Pharmaceutical Impurity Synthesis And Isolation Services Market To Reach $1.94 Billion By 2030

Pharmaceutical Impurity Synthesis And Isolation Services Market Growth & Trends

The global pharmaceutical impurity synthesis and isolation services market size is expected to reach USD 1.94 billion by 2030, growing at a CAGR of 8.03% during the forecast period, according to a new report by Grand View Research, Inc.

Pharmaceutical impurity testing, quantification, and analytical control strategies are important in optimizing safety, purity, and quality control for finished drug products and drug substances. Pharmaceutical impurities can arise from several sources and include reagents, starting materials and their contaminants, catalysts, intermediates, solvents, excipients and their contaminants, and degradation products.  

The growing complexity of pharmaceutical formulations is also contributing to market growth. With the increasing development of biologics, complex generics, and novel drug delivery systems, the nature of impurities has become more diverse and challenging to identify. This complexity necessitates advanced analytical techniques and expert services for accurate impurity profiling. Companies seek specialized services to handle these requirements, driving demand for impurity synthesis and isolation services. Thus, the aforementioned factors contribute to market growth.

Moreover, continuous technological advancements in analytical techniques further driving the demand for impurity synthesis and isolation services. The development of more sophisticated methods, such as high-resolution mass spectrometry and advanced chromatographic techniques, enables more precise detection and characterization of impurities. Service providers that adopt and integrate these cutting-edge technologies would easily meet the growing needs of the pharmaceutical industry, further driving growth in the market.

Growing collaboration and outsourcing trends in the pharmaceutical industry play a significant role in the market dynamics. Pharmaceutical companies are increasingly outsourcing impurity synthesis and isolation to specialized service providers to focus on their core competencies and reduce operational costs. This outsourcing trend creates opportunities for service providers to expand their offerings and cater to global clients. Thus, the aforementioned factors are driving the growth of the market.

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Pharmaceutical Impurity Synthesis And Isolation Services Market Report Highlights

• Based on service, the isolation service segment dominated the market with a share of 39.41% in 2023. Isolation of impurities is a fundamental aspect of ensuring the safety and efficacy of pharmaceutical products. Regulatory agencies require comprehensive impurity profiles, which necessitate effectively isolating these substances from drug formulations.

• Based on impurity type, the inorganic impurities segment dominated the market in 2023. Technological advancements have played a significant role in dominating the segment of inorganic impurities. Innovations in analytical techniques, such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Atomic Absorption Spectroscopy (AAS), have greatly enhanced the ability to detect and quantify inorganic impurities with high sensitivity and accuracy.

• Based on technique, the chromatography segment accounted for the largest revenue share in 2023. Increasing complexity of pharmaceutical formulations is driving the demand for advanced chromatographic techniques. Modern drugs, including biologics, peptides, and complex generics, often involve intricate mixtures that require proper separation methods.

• Based on application, the commercial manufacturing segment accounted for the largest revenue share in 2023. Growing global pharmaceutical market and expanding pharmaceutical production facilities worldwide are contributing to the segment's growth. As pharmaceutical companies increase their production capacities and enter new markets, the need for reliable impurity analysis services grows significantly.

• Based on end use, the biotech and pharmaceutical companies segment accounted for the largest revenue share in 2023. Biotech and pharmaceutical companies' significant investment in research and development (R&D) is contributing to the segment’s growth.

• North America dominated the market with a revenue share of 37.98% in 2023. The regional revenue growth is owing to high R&D activities and government initiatives. Moreover, strong presence of pharmaceutical companies and outsourcing service providers is another major factor expected to propel market growth.

Pharmaceutical Impurity Synthesis And Isolation Services Market Segmentation

Grand View Research has segmented the global pharmaceutical impurity synthesis and isolation services market based on service, impurity type, technique, application, end use, and region:

Pharmaceutical Impurity Synthesis & Isolation Service Outlook (Revenue, USD Million, 2018 - 2030)

• Synthesis Services

• Isolation Services

• Analytical Services

Pharmaceutical Impurity Synthesis & Isolation Services Impurity Type Outlook (Revenue, USD Million, 2018 - 2030)

• Organic Impurities

• Inorganic Impurities

• Residual Solvents

Pharmaceutical Impurity Synthesis & Isolation Services Technique Outlook (Revenue, USD Million, 2018 - 2030)

• Chromatography

• HPLC

• Gas Chromatography

• Preparative Chromatography

• Others

• Spectroscopy

• Mass Spectroscopy

• Nuclear Magnetic Resonance (NMR) Spectroscopy

• Others

• Crystallization

• Hyphenated Techniques

• Others

Pharmaceutical Impurity Synthesis & Isolation Services Application Outlook (Revenue, USD Million, 2018 - 2030)

• Drug Development

• Commercial Manufacturing

• Quality Control

• Regulatory Compliance

Pharmaceutical Impurity Synthesis & Isolation Services End Use Outlook (Revenue, USD Million, 2018 - 2030)

• Biotech & Pharmaceutical Companies

• Contract Research Organizations (CRO)

• Others

Pharmaceutical Impurity Synthesis & Isolation Services Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

• U.S.

• Canada

• Mexico

• Europe

• UK

• Germany

• France

• Italy

• Spain

• Denmark

• Sweden

• Norway

• Asia Pacific

• China

• Japan

• India

• Australia

• South Korea

• Thailand

• Latin America

• Brazil

• Argentina

• Middle East and Africa (MEA)

• South Africa

• Saudi Arabia

• UAE

• Kuwait

List of Key Players in Pharmaceutical Impurity Synthesis & Isolation Services Market

• Eurofins Scientific

• Charles River Laboratories

• Wuxi AppTec

• SGS Société Générale de Surveillance SA.

• Intertek Group Plc

• Almac Group

• Cambrex Corporation

• Pharmaron

• Laboratory Corporation of America Holdings

• Syngene International Limited

• PCI Pharma Services

• Catalent Inc.

• Symeres

• Piramal Pharma Solutions

• Frontage Labs

• Veeda Clinical Research