Pyrogen Testing Market Size, Share, Growth Analysis, By Product(Consumables, Instruments, and Services), By Test Type(LAL Test, Chromogenic Test, Turbidimetric Test, Gel Clot Test), By End-Use(Pharmaceutical and Biotechnology Companies, Medical Devices Companies, and Others), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35D2271 |
Region:
Global |
Published Date: October, 2024
Pages:
176
|Tables:
93
|Figures:
71
Pyrogen Testing Market Insights
Global Pyrogen Testing Market size was valued at USD 1322.30 Million in 2022 and is poised to grow from USD 1499.48 Million in 2023 to USD 4100.59 Million by 2031, growing at a CAGR of 13.4% in the forecast period (2024-2031).
Pyrogen testing is a crucial process that ensures decontamination of diverse medical and pharmaceutical devices. The testing helps these instruments stay free from pyrogens – elements that may induce fever. The market has been progressing on the back of the rising awareness of patient safety, strict regulatory needs, and the growing production of pharmaceutical and biologics. The market is also driven by the increased focus on quality control, the need for compliance with international principles, and improvements in testing technologies. Nonetheless, the market is restrained by the constantly changing regulatory and compliance landscape and low awareness and adoption of the said procedure. Yet, the market is projected to witness significant growth over the forthcoming years owing to the growing digitalization and automation in testing processes and the expansion of biologics and biopharmaceuticals.
Market Snapshot - (2024-2031)
Global Market Size
Largest Segment
Fastest Growth
Growth Rate
CAGR
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Pyrogen Testing Market Segmental Analysis
The global pyrogen testing market is segmented based on Product, Test Type, End-Use, and Region. Based on Product, the market is divided into Consumables, Instruments, Services. Based on Test Type, the market is divided into LAL Test, Chromogenic Test, Turbidimetric Test, Gel Clot Test, In Vitro Pyrogen Test, Rabbit Test. Based on End-Use, the market is divided into Pharmaceutical and Biotechnology Companies, Medical Devices Companies, Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
Analysis by Product
Based on product, the pyrogen testing market is segmented as consumables, instruments, and services. The consumables segment held a significant share of the market in 2023 and is anticipated to lead over the forecast period owing to its frequent use in testing processes. Consumables, such as syringes, test kits, and reagents are repetitively used, resulting in consistent demand, thus the segment growth. They are vital for conducting pyrogen tests like (LAL) Litmus Amebocyte Lysate assays. Their fundamental role further drives the demand. Moreover, since the biopharmaceutical and pharmaceutical industries are expanding, testing has increased too. This further impacts on the consumables demand.
The instruments segment is anticipated to be the fastest-growing segment owing to the increasing number of technological improvements and significant initial investment. The improved pyrogen testing devices like high-throughput systems and automated LAL analyzers offer better speed, efficiency, and accuracy, increasing their preference. Moreover, strict regulatory norms increase the demand and use of improved instruments for compliant and reliable testing. This increases the demand for well-developed equipment.
Analysis by End-Use
Based on end-use, the market is segmented into pharmaceutical and biotechnology companies, medical devices companies, and others. The pharmaceutical and biotechnology companies segment dominated the market in the past years and is projected to lead in future as well owing to strict regulatory need for product quality and safety. Biotechnology and the pharmaceutical companies should essentially test for pyrogens in order to adhere to and avoid ill-effects in patients. The increased risks associated with contamination is increasing the demand for confirming safety of biologics, drugs, and medical devices. This is notably propelling the demand from these companies, thus the segment’s growth.
On the other hand, the medical devices companies' segment is projected to hold a significant market share in the coming years owing to the increased need for safety in these companies. The growing number of medical devices patients encounter, mainly in painful surgeries. This increases the demand for higher levels of safety thus driving the demand for reliable and effective pyrogen testing in medical devices companies. Also, strict regulatory standards that require rigorous pyrogen testing to ensure biocompatibility and safety have increased the demand from these companies.
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Pyrogen Testing Market Regional Insights
North America is currently dominating and is likely to continue so during the forecast period. This is owing to its well-developed healthcare infrastructure, growing investment in biotechnology and pharmaceutical research. The growth of this region is also significantly impacted by strong regulatory frameworks like the ones from the U.S. FDA and the presence of several established players in biotechnology and pharmaceutical companies. Furthermore, the regional growth is driven by the growing number of research and development activities and improvements in testing. These factors contribute to the growth of the market in North America. The key players operating in the region include Charles River Laboratories, Lonza Group, BioTek Instruments, Thermo Fisher Scientific, Vortex Biosciences, and more.
Asia-Pacific is the fastest-growing region in the global pyrogen testing market due to the increasing investments in biotechnology and pharmaceutical sectors, expanding regulatory framework, and heavy investments in healthcare infrastructure. Moreover, the growing demand for compliance and quality control and progressing medical devices and drug development market are driving the regional growth. in addition, increased emphasis on enhancing manufacturing standards and catering to international protocols is significantly impacting the market growth in the region.
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Pyrogen Testing Market Dynamics
Drivers
Growing Biologics and Drug Development
- The development of novel drug classes, advanced therapies and biologics, including gene therapies, monoclonal antibodies, and cell therapies is rigorously demanding highly efficient and reliable testing process for ensuring high efficacy and safety of complex products. Also, the increasing research and development activities in biotechnology and pharmaceutical industries is necessitating the demand for pyrogen testing in the growing volume of devices.
Growth of Biopharmaceutical Industry
- The speedy growth of biopharmaceutical production with emphasis on complex and high-value devices is fueling the need for precise and reliable testing to cater to the quality and safety standards. Also, the growing biopharmaceutical production and the increased demand for quality efficacy during the entire manufacturing process is surging the demand for the said testing.
Restraints
Complexity of Testing Processes
- Pyrogen testing needs specialized skills and knowledge. The increased complexity of testing processes like sample testing, preparation, and result interpretation is notably demand professional experts, which could be difficult for a few facilities and settings. Also, pyrogen testing is time consuming since it comprises multiple stages. This could probably slow down development of the products and approval procedures.
Standardization and Regulatory Issues
- Different regions have diverse regulatory standards associated with pyrogen testing. This could create complications for the global enterprises aiming for compliance in different markets. This may notably impact the growth of the market negatively. Also, constant changes and updates in regulatory guidelines may result in extra costs and uncertainties for firms wanting to adapt their testing techniques to stay compliant.
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Pyrogen Testing Market Competitive Landscape
The global pyrogen testing market is a highly competitive global market driven by many international competitors. Prominent corporations with cutting-edge AI and ML technology are Google, IBM, Microsoft, and NVIDIA. To support a wide range of applications across industries, these industry experts concentrate on creating cutting-edge algorithms, scalable platforms, and reliable infrastructure. Rapid advances in technology, strategic alliances, and large expenditures on research and development define the competitive environment.
Top Player’s Company Profiles
- Merck KGaA
- GenScript
- Hyglos GmbH
- Ellab A/S
- Lonza
- Thermo Fisher Scientific, Inc.
- Charles River Laboratories, Inc.
- Associates of Cape Cod, Inc.
- Pyrostar
- Abbott Laboratories
- AstraZeneca
- Heraeus Medical
- Wako Pure Chemical Industries
- Roche Diagnostics
- Biosafe Technologies
Recent Developments
- In July 2022, Merck declared the unveiling of its (MAT) Microbiology Application and Training laboratory in Bengaluru. This lab offers technical expertise and facilities to aid the Indialife science group on capability development of microbial quality control.
- In June 2024, GenScript Biotech Corporation introduced its ultra-modern offering, named ‘GenScript FLASH Gene service’. This super-fast (S2P) sequence-to-plasmid service addresses urgent need for providinggene constructs with impeccable quality, speed, and cost-efficiency.
- In April 2023, Ellab declares acquisition and merger of Complete Technical Solutions (CQV) Ltd. This acquisition represents sustained execution of Ellab’s strategy of increasing its domain services for emerging as a complete solution provider in main markets in the pharma and biotech industry.
Pyrogen Testing Key Market Trends
- High-Throughput Screening and Automation: Integrating automation in pyrogen testing is improving accuracy and efficiency. The newly integrated automation systems can capably manage huge sample volumes and conduct tests with better consistency. This reduces operational costs and human errors. Also, improvements in high-throughput screening techniques enable speedy and exhaustive testing of several samples at the same time.
- Introduction of Alternate Methods: Novel techniques like PCR (polymerase chain reaction) and several molecular diagnostic methods are currently being studied for their capabilities to offer highly sensitive and speedy pyrogen detection. Moreover, nanotechnology innovations are also being explored for their potential to improve specificity and sensitivity of detection techniques. These alternate methods will fuel the growth of the market in the future.
Pyrogen Testing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the pyrogen testing market is witnessing considerable growth due to the growing focus on patient safety, increasing education and awareness, and the rising concerns regarding contaminations. The market is also propelled by the speedy growth of the biopharmaceutical sector. However, the market is restrained by complications of testing procedures and the emergence of alternative testing methods. North America is anticipated to lead the market owing to the improved healthcare infrastructure, growing investments in biotechnology and pharmaceutical companies, and developed regulatory architecture. Some opportunities for the growth of the pyrogen testing market include the growing number of strategic collaborations and partnerships, increased quality assurance services, and technological advancements.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 1322.30 Million |
| Market size value in 2031 | USD 4100.59 Million |
| Growth Rate | 13.4% |
| Base year | 2023 |
| Forecast period | (2024-2031) |
| Forecast Unit (Value) | USD Million |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Pyrogen Testing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Pyrogen Testing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Pyrogen Testing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Pyrogen Testing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Pyrogen Testing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Pyrogen Testing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Pyrogen Testing Market Report Snapshots
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