As per our report, the global pyrogen testing market size is estimated to be worth USD 1769.11 million by 2026 and USD 929.78 million in 2021, registering a CAGR of 13.73% during the forecast period.
Pyrogens are substances produced by the bacterium, when released into the blood, produce fever. Pyrogen testing is used to ensure these toxic substances are absent in the body. Pyrogen contamination can be caused due to various reasons such as environmental factors, through contaminated solute, solvent, container, and apparatus. When contaminated drugs are injected into the bloodstream, the toxins bypass the normal defense mechanism to overcome these white blood cells in the body start releasing another form of pyrogen, causing a high fever, which in some cases may even lead to shock and death.
Increasing response for pyrogen testing produced in the pharmaceutical and biotechnology trade is a significant feature contributing to the market growth.
Rapidly growing pharmaceutical and biotechnology manufacturing and a growing number of new therapeutics promotions are expected to increase the demand for pyrogen testing products. Growing investment in R&D by manufacturing syndicates and the government for new product development is one more significant factor subsidized towards the growth of the marketplace. New product development and launch is a key strategy attained by manufacturers to sustain their dominance and to gain maximum revenue share in the division.
The global pyrogen testing market is further expected to show significant growth owing to the increasing number of biological products. Growing government support and the arrival of new drugs are also fuelling the growth of the market. In addition, the rise in chronic disease burden and increasing emphasis on Research and development are primary reasons driving the market growth.
However, complex regulatory policies and unclear reimbursement issues are restraining market growth.
The growing need for rehabilitative drugs for life-threatening diseases like cancer and diabetes emphasizes the need for drug research and development. Hence, the need for pyrogen testing kits for effective quality monitoring and regulation is expected to offer lucrative growth opportunities for the market. Furthermore, expanding outsourcing operations in the pharmaceutical sector in developed countries, increased understanding of pyrogen testing rising per capita healthcare spending will create business opportunities. Hence, increased healthcare spending, providing attractive growth opportunities for players in the global pyrogen testing market.
strong government control of the tests, a lack of in-depth awareness of the experiments, and a growing revolution in existing technology could pose a threat to this market.
Impact of COVID-19 on the global pyrogen testing market:
COVID-19 is a recently found novel coronavirus that causes an infectious disease. Within a short period of time, it had exploded all over the world. Since the World Health Organization (WHO) proclaimed COVID-19 to be a pandemic, several established pharmaceutical and biopharmaceutical firms and small start-ups have come forward to produce therapies and vaccines to combat the infection caused by the novel coronavirus. According to the WHO, there are currently 70 vaccine candidates in production, with three being evaluated in clinical trials. The social and economic costs of the pandemic have encouraged governments around the world to raise funding for vaccine production, resulting in a rise in the use of pyrogen testing materials in COVID-19 research. The industry is projected to expand as COVID-19 levels increase, owing to increased demand for research and vaccine production, fueling the overall market growth.
Market Size Available
2020 to 2026
2021 to 2026
By Product, Application, Test Type, and Region
Various Analyses Covered
Global, Regional & Country Level Analysis, Segment-Level Analysis, DROC, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities
North America, Europe, APAC, Latin America, Middle East & Africa
This research report on the global pyrogen testing market has been segmented and sub-segmented based on the product, application, test type, and region.
Pyrogen Testing Market - By Product:
Based on the product, in 2020, the kits and reagents segment had the largest share of the pyrogen testing market. Pharmaceuticals, biologics, and medical device development are increasing as the prevalence of chronic diseases increases. As a result of the increased production of these products, pyrogen measuring consumables such as kits and reagents are becoming more widely used. Furthermore, because of technical advancements in goods, the instruments segment is projected to rise at a healthy rate over the forecast period. The PyroDetect System, for example, is a non-animal alternative to the rabbit test that provides high-quality in vitro identification of non-endotoxin and endotoxin contamination.
Pyrogen Testing Market - By Application:
Based on the application, owing to the expanded production of pharmaceuticals, biopharmaceuticals, and other biologic products, pharmaceuticals and biotechnology firms led the overall demand in 2020. As a result, the growing need for pyrogen testing consumables and instruments in these industries propels the pyrogen testing industry forward. Over the projected era, the medical device companies segment is expected to rise dramatically. Pyrogen research is likely to become more widespread in the near future due to the launch of technologically innovative products and the increasing demand for high-quality medical instruments for therapeutic and diagnostic uses.
Pyrogen Testing Market - By Test Type:
Due to the growing demand for animal-free detection tests and their high reliability and reproducibility during detection, LAL tests are projected to rise faster during the forecast period. The most popular pyrogen testing technique was the rabbit pyrogen test. However, the rising need for animal-free testing is a major factor that may restrict the use of this test form in the near future. In addition, the opportunity to evaluate a substance without damaging live animals is increasing the success of animal-free testing.
Pyrogen Testing Market - By Region:
Geographically, the North American pyrogen testing market is estimated to dominate the global market for pyrogen testing during the forecast period owing to an increasing number of new biologics in the region. Because of the presence of many major biotechnology and biopharmaceutical companies in this field, such as Pfizer Inc., F. Hoffmann-La Roche AG, and Amgen Inc., North America led the market with the highest sales share. In addition, North America's well-developed healthcare and science infrastructure and a strong emphasis on innovative drug production have driven regional demand expansion.
Asia-Pacific is estimated to be the fastest-growing region due to the continuously growing population and growing healthcare expenditure. Due to untapped opportunities in the area, Asia Pacific is expected to expand faster during the forecast period. Many manufacturers focus on drug discovery, growth, and production efforts in Asian countries such as China and India. In addition, clinical research organizations are now concentrating their clinical trials in Asian countries. Some of the key factors driving the sector's growth in this area are the availability of less strict government regulations for drug production, a large gene pool, and a rapidly expanding healthcare infrastructure.
KEY MARKET PARTICIPANTS:
In 2020, Charles River Laboratories, Inc. (US), Merck KGaA, Thermo Fisher Scientific, Inc. (the US), and Associates of Cape Cod, Inc. (the US) accounted for the majority of the market share.
Some of the major companies discussed in the report are Associates of Cape Cod, Inc., Lonza Group, Merck Kgaa, Ellab A/S, Genscript, Hyglos GmbH, Thermo Fisher Scientific, Inc., Charles River Laboratories, Inc., Wako Chemicals Usa, Inc., and WUXI Pharmatech (Cayman) Inc.
Consolidation to a high degree, strict rules on animals' use, proven players will serve as a big impediment to newcomers.
The global pyrogen testing market has fierce competition, and only the major corporations have the capacity to bear heavy capital expenditures as well as high R&D and production costs. Thus, it is further discouraging the other companies from entering the market. Furthermore, the market's top players are big and well-established, with a high brand loyalty level.
1.1 Market Definition
1.2 Study Deliverables
1.3 Base Currency, Base Year and Forecast Periods
1.4 General Study Assumptions
2. Research Methodology
2.2 Research Phases
2.2.1 Secondary Research
2.2.2 Primary Research
2.2.3 Econometric Modelling
2.2.4 Expert Validation
2.3 Analysis Design
2.4 Study Timeline
3.1 Executive Summary
3.2 Key Inferences
3.3 New Developments
4. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
4.1 Market Drivers
4.2 Market Restraints
4.3 Key Challenges
4.4 Current Opportunities in the Market
5. Market Segmentation
5.1 By Product
5.1.1 Kits and Reagents
5.2 By Application
5.2.1 Pharmaceutical and Biological Manufacturing
5.2.2 Medical Device Manufacturing
5.2.3 Other Applications
5.3 By Test Type
5.3.1 LAL Tests
18.104.22.168 Chromogenic Tests
22.214.171.124 Turbidimetric Tests
126.96.36.199 Gel Clot Tests
5.3.2 In-Vitro Tests
5.3.3 Rabbit Tests
6. Geographical Analysis
6.1 North America
6.1.2 United States
6.3.5 South Korea
6.4 Latin America
6.4.4 Rest of Latin America
6.5 Middle East & Africa
7. Strategic Analysis
7.1 PESTLE analysis
7.2 Porter’s Five analysis
7.2.1 Bargaining Power of Suppliers
7.2.2 Bargaining Power of Consumers
7.2.3 Threat of New Entrants
7.2.4 Threat of Substitute Products and Services
7.2.5 Competitive Rivalry within the Industry
8. Market Leaders' Analysis
8.1 Associates of Cape Cod, Inc.
8.1.2 Product Analysis
8.1.3 Strategic Evaluation and Operations
8.1.4 Financial analysis
8.1.5 Legal issues
8.1.6 Recent Developments
8.1.7 SWOT analysis
8.1.8 Analyst View
8.2 Charles River Laboratories, Inc.
8.3 Lonza Group
8.4 Merck Kgaa
8.5 Ellab A/S
8.7 Hyglos GmbH
8.8 Thermo Fisher Scientific, Inc.
8.9 Wako Chemicals USA, Inc.
8.10 WUXI Pharmatech (Cayman) Inc.
9. Competitive Landscape
9.1 Market share analysis
9.2 Merger and Acquisition Analysis
9.3 Agreements, collaborations and Joint Ventures
9.4 New Product Launches
10. Expert Opinions
10.1 Market Outlook
10.2 Investment Opportunities
a) List of Tables
b) List of Figures