Advances in pharmaceutical biotechnology are revolutionizing the industry. Medications derived from living organisms such as therapeutic antibodies and cell therapies can treat complex diseases, targeting individual patients’ unique genetic makeup.
But biotechnology is not without its challenges. Commercial translational development of healthcare biotechnology products is complicated by a host of factors including reimbursement and pricing, clinical trial design and execution, and intellectual property protection.
Product Development
In addition to providing a new source of revenue and enhancing R&D productivity, many large pharmaceutical companies are using biotechnology to streamline the development process. This can be a critical step as they face many challenges, including increased market expectations, near-term patent expirations on top products, and the onerous time, cost, and risk of new drug development.
Biotechnology is a rapidly evolving field that offers tremendous promise for future advancements in medicine, agriculture, industrial processing, and energy. Many of these innovations will have an impact on the lives of individuals around the world. Among other things, biotechnology may improve the efficacy of vaccines, reduce, or eliminate infectious diseases such as malaria and HIV/AIDS, and lead to better crop yields and food quality.
To achieve these goals, biotech firms must be highly innovative, agile, and able to collaborate effectively with multiple partners. They must also have access to substantial amounts of capital to finance research and development efforts, as well as forge strategic partnerships with emerging biotech firms, academic institutions, and clinical contract research organizations.
The biotech industry also needs to develop the capabilities required for high-volume manufacturing of affordable medicines. At the low end, this will include the ability to produce small batches of fully personalized cell therapies that can treat a wide range of illnesses. At the other end, this will mean developing the manufacturing capacity to produce insulin or vaccines against diseases such as malaria that continue to take the lives of millions of people in poorer countries.
Biotech companies need to be mindful of environmental impacts. They must invest in technologies that minimize emissions and conserve resources and work with partners to build the needed infrastructure. They must also ensure that their production processes are in line with sustainable development goals and global environmental agreements.
In addition, they must be transparent and communicate their progress on these issues to investors and the public. They must also support international scientific and technical harmonization efforts.
This is especially important as well because the industry’s complex supply chains often involve many players, and addressing climate change requires cooperation across all sectors. To this end, a recent study found that 91% of publicly traded companies analyzed do not have climate commitments aligned with a 1.5@C degree warming scenario, the level of greenhouse gas (GHG) emission reductions needed to avoid the most severe impacts of climate change.
Clinical Trials
The development of a new pharmaceutical treatment typically involves multiple stages, including animal testing and clinical trials. Biotechnology enables scientists to develop and test promising new treatments in animals before beginning clinical trials with human patients. This allows for faster and more accurate assessments of treatment efficacy and safety.
In addition, the use of recombinant DNA technology allows for the rapid creation of genetically modified cells and living organisms for a wide variety of applications, from developing vaccines to enhancing crop production. This provides a powerful tool for researchers looking to find new ways to treat diseases, improve health care outcomes, and extend life expectancy.
Biotechnology has helped drive medical advances in many areas, including cancer, heart disease, and diabetes. This year, breakthroughs with CRISPR gene editing and immunotherapy therapies are expected to lead to the first ever cure for leukemia, as well as new drugs that can slow or even stop the progression of Alzheimer’s disease.
Despite these advances, the pharmaceutical industry is facing an uphill battle. The patent expiration of key blockbuster products is putting significant pressure on pharma’s bottom line. This is exacerbated by inflation in labor, raw materials, and transportation costs, which are unlikely to be fully passed on to consumers. Over the next ten years, these trends are expected to push pharma’s operating margins down by 25 percent.
To address these challenges, pharma is attempting to speed up product development by introducing new R&D strategies and operating models. As a result, the industry may soon see its most significant shift in three decades.
As a result, pharma could see its traditional research and development processes disintegrate, as large pharma companies outsource the more labor-intensive aspects of drug discovery to small biotech firms that are more agile in design and execution. This could allow pharma to reduce its investment in less profitable activities and focus resources on higher-margin opportunities. Ultimately, this could help the industry regain its footing and make the necessary adjustments to thrive in the future. To learn more about this and other recent trends in the pharma industry, download our free whitepaper: The Future of Pharma is Biotech: A Guide to Successful Strategic Planning for Biotechnology and the Pharmaceutical Industry.
Regulatory Approval
As companies develop new medicines, they must submit their findings to regulatory authorities for approval. This process is typically long, time-consuming, and expensive – but one of the most important components of successful pharmaceutical development.
The long-term outlook for biopharma is bright, with innovative technologies such as cellular therapies, immunotherapies, and gene therapy poised to bring significant benefit to patients around the world. These advancements could treat conditions that are difficult or impossible to manage using current drugs, as well as open the door for a whole new era of treatments.
In the short term, however, the industry faces many challenges. The patent cliff is chipping away at big pharma’s established revenue streams, while in-house R&D continues to generate lower returns on investment. To thrive, biotechs must evolve their operating models by combining cutting-edge innovation with a renewed focus on efficiency and resilience in business fundamentals.
Ultimately, biotech firms will be key to filling pipeline gaps caused by the patent cliff and other disruptions. The best companies will embrace this change by integrating innovative technological solutions that support a data-driven, intelligent healthcare system.
With an emphasis on efficiency and resilience, pharmaceutical manufacturers are also leveraging technology to optimize supply chains, improve quality, and increase agility. In addition, they are deploying advanced digital technologies and data analytics to perfect manufacturing processes, enhance process and product analysis, and deliver greater visibility across the value chain.
As the pace of drug development slows and the industry adapts to this changing landscape, it will be vital for both big pharma and small biotechs to embrace technological innovation. Companies that can fuse their inventive energies with a renewed focus on efficient, resilient operations will emerge from this downturn stronger than ever. As they do so, they will be positioned to lead the industry in a new era of smarter healthcare.
Commercialization
For pharmaceutical companies, biotechnology is a major driver of innovation. The technology allows them to create drugs and vaccines that can help to prevent, treat, or cure a wide variety of diseases, including cancer, AIDS, and tuberculosis. Technology is also used in the manufacture of many products we use every day, from alcohol to penicillin and from genetically modified crops to innovative materials. Biotechnology has also been used to address environmental problems such as developing biodegradable plastics and using microorganisms to clean up contaminated sites.
The diversity of biotechnology is what makes it so powerful and offers so much promise for the pharmaceutical industry. It allows companies to develop medicines that target diseases at different levels and to tackle many problems that have been difficult or impossible to solve in the past.
Biotechnology is transforming the pharmaceutical industry, with a significant increase in monoclonal antibodies and other biologics. These new medicines are often much more effective than existing therapies and can treat a broad range of serious conditions. However, they are also more expensive to develop and produce than small-molecule drugs. The development of these drugs has prompted some big pharmaceutical companies to re-evaluate their decades-old R&D strategies and to invest in the discovery of new targets and therapeutic approaches.
Similarly, the development of biotechnology is forcing companies to re-evaluate their manufacturing processes. Biotechnology requires large-scale biopharmaceutical production facilities that are typically more complex and costly to operate than conventional pharmaceutical plants. This includes the need for high capital investment in equipment, long process durations and the use of expensive raw materials. It also requires skilled workforces with experience in the operation of these types of facilities.
This re-evaluation of pharmaceutical R&D and manufacturing is also driving companies to develop more innovative products to meet consumer demands. In the future, these demands may include targeted medicine that is designed to treat specific patient groups or a combination of drugs that treats multiple diseases in an integrated manner. In addition, the rapid response required to meet high demand will likely lead to more lean manufacturing designs that eliminate warehouse stocks and are made to order rather than forecasted.
