Until a few years ago, biopharmaceuticals lay in the margins of traditional pharmacy, with synthesis-based medicine heavily invested in. The rise of biotechnology has changed the equation, allowing us to further explore the power of living organisms. Now biopharma is revolutionizing the pharmaceuticals sector, offering new solutions and treatments such as cell- and gene-therapy and customized treatments. This new trend is attracting investors and big pharma, creating a shift that ultimately brings into question the fate of traditional pharmaceuticals.
Biopharma vs Traditional Pharma
First things first: a pharmaceutical is any substance used in the diagnosis, treatment, or prevention of disease or organic malfunction. Traditional pharmacology has been using plant- and chemical-based compounds, manufacturing drugs through chemical synthesis. In contrast, biopharmaceuticals, as the name gives away, are manufactured in living organisms, such as bacteria, yeast, and mammalian cells.
Biopharmaceuticals are among the most sophisticated and elegant achievements of modern science. Using biotechnology’s advances in genetics research, biopharma seeks to duplicate or change the function of a living cell for medical purposes. The result can be proteins, including antibodies and nucleic acids – mostly DNA and RNA. For example, immunomodulators affect the immune system, while enzymes speed up biochemical reactions. While this seems almost futuristic, the first biopharmaceutical drug developed and approved for therapeutic use dates forty years back: recombinant human insulin, going by the trade name Humulin, was manufactured by Genentech and marketed by Eli Lilly in 1982.
How Medicine is Revolutionized by Biopharma
Given its capability, it is no surprise that biopharma is revolutionizing the world of medicine and saving the lives of thousands of people every day. Patients suffering from cancer, diabetes, cardiovascular disease, immune diseases, and other health problems already reap the benefits of existing biopharmaceutical products. Meanwhile, radically new concepts are making it to the market.
One of the greatest advantages of biopharmaceuticals is their ability to offer targeted and customized treatments. With the help of data-power diagnosis and analysis, medical staff can design therapies highly effective for just a few people or even a particular person. Not only can biologics, or drugs made from living organisms, be produced to the particular patient’s needs, but it can be produced using the patient’s very own cells and genome.
First of these developments is cell therapy, which injects or implants viable cells into a patient for medicinal impact. The techniques include Provenge, a form of therapy used to treat prostate cancer by exploiting the patient’s own immune system. A similar form of immunotherapy, CAR-T cell therapy uses the immune system’s white blood cells to destroy cancer cells.
While still in early stages, an even more promising method is gene therapy: this technique uses genetic modification, targeting diseases often driven by a single or a few genetic mutations. Companies such as Solid Biosciences are developing gene-based treatments for muscular dystrophy. Meanwhile, UniQure, a company specializing in gene therapy, has its eye on Huntington’s disease and Hemophilia B. Other conditions potentially within the grasp of this revolutionary medicine are sickle cell disease and cystic fibrosis. In fact, gene therapy could go as far as offering solutions for regenerative medicine, regrowing, repairing, or replacing damaged tissues or organs.
Is Biopharma Replacing Traditional Pharma?
Since its conception, biopharma has witnessed a soaring success and more importantly, many future promises. With this kind of potential, the market can hardly remain indifferent. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 percent of the pharma market. It is the fastest-growing sector of this industry, and by a margin: biopharma’s annual growth rate of over 8 percent is double that of conventional pharma, a rate expected to continue in the future. As biopharma goes mainstream, the future of traditional pharmaceuticals is brought into question.
Nevertheless, there are major challenges to overcome before this new technology can dominate the pharmaceutical market. First, scaling up the manufacturing of biopharmaceutical compounds requires capabilities of extreme sophistication. As Teva or any firm embracing biopharmaceuticals is confronting, genetically modified cells producing these substances must be frozen for storage, thawed without damage, transported safely, and grown in unusual lab environments. The cells and their pharmaceutical products tend to be fragile, heat sensitive and easy to contaminate.
Another challenge is sustainability. The conditions required for biopharma manufacturing require single-use technology: as opposed to steel tech, plastics and similar materials are flexible, useful for multi-product facilities, and avoid product carry-over, which is essential given the fragility and susceptibility to contamination of biological organisms and compounds. Yet single-use materials are extremely wasteful and pollutant. One solution is to recycle them: Genentech’s Green BioPharma program prioritizes recycling single-use laboratories, as well as using more environmentally friendly chemicals and innovative technologies that minimize the footprint. This vision offers blueprints for sustainable pharmaceutical companies across the globe.
How Big Pharma is Joining the Revolution
Despite the challenges, the biopharma revolution is only accelerating, and with it starts a dramatic shift in the market as the big players adapt to the new rules. Big pharma are still in the process of entering the biopharma sector, leaving room for smaller companies. As of 2020, only five of the top twenty companies in cell and gene therapy are large biopharma: Novarties, BMS, Biogen, Gilead, and Roche. One strategy is acquiring specialized companies: for example, German-based Bayer has acquired Asklepios BioPharmaceutical, a company pioneering gene therapy.
Some companies are not expanding, but rather choosing to focus on biopharma. Novartis and Pfizer are transitioning towards ‘pure play’ biopharmaceuticals, abandoning non-core and adjacent businesses. In this manner they can brand themselves as experts and leaders in the field, as well as maximize research and investment. For that sake, pharma giants are prepared to collaborate when in need. This was the case with Pfizer and BioNTech, who entered a joint venture to co-develop a COVID-19 vaccine.
Despite many challenges, the opportunities offered by biopharmaceuticals to prevent or treat a vast array of stubborn and deadly diseases could downright eclipse the traditional pharmaceutical industry. With such promises already being fulfilled, the pharma companies, big and small, are quick to adapt. Being so central to our health, the revolutionary developments in pharmacology are bound to have, and in fact are already having, a tremendous impact on our lives and our society.