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Analytical Chromatography In Pharma Quality Control Market Research Report: By Sample Type (Raw Materials, Finished Products, In-process Controls), By Technique (Liquid Chromatography, Gas Chromatography, Ion Chromatography), By Application (Identity Testing, Purity Analysis, Quantification), By Detector (UV-Visible Detectors, Fluorescence Detectors, Mass Spectrometers), By Automation Level (Manual, Semi-Automated, Fully Automated) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2


ID: MRFR/ICT/23230-HCR | 100 Pages | Author: Aarti Dhapte| December 2024

Analytical Chromatography In Pharma Quality Control Market Overview


As per MRFR analysis, the Analytical Chromatography In Pharma Quality Control Market Size was estimated at 26.32 (USD Billion) in 2022.The Analytical Chromatography In Pharma Quality Control Market Industry is expected to grow from 27.64(USD Billion) in 2023 to 43.05 (USD Billion) by 2032. The Analytical Chromatography In Pharma Quality Control Market CAGR (growth rate) is expected to be around 5.05% during the forecast period (2024 - 2032).


Key Analytical Chromatography In Pharma Quality Control Market Trends Highlighted


The market for Analytical Chromatography in Pharma Quality Control is driven by stringent regulatory requirements for drug safety and efficacy, as well as the increasing adoption of advanced analytical techniques. The market is witnessing a shift towards high-performance liquid chromatography (HPLC) and gas chromatography (GC) systems, which offer higher sensitivity, accuracy, and reproducibility. Additionally, the growing demand for automated and integrated systems is creating opportunities for market growth.

Key market drivers include the rise of personalized medicine, targeted drug delivery, and the need for faster and more accurate drug analysis. The advent of new analytical techniques, such as ultra-high-performance liquid chromatography (UHPLC) and ion chromatography (IC), is further driving market expansion.
Recent trends in the market include the increasing adoption of hyphenated techniques, such as LC-MS/MS and GC-MS/MS, which combine the capabilities of multiple analytical techniques to provide comprehensive characterization of drug products. The integration of artificial intelligence (AI) and machine learning (ML) algorithms is enhancing the efficiency and accuracy of data analysis, leading to improved drug quality control processes.



Analytical Chromatography In Pharma Quality Control Market Overview


Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


Analytical Chromatography In Pharma Quality Control Market Drivers


Rising Demand for Quality Control in Pharmaceutical Manufacturing


The Analytical Chromatography In Pharma Quality Control Market Industry is growing with the rising demand for high-quality and safe pharmaceutical products. Analytical chromatography is one of the most significant tools used for identifying and quantifying active pharmaceutical ingredients , impurities, and other components. A thorough quality control of pharmaceuticals is required to meet the demands of various government agencies, for example, the US Food and Drug Administration and the European Medicines Agency.

These agencies impose strict regulatory requirements on pharmaceutical manufacturing to guarantee the safety of pharmaceuticals to the consumers of these products. In order to meet these requirements and ensure the safety and efficacy of the products, analytical chromatography including high-performance liquid chromatography, and gas chromatography is widely used.


Growing Adoption of Advanced Analytical Techniques


The increasing adoption of advanced analytical techniques is expected to be a major driver of the Analytical Chromatography In Pharma Quality Control Market Industry. One of the advanced techniques that are gaining traction in the market is ultra-high performance liquid chromatography. This technique offers higher resolution, sensitivity, and speed compared to traditional analytical methods. Similarly, ultra-high-performance gas chromatography is another technique that is gaining popularity.

These advanced techniques make it possible to detect and identify trace impurities, contaminants, and degradation products.encodeURIComponent(”’) This is crucial for ensuring the safety and efficacy of pharmaceutical products. The use of such advanced analytical techniques is likely to have a positive impact on the growth of the market in the coming years.


Increasing Need for Contract Analytical Services


The companies in pharmaceutical sector are increasingly taking the services of contract analytical laboratories in their product quality control and other analytical testing. With the evolution of this trend number of companies are opting for such services for the purpose of cost saving and utilizing the expertise available in contract analytical laboratories. Contract analytical laboratories offer a variety of analytical services which includes analytical chromatography.

The analytical chromatography in pharma quality control market industry is expected to grow in accordance with the growing demand for contract analytical services in the market.


Analytical Chromatography In Pharma Quality Control Market Segment Insights


Analytical Chromatography In Pharma Quality Control Market Sample Type Insights


The Sample Type segment is further classified into Raw Materials, Finished Products, and In-process Controls. Currently, the largest share is occupied by the Raw Materials segment, which accounts for 35.4%. The high percentage is attributed to the high demand for raw material testing in order to guarantee the product’s safety and quality. It is for this reason that the segment is projected to maintain such a high level of demand throughout the forecast period.

At the same time, as the demand for finished product testing is also growing due to the need to ensure quality and compliance of the product by different agencies, inspectors, and customers, the particular segment is also expected to witness the highest CAGR of 5.5% and thus, will be the leader in this regard.Also, the in-process controls segment is currently relatively significant with a 29.8% share.

Owing to the necessity of real-time monitoring of the production process and the manufacturing waste reduction, it is also supposed to maintain its rate in the forecast period. Thus, the importance of the Sample Type segment as a whole is beyond doubt. Moreover, all of its classifications witnessed substantial development due to the growing demand of users to guarantee the product quality and safety through the analytical chromatography.


Analytical Chromatography In Pharma Quality Control Market by insights
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


Analytical Chromatography In Pharma Quality Control Market Technique Insights


The Technique segment is further divided into Liquid Chromatography, Gas Chromatography, and Ion Chromatography. The Liquid Chromatography segment dominated the Analytical Chromatography In Pharma Quality Control Market in 2023, and the trend is likely to continue in the coming years. The growth of the segment can be attributed to the versatility of the technique and its wide range of applications in the pharmaceutical sector. The Gas Chromatography segment is expected to grow at a steady rate over the forecast period because it is a technique used to separate and analyze volatile compounds and can be used to identify active pharmaceutical ingredients as well as impurities in pharmaceutical products.

The Ion Chromatography segment is likely to witness a significant growth rate in the coming years as it is increasingly being used in the analysis of ionic species in pharmaceutical products.


Analytical Chromatography In Pharma Quality Control Market Application Insights


The applications of analytical chromatography in pharma quality control play a critical role in ensuring the safety and efficacy of pharmaceutical products. Identity testing, purity analysis, and quantification are key applications that drive the growth of the Analytical Chromatography In Pharma Quality Control Market. Identity Testing: Analytical chromatography is widely used to identify the presence of specific compounds in pharmaceutical products. This is essential for confirming the identity of active pharmaceutical ingredients (APIs) and excipients, ensuring that the correct substances are used in the manufacturing process.

The Analytical Chromatography In Pharma Quality Control Market revenue for identity testing is expected to reach USD 9.5 billion by 2024, exhibiting a significant growth rate. Purity Analysis: Analytical chromatography is employed to determine the purity of pharmaceutical products by detecting and quantifying impurities. This helps ensure that the products meet regulatory standards and are free from contaminants that could compromise their safety or efficacy. The Analytical Chromatography In Pharma Quality Control Market segmentation for purity analysis is projected to reach USD 12.3 billion by 2024, indicating the high demand for accurate and reliable purity testing.

Quantification: Analytical chromatography plays a crucial role in quantifying the concentration of APIs and other components in pharmaceutical products. This is essential for ensuring that the products meet the labeled potency and dosage requirements. The Analytical Chromatography In Pharma Quality Control Market data for quantification is estimated to reach USD 10.8 billion by 2024, highlighting the importance of precise and reproducible quantification methods. These applications are supported by technological advancements in chromatography techniques, such as high-performance liquid chromatography (HPLC) and gas chromatography (GC), which enable faster, more sensitive, and more accurate analysis.

The growing demand for quality control in the pharmaceutical industry continues to drive the growth of the Analytical Chromatography In Pharma Quality Control Market, with market growth expected to remain strong in the coming years.


Analytical Chromatography In Pharma Quality Control Market Detector Insights


The Detector segment plays a crucial role in the Analytical Chromatography In Pharma Quality Control Market. Among the key detector types, UV-Visible Detectors held the largest revenue share in 2023, owing to their widespread adoption in various pharmaceutical applications. Fluorescence Detectors are expected to witness significant growth over the forecast period due to their high sensitivity and selectivity. Mass Spectrometers, with their advanced capabilities for compound identification and characterization, are anticipated to drive the market growth, particularly in the field of biopharmaceutical analysis.

The Analytical Chromatography In Pharma Quality Control Market revenue for the Detector segment is projected to reach USD 12.56 billion by 2028, expanding at a CAGR of 5.8% during the forecast period.


Analytical Chromatography In Pharma Quality Control Market Automation Level Insights


The Automation Level segment of the Analytical Chromatography In Pharma Quality Control Market is segmented into Manual, Semi-Automated, and Fully Automated. The Fully Automated segment is expected to hold the largest market share in 2023, and is projected to continue to grow at the highest CAGR during the forecast period. This growth is attributed to the increasing adoption of automation in the pharmaceutical industry to improve efficiency and reduce costs. The Semi-Automated segment is also expected to witness significant growth, as it offers a balance between manual and automated processes.

The Manual segment is expected to account for a smaller share of the market, as it is gradually being replaced by automated technologies. Overall, the Automation Level segment is expected to contribute significantly to the growth of the Analytical Chromatography In Pharma Quality Control Market, driven by the increasing demand for automation in the pharmaceutical industry.


Analytical Chromatography In Pharma Quality Control Market Regional Insights


The regional segmentation of the Analytical Chromatography In Pharma Quality Control Market offers insights into the market's footprint across different geographies. North America, with a market valuation of USD 9.85 billion in 2023, is projected to lead the market with a CAGR of 4.6%. Europe follows closely with a market size of USD 8.2 billion in 2023 and a projected CAGR of 4.8%. The Asia Pacific region is anticipated to exhibit significant growth, with a CAGR of 5.4%, reaching a market value of USD 6.1 billion by 2032. South America and MEA are also expected to contribute to the overall market growth, with CAGRs of 4.9% and 5.2% respectively.

These regional insights assist market players in understanding the market dynamics and tailoring their strategies accordingly.


Analytical Chromatography In Pharma Quality Control Market by regional insights
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


Analytical Chromatography In Pharma Quality Control Market Key Players And Competitive Insights


Major players in Analytical Chromatography In Pharma Quality Control Market are constantly developing new products and technologies to gain a competitive edge. They are also focusing on strategic partnerships and acquisitions to expand their reach and product portfolio. The Analytical Chromatography In Pharma Quality Control Market industry is characterized by intense competition, with leading players constantly investing in research and development to stay ahead of the curve. These players are also focusing on expanding their geographic reach and diversifying their product offerings to cater to the needs of a growing customer base.

One of the leading players in the Analytical Chromatography In Pharma Quality Control Market is Waters Corporation. The company offers a wide range of analytical instruments, consumables, and software solutions for various applications in the pharmaceutical, academic, and industrial sectors. Waters Corporation has a strong presence, with operations in over 100 countries. The company is known for its innovative products and its commitment to providing high-quality customer service. Another leading player in the Analytical Chromatography In Pharma Quality Control Market is Agilent Technologies Inc. The company offers a comprehensive range of analytical instruments, including gas chromatographs, liquid chromatographs, and mass spectrometers. Agilent Technologies Inc. has a strong customer base in the pharmaceutical, chemical, and food industries. The company is known for its high-performance products and its focus on providing total solutions to its customers.

A major competitor to Waters Corporation and Agilent Technologies Inc. is Thermo Fisher Scientific Inc. The company offers a wide range of analytical instruments, reagents, and consumables for various applications in the pharmaceutical, environmental, and food industries. Thermo Fisher Scientific Inc. has a strong presence, with operations in over 50 countries. The company is known for its innovative products and its commitment to providing comprehensive solutions to its customers.


Key Companies in the Analytical Chromatography In Pharma Quality Control Market Include:




  • Shimadzu Corporation




  • Merck KGaA




  • Tosoh Bioscience LLC




  • Hitachi HighTechnologies Corporation




  • Dionex Corporation




  • GE Healthcare




  • Supelco Analytical




  • Waters Corporation




  • Phenomenex, Inc.




  • Thermo Fisher Scientific




  • BioRad Laboratories, Inc.




  • Restek Corporation




  • Agilent Technologies




  • JASCO Incorporated




  • PerkinElmer, Inc.




Analytical Chromatography In Pharma Quality Control Market Industry Developments


The Analytical Chromatography In Pharma Quality Control Market is projected to reach USD 43.05 billion by 2032, exhibiting a CAGR of 5.05% during the forecast period (2024-2032). The increasing demand for high-quality pharmaceuticals and stringent regulatory requirements for product safety and efficacy are driving market growth. Technological advancements in chromatography techniques, such as the integration of artificial intelligence (AI) and machine learning (ML), are further enhancing market prospects.

Key market players are investing in research and development to introduce innovative analytical solutions for pharma quality control. Recent industry developments include:

Agilent Technologies announced the launch of its Intuvo 9000 GC system, designed to improve efficiency and productivity in pharmaceutical analysis.
Shimadzu Corporation introduced its Nexera UC system, which combines ultra-high-performance liquid chromatography (UHPLC) with mass spectrometry (MS) for enhanced sensitivity and selectivity.
Thermo Fisher Scientific acquired Dionex Corporation, expanding its portfolio of analytical chromatography solutions for the pharma sector.


Analytical Chromatography In Pharma Quality Control Market Segmentation Insights


Analytical Chromatography In Pharma Quality Control Market Sample Type Outlook






    1. Raw Materials




    2. Finished Products




    3. In-process Controls






Analytical Chromatography In Pharma Quality Control Market Technique Outlook






    1. Liquid Chromatography




    2. Gas Chromatography




    3. Ion Chromatography






Analytical Chromatography In Pharma Quality Control Market Application Outlook






    1. Identity Testing




    2. Purity Analysis




    3. Quantification






Analytical Chromatography In Pharma Quality Control Market Detector Outlook






    1. UV-Visible Detectors




    2. Fluorescence Detectors




    3. Mass Spectrometers






Analytical Chromatography In Pharma Quality Control Market Automation Level Outlook






    1. Manual




    2. Semi-Automated




    3. Fully Automated






Analytical Chromatography In Pharma Quality Control Market Regional Outlook






    1. North America




    2. Europe




    3. South America




    4. Asia Pacific




    5. Middle East and Africa





Report Attribute/Metric Details
Market Size 2022 26.32(USD Billion)
Market Size 2023 27.64(USD Billion)
Market Size 2032 43.05(USD Billion)
Compound Annual Growth Rate (CAGR) 5.05% (2024 - 2032)
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Base Year 2023
Market Forecast Period 2024 - 2032
Historical Data 2019 - 2023
Market Forecast Units USD Billion
Key Companies Profiled Shimadzu Corporation ,Merck KGaA ,Tosoh Bioscience LLC ,Hitachi HighTechnologies Corporation ,Dionex Corporation ,GE Healthcare ,Supelco Analytical ,Waters Corporation ,Phenomenex, Inc. ,Thermo Fisher Scientific ,BioRad Laboratories, Inc. ,Restek Corporation ,Agilent Technologies ,JASCO Incorporated ,PerkinElmer, Inc.
Segments Covered Sample Type ,Technique ,Application ,Detector ,Automation Level ,Regional
Key Market Opportunities Rapidly expanding biopharmaceutical marketHigh demand for accurate and reliable QC testingGrowing adoption of LCMS and GCMS techniquesIncreasing focus on API characterization and impurity profilingStringent regulatory requirements driving innovation
Key Market Dynamics Technological advancements stringent regulations rising demand for biopharmaceuticals growing need for quality control increasing outsourcing
Countries Covered North America, Europe, APAC, South America, MEA


Frequently Asked Questions (FAQ) :

The Analytical Chromatography In Pharma Quality Control Market is expected to reach a value of USD 43.05 billion by 2032, exhibiting a CAGR of 5.05% during the forecast period (2023-2032).

North America is expected to dominate the Analytical Chromatography In Pharma Quality Control Market throughout the forecast period, owing to the presence of a large number of pharmaceutical and biotechnology companies, stringent regulatory requirements, and advanced healthcare infrastructure.

The key growth drivers of the Analytical Chromatography In Pharma Quality Control Market include increasing demand for high-quality and safe pharmaceuticals, growing adoption of analytical chromatography techniques for drug discovery and development, and favorable government regulations.

The major applications of Analytical Chromatography In Pharma Quality Control include identification and quantification of active pharmaceutical ingredients (APIs), impurities, and excipients, stability testing, and quality control of raw materials and finished products.

The key competitors in the Analytical Chromatography In Pharma Quality Control Market include Agilent Technologies, Waters Corporation, Shimadzu Corporation, Thermo Fisher Scientific, and Merck.

The challenges faced by the Analytical Chromatography In Pharma Quality Control Market include high cost of equipment and consumables, stringent regulatory requirements, and lack of skilled professionals.

The opportunities for growth in the Analytical Chromatography In Pharma Quality Control Market include increasing demand for personalized medicine, technological advancements, and expanding applications in emerging markets.

The Analytical Chromatography In Pharma Quality Control Market is expected to exhibit a CAGR of 5.05% during the forecast period (2023-2032).

The key trends in the Analytical Chromatography In Pharma Quality Control Market include the adoption of hyphenated techniques, miniaturization of instruments, and increasing use of automation and software.

The COVID-19 pandemic had a positive impact on the Analytical Chromatography In Pharma Quality Control Market, as it increased the demand for rapid and accurate testing of drugs and vaccines.

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