4 min read

3 Trends Shaping Drug Development and Manufacturing Strategies

4 min read

The globalization of pharmaceutical medicines has led to an increased demand for drugs and therapeutics of all kinds.

From vaccination programs that serve global populations to highly personalized treatments for rare diseases, ensuring the safe, effective and affordable manufacture of medicines has always remained the main goal for the pharmaceutical industry.

With treatments growing in complexity and demand continuing to rise, pharmaceutical companies must explore more innovative ways to meet this shared goal.

Here, we’ll explore the key trends shaping the development and manufacturing strategies across the pharmaceutical industry and discuss how strategic partnerships can help build a solid foundation for success.

Oral solid dose development continues to dominate

Oral solid dose (OSD) drug formulations have long been a key focus for the pharmaceutical industry, and the drive to accelerate their global development shows no signs of slowing.

Driving the increasingly global nature of pharmaceutical-based healthcare and commoditization of OSDs is the increased availability of generics and the rising consumption of over-the-counter (OTC) medications.

While large molecule biologics are also on the rise as a result of increased demand for treatments for rare and orphan diseases, the pharmaceutical market remains firmly dominated by small molecule API OSD drugs. Of the 50 novel drugs approved in 2021 by the FDA in the U.S. alone, 22 were either tablets or capsules.

Rising pharmaceutical demand in Asia

While North America is still the largest player in the global pharmaceutical market, Asia-Pacific has overtaken Western Europe as the second-largest region in recent years.

Rapid growth in this region can be attributed to the rise of low-priced generics, leading to greater affordability of drug products. In turn, this has meant that healthcare providers are able to dispense pharmaceutical products to patients with much greater efficiency.

Economies across this region are also seeing an increase in per-capita GDP, leading to more government-supported healthcare programs, rapid urbanization, and other socio-political factors impacting society. As a result, these are providing populations with greater access to more therapies and medicines.

Drug developers are keen to meet this demand, however, they must ensure their go-to-market strategies are informed by a clear understanding of the different regulatory and economic landscapes of the areas they are operating in - whether they be in Asia-Pacific, North American, or European markets.

The key to achieving this lies in ensuring that pharmaceutical companies have the insights, data, and local knowledge they need to guide their critical decisions.

The ever-expanding biopharmaceutical market

Advancements in biopharmaceutical science are having a significant impact on the industry, and are shaping a lot of strategic outsourcing decisions.

The biologics segment in particular is dominated by smaller companies and start-ups equipped with strong intellectual capital. These companies are focused on meeting their key development and clinical milestones while securing buy-in from investors.

There are also rapid advancements being made in the large molecule biopharmaceutical space, with commercial-scale manufacturing having to adapt to changing demands.

These demands include managing the challenging shift to small-batch manufacturing. As large molecule APIs are effective in small doses, they don’t require large batch sizes. However, depending on the drug in production, for example highly targeted cancer therapies, there are additional complexities to contend with - particularly when it comes to upstream and downstream processing.

This means that manufacturers must ensure they are equipped with the expertise and infrastructure to handle highly complex small batch sizes.

Building a solid foundation for success

These trends in the pharmaceutical industry are seeing pharmaceutical companies innovate beyond what has previously been possible through the development of complex drug products and expansion into larger regions.

The complexities and nuances that accompany these trends mean that innovators must strengthen their business models to manage higher costs of development and lengthened timelines.

To overcome these challenges, companies are turning to strategic CDMO partnerships to harness the additional resources and capabilities they provide.

By partnering with the right CDMO, pharmaceutical companies can deliver the depth of services that are in demand in a more economical and efficient way. These partnerships offer local knowledge and industry expertise and regulatory support across the regions they operate in, as well as extra capacity, scale, formulation processing capabilities, and wider availability.

Download our latest whitepaper to learn more about the key drivers of pharmaceutical change and the reasons to choose the right CDMO to put your drug product on a solid foundation for success.