1 Global Nitrosamines Testing Market Insight Analysis
The global Nitrosamines Testing market is valued at USD 152.83 million in 2024, with a CAGR of 12.82% from 2024 to 2033.
Nitrosamine Testing is a method to detect the presence and quantity of nitrosamines in foods or medicines.
Nitrosamines are a class of carcinogen impurities, which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea and nitrite or other nitrogenous compounds with nitrogen in the +3 state. Nitrosamines became a greater focus for the pharmaceutical industry following a series of recalls related to contamination. Nitrosamines can be found in low concentrations in a variety of sources, including API’s and Excipients.
Nitrosamines can be very difficult to detect, making a rigorous nitrosamine test method an absolute necessity for foods manufacturers and pharmaceutical manufacturers.
Figure Global Nitrosamines Testing Market Size (M USD) and CAGR (2024-2033)
2 Nitrosamines Testing Market Growth Drivers and Restraints
Regulatory supervision: The strict control of nitrosamine impurities by regulatory agencies in various countries has prompted companies to increase their testing efforts. For example, the FDA requires pharmaceutical companies to conduct risk assessments on their products to detect nitrosamine impurities, and the EMA stipulates that relevant pharmaceutical companies must review the nitrosamine impurities in their drugs. These regulations require pharmaceutical companies to conduct nitrosamine testing in order to comply with regulations, thereby stimulating market demand growth.
Driven by industry development: The global pharmaceutical industry continues to develop, and investment in active pharmaceutical ingredients (API) has increased. Pharmaceutical companies such as Eli Lilly and Amgen have invested in building factories to expand API production. As a key ingredient in drugs, APIs need to strictly detect nitrosamine impurities during their production process, which has driven the development of the nitrosamine testing market.
Market demand growth: Consumers’ increased attention to food safety and drug quality has prompted food and pharmaceutical companies to pay attention to nitrosamine testing. As a carcinogen, nitrosamines are present in food and drugs and can harm health. In order to ensure product quality and safety, companies actively conduct testing to promote the expansion of the market.
Difficulty in testing: There are many technical difficulties in the detection of nitrosamine impurities. Trace impurities in test materials, contamination during sample preparation, in-situ generation of nitrosamines during analysis, and interference from co-eluting analytes will all affect the accuracy of test results and increase the difficulty and cost of testing.
Complex sources of impurities: The sources of nitrosamine impurities are diverse and uncertain. In the pharmaceutical process, raw materials, production processes, recycled materials, etc. may introduce impurities. For example, in drug production, multiple reagents may be the source of nitrosamine impurities, and there may be differences between different batches of raw materials, making it difficult to accurately detect the source of impurities.
3 Technological Innovations in the Nitrosamines Testing Market
Optimization of detection methods: Liquid chromatography-mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) are mainly used in the market to detect nitrosamines. LC-MS/MS has advantages in the analysis of complex matrix samples, can directly detect nitrosamines, and has high selectivity, accuracy and low limit of quantification; GC-MS is widely used in the determination of volatile nitrosamines, and can separate and identify complex organic mixtures. Enterprises continue to optimize these technologies, such as improving instrument sensitivity and shortening detection time, to improve detection efficiency and accuracy.
New technology exploration: With the development of science and technology, enterprises and scientific research institutions are actively exploring new detection technologies. For example, developing more efficient sample pretreatment methods, reducing impurity interference, and improving detection accuracy; researching new detection reagents and materials, enhancing the ability to identify nitrosamines, and providing the market with more advanced detection methods.
Enhance market competitiveness: Enterprises integrate resources through mergers and acquisitions and reorganizations to enhance competitiveness. For example, SGS acquired Industry Lab to expand its food service and laboratory network in Europe; and acquired Penumbra Security, Inc. to enhance its capabilities in network security testing and further consolidate its market position.
4 Global Nitrosamines Testing Market Size by Type
LC-MS is a powerful analytical technique that combines the separation capabilities of liquid chromatography with the detection capabilities of mass spectrometry. This method is particularly effective for analyzing complex matrices and detecting trace levels of nitrosamines in samples. In 2024, the market value for LC-MS in nitrosamines testing is projected to be $55.46 million. This segment is expected to grow steadily due to its high sensitivity and accuracy, making it a preferred choice for detecting nitrosamines in pharmaceuticals and food products.
GC-MS is another widely used technique in nitrosamines testing. It combines the separation power of gas chromatography with the detection and identification capabilities of mass spectrometry. GC-MS is particularly effective for analyzing volatile nitrosamines and is commonly used in the detection of these compounds in various industrial applications. In 2024, the market value for GC-MS in nitrosamines testing is projected to be $97.37 million. This segment is expected to grow significantly due to its versatility and reliability in detecting nitrosamines in complex samples.
Table Global Nitrosamines Testing Market Size by Type in 2024
Type | Market Size (M USD) 2024 |
|---|---|
Liquid Chromatography and Mass Spectrometry | 55.46 |
Gas Chromatography and Mass Spectrometry | 97.37 |
5 Global Nitrosamines Testing Market Size by Application
The pharmaceutical industry is the largest application segment for nitrosamines testing due to the stringent regulatory requirements and the high stakes involved in ensuring product safety. In 2024, the market value for nitrosamines testing in the pharmaceutical industry is projected to be $74.02 million. This segment is expected to grow significantly due to the increasing demand for safe and effective pharmaceutical products. The presence of nitrosamines in APIs (Active Pharmaceutical Ingredients) and excipients necessitates rigorous testing to comply with regulations set by the FDA and EMA. The growth in this segment is also driven by the increasing number of drug recalls related to nitrosamine contamination, which has heightened awareness and investment in testing services.
The chemical industry is another significant application area for nitrosamines testing. In 2024, the market value for this segment is estimated to be $17.81 million. Chemicals used in various industrial processes can contain nitrosamines, making it essential to test these products to ensure they do not pose health risks. The growth in this segment is driven by the increasing production of chemicals and the need to comply with environmental and safety regulations. The chemical industry’s reliance on nitrosamines testing is expected to grow as more stringent regulations are implemented globally.
The food industry is also a crucial application area for nitrosamines testing due to the potential presence of nitrosamines in food products. In 2024, the market value for nitrosamines testing in the food industry is projected to be $37.59 million. Nitrosamines can form in food products through the reaction of nitrates and secondary amines, particularly in processed meats and dairy products. The increasing awareness of the health risks associated with nitrosamines has led to stricter regulations and higher demand for testing services. The food industry’s focus on safety and quality assurance is driving the growth of nitrosamines testing in this segment.
Table Global Nitrosamines Testing Market Size by Application in 2024
Application | Market Size (M USD) 2024 |
|---|---|
Pharmaceutical Industry | 74.02 |
Chemical Industry | 17.81 |
Food Industry | 37.59 |
Others | 23.41 |
6 Global Nitrosamines Testing Market Size by Region
North America remains a dominant player in the Nitrosamines Testing market, with a projected revenue of approximately $59.99 million in 2024. The region’s robust pharmaceutical industry, advanced technological infrastructure, and stringent regulatory environment contribute to its leading position. Companies such as Eurofins and SGS have a significant presence in this region, offering comprehensive testing services. The market is further bolstered by the high demand for API testing and the continuous investment in R&D for new drug development.
Europe is another key region, with an estimated market revenue of $42.77 million in 2024. The European market benefits from a strong pharmaceutical industry and a well-established regulatory framework. The EMA’s guidelines on nitrosamine impurities have driven the demand for testing services. Companies like Selvita and KYMOS Group are prominent players in this region, providing specialized testing solutions. The market is also influenced by the increasing focus on quality control and compliance with international standards.
The Asia-Pacific region, particularly China and Japan, is experiencing significant growth in the Nitrosamines Testing market. China’s market revenue is projected to reach $15.02 million in 2024, driven by its growing pharmaceutical industry and increasing regulatory scrutiny. Japan, with a projected revenue of $12.79 million, is also a notable market, supported by its advanced technological capabilities and stringent quality control measures. The region’s growth is further fueled by the increasing demand for API testing and the need to comply with international regulatory standards.
The Middle East and Africa region is expected to have a market revenue of $4.34 million in 2024. While this region has a smaller market size compared to North America and Europe, it is growing rapidly. The demand for Nitrosamines Testing is driven by the need to ensure the safety of imported pharmaceuticals and the development of local pharmaceutical industries. The region’s market is also influenced by international trade agreements and the increasing focus on quality control.
India’s Nitrosamines Testing market is projected to reach $8.23 million in 2024. The country’s growing pharmaceutical industry and increasing regulatory compliance requirements are key drivers of market growth. India is a major exporter of APIs and finished drug products, necessitating rigorous testing to meet international standards. The market is further supported by the presence of several testing laboratories and the increasing investment in R&D.
South America’s market revenue is estimated at $3.72 million in 2024. The region’s market is influenced by the need to ensure the safety of pharmaceutical products and the increasing focus on regulatory compliance. The market is also driven by the growing pharmaceutical industry and the need to meet international standards for drug safety and quality.
Figure Global Nitrosamines Testing Market Size (M USD) by Region in 2024
7 Global Nitrosamines Testing Market Analysis by Major Players
Eurofins
Company Profile
Eurofins is a leading global provider of testing and support services, established in 1987. The company operates in multiple regions, including America, Asia-Pacific, Europe, and South Africa. Eurofins is renowned for its comprehensive range of services catering to the pharmaceutical, food, environmental, agriscience, and consumer products industries, as well as governments. The company’s extensive network of laboratories and advanced analytical capabilities make it a trusted partner for nitrosamines testing.
Business Overview
Eurofins provides a wide array of testing services, including those for nitrosamines. The company’s nitrosamines testing services are designed to meet the stringent requirements of regulatory bodies such as the FDA and EMA. Eurofins’ laboratories are equipped with state-of-the-art Liquid Chromatography and Mass Spectrometry (LC-MS) and Gas Chromatography and Mass Spectrometry (GC-MS) systems, which are essential for detecting and quantifying nitrosamines in various samples. Eurofins’ services include method validation, risk evaluation, and confirmatory testing for nitrosamines in pharmaceuticals and other products.
Product Offered
Eurofins offers comprehensive nitrosamines testing services tailored to meet the needs of the pharmaceutical industry. Their services include validating methods for detecting nitrosamines in sartans, ranitidine, and metformin, as well as screening methods for risk evaluation. Eurofins’ testing methods are designed to provide accurate and reliable results, ensuring compliance with regulatory standards and safeguarding consumer health.
SGS
Company Profile
SGS, founded in 1878, is a global leader in inspection, verification, testing, certification, and quality assurance services. Headquartered in Geneva, Switzerland, SGS operates worldwide and serves a diverse range of industries, including agriculture, food, minerals, oil, gas, chemicals, consumer and retail, certification, industrial services, environment, health and safety, transportation, and governments and institutions.
Business Overview
SGS offers a comprehensive suite of nitrosamines testing services using advanced analytical techniques such as Liquid Chromatography and Mass Spectrometry (LC-MS). The company’s testing methods are designed to detect trace levels of nitrosamines in pharmaceutical products, raw materials, and APIs. SGS’ commitment to quality and compliance with international standards makes it a preferred choice for nitrosamines testing.
Product Offered
SGS has developed a robust LC-MS method for detecting nitrosamine traces in various samples. Their testing services are designed to meet the recommended limits of detection and quantification (LOD/LOQ) as specified by regulatory authorities. SGS’ nitrosamines testing services are tailored to support clients in meeting regulatory requirements and ensuring product safety. The company’s extensive experience and expertise in analytical testing make it a reliable partner for nitrosamines testing.
Alcami Corporation, Inc.
Company Profile
Alcami Corporation, Inc., established in 1979, is a leading pharmaceutical company primarily operating in North America. Alcami offers a wide range of services, including the development and manufacturing of active pharmaceutical ingredients, analytical testing, formulation development, packaging, and labeling services. The company’s commitment to quality and innovation has positioned it as a key player in the nitrosamines testing market.
Business Overview
Alcami Corporation, Inc. provides comprehensive nitrosamines testing services using advanced analytical instruments such as LC-MS and GC-MS. The company’s services include screening, method validation, and routine batch analysis for nitrosamines. Alcami’s expertise in handling low-level impurities and challenging matrices makes it a trusted provider of nitrosamines testing services.
Product Offered
Alcami offers two main nitrosamines testing services: screening and method validation/testing. The screening service uses Alcami’s in-house methods to determine the presence of nitrosamines in raw materials or drug products. The method validation and testing service is necessary when nitrosamines are detected in materials associated with drug production or when the risk assessment indicates the presence of components that can form nitrosamines. Alcami’s services are designed to support clients in meeting regulatory requirements and ensuring product safety.