Global Pharmaceutical Impurity Testing Service Market Growth (Status and Outlook) 2025-2031

The global Pharmaceutical Impurity Testing Service market size is predicted to grow from US$ million in 2025 to US$ million in 2031; it is expected to grow at a CAGR of %from 2025 to 2031.

Pharmaceutical impurity testing service refers to the analysis and identification of impurities present in pharmaceutical products. Impurities can be defined as any component present in the drug substance or drug product that is not the desired chemical entity. These impurities can be generated during the manufacturing process, degradation of the drug substance or product, or even from the packaging materials.

Pharmaceutical impurity testing is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. It helps in identifying and quantifying impurities, including organic impurities, inorganic impurities, residual solvents, and potential genotoxic impurities. The testing is performed using various analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), and nuclear magnetic resonance (NMR).

The impurity testing service is typically provided by specialized laboratories or contract research organizations (CROs) that have expertise in pharmaceutical analysis. These service providers follow regulatory guidelines and standards, such as those set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to ensure accurate and reliable results.

The impurity testing service helps pharmaceutical companies in complying with regulatory requirements, such as those outlined in the United States Pharmacopeia (USP) and European Pharmacopoeia (EP). It also assists in the development and optimization of manufacturing processes, as well as in the investigation of product failures or quality issues.

The global pharmaceutical market is 1475 billion USD in 2022, growing at a CAGR of 5% during the next six years. The pharmaceutical market includes chemical drugs and biological drugs. For biologics is expected to 381 billion USD in 2022. In comparison, the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U.S. dollars in 2022. The pharmaceutical market factors such as increasing demand for healthcare, technological advancements, and the rising prevalence of chronic diseases, increase in funding from private & government organizations for development of pharmaceutical manufacturing segments and rise in R&D activities for drugs. However, the industry also faces challenges such as stringent regulations, high costs of research and development, and patent expirations. Companies need to continuously innovate and adapt to these challenges to stay competitive in the market and ensure their products reach patients in need. Additionally, the COVID-19 pandemic has highlighted the importance of vaccine development and supply chain management, further emphasizing the need for pharmaceutical companies to be agile and responsive to emerging public health needs.

LPI (LP Information)' newest research report, the “Pharmaceutical Impurity Testing Service Industry Forecast” looks at past sales and reviews total world Pharmaceutical Impurity Testing Service sales in 2024, providing a comprehensive analysis by region and market sector of projected Pharmaceutical Impurity Testing Service sales for 2025 through 2031. With Pharmaceutical Impurity Testing Service sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Pharmaceutical Impurity Testing Service industry.

This Insight Report provides a comprehensive analysis of the global Pharmaceutical Impurity Testing Service landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyses the strategies of leading global companies with a focus on Pharmaceutical Impurity Testing Service portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Pharmaceutical Impurity Testing Service market.

This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Pharmaceutical Impurity Testing Service and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Pharmaceutical Impurity Testing Service.

This report presents a comprehensive overview, market shares, and growth opportunities of Pharmaceutical Impurity Testing Service market by product type, application, key players and key regions and countries.

Segmentation by Type:
Biopharmacuetical Process-related Impurities Analysis
Organic Impurities Analysis
Solvent Residual Analysis
Elemental Impurities Analysis
Genotoxic Impurities Analysis
Other

Segmentation by Application:
Pharmaceutical
Health Products
Other

This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries

The below companies that are profiled have been selected based on inputs gathered from primary experts and analyzing the company's coverage, product portfolio, its market penetration.
Alfa Chemistry
Eurofins Scientific
Intertek
Element
Nelson Laboratories
Charles River
Creative Proteomics
SGS
Drug Development Solutions
Selvita
Auriga Research
BHP
Jordi Labs
GBA Group
Synergy Health Utrecht
LYF Research
CPL

Please note: The report will take approximately 2 business days to prepare and deliver.