will be an important quality assurance measure to ensure patient safety.
- For the treatment of COVID-19, two anti-SARS-CoV antibody products, Bamlanivimab and the Casirivimab and Imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies, Levilimab and Itolizumab, had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively.
- Increasing adoption of endotoxin testing for COVID-19 research and drug development to favor market growth. The economic and social burden of the COVID-19 pandemic has prompted government bodies across the globe to increase support for vaccine development, which has led to an increase in the adoption of endotoxin testing products for COVID-19 research.
- In September 2020, the German government awarded the mRNA-based vaccine makers, BioNTech and CureVac, a sum of USD 745 million to drive the development of their respective COVID-19 candidates.
- In July 2020, the UK government announced that an additional USD 138.14 million (GBP 100 million) would be contributed to vaccine manufacturing to ensure that successful COVID-19 prophylactic can be produced in the UK boosting the biologics safety testing market in UK.
The various initiatives by the players of this market and usage of a wide range of biologics safety testing products and services in COVID-19 research have helped researchers gain a better understanding of the Coronavirus. Hence, COVID-19 has positively impacted the biologics safety testing market to a certain extent as vaccine manufacturing is expected to increase due to COVID-19, bacterial safety testing will be an important quality assurance measure to ensure patient safety.
Biologics Saftey Testing Market Dynamics
Drivers: Growth in the biosimilars and biologics markets
Many companies are investing heavily in the development of biologics and biosimilars. Currently, more than half of the drug candidates in the discovery stage are biologics, such as proteins, peptides, and monoclonal antibodies. Biologics are expected to contribute around half of the revenue generated by the top 100 pharmaceutical products in the coming years.
According to the FDA, the number of new biologics approved in the US increased from 22 in 2016 to 48 in 2019. Growing investments by biopharmaceutical companies in order to develop biologics and biosimilars are further expected to increase the number of approved products worldwide.
Opportunity: Emerging markets offer lucrative opportunities
Countries across the APAC are highly lucrative markets for the life sciences industry. For instance, India has been taking significant initiatives, including encouraging public-private partnerships (PPPs) in biopharmaceutical R&D projects, to establish itself as the worlds leading major biopharmaceutical innovation hub. South Korea is also taking initiatives to become a global biotechnology hub with a focus on biosimilars, vaccine production, and stem cell therapies. The South Korean government is establishing a bio cluster that will serve as a center for universities to collaborate on R&D. Aiming to make the investment. Lucrative and to attract investors, the Korean Research-based Pharmaceutical Industry Association has offered a proposal according to which corporate tax exemptions will be provided for 15 years or a 515% relaxation for multinational biopharmaceutical companies.
Emerging markets also provide room for innovation. China has a large, well-educated talent pool, with substantial government and private funding in the countrys biopharmaceutical industry. This has resulted in many large pharmaceutical companies establishing state-of-the-art research facilities in China to drive the next breakthrough drug discoveries in conjunction with other Asian countries such as India. Biopharmaceutical and biotechnology companies in such emerging markets invest heavily in research to develop breakthrough molecules. The growing demand for remedial treatments for life-threatening diseases, such as cancer and diabetes, is highlighting the need for drug R&D and thereby the demand for biologics safety testing kits for effective quality testing and control.
Challenge: Dearth of skilled professionals
The biologics safety testing industry is constantly evolving with advancements in technologies and the development of new and improved safety testing programs across various industries. Highly skilled professionals are required to keep pace with the continuing changes in analytical technologies and safety testing methodologies. They need to understand the safety, efficacy, and usability of equipment like PCR, spectrophotometers, and fully automated mycoplasma detection systems prior to their application.
The success of biological safety tests depends mainly on the expertise of the analysts as much as the environmental conditions under which the test is performed. For optimal efficacy, biologics safety testing needs to be conducted by skilled professionals with sufficient knowledge of the nuances of this field. Countries across the Middle East & Africa and Latin America are facing a shortage and maldistribution of skilled personnel in the context of biologics safety testing services. These regions are facing challenges in attracting and retaining highly skilled professionals, as they compete with pharmaceutical, biotechnology, and medical device companies, contract research organizations, and academic and research institutions for qualified and experienced professionals. To compete effectively, companies are required to offer higher compensation and other benefits, which may affect the financial stability and results of operations, especially in small-scale analytical testing companies. These regions are also experiencing a substantial deficit of untapped human capital due to insufficient education and training. This shortage of skilled professionals may hamper the adoption of new technologies and methodologies, thereby limiting the growth of the biologics safety testing market.
By product segment, the service segment accounted for the largest share of the Biologics Safety Testing market in 2020.
Based on product and service, the biologics safety testing market is segmented into consumables, services, and instruments. In 2020, the services segment accounted for the largest market share. The large share of this segment can be attributed to the limited finances of biopharmaceutical manufacturers, capacity constraints, need for reduction in the time to market, complex manufacturing requirements, large investments required for establishing manufacturing facilities, and the increasing drugs pipeline, all of which have prompted the shift towards the outsourcing of biologics safety testing to service providers.
By test type, the residual host-cell proteins and DNA detection tests segment accounted for the largest share of the Biologics Safety Testing market in 2020.
Based on test type, the biologics safety testing market is segmented into residual host-cell proteins and DNA detection tests, endotoxin tests, sterility tests, mycoplasma tests, bioburden tests, and virus safety tests. In 2020, the residual host-cell proteins and DNA detection tests segment accounted for the largest market share. The rising demand for residual HCP and DNA detection tests for recombinant proteins and increasing focus on the quality of drugs are the major factors driving the growth of this segment.
By application, the monoclonal antibodies manufacturing segment accounted for the largest market share the Biologics safety testing market in 2020.
Based on application, the biologics safety testing market is segmented into monoclonal antibodies manufacturing, vaccines manufacturing, blood and blood products manufacturing, cellular and gene therapy products manufacturing, and other applications. In 2020, the monoclonal antibodies manufacturing segment accounted for the largest market share. The large share of this segment can be attributed to the rising prevalence of diseases and increasing government initiatives for the development of monoclonal antibody drugs.
North America accounted for the largest share of the Biologics safety testing market in 2020.
North America accounted for the largest share of the biologics safety testing market in 2020. Rapid growth in the biopharmaceutical industry is the major factor driving the growth of the North American biologics safety testing market. Growing academic and government investments, rising demand for high-quality research tools for data reproducibility, increasing awareness among consumers about product safety, and the presence of major market players in this region are also driving the market for biologics safety testing in North America.
Key Market Players
Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), and Eurofins Scientific (Luxembourg). The key players in this market are focusing on strategic expansions, partnerships, and product launches and approvals to expand their presence in the market.
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Report Metric |
Details |
|
Market Size Available for Years |
20192026 |
|
Base Year Considered |
2020 |
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Forecast Period |
20212026 |
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Forecast Units |
Value (USD Billion) |
|
Segments Covered |
Product & Service, Application, Test, and Region |
|
Geographies Covered |
North America, Europe, APAC , LATAM and MEA |
|
Companies Covered |
The major market players include Maravai Lifesciences (US), Associates of Cape Cod, Inc. (US), bioMιrieux SA (France), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), and Nelson Laboratories, LLC (US), Bio-Rad Laboratories, Inc. (US) and QIAGEN (Germany), Agilent Technologies, Inc. (US), Pacific BioLabs (US), Microcoat Biotechnologie GmbH (Germany), PromoCell GmbH (Germany), FUJIFILM Wako Pure Chemical Corporation (Japan), and Almac Group (UK). Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), and Eurofins Scientific (Luxembourg). |
The study categorizes the biologics safety testing market into the following segments and subsegments:
Biologics Safety Testing Market, by Product & Services
- Consumables
- Instrument
- Services
Biologics Safety Testing Market, by Application
- Vaccine Manufacturing
- Monoclonal Antibodies Manufacturing
- Cellular & Gene Therapy Products Manufacturing
- Blood and Blood Products Manufacturing
- Other Application
Biologics Safety Testing Market, by Test Type
- Endotoxin Test
- Sterility Test
- Mycoplasma Tests
- Bioburden Tests
- Residual Host-cell Proteins & DNA Detection Tests
- Virus safety Test
Biologics Safety Testing Market, by Region
- North America
- US
- Canada
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Rest of Asia Pacific
- Latin America
- Brazil
- Mexico
- RoLATAM
- The Middle East and Africa
Recent Developments
- In 2021 Charles River Laboratories, Inc. (US) launched a new detection tool, EndoScan-V, a validated endotoxin detection and measurement software used to generate and report quantitative test data. The software performed the requisite measurements and calculations and created test reports with the convenience of digital signature report approval.
- In 2021, Charles River Laboratories, Inc. (US) acquired Cognate BioServices to expand its offerings in cell and gene therapy development, testing, and manufacturing, providing clients with an integrated solution from basic research and discovery through CGMP production.
- In 2021, Charles River Laboratories, Inc. (US) partnered with JADE Biomedical to expand its biological testing solutions capabilities geographically and cater to the increasing demand for biologics therapeutics, especially cell and gene therapies. This strategic relationship enabled JADE to expand its current global Good Manufacturing Practice (GMP) product testing operations in Shanghai into a second facility and further build upon its current offering of comprehensive biologics quality management and testing services.
- In 2021, Lonza launched the PyroTec PRO Automated Robotic Solution for endotoxin testing. The new PyroWave Reader add-on has been designed specifically for use with the sustainable PyroGene Recombinant Factor C (rFC) Assay.
Frequently Asked Questions (FAQ):
What is the current size of the Biologics safety testing market?
The global biologics safety testing market is projected to reach USD 6.2 billion by 2026 from USD 3.4 billion in 2021, at a CAGR of 12.4% during the forecast period.
Who are the leading players in the biologics safety testing market?
Prominent players in the biologics safety testing market are Charles River Laboratories, Inc. (US), Lonza (Switzerland), Thermo Fisher Scientific, Inc. (US), Merck KGaA (Germany), SGS SA (Switzerland), WuXi AppTec (China), and Eurofins Scientific (Luxembourg). The key players in this market are focusing on strategic expansions, partnerships, and product launches and approvals to expand their presence in the market.
What are the major drivers of the biologics safety testing market?
The growth of the global biologics safety testing market is driven by factors such as the growth in the biologics and biosimilars markets, growing concerns over cell culture contamination, and rising biopharmaceuticals R&D activities and investments. In addition, emerging markets and increasing biopharmaceutical outsourcing are expected to provide significant growth opportunities for players in the biologics safety testing market.
What is the COVID-19 impact on the biologics safety testing market?
The various initiatives by the players of biologics safety testing market and usage of a wide range of biologics safety testing products and services in COVID-19 research have helped researchers gain a better understanding of the Coronavirus. Hence, COVID-19 has positively impacted the biologics safety testing market to a certain extent as vaccine manufacturing is expected to increase due to COVID-19, bacterial safety testing will be an important quality assurance measure to ensure patient safety. .
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TABLE OF CONTENTS
1 INTRODUCTION (Page No. - 25)
1.1 OBJECTIVES OF THE STUDY
1.2 MARKET DEFINITION
1.2.1 INCLUSIONS & EXCLUSIONS OF THE STUDY
1.2.2 MARKETS COVERED
FIGURE 1 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION
1.2.3 YEARS CONSIDERED FOR THE STUDY
1.3 CURRENCY
1.4 LIMITATIONS
1.5 STAKEHOLDERS
1.6 SUMMARY OF CHANGES
2 RESEARCH METHODOLOGY (Page No. - 30)
2.1 RESEARCH APPROACH
FIGURE 2 RESEARCH DESIGN
2.1.1 SECONDARY DATA
2.1.2 PRIMARY DATA
FIGURE 3 BREAKDOWN OF PRIMARIES: BIOLOGICS SAFETY TESTING MARKET
2.1.3 MARKET DATA ESTIMATION AND TRIANGULATION
2.1.4 DATA TRIANGULATION
FIGURE 4 DATA TRIANGULATION METHODOLOGY
2.2 MARKET ESTIMATION METHODOLOGY
FIGURE 5 MARKET SIZE ESTIMATION: COMPANY REVENUE ANALYSIS-BASED ESTIMATION
FIGURE 6 MARKET SIZE ESTIMATION: SEGMENTAL ANALYSIS-BASED ESTIMATION
FIGURE 7 BIOLOGICS SAFETY TESTING MARKET: FINAL CAGR PROJECTIONS (2021−2026)
FIGURE 8 BIOLOGICS SAFETY TESTING: CAGR PROJECTIONS FROM THE ANALYSIS OF DEMAND-SIDE DRIVERS, OPPORTUNITIES, AND CHALLENGES
FIGURE 9 BIOLOGICS SAFETY TESTING MARKET: SEGMENTAL ASSESSMENT
2.3 INDUSTRY INSIGHTS
2.4 RESEARCH ASSUMPTIONS
3 EXECUTIVE SUMMARY (Page No. - 39)
FIGURE 10 BIOLOGICS SAFETY TESTING MARKET SHARE, BY PRODUCT & SERVICE, 2020
FIGURE 11 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2021 VS. 2026 (USD MILLION)
FIGURE 12 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2021 VS. 2026 (USD MILLION)
FIGURE 13 GEOGRAPHICAL SNAPSHOT OF THE BIOLOGICS SAFETY TESTING MARKET
4 PREMIUM INSIGHTS (Page No. - 42)
4.1 BIOLOGICS SAFETY TESTING MARKET OVERVIEW
FIGURE 14 GROWTH IN THE BIOLOGICS AND BIOSIMILARS MARKETS TO DRIVE MARKET GROWTH
4.2 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION AND COUNTRY (2020)
FIGURE 15 MONOCLONAL ANTIBODIES MANUFACTURING SEGMENT ACCOUNTED FOR THE LARGEST SHARE OF THE NORTH AMERICAN MARKET IN 2020
4.3 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE
FIGURE 16 RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS SEGMENT TO REGISTER THE HIGHEST CAGR DURING THE FORECAST PERIOD
5 MARKET OVERVIEW (Page No. - 45)
5.1 MARKET DYNAMICS
FIGURE 17 BIOLOGICS SAFETY TESTING MARKET: DRIVERS,OPPORTUNITIES, & CHALLENGES
5.1.1 DRIVERS
5.1.1.1 Growth in the biosimilars and biologics markets
FIGURE 18 TOTAL NUMBER OF NEW BIOLOGICS LICENSE APPLICATION APPROVALS, NDA APPROVALS, AND FILINGS (20052019)
TABLE 1 LIST OF BIOLOGICAL LICENSE APPLICATION APPROVALS IN THE US, 2019
5.1.1.2 Growing concerns over cell culture contamination
5.1.1.3 Rising biopharmaceuticals R&D activities and investments
FIGURE 19 R&D SPENDING BY PHRMA MEMBER COMPANIES,20012019 (USD BILLION)
TABLE 2 PHARMACEUTICAL R&D SPENDING, BY COMPANY, 2019 VS. 2026 (USD BILLION)
5.1.2 OPPORTUNITIES
5.1.2.1 Emerging markets offer lucrative opportunities
5.1.2.2 Increasing biopharmaceutical outsourcing
5.1.3 CHALLENGES
5.1.3.1 Dearth of skilled professionals
5.2 IMPACT OF COVID-19 ON THE BIOLOGICS SAFETY TESTING MARKET
5.3 PRICING ANALYSIS
TABLE 3 AVERAGE SELLING PRICE OF BIOLOGICS SAFETY TESTING PRODUCTS (2020)
5.4 VALUE CHAIN ANALYSIS
FIGURE 20 VALUE CHAIN ANALYSIS OF THE BIOLOGICS SAFETY TESTING MARKET
5.5 ECOSYSTEM ANALYSIS OF THE BIOLOGICS SAFETY TESTING MARKET
FIGURE 21 ECOSYSTEM ANALYSIS OF THE BIOLOGICS SAFETY TESTING MARKET
5.6 PATENT ANALYSIS
FIGURE 22 NUMBER OF PATENTS GRANTED IN THE LAST 20 YEARS
TABLE 4 TOP 10 GRANTED PATENT OWNERS (US) IN THE LAST 20 YEARS
FIGURE 23 TOP 10 PLAYERS WITH THE HIGHEST NUMBER OF PATENT APPLICATIONS
5.7 REGULATORY ANALYSIS
5.7.1 US
5.7.2 EUROPE
5.8 PORTERS FIVE FORCES ANALYSIS
TABLE 5 HIGH CAPITAL INVESTMENTS TO RESTRICT THE ENTRY OF NEW PLAYERS
5.8.1 THREAT OF NEW ENTRANTS
5.8.2 THREAT OF SUBSTITUTES
5.8.3 BARGAINING POWER OF BUYERS
5.8.4 BARGAINING POWER OF SUPPLIERS
5.8.5 INTENSITY OF COMPETITIVE RIVALRY
6 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE (Page No. - 58)
6.1 INTRODUCTION
TABLE 6 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
6.2 SERVICES
6.2.1 INCREASING OUTSOURCING OF BIOLOGICS SAFETY TESTING BY PHARMA & BIOPHARMA COMPANIES TO DRIVE THE MARKET GROWTH
TABLE 7 BIOLOGICS SAFETY TESTING SERVICES MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 8 NORTH AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET,BY COUNTRY, 20192026 (USD MILLION)
TABLE 9 EUROPE: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 10 ASIA PACIFIC: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 20192026 (USD MILLION)
6.3 CONSUMABLES
6.3.1 REPEAT PURCHASE OF ASSAYS, KITS, & REAGENTS TO DRIVE THE MARKET GROWTH
TABLE 11 BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 12 NORTH AMERICA: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 13 EUROPE: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 14 ASIA PACIFIC: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 20192026 (USD MILLION)
6.4 INSTRUMENTS
6.4.1 THE DEMAND FOR FULLY AUTOMATED INSTRUMENTS IS INCREASING IN RESEARCH APPLICATIONS
TABLE 15 BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 16 NORTH AMERICA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 17 EUROPE: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 18 ASIA PACIFIC: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
7 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE (Page No. - 65)
7.1 INTRODUCTION
TABLE 19 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
7.2 RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS
7.2.1 RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS TO REGISTER THE HIGHEST GROWTH RATE IN THE FORECAST PERIOD
TABLE 20 RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 21 NORTH AMERICA: RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 22 EUROPE: RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 23 ASIA PACIFIC: RESIDUAL HOST-CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
7.3 MYCOPLASMA TESTS
7.3.1 GROWING CONCERNS OVER CELL CULTURE CONTAMINATION TO DRIVE MARKET GROWTH
TABLE 24 MYCOPLASMA TESTS MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 25 NORTH AMERICA: MYCOPLASMA TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 26 EUROPE: MYCOPLASMA TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 27 ASIA PACIFIC: MYCOPLASMA TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
7.4 STERILITY TESTS
7.4.1 STERILITY TESTING IS MANDATORY AT EVERY STAGE IN THE DRUG DEVELOPMENT AND PRODUCTION PROCESS
TABLE 28 STERILITY TESTS MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 29 NORTH AMERICA: STERILITY TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 30 EUROPE: STERILITY TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 31 ASIA PACIFIC: STERILITY TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
7.5 ENDOTOXIN TESTS
7.5.1 INCREASING ADOPTION OF ENDOTOXIN TESTING FOR COVID-19 RESEARCH AND DRUG DEVELOPMENT TO FAVOR MARKET GROWTH
TABLE 32 ENDOTOXIN TESTS MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 33 NORTH AMERICA: ENDOTOXIN TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 34 EUROPE: ENDOTOXIN TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 35 ASIA PACIFIC: ENDOTOXIN TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
7.6 VIRUS SAFETY TESTS
7.6.1 HIGHER UPTAKE OF VIRUS SAFETY TESTS IN THE DEVELOPMENT OF VACCINES AND CELL & GENE THERAPY TO DRIVE THE GROWTH OF THIS SEGMENT
TABLE 36 VIRUS SAFETY TESTS MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 37 NORTH AMERICA: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 38 EUROPE: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 39 ASIA PACIFIC: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
7.7 BIOBURDEN TESTS
7.7.1 INCREASING FOCUS ON DRUG SAFETY STANDARDS HAS INCREASED THE DEMAND FOR MICROBIOLOGICAL BIOBURDEN TESTING IN THE BIOLOGICS INDUSTRY
TABLE 40 BIOBURDEN TESTS MARKET, BY REGION, 20192026 (USD MILLION)
TABLE 41 NORTH AMERICA: BIOBURDEN TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 42 EUROPE: BIOBURDEN TESTS MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 43 ASIA PACIFIC: BIOBURDEN TESTS MARKET, BY COUNTRY,20192026 (USD MILLION)
8 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION (Page No. - 78)
8.1 INTRODUCTION
TABLE 44 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
8.2 MONOCLONAL ANTIBODIES MANUFACTURING
8.2.1 MONOCLONAL ANTIBODIES MANUFACTURING IS THE LARGEST APPLICATION SEGMENT
TABLE 45 BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES MANUFACTURING, BY REGION, 20192026 (USD MILLION)
TABLE 46 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
TABLE 47 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
TABLE 48 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
8.3 VACCINES MANUFACTURING
8.3.1 GROWING PREVALENCE OF INFECTIOUS DISEASES TO SUPPORT THE GROWTH OF THIS SEGMENT
TABLE 49 BIOLOGICS SAFETY TESTING MARKET FOR VACCINES MANUFACTURING, BY REGION, 20192026 (USD MILLION)
TABLE 50 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
TABLE 51 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
TABLE 52 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
8.4 BLOOD & BLOOD PRODUCTS MANUFACTURING
8.4.1 SAFETY TESTING IS A CRITICAL PARAMETER IN THE REGULATORY APPROVAL FOR BLOOD PRODUCTS
TABLE 53 BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS MANUFACTURING, BY REGION, 20192026 (USD MILLION)
TABLE 54 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
TABLE 55 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
TABLE 56 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
8.5 CELLULAR & GENE THERAPY PRODUCTS MANUFACTURING
8.5.1 INCREASING APPROVALS OF CELLULAR AND GENE THERAPY PRODUCTS TO DRIVE MARKET GROWTH
TABLE 57 BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS MANUFACTURING, BY REGION, 20192026 (USD MILLION)
TABLE 58 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
TABLE 59 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS MANUFACTURING, BY COUNTRY,20192026 (USD MILLION)
TABLE 60 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS MANUFACTURING, BY COUNTRY, 20192026 (USD MILLION)
8.6 OTHER APPLICATIONS
TABLE 61 BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY REGION, 20192026 (USD MILLION)
TABLE 62 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 20192026 (USD MILLION)
TABLE 63 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 20192026 (USD MILLION)
TABLE 64 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 20192026 (USD MILLION)
9 BIOLOGICS SAFETY TESTING MARKET, BY REGION (Page No. - 89)
9.1 INTRODUCTION
TABLE 65 BIOLOGICS SAFETY TESTING MARKET, BY REGION, 20192026 (USD MILLION)
9.2 NORTH AMERICA
FIGURE 24 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SNAPSHOT
TABLE 66 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 67 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 68 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 69 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.2.1 US
9.2.1.1 The US dominates the North American biologics safety testing market
TABLE 70 US: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 71 US: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 72 US: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.2.2 CANADA
9.2.2.1 Growing biopharmaceutical industry in the country to favor market growth
TABLE 73 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 74 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 75 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.3 EUROPE
TABLE 76 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 77 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 78 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 79 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.3.1 GERMANY
9.3.1.1 Increasing investments in biologics to drive the market in Germany
TABLE 80 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 81 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 82 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.3.2 UK
9.3.2.1 Increase in vaccine manufacturing to drive market growth
TABLE 83 UK: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 84 UK: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 85 UK: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.3.3 FRANCE
9.3.3.1 Government initiatives to strengthen R&D activities will propel market growth
TABLE 86 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 87 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 88 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.3.4 ITALY
9.3.4.1 Favorable government support to drive market growth in Italy
TABLE 89 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION,20192026 (USD MILLION)
TABLE 90 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 91 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.3.5 SPAIN
9.3.5.1 Increase in biologics production to support market growth
TABLE 92 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 93 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 94 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.3.6 REST OF EUROPE (ROE)
TABLE 95 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 96 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 97 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.4 ASIA PACIFIC
FIGURE 25 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET SNAPSHOT
TABLE 98 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 20192026 (USD MILLION)
TABLE 99 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 100 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 101 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.4.1 CHINA
9.4.1.1 China is the fastest-growing country for biologics safety testing products and services
TABLE 102 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 103 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 104 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.4.2 JAPAN
9.4.2.1 Expansion of biologics manufacturing plants in Japan to support market growth
TABLE 105 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 106 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 107 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.4.3 INDIA
9.4.3.1 Growth in the biologics market to dive the adoption of biologics safety testing products and services in India
TABLE 108 BIOLOGICS AND BIOSIMILARS APPROVED IN INDIA, 20142019
TABLE 109 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 110 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 111 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.4.4 REST OF ASIA PACIFIC
TABLE 112 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 113 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 114 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.5 LATIN AMERICA
9.5.1 GROWING APPROVAL OF BIOSIMILARS TO SUPPORT MARKET GROWTH
TABLE 115 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 116 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 117 LATIN AMERICA BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
9.6 MIDDLE EAST & AFRICA
9.6.1 INCREASING R&D INVESTMENTS AND THE DEVELOPMENT OF NEW DRUGS ARE KEY FACTORS DRIVING MARKET GROWTH
TABLE 118 MIDDLE EAST & AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 20192026 (USD MILLION)
TABLE 119 MIDDLE EAST & AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 20192026 (USD MILLION)
TABLE 120 MIDDLE EAST & AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 20192026 (USD MILLION)
10 COMPETITIVE LANDSCAPE (Page No. - 121)
10.1 OVERVIEW
10.2 MARKET RANKING ANALYSIS
FIGURE 26 BIOLOGICS SAFETY TESTING MARKET RANKING, 2020
10.3 COMPANY EVALUATION MATRIX
10.3.1 STARS
10.3.2 EMERGING LEADERS
10.3.3 PERVASIVE PLAYERS
10.3.4 PARTICIPANTS
FIGURE 27 BIOLOGICS SAFETY TESTING MARKET: COMPANY EVALUATION MATRIX, 2020
10.4 COMPETITIVE LEADERSHIP MAPPING FOR START-UPS
10.4.1 PROGRESSIVE COMPANIES
10.4.2 STARTING BLOCKS
10.4.3 DYNAMIC COMPANIES
10.4.4 RESPONSIVE COMPANIES
FIGURE 28 BIOLOGICS SAFETY TESTING: COMPETITIVE LEADERSHIP MAPPING FOR START-UPS, 2020
10.5 MARKET EVALUATION FRAMEWORK
TABLE 121 MARKET EVALUATION FRAMEWORK: EXPANSIONS & PRODUCT LAUNCHES ARE THE KEY GROWTH STRATEGIES ADOPTED BY MARKET PLAYERS
10.6 COMPANY PRODUCT FOOTPRINT
TABLE 122 BIOLOGICS SAFETY TESTING MARKET: PRODUCT PORTFOLIO ANALYSIS
10.7 COMPANY TEST TYPE FOOTPRINT
TABLE 123 BIOLOGICS SAFETY TESTING MARKET: TEST TYPE ANALYSIS
10.8 COMPANY GEOGRAPHIC FOOTPRINT
TABLE 124 BIOLOGICS SAFETY TESTING MARKET: GEOGRAPHIC ANALYSIS
10.9 COMPANY FOOTPRINT
TABLE 125 BIOLOGICS SAFETY TESTING MARKET: COMPANY FOOTPRINT
10.1 COMPETITIVE SCENARIO
10.10.1 BIOLOGICS SAFETY TESTING MARKET: PRODUCT LAUNCHES, JANUARY 2018-APRIL 2021
10.10.2 BIOLOGICS SAFETY TESTING MARKET: DEALS, JANUARY 2018-APRIL 2021
10.10.3 BIOLOGICS SAFETY TESTING MARKET: OTHER DEVELOPMENTS,JANUARY 2018-APRIL 2021
11 COMPANY PROFILES (Page No. - 133)
(Business Overview, Products & services offered, Recent Developments, and Right to win)*
11.1 KEY PLAYERS
11.1.1 CHARLES RIVER LABORATORIES, INC.
TABLE 126 CHARLES RIVER LABORATORIES: BUSINESS OVERVIEW
FIGURE 29 CHARLES RIVER LABORATORIES: COMPANY SNAPSHOT (2020)
11.1.2 LONZA
TABLE 127 LONZA: BUSINESS OVERVIEW
FIGURE 30 LONZA: COMPANY SNAPSHOT (2020)
11.1.3 THERMO FISHER SCIENTIFIC, INC.
TABLE 128 THERMO FISHER SCIENTIFIC: BUSINESS OVERVIEW
FIGURE 31 THERMO FISHER SCIENTIFIC, INC.: COMPANY SNAPSHOT (2020)
11.1.4 MERCK KGAA
TABLE 129 MERCK KGAA: BUSINESS OVERVIEW
FIGURE 32 MERCK KGAA: COMPANY SNAPSHOT (2020)
11.1.5 SGS SA
TABLE 130 SGS SA: BUSINESS OVERVIEW
FIGURE 33 SGS SA: COMPANY SNAPSHOT (2020)
11.1.6 EUROFINS SCIENTIFIC
TABLE 131 EUROFINS SCIENTIFIC: BUSINESS OVERVIEW
FIGURE 34 EUROFINS SCIENTIFIC: COMPANY SNAPSHOT (2020)
11.1.7 WUXI APPTEC
TABLE 132 WUXI APPTEC: BUSINESS OVERVIEW
FIGURE 35 WUXI APPTEC: COMPANY SNAPSHOT (2020)
11.1.8 ASSOCIATES OF CAPE COD, INC.
TABLE 133 ASSOCIATES OF CAPE COD: BUSINESS OVERVIEW
11.1.9 BIOMΙRIEUX SA
TABLE 134 BIOMΙRIEUX SA: BUSINESS OVERVIEW
FIGURE 36 BIOMΙRIEUX SA: COMPANY SNAPSHOT (2020)
11.1.10 SAMSUNG BIOLOGICS
TABLE 135 SAMSUNG BIOLOGICS: BUSINESS OVERVIEW
FIGURE 37 SAMSUNG BIOLOGICS: COMPANY SNAPSHOT (2020)
11.1.11 GENSCRIPT
TABLE 136 GENSCRIPT: BUSINESS OVERVIEW
FIGURE 38 GENSCRIPT: COMPANY SNAPSHOT (2020)
11.1.12 SARTORIUS AG
TABLE 137 SARTORIUS AG: BUSINESS OVERVIEW
FIGURE 39 SARTORIUS AG: COMPANY SNAPSHOT (2020)
11.1.13 ROCHE DIAGNOSTICS (A DIVISION OF F. HOFFMAN-LA ROCHE LTD.)
TABLE 138 F. HOFFMANN-LA ROCHE LTD.: BUSINESS OVERVIEW
FIGURE 40 F. HOFFMANN-LA ROCHE LTD.: COMPANY SNAPSHOT (2020)
11.1.14 PACIFIC BIOLABS
TABLE 139 PACIFIC BIOLABS: BUSINESS OVERVIEW
11.1.15 NELSON LABORATORIES, LLC (A PART OF SOTERA HEALTH)
TABLE 140 NELSON LABORATORIES: BUSINESS OVERVIEW
11.1.16 AGILENT TECHNOLOGIES, INC.
TABLE 141 AGILENT TECHNOLOGIES: BUSINESS OVERVIEW
FIGURE 41 AGILENT TECHNOLOGIES: COMPANY SNAPSHOT (2020)
11.1.17 MARAVAI LIFESCIENCES
TABLE 142 MARAVAI LIFESCIENCES: BUSINESS OVERVIEW
FIGURE 42 MARAVAI LIFESCIENCES: COMPANY SNAPSHOT (2020)
11.2 OTHER PLAYERS
11.2.1 QIAGEN
11.2.2 BIO-RAD LABORATORIES, INC.
11.2.3 MICROCOAT BIOTECHNOLOGIE GMBH
11.2.4 INVIVOGEN
11.2.5 PROMOCELL GMBH
11.2.6 ACCUGEN LABORATORIES, INC.
11.2.7 FUJIFILM WAKO PURE CHEMICAL CORPORATION
11.2.8 ALMAC GROUP
*Details on Business Overview, Products & services offered, Recent Developments, and Right to win might not be captured in case of unlisted companies.
12 APPENDIX (Page No. - 180)
12.1 DISCUSSION GUIDE
12.2 KNOWLEDGE STORE: MARKETSANDMARKETS SUBSCRIPTION PORTAL
12.3 AVAILABLE CUSTOMIZATIONS
12.4 RELATED REPORTS
12.5 AUTHOR DETAILS
This market research study involved the extensive use of secondary sources, directories, and databases to identify and collect information useful for this technical, market-oriented, and financial study of the global biologics safety testing market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, among other experts, to obtain and verify critical qualitative and quantitative information and to assess market prospects. The size of the biologics safety testing market was estimated through various secondary research approaches and triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
The secondary sources referred to for this research study included publications from government sources such as the Biotechnology and Biological Sciences Research Council (BBSRC), United States Food and Drug Administration (FDA), National Center for Biotechnology Information (NCBI), World Bank, World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Organisation for Economic Co-operation and Development (OECD), National Institutes of Health (NIH), and American Society for Microbiology (ASM).
Secondary sources also include corporate and regulatory filings (such as annual reports, SEC filings, investor presentations, and financial statements); business magazines and research journals; press releases; and trade, business, and professional associations, among others. Secondary data was collected and analyzed to arrive at the overall size of the global biologics safety testing market, which was validated through primary research.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the global biologics safety testing market scenario through secondary research. Several primary interviews were conducted with market experts from both the demand (such as personnel from research centers, government and academic institutes, and pharmaceutical & biopharmaceutical companies) and supply sides (such as C-level and D-level executives, product managers, marketing and sales managers of key manufacturers, distributors, and channel partners) across five major regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. Approximately 80% and 20% of primary interviews were conducted with supply-side and demand-side participants, respectively. This primary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
To know about the assumptions considered for the study, download the pdf brochure
Data Triangulation
After arriving at the overall size of the biologics safety testing market through the methodology mentioned above, this market was split into several segments and subsegments. Market breakdown procedures were employed, wherever applicable, to arrive at the exact market value for the key segments and subsegments. The extrapolated market data was triangulated by studying various macroindicators and regional trends from both demand and supply-side participants.
Report Objectives
- To define, describe, and forecast the biologics safety testing market on the basis of product, application, end user, and region
- To provide detailed information regarding the factors influencing the market growth (such as drivers, opportunities, restraints, and challenges)
- To strategically analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall biologics safety testing market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To profile the key players in the global biologics safety testing market and comprehensively analyze their core competencies2 and market rankings
- To forecast the size of the market segments in North America, Europe, the Asia Pacific (APAC), Latin America, and the Middle East and Africa
- To track and analyze competitive developments such as product launches, product approvals, expansions, acquisitions, partnerships, collaborations, and agreements in the biologics safety testing market
Available Customizations:
With the given market data, MarketsandMarkets offers customizations as per your companys specific needs. The following customization options are available for the report:
Geographical Analysis
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Company Information
- Detailed analysis and profiling of additional market players (up to 5)
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Growth opportunities and latent adjacency in Biologics Safety Testing Market