Pharmaceutical Quality Control Market Research Report- Forecast till 2032

Pharmaceutical Quality Control Market Research Report Information By Product (Consumable, Instruments, and Services), By Analysis Type (Sterility Testing, Bioburden Testing, Endotoxin Testing, Stability Testing, Extractable & Leachable Testing, Raw Material Testing, and Others), By Products Tested (Vaccines, Plasma Product, and Drugs), and By Region (North America, Europe, Asia-Pacific, and Rest Of The World) โ€“ Market Forecast Till 2032

ID: MRFR/HC/8233-HCR | 120 Pages | Author: Kinjoll Dey | March 2024         

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Global Pharmaceutical Quality Control Market Overview


Pharmaceutical Quality Control Market size was valued at USD 4.1 Billion in 2022. The Pharmaceutical Quality Control market industry is projected to grow from USD 4.6 Billion in 2023 to USD 11.5 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 12.10% during the forecast period (2023 - 2032).Drug production is becoming more expensive, and there is an increasing need to adhere to regulatory regulations, are the key market drivers enhancing the market growth. 


Pharmaceutical Quality Control Market Overview


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


Pharmaceutical Quality Control Market Trends



  • Increasing cost of drug manufacturing is driving the market growth


In the pharmaceutical sector, manufacturing costs make up a considerable amount of a company's overall costs. A new drug's development costs have likewise been constantly rising. The projected investment needed to take a lab-conceived idea from successful commercialisation is USD 2 billion. Pharmaceuticals with a recognisable brand name might cost up to 27–30% of sales. Pharmaceutical companies are expanding their R&D expenditures on the one hand to produce more products, but their R&D investments' productivity,is declining in comparison to the number of pharmaceuticals that are released onto the market each year, which has an impact on a significant chunk of their overall cost structure. Many pharma and biotech industries are focused on simplifying their processes with the aid of quality management systems as a result of mounting demand to lower overall process costs.


Pharmaceutical companies are heavily regulated because the health and wellbeing of consumers are directly impacted by drugs, medical devices, and other pharmaceuticals. In order to sell their goods, manufacturers must adhere to a number of quality criteria. Small and mid-sized pharmaceutical businesses are concentrating on following laws in order to produce better products and maintain their competitiveness in the market as a result of the pharmaceutical industry's rapid expansion. The Food and Drug Administration (FDA) regulates the U.S. market, which is where the majority of businesses operating in developing nations like China and India ship their goods.The FDA inspects the facilities and operating methods of all pharmaceutical manufacturing activities in the U.S. as well as those abroad operations of businesses who routinely sell their goods in the U.S. The FDA's current good manufacturing practises (cGMP) must therefore be followed by these facilities and their processes. To produce and market their goods, businesses must also abide by the International Organisation for Standardisation (ISO), 21 CFR Part 211, and ICH Guideline Q10. Manufacturers are eager to embrace quality management systems due to the rising significance of regulatory requirements and the expanding market.


The primary reasons propelling the pharmaceutical quality controls market are the increasing number of accredited clinical laboratories, increased acceptance of third-party quality controls, and growing preference for external quality assessment help. The quantity of laboratory tests performed has increased due to the rise in the prevalence of various diseases worldwide. Both the public and private sectors are increasing the number of laboratories to meet this requirement. Clinical laboratories must obtain accreditation from regulatory organisations like the International Organisation for Standardisation and other comparable standards in order to conduct diagnostic tests in the majority of nations. The appropriate authorities assess a laboratory's competency and quality system in comparison to predetermined standards during the accreditation procedure.Thus, driving the Pharmaceutical Quality Control market revenue.


Pharmaceutical Quality Control Market Segment Insights


Pharmaceutical Quality Control Product Insights


The Pharmaceutical Quality Control market segmentation, based on Product, includes Consumable, Instruments, and Services. Consumables segment dominated the market in 2022. The primary auxiliary materials utilised in production are consumables. Consumables can be divided into three categories: those that don't affect quality, those that do, and those that do so directly. According to projections, the service sector will expand the fastest. Additionally, the highest market share for pharmaceutical quality and control is in the instruments area.


Pharmaceutical Quality Control Analysis Type Insights


The Pharmaceutical Quality Control market segmentation, based on Analysis Type, includes Sterility Testing, Bioburden Testing, Endotoxin Testing, Stability Testing, Extractable & Leachable Testing, Raw Material Testing, and Others. Bioburden testing segment dominated the market in 2022. Anaerobic Count Testing, Aerobic Count Testing, Mould Count Testing, In Vitro, Spore Count Testing, Endotoxin Testing, LAL, and Others are the several categories under which bioburden testing is broken down. Bacterial population in a sample is analysed using an aerobic count assay. It aids in displaying the product's quality and degree of deterioration. Wound culture, also known as the anaerobic count test, is carried out without the use of oxygen.


Pharmaceutical Quality Control Products Tested Insights


 The Pharmaceutical Quality Control market segmentation, based on Products Tested, includes Vaccines, Plasma Product, and Drugs. Vaccines segment dominated the pharmaceutical quality control market in 2022. Finding essential choices for quality control and vaccine production is really important. The sub-segment for drugs is predicted to increase at the quickest rate overall.


Figure 1: Pharmaceutical Quality Control Market, by Products Tested, 2022 & 2032 (USD Billion) 


Pharmaceutical Quality Control Market, by Products Tested, 2022 & 2032


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


Pharmaceutical Quality Control Regional Insights


By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. The North America Pharmaceutical Quality Control Market dominated this market in 2022 (45.80%). This is as a result of the developed healthcare systems in the United States and Canada, the presence of numerous top producers of molecular quality control products in the area, and the accessibility of cutting-edge technologies in the area. Further, the U.S. Pharmaceutical Quality Control market held the largest market share, and the Canada Pharmaceutical Quality Control market was the fastest growing market in the North America region.


Further, the major countries studied in the market report are The US, Canada, German, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.


Figure 2: PHARMACEUTICAL QUALITY CONTROL MARKET SHARE BY REGION 2022 (USD Billion) 


PHARMACEUTICAL QUALITY CONTROL MARKET SHARE BY REGION 2022


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


Europe Pharmaceutical Quality Control market accounted for the healthy market share in 2022. Over the length of the forecast, significant investments in R&D for the pharmaceutical industry are anticipated to boost the market for pharmaceutical quality control in Europe. The research-based pharmaceutical business spent an estimated €35,200 million on R&D in Europe in 2017, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).Further, the German Pharmaceutical Quality Control market held the largest market share, and the U.K Pharmaceutical Quality Control market was the fastest growing market in the European region.


The Asia Pacific Pharmaceutical Quality Control market is expected to register significant growth from 2023 to 2032. A vast number of pharmaceutical businesses are responsible for this market's expansion. The largest producers of generic drugs and biopharmaceuticals are found in the pharmaceutical industries of China and India, and the majority of companies that offer quality management systems are concentrating on gaining market share in these significant pharmaceutical markets. Moreover, China’s Pharmaceutical Quality Control market held the largest market share and the Indian Pharmaceutical Quality Control market was the fastest growing market in the Asia-Pacific region.


Pharmaceutical Quality Control Key Market Players & Competitive Insights


Leading market players are investing heavily in research and development in order to expand their product lines, which will help the Pharmaceutical Quality Control market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, Pharmaceutical Quality Control industry must offer cost-effective items.


Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the Pharmaceutical Quality Control industry to benefit clients and increase the market sector. In recent years, the Pharmaceutical Quality Control industry has offered some of the most significant advantages to medicine. Major players in the Pharmaceutical Quality Control market, including BioMerieux SA SGS S.A., Charles River Laboratories International Inc., WiXi AppTec, Merck KGaA, Thermo Fisher Scientific Inc., Toxikon Corporation, Sartorius AG, REMI Group, and Perkin Elmer, are attempting to increase market demand by investing in research and development Products Testeds.


The discovery, development, manufacture, and supply of disease-state specimens and tissues for processed biological materials, research and development, immunoassay reagents, and quality control products and technologies are all performed by LGC Clinical Diagnostics Inc (LGC Clinical Diagnostics), formerly SeraCare Life Sciences Inc. The company's main offerings include digital PCR instruments, controls and reference materials, SARS-COV-2, plasma, and serum diluents and derivatives, next-generation sequencing tools, and cell culture reagents. To develop, produce, and deliver a variety of highly characterised cell line genomic DNA and formalin-fixed, paraffin-embedded standards with substantiated low, mid, and high levels of mutational burden within their exome regions in June 2021, SeraCare partnered with the International Quality Network for Pathology.


For use in life science research, healthcare, analytical chemistry, and other markets, Bio-Rad Laboratories Inc (Bio-Rad) develops, produces, and markets a variety of products and systems. Reagents, apparatus, laboratory equipment, test systems, informatics systems, test kits, and specialised quality controls are among the company's main offerings. In order to offer its customers a complete array of InteliQ products and Unity QC data management systems, as well as customer training and equipment maintenance, Bio-Rad and Roche Diagnostics agreed into a cooperation in May 2021.


Key Companies in the Pharmaceutical Quality Control market include



Pharmaceutical Quality Control Industry Developments


May 2019:The extension of the Milbourn location of Intertek Group Plc's pharmaceutical services laboratory was announced.


Pharmaceutical Quality Control Market Segmentation


Pharmaceutical Quality Control Product Outlook




  • Consumables




  • Instruments




  • Services




Pharmaceutical Quality Control Analysis Type Outlook




  • Sterility Testing




  • Bioburden Testing




  • Endotoxin Testing




  • Stability Testing




  • Extractable & Leachable Testing




  • Raw Material Testing




  • Others




Pharmaceutical Quality Control Products Tested Outlook




  • Vaccines




  • Plasma Product




  • Drugs




Pharmaceutical Quality Control Regional Outlook




  • North America






  • U.S.




  • Canada






  • Europe






  • Germany




  • France




  • UK




  • Italy




  • Spain




  • Rest of Europe






  • Asia-Pacific




    • China




    • Japan




    • India




    • Australia




    • South Korea




    • Australia




    • Rest of Asia-Pacific






  • Rest of the World




    • Middle East




    • Africa




    • Latin America





Report Scope:

Report Attribute/Metric Details
Market Products Tested 2022 USD 4.1 Billion
Market Products Tested 2023 USD 4.6 Billion
Market Products Tested 2032 USD 11.5 Billion
Compound Annual Growth Rate (CAGR) 12.10% (2023-2032)
Base Year 2022
Market Forecast Period 2023-2032
Historical Data 2018- 2022
Market Forecast Units Value (USD Billion)
Report Coverage Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
Segments Covered Product, Analysis Type, Products Tested, and Region
Geographies Covered North America, Europe, Asia Pacific, and the Rest of the World
Countries Covered The U.S., Canada, German, France, U.K, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil
Key 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, and Perkin Elmer
Key Market Opportunities Increasing demand for pharmaceutical quality control outsourcing
Key Market Dynamics Increasing cost of drug manufacturing and increasing demand to comply with regulatory requirements




Frequently Asked Questions (FAQ) :

The Pharmaceutical Quality Control market Products Tested was valued at USD 4.1 Billion in 2022.

The market is projected to grow at a CAGR of 12.10% during the forecast period, 2023-2032.

The key players in the market BioMerieux SA SGS S.A., Charles River Laboratories International Inc., WiXi AppTec, Merck KGaA, Thermo Fisher Scientific Inc., Toxikon Corporation, Sartorius AG, REMI Group, and Perkin Elmer

The Consumables Product dominated the market in 2022.

The Bioburden Testing Analysis Type had the largest share in the market.

Key Questions Answered

  • Global Market Outlook
  • In-depth analysis of global and regional trends
  • Analyze and identify the major players in the market, their market share, key developments, etc.
  • To understand the capability of the major players based on products offered, financials, and strategies.
  • Identify disrupting products, companies, and trends.
  • To identify opportunities in the market.
  • Analyze the key challenges in the market.
  • Analyze the regional penetration of players, products, and services in the market.
  • Comparison of major playersโ€™ financial performance.
  • Evaluate strategies adopted by major players.
  • Recommendations
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