Published: December 2023 | Report Code: 12785 | Available Format: PDF | Pages: 310
The global pyrogen testing market generated a revenue of USD 1,406.4 million in 2023, which is expected to witness a CAGR of 7.3% during 2024–2030, to reach USD 2,284.2 million. This is attributed to the rising adoption of pyrogen testing within the biopharmaceutical industry. Moreover, the surging growth in the pharmaceutical and biotechnology sectors along with the rising number of new biologics research and launches is expected to boost the demand for such testing for making safe and effective drugs.
Moreover, the growth of the market is driven by the surging preference for personalized medicine across the population, the increasing R&D initiatives in the biopharmaceutical industry, the rising incidence of communicable and chronic diseases globally, and the growing awareness among people about food hygiene and safety. In addition, increased cases of COVID-19 all over the world and the presence of regulatory guidelines for mandating such testing for drug developments are some other factors boosting the growth of the market.
Furthermore, the testing of pyrogen is crucial for any drug, especially in the case of parenteral drugs. Before parenteral drugs are released onto markets, they have to be tested for certain toxins and pyrogens. As fever-inducing substances, pyrogens can be life-threatening to patients, if injected into the body. So, companies are followed a number of pyrogen detection tests before sending any drug to the market.
With advancing healthcare systems and strategic initiatives taken by governments for safe and effective drugs, pyrogen testing plays a crucial role for any drug and substance, as it helps in the confirmation of the existence of pyrogen bacteria. Products that have the presence of pyrogen could cause harmful effects on the human body, such as fever, and can lead to death in some cases.
Moreover, the COVID-19 pandemic showed a positive impact on the market. This is because governments and regulatory bodies increased their support for the finding and launch of vaccines for this disease. This helped upsurge in the acceptance of pyrogen testing products for the research. In order to ensure patient safety, bacterial endotoxin testing (BET) is observed to be a crucial quality assurance measure. Further, it has significant applications in preventing other infectious ailments.
Pyrogen testing is a crucial step for every drug and therapeutics to make it safe and effective. Rise in the number of cancer cases and genetic diseases, personalized therapies gained advantages in the treatment of such diseases. Personalized medicine has the advantage that it utilizes people’s genetic profiles to help in decision-making for the diagnosis, prevention, and treatment of diseases. Thus, patients and companies are rapidly adopting personalized medicine. Moreover, personalized treatment-based approaches to clinical and genomic characteristics are becoming more common among patients with cancer and immunologic disorders. Hence, the rising demand for personalized medicine is one of the main factors driving the demand for pyrogen testing solutions.
In addition, as there is a large pool of patients with idiosyncrasy and they want personalized medicine for better efficacy and due to individuals’ vulnerability to infection and impulsiveness in the course of prognosis, ailment, and treatment response, the demand for personalized medicine is growing, which, in turn, the need for pyrogen testing is rapidly increasing.
The demand for novel drugs and therapies across the world is increasing, owing to the rising prevalence of chronic and infectious diseases such as diabetes, cancer, heart disease, and TB. Additionally, the growing geriatric population with the incidence of chronic diseases is another factor for the high need for novel drugs and therapies. According to the WHO, in 2020, cancer was a leading cause of death across the world, with nearly 10 million deaths. Furthermore, governments are taking initiatives to boost their healthcare infrastructure, which leads to growth in the pharmaceutical industry. Hence, the rising demand for novel medicine and therapeutics is driving the market growth.
Market Size in 2023
USD 1,406.4 Million
Market Size in 2024
USD 1,496.4 Million
Revenue Forecast in 2030
USD 2,284.2 Million
Market Trends, Drivers, and Restraints; Revenue Estimation and Forecast; Segmentation Analysis; Companies’ Strategic Developments; Market Share Analysis of Key Players; Company Profiling
By Offering; By Type; By End User; By Region
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Based on product, the assays, kits, and reagents category accounted for the largest revenue share, of 50%, in 2023 in the market, and it is further expected to maintain its dominance in the future. This is ascribed to the increasing inclination for kit-based testing approaches and the rapidly rising requirements of assays, reagents, and kits in performing pyrogen tests in large numbers. Moreover, the surging prevalence of chronic and infectious diseases gives rise to the production of pharmaceutical products. Thus, the increasing production of such products has boosted the demand for pyrogen testing consumables.
On the other hand, the instruments category is projected to witness the fastest growth in the coming years. This can be due to the several advantages offered by such instruments as compared to others, such as these have drastically improved testing efficiency by boosting accuracy and minimizing errors, unlike manual testing, where samples get mixed up and end up causing costly and dangerous mishaps. Moreover, these help in proving safety standards while performing any test in laboratories, and sometimes they enable the way to automate some processes.
Based on end user, the pharmaceutical and biotechnology companies category accounted for the largest revenue share, of 35%, in 2023, and it is further projected to maintain its dominance in the future. This is ascribed to the upsurge in the production of pharmaceuticals, biologics, novel medicine, and other products, so the need for pyrogen testing is on the rise. Moreover, the rising preference for personalized medicine and the increasing incidence of infectious and chronic diseases are driving the market growth in this category.
On the other hand, the medical device companies category is projected to witness the fastest growth over the forecast period. This can be attributed to the introduction of technologically advanced products and the upsurge in the demand for advanced and high-quality medical devices for numerous purposes such as therapeutic and diagnostic. Moreover, with technological advancements, the need for advanced therapeutic and diagnostic approaches is rising, which, in turn, drives the demand for pyrogen testing.
North America captured the largest market share, of 55%, in 2023. This is attributed to the ongoing developments in the fields of pharmaceutical and biotechnology, and the rising spending on pharmaceutical and biopharmaceutical research and expansion by top players in the region. Furthermore, the increasing pharmaceutical drug pipelines, the rising number of drug approvals, and the growing awareness of product safety and food safety are other major factors boosting the regional market growth.
In North America, the U.S. leads the market. This is due to the presence of developed healthcare infrastructure, increased focus on new drug development, and the presence of major biotechnology and biopharmaceutical firms, such as Pfizer Inc. and F. Hoffmann-La Roche AG, in the country. Moreover, Canada is also contributing significant revenue to the North American market. This is attributed to the growing pharmaceutical and biotechnology industry, the surging awareness about the safety of drugs, and the increasing R&D activities in the nation.
Furthermore, the European market is showing significant growth. This is ascribed to the surging pharmaceutical sector, the growing geriatric population, the increasing number of drug pipelines, and the rising awareness about food hygiene and drug safety in the region. In Europe, Germany is significantly contributing to the market. This is attributed to the growing government support for pharmaceutical and biotechnology companies and continuous research and development for advanced pharmaceutical products and devices in the country.
The report analyzes the impact of the major drivers and restraints on the pyrogen testing market, to offer accurate market estimations for 2017-2030.
Based on Offering
Based on Type
Based on End User
The pyrogen testing market size stood at USD 1,406.4 million in 2023.
During 2024–2030, the growth rate of the pyrogen testing market will be around 7.3%.
Pharmaceutical and biotechnology companies is the largest end user in the pyrogen testing market.
The major drivers of the pyrogen testing market include the growing pharmaceutical and medical device industries, the rising adoption of pyrogen testing during the production and before the marketing of pharmaceutical drugs and medical devices, and the increasing incidence of chronic and infectious diseases.
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