Pharmaceutical Analytical Testing Market Hits US$ 18.3 Billion by 2033

Introduction

The global Pharmaceutical Analytical Testing Market is projected to grow significantly, from USD 8.4 billion in 2023 to USD 18.3 billion by 2033, marking a CAGR of 8.1%. This growth is fueled by multiple factors influencing the sector, according to insights from various health organizations, companies’ news sections, media, press release notes, and government websites.

Innovation and investment in Research & Development (R&D) are driving forces behind this expansion. The pharmaceutical sector’s focus on developing new drugs and therapies necessitates extensive analytical testing to ensure safety and compliance from early discovery through to market. These R&D efforts are supported not only by profits but also through increasing debt levels, which underscores a growing demand for analytical services to manage regulatory requirements and ensure product efficacy.

Regulatory compliance and quality metrics also play crucial roles. With stringent standards set by regulatory bodies like the FDA, pharmaceutical companies must meet high safety and quality benchmarks, necessitating comprehensive analytical testing. The FDA’s implementation of consensus metrics for product quality further underscores the importance of this testing in maintaining compliance and enhancing quality throughout the production cycle.

The shift towards Integrated Continuous Manufacturing (ICM) marks a move to more efficient production processes in the pharmaceutical industry. This method reduces production time and requires robust analytical testing to ensure quality standards are met with each batch. The adoption of technologically advanced manufacturing processes underlines the increasing need for sophisticated analytical testing services.

The financial landscape of the pharmaceutical industry, characterized by significant investments in intangible assets and a shift towards financialization, influences the demand for analytical testing. This testing is essential to validate the investments made in R&D and ensure the profitability and compliance of new products. Additionally, the growth in generic and specialty pharmaceuticals, driven by patent expirations and the need for drugs targeting specific conditions, further boosts the demand for analytical testing services.

Recent industry developments include Labcorp’s acquisition of BioReference Health’s Diagnostics business from OPKO Health in September 2024 for $237.5 million, excluding operations in New York and New Jersey. This acquisition, which is expected to generate approximately $100 million in annual revenue, strategically enhances Labcorp’s laboratory services across the U.S. Moreover, Eurofins’ investment of €152 million in 2023 to secure more of its strategic sites highlights its commitment to long-term growth and operational expansion, while SGS’s acquisition of Silver State Analytical Laboratories and Excelchem Laboratories in May 2023 strengthens its environmental testing capabilities in the western U.S.

Key Takeaways

• The market is expected to grow from USD 8.4 billion in 2023 to USD 18.3 billion by 2033, at a CAGR of 8.1%.
• FDA and EMA require stringent testing to ensure pharmaceutical quality and safety, impacting market practices.
• Technological innovations, including real-time analytics and advanced spectroscopy, are boosting testing capabilities and market competitiveness.
• Bioanalytical Testing led the market in 2023, contributing over 40% due to its crucial role in clinical and non-clinical testing.
• In 2023, pharmaceutical companies held the largest market segment, representing over 47% of the total market share.
• Expanding into emerging markets is vital due to increasing pharmaceutical consumption and regulatory needs.
• Quality by Design (QbD) is being adopted more widely to enhance development efficiency and product quality.
• In 2023, North America held a 53% market share, while Asia-Pacific is emerging as the fastest-growing region due to rising healthcare investments.
• Leading firms like SGS SA, Labcorp, and Eurofins Scientific dominate with their extensive networks, focusing on quality and compliance.

Pharmaceutical Analytical Testing Statistics

• 2023 Market Size: The total market size in 2023 is 8.4 billion USD.
• 2024 Market Size: Estimated to increase to 9.1 billion USD.
• 2025 Market Size: Projected to grow to 9.8 billion USD.
• 2026 Market Size: Expected to reach 10.6 billion USD.
• 2027 Market Size: Forecasted to be 11.5 billion USD.
• 2028 Market Size: Anticipated to expand to 12.4 billion USD.
• 2029 Market Size: Set to rise to 13.4 billion USD.
• 2030 Market Size: Projected to grow to 14.5 billion USD.
• 2031 Market Size: Estimated to reach 15.7 billion USD.
• 2032 Market Size: Expected to be 16.9 billion USD.
• 2033 Market Size: Forecasted to increase to 18.3 billion USD.
• CAGR 2023-2033: The market will grow at a compound annual growth rate (CAGR) of 8.1%.
• Market Segmentation: Includes Bioanalytical Testing, Method Development & Validation, Stability Testing, and Others.

Health and Technology Sectors Projected Growth

• The HPLC sector is expected to grow from USD 4.5 billion in 2023 to about USD 8.1 billion by 2033, with a 6.1% annual growth rate.
• Chromatography software is projected to increase from USD 1.2 billion in 2023 to USD 3.3 billion by 2033, at a 10.6% annual growth rate.
• Surgical microscopes are anticipated to grow from USD 1,045 million in 2022 to USD 3,020 million by 2032, at an 11.5% annual growth rate.
• Genetic testing is estimated to increase from USD 15.9 billion in 2022 to USD 39.2 billion by 2032, growing annually at 9.7%.
• Vitamin D testing is expected to rise from USD 918 million in 2023 to USD 1,786 million by 2032, with a 7.9% growth rate.
• Drug abuse testing is forecasted to grow from USD 6.8 billion in 2023 to USD 11.8 billion by 2032, at a 6.5% growth rate.
• Mycoplasma testing is expected to expand from USD 766.63 million in 2022 to USD 2,338 million by 2032, growing annually at 12.11%.
• Rare disease genetic testing is projected to grow from USD 918.94 million in 2023 to USD 3,051.6 million by 2032, with a 13.1% annual growth rate.
• HPV testing is expected to increase from USD 4.6 billion in 2022 to USD 13.9 billion by 2032, at a 4.3% annual growth rate.
• Bleeding disorder testing is expected to grow from USD 6.8 billion in 2022 to USD 16.3 billion by 2032, with a 9.4% annual growth rate.
• Biological safety testing is projected to expand from USD 4.8 billion in 2023 to USD 13.4 billion by 2033, at a 10.9% annual growth rate.
• Enteric disease testing is expected to grow from USD 3.9 billion in 2023 to USD 5.1 billion by 2033, with a 2.8% growth rate.
• Clinical biomarker testing is forecasted to grow from USD 873.6 million in 2023 to USD 1,750.9 million by 2033, at a 7.2% growth rate.
• Apolipoprotein testing is projected to increase from USD 20.82 billion in 2023 to USD 49.09 billion by 2033, growing annually at 8.2%.
• Triglycerides testing reagents are expected to grow from USD 112.2 billion in 2023 to USD 197.2 billion by 2033, at a 5.8% annual growth rate.
• Preterm birth and PROM testing are projected to grow from USD 1.4 billion in 2023 to USD 3.1 billion by 2033, at an 8.4% annual growth rate.
• Silver-based antimicrobial agents are forecasted to increase from USD 257.5 million in 2023 to USD 649.9 million by 2033, growing annually at 9.7%.
• Microbial fermentation APIs are expected to grow from USD 61.2 billion in 2023 to USD 71 billion by 2033, at a 1.5% annual growth rate.
• Microbial fermentation technology is projected to increase from USD 33.8 billion in 2023 to USD 59.4 billion by 2033, at a 5.8% growth rate.

Emerging Trends

• Increased Regulation Compliance: Pharmaceutical companies are increasingly committed to stringent regulatory compliance, particularly during the early phases of drug development. This trend is driven by the need to meet FDA standards and other global regulations, compelling companies to enhance their analytical testing frameworks. These improved protocols are crucial not only for achieving compliance but also for ensuring the safety and efficacy of pharmaceutical products before they reach the market. This focus on rigorous testing protocols helps mitigate risks and streamline the approval processes.
• Adoption of Advanced Technologies: The pharmaceutical industry is rapidly embracing advanced technologies in analytical testing. The integration of high-throughput techniques and sophisticated data analytics, including artificial intelligence (AI) and machine learning, is revolutionizing drug testing and development. These technologies enable more accurate predictions of drug behaviors and outcomes, significantly enhancing both the efficiency and precision of pharmaceutical research. This technological advancement is setting new standards in how drugs are developed and tested, promising quicker and more reliable results.
• Focus on Real-world Data: There is a growing emphasis on the use of real-world data (RWD) in pharmaceutical analytical testing. Companies are increasingly gathering and analyzing data from various healthcare settings to support regulatory submissions and refine market access strategies. By utilizing RWD, pharmaceutical companies aim to better understand how drugs perform in real-life scenarios, beyond controlled clinical trials. This approach helps in predicting patient outcomes and drug efficacy more accurately, ensuring that therapeutic solutions are both effective and safe in diverse patient populations.
• Sustainability Practices: Environmental sustainability is becoming a priority in pharmaceutical analytical testing. The industry is moving towards greener analytical methodologies by reducing the use of solvents, minimizing energy consumption, and implementing effective waste management strategies during the drug testing process. These practices not only help in reducing the environmental footprint of pharmaceutical development but also align with global sustainability goals, making the industry a part of broader efforts to protect the environment while maintaining high standards of drug safety and efficacy.

Use Cases

• Increased Regulation Compliance: Pharmaceutical companies are increasingly committed to stringent regulatory compliance, particularly during the early phases of drug development. This trend is driven by the need to meet FDA standards and other global regulations, compelling companies to enhance their analytical testing frameworks. These improved protocols are crucial not only for achieving compliance but also for ensuring the safety and efficacy of pharmaceutical products before they reach the market. This focus on rigorous testing protocols helps mitigate risks and streamline the approval processes.
• Adoption of Advanced Technologies: The pharmaceutical industry is rapidly embracing advanced technologies in analytical testing. The integration of high-throughput techniques and sophisticated data analytics, including artificial intelligence (AI) and machine learning, is revolutionizing drug testing and development. These technologies enable more accurate predictions of drug behaviors and outcomes, significantly enhancing both the efficiency and precision of pharmaceutical research. This technological advancement is setting new standards in how drugs are developed and tested, promising quicker and more reliable results.
• Focus on Real-world Data: There is a growing emphasis on the use of real-world data (RWD) in pharmaceutical analytical testing. Companies are increasingly gathering and analyzing data from various healthcare settings to support regulatory submissions and refine market access strategies. By utilizing RWD, pharmaceutical companies aim to better understand how drugs perform in real-life scenarios, beyond controlled clinical trials. This approach helps in predicting patient outcomes and drug efficacy more accurately, ensuring that therapeutic solutions are both effective and safe in diverse patient populations.
• Sustainability Practices: Environmental sustainability is becoming a priority in pharmaceutical analytical testing. The industry is moving towards greener analytical methodologies by reducing the use of solvents, minimizing energy consumption, and implementing effective waste management strategies during the drug testing process. These practices not only help in reducing the environmental footprint of pharmaceutical development but also align with global sustainability goals, making the industry a part of broader efforts to protect the environment while maintaining high standards of drug safety and efficacy.

Key Players Analysis

SGS SA

SGS SA is a prominent leader in the pharmaceutical analytical testing sector, operating through a global network of state-of-the-art laboratories to ensure product quality and compliance with international regulatory standards. Their services span across comprehensive testing solutions including quality control of raw materials, active pharmaceutical ingredients (APIs), and final products.

SGS’s laboratories are equipped to perform a wide range of tests such as assay, impurities, dissolution, and physical properties like viscosity and particle size distribution, ensuring accurate and reliable results. Additionally, SGS provides method development and validation, which are critical for maintaining the rigor and integrity required in pharmaceutical development. Their focus on delivering timely and precise outcomes helps pharmaceutical companies make informed decisions regarding their products.

Labcorp

Labcorp plays a significant role in the pharmaceutical analytical testing sector by providing comprehensive bioanalytical and analytical chemistry services that support drug development from discovery through clinical stages. With over 900 methods developed annually, Labcorp handles 1.2 million sample analyses across various platforms, such as LC-MS and immunoanalytical systems.

Their services are designed to meet rigorous regulatory standards and include innovative techniques like cell and gene therapy testing. Labcorp’s commitment to quality and regulatory compliance is evident through their involvement in key regulatory discussions and contributions to the Global Bioanalytical Consortium, which shapes the pharmaceutical testing landscape​.

Eurofins Scientific

Eurofins Scientific is a prominent player in the pharmaceutical analytical testing sector, offering a broad range of services crucial for drug safety and efficacy. The company operates a vast network of laboratories globally, significantly enhancing its testing capabilities. Eurofins provides critical services such as microbiological testing, toxicology, biosafety, and various custom testing services including for gene and cell therapies. Their operations are notable for supporting clinical trials through extensive services from materials management to pharmaceutical release testing.

Eurofins has consistently expanded its capabilities through acquisitions and infrastructure enhancements, ensuring advanced IT solutions for laboratory management and data handling. This strategic growth allows Eurofins to offer high-quality analyses efficiently, catering to complex and evolving pharmaceutical needs. Their commitment to innovation and quality underpins their reputation as a leader in the field, with over 400 million tests performed annually across their extensive laboratory network.

Pace Analytical Services LLC

Pace Analytical Services LLC plays a significant role in the pharmaceutical analytical testing sector, offering a comprehensive range of services that accelerate drug development and ensure compliance with regulatory standards. They specialize in providing advanced analytical development services, including the characterization and testing of small molecules, biologics, and nucleic acids.

Pace’s facilities are equipped with cutting-edge technology that supports extensive testing capabilities such as raw materials testing, lot release testing, and stability & storage testing. Their expertise also extends to process development, ensuring that manufacturing processes are robust and scalable. Additionally, Pace offers specialized services in extractables and leachables testing, which are critical for verifying the safety and efficacy of pharmaceutical products.

Intertek Group plc

Intertek Group plc plays a significant role in the pharmaceutical analytical testing sector, leveraging its extensive network of over 1,000 laboratories across 100 countries to offer comprehensive quality and safety solutions. In 2023, the company emphasized its commitment to the pharmaceutical industry by providing a wide range of GLP, GCP, and cGMP compliant services.

These services span the entire drug development lifecycle, from method development and validation to regulatory guidance and supply chain assurance. Intertek’s analytical testing capabilities are particularly robust, focusing on pharmaceutical and healthcare consulting, which supports the production and safety of pharmaceutical products globally.

PPD Inc (Thermo fisher Scietific Inc.)

PPD Inc., now a part of Thermo Fisher Scientific, operates within the pharmaceutical analytical testing sector, providing a comprehensive suite of services that accelerate drug development. This integration allows Thermo Fisher to enhance its laboratory products and services segment, utilizing PPD’s expertise in clinical development and analytical services to serve pharmaceutical, biotechnology, medical device, and government organizations effectively.

The services offered include everything from early drug development phases through regulatory approval, emphasizing patient-centered strategies and utilizing advanced data analytics to improve drug development productivity. Their global laboratory network employs innovative technologies and extensive scientific expertise to support the development of small molecules, biologics, vaccines, and cell and gene therapies. This strategic collaboration aims to deliver high-quality data that meet rigorous regulatory standards, ultimately facilitating faster and more informed decision-making in drug development.

Wuxi AppTec

WuXi AppTec plays a significant role in the pharmaceutical analytical testing sector, providing comprehensive solutions across various stages of drug development. With over 400 specialized staff, the company offers a broad range of analytical and regulatory CMC services, supporting clients from preclinical phases through market supply.

Their operations span an impressive 8,500 square meters of laboratory space in Shanghai, designed to handle stability studies, method development, and validation for both small and large molecule products. This facility adheres to international standards, having undergone numerous inspections by global regulatory authorities, which affirm its commitment to maintaining high-quality standards. WuXi AppTec has successfully conducted stability programs for over 2,000 batches of API and drug product and prepared more than 50 CMC dossiers, showcasing their extensive experience and capability in this field.

Boston Analytical

Boston Analytical, recently rebranded as BA Sciences, operates prominently in the pharmaceutical analytical testing sector. The company, based in Salem, NH, is renowned for its expertise spanning over 30 years, serving the pharmaceutical, biopharmaceutical, and medical device industries. Their laboratory is cGMP compliant, FDA registered, and ISO certified, ensuring high-quality testing services.

BA Sciences offers a comprehensive range of services, including analytical development, validation, microbiology testing, and stability testing. They specialize in various forms of testing such as dissolution, raw material, in-process, and lot release testing, catering to all phases of drug development and release. The rebranding to BA Sciences reflects their commitment to innovation and excellence, aiming to set new standards in global life sciences analytical testing.

Charles River Laboratories

Charles River Laboratories plays a significant role in the pharmaceutical analytical testing sector, primarily focusing on ensuring the safety and efficacy of biologics through comprehensive testing services. Their labs perform over 40,000 tests annually, supporting a wide array of products, including monoclonal antibodies, vaccines, and cell therapies.

Their facilities are equipped with state-of-the-art technologies and adhere to rigorous regulatory standards to guarantee biologic safety across all phases of development. Additionally, their bioanalytical services span from early discovery through clinical validation, integrating global expertise to streamline development processes and enhance methodological reliability. This dual focus on biologics and bioanalytical testing highlights their crucial role in advancing pharmaceutical development through innovation and rigorous safety assessments.

West Pharmaceutical Services Inc

West Pharmaceutical Services Inc. is actively engaged in the pharmaceutical analytical testing sector, particularly focusing on ensuring the integrity and safety of drug packaging and delivery systems. Their analytical services span a wide array of testing and validation methods, including studies on extractables and leachables, particle analysis, and container closure integrity. These services are crucial for drug developers as they navigate complex regulatory landscapes and aim to meet stringent safety standards.

West employs a variety of advanced techniques in their testing processes, such as Volatile Organic Compounds analysis using Headspace Gas Chromatography-Mass Spectrometry, and Non-volatile Organic Compounds analysis through High Resolution Accurate Mass Liquid Chromatography-Mass Spectrometry. These methods help ensure that packaging systems are free of any contaminants that could compromise drug safety and efficacy. Additionally, West’s services support pharmaceutical, biotech, and medical device manufacturers throughout the product lifecycle, from initial development through to commercialization​

Conclusion

The Pharmaceutical Analytical Testing Market is poised for significant growth due to the increasing demand for drug safety, efficacy, and regulatory compliance. Advancements in technology, such as high-throughput screening and real-world data analysis, are revolutionizing the field, enhancing testing accuracy and efficiency. The market’s expansion is also driven by a surge in generic and specialty pharmaceuticals, necessitating rigorous analytical testing. Key industry developments, such as strategic acquisitions and investments in testing capabilities, highlight the sector’s commitment to quality and compliance. As pharmaceutical companies continue to navigate complex regulatory landscapes, the reliance on sophisticated analytical testing services will remain crucial in ensuring product safety and market success. This dynamic field is expected to continue its upward trajectory, reflecting its critical role in the pharmaceutical industry’s future.

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