Over the last several decades, the global pharmaceutical industry has experienced a significant shift in focus. Once dominated by the one-size-fits-all treatment options of small molecules, the market has been revolutionized by the personalized approach of biologics. As a result, the research paradigm is now focused on treatments that target smaller, more homogenous patient groups rather than the pharmaceutical products of the past known to treat a multitude of diseases and illnesses.
According to Yahoo Finance, biologics represent the fastest growing product segment within the global pharmaceutical industry. After supporting more than 6,000 API deliveries over the last three years, we can certainly confirm that they are on the rise.
Biologics Offer Advantages Over Small Molecule Drugs
Biopharmaceuticals offer many distinct advantages over small molecules, making them a popular option among patients, care teams, and drug makers alike. With small molecule treatments, there are often side effects and concerns surrounding toxicity and efficacy. Biologics can offer more targeted therapies, which means patients typically experience reduced side effects, and doctors don’t have the same safety concerns.
Another reason for the rise in popularity of biologics is their ability to reach elusive targets previously deemed “undruggable” with small molecule treatment options. Biopharmaceuticals have the potential to treat a broader range of conditions and serve small patient populations like those with rare or orphan diseases. As a result, in many therapeutic areas research is dominated by biologics, and companies are regularly making groundbreaking developments like cell and gene therapies.
Challenges with Biologics
While biologics may offer some revolutionary advantages over small molecules, the sector faces some considerable challenges. Most notably, biologics are less accessible than the more economically sustainable small molecules. These drugs aren’t as readily available and are often cost-prohibitive to the patient.
Since biologics are personalized therapies, the scale at which these drugs are created is much smaller than typical pharmaceuticals. Finding an efficient manufacturing solution for the small scale of biopharmaceuticals can be a challenge. The biomanufacturing solution must be suitably ‘scalable’ as the new treatment progresses through clinical trials and commercialization. Typically, high investments are required to create a safe and efficient biologics manufacturing plant.
The other obstacle with them is complexity. Biologic molecules are large, complex structures that require extensive analytical data.
This complexity can make it quite challenging for researchers to use conventional methodologies. If companies want to develop better biopharmaceuticals, analytical technology needs to continue to push the ‘improvement’ envelope – whether that be speed-, size-, cost- or accuracy-based.
The lack of global custom synthesis capacity can be an additional barrier for smaller innovative companies that don’t have the capability to invest millions of dollars upfront. Most companies manufacture biologics or biosimilars for their own consumption. Companies that are offering custom synthesis are doing this on an exclusive basis since development timelines are long and require substantial resources.
Significant Opportunity for Biologics
Despite these challenges, the biologics trend is not slowing down anytime soon. The challenges also prove that there is a significant opportunity and untapped potential for them. As technology improves, investors and researchers will continue to drive the sector forward.
Outside of technological improvements, another growth opportunity for biologics is patent expiration. Several top-selling biologics have patents set to expire soon, which could open the door for biosimilar versions. This situation is particularly pertinent in oncology, where they currently make up half of the pharmacological market. By 2023, patents on nearly 20 oncology biologics will expire, which could lead to more biosimilars in cancer care. Since the costs of these drugs are so high, approval of biosimilars in oncology would also be an important breakthrough in access to care.
Aside from oncology, biologics are already being applied to fields such as chronic diseases (e.g., autoimmune diseases and infectious diseases).
As the burden of chronic disease increases, the demand for targeted therapies will also increase. As a result, pharmaceutical companies and service providers will undoubtedly find opportunities to provide new avenues for biologic-based treatments.
Supporting Pharma Clients with Biologics Sourcing
Biologics are disrupting the industry and improving patient lives in ways we never thought possible. The sector is sure to show robust growth for decades to come.
As these opportunities arise, LGM Pharma will continue to support the industry and our clients with all of their R&D and commercial needs. With our extensive network of prequalified and geographically distributed API manufacturers, we can source any biological product – as well as every other type of molecule. We have built strong relationships with API manufacturers and, as a result, have been able to support the industry’s shift towards biopharmaceuticals.