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, 2021 | Region : Global

Pharmaceutical Quality Control Market Forecast

Pharmaceutical Quality Control Market is expected to hold a value of USD 9,696.72 Million by 2027 and is expected to register a growth of 12.1% from 2020 to 2027.

Pharmaceutical Quality Control Market Synopsis

Quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. Quality control is an integral operation of the pharmaceutical industry. A high demand for pharmaceutical quality controls due to the outbreak of COVID-19 globally, growing pharmaceutical industry, and high research and development expenditures are the key factors that are expected to drive the market growth. Moreover, the launching of products, rapid advancements in technologies, and a rise in policies and regulations by the government are also expected to boost pharmaceutical quality control market growth.

Pharmaceutical Quality Control Market Influencer

The outbreak of COVID-19, leading to increased demand for pharmaceutical quality control market.


  • High demand for pharmaceutical quality controls due to outbreak of COVID-19 globally

  • Growing pharmaceutical industry, According to the Pharmaceutical Research and Manufacturers Association (PhRMA), US firms conduct over half the world’s research & development in pharmaceuticals. The members of the Pharmaceutical Research and Manufacturing Association had invested USD 79.6 billion in research and development in 2018 for establishing the biopharmaceutical sector. This increasing investments and product development are pushing the growth of the pharmaceutical industry

  • Launch of new medicinal products. High research and development expenditures. According to the Congressional Research Service (CRS) report, in 2018, global research and development expenditure was recorded to be about USD 2.107 trillion

  • Rapid advancements in technologies are driving change

  • Changes in drug policies and regulations by the government to assure that pharmaceutical products meet safety requirements

Pharmaceutical Quality Control Market Restraints

  • Technical issues associated with quality control systems.

Pharmaceutical Quality Control Market Segmentation

By Product

  • Consumables: Consumables are the key materials that are used in support of manufacturing or which are coming in contact with the product during manufacturing that may not become part of the final product. Consumables are categorized into three categories, direct quality impacting consumables, indirect quality impacting consumables, and non-quality impacting consumables.

  • Instruments: This is the largest segment Instruments encompass a wide variety of products, equipment, and machinery. Each instrument plays an important role in each unique step in the manufacturing process. The instruments required in quality control of the pharmaceutical industry are analytical balance, pH meter, conductivity meter, viscometer, ultraviolet-visible spectrophotometer, high-performance liquid chromatography, gas-liquid chromatography, and titrator.

  • Services: Pharmaceutical quality control market segment is the fastest-growing segment. Services are designed to address problems at different stages for effective quality management. The services are generally provided in the form of preventive quality control, corrective quality control, and laboratories.

By Analysis Type

  • Sterility Testing: This is the largest and fastest-growing segment. Sterility testing is a key Good Manufacturing Practice (GMP) Microbiology testing requirement for sterile pharmaceuticals, medical devices, and materials, to ensure they are safe for use.

    • Membrane Filtration: Membrane filtration process is a physical separation method characterized by the ability to separate molecules of different sizes and characteristics. Membrane filtration involves the use of membrane technology for the separation of biomolecules and particles for the concentration of process fluids.

    • Direct Inoculation: In the direct inoculation method, the test articles are inoculated directly into tubes or bottles that contain an appropriate medium and are incubated for 14 days. Direct inoculation is done in two types of medium for the detection of aerobic and anaerobic microorganisms.

    • Others: Other sterility testing includes bacteriostatic and fungistatic contamination. This testing is also referred to as sterility validation, qualification, or verification. It is important to determine if the test article that will be tested for sterility contains elements that will interfere with the growth of microorganisms within the growth media used for the assay. In this test, low numbers of microorganisms are added to a media volume containing the test material to confirm that the test material does not interfere with the organism’s growth.

  • Bioburden Testing: The bioburden testing or total viable count testing is the measure of microbial contamination levels on or in a product.

    • Aerobic Count Testing: This is used as an indicator of the bacterial population on a sample and can be used to indicate the quality and spoilage level of a product. It is a generic test that grows aerobically at mesophilic temperatures.

    • Anaerobic Count Testing: This test is also known as wound culture. This test looks for certain bacteria in a wound or an infection in a fluid sample. These bacteria are anaerobic because they don’t need oxygen to grow. Thus, an anaerobic count testing means the test which is done without letting oxygen get to the sample.

    • Spore Count Testing: Spore count testing is a common, in-coming inspection test for biological indicator users. This test serves as one of the simpler tools that an end user can use to ensure the quality of the product they are receiving.

    • Fungi/ Mold Count Testing: This test is used to detect and quantify the amount of fungal growth on plant material, and allow for the identification of viable mold species present. The amount of fungi is reported as the number of colony-forming units.

    • Endotoxin Testing: The endotoxin test is a test to detect or quantify endotoxins from gram-negative bacteria using amoebocyte lysate from the horseshoe crab. There are three methods for this test, i.e. the gel-clot technique, the turbidimetric technique, and the chromogenic technique.

    • In vitro: In vitro refers to the technique of performing a given procedure in a controlled environment outside of a living organism. Thus, endotoxin testing is usually done in the form of in vitro method.

    • LAL: The Limulus amoebocyte lysate (LAL) testing, is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products, and is an important part of pharmaceutical microbiology.

    • Others: The other endotoxin testing includes the rabbit pyrogen test. This test is an in vivo test which is used to detect pyrogens qualitatively. This method can detect non-bacterial endotoxin pyrogens as well as bacterial endotoxins.

  • Stability Testing: Stability testing assesses how to quality of a drug substance or drug product, and it’s packaging, varies within time under the influence of environmental factors, including temperature, humidity, and light.

  • Extractable & Leachable Testing: Extractable analysis identifies substances that could potentially migrate from polymeric, metallic, or glass material into the patent or consumer, including dyes, catalysts, and plasticizers. The leachable analysis identifies substances that migrate from polymeric, metallic, or glass material into the patient and are typically a subset of those identified in the extractable analysis. This type of analysis is required when there is a risk that harmful substances may have leached into a liquid product, such as eye drops, from its container or packaging.

  • Raw Material Testing: Raw material testing is determined by the manufacturer. A conservative approach would be to perform a complete analysis of each lot of raw materials received.

  • Others: Other testing techniques includes antimicrobial efficacy testing and residual solvent testing

By-Products Tested

  • Vaccines: This is the largest segment. There is a need to identify viable options for vaccine production and quality check without affecting their quality, potency, and efficacy. For quality control of vaccines, a test for potency is one of the required tests consisting of either in vitro or in vivo tests or both, designed for each product to indicate its potency adequately to satisfy the interpretation of potency.

  • Plasma Product: The provision of plasma products requires the availability of sufficient plasma of assured quality and safety. Plasma donor selection, collection procedures, testing methods, donation handling, storage, and transportation of plasma follows defined quality assurance procedures.

  • Drugs: This is the fastest-growing segment. Quality control for the approval of drugs comprises identity, purity, and contest testing and is carried out according to the manufacturer’s instructions.

Pharmaceutical Quality Control Market By Region

  • Americas: In 2017, the US Food and Drug Administration (FDA) introduced a Drug Competition Action Plan to bring generic drugs to pharmaceutical quality control market. Thus, quality control for drugs is required for therapeutically active formulations for the performance to be consistent and predictable. Hence, an increase in demand for pharmaceutical quality control market is expected during the forecast period.

  • Europe: In Europe, there is an increase in research and development expenditure. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2018, the research-based pharmaceutical industry invested and estimated 39,776 million USD in research and development.

  • Asia-Pacific: A large variation in pharmpharmaceutical quality control spending is observed in this region. According to the Organization for Economic Co-operation and Development (OECD) report, in 2016, China had 288 USD purchasing power parity. Thus, a rise in investment for the pharmaceutical industry is expected to drive the pharmaceutical quality control market.

  • Middle East & Africa: The rise in research and development expenditure, growing pharmaceutical industry, and policies and regulations by the government are expected to drive the pharmaceutical quality control market growth during the forecast period.

Pharmaceutical Quality Control Market Key Players

  • Merck KGaA

  • bioMérieux SA

  • Charles River Laboratories International, Inc.

  • Sartorious AG

  • WuXi AppTec

  • Thermo Fisher Scientific, Inc.

  • SGS S.A.

  • Eurofins Scientific

  • Toxikon Corporation

Table of Contents


1.1. Market Attractiveness Analysis

1.1.1. Global Pharmaceutical Quality Control Market, by Product

1.1.2. Global Pharmaceutical Quality Control Market, by Analysis Type

1.1.3. Global Pharmaceutical Quality Control Market, by Products Tested

1.1.4. Global Pharmaceutical Quality Control Market, by Region


2.1. Definition

2.2. Scope of the Study

2.3. Market Structure


3.1. Overview

3.2. Data Mining

3.3. Secondary Research

3.4. Primary Research

3.4.1. Primary Interviews and Information Gathering Process

3.4.2. Breakdown of Primary Respondents

3.5. Forecasting Techniques

3.6. Market Size Estimation

3.6.1. Bottom-Up Approach

3.6.2. Top-Down Approach

3.7. Data Triangulation

3.8. Validation


4.1. Introduction

4.2. Drivers

4.2.1. Growing pharmaceutical industry

4.2.2. Product launches

4.2.3. High research and development expenditures

4.3. Restraints

4.3.1. Presence of Ambiguous Regulatory Framework

4.4. Opportunities

4.5. COVID 19 Impact Analysis

4.5.1. Cost of Drugs and Raw Material

4.5.2. Research and Development Impact Analysis

4.5.3. Demand & Supply Gap Analysis

4.5.4. Opportunity Analysis


5.1. Value Chain Analysis/Supply Chain Analysis

5.2. Porter’s Five Forces Model

5.2.1. Bargaining Power of Suppliers

5.2.2. Bargaining Power of Buyers

5.2.3. Threat of New Entrants

5.2.4. Threat of Substitutes

5.2.5. Intensity of Rivalry


6.1. Overview

6.2. Consumables

6.3. Instruments

6.4. Services


7.1. Overview

7.2. Sterility Testing

7.2.1. Membrane Filtration

7.2.2. Direct Inoculation

7.2.3. Others

7.3. Bioburden Testing

7.3.1. Aerobic Count Testing

7.3.2. Anaerobic Count Testing

7.3.3. Spore Count Testing

7.3.4. Fungi/Mold Count Testing

7.4. Endotoxin Testing

7.4.1. In Vitro

7.4.2. Lal

7.4.3. Others

7.5. Stability Testing

7.6. Extractable & Leachable Testing

7.7. Raw Material Testing

7.8. Others


8.1. Overview

8.2. Vaccines

8.3. Plasma Product

8.4. Drugs

8.5. Others


9.1. Overview

9.2. Americas

9.2.1. North America US Canada

9.2.2. Latin America

9.3. Europe

9.3.1. Western Europe Germany France UK Italy Spain Rest of Western Europe

9.3.2. Eastern Europe

9.4. Asia-Pacific

9.4.1. China

9.4.2. India

9.4.3. Japan

9.4.4. Australia

9.4.5. South Korea

9.4.6. Rest of Asia-Pacific

9.5. Middle East & Africa

9.5.1. Middle East

9.5.2. Africa


10.1. Introduction

10.2. Competitive Analysis

10.3. Market Share Analysis

10.4. Major Growth Strategy in the Global Pharmaceutical Quality Control Market

10.5. Competitive Benchmarking

10.6. Leading Player in terms of Number of Developments in Global Pharmaceutical Quality Control Market

10.7. Key Developments & Growth Strategies

10.7.1. New Product Launch

10.7.2. Merger & Acquisition

10.7.3. Joint Ventures

10.8. Major Players Financial Matrix

10.8.1. Sales & Operating Income 2019

10.8.2. Major Players R&D Expenditure 2019


11.1. Merck KGaA

11.1.1. Company Overview

11.1.2. Financial Overview

11.1.3. Product Offered

11.1.4. Key Developments

11.1.5. SWOT Analysis

11.1.6. Key Strategies

11.2. bioMérieux SA

11.3. Charles River Laboratories International, Inc.

11.4. Sartorius AG

11.5. WuXi AppTec

11.6. Thermo Fisher Scientific, Inc.

11.7. SGS S.A.

11.8. Eurofins Scientific

11.9. Sartorius AG

11.10. Toxikon Corporation

11.11. Others


12.1.1. Discussion Blueprint

12.1.2. Related Reports


This table of content is tentative and subject to change as the research progresses.

 In section 11, only the top 10 companies will be profiled. Each company will be profiled based on the Market Overview, Financials, and Product Portfolio, Business Strategies, and Recent Developments parameters.

 Please note: The financial details of the company cannot be provided if the information is not available in the public domain and or from reliable sources.

This table of content is tentative and subject to change as the research progresses.

Please Note:  Financial details of company cannot be provided if the information of the company is not available in public domain and or reliable source.

Pharmaceutical Quality Control Market