Pharmaceutical Quality Control Market (By Product: Services, Consumables, Instruments; By Analysis Type: Sterility Testing, Raw Material Testing, Bioburden Testing, Extractable & Leachable Testing, Endotoxin Testing, Raw Material Testing; By Product Tested: Vaccines, Drugs, Plasma Products) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

The global pharmaceutical quality control market size was valued at USD 11.45 billion in 2023 and is anticipated to reach around USD 36.46 billion by 2033, growing at a CAGR of 12.28% from 2024 to 2033. The rising demand for medication due to the rising prevalence of chronic diseases is driving the growth of the market.

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Pharmaceutical Quality Control Market Key Takeaways

• The North America pharmaceutical quality control market size accounted for USD 3.89 billion in 2023 and is expected to attain around USD 12.58 billion by 2033.
• North America led market with the biggest market share of 34% in 2023.
• Asia Pacific is expected to witness the fastest growth in the market during the forecast period.
• By product, the services segment dominated the market with the highest share in 2023.
• By product, the consumables segment is expected to increase its market growth during the forecast period.
• By analysis type, the sterile testing segment dominate the market in 2023.
• By product testing, the vaccine segment projected the highest growth in the market during the forecast period.

Pharmaceutical Quality Control Market Size in the U.S. 2024 to 2033

The U.S. pharmaceutical quality control market size was estimated at USD 2.73 billion in 2023 and is predicted to be worth around USD 8.81 billion by 2033, at a CAGR of 12.42% from 2024 to 2033.

North America led the pharmaceutical quality control market with the largest market share in 2023. The growth of the market in the region is increasing due to the well-developed healthcare infrastructure and the rising investment by pharmaceuticals in drug development and launch that drives the growth of the market in the region. The growth in the pharmaceutical and healthcare industry are driving the demand for the quality control unites for the detection and safety of the medical drugs. The higher availability of the major healthcare centers and pharmaceutical giants are accelerating the growth of the pharmaceutical quality control market in the region.

• The investment of the research and development on drug by the USA pharma industry is around $60 billion per year.
• Among the top 10 pharmaceuticals major 5 pharmaceuticals company’s headquarters are in the United States.
• As per the projection, the United States will spend around $605 to $635 billion on medicines by 2025.
• There are 2655 pharma companies are located in the U.S. as of 2023.
• And there are 368 generic pharmaceutical manufacturing companies in the United States.

Asia Pacific is expected to witness the fastest growth in the pharmaceutical quality control market during the forecast period. The growth of the market in the region is expected to rise due to the rising population and the growing demand for the effective and safer drug for the treatment of the diseases. The rising interventions of the regional governments for the development of healthcare infrastructure, and pharmaceutical industry are driving the demand for the quality control units in the pharma industry that contributed to the expansion of the pharmaceutical quality control market in the region.

Pharmaceutical Quality Control Market Size in Asia Pacific 2023 to 2033

The Asia Pacific pharmaceutical quality control market size was calculated at USD 2.98 billion in 2023 and is projected to expand around USD 9.66 billion by 2033, poised to grow at a CAGR of 12.48% from 2024 to 2033.

Pharmaceutical Quality Control Market Overview

The pharmaceutical quality control market offers services that are responsible for ensuring the purity and identity of a particular pharmaceutical. Quality control ensures the quality of the drug once it is fully manufactured, it tests and approves the drug quality as per the set regularity standards. Quality control departments in the pharmaceutical industry are important to the efficiency, safety, and consistency of pharmaceutical products. It works on the inspection and safety of the drug for detecting and preventing defects in the manufacturing process. The rising demand for healthcare infrastructure and medication along with the investments in research and development activities in the pharmaceutical industry is driving the growth of the pharmaceutical quality control market.

Pharmaceutical Quality Control Market Growth Factors

• The increasing demand for the healthcare and pharmaceutical facilities are driving the expansion of the market.
• The rising prevalence of the chronic diseases in the aged population which drives the demand for the effective treatment that drives the demand for the pharmaceutical quality control.
• The rising investment on the research and development activities by the pharmaceutical industry for the development and launch of the new drug formulation that drive the growth of the market.
• The increasing number of healthcare facilities like clinical laboratories, hospitals, multispecialty centers are boosting the expansion of the market.
• The increase in the government policies in the safety standards for the drug development and launch is boosting the demand for the pharmaceutical quality control market.

Pharmaceutical Quality Control Market Scope

Pharmaceutical Quality Control Market Dynamics

Driver: Increasing chronic diseases

The rise in the prevalence of the chronic diseases is driving the demand for the effective and safer drug and treatment medication which drives the development in the pharmaceutical industry and further contributes for the growth of the pharmaceutical quality control market. The rising aging population and the environmental conditions are the factors that cause severe illness.

Additionally, the rising shift in the lifestyle and the adoption of smoking and increased consumption of alcohol by the younger population are results in the increasing chronic diseases such as cancer, cardiovascular diseases, respiratory illness, etc. that drives the demand for the effective treatment medication that driving the demand for the innovation in the drug development that directly contributed to the expansion of the pharmaceutical quality control market.

Restraint: Lack of professionals

Quality control in the pharmaceutical industry often requires specialized techniques and instruments for analyzing raw materials, intermediates, and finished products. These techniques, such as chromatography, spectroscopy, and mass spectrometry, require skilled professionals with in-depth knowledge and experience to operate effectively and interpret results accurately. Quality control processes are critical for identifying potential issues such as impurities, contaminants, or deviations from specifications that could affect the safety, efficacy, or stability of pharmaceutical products. Without skilled professionals to perform thorough and accurate analyses, there's an increased risk of errors or oversight, which could lead to product recalls, regulatory sanctions, or compromised patient safety. Thereby, the factor is observed to restrain the growth of the pharmaceutical quality control market.

Opportunity: Technological advancements

The increasing adoption of technological advancements in the quality control in pharmaceutical is observed to offer lucrative opportunities for the pharmaceutical quality control market’s growth. The continuing advancements of technologies in the healthcare sector are enhancing the quality and safety of the drug and driving the growth of the market. The rising demand for the healthcare infrastructure and the rising investment by the government for the development and the launch of pharmaceutical units are results in the increased demand for the pharmaceutical quality control for detecting and preventing any defects in the drug manufacturing process. Thus, the rising demand for pharmaceuticals industry and technological advancements are positively influencing the growth of the market.

Product Insights

The services segment dominated the market with the highest share in 2023. The growth of the segment is attributed to the rising demand for quality control services in the pharmaceutical industry for maintaining the safety of the drug and detecting manufacturing defects. Additionally, the rising investment in the research and development activities in the development of the novel drugs for that drives the expansion of the pharmaceutical quality control services.

The consumables segment is expected to grow at a significant rate during the forecast period. The growth of the segment is expected to dominate due to the rising demand for the medical consumables such as bandages, syringes, gloves, cotton wool, catheters, infusion sets, sutures, and intravenous cannulas, etc. the rise in the surgical procedures and maintaining the hygiene and safety from the bacterial infections that are driving the demand for the pharmaceutical consumables.

Analysis Type Insights

The sterile testing segment dominated the pharmaceutical quality control market in 2023. The rising demand for the sterile testing of pharmaceutical products for removing viable microorganisms. Sterile testing also depends on the procedural methods which can actively prevent contamination of biological products, like goods manufacturing process, and clean room technology. WHO assigns the sterile testing that are applicable for the various range of the biological medicinal products like blood products, vaccines, biotechnology products, cell and tissue products, etc. the increasing demand for the sterile testing in the pharmaceutical industry for ensuring the drug safety.

The raw material testing segment is showing an exponential growth in the market during the upcoming period. Raw material testing is one of the important parts of pharmaceutical products manufacturing. It is crucially important to test each raw material before manufacturing drug and food products. As per the FDA guidelines it is mandatory to check the quality of the raw material for manufacturing of the drug and food products. Quality checking of the raw material before starting the manufacturing process is highly important. It reduces the chances of manufacturing low-quality finished products and reduces the product recall possibilities.

Product Testing Insights

The vaccine segment dominated the pharmaceutical quality control market in 2023. The higher demand for the quality control application in the vaccine due to the higher use of the vaccine in the treatment of several health issues. The increasing demand for several vaccinations from the prevention of infectious diseases and other chronic illnesses is again observed to expand the segment’s growth. Vaccines are more effective in treatment and reduces the recovery time of the patients, though the drug is directly injected to the blood stream in the body. The increasing demand for the vaccines in the future for fighting against the diseases like Covid-19 and others are driving the demand for the vaccine testing for ensuring the safety and manufacturing defects.

Pharmaceutical Quality Control Market Recent Developments

• In May 2023, the proposal sent by the Maharashtra Food and Drug Administration (FDA) to the State Government for launching the ‘Quality Assurance Portal’ for offering safe and effective medicines to the patients and consumers.
• In April 2024, SaniSure, a leading provider of the single-use bioprocessing products, launched the Fill4Sure, a custom single-use filling assembly, introduce for accelerate the drug speed to the market and build efficiency, security, and repeatability into drug product filling.
• In April 2024, The country's drug regulator is recently introduces the guidelines issued by theCentral Drugs Standard Control Organization (CDSCO), associated with the WHO Technical Report Series (TRS) on the good distribution practices for banning the adulterated, spurious, and 'sub-standard' pharmaceutical products in the market.

Pharmaceutical Quality Control Market Companies

• Wixi Apptec
• Biomerieux SA
• Merck Kgaa
• Thermo Fisher Scientific Inc.
• REMI Group
• Perkin Elmer
• Shimadzu Scientific Instruments
• Esco Micro Pte. Ltd.
• Charles River Laboratories International Inc.
• Danaher Corporation
• Mettler Toledo
• Waters Corporation
• Toxikon Corporation
• Lucideon Limited
• Sartorius AG
• BRAM-COR SPA
• SGS S.A.

Segments Covered in the Report

By Product

• Services
• Consumables
• Instruments

By Analysis Type

• Sterility Testing
• Raw Material Testing
• Bioburden Testing
• Extractable & Leachable Testing
• Endotoxin Testing
• Raw Material Testing

By Product Tested

• Vaccines
• Drugs
• Plasma Products

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa