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Challenges and Opportunities Facing Biopharma Companies

Biopharma Opportunities Today and Beyond

Biopharmaceuticals are projected to reach over $526 million by 2025. It is the most sophisticated and refined achievement of modern science.

While this field is promising, the biopharma industry presents challenges that need to be addressed. There are numerous reasons why the industry’s rapid growth and increasing importance are creating new challenges and opportunities. To keep up with the current business landscape, biopharma companies must evaluate and fundamentally reassess many of their current strategies, technologies, and operational approaches.

Stay ahead of the trends, read this guide to better understand the various biopharma opportunities and problems companies could face in biopharmaceuticals today.

Challenges Facing Biopharma Companies

There are many issues that biopharma companies face more often in the modern world. They include:

  • Regulatory risks
  • Complex supply chains
  • Evolving regulatory standards (i.e., GDPR and 21 CFR Part 11)
  • Tracking inventory
  • Lack of coordination

The following elaborates on these in more detail so that you can judge how they might affect you.

Regulatory Risks

Over the past thirty years, we have seen an overhaul in how we develop and produce pharmaceuticals. Even the marketing, shipping, and distribution methods of these products have seen upheaval. This is in part due to increased globalization in who or where companies target their efforts.

As companies attempt to focus on a global market, they are seeing many more issues with regulations. This is due to the need to submit applications for pharmaceutical approval to several countries.

These different areas will all have very different requirements for scrutiny of one another. Thus, a separate block of work will need to occur for each one. Various locations may also have very different ideas of what they need when it comes to clinical trials or test studies.

Such different requirements mean that the amount of work done increases severalfold. This then pushes up the cost of introducing something new to a market. On top of that, it can drive the time to market up, preventing consumers from receiving their needed medication at the time that they need it.

Developing countries will also see this multiply. Many of these regions cannot even process the regulatory steps needed to bring all drugs into the market. This leads to a long backlog that can take months or even years to get through.

Evolving Regulatory Standards

As regulations change based on the whims of regulatory bodies, every new company must adopt brand-new processes. Compliance demands new training, overhauled manufacturing lines, and new equipment. All this costs the manufacturer time and money, and often employees, as workers do not always react well to changing demands.

In the past five years, this has increased dramatically, with a boost in the digitalization of all processes. Despite a lot of this coming from a significant global event, you should expect this to continue well into the future too.

  • GDPR-Since its introduction in 2018, many different companies have found themselves fined for breaches of its rules.  Pharmaceutical companies can do plenty to protect themselves from such fines. They often start by protecting or anonymizing their data. Still, this is a lot of busy work that takes time and money away from more important processes. On top of this, the existence of GDPR means that a lot of pharmaceutical service users now have a much higher level of understanding of their rights. When they assert those rights, sometimes out of ignorance or malice, this puts more stress on companies. Finally, GDPR puts more pressure on companies to discover and assess data breaches. The risks mean that they must spend much more on IT security and protection.
  • 21 CFR Part 11: This FDA guideline informs companies on how they should use and record electronic records or digital signatures. To be able to comply with 21 CFR Part 11, a biopharma company must perform several checks to ensure that these are secured, including:
  1. Data encryption
  2. Tracking record validity
  3. Ensuring user credentials
  4. Auditing
  5. Password expiration policies

This list is not exhaustive, but in general, it means that all companies have many more steps that they need to take in security. This is even relevant in organizations that have not had security concerns in the past and are not likely to in the future.

Complex Supply Chain and Operations

Companies these days need to go through more steps to get a product to market in a global enterprise of biopharma supply and demand. Thus, over time, supply chains have started to become complex. This leads to problems when attempting to get anything, but the simplest processes are completed.

As these supply chains become more convoluted, they start to develop weak points. In these places, risks increase severalfold, and issues can cause problems that would not harm a more robust process. If these are not resolved, then the companies are putting themselves in danger of huge losses when things go wrong.

Keeping Track of Inventory

As companies grow, they start to gain larger inventories of more products for worldwide distribution. Although this is often a “good problem”, as it means the growth of the business, it comes with its own problems. While electronic tracking helps ensure that many of these products are not lost, it can start to be harder to ensure that they are all accounted for.

The ways that this is often resolved come down to buying, developing, or hiring new electronic methods of tracking. These include:

  • QR-coded containers
  • Cloud-based tracking software
  • Inventory management systems in warehouses
  • Inventory management systems are used by the transportation method.

Each of these costs the companies involved time in the installation and training of these methods. 

Lack of Coordination Between Other Departments and Stakeholders

Before unification, separate parts of a company might use different methods for tracking their processes. Some might use paper tracking while others use computer software. On top of this, even the software that they use might be different between offices due to a wish for independence.

These disparate methods can create major problems in nonconformance with regulations.

Instead, biopharma companies must now attempt to use the same systems. This ensures that data is tracked and protected between each region. It also makes sure that the office conforms to the appropriate regulations.

Delayed Product Launches

The past few years have seen a lot of change in how R&D occurs in many industries. This has had the knock-on effect of slowing down the speed at which things go to market. This prevents the timely delivery of products.

To mitigate this, one must have a robust process going from conception through R&D, compliance checks, and manufacturing. With all the listed issues in this article, these steps could slow down further. Therefore, an organization must ensure that its compliance process is as fast as possible.

Compliance builders can help you run through these regulatory checks with greater speed. You can then stop worrying about this part of the process and focus on other troubled areas instead.

Biopharma Opportunities

Moving forward, we can expect to see the emergence of diseases that we did not know about before. On top of that, we should expect that existing strains will gain resistance to vaccines or other medications. These will need new, stronger, or unique pharmaceuticals to help combat them. We will want to ensure that these medicines and other tools are available quickly. Thus, it will be important to make sure that we can evaluate their compliance with market regulations as fast as possible. On top of this, compliance monitoring software is advancing at an unprecedented level. New thinking in terms of UX (user experience) and compliance processes means that new software is easier and faster to use. It can also keep up with the needs of an ever-fluctuating market. If you undergo regulatory inspections, real-time compliance monitoring software can help you prepare your records. These assessments will then conclude that your records are both reliable and trustworthy. On top of that, with compliance monitoring software, you can protect your data assets. You will create a strong audit trail that allows you to ensure the robustness of your security and the safety of your data. Thus, you can know that you can mitigate risks when it comes to regulations.

How Compliance Builders Help

Biotech companies need compliance monitoring software. It ensures that your data is reliable and accurate, allowing you to have the assurance that you are compliant with all regulations. This innovative software like Xybion’s Compliance Builder, will allow you to track nonconformance and regulatory risks, which will give you an effective way to prevent the escalation of further problems. Such software helps you stay primed for any complex regulatory obligations that governments throw at you. At the same time, you can ensure that your data is not compromised.

If you want to know more about how Compliance Builder, a real-time compliance monitoring software specifically designed to help companies pass audits and 21 CFR Part 11 compliance, works, book a demo today. And discover how it ensures data integrity and mitigates compliance risks for instruments, equipment, and digital processes.


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