John Sterling Editor in Chief Genetic Engineering & Biotechnology News
Life sciences set to blossom under impact of transformative technologies.
As the biotech industry enters a new year the key trends to watch will be those involving the technologies and markets that are expected to grow quickly during 2015. They will be the important drivers of life science R&D and help move biotech into wholly new areas. From a strictly monetary perspective, merger and acquisition activity will continue to constitute a financial and resource allocation trend critical to the growth of the bioindustry.
- Big Data—Everyone talks about the big data challenge. Biostatisticians and bioinformatics specialists are working overtime on difficult problems and ever more complex solutions to handle the deluge of information. What we can be sure of is that big data will get even bigger in 2015.
- Biosimilars—Frost & Sullivan estimates that the biosimilar market will grow from $1.2 billion in 2013 to $23 billion in 2019. As of mid-November, the EMA had approved over 20 biosimilar products for Europe. The U.S. entered the field in July when Sandoz filed the first biosimilar application in July with the FDA for filgrastim (which Amgen has subsequently challenged). Expect more filings in the U.S. and Europe next year and some approvals are likely as well.
- Clinical Omics—Genomics technologies, next generation sequencing techniques, and biomarker studies are migrating out of research-based laboratory work and into clinical applications. The stage is already being set for the practice of genomic-based medicine in the not-too-distant future.
- Ebola and other Emerging Viruses—Ebola has taken a devastating toll on West Africa and a few scattered cases have been treated in the West, particularly in the U.S. Ebola most likely will never completely disappear, and Mers, H7-N9, and H5-N1viruses could be potential killer pandemics. As the rapid development of new drugs to treat Ebola has shown, there is a huge opportunity for diagnostic and therapeutic firms to tackle the problem of emerging viruses.
- Epigenetics—Young scientists looking for a promising career would do well to consider a research path in epigenetics. Tied intimately to our genomes, epigenetics, with a potential market value of over $783 million in five years, can help answer many of the genetic questions that our genes can’t.
- Immuno-Oncology—Pfizer recently agreed to pony up almost $3 billion in an agreement with Merck KGaA to develop and commercialize an anti-PD-L1 antibody for the potential treatment of multiple types of cancer. This is the latest in a number of deals designed to develop drugs to help the body’s immune system fight cancer.
- M&As—The Burrill Report noted that life science M&A deals through the first nine months of 2014 totaled $231.5 billion, vs. $131.8 billion last year. According to Biopharm Insight, “As healthcare companies and providers consider the implications of the Affordable Care Act, the recovering economy, and the demand for capital and IT improvements, many entities will look to mergers and acquisitions as a means to bolster their resources and further their integrated delivery models.”
- Nanomedicine—Nanomedicinal therapy targets small quantities of a drug to a specific part of the body. Manufactured and formulated in low quantities, the goals of the nanomedicine approach are cost savings, fewer side-effects, and rapid treatment of disease.
- Personalized Medicine—Personalized medicine is rapidly developing and is characterized by the use of such technologies as regenerative medicine, tissue engineering, stem cells, genomic medicine, pharmacogenomics, etc. Many experts believe that tailored diagnostics and therapies individualized for each patient will be part of routine medical practice within 10 years.
- Synthetic Biology—A European Committee group defined the field as follows: “Synthetic biology is the engineering of biology: the synthesis of complex, biologically based (or inspired) systems, which display functions that do not exist in nature…[it] will enable the design of ‘biological systems’ in a rational and systematic way.” A good example is work that Craig Venter and colleagues are doing re-engineering pigs and altering their genetic codes to allow the animals to grow human lungs for transplants. And synthetic biologists are already putting the technology to use for the development of biofuels, vaccines and antibodies, plants, industrial enzymes, and bio-based chemicals.