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Analyzing Current Trends in Oral Solid Dosage Manufacturing with Top Contract Service Providers

According to a report by the Pharmaceutical Research and Manufacturers of America (PhRMA), oral solid dosage (OSD) products constitute 60% of the global pharmaceutical market. This establishes OSD as the largest category of pharmaceuticals manufactured and sold worldwide (Pharmaceutical Research and Manufacturers of America, 2020).

The PhRMA report further projects a compound annual growth rate (CAGR) of 5.5% for the OSD market between 2020 and 2025. This growth is attributed to several factors, including the increasing prevalence of chronic illnesses, the aging population, and the growing demand for personalized medicine (Pharmaceutical Research and Manufacturers of America, 2020).

Despite the growing popularity of biologics, OSD forms remain the preferred choice of healthcare professionals and patients due to their exceptional cost-effectiveness, ease of manufacturing, and patient-friendly dosing options.

The market for outsourcing small molecules is projected to reach $100 billion by 2028, with a CAGR of 7.5% from 2022 to 2028. This growth is driven by increasing demand for innovative drugs, rising costs of drug discovery and development, and the trend of outsourcing to Contract Research Organizations (CROs).

As a result of these factors, approvals for tablets and capsules are expected to outpace those for injectables in 2023 and beyond. This trend benefits both patients and pharmaceutical companies. Patients will have access to a wider range of OSD products, while pharmaceutical companies can streamline their operations and reduce costs by emphasizing OSD development and manufacturing.

Shrinking Batches and Heightened Potency

The OSD market is currently experiencing a notable transformation driven by various influential trends. It is the small and medium-sized sponsor companies that are at the forefront of bringing about disruptive changes. The demand for flexibility in terms of cost, access, and cycle times from drug sponsors, distributors, and patients is a key driver that has led to a focus on processing smaller batches. This trend is further compounded by the declining value of blockbuster drugs as their patent protections expire.

In addition to these trends, extensive research has identified several other factors shaping the OSD market:

  1. Advanced Drug Delivery Systems: The market is witnessing growing interest in advanced drug delivery systems, including controlled-release formulations, nanotechnology-based formulations, and oral films. These systems offer improved drug efficacy, enhanced patient compliance, and better therapeutic outcomes.
  2. Technological Advancements: Rapid progress in technology, such as process automation, artificial intelligence, and continuous manufacturing, is revolutionizing the OSD market. These technological advancements enable improved production efficiency, cost reduction, and real-time monitoring of manufacturing processes.
  3. Regulatory Landscape: The evolving regulatory landscape, with a strong emphasis on quality, safety, and efficacy, continues to shape the OSD market. Pharmaceutical companies are adapting their manufacturing processes and quality control systems to meet stringent regulatory requirements.
  4. Increased Outsourcing: There is a noticeable trend of outsourcing drug development and manufacturing activities to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). This enables pharmaceutical companies to leverage external expertise, reduce costs, and access specialized capabilities.

These trends collectively contribute to the ongoing transformation of the OSD market, fostering innovation, flexibility, and improved patient outcomes.

The OSD market is currently witnessing a significant trend characterized by the growing demand for high-potency active pharmaceutical ingredients (HPAPIs). According to industry projections, the HPAPIs market is expected to reach a valuation of $27 billion by 2023. This surge in demand for HPAPIs can be attributed to the increasing expectations of global consumers, particularly in the Asia Pacific region, where access to medicine has greatly improved.

A study conducted by MarketsandMarkets reveals that the HPAPIs market is projected to experience a compound annual growth rate (CAGR) of 9.1% between 2018 and 2023. The report emphasizes that the rising need for targeted therapies and advancements in oncology treatments are key drivers fueling the demand for HPAPIs. Additionally, the prevalence of chronic diseases worldwide has contributed to the growing demand for these specialized pharmaceutical ingredients. The Asia Pacific market, in particular, is expected to witness substantial growth in the HPAPIs market. Factors such as the expansion of healthcare infrastructure, increased pharmaceutical manufacturing capabilities, and a larger population with improved access to medical treatments are driving this growth.

Drug delivery technologies for modified-release dosage forms, bioavailability enhancement, and highly potent compounds are also contributing to the growth of the OSD market. The pharmaceutical industry is currently facing a pipeline full of poorly soluble and complex compounds, creating a significant demand for advanced bioavailability-enhancing technologies like spray drying and hot melt extrusion (HME). Specialized dosage forms like controlled release, pediatric, and geriatric delivery forms are also experiencing high demand, with the rise in oncology treatments, which typically involve more potent drugs, being a major contributor.

Manufacturers are actively tackling the challenge of poor solubility in pharmaceuticals by adopting HME (Hot Melt Extrusion) technology, which is gaining significant recognition and acceptance. A substantial proportion, up to 70%, of newly developed chemical entities (NCEs) face issues related to low solubility and/or limited bioavailability. In response, innovative products are being formulated to cater to specific indications and target smaller patient populations, particularly within the field of oncology. This shift in focus necessitates the development of manufacturing processes that can accommodate smaller scales.

The OSD (Oral Solid Dosage) market is undergoing rapid evolution and transformation. Our company is proud to be actively involved at the forefront of this revolution, playing a crucial role in shaping the future of the pharmaceutical industry.

We are dedicated to driving innovation and advancements that address the solubility challenge and cater to the evolving needs of patients and healthcare providers.

“There has been a noticeable rise in the need for tailored drug administration methods like controlled release, pediatric, and geriatric formulations. One of the reasons behind this trend is the growing use of high-potency oncology treatments—Renejix source”

Opportunities for Growth in Lean Manufacturing Pursuits for Pharma

The adoption of lean manufacturing practices can revolutionize the growth potential of the pharmaceutical industry. This industry has long been challenged by unpredictable supply chains, leading it to rely on large inventories and hefty profit margins for protection. However, the rising demand for cost-effective operations has made optimizing manufacturing processes a critical imperative. This optimization allows the industry to achieve high returns on investment for capital-intensive operations while maintaining reasonable costs of goods.

Regarding the trend towards smaller batch sizes in the industry, John Anderson, the COO of a prominent pharmaceutical company, emphasizes the importance of streamlined processes as the way forward. Anderson emphasizes that the evolving market necessitates efficient changeovers to meet the diverse requirements of customers and contract development and manufacturing organizations (CDMOs). Furthermore, he highlights the significance of vertical integration in developing capabilities that cover the entire spectrum from development to commercialization. According to Anderson, this integration is crucial in today’s highly competitive market, enabling companies to stay ahead and effectively address the changing dynamics of the industry.

Renejix’s expert acknowledges the significance of end-to-end solutions that cover drug discovery, commercial manufacturing, and packaging. This need remains a significant driving force in the pharmaceutical outsourcing landscape. Outsourcing partners, like Renejix, play a critical role in enhancing the success rate of pharmaceutical projects. They closely monitor a project’s milestones and understand the interplay between each phase of the product’s development and manufacturing journey. By prioritizing the patient’s needs throughout the process, these partnerships become mutually beneficial and long-lasting. Embracing lean manufacturing and end-to-end solutions will enable the pharmaceutical industry to unlock new growth opportunities and stay ahead of the curve, according to Rene’s expert.

Solving Solubility Challenges

To address the challenges posed by poorly soluble or badly bioavailable active pharmaceutical ingredients (APIs), it is crucial to stay at the forefront of cutting-edge technology solutions. Contract service providers (CSPs) play a vital role in this endeavor by continuously innovating to overcome these challenges.

According to a study conducted by Gupta, Aggarwal, and Gupta in 2019, the use of solutions such as fluid bed and spray drying is increasingly prevalent for newly discovered APIs that exhibit reduced solubility or poor bioavailability. Additionally, dry granulation processing is gaining popularity as an effective solution.

These technologies have the potential to enhance the solubility and bioavailability of APIs, leading to improved efficacy, safety, and patient compliance. CSPs assist drug developers in selecting the most appropriate technology for their specific requirements and optimizing the formulation process.

Collaborating with CSPs enables drug developers to expedite the development of new drugs and bring them to market more efficiently.

This not only improves patients’ lives but also has a significant impact on the global healthcare industry.

Mini-tablets provide unparalleled dosing flexibility, particularly in the treatment of pediatric and geriatric patients. Another notable technology that enhances the solubility and/or bioavailability of APIs belonging to the Biopharmaceutics Classification System (BCS) class II and IV is the utilization of amorphous solid dispersions (ASDs) through hot melt extrusion (HME). Additionally, extrusion can serve as a viable alternative to batch granulation processes, leading to improved efficiency and cost-effectiveness.

In a study conducted by Wang, Zhang, and Wang in 2021, ASDs prepared using HME demonstrated significantly enhanced solubility and bioavailability compared to their crystalline counterparts. The researchers also concluded that HME was a more efficient and cost-effective approach when compared to batch granulation.

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Vineeth

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