The Top 10 Challenges That Affected Pharma in 2024

Imagine a tightrope walker high in the air without a safety net. Now imagine that this tightrope walker is on a bicycle, and on his head, he balances a bottle full of water. But that’s not all. This tightrope walker is competing against four others with the exact same challenges. The first to reach the other end of the rope without dropping anything along the way wins. That’s modern pharma. 

In many ways, other businesses would love to have what we have — a market that is eager for every incremental improvement we can make. But we’re also tasked with balancing risk with cost and speed with diligence. That’s never been easy. But in 2024, we had some additional challenges. In this blog, I’ll explore them, as well as offer a few tips that we’ve seen work.

1. Persistent Drug Pricing and Access Issues

There are a number of reasons that the U.S. is an attractive and important market: It’s the largest pharmaceutical market in the world, patients tend to pay higher prices for pharmaceuticals, and the stringent approval process is respected worldwide.  

But those conditions are not as ideal as they might seem. Here are a few stats I saw recently that I think encapsulate the problem:

• The median annual price for new drugs is now $300,000 — a 35% increase compared to the previous year
• Nearly 30% of Americans say they haven’t taken their medication as prescribed due to cost
• More than 1.1M Medicare patients alone may die over the next decade because they cannot afford to pay for their medications
• Drug shortages in recent years have added 20% to drug-related expenses in US hospitals

So if the “ideal” drug market on paper is far less than ideal in practice, what hope do low- and middle-income countries have? None of this will be a surprise to anyone in our industry, but when you add fragmented supply chains and special shipping and storage challenges to the mix, you get persistent patient compliance challenges. 

But persistent challenges don’t have to be permanent obstacles. And while treatments are often developed to target more profitable markets, that doesn’t mean that the rest of the world has to be left out. At Corealis, besides our obvious specialty in oral solid dosage (OSD) development, we also specialize in helping our clients understand where they can save time and money throughout the drug development process without increasing risk. We consider different regulatory environments and work to minimize any manufacturing, shipping, and storage challenges early. 

2. Skyrocketing Research and Development Costs

The rising prices of new treatments don’t come out of left field. Where you have increasing regulation you often see increased timelines and costs. 

But that’s not the only reason we see the rise in drug prices I shared earlier. The price of raw materials has also gone up significantly. And because failure rates remain so high, drug developers have fewer opportunities to recoup any losses. 

A CDMO won’t be able to influence the cost of raw materials, but a good one should know which suppliers will consistently provide high-quality ingredients reliably and for the best price. But from where we sit, it’s evident that most OSDs that fail did so because of critical design flaws that should have been caught very early on in the process. 

Many drug developers believe that postponing partnering with a CDMO is an effective strategy to reduce cost. However, we often find that, depending on the partner, the reverse is true. A CDMO can often save a client a great deal of time and money, but only when they’re brought in early enough in the process. 

3. Difficulty Attracting Investment 

Drugs are more expensive than ever before, in no small part because they’re more expensive to discover, develop, and manufacture than ever before. And to make matters worse, funding is often harder to find … or at least, harder to find than it was in 2020. 

Investors are understandably more cautious about investing in pharma right now, but that doesn’t mean the well is dry. At Corealis, we’ve found that investors typically know what they’re looking for. And when they see a good opportunity to make a profit without taking on too much risk, they’ll consider it, especially when it helps them balance their portfolio. We have the good fortune to be partially owned by an investment firm, and the relationship has brought us both a better understanding of how investors and drug developers can help each other.  

However, if you’re a newer player in the market, gone are the days when a biotech company could expect easy money — especially early on in the process — without having to demonstrate that they were managing risk responsibly.

4. Evolving Regulatory Compliance and Quality Control Standards

As our industry evolves, so do regulations. But by and large, I don’t have the complaints that an outsider might expect. Generally speaking and thanks in part to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulators in many different parts of the world are relatively in sync with one another. That’s a tremendous gift, and one that a good many industries do not receive. Also, if you present consistent, high-quality data that makes a regulator’s life easier, not only are they quicker to respond/approve, but also tend to have longer memories for those with a “good reputation.” 

In some cases, using innovative manufacturing processes or ingredients may require additional data, which can add costs and time. But we’ve found that if you present solid science, you get solid results. Also, many regulators have indicated that they are receptive to reducing the need for some preclinical tests when technology presents a suitable alternative. 

ICH Guidelines and Regulations in 2023-2024

The ICH has had a busy few years! Here are the guidelines that are either pending or have been implemented by Health Canada recently. 

Ensuring Compliance With cGMP Guidelines in Manufacturing

Much of the documentation in our development and manufacturing processes is becoming digitized, and while those innovations have made it quicker and easier to bring a wider variety of treatments to market, managing, maintaining, and protecting our data is more challenging. 

Any failure to maintain data integrity and accuracy can lead to regulatory action.

5. Digital Transformation and AI Integration

Any new technology that has the potential to help drug developers save time and money is attractive, but AI also presents a few challenges. 

If you’ve wondered why many CDMOs have appeared reluctant to fully embrace AI, here’s why:  

• Many drug developers need to prioritize updating specialized equipment over their IT infrastructure
• Any new digital technologies need to comply with strict regulatory requirements, including transparency, explainability, and validation, all of which are challenging when it comes to new digital tools
• There are ethical concerns around using AI in drug development, especially when it comes to clinical trial design and the use of patient data 

At Corealis, we’re cautiously optimistic about AI. In fact, we’re currently exploring new ways that AI-based technology can help us streamline prototyping and clinical trial material manufacturing. As is the case in most other industries, when this technology is in experienced hands and properly secured, it can be an incredible asset. But it’s not a substitute for solid science.

6. Manufacturing Challenges for Clinical Trial Materials and Commercial Drug Products

Being able to predict the demand for any new treatment is often difficult, which often leads to scarcity issues. But even though it’s been almost five years since the pandemic, it’s still having an impact on global supply chains. On top of that, ongoing geopolitical conflicts around the world continue to disrupt trade and limit access to raw materials. 

Understandably, there’s now an increased demand for more localized production, but adding those capabilities can also add cost.  

7. Higher Standards for Product Stability and Quality Assurance

OSD formulation is nothing new. A wealth of opportunities still remain for better, safer, and more competitive OSD treatments, but more advanced therapies often require a more complex formulation. 

Add to this the fact that regulators around the world are setting a higher bar for stability and quality, and you can understand why drug development costs keep rising. 

How Better Drug Stability Testing and Forced Degradation Studies Can Help 

At Corealis, we often find that biotech companies tend to rush through pre-formulation in a desire to save time and money. However, more upfront investment early on in the drug development process often pays off later, when large setbacks can be devastating.

A skilled CDMO will know when you can safely skip a few steps according to your specific project’s needs and your own risk tolerance. But generally speaking, carrying out forced degradation studies earlier in the process can generate advanced stability results, which can ultimately help you design a product that lasts longer in potentially harsher conditions while remaining effective — thus avoiding recalls, and meeting (or even exceeding) regulatory expectations.  

8. Worsening Patient Compliance in Clinical Trials

Patient compliance challenges aren’t new, but there are many reasons that we’re seeing more of them in 2024.  

Many recent trials have more complex protocols, which can be overwhelming and disruptive for patients. And some of these trials can last years, which makes it even more difficult to maintain consistent compliance. And if a patient starts to suspect they are being given a placebo, it can undermine their motivation to remain in the study. 

Trial fatigue is also a reality for some patient populations — particularly if they’ve experienced unpleasant side effects. And across the board, we’re also seeing new privacy concerns around the use of patient data. 

At Corealis, we try to preempt some of these challenges early in our formulation strategy, including minimizing any potential side effects and compliance complexities for patients. We also take great care to match our placebos to a client’s protocol, mimicking the look and feel — and also some of the side effects — a patient would expect to feel if they were taking the target drug. 

9. Pressure To Improve Environmental Sustainability

Drug development and production can be energy-intensive, often consuming a large amount of water, and producing a significant amount of waste. And because the process is also time-consuming and costly, it is very difficult to prioritize sustainability. 

That doesn’t mean it’s impossible. We’ve made respect for environmental resources one of our core values at Corealis because while sustainability improvements are challenging for our entire industry, there’s quite a bit that an individual scientist can do to minimize our impact on the environment. 

10. Talent Acquisition and Retention

It’s hard to imagine an industry right now that hasn’t been affected by evolving employee expectations, inflation, and the large number of seasoned leaders hitting retirement age at the same time. 

However, drug development has always required specialized skills, and those skills have evolved rapidly where science and technology intersect. These innovations hold great promise, but they’ve outpaced the supply of new talent to fill these roles.

Simplifying OSD Development and Clinical Trial Manufacturing

You find a lot of optimists in pharma, and that’s certainly true at Corealis. In many ways, the past few years have proved to be especially challenging for our industry, but necessity is the mother of invention. For every challenge, new technologies are also emerging that will, in time, make it easier to bring new treatments to more patients around the world. 

We’ve purposefully remained focused, choosing to specialize in OSD formulation development and clinical trial supply manufacturing. In doing so, we’re perfectly situated to help clients prevent many of the biggest challenges I’ve just outlined from negatively affecting drug development projects. 

We know how to keep projects on time and on budget, reduce risk while maintaining quality, help clients attract investment earlier, and anticipate and address issues that could compromise patient compliance or jeopardize regulatory approval. And our leadership team has been with us since we were founded in 2005. 

So, from where I sit, the challenges our industry faces are formidable but certainly not insurmountable. If you’d like to talk shop with any members of our team, you’re always welcome to request a meeting. We also make a point of attending a wide variety of industry events. Click the link below to see if our schedules align.