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Global Pharmaceutical Quality Control Market size was valued at USD 4.4 Billion in 2022. The Pharmaceutical Quality Control market industry is projected to grow from USD 4.8 Billion in 2023 to USD 11.8 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 12.50% 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.
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Source: Secondary Research, Primary Research, Research Layer Database and Analyst Review
Manufacturing costs account for a sizeable portion of a company's overall costs in the pharmaceutical industry. The price of creating a new medicine has also been rising steadily. A lab-conceived innovation is expected to require an investment of USD 2 billion to bring it to successful commercialization. Drugs with identifiable brand names may cost as much as 27–30% of sales. On the one hand, pharmaceutical companies are increasing their R&D spending to produce more products, but on the other hand, the productivity of their R&D investments is declining relative to the number of pharmaceuticals that are released onto the market each year, which has an effect on a sizeable portion of their overall cost structure. There is a growing need to reduce total process costs, thus many companies in the pharmaceutical and biotech sectors are concentrating on streamlining their processes with the help of quality management systems.
Because medications, medical devices, and other pharmaceuticals directly affect consumers' health and wellbeing, pharmaceutical corporations are subject to strict regulations. Manufacturers are required to uphold a number of standards of quality in order to market their products. Because of the pharmaceutical industry's rapid growth, small and mid-sized pharmaceutical enterprises are focusing on adhering to the law in order to manufacture better products and keep their competitiveness in the market. The U.S. market, to which the majority of companies operating in developing nations like China and India export their products, is governed by the Food and Drug Administration (FDA). The FDA inspects the facilities and operational procedures of all pharmaceutical manufacturing operations conducted in the United States as well as those conducted abroad by companies that regularly sell their products in the country. Therefore, these facilities and their methods must adhere to the FDA's current good manufacturing practises (cGMP). Businesses must also follow the International Organisation for Standardisation (ISO), 21 CFR Part 211, and ICH Guideline Q10 in order to manufacture and sell their products. The increasing importance of regulatory requirements and the growing worldwide market have manufacturers eager to adopt quality management systems.
The rise in recognised clinical laboratories, the acceptance of third-party quality controls, and consumers' growing preference for outside assistance with quality assessment are the main factors driving the global market for pharmaceutical quality controls. Due to the rise in the prevalence of numerous diseases around the world, there are now more laboratory tests being done. To address this requirement, both the public and commercial sectors are expanding the number of laboratories. The majority of countries need clinical laboratories to receive accreditation from regulatory bodies like the International Organisation for Standardisation and other groups with comparable standards before they may perform diagnostic tests. During the accreditation process, the competent authorities evaluate a laboratory's competency and quality system in comparison to specified requirements.
the development of molecular diagnostic techniques for the identification of infectious diseases and cancer. The market's growth was influenced by factors such as an increase in the number of accredited clinical laboratories, end users' adoption of third-party quality controls, and demand for external quality assessment help. Setting up a QC process in a clinical lab is very expensive. In addition, laboratories use expert personnel to oversee the QC system. Additionally, QC processes cost the same amount regardless of how many tests are performed. As a result, clinical laboratories with little capacity for diagnostic testing find the cost of developing QC procedures to be exorbitant. This is expected to make it more difficult for hospitals and laboratories in wealthy and developing nations to conduct quality control practises due to cost constraints. Technology improvements have led to the emergence of a brand-new class of multi-analyze and multi-instrument controls. These inventive controls, which combine numerous instrument-specific controls into a single control, can help clinical laboratories save money. Thus, driving the Pharmaceutical Quality Control market revenue.
The global Pharmaceutical Quality Control market segmentation, based on Product, includes Consumable, Instruments, and Services. Consumables segment dominated the global market in 2022. Consumables are the main auxiliary materials used in production. Consumables can be categorised into three groups: those who have no impact on quality, those who do, and those who have an immediate impact. The service sector is predicted to grow at the fastest rate. Additionally, the instruments sector has the largest market share for pharmaceutical quality and control.
The global 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 global market in 2022. Bioburden testing is divided into numerous areas, including Anaerobic Count Testing, Aerobic Count Testing, Mould Count Testing, In Vitro, Spore Count Testing, Endotoxin Testing, LAL, and Others. An aerobic count assay is used to assess the bacterial population in a sample. It helps to show the product's quality and level of degradation. The anaerobic count test, sometimes referred to as wound culture, is performed without the use of oxygen.
The global Pharmaceutical Quality Control market segmentation, based on Products Tested, includes Vaccines, Plasma Product, and Drugs. Vaccines segment dominated the global Pharmaceutical Quality Control market in 2022. It's crucial to make the right decisions about vaccine production and quality control. The medicine sub-segment is expected to grow at the fastest rate overall.
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Source: Secondary Research, Primary Research, Research Layer Database and Analyst Review
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 due to the fact that the United States and Canada have advanced healthcare systems, that the region is home to a large number of leading manufacturers of molecular quality control products, and that advanced technologies are easily accessible. 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.
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Europe Pharmaceutical Quality Control market accounted for the healthy market share in 2022. Over the course of the forecast, it is predicted that sizable investments in R&D for the pharmaceutical sector will expand the European market for pharmaceutical quality control. The European Federation of Pharmaceutical Industries and Associations (EFPIA) estimates that the research-based pharmaceutical industry spent €35,200 million on R&D in Europe in 2017. 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. The growth of this industry is due to the numerous pharmaceutical companies. The pharmaceutical industries of China and India are home to the largest producers of biopharmaceuticals and generic medications, and the majority of businesses that provide quality management systems are focusing on expanding their market share in these important 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.
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 global 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 global 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.
LGC Clinical Diagnostics Inc. (LGC Clinical Diagnostics), formerly SeraCare Life Sciences Inc., is responsible for the discovery, development, manufacture, and supply of disease-state specimens and tissues for processed biological materials, research and development, immunoassay reagents, and products and technologies for quality control. Digital PCR instruments, controls and reference materials, SARS-COV-2, plasma, and serum diluents and derivatives, next-generation sequencing tools, and cell culture reagents are among the primary products offered by the company. In June 2021, SeraCare will collaborate with the International Quality Network for Pathology 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.
Bio-Rad Laboratories Inc (Bio-Rad) develops, manufactures, and markets a range of products and systems for use in life science research, healthcare, analytical chemistry, and other sectors. The company's principal products include reagents, apparatus, laboratory equipment, test systems, informatics systems, test kits, and specialised quality controls. In May 2021, Bio-Rad and Roche Diagnostics entered into a global cooperation in order to provide their clients with a full range of InteliQ products and Unity QC data management systems, as well as customer training and equipment maintenance.
· 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
May 2019: The pharmaceutical services lab of Intertek Group Plc was announced to have expanded its Milbourn facility.
· Consumables
· Instruments
· Services
· Sterility Testing
· Bioburden Testing
· Endotoxin Testing
· Stability Testing
· Extractable & Leachable Testing
· Raw Material Testing
· Others
· Vaccines
· Plasma Product
· Drugs
· 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 Attribute/Metric |
Details |
|
Market Products Tested 2022 |
USD 4.4 Billion |
|
Market Products Tested 2023 |
USD 4.8 Billion |
|
Market Products Tested 2032 |
USD 11.8 Billion |
|
Compound Annual Growth Rate (CAGR) |
12.50% (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 |
The global Pharmaceutical Quality Control Market was valued at USD 4.4 billion in 2022, and it is estimated to reach USD 11.8 billion by 2032.
The global market is projected to grow at a CAGR of 12.50% during the forecast period, 2023-2032.
North America had the largest share in the global market
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 global market.
Report Code :
RL6591
Published on :
Aug 2023
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