Pyrogen Testing Market - Global Forecast to 2026, by Test Type (Limulus Amoebocyte Lysate Test, TAL Test, Monocyte Activation Test, Rabbit Pyrogen Test, and Recombinant Factor C Assay), by Product Type (Instruments, Kits, and Reagents), by End User (Pharmaceutical and Biotech Companies, Food and Beverages Companies, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) — Size, Share, Outlook, and Opportunity Analysis, 2018-2026

  • Published On : Mar 2019 |
  • Pages : 153 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Global Pyrogen Testing Market – A Novel Approach for Detecting Pyrogen Contamination

Pyrogen testing plays a major role in advanced healthcare, as it shows the presence of pyrogen in an organism that causes fever. Pyrogen can be found in lipopolysaccharides and lepoteichoic acid. Contaminated pyrogenic products can cause harmful effects such as fever in human body.

The global pyrogen testing market size was valued at US$ US$ 689.9 million in 2017, and is expected to exhibit a CAGR of 12.4% over the forecast period (2018 – 2026).

Figure 1. Global Pyrogen Testing Market Value (US$ Mn), by Region, 2017

                   Pyrogen Testing  | Coherent Market Insights                       

Source: Coherent Market Insights Analysis

Increasing demand for testing of pyrogen contamination in medical devices and drugs is expected to propel growth of the pyrogen testing market

Pyrogen testing is used in detection of pyrogen contamination in pharmaceutical dosage forms and medical devices. Pyrogen contaminated injections post administration can cause temperature dysregulation (fever), bodyache, inflammation, shock, multiorgan failure, and other life threatening problems.

Moreover, increasing research and development of therapeutic drugs and medical devices is propelling growth of the pyrogen testing market over the forecast period. According to the United Nations Educational, Scientific and Cultural Organization (UNESCO), November 2016, an estimated US$ 1.7 trillion of global spending in research and development for various medical applications. Moreover, the U.S. Food and Drug Administration (FDA) and its Center for Drug Evaluation and Research (CDER), has approved around 59 novel drugs in 2018 compared to 46 approvals of new molecule entities in 2017.           

Figure 2. Global Pyrogen Testing Market Share (%), by Test Type, 2018 and 2026

Pyrogen Testing  | Coherent Market Insights

                                                                            Source: Coherent Market Insights Analysis

Increasing research and development in healthcare sector in North America is expected to bolster the market growth

North America holds dominant position in the pyrogen testing market, owing to high prevalence of cardiovascular disease. According to the European Federation of Pharmaceutical Industries and Association (EFPIA) report, 2018, an estimated US$ 48,111 million and US$ 82,418 million pharmaceutical expenditure was recorded in 2015 and 2016 respectively, in the U.S.

Increasing number of approvals for new molecule entities (NMEs) by regulatory agencies in this region is expected to bolster the market growth over the forecast period. In 2018, the U.S. Food and Drug Administration (FDA), approved 59 new molecule entities which enables new treatment options for patients and advances in health care for the American people.

Moreover, key players in the market are focused on collaboration activities for development of new kits and reagents used in detection of pyrogen in pharmaceutical products and devices. For instance, in May 2018, Merck and Solvias announced collaboration plans to develop PyroMAT System, a new kit for detection of pyrogen.

Key Players

Major players operating in the global pyrogen testing market include Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associates of Cape Cod Inc., Charles River Laboratories Inc., GenScript, WuXi PharmaTech (Cayman), Inc., bioMérieux, Wako Chemicals USA, Inc., Sanquin,  Ellab A/S, and Pyrostar

Pyrogen testing is detection of pyrogen in pharmaceutical drugs and devices. The contaminated devices or drugs when introduced in body can cause fever, shock, inflammation, and other problems. Pyrogen testing consists of kits, reagents, and instruments, which enables pyrogen and endotoxins detection by in-vitro methods and minimizes the usage of animal testing.

Market Dynamics

Increasing research and development in the field of pyrogen testing and advancements in technology for detection of endotoxin is a major factor driving pyrogen testing market growth. According to the Pharma R&D Annual Review, 2018, an estimated drug count in 2017 was around 14,872, while in 2018 it was around 15,267, resulting in an overall pipeline growth by 2.7% in 2018. Stringent government regulations and rising focus on in-vitro testing for detection of pyrogen is one of the major factors boosting growth of the market. For instance, in June 2012, the U.S. Food and Drug Administration (FDA) provided guidelines for pyrogen and endotoxin testing to industries.

Key features of the study:

  • This report provides in-depth analysis of the pyrogen testing market and provides market size (US$ million) and Compound Annual Growth Rate (CAGR %) for the forecast period (2018 – 2026), considering 2017 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategy adopted by key players
  • It profiles key players in the global pyrogen testing market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study include Thermo Fisher Scientific, Merck KGaA, Lonza Group, Associates of Cape Cod Inc., Charles River Laboratories Inc., GenScript, WuXi PharmaTech (Cayman), Inc., bioMérieux, Wako Chemicals USA, Inc., Sanquin, Ellab A/S, and Pyrostar
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global pyrogen testing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the pyrogen testing market

Detailed Segmentation:

  • Global Pyrogen Testing Market, By Test Type:
    • Limulus Amoebocyte Lysate (LAL) Test
    • TAL Test
    • Monocyte Activation Test (MAT)
    • Rabbit Pyrogen Test (RPT)
    • Recombinant Factor C Assay (rFC)
  • Global Pyrogen Testing Market, By Product Type:
    • Instruments
    • Kits
    • Reagents
  • Global Pyrogen Testing Market, By End User:
    • Pharmaceutical and Biotech Companies
    • Food and Beverages Companies
    • Others
  • Global Pyrogen Testing Market, By Region:
    • North America
      • By Test Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Product Type:
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Test Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Product Type:
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Test Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Product Type:
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Test Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Product Type:
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Test Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Product Type:
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Test Type:
        • Limulus Amoebocyte Lysate (LAL) Test
        • TAL Test
        • Monocyte Activation Test (MAT)
        • Rabbit Pyrogen Test (RPT)
        • Recombinant Factor C Assay (rFC)
      • By Product Type:
        • Instruments
        • Kits
        • Reagents
      • By End User:
        • Pharmaceutical and Biotech Companies
        • Food and Beverages Companies
        • Others
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Thermo Fisher Scientific *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • Merck KGaA
    • Lonza Group
    • Associates of Cape Cod Inc.
    • Charles River Laboratories Inc.
    • GenScript
    • WuXi PharmaTech (Cayman), Inc.
    • bioMérieux
    • Wako Chemicals USA, Inc.
    • Sanquin
    • Ellab A/S
    • Pyrostar

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Test Type
      • Market Snippet, By Product Type
      • Market Snippet, By End User
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Pipeline Analysis
    • Reimbursement Scenario
    • Epidemiology
    • PEST Analysis
    • Regulatory Scenario
    • New Product Launches
    • Collaborations and Agreements
    • Market Trends
  4. Global Pyrogen Testing Market, By Test Type, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Limulus Amoebocyte Lysate (LAL) Test
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • TAL Test
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Monocyte Activation Test (MAT)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Rabbit Pyrogen Test (RPT)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Recombinant Factor C Assay (rFC)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  5. Global Pyrogen Testing Market, By Product Type, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Instruments
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Kits
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Reagents
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  6. Global Pyrogen Testing Market, By End User, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Pharmaceutical and Biotech Companies
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Food and Beverages Companies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  7. Global Pyrogen Testing Market, By Region, 2018 – 2026, (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Test Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • U.S.
        • Canada
    • Latin America
      • Market Size and Forecast, By Test Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Test Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • Germany
        • U.K.
        • France        
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Test Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of APAC
    • Middle East
      • Market Size and Forecast, By Test Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Test Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Mn)
        • South Africa
        • Central Africa
        • North Africa
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      •  Thermo Fisher Scientific
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Merck KGaA
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Lonza Group
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Associates of Cape Cod Inc.
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      •  Charles River Laboratories Inc.
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • GenScript
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • WuXi PharmaTech (Cayman), Inc.
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • bioMérieux
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Wako Chemicals USA, Inc.
        •  Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Sanquin
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Ellab A/S
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Pyrostar
        • Company Overview
        • Product Type Type Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 23 market data tables and 26 figures on "Pyrogen Testing Market - Global forecast to 2026”.

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

Choose License Type

"How Can I Help You" ?

Finding it difficult to find the research that would cater to your business demands? Give us a chance to help you. One of our Research Consultants will connect to provide a customized solution.

[email protected]

Key Benefits

  • Custom Research Solution

    Talk to our research consultant to design an exclusive report as per your research needs.

  • Customer Fulfilment

    We aim to fulfil client's research demands with tailored research solutions.

  • Quick Turnaround Time Reports

    We aim to provide research studies in quickest turnaround time and in a much cost effective manner.

  • 360-degree Approach

    We cover each industry from supply and demand side with an aim to provide a most holistic research study.

  • Assured Quality

    We strive to provide most accurate and reliable research findings in our research reports.