Oral solid dosage (OSD) products have been around since the mid 1800s and still remain the largest category of pharmaceuticals manufactured today—and the most common dose form physicians prescribe for a variety of indications.

Reasons oral solids remain dominant include their cost-effectiveness, manufacturing efficiencies, the stability of the drug product compared to biologics (which require ultra-cold storage conditions) and their patient-friendly nature.

In fact, according to a recent market analysis report by Grand View Research, the global oral solid dosage contract manufacturing market size was estimated at $36.50 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 5.97% from 2024 to 2030, driven by increasing advancements in drug delivery technology, including targeted drug delivery and sustained release dosage forms, investments by contract development manufacturing organizations to expand oral solid dosage development, and demand for novel therapies.

Oral solids are not likely to be replaced anytime soon, as new advancements in integrating 3D printing in OSD manufacturing, as well as controlled-release technologies, create new growth opportunities in the market.

The following offers perspectives from CDMOs and CROs on today’s oral solid dosage trends across drug development, manufacturing and more.

State of the Market

While there has been a greater focus on biologics and injectable drug products in recent years, oral solid dosage forms remain dominant in the market, according to David O’Connell, director of scientific affairs at PCI Pharma Services.

Anil Andrade, vice president global sales at ACG World, concurs. He calls the market for outsourcing “relatively mature” and reports seeing “even greater demand for OSD development and manufacturing.”

“Innovation in drug discovery and development is not just with big multinational pharma companies,” Andrade observes. “Smaller, agile, diverse start-ups are mushrooming around the globe, targeting niche patient populations and diseases, who are looking at CDMOs with the technology available to develop drugs.”

Srinivasan Shanmugam, executive director of pharmaceutical sciences, business support, and new technologies, Adare Pharma Solutions, says the market for outsourcing OSD development and manufacturing has been experiencing “significant growth” driven by the following factors: cost reduction, access to expertise, accelerated timelines, globalization, risk mitigation, and flexibility and scalability.

Pharmaceutical companies are looking for cost-effective partnerships and specialized expertise in manufacturing processes and platform technologies for differentiated products and customer-centric dosing solutions, Shanmugam explains. Similarly, the drive for faster time to market leads to outsourcing to get access to expertise, resources, and the infrastructure of CDMOs.

Furthermore, a growing emphasis on global reach and access to new markets leads to using CDMOs that can utilize local languages, have access to knowledge, and specific expertise in emerging markets. Partnering with CDMOs also helps reduce risk in terms of regulatory and quality compliance, minimize supply chain disruptions, and strengthen IP protection.

Lastly, the flexible, scalable resources, and capacity CDMOS offer can lead to cost-effectiveness to help meet changing business needs.

On the other hand, Richard Sidwell, chief scientific officer, Societal CDMO, offers a different perspective. He describes the current state of the market for outsourcing oral solid dose development and manufacturing as “steady, but slower.”

“In 2023, we saw the funding environment for small and early-stage pharmaceutical companies decline from its highs between 2020 and 2022,” he says. “Funding seems to have reverted to trend, around 2019 levels. This has left many small companies struggling or at least being more cautious with their available funds. At the same time, inflation has put pressure on development budgets. This has led to companies advancing fewer projects and making careful decisions about what projects to advance and how.”

Market Trends

Two major trends in the OSD marketplace as identified by PCI’s O’Connell are desire for sponsors to find a CDMO that can develop a drug product and then scale their manufacturing processes in-house, along with a growing interest in specialized dosage forms.

He says that sponsors are beginning to see the benefits of sticking with one CDMO that can scale their processes, because it removes the need to transfer the product to a larger CMDO for phase III/commercial supply, thereby saving time and money, and reducing supply chain complexity and risk.

“There’s also a growing interest in the development and manufacturing of specialized dosage forms, such as controlled-release, extended-release, and targeted delivery systems, to enhance patient adherence and improve drug efficacy,” O’Connell adds. “The demand for highly potent molecules is greater than ever, as their ability to target diseases while reducing side effects improves therapeutic outcomes and make the drug products more patient-friendly.”

ACG’s Andrade pinpoints drugs for smaller patient populations as a key trend. “This means smaller product volumes for development of niche drugs, which are expensive to manufacture and ship,” he says. “Contract manufactures need to have a wide array of available technologies and capabilities to make these new drugs. This requires having a readily available and highly skilled workforce, which, in turn, necessitates significant investment.”

Brad Gold, head, global formulations at Piramal Pharma Solutions, also noted smaller batch sizes as a significant trend. “Over the past five years, we’ve seen an increase in the targeted therapeutic areas and orphan indications, leading to overall smaller annual product volume and consequently, smaller batch sizes,” he says. “The ability for a CDMO partner to adapt to this trend is key. The integrated service offerings under one CDMO provider, or better, under one FDA site registration, has proven to be pivotal in overall drug development.”

Gold adds, “Moving toward a provider that can offer API or ADC development and manufacture combined with the flexibility of either oral solid dosage forms or sterile fill/finish development and manufacturing, will be a key driver to shortening overall timelines toward product approval.”

Adare’s Shanmugam makes a similar observation. “As drug development becomes more targeted and specific, companies are looking for partners with a deep understanding of their particular therapeutic area or formulation challenges,” he says. “Specialized CDMOs could provide tailored solutions and insights, contributing to more efficient development processes.”

From a healthcare authority perspective, Societal’s Sidwell identifies drug safety as an area of focus. “Guidances and actions on impurities or contamination, such as nitrosamines and ethyl glycol, are getting significant attention.”

Andrade agrees that regulatory framework remains paramount and continues to “form a backdrop on how manufacturers can mitigate risk while maintaining product quality, which can have an impact on the drug development process and cost.”

Ensuring consistent product quality is essential for CDMOs. “Maintaining rigorous quality assurance and control processes throughout the manufacturing lifecycle is critical on a global level, and any lapses in these areas can have serious consequences, including regulatory actions,” says Shanmugam.

Overcoming Supply Chain Uncertainty

The challenge of supply chain uncertainty is a common thread among many of the industry experts that shared their insights for this article.

“The pharmaceutical industry, like many others, faces risks related to supply chain disruptions,” comments Adare’s Shanmugam. “Issues such as shortages of raw materials, transportation challenges, and geopolitical factors can impact the reliable and timely supply of materials, affecting manufacturing schedules.”

Sidwell says, “The major challenge in the market for outsourcing oral solid dose development right now is finding ways to optimize between constraints on funding, elevated safety/regulatory expectations, and uncertain supply.”

O’Connell also cites supply chain uncertainty as a major obstacle for the market. He explains that managing lead times have suffered as a result of supply chain complexities—particularly since the COVID-19 pandemic. “The increased demand for outsourcing activities, and the increased demand for potent and non-potent OSD products, naturally puts additional strain on the already complex supply chain,” he remarks. “If any additional disruptions occur—like the COVID-19 pandemic, for example—it adds another layer of pressure on the sourcing of raw materials, managing lead times, and ensuring timely delivery of drug products to the clinic or market.”

The solution to supply chain issues? O’Connell says, “Such challenges are mitigated when the CDMO and their client maintains open channels of communication, and a proactive planning approach is vital to ensure timelines are met.”

Piramal’s Gold adds, “While raw material supplies and reliability have improved somewhat over the post-Covid years, the adeptness of a CDMO to leverage its multiple sites’ purchasing advantage to overcome these supply issues remains critical to meeting clients’ clinical development needs.”

Other Challenges

Matching the specific needs of pharmaceutical companies with the capabilities of CDMOs can be challenging. “The demand for advanced manufacturing technologies for specialized dosage forms and the need for scalability can outstrip the available capacity or technological capabilities of some CDMOs,” O’Connell says. “This means that pharma companies need to perform robust due diligence on their proposed CDMO partner to ensure they can adequately support them throughout the product lifecycle.

“This leads into the cost implications of outsourcing development and manufacturing projects. The CDMO industry is highly competitive, and clients often make decisions in terms of the overall cost of the project. But it’s true to say that you often get what you pay for, and saving costs in the short-term may lead to increased costs at a later date, should the need to transfer to another CDMO arise, or if anything goes wrong with the development and manufacturing program,” O’Connell warns.

Another potential obstacle for the market is a proposed ban on the use of titanium dioxide (TiO₂) in Europe.

The potential ban was prompted by a scientific opinion from the European Food Safety Authority (EFSA) in May 2021 that concluded that TiO₂ (also known as E 171) is not considered safe when used as a food additive. Shortly after, in January 2022, the European Commission published a regulation removing the authorization for TiO₂ as a food additive and opening up the possibility of extending the ban to pharmaceuticals.

Andrade states, “It is well-documented that many pharma groups are fighting this ban—citing that it will create drastic drug shortages and affect a multitude of authorized pharmaceuticals.”

The European Commission is expected to make a final decision on the ban in February 2025.

Looking Forward: AI and More

What does the future hold for the market for outsourcing oral solid dose development and manufacturing? “As with most industries in 2024, all eyes are on AI,” says Sidwell. “There is an enormous race going on as fundamental advances in AI progress, and countless people look for the next breakthrough application.”

He explains, “Offerings are as diverse as real-time image analysis, data analysis, generative design, research/document summarization, and text generation for purposes ranging from internal communications (think email), to report writing and even marketing copy. It remains to be seen which applications will find a place in real practice, and it’s safe to say many applications will find fleeting success before being overtaken by something new.”

There is a convergence between the drug discovery process, digitization and AI, with companies using AI and data to introduce and deliver new drugs. Andrade observes, “There is already a great deal of investment going into this space. Companies are developing platforms, which integrate big data, automation and engineering across the sciences to aid and reduce costs in the drug discovery and development process.”

Beyond the rise of AI, Piramal’s Gold identifies two other mounting trends. “Repurposing of either existing drugs or previously shelved assets continues to be a growing trend of drug development,” he says. “Fixed dose combinations in a variety of therapeutic areas (e.g. oncology, pain) that hit multiple targets are also gaining momentum.”

Gold explains, “Very few CDMOs can offer the various dosage forms capable of delivering these drugs to multiple population groups. The continued momentum of the minitablet dosage form and the adaptability of CDMOs to offer production and packaging of these dosage units is important to clients needing a pediatric option for their drug products.”

Finally, there is an increased focus on improving the safety and efficacy of tablets and capsules containing highly potent APIs as a possible new direction for the industry. For example, PCI’s O’Connell points to muti-layer coating and controlled release formulations that are being developed to ensure precise dosing and targeted delivery, which minimize drug product exposure to non-target tissues.

“This approach enhances the therapeutic effect while reducing side effects, which is particularly important for oncology drug products containing HPAPIs,” O’Connell concludes.