Pharmaceutical Analytical Testing Market is Estimated to Witness High Growth Owing to Growing Need for Drug Safety & Strict Regulations
The Pharmaceutical Analytical Testing Market is estimated to be valued at USD 8.41 billion in 2024, exhibiting a CAGR of 8.7% over the forecast period (2024-2031). The rising number of failed clinical trials due to incorrect analytical testing and growing need for ensuring drug safety throughout the drug development process are driving the demand for analytical testing in the pharmaceutical industry. Furthermore, stringent regulations around drug development and approval processes are also propelling the growth of the pharmaceutical analytical testing market.
Market Dynamics:
The growth of the pharmaceutical analytical testing market is driven by the growing need for drug safety throughout the drug development process and stringent regulatory frameworks. The drug development process involves rigorous analytical testing at various stages starting from pre-clinical to post approval to ensure safety and effectiveness of drugs. Failed clinical trials due to flawed analytical methods during early development stages results in significant losses to pharmaceutical companies. Furthermore, regulatory agencies have implemented strict guidelines around drug approvals and quality controls which necessitate comprehensive analytical testing. Adherence to quality standards set by regulatory bodies such as U.S.FDA and EMA have become imperative which is further propelling the demand for analytical services in the pharmaceutical industry.
Growing Demand for Generic Drugs is Driving Growth in Pharmaceutical Analytical Testing
The demand for generic drugs has been steadily increasing over the past decade. As patent cliffs leave the doors open for generic equivalents of blockbuster drugs, pharmaceutical companies are rushing to capture market share in the off-patent drug market. However, generic drugs must undergo rigorous analytical testing to prove bioequivalence to the original brand name drug. This testing ensures generic drugs deliver the same clinical effect as the brand drug. The growth of the generic drug industry has directly increased the need for analytical testing services during generic drug development and manufacturing. As the patent cliff continues putting pressure on major pharmaceutical companies, the demand for cost-effective generic drugs will keep driving analytical testing market growth.
Stringent Regulatory Compliance is Necessitating More Robust Analytical Method Validations
Regulatory bodies across the globe are tightening standards and enforcing stricter compliance in the pharmaceutical sector. Recent incidents involving drug quality issues have increased regulatory scrutiny. Pharmaceutical manufacturers and drug authorities now demand more robust validations for analytical test methods. Method validations prove a testing process is suitable to consistently deliver quality results. The increased focus on method validations necessitates specialized testing services to demonstrate testing procedures can effectively detect critical product attributes. Analytical service providers are seeing growing demand for method development and validation support services to meet evolving compliance needs. Stricter regulations are bolstering the analytical testing market as pharmaceutical companies outsource more complex method validations.
Budget Cuts in R&D Spending Pose a Threat
Despite steady growth trends, budget cuts remain a concern for the pharmaceutical analytical testing market. In recent years, big pharma companies have trimmed R&D budgets as drug development becomes more complex and riskier. Reduced R&D budgets translate to less outsourced analytical testing contracts during drug development. Furthermore, the generic drug boom has pressured brand drug sales, impacting R&D budgets. Analytical service providers heavily rely on projects from large pharma and biotech firms. Spending cuts threaten future testing volumes. Staying ahead of budget-driven project delays or cancellations will be important for testing companies to sustain growth.
Staffing Shortages Hamper Market Expansion
A shortage of qualified analytical chemists and technicians has posed challenges for expanding operations. The specialized analytical skill set attracts high salaries, making staff retention difficult. Furthermore, there is growing competition for talent from the biotech sector. Delayed projects and constrained capacities result when analytical service providers struggle to find and keep qualified staff. To meet rising industry demand, testing companies must find creative solutions to the staffing problem through improved training programs, competitive benefits, and flexible work arrangements. Overcoming human resource constraints will be critical to unlock the market's full potential.
Outsourcing Trend Presents Opportunity
One of the biggest opportunities in the pharmaceutical analytical testing market comes from the rising outsourcing trend. Increasingly complex validation methods, budget pressures, and the need to focus internal resources on core competencies are driving more pharmaceutical manufacturers to outsource analytical testing functions. By outsourcing, drug companies gain specialized capabilities and flexible capacities without major investments. This allows them to better manage costs and timelines. As outsourcing grows in popularity, established analytical service providers stand to capture a larger share of the expanding market. Those able to offer a full suite of customized solutions will appreciate the most significant growth under this trend.
Advent of New Therapies Spurs Novel Method Development
The development of advanced therapies like biologics, cell and gene therapies is stimulating the demand for novel analytic methods. These complex next-gen treatments require high-sensitivity analytics to fully characterize minute molecule structures and probe intricate biological mechanisms. Pharma analytical testing providers see opportunity in collaborating with drug developers to design cutting-edge methods for characterizing emerging modalities. Developing specialized expertise early positions service companies well to serve the analytical needs of revolutionary new drugs. As therapies progress from research to market approval, validated novel methods translate to recurring testing revenues. Staying on the forefront of therapeutic innovation seeds future growth opportunities.
Link - https://www.coherentmarketinsights.com/market-insight/pharmaceutical-analytical-testing-market-5383
Key Development
- On March 13, 2024, LGM Pharma, a leading contract development and manufacturing organization (CDMO), revealed a significant investment exceeding $2 million in its analytical testing services. This investment accompanies a 50% expansion in offerings. Additionally, the company will introduce suppository manufacturing capabilities and extend its facility in Rosenburg, Texas. These advancements aim to provide customers with more efficient and comprehensive manufacturing solutions.
- On March 4, 2024, SCHOTT Pharma’s PartnerLab, a shop for drug developers, offered a comprehensive suite of analytical tests crucial for drug submission, aiding pharmaceutical companies in navigating complexity, ensuring product quality, and accelerating market entry. Registered with the FDA as an independent lab, SCHOTT Pharma streamlines drug submission processes for its partners.
- In July 2023, Recipharm, a global contract development and manufacturing organization (CDMO), inaugurated a new analytical laboratory in Bengaluru, India. This investment addresses the growing demand for reliable testing services, filling a crucial market need and prioritizing product safety, regulatory compliance, consumer protection, and patient well-being.
- In March 2022, American Association for Cancer Research (AACR) annual meeting, Transgene, a France-based biotech company, is set to present a poster featuring promising preliminary Phase 1 data on TG4050, its individual Neoantigen cancer vaccine.
- In March 2021, Teracero Pharma Inc., a pharmaceutical company in collaboration with its Germany-based partner, nal von Minden GmbH, a specialist in in-vitro diagnostics, disclosed that Health Canada granted authorization for the importation and commercialization of nal von Minden’s NADAL COVID-19 IgG/IgM Test
Key Players: SGS SA, Labcorp, Eurofins Scientific, Pace Analytical Services LLC, Intertek Group plc, PPD Inc (Thermo fisher Scietific, Inc.), Wuxi AppTec, Boston Analytical, Charles River Laboratories, West Pharmaceutical Services, Inc, Laboratory Testing Inc, Steris, Fare Labs Food Analysis & Research Laboratory. , Bee Pharmo Labs Pvt Ltd, Doctors Analytical Laboratories Pvt Ltd., Autocal Solutions Pvt Ltd, and Apple Pharmaceuticals
