Beneath the chaos of the COVID-19 pandemic, some broader biopharma trends have remained constant. Global demand for low-cost, effective therapeutics continues to grow. To stay competitive and fulfill this need, biopharma companies need to optimize their manufacturing workflows. This means arming themselves with the right tools, strategies and skillsets to create the most efficient protocols possible.
Through our experience working hand-in-hand with biopharma companies, we have noticed trends that we anticipate will continue throughout the year, shaping the biopharma industry in 2021.
Increased investment in biosimilars
Biosimilars, essentially the generic version of biological therapeutics, could broaden access to many popular but expensive drugs. It’s a recent opportunity: The first biosimilar, filgrastim-sndz, was approved in the U.S. in 2015. But as more biologic patents expire, demand and competition for biosimilar development will continue to grow. A report from McKinsey & Company forecasts that the global biosimilar market could more than double to $15 billion by the early 2020s. Biosimilars are especially popular for emerging regions because they are cheaper than the original product. As such, McKinsey predicts $5-8 billion of the 2025 estimate will come from these emerging markets.
But while biosimilar developers are aiming to make a product as affordably as possible, the companies that own the original drugs are also streamlining their manufacturing processes, driving down the cost of the brand-name therapy. This places added pressure on biosimilar developers to create a significantly cheaper alternative. And all the while, they are competing against a whole field of other companies that are also targeting the same 10-15 biologics.
Biosimilar manufacturers spend a significant amount of time proving that their product is equivalent to the original therapy. To offset this investment and to deliver the greatest cost benefit, manufacturers must be extremely efficient. Ideally, manufacturers have facilities that can produce more than one biosimilar. The facilities must also be flexible, so the manufacturer can adapt to the market needs at that time. If the ongoing COVID-19 pandemic has taught us anything, it is that the market can shift needs significantly at a moment’s notice. In 2021, we anticipate biosimilar developers and manufacturers will focus on streamlining processes in order to develop these products in the most cost-efficient way possible.
Implementing process intensification for increased sustainability
Streamlining processes by increasing efficiency with less time, input materials, steps or facilities is referred to as process intensification. While this concept is not new, biopharma manufacturers are increasingly embracing this approach due to heightened demand for fast production and cheap drugs.
One way to achieve process intensification is by implementing single-use products because this can lead to more flexible manufacturing that requires a smaller facility footprint. An added benefit of single-use products is that they are often more sustainable than their stainless steel counterparts.
While it may seem counterintuitive that single-use products would be more sustainable because they are disposable, there are a significant number of benefits that contribute to this. For one, single-use products decrease the need for strict cleaning protocols. This means less energy and water is wasted. On the other hand, the traditional stainless steel products require cleaning with harsh chemicals, which negatively impacts the environment. In addition, single-use technologies allow manufacturers to operate with a smaller carbon footprint and respond to changing demand, creating less overall waste in the long run.
Emerging manufacturing platforms
To stay competitive in 2021, manufacturers may need to produce a wider range of pharmaceutical products than has been expected from them in the past. In addition to the traditional modalities, there is an expectation for more novel modalities, such as viral vectors, nucleic acids, fusion proteins and complex drug conjugates. This gets complicated because many of these require new manufacturing platforms. To keep costs down, it is important that biopharma manufacturers can easily transition between indications.
We have seen this need for flexibility heightened during the past year as developers rushed to produce a vaccine against SARS-CoV-2. For example, some of the leading vaccines in development are mRNA-based, such as the Moderna and Pfizer/BioNTech vaccines. This is a newer platform that, prior to the pandemic, had not been used in licensed vaccines. However, when facilities are equipped to produce an mRNA vaccine, they will more easily be able to pivot to producing a vaccine against a new indication. This is because the same process can be used to develop vaccines for different indications.
This flexibility has proven especially useful during this pandemic when manufacturers had to rapidly scale to produce millions and millions of doses. The platform relies on enzymatic synthesis rather than cell cultures, which makes the manufacturing process much simpler and faster. As such, it will be an important tool for manufacturers to have, so they are prepared for a future pandemic or outbreak when vaccines must be developed quickly. Further, mRNA vaccines are easier to produce than traditional vaccines, so they are easier for local facilities to manufacture. Regional production helps ease distribution — another important factor when time is of the essence.
As we head into 2021, we anticipate manufacturers investing in mRNA and other flexible platforms that allow them to produce the most impactful pharmaceuticals with the greatest speed and efficiency.
Cell and gene therapies
Over the past years, we have seen cell and gene therapies emerge as a promising therapeutic area. For example, Luxturna from Spark Therapeutics was approved for retinal dystrophy just a few years ago. Early successes have been largely focused on rare diseases. As we learn more and the area matures, we can expect cell and gene therapies to emerge in other fields, such as oncology and other chronic diseases.
While just 10 cell and gene therapies have thus far gained approval from the U.S. Food and Drug Administration, more than a thousand are in the pipeline. We expect cell and gene therapy to continue this surge of popularity. In fact, the FDA has predicted that by 2025 there will be an additional 10-20 approved each year. Further, the gene therapy market is anticipated to have a 30 percent compound annual growth rate between 2020 and 2030.
Cell and gene therapies are a promising area, but they are still not mature. While there is great demand for these therapeutics, the manufacturing capacity is limited. For this reason, we have seen a lot of CDMOs that specialize in viral vectors emerging. We can anticipate this trend will continue into 2021. We have also seen regulatory agencies establish more approval pathways and guidance in recent years to help standardize the industry.
A shift toward Bioprocessing 4.0
There are many tools and steps that make up a bioprocessing workflow. But all of these leave room for lost time and human error. With the need to produce therapeutics quickly and cost effectively, workflows need to be as efficient as possible.
With this efficiency in mind, many in the biopharma industry are moving toward Bioprocessing 4.0, where the tools in a workflow are all connected digitally. This means manufacturers can automate and connect each step, which significantly reduces inefficiencies. With its integrated feedback loops and machine learning capabilities, Bioprocessing 4.0 solutions further improve on an already automated workflow.
Two areas that can significantly benefit from Bioprocessing 4.0 are equipment cleaning and data validation. For examples, manufacturers can implement fully automated, upstream single-use bioreactors into the workflow. These single-use products significantly cut down on time and cost associated with cleaning. Newer bioreactors have in-line sensors that can provide real-time information. Together, this information can be used for data validation by providing insight into the Critical Quality Attributes (CQAs) and allowing for the process to be adjusted while it is still ongoing. Facilities can also recreate their workflow digitally in order to help improve process controls or run simulations, if needed. Ultimately, this decreases the need for the team to conduct off-line data testing. By improving just these two areas, manufacturing timelines can be cut down by weeks.
Biopharma in 2021
The COVID-19 pandemic underscored what we already knew to be true in the biopharma industry: We need to make therapeutics faster and more affordably. Now that we have seen that need truly highlighted over the past year, 2021 will be an inflection point for the industry. In our highly regulated, capital-intensive industry, companies may be reluctant to dive headfirst into new technologies. But the need for progress has never been greater and these new approaches are fast becoming the norm as the field moves forward.
- Expanding biosimilar market
- Push for more streamlined production
- Adoption of new manufacturing platforms
- Continued interest in cell and gene therapy
- Increased automation in equipment cleaning and data validation