Certified Global Research Member
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 players’ financial performance.
- Evaluate strategies adopted by major players.
- Recommendations
Why Choose Market Research Future?
- Vigorous research methodologies for specific market.
- Knowledge partners across the globe
- Large network of partner consultants.
- Ever-increasing/ Escalating data base with quarterly monitoring of various markets
- Trusted by fortune 500 companies/startups/ universities/organizations
- Large database of 5000+ markets reports.
- Effective and prompt pre- and post-sales support.
The pharmaceutical quality control market is growing fast because the worldwide medicine business wants to make sure that drugs are safe and work well. As rules get stricter, strong checks are needed more and more to control quality. Groups like the FDA and EMA are making their rules stronger. They tell pharmaceutical companies they must follow tough quality checks for good reason. This made businesses spend money on new tools and ways to follow changing rules set by the government.
The market is changing towards complex analysis tools like chromatography, spectroscopy and mass spectrometry. These tools allow for accurate and dependable study of medicine products, making sure they follow rules. As medicines get more complicated because of improvements in drug delivery and biotechnology, the need for advanced quality control has gotten stronger. Businesses are using new ways to measure the quality of complicated mixtures correctly.
A lot of pharmaceutical companies are sending their quality checks to experts in the field. This way of doing things is pushed by the need to cut down expenses for running a business, get special know-how and make it easier to manage. Companies that do research are very important in giving quality control services. Making sure data is correct and keeping full records have become very important in checking the quality of medicines.
There is a growing interest in using electronic systems and computer programs that make data more accurate, traceable, and comply with rules. Old ways to test tiny living things take too long. This slows down when new medicines can be sent out. The market is seeing a move towards fast microbe testing methods that give results quickly without losing accuracy. This is very important for making sure drugs get to the market quickly.
The world-wide pharmaceutical supply chains have added problems with keeping high quality in different places across the globe. Businesses are using the same safety rules to make sure that product quality is consistent no matter where it's made. In the pharmaceutical industry, machines like AI and IoT along with Big Data are being added more often to check quality. These tools make it easier to automate, look at data and make decisions. They help quality control become more effective and efficient too.
Covered Aspects:
| Report Attribute/Metric | Details |
|---|---|
| Market Opportunities | Increasing demand for pharmaceutical quality control outsourcing |
| Market Dynamics | Increasing cost of drug manufacturing and increasing demand to comply with regulatory requirements |
Pharmaceutical Quality Control Market Highlights:
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 (2024 - 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.
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, 2023 & 2032 (USD Billion)
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 2023 (USD Billion)
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 2024 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
- 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
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
-
Leading companies partner with us for data-driven Insights
Kindly complete the form below to receive a free sample of this Report
Tailored for You
- Dedicated Research on any specifics segment or region.
- Focused Research on specific players in the market.
- Custom Report based only on your requirements.
- Flexibility to add or subtract any chapter in the study.
- Historic data from 2014 and forecasts outlook till 2040.
- Flexibility of providing data/insights in formats (PDF, PPT, Excel).
- Provide cross segmentation in applicable scenario/markets.
