The Rise of the Biopharmaceuticals Industry and the Hurdles It Faces

Biopharmaceutical products are making their presence felt in the compound manufactured drug dominated traditional pharmaceutical market.

Typically derived from lifeforms, such as cells, Nucleic acids (RNA, DNA), protein antibodies and other bio cultivated, non-engineered methods, biopharmaceuticals are medically produced drugs to aide in the treatment of disease, cancers, and other therapeutic uses. The first biopharmaceutical substance approved for analeptic use was back in the early ’80s and called rHI, or recombinant human insulin.

Its popularity has steadily risen in the past few years, and the pharma corporations are taking note of the steady emergence of non-conventional pharmaceuticals. Sales have grown to 20% in market share of total sales in the pharmaceutical sales category in the past few years. Recently, its Compound Annual Growth Rate, or CAGR has hovered just under 10%, which is about double the rate of growth to that of conventional pharmaceuticals. Biopharma has started to invest heavily in reach and development and biotechnological patents. Nearly one-third of drugs in the clinical trial stage is of the biologics variety.

Their products come from an array of properties such as recombinant proteins, hormones, vaccines, monoclonal antibodies, synthetic peptides, antibody-drug conjugates, fusion proteins, oligonucleotides, and recombinant enzymes, to name a few. However, Monoclonal antibodies (mAbs) remains the most abundant group of biopharmaceuticals on the exchange, as they can target cancerous cells attacking the immune system. And while this biological passageway to medicine is an innovative and disruptive approach to traditional pharma practices, it is not without its hurdles.

Biopharmaceuticals are a sophisticated and efficient manner of treatment. However, their manufacturing proves costly, complex, and cumbersome. Working with genetically transformed living cells, like recombinant proteins, comes with challenges that traditional synthetic drug production is lacking in its equation. Consistently cultivating these molecules and maintaining its integrity in a large automated order, while still adhering to a high-quality standard, is expensive.

The large molecules that are needed to manufacture biopharmaceuticals on an industrial level create a dependence on their environment in order to replicate them. Modification of complex biomolecules may affect the safety and overall efficacy of the medicinal product. Oxidation, hydrolysis, disulfide formation can occur during post-translational modification if the drug is controlled and closely monitored.

If exposed to particular stresses during shipment, storage, or even in the production itself, instances of aggregation and denaturation could transpire. In short, the slightest or subtle change to the products organic properties could have unfavorable results to the effectiveness of the drug.

Outside the manufacturing facilities themselves, there are other obstacles. The race to improve R&D productivity is a complicated course to navigate. A few companies are increasing their R&D budget to up to forty percent. To maintain and operate a sustainable model, access to emerging technologies and sound academia and biotech expertise are paramount but may not be readily available on-site and in house.

Alas, these challenges will not impede the growth of the biopharmaceuticals trade. The drugs have proven effective in the curing and comforting of patients. The industry is ever-evolving and with promises of new cell therapies, low-cost vaccines, immune disease treatments, and cancer remission prospects, the biopharmaceutical market with continue to thrive.

For more information on biopharmaceuticals follow Carsten on his website and Twitter.