• Cat-intel
  • MedIntelliX
  • Resources
  • About Us
  • Request Free Sample ×

    Kindly complete the form below to receive a free sample of this Report

    Leading companies partner with us for data-driven Insights

    clients tt-cursor

    Analytical Chromatography In Pharma Quality Control Market

    ID: MRFR/ICT/23230-HCR
    100 Pages
    Aarti Dhapte
    September 2025

    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 2034.

    Share:
    Download PDF ×

    We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

    Analytical Chromatography In Pharma Quality Control Market Research Report- Forecast till 2034 Infographic
    Purchase Options
    $ 4,950.0
    $ 5,950.0
    $ 7,250.0

    Analytical Chromatography In Pharma Quality Control Market Summary

    The Global Analytical Chromatography In Pharma Quality Control Market is projected to grow significantly from 8.66 USD Billion in 2024 to 52.7 USD Billion by 2035.

    Key Market Trends & Highlights

    Analytical Chromatography In Pharma Quality Control Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 17.85% from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 52.7 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 8.66 USD Billion, laying a strong foundation for future expansion.
    • Growing adoption of analytical chromatography due to increasing regulatory requirements is a major market driver.

    Market Size & Forecast

    2024 Market Size 8.66 (USD Billion)
    2035 Market Size 52.7 (USD Billion)
    CAGR (2025-2035) 17.85%

    Major Players

    Waters Corporation, Agilent Technologies Inc., Thermo Fisher Scientific Inc., Shimadzu Corporation, Merck KGaA, Tosoh Bioscience LLC, Hitachi High-Technologies Corporation, Dionex Corporation, GE Healthcare, Supelco Analytical, Phenomenex, Inc., BioRad Laboratories, Inc., Restek Corporation, JASCO Incorporated, PerkinElmer, Inc.

    Analytical Chromatography In Pharma Quality Control Market Trends

    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.

    Figure 1: Analytical Chromatography In Pharma Quality Control Market Size, 2025-2034 (USD Billion)

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    The increasing complexity of pharmaceutical formulations necessitates advanced analytical techniques, such as chromatography, to ensure product quality and regulatory compliance.

    U.S. Food and Drug Administration (FDA)

    Analytical Chromatography In Pharma Quality Control Market Drivers

    Rising Demand for Quality Control

    The Global Analytical Chromatography In Pharma Quality Control Market Industry experiences a notable increase in demand for quality control measures. This surge is primarily driven by the need for stringent regulatory compliance and the assurance of drug safety and efficacy. As pharmaceutical companies strive to meet the expectations of regulatory bodies, the adoption of analytical chromatography techniques becomes essential. In 2024, the market is projected to reach 8.66 USD Billion, reflecting the industry's commitment to enhancing quality control processes. This trend is likely to continue, as the focus on patient safety and product reliability intensifies.

    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.

    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.

    Get more detailed insights about Analytical Chromatography In Pharma Quality Control Market Research Report- Forecast till 2034

    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

    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 market include

    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.

    Future Outlook

    Analytical Chromatography In Pharma Quality Control Market Future Outlook

    The Analytical Chromatography in Pharma Quality Control Market is projected to grow at a 17.85% CAGR from 2024 to 2035, driven by technological advancements and regulatory demands.

    New opportunities lie in:

    • Invest in automation technologies to enhance efficiency in quality control processes.
    • Develop innovative chromatography solutions tailored for biologics and complex molecules.
    • Expand service offerings to include comprehensive training and support for chromatography users.

    By 2035, the market is expected to achieve substantial growth, reflecting increased demand for quality assurance in pharmaceuticals.

    Market Segmentation

    Analytical Chromatography In Pharma Quality Control Market Detector Outlook

    • UV-Visible Detectors
    • Fluorescence Detectors
    • Mass Spectrometers

    Analytical Chromatography In Pharma Quality Control Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    Analytical Chromatography In Pharma Quality Control Market Technique Outlook

    • Liquid Chromatography
    • Gas Chromatography
    • Ion Chromatography

    Analytical Chromatography In Pharma Quality Control Market Application Outlook

    • Identity Testing
    • Purity Analysis
    • Quantification

    Analytical Chromatography In Pharma Quality Control Market Sample Type Outlook

    • Raw Materials
    • Finished Products
    • In-process Controls

    Analytical Chromatography In Pharma Quality Control Market Automation Level Outlook

    • Manual
    • Semi-Automated
    • Fully Automated

    Report Scope

    Report Attribute/Metric Details
    Market Size 2024 30.51 (USD Billion)
    Market Size 2025 32.55 (USD Billion)
    Market Size 2034 49.95 (USD Billion)
    Compound Annual Growth Rate (CAGR) 5.52% (2025 - 2034)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2024
    Market Forecast Period 2025 - 2034
    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

    FAQs

    What is the market size of the Analytical Chromatography In Pharma Quality Control Market?

    Analytical Chromatography In Pharma Quality Control Market is expected to reach a value of USD 49.95 billion by 2034, exhibiting a CAGR of 5.52% during the forecast period 2025-203.

    Which region is expected to dominate the Analytical Chromatography In Pharma Quality Control Market?

    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.

    What are the key growth drivers of the Analytical Chromatography In Pharma Quality Control Market?

    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.

    What are the major applications of Analytical Chromatography In Pharma Quality Control?

    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.

    Who are the key competitors in the Analytical Chromatography In Pharma Quality Control Market?

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

    What are the challenges faced by the Analytical Chromatography In Pharma Quality Control Market?

    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.

    What are the opportunities for growth in the Analytical Chromatography In Pharma Quality Control Market?

    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.

    What is the expected growth rate of the Analytical Chromatography In Pharma Quality Control Market?

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

    What are the key trends in the Analytical Chromatography In Pharma Quality Control Market?

    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.

    What is the impact of COVID-19 on the Analytical Chromatography In Pharma Quality Control Market?

    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.

    Report Infographic
    Free Sample Request

    Kindly complete the form below to receive a free sample of this Report

    Customer Strories

    “I am very pleased with how market segments have been defined in a relevant way for my purposes (such as "Portable Freezers & refrigerators" and "last-mile"). In general the report is well structured. Thanks very much for your efforts.”

    Victoria Milne Founder
    Case Study

    Chemicals and Materials