Pharmaceutical Quality Control Market

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.

The Global Pharmaceutical Quality Control Market Industry is poised for substantial growth, with projections indicating a market value of 5.16 USD Billion in 2024 and an anticipated increase to 16.2 USD Billion by 2035. This growth trajectory suggests a compound annual growth rate (CAGR) of 10.96% from 2025 to 2035. The factors driving this growth include rising regulatory compliance, technological advancements, increasing demand for biopharmaceuticals, globalization of supply chains, and growing consumer awareness. These dynamics collectively indicate a robust future for the quality control sector within the pharmaceutical industry.

The Global Pharmaceutical Quality Control Market Industry is experiencing heightened scrutiny from regulatory bodies, necessitating stringent adherence to quality standards. Regulatory agencies such as the FDA and EMA impose rigorous guidelines that pharmaceutical companies must follow to ensure product safety and efficacy. This compliance is crucial, as non-compliance can lead to severe penalties and product recalls. As a result, companies are investing significantly in quality control measures, which is projected to drive the market value to 5.16 USD Billion in 2024. The emphasis on regulatory compliance is likely to sustain growth in the industry, fostering innovations in quality assurance technologies.

The Global Pharmaceutical Quality Control Market Industry is witnessing a surge in demand for biopharmaceuticals, which necessitates robust quality control measures. Biopharmaceuticals, including monoclonal antibodies and vaccines, require stringent quality assessments to ensure their safety and effectiveness. As the biopharmaceutical sector expands, driven by advancements in biotechnology, the need for specialized quality control processes becomes paramount. This trend is likely to contribute to the market's growth, as companies invest in sophisticated quality control systems to meet the unique challenges posed by biopharmaceuticals. The industry's evolution is expected to align with the projected CAGR of 10.96% from 2025 to 2035.

The globalization of pharmaceutical supply chains is significantly impacting the Global Pharmaceutical Quality Control Market Industry. As companies source raw materials and components from various regions, ensuring consistent quality across the supply chain becomes increasingly complex. This globalization necessitates the implementation of comprehensive quality control systems to monitor and manage quality at every stage of production. Companies are compelled to adopt standardized quality practices to mitigate risks associated with supply chain variability. This trend is likely to drive investments in quality control technologies and processes, further propelling market growth in the coming years.

Technological innovations are transforming the Global Pharmaceutical Quality Control Market Industry, enhancing the efficiency and accuracy of quality assessments. Advanced technologies such as artificial intelligence, machine learning, and automation are being integrated into quality control processes. These technologies facilitate real-time monitoring and data analysis, allowing for quicker decision-making and improved product quality. As companies adopt these innovations, the market is expected to grow significantly, with projections indicating a rise to 16.2 USD Billion by 2035. The ongoing technological evolution is likely to create a competitive edge for organizations that prioritize quality control in their operations.

Consumer awareness regarding pharmaceutical product safety is on the rise, influencing the Global Pharmaceutical Quality Control Market Industry. Patients and healthcare providers are increasingly demanding transparency and assurance of product quality. This heightened awareness drives pharmaceutical companies to prioritize quality control measures to maintain consumer trust and meet regulatory expectations. As a result, organizations are investing in quality assurance programs and certifications to demonstrate their commitment to safety. This trend is expected to contribute to the market's expansion, as companies recognize the importance of quality control in sustaining their reputation and competitiveness.

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, Market Research Future 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.

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.