Relatório global de análise do tamanho, quota e tendências do mercado de excipientes farmacêuticos – Visão geral do setor e previsão para 2031

Análise de mercado de excipientes farmacêuticos

O mercado dos excipientes farmacêuticos está a assistir a um crescimento substancial, impulsionado pela crescente procura de formulações avançadas de medicamentos e pelo crescente foco nos sistemas de distribuição de medicamentos. À medida que as empresas farmacêuticas se esforçam por melhorar a biodisponibilidade e a adesão dos doentes, os excipientes desempenham um papel crítico no desenvolvimento de formulações eficazes e estáveis. Os desenvolvimentos recentes neste mercado incluem a introdução de excipientes multifuncionais que servem funções tradicionais, como aglutinantes e enchimentos, e oferecem funcionalidades melhoradas, como solubilidade melhorada e perfis de libertação direcionados. As inovações em materiais biocompatíveis também estão a ganhar força, especialmente para formulações parenterais, para garantir a segurança e eficácia. Além disso, o aumento da medicina personalizada impulsionou o desenvolvimento de excipientes personalizados que atendem às necessidades específicas dos doentes, levando a um aumento da investigação e do investimento nesta área. As agências reguladoras estão também a evoluir as suas orientações, promovendo a utilização de excipientes com perfis de segurança comprovados. Além disso, as colaborações entre os fabricantes de excipientes e as empresas farmacêuticas estão a aumentar, promovendo a inovação e alargando o âmbito das aplicações. No geral, o mercado dos excipientes farmacêuticos está preparado para um crescimento contínuo, com os avanços contínuos a impulsionar a evolução das formulações de medicamentos e dos sistemas de administração.

Tamanho do mercado de excipientes farmacêuticos

O tamanho global do mercado de excipientes farmacêuticos foi avaliado em 8,31 mil milhões de dólares em 2023 e deverá atingir os 13,86 mil milhões de dólares até 2031, com um CAGR de 6,60% durante o período de previsão de 2024 a 2031. Além dos insights sobre os cenários de mercado, como o valor de mercado, a taxa de crescimento, a segmentação, a cobertura geográfica e os grandes players, os relatórios de mercado com curadoria da Data Bridge Market Research incluem também a análise especializada aprofundada, a epidemiologia dos doentes, a análise de pipeline, a análise de preços e a estrutura regulatória.

Tendências do mercado de excipientes farmacêuticos

“ Crescente procura de excipientes naturais e de base biológica”

The pharmaceutical excipients market is witnessing substantial growth, driven by the increasing demand for advanced drug formulations and the rising focus on drug delivery systems. One significant trend in the pharmaceutical excipients market is the growing demand for natural and bio-based excipients, driven by increasing consumer awareness of safety and environmental sustainability. As pharmaceutical companies seek to develop formulations that align with health-conscious consumer preferences, the shift towards natural ingredients is becoming more pronounced. For instance, excipients derived from plant sources, such as starch and cellulose, are gaining popularity due to their compatibility with various drug formulations and their perceived safety advantages over synthetic alternatives. Companies such as Roquette are leading the charge by offering a range of natural excipients that meet both regulatory requirements and consumer expectations. Such trend is further supported by regulatory bodies advocating for the use of safer, more environmentally friendly materials in pharmaceutical products. As a result, the adoption of natural and bio-based excipients is expected to accelerate, helping manufacturers enhance the safety profiles of their drug formulations while also appealing to a more environmentally conscious market.

Report Scope and Pharmaceutical Excipients Market Segmentation 

Pharmaceutical Excipients Market Definition

Pharmaceutical excipients encompass all components of a drug except for the active pharmaceutical ingredients. These substances do not have medicinal effects on their own; instead, they are used to improve the physiological absorption of the drug. Being inert, pharmaceutical excipients ensure that the drug is delivered to patients in the appropriate form. While traditional excipients were typically simple molecules, advancements in technology and the growing need for innovative drug delivery systems have led to increased complexity in pharmaceutical excipients.

Pharmaceutical Excipients Market Dynamics

Drivers

• Increasing Production and Use of Generic Drugs

According to the U.S. Food and Drug Administration (FDA) and the National Center for Biotechnology Information (NCBI), a generic drug is designed to resemble an approved brand-name drug in dosage form, encompassing similar safety, strength, route of administration, quality, and performance. Although the cost savings associated with generic drug use may not be immediately evident after a drug's patent expires, competition in the generic market typically leads to significant price reductions. Generally, two to three years following the loss of exclusivity, the price of a generic drug is often 60-70% lower than that of its brand-name counterpart. In India, where per capita spending on healthcare is high, the availability of generic drugs can result in substantial savings that can be redirected to address other health issues. The national adoption of generic medications has seen significant growth in recent years, and the availability of affordable alternatives to branded drugs is likely to further stimulate the pharmaceutical industry. Consequently, the increasing demand for and production of generic drugs are expected to drive growth in the global pharmaceutical excipients market, as their lower costs encourage higher usage.

• Rising Demand for Excipients

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 (Alemanha)
• Ashland (EUA)
• Evonik (Alemanha)
• Dow (EUA)
• Croda International Plc (Reino Unido)
• Roquette Frères (França)
• A Lubrizol Corporation (EUA)
• BASF SE (Alemanha)
• (EUA)
• BENEO (Alemanha)
• Comércio Chemie (Alemanha)

Últimos Desenvolvimentos no Mercado dos Excipientes Farmacêuticos

• Em outubro de 2023, a Clariant, uma empresa de especialidades químicas comprometida com a sustentabilidade, apresentou a sua nova linha de soluções de ingredientes farmacêuticos de alto desempenho destinadas a promover o desenvolvimento de medicamentos seguros e eficazes. Além disso, a Clariant Health Care alargou a sua seleção de excipientes funcionais desenvolvidos para enfrentar os desafios relacionados com a entrega e a biodisponibilidade de ingredientes farmacêuticos ativos (APIs).
• Em setembro de 2023, a Roquette, empresa especializada em ingredientes vegetais e que oferece excipientes farmacêuticos e nutracêuticos, adicionou três novos tipos de excipientes ao seu portefólio. Estas novas classes são especificamente adaptadas para ingredientes farmacêuticos e nutracêuticos ativos sensíveis à humidade
• Em junho de 2023, a Ashland lançou o Polyplasdone Plus, um superdesintegrante multifuncional de compressão direta coprocessado que incorpora um deslizante e um lubrificante. Concebido para agilizar o desenvolvimento e poupar tempo, este desintegrante multifuncional melhora o fluxo de pó e a lubrificação no fabrico farmacêutico. Ao reduzir duas etapas de fabrico e simplificar a configuração do equipamento, este produto inovador não só melhora a dureza dos comprimidos, como também garante a produção consistente de produtos de alta qualidade em processos de fabrico em lote e contínuos.
• Em setembro de 2022, a DFE Pharma, um importante fornecedor de soluções de excipientes farmacêuticos e nutracêuticos, lançou o seu novo Centro de Excelência “Closer to the Formulator” (C2F) em Hyderabad, Índia. O C2F visa ajudar as empresas farmacêuticas a reduzir o tempo desde o conceito até ao produto comercial acabado, aproveitando a sua experiência em todas as fases do desenvolvimento farmacêutico. Esta iniciativa permitiu à empresa demonstrar o seu progresso no sector
• Em fevereiro de 2022, o Kerry Group Plc, líder global em sabor e nutrição, anunciou duas aquisições significativas de biotecnologia que melhoraram a sua experiência, portfólio de tecnologia e capacidades de fabrico. A empresa adquiriu a c-LEcta, uma importante empresa de inovação em biotecnologia especializada em fermentação de precisão, bioprocessamento otimizado e biotransformação, juntamente com a Enmex, um fabricante de enzimas bem estabelecido no México que fornece diversas soluções de bioprocessos para alimentos, setores de bebidas e nutrição animal

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