Pharmaceutical excipients are inert substances used as carriers for the active pharmaceutical ingredients and help in improving the effectiveness of drug delivery. They play a vital role in enhancing the bioavailability, stability and manufacturability of drug formulations. Excipients such as preservatives, colorants, coatings etc. are added to oral medications to protect them from deterioration and maintain the required consistency, color and shelf life.
The Global Pharmaceutical Excipients Market Size is estimated to be valued at US$ 12.33 Mn in 2024 and is expected to exhibit a CAGR of 6.9% over the forecast period 2024 to 2031, as highlighted in a new report published by Coherent Market Insights.
Market Opportunity:
Regulatory compliance in the pharmaceutical excipients sector continues to remain stringent. Regulatory agencies such as the USFDA have strengthened guidelines to ensure high quality standards of excipients used in drug formulations. This has augmented the demand for well-characterized excipients that meet robust documentation requirements and confirmation of safety and efficacy. With growing regulatory scrutiny, pharmaceutical companies require reliable excipient suppliers who can offer compliance to current Good Manufacturing Practice regulations. The increasing focus on regulatory standards is expected to open growth opportunities for excipient manufacturers with proven track record in quality and regulatory knowledge. Continuous investments in enhancing compliance capabilities will help establish leadership in this competitive market space.
Porter's Analysis
Threat of new entrants: High capital requirements and stringent regulatory standards pose significant barriers for new players.
Bargaining power of buyers: Large pharmaceutical companies have considerable bargaining power due to their scale.
Bargaining power of suppliers: Leading players have stronger bargaining power due to their global presence and product differentation.
Threat of new substitutes: Limited threat as excipients have distinct properties required for drug delivery.
Competitive rivalry: Intense competition among existing players to develop novel technologies and inorganic strategies.
SWOT Analysis
Strengths: Growing Pharma industry and R&D investments driving demand. Wide applications in drug formulations.
Weaknesses: Regulatory compliance and quality control issues. Supply chain disruptions impact availability.
Opportunities: Emerging economies providing new growth avenues. Nanotechnology based novel excipients.
Threats: Stringent regulations delaying approvals. Patent expiries increasing price competition.
Key Takeaways
The global pharmaceutical excipients market is expected to witness high growth. The global pharmaceutical excipients market is estimated to be valued at US$ 12.33 Mn in 2024 and is expected to exhibit a CAGR of 6.9% over the forecast period 2024 to 2031.
North America dominates currently due to concentration of leading pharma companies and stringent regulatory approvals. However, Asia Pacific is poised to grow at the fastest rate supported by expanding pharmaceutical manufacturing base in India and China. Asia Pacific is poised to grow at the fastest rate supported by expanding pharmaceutical manufacturing base in India and China. These countries offer cost advantages and growing generics market, attracting investments by global players into local production. However, regulatory challenges and quality issues also exist in the region.
Key players operating in the pharmaceutical excipients market are Waters Corporation, Agilent Technologies Inc., Bruker Corporation, SCIEX, Shimadzu Corporation, Danaher, Thermo Fisher Scientific Inc., Shimadzu, and PerkinElmer Inc. Regulatory approvals and product launches have allowed these players to gain significant shares. Partnerships with drug makers and acquisitions are also strengthening their positions.
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