by The global pharmaceutical excipients market is a vital part of drug manufacturing. Excipients act as bulking agents, coatings, stabilizers, and lubricants to enhance the characteristics of active pharmaceutical ingredients and improve drug delivery. Commonly used excipients include carbohydrates such as lactose and sucrose, inorganic substances like calcium phosphate, and organics like magnesium stearate and glycerin.
The pharmaceutical excipients market is estimated to be valued at US$ 12.33 Bn in 2024 and is expected to exhibit a CAGR of 6.9% over the forecast period of 2024 to 2030.
Advancements in analytical technologies are enabling the development of high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and tandem mass spectrometry that allow for accurate identification and quantification of excipients. This is essential to ensuring drug safety, efficacy, and compliance with global regulations. Analytical testing during various stages such as clinical trials and post-approval can detect contaminants, degraded compounds, and verify the excipient composition against product specifications.
Key Takeaways
– Key players operating in the Global Pharmaceutical Excipients Market Size are Waters Corporation, Agilent Technologies Inc., Bruker Corporation, SCIEX, Shimadzu Corporation, Danaher, Thermo Fisher Scientific Inc., Shimadzu, and PerkinElmer Inc.
– Growing demand for contract manufacturing and customized blends offers lucrative opportunities for industry players to expand service offerings and drive greater uptake of analytical solutions.
– Technological developments spanning mass spectrometry, chromatography, spectroscopy, and other techniques enable advanced characterization, impurity profiling, and multi-attribute methodologies supporting regulatory filings.
Market Drivers
Advancements in analytical technologies are enabling greater efficiency, sensitivity, and specificity across compound identification, quantitative analysis, and quality control testing over the lifecycle of drug products and excipients. Tools such as HPLC, UPLC, LC-MS/MS, NMR, and Raman spectroscopy can accelerate method validation, reduce cost and time to market, and help manufacturers meet stringent regulatory compliance standards for pharmaceutical excipients.
Current Challenges in Pharmaceutical Excipients Market
The pharmaceutical excipients market is facing various challenges which is hindering the growth of the market. Stringent regulations regarding the selection and approvals of excipients is a major concern area. Regulatory authorities like FDA change their guidelines and standards time to time which creates confusions among manufacturers. Finding suitable substitutes for excipients going off patents is another challenge as they need to ensure safety, efficacy and compatibility of substitute. Maintaining quality and consistency of excipients during large scale production is a tough task for players. Moreover, developing multifunctional and novel excipients supporting new drug delivery mechanisms require high R&D investments which increases the cost of excipients.
SWOT Analysis
Strength: Wide applications in various dosage forms like tablets, capsules etc. helps sustain demand. Weakness: Stringent regulatory norms increases compliance cost. Opportunity: Growing biosimilars market and focus on patient-centric formulations offer opportunities. Threats: Price erosion due to low entry barriers and increasing availability of substitutes poses threat.
Geographical Regions
North America region currently dominates the pharmaceutical excipients market in terms of value. This is majorly attributed to well-established pharmaceutical industry, presence of major players and stringent regulatory guidelines regarding excipients. Europe constitutes second largest market owing to high outsourcing activities by pharmaceutical companies for formulation development. Asia Pacific is considered as the fastest growing regional market due to increasing generic production, low manufacturing costs and rising drug R&D activities in countries like India and China.
SWOT Analysis
Strength: Wide applications in various dosage forms like tablets, capsules etc. helps sustain demand.
Weakness: Stringent regulatory norms increases compliance cost.
Opportunity: Growing biosimilars market and focus on patient-centric formulations offer opportunities.
Threats: Price erosion due to low entry barriers and increasing availability of substitutes poses threat.
Geographical Regions
North America region currently dominates the pharmaceutical excipients market in terms of value. This is majorly attributed to well-established pharmaceutical industry, presence of major players and stringent regulatory guidelines regarding excipients. Europe constitutes second largest market owing to high outsourcing activities by pharmaceutical companies for formulation development. Asia Pacific is considered as the fastest growing regional market due to increasing generic production, low manufacturing costs and rising drug R&D activities in countries like India and China.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
