Sustained Release Excipients Market By Product Type (Polymers, Gelatin, Minerals, Sugars, and Others), By Route of Administration (Oral, Subcutaneous, Transdermal, Intravenous, and Others), By Technology (Microencapsulation, Targeted Delivery, Wurster Technique, and Others), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2024-2033

Report Overview

The Global Sustained Release Excipients Market size is expected to be worth around US$ 3.2 Billion by 2033, from US$ 1.4 Billion in 2023, growing at a CAGR of 8.5% during the forecast period from 2024 to 2033. North America dominated the market with a share exceeding 42.4%, achieving a market value of US$ 0.6 billion for the year.

The sustained release excipients market is expanding due to the increasing demand for controlled and targeted drug delivery systems. These excipients are essential for creating pharmaceutical products with extended or controlled release profiles. By enhancing stability, efficacy, and patient compliance, sustained release excipients play a pivotal role in improving treatment outcomes. Their integration in medications ensures a steady release of active ingredients over time, which is crucial for therapeutic effectiveness.

Personalized medicine’s growing prominence in healthcare is significantly boosting the use of sustained release excipients. These substances are vital for developing oral tablets, capsules, and injectables with precise release mechanisms. This approach not only improves therapeutic results but also minimizes potential side effects. As the industry shifts towards more personalized treatment plans, the reliance on advanced excipient technologies continues to rise.

In February 2022, Oakrum Pharma LLC, in partnership with ANI Pharmaceuticals, received FDA approval for a generic version of Cystadane (betaine anhydrous) oral solution powder. This product employs sustained release technology, illustrating the growing importance of these formulations in the development of generic drugs. Additionally, the approval grants Oakrum Pharma a 180-day exclusivity period under the Competitive Generic Therapy program, highlighting their market advantage.

The sustained release excipients market is witnessing a surge in research and development efforts. Current trends focus on creating new excipient formulations that enhance the release mechanisms and bioavailability of active pharmaceutical ingredients. These advancements are crucial for the next generation of drug delivery systems, driving innovation and effectiveness in medication development.

The integration of biologics and complex drug formulations is opening up new opportunities for the sustained release excipients market. Advancements in nanotechnology and the development of excipients that enable site-specific drug delivery are set to propel the market forward. As technologies evolve, the potential for innovative excipient solutions that meet the modern demands of medicine increases, promising significant growth in the sector.

Key Takeaways

• In 2023, the market for Sustained Release Excipients generated a revenue of US$ 1.4 billion, with a CAGR of 8.5%, and is expected to reach US$ 3.2 billion by the year 2033.
• The product type segment is divided into polymers, gelatin, minerals, sugars, and others, with polymers taking the lead in 2023 with a market share of 39.2%.
• Considering route of administration, the market is divided into oral, subcutaneous, transdermal, intravenous, and others. Among these, oral held a significant share of 48.9%.
• Furthermore, concerning the technology segment, the market is segregated into microencapsulation, targeted delivery, wurster technique, and others. The targeted delivery sector stands out as the dominant player, holding the largest revenue share of 37.4% in the Sustained Release Excipients market.
• North America led the market by securing a market share of 42.4% in 2023.

Product Type Analysis

The polymers segment led in 2023, claiming a market share of 39.2% owing to their widespread use in drug formulation, particularly for controlled and sustained release applications. Polymers are expected to remain a dominant excipient type because of their versatility in drug delivery systems. The increasing demand for oral drug formulations that provide consistent therapeutic effects over an extended period is likely to drive the adoption of polymer-based excipients.

The ability of polymers to modify drug release rates, enhance stability, and improve patient compliance makes them a preferred choice in the pharmaceutical industry. Additionally, advancements in polymer science, such as the development of biodegradable and biocompatible polymers, are anticipated to further expand the range of applications, including targeted therapies for chronic conditions. These factors are expected to contribute to the steady growth of the polymer segment in the market.

Route of Administration Analysis

The oral held a significant share of 48.9% due to its convenience, patient compliance, and cost-effectiveness. The growing trend toward once-daily formulations, which reduce the frequency of dosing while maintaining consistent drug levels in the bloodstream, is anticipated to drive demand for sustained release excipients in oral dosage forms.

The increasing prevalence of chronic diseases, such as diabetes, cardiovascular diseases, and cancer, is likely to contribute to the demand for oral formulations that provide long-term management of these conditions. As pharmaceutical companies focus on improving the bioavailability and efficacy of oral drugs, the oral segment is projected to grow steadily in the sustained release excipients market.

Technology Analysis

The targeted delivery segment had a tremendous growth rate, with a revenue share of 37.4% owing to the increasing demand for precision medicine and the need for more efficient drug delivery systems. Targeted delivery technologies, such as microencapsulation and specialized excipients, are expected to provide improved therapeutic outcomes by delivering drugs directly to the site of action, minimizing side effects, and enhancing bioavailability.

The growing focus on personalized medicine, where treatments are tailored to the specific needs of patients, is likely to drive the adoption of targeted delivery systems. Additionally, the increasing prevalence of diseases requiring specialized treatment, such as cancer and autoimmune disorders, is anticipated to fuel the demand for targeted drug delivery technologies. The continued advancement of techniques like the Wurster method, which enhances drug release control, is expected to further accelerate the growth of the targeted delivery segment in the market.

Key Market Segments

By Product Type

• Polymers
• Gelatin
• Minerals
• Sugars
• Others

By Route of Administration

• Oral
• Subcutaneous
• Transdermal
• Intravenous
• Others

By Technology

• Microencapsulation
• Targeted Delivery
• Wurster Technique
• Others

Drivers

Rise in Innovation Driving the Market

The rise in innovation is significantly driving the sustained release excipients market. New advancements in excipient technology are improving the functionality, stability, and performance of pharmaceutical products, thus expanding their applications. In June 2023, International Flavors & Fragrances, Inc. launched a new line of oral excipients in China to meet the growing demand for pharmaceutical ingredients in the region.

This includes products like METHOCEL, which are specifically designed to enhance drug stability and release control. The ongoing innovation in sustained release technologies is expected to improve drug delivery systems by offering more effective, predictable, and controlled drug release over time. As pharmaceutical companies seek more efficient methods of drug formulation, demand for high-performance excipients is likely to grow.

Furthermore, advancements in the development of novel excipients for oral and injectable dosage forms are anticipated to accelerate market growth. This trend reflects the broader push towards more personalized and effective therapeutic solutions in the pharmaceutical industry.

Restraints

High Cost of Production Restraining the Market

High production costs associated with sustained release excipients are likely to restrain the growth of the market. The development and manufacture of high-quality excipients require sophisticated processes, specialized equipment, and raw materials, all of which contribute to elevated production expenses. These costs are expected to impede market growth, particularly for smaller pharmaceutical companies that may not have the resources to invest in such technologies.

Additionally, the complexity involved in maintaining the quality and consistency of sustained release excipients throughout production further increases costs. As the demand for higher-quality and more specialized excipients rises, companies may face challenges in keeping prices competitive, which could limit adoption in price-sensitive regions. The financial burden of developing and scaling production of these excipients could slow the growth of the market.

Furthermore, stringent regulatory requirements for the approval of excipients add to the overall cost of production, creating additional barriers to market expansion.

Opportunities

Increasing Use of Natural Supplements Creating Opportunities for the Market

The increasing use of natural supplements presents significant opportunities for the sustained release excipients market. As more consumers turn to herbal and natural products for health management, pharmaceutical companies are incorporating sustained release technologies into these formulations to improve the efficacy and convenience of natural supplements.

In September 2022, Nutriventia introduced Prolanza, a sustained-release ashwagandha extract designed to provide prolonged support for stress management. This innovation showcases an emerging trend where natural, plant-based ingredients are combined with advanced drug delivery systems for enhanced therapeutic benefits.

The rising demand for natural supplements with extended effects is expected to drive the use of sustained release excipients in the development of these products. As consumer preferences shift towards more holistic and long-acting solutions, the market for sustained release excipients is anticipated to grow. This trend reflects a broader movement toward natural health products, where sustained release technologies can offer improved dosage control and longer-term benefits, making them more appealing to consumers. The use of such excipients in natural formulations is likely to expand the market significantly.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors have a considerable impact on the sustained release excipients market, influencing both production and demand. Economic downturns can reduce pharmaceutical investments, particularly in advanced drug delivery technologies, which may slow market growth. However, economic recoveries and increased healthcare spending generally drive demand for innovative drug delivery systems, particularly those that enhance patient compliance.

Geopolitical factors, such as trade policies and regulatory changes, can disrupt the supply of raw materials, leading to production delays and price volatility. On the positive side, the growing focus on patient-centered healthcare, coupled with an increasing emphasis on chronic disease management, supports the demand for sustained release formulations.

Additionally, regulatory incentives for advanced drug technologies and the rise of personalized medicine offer promising opportunities for growth. The market is likely to continue its upward trajectory as the pharmaceutical industry increasingly invests in novel drug delivery solutions.

Trends

Rising Collaborations and Partnerships Driving the Sustained Release Excipients Market

Rising collaborations and partnerships have become a prominent trend driving growth in the sustained release excipients market. Companies are increasingly teaming up to enhance product development, streamline manufacturing processes, and address challenges in drug formulation.

These partnerships enable firms to pool resources and expertise, accelerating innovation in drug delivery systems. For example, in March 2022, Hovione expanded its oral drug delivery portfolio through a collaboration with Zerion Pharma. This partnership focuses on advancing technologies to tackle challenges related to low drug solubility, improving the overall effectiveness of drug formulations.

Such collaborations are expected to foster the development of more efficient and effective excipient solutions, contributing to the expansion of the market. As the demand for improved drug delivery systems continues to grow, the sustained release excipients market is projected to benefit significantly from ongoing strategic partnerships.

Regional Analysis

North America is leading the Sustained Release Excipients Market

North America dominated the market with the highest revenue share of 42.4% owing to advancements in drug formulations and an increasing demand for controlled-release medications. The growing preference for once-daily medications, which enhance patient compliance and convenience, has particularly contributed to the market expansion. In March 2022, Athena Bioscience LLC launched Nexiclon XR, the first once-daily extended-release clonidine tablet for the treatment of hypertension.

This launch highlighted the need for sustained release excipients in developing products that provide a consistent therapeutic effect over time. Additionally, the increasing prevalence of chronic diseases such as hypertension, diabetes, and neurological disorders has led to greater demand for sustained release formulations, as they offer more reliable management of these conditions.

The rise in research and development activities focused on improving the bioavailability and stability of drugs has also fueled market growth. Moreover, the regulatory support and approval processes for these advanced formulations have further contributed to the growing demand for sustained release excipients in the North American pharmaceutical market.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to grow with the fastest CAGR owing to expanding healthcare access, rising chronic disease prevalence, and improvements in pharmaceutical manufacturing capabilities.

As healthcare infrastructure improves in countries like India and China, there is likely to be an increasing demand for medications with enhanced therapeutic profiles, including those using sustained release technologies. In July 2022, Dr. Reddy’s Laboratories Ltd. introduced its generic version of Fesoterodine Fumarate Extended-Release Tablets in the U.S. market, providing an affordable alternative to Toviaz. This product’s approval by the USFDA reflects the growing importance of extended-release formulations in managing conditions like overactive bladder, which are becoming more prevalent in the region.

The anticipated growth in the Asia Pacific market will also be supported by rising disposable incomes, greater awareness of advanced drug delivery systems, and the increasing availability of cost-effective generic formulations. As more local and international pharmaceutical companies invest in R&D to develop sustained release drugs, the market for sustained release excipients is projected to grow across the region.

Key Regions and Countries

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Russia
  • Netherland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • New Zealand
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of MEA

Key Players Analysis

The major players in the Sustained Release Excipients market are actively engaged in the development and introduction of innovative products, as well as implementing strategic initiatives aimed at enhancing their competitive positioning. Key players in the sustained release excipients market focus on strategies such as technological advancements, expanding product portfolios, and forming strategic partnerships to drive growth.

Companies invest heavily in research and development to enhance the functionality of excipients, improving their ability to control drug release rates and improve patient outcomes. Collaborations with pharmaceutical manufacturers and contract research organizations help to ensure the widespread adoption of these excipients in drug formulation.

Additionally, market players focus on expanding their geographical presence, particularly in emerging markets where demand for controlled-release formulations is increasing. Companies also emphasize sustainability by developing excipients with environmentally friendly characteristics. One of the key players in the market is Ashland Global Holdings, a global leader in specialty chemicals and materials. Ashland’s pharmaceutical division offers a wide range of excipients, including those designed for controlled and sustained release applications.

The company’s growth strategy centers on continuous product innovation, expanding its global reach through strategic acquisitions, and investing in R&D to create excipients that meet the evolving needs of the pharmaceutical industry. Ashland also focuses on providing customized solutions for drug manufacturers to enhance the performance of their drug delivery systems.

Top Key Players in the Sustained Release Excipients Market

• Pfizer
• Merck KGaA
• International Flavors & Fragrances, Inc.
• Gattefossé
• Evonik Industries
• Croda International Plc
• Biohaven Pharmaceutical Holding Company
• BASF
• Ashland Global

Recent Developments

• In June 2023: Croda International Plc. began construction on a new manufacturing facility in Pennsylvania, USA, to increase its production capacity. This expansion is expected to meet the rising demands of the industry, enabling the company to better serve its growing customer base.
• In February 2022: Biohaven Pharmaceutical Holding Company and Pfizer expressed optimism for the approval of rimegepant, a CGRP receptor antagonist, recommending the 75 mg dose for marketing authorization. This oral dissolving tablet aims to provide relief for individuals suffering from migraines.

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