Global Pharmaceutical Excipients Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2031

Análisis del mercado de excipientes farmacéuticos

El mercado de excipientes farmacéuticos está experimentando un crecimiento sustancial, impulsado por la creciente demanda de formulaciones avanzadas de medicamentos y el creciente enfoque en los sistemas de administración de medicamentos. A medida que las compañías farmacéuticas se esfuerzan por mejorar la biodisponibilidad y el cumplimiento del tratamiento por parte de los pacientes, los excipientes desempeñan un papel fundamental en el desarrollo de formulaciones efectivas y estables. Los desarrollos recientes en este mercado incluyen la introducción de excipientes multifuncionales que cumplen funciones tradicionales, como aglutinantes y rellenos, y ofrecen funcionalidades mejoradas, como una mejor solubilidad y perfiles de liberación dirigidos. Las innovaciones en materiales biocompatibles también están ganando terreno, en particular para formulaciones parenterales, para garantizar la seguridad y la eficacia. Además, el auge de la medicina personalizada ha impulsado el desarrollo de excipientes personalizados que atienden las necesidades específicas de los pacientes, lo que ha llevado a un aumento de la investigación y la inversión en esta área. Las agencias reguladoras también están evolucionando sus pautas, promoviendo el uso de excipientes con perfiles de seguridad probados. Además, las colaboraciones entre los fabricantes de excipientes y las compañías farmacéuticas están en aumento, fomentando la innovación y ampliando el alcance de las aplicaciones. En general, el mercado de excipientes farmacéuticos está preparado para un crecimiento continuo, con avances constantes que impulsan la evolución de las formulaciones de medicamentos y los sistemas de administración.

Tamaño del mercado de excipientes farmacéuticos

El tamaño del mercado mundial de excipientes farmacéuticos se valoró en USD 8.31 mil millones en 2023 y se proyecta que alcance los USD 13.86 mil millones para 2031, con una CAGR del 6,60% durante el período de pronóstico de 2024 a 2031. Además de los conocimientos sobre escenarios de mercado como el valor de mercado, la tasa de crecimiento, la segmentación, la cobertura geográfica y los principales actores, los informes de mercado seleccionados por Data Bridge Market Research también incluyen un análisis profundo de expertos, epidemiología del paciente, análisis de la cartera, análisis de precios y marco regulatorio.

Tendencias del mercado de excipientes farmacéuticos

“ Creciente demanda de excipientes naturales y de origen biológico”

El mercado de excipientes farmacéuticos está experimentando un crecimiento sustancial, impulsado por la creciente demanda de formulaciones avanzadas de medicamentos y el creciente enfoque en los sistemas de administración de medicamentos. Una tendencia significativa en el mercado de excipientes farmacéuticos es la creciente demanda de excipientes naturales y de base biológica, impulsada por la creciente conciencia de los consumidores sobre la seguridad y la sostenibilidad ambiental. A medida que las compañías farmacéuticas buscan desarrollar formulaciones que se alineen con las preferencias de los consumidores conscientes de la salud, el cambio hacia los ingredientes naturales se está volviendo más pronunciado. Por ejemplo, los excipientes derivados de fuentes vegetales, como el almidón y la celulosa, están ganando popularidad debido a su compatibilidad con varias formulaciones de medicamentos y sus ventajas de seguridad percibidas sobre las alternativas sintéticas. Empresas como Roquette están liderando el cambio al ofrecer una gama de excipientes naturales que cumplen con los requisitos regulatorios y las expectativas de los consumidores. Esta tendencia se ve respaldada además por los organismos reguladores que abogan por el uso de materiales más seguros y respetuosos con el medio ambiente en los productos farmacéuticos. Como resultado, se espera que la adopción de excipientes naturales y de base biológica se acelere, ayudando a los fabricantes a mejorar los perfiles de seguridad de sus formulaciones de medicamentos y al mismo tiempo a atraer a un mercado más consciente del medio ambiente.

Alcance del informe y segmentación del mercado de excipientes farmacéuticos 

Definición del mercado de excipientes farmacéuticos

Los excipientes farmacéuticos comprenden todos los componentes de un fármaco, excepto los principios activos. Estas sustancias no tienen efectos medicinales por sí mismas, sino que se utilizan para mejorar la absorción fisiológica del fármaco. Al ser inertes, los excipientes farmacéuticos garantizan que el fármaco llegue al paciente en la forma adecuada. Si bien los excipientes tradicionales eran moléculas simples, los avances tecnológicos y la creciente necesidad de sistemas innovadores de administración de fármacos han aumentado la complejidad de los excipientes farmacéuticos.

Dinámica del mercado de excipientes farmacéuticos

Conductores

• Aumento de la producción y el uso de medicamentos genéricos

Según la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) y el Centro Nacional de Información Biotecnológica (NCBI), un medicamento genérico está diseñado para parecerse a un medicamento de marca aprobado en forma de dosificación, abarcando seguridad, potencia, vía de administración, calidad y rendimiento similares. Aunque los ahorros de costos asociados con el uso de medicamentos genéricos pueden no ser evidentes inmediatamente después de que expire la patente de un medicamento, la competencia en el mercado de genéricos generalmente conduce a reducciones significativas de precios. Por lo general, dos o tres años después de la pérdida de exclusividad, el precio de un medicamento genérico suele ser un 60-70% más bajo que el de su contraparte de marca. En la India, donde el gasto per cápita en atención médica es alto, la disponibilidad de medicamentos genéricos puede resultar en ahorros sustanciales que pueden redireccionarse para abordar otros problemas de salud. La adopción nacional de medicamentos genéricos ha experimentado un crecimiento significativo en los últimos años, y es probable que la disponibilidad de alternativas asequibles a los medicamentos de marca estimule aún más la industria farmacéutica. En consecuencia, se espera que la creciente demanda y producción de medicamentos genéricos impulse el crecimiento en el mercado mundial de excipientes farmacéuticos, ya que sus costos más bajos alientan un mayor uso.

• Demanda creciente de excipientes

Pharmaceutical excipients are substances included in pharmaceutical dosage forms that do not provide direct therapeutic effects but serve to aid in the manufacturing, protection, support, or enhancement of stability and availability. With the growing development of the global pharmaceutical sector, the role of excipients has become increasingly significant. Recently, the rising demand for generic drugs has further boosted the need for excipients. In addition, there has been a notable increase in chronic disease cases. Excipients are inert substances, distinct from active pharmaceutical ingredients, that are incorporated into the manufacturing process or dosage forms of pharmaceutical products. They are commonly used in drug formulations to add bulk to solid forms, ensure long-term stability, and facilitate drug absorption. Moreover, excipients enhance the overall safety and functionality of products during use or storage. As a result, the extensive application of excipients in drug formulation is expected to drive growth in the global pharmaceutical excipients market.

Opportunities

• Rising Technological Advancements in Drug Formulation

Technological advancements in drug formulation and excipient technology are transforming the pharmaceutical landscape by enabling the development of multifunctional excipients that enhance the efficacy and patient-friendliness of medications. For instance, excipients such as Polyplasdone Plus, a multifunctional superdisintegrant, improve tablet disintegration and enhance powder flow and lubrication, thereby streamlining the manufacturing process. These innovations facilitate the production of high-quality drugs and address specific patient needs, such as improving the bioavailability of active pharmaceutical ingredients. As pharmaceutical companies increasingly seek to create more effective and tailored drug formulations, the demand for advanced excipients is set to rise significantly. This trend presents a substantial market opportunity for excipient manufacturers to expand their product offerings and capture a larger share of the growing pharmaceutical market, ultimately driving improvements in therapeutic outcomes and patient satisfaction.

• Increasing Expansion of Biopharmaceuticals

The expansion of biopharmaceuticals is driving a growing demand for specialized excipients capable of stabilizing proteins and peptides, which are crucial for the efficacy of these complex drugs. For instance, excipients such as sucrose and trehalose are commonly used to protect biologics during freeze-drying processes, helping to maintain their structural integrity and activity. As the biopharmaceutical industry continues to advance, with an increasing number of therapeutic proteins and monoclonal antibodies entering the market, the need for excipients that can enhance the stability and bioavailability of these products becomes paramount. This presents a significant market opportunity for excipient suppliers to innovate and develop tailored solutions that meet the unique challenges posed by biopharmaceutical formulations. By investing in research and development to create excipients specifically designed for biopharmaceutical applications, suppliers can position themselves as essential partners in the evolving landscape of drug development, ultimately capturing a larger share of the expanding biopharmaceutical market.

Restraints/Challenges

• Increasing Regulatory Stringency

Generic drug approval regulations are largely uniform across the globe, with minimal variations in developing countries. This is primarily due to the fact that bioequivalence (BE) studies are not mandatory in these regions for obtaining generic drug approvals. Medical experts emphasize that governments must ensure the consistent quality of all generic medications to instill confidence among healthcare providers. Only then will doctors feel assured in prescribing generic drugs. A significant factor contributing to the skepticism among physicians and patients alike is the absence of stringent regulatory requirements concerning the number of generic drugs allowed and the permissible levels of impurities.

• Intellectual Property (IP) Issues

Intellectual property (IP) issues pose significant challenges in the global pharmaceutical excipients market, particularly as the patenting of novel excipient technologies can create barriers for smaller companies and new entrants. When larger firms secure patents for innovative excipients, they effectively restrict access to these crucial materials, limiting the ability of smaller companies to develop and market competitive products. For instance, if a major pharmaceutical company patents a multifunctional excipient that significantly enhances drug stability and bioavailability, smaller firms may find it difficult to innovate without infringing on those patents. This situation can lead to reduced competition in the market, stifling the development of new formulations that could address unmet medical needs. Moreover, the high costs associated with patent litigation can further deter smaller companies from entering the market or pursuing innovative excipient solutions.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Pharmaceutical Excipients Market Scope

The market is segmented on the basis of functionality, dosage form, route of administration, end user, and distribution channel. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Functionality

• Binders and Adhesives
• Disintegrants
• Coating Material
• Coloring Agents
• Solubilizers
• Flavors
• Sweetening Agents
• Diluents
• Lubricants
• Buffers
• Emulsifying Agents
• Preservatives
• Antioxidants
• Sorbents
• Solvents
• Emollients
• Glidants
• Chelating Agents
• Antifoaming Agents
• Others

Dosage Form

• Solid
• Semi-Solid
• Liquid

Route of Administration

• Oral Excipients
• Topical Excipients
• Parenteral Excipients
• Other Excipients

End User

• Pharmaceutical and Biopharmaceutical Companies
• Contract Formulators
• Research Organizations and Academics
• Others

Distribution Channel

• Direct Tender
• Retail Sales
• Others

Pharmaceutical Excipients Market Regional Analysis

The market is analysed and market size insights and trends are provided by country, functionality, dosage form, route of administration, end user, and distribution channel as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America leads the nootropics market, primarily driven by significant investments in research and development, which are anticipated to fuel further growth. Within this region, the United States holds a dominant position thanks to the presence of major industry players such as Evonik, Dow, and Croda International Plc. These companies' commitment to innovation and product development enhances the competitive landscape, positioning North America as a key hub for nootropic advancements.

China is leading the Asia-Pacific region in the pharmaceuticals market, driven by a significant increase in the production of generic drugs. This growth can be attributed to the country’s strong investments in research and development, which enhance the manufacturing capabilities and innovation in the pharmaceutical sector. In addition, the expanding healthcare infrastructure and rising consumer demand for affordable medications further support China's dominance in this rapidly evolving market.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.  

Pharmaceutical Excipients Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Pharmaceutical Excipients Market Leaders Operating in the Market Are:

• Kerry Group plc. (Ireland)
• DFE Pharma (Germany)
• Cargill, Incorporated (U.S.)
• Pfanstiehl (U.S.)
• Colorcon (U.S.)
• MEGGLE GmbH & Co. KG (Germany)
• Omya AG (Switzerland)
• Peter Greven GmbH & Co. KG (Germany)
• Ashland (U.S.)
• Evonik (Germany)
• Dow (U.S.)
• Croda International Plc (U.K.)
• Roquette Frères (France)
• The Lubrizol Corporation (U.S.)
• BASF SE (Germany)
• Avantor, Inc. (U.S.)
• BENEO (Germany)
• Chemie Trade (Germany)

Latest Developments in Pharmaceutical Excipients Market

• In October 2023, Clariant, a specialty chemicals company committed to sustainability, introduced its new range of high-performing pharmaceutical ingredient solutions aimed at advancing the development of safe and effective medications. In addition, Clariant Health Care expanded its selection of functional excipients designed to address challenges related to the delivery and bioavailability of active pharmaceutical ingredients (APIs)
• In September 2023, Roquette, a company specializing in plant-based ingredients and offering pharmaceutical and nutraceutical excipients, added three new excipient grades to its portfolio. These new grades are specifically tailored for moisture-sensitive active pharmaceutical and nutraceutical ingredients
• In June 2023, Ashland launched Polyplasdone Plus, a co-processed multifunctional direct compression superdisintegrant that incorporates a glidant and lubricant. Designed to streamline development and save time, this multifunctional disintegrant enhances powder flow and lubrication in pharmaceutical manufacturing. By reducing two manufacturing steps and simplifying equipment setup, this innovative product not only improves tablet hardness but also ensures the consistent production of high-quality products in both batch and continuous manufacturing processes
• In September 2022, DFE Pharma, a prominent provider of pharmaceutical and nutraceutical excipient solutions, launched its new “Closer to the Formulator” (C2F) Center of Excellence in Hyderabad, India. The C2F aims to assist pharmaceutical companies in reducing the time from concept to finished commercial product by leveraging its expertise throughout all stages of pharmaceutical development. This initiative has allowed the company to demonstrate its progress in the industry
• In February 2022, Kerry Group Plc, a global leader in taste and nutrition, announced two significant biotechnology acquisitions that enhanced its expertise, technology portfolio, and manufacturing capabilities. The company acquired c-LEcta, a top biotechnology innovation firm specializing in precision fermentation, optimized bio-processing, and bio-transformation, along with Enmex, a well-established enzyme manufacturer in Mexico that provides various bio-process solutions for the food, beverage, and animal nutrition sectors

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