Over the last two decades, the pharmaceutical industry has been forced to undertake significant structural changes to address challenges from regulatory policies, patent expiration of blockbusters, lower productivity, innovation gaps, and price competition from generics.
Outsourcing of research, layoffs, and mergers and acquisitions have become commonplace in an industry which had previously been almost resistant to these activities. Between 2000 and 2010, more than 1300 mergers and acquisitions, with a value of more than $690 billion, took place globally. This eliminated more than 300.000 pharmaceutical jobs, a decrease in internal resources that has forced the industry to explore strategies to improve efficiency of R&D.
Many companies are increasing their focus on externally driven R&D activities. Today, the industry is changing its business model along with the long-held position that all R&D activities should be done internally.
Contract research organizations (CROs) and contract manufacturing organizations (CMOs) have become an integral part of the pharmaceutical industry, providing active pharmaceutical ingredients and drug candidates that are improving pharmaceutical productivity. At the same time, academic drug discovery institutions have joined the drug development landscape. The pharmaceutical industry has recognized the potential of combining cutting-edge academic research and has expanded its effort to engage academic drug discovery institutions through traditional sponsored research programs and other forms of collaboration.
Big pharma has expanded its bio-pharmaceutical efforts, and a significant number of new drugs approved in the last five years have been therapeutic proteins and antibodies. Many of these biotherapeutics represent a “personalized medicine” approach, which holds promise for specifically targeting diseases.
The role that a patient’s genetic makeup plays in his or her efficacy (pharmacogenomics) and safety (pharmacogenetics) has become a key focus of pharmaceutical companies and regulatory agencies as well. Considering the increase in healthcare costs, personalized medicine is poised to revolutionize the industry, and will lead to effective diagnostic tools that can provide early prediction of diseases and lead effective preventive and therapeutic intervention.
Modern industrial research facilities depend on IT tools to drive productivity, interpret data, maintain records, and support functional teams, and drug discovery scientists are supported by a wide range of innovative IT systems. Computational tools are an integral part of drug discovery. The success of any drug discovery project depends largely on the quality of leads taken into the discovery phase. Any technology that can support this process may have a significant impact; for example, analysis of millions of data points provided by biological screening using high-throughput systems. Industry-standard tools for analysis of pharmacokinetics, pharmacodynamics, and clinical trial data can also help researchers better understand how potential new therapeutics behave in an in-vivo setting.
Regardless of the challenges the pharmaceutical industry is facing, researchers and industry leaders will continue their commitment to innovate and discover further innovative drugs that address unmet medical needs and treat various diseases. The industry will continue to partner with CROs and CMOs to provide active pharmaceutical ingredients (APIs), drug candidates, and improve pharma productivity. It will also continue its relationships with academic institutions to gain early access to innovative drug candidates that address the innovation gap. The partnership between pharma and academia is expected to grow during the next decade as many academic drug discovery institutions target discovery and validation.
For more on technology in the life sciences industry, see Transforming Life Sciences To Reduce Costs, Increase Value, And Improve Outcomes.