Pharmaceutical Quality Control Market Research Report- Forecast till 2027

Pharmaceutical Quality Control Market: By Product (Consumables, Instruments, Services), Analysis Type (Sterility Testing, Bioburden Testing, Endotoxin Testing, Stability Testing, Extractable & Leachable Testing, Raw Material Testing, Others), Products Tested (Vaccines, Plasma Product, Drugs), Region (Americas, Europe, Asia-Pacific, Middle East & Africa)-Forecast to 2027

ID: MRFR/HC/8233-HCR | February 2023 | Region: Global | 120 Pages         

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Pharmaceutical Quality Control Market

Pharmaceutical Quality Control Market is expected to hold a value of USD 9.69 Billion With CAGR 12.1% by 2027

By Product Consumables Instruments Services
By Analysis Type Sterility Testing Bioburden Testing Endotoxin Testing Stability Testing Extractable & Leachable Testing Raw Material Testing Others
By Products Tested Vaccines Plasma Product Drugs
Key Players
Companies Profiled   BioMerieux SA   SGS S.A.   Charles River Laboratories International Inc.   WiXi AppTec   Merck KGaA   Thermo Fisher Scientific Inc.   Toxikon Corporation   Sartorius AG   REMI Group   Perkin Elmer
Market Driving Forces   High demand for pharmaceutical quality controls due to outbreak of COVID-19 globally   Investments and product development are pushing the growth of the pharmaceutical industry
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Market Overview

The Pharmaceutical Quality Control Market is anticipated to reach around 12.1%. It is evaluated that the market value will further increase up to USD 9.69 Billion by the studied forecast period 2020-2027. Pharmaceutical quality control means the mandatory procedures which are used for ensuring the purity and quality of a pharmacy product.  It is one of the crucial operations in the pharmaceutical industry.

In the future years, the Pharmaceutical Quality Control Market Value is estimated to rise at a significant rate. Several drivers and investments by key players are anticipated to be favorable for the market. Hence, the Americas region is anticipated to dominate the market in the upcoming years.

COVID-19 Analysis

The coronavirus disease played a massive role in boosting Pharmaceutical Quality Control market growth. Due to the outbreak, the demand for safe and sterile products increased. Therefore, it increased the focus of pharmaceutical companies to manufacture quality products. Also, developments and investments by key players had positive impact on the Pharmaceutical Quality Control Market Value.

Market Dynamics

Market Drivers

Factors such as the increasing demand for quality control of pharmaceutical products are driving the market. Also, the increasing presence of various key players in the pharmaceutical industry will further drive the Pharmaceutical Quality Control Market.


Various technical issues in testing and other procedures are depicted to affect the market growth.


The production of new medical products and rapid advancements in technology is evaluated to offer new opportunities for market growth.


Several challenges such as lack of skilled professionals, low awareness, and halt in the supply chain can be significant challenges for the market. 

Cumulative Analysis

The Compound Annual Growth Rate (CAGR) of the Pharmaceutical Quality Control Market is estimated to grow at 12.1%. According to the Pharmaceutical Quality Control Market Analysis, the market value will further improve up to USD 9,696.72 Million by the studied forecast period 2020-2027. Hence, the drivers and the restraints will result in significant growth in the future years.

Value Chain Analysis

The improvement in the quality of pharmaceutical products will simultaneously increase the Pharmaceutical Quality Control Market. Also, the investments by key players and supportive policies by governments, and rising technological developments are further estimated to improve the value chain of the market.

Pharmaceutical Quality Control Market Segmentations

The Pharmaceutical Quality Control Market Size is divided into various segments such as product, analysis type, and products tested. Based on product, the market is segmented into Instruments, Consumables, and Services. The consumables are the main supportive materials that are used for manufacturing. There are three categories of consumables i.e. non-quality impacting, quality impacting, and directly impacting quality. The service segment is estimated to grow at the fastest rate. Also, the instruments segment comprises the largest Pharmaceutical Quality, Control Market Share.

On the basis of analysis type, the market is segmented into Bioburden Testing, Sterility Testing, Leachable and Extractable Testing, Stability Testing, Raw Materials, and Others. The bioburden testing is segmented into Anaerobic Count Testing, Aerobic Count Testing, Mould Count Testing, In Vitro, Spore Count Testing, Endotoxin Testing, LAL, and Others. Aerobic count testing is used for analyzing the population of bacteria in a sample. It helps to indicate the spoilage and quality of the product. The anaerobic count test is known as wound culture which is done without the presence of oxygen. However, the fungi test is done for detecting the quantity of fungal growth, and the in-vitro testing, the process is done in a controlled environment. Also, the LAL stands for Limulus amoebocyte lysate testing for detecting the concentration or presence of the bacterial endotoxins among biological products and drugs.

The Sterility Testing is divided into direct inoculation, membrane filtration, and others. The membrane filtration is used for separating the molecules of different molecules and sizes. In the direct inoculation process, the articles are directly inoculated into tubes and bottles for 14 days. The other-sub segment includes fungistatic and bacteriostatic contamination. This process is also known as verification, qualification, or validation.

Furthermore, Stability Testing is done to determine the quality of a drug product or substance. Also, the Leachable and Extractable Testing is helpful to analyze the substances that can migrate from glass, metallic and polymeric material to the customer such as dyes, plasticizers, etc. Based on raw material, the testing is done by the manufacturers to analyze the raw materials.

On the basis of By-Products tested, the market is divided into Plasma Products, Vaccines, and Drugs. Plasma products need to have a sufficient amount of plasma for safety and quality. Donor selection, procedures, donation, testing, storage, etc. are required for quality assurance. The vaccines are considered the largest sub-segment. There is an immense need for identifying crucial options for quality checking and vaccine production. Lastly, the drug sub-segment is projected to grow at the fastest rate.

Regional Analysis

Based on region, the Pharmaceutical Quality Control Market Size is segmented into Europe, Americas, Africa, and the Middle East and Europe. The Americas is evaluated to hold the largest share in the market. In 2017, the FDA announced a competition plan to boost the presence of generic drugs in the quality market. That's why this region will have enormous growth in the future years.

Secondly, Europe is predicted to hold the second-largest Pharmaceutical Quality Control Market Share. The investments by the key players in the pharmaceutical industry are the major reason for the significant share.

Moreover, Asia-Pacific is also anticipated to have significant growth in the studied forecast period. China in 2018 comprised of purchasing power worth USD 200 Million. Therefore, the increase in investments in the pharmaceutical industry is anticipated to boost market growth.

The development and research in Africa and the Middle East are evaluated to play a major role in boosting market growth. Also, supportive regulations and policies by the company will further improve the market in this region.

Competitive Landscape

The Pharmaceutical Quality Control Market is highly competitive. Various players across the world play a significant role in improving market growth. These key players apply various market strategies such as mergers, partnerships, new ventures, acquisitions, new product launches, collaborations, etc. Some of the key players enhancing the Pharmaceutical Quality Control Market Value are as follows.

  • BioMerieux SA

  • SGS S.A.

  • Charles River Laboratories International Inc.

  • WiXi AppTec

  • Merck KGaA

  • Thermo Fisher Scientific, Inc.

  • Toxikon Corporation

  • Sartorius AG

  • REMI Group

  • Perkin Elmer

  • Esco Micro Pte. Ltd.

  • Mettler Toledo

  • Waters Corporation

  • Shimadzu Scientific Instruments


  • Lucideon Limited

  • Danaher

Recent Developments

No Recent Developments were found.

Report Overview

The overview of the Pharmaceutical Quality Control Market Forecast is as follows.

  • Market Overview

  • COVID-19 Analysis

  • Dynamics of the Market

  • Value Chain Analysis

  • Market Segmentation

  • Regional Analysis

  • Competitive Analysis

  • Recent Development

Report Score and Segmentation

The main aim of the report score is to provide a comprehensive Pharmaceutical Quality Control Market Outlook. It covers valuable information such as drivers, key players, market value, challenges, etc. Therefore, the information provided in this report is collected from various secondary and primary sources.


  • By Product




  • By Analysis Type

  • Bioburden Testing

  • Anaerobic Count Testing

  • Aerobic Count Testing

  • Mold/Fungi Count Testing

  • Endotoxin Testing

  • Spore Count Testing

  • LAL

  • In Vitro

  • Others

  • Sterility Testing

  • Direct Insulation

  • Membrane Filtration

  • Others

  • Stability Testing

  • Raw Material

  • Leachable and Extractable Testing

  • Others

By-Products Tested

  • Drugs

  • Vaccines

  • Plasma Product

By Region

  • Europe

  • Americas

  • Asia-Pacific

  • Africa and the Middle East

Report Scope:

Report Attribute/Metric Details
  Market Size   USD 9.69 Billion
  CAGR   12.1%
  Base Year   2019
  Forecast Period   2020-2027
  Historical Data   2018
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Product, Analysis Type and Products Tested
  Geographies Covered    North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Merck KGaA (Germany), bioMérieux SA (France), Charles River Laboratories International, Inc. (US), Sartorious AG (Germany), WuXi AppTec (China), Thermo Fisher Scientific, Inc. (US), SGS S.A. (Switzerland), Eurofins Scientific (Luxembourg), Toxikon Corporation (US).
  Key Market Opportunities   The Outbreak of COVID-19, leading to increased demand for Pharmaceutical Quality Control.
  Key Market Drivers

  • Growing Pharmaceutical Industry.
  • Launch of New Medicinal Products.
  • Rapid Advancements in Technologies are Driving Change.
  • Changes in Drug Policies and Regulations by the Government to assure that Pharmaceutical Products meet Safety Requirements\r\n

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    Frequently Asked Questions (FAQ) :

    Global Pharmaceutical Quality Control Market would register a growth of 12.1%.

    The forecast period of the Global Pharmaceutical Quality Control Market is 2020 to 2027.

    Global Pharmaceutical Quality Control Market will gain a valuation of USD 9.69 Billion by 2027.

    Charles River Laboratories International, Inc., Thermo Fisher Scientific, Inc., WuXi AppTec, Sartorious AG are the top players investing in the global pharmaceutical quality control market.

    The study of the global pharmaceutical quality control market is studied through a segment of product and analysis type.