Defining the Life Science Industry

What’s in a name?  Apparently a lot because I’ve noticed more and more companies adopting the “life science” moniker – big pharmas, biotechs, CROs, even IT and software companies.  I’ve even seen reports from top-tier consulting firms that include hospitals and physicians in what they refer to as the “life science” space.

As we begin our build up to the 2008 Life Science Industry Awards, I thought it would be useful to revisit how we here at BioInformatics define the “life science industry” and our definition is pretty straightforward: companies that sell products, instruments and services to life scientists.

The life science market is comprised of thousands of products ranging from advanced instrumentation to common laboratory chemicals.  In attempting to define any market—especially one so broad and diverse—one is challenged by where to set boundaries with adjacent markets and the definition of where one product category ends and another begins. Such an analysis is always subjective and open to interpretation and further complicated by the need to make trade-offs between the breadth of the market, and the depth of the products to be considered within each category.

For the purpose of the Life Science Industry Awards, we decided that market and product segmentation is most easily understood in terms of the most commonly used scientific techniques. In all, 14 broad techniques were used to define the market’s product categories and the study of biological processes as the delimiters of the overall market’s boundaries.

Sorry Big Pharma: Here’s what life science companies make:

Cell Biology Instrumentation (Flow Cytometer-based)
Through optical means, flow cytometers distinguish cells on the basis of size and shape in addition to the presence of many different molecules inside and on the surface of the cells. The appeal of flow cytometry arises from the flexibility and sensitivity of fluorescence technology combined with the technique’s high speed and powerful data integration capabilities. Although flow cytometry has enabled scientists to analyze a variety of cell types since the late 1970’s, today’s technology applications, from cell sorting to apoptosis, are even more broad reaching and powerful in the life science research market. However, scientists are at various levels of sophistication and have differing experimental needs when it comes to this versatile technology. Some think of flow cytometry as a “black box,” while others can easily operate the most sophisticated of cytometers.

Cell Biology Instrumentation (Microscope-based)
Historically, microscopy has always been a driving force in the study of cells.  Today, however, cell biologists are increasingly taking advantage of new and more powerful technologies for visualizing the interior of live cells.  Exciting developments in microscopes and associated dyes, staining protocols and preparation techniques are helping scientists understand even more about the structure and function of cells.

Cell Biology Kits & Reagents

Advances in the area of kits and reagents have enabled cell biology researchers to understand the fundamental processes that cells undergo. For example, cytokine and growth factor research has provided unprecedented insight into how the body controls development and regulates its response to disease and infection. This particular area of research has attracted many life science suppliers, both large distributors as well as niche vendors, who are competing for a share of this market. Additionally, highly specific antibodies have provided a way to identify protein actions and cell signaling pathways in most phases of the cell lifecycle. The category Cell Biology Kits & Reagents includes consumable products that are used to study the physiological properties of cells such as their structure and organelles, their environment and interactions, their life cycle, division, function and death. Examples include apoptosis assay kits, cytokine detection assays, and signal transduction and transfection reagents.

Cell Culture Media & Reagents
There is sometimes a tendency to equate innovation with high-tech equipment, while taking for granted the commonplace reagents in every laboratory. However, scientists need these reagents to work consistently, reliably and with high performance results every day in order to conduct their experiments. The category of Cell Culture Media & Reagents encompasses those products used for growing and maintaining cell lines or strains under laboratory conditions. Without quality mainstays such as cell culture, media, and media supplements everyday functioning in the lives of cells and scientists alike would be difficult.

Computer Hardware
Despite the innovations in the manufacturing area of biology, a bottleneck in data integration and analysis has made personal computers, workstations and minicomputers important fixtures in the lab. Scientists worldwide are acquiring genomics data through the use of techniques such as amplification, DNA microarray expression, genotyping, real-time PCR, RNA interference and sequencing. Because scientists are increasingly compiling data from multiple sources and instrument platforms that were never intended to be compatible, instrumentation suppliers and information technology (IT) vendors are challenged to provide solutions that integrate this data. These companies are also faced with the challenges of disseminating this data to other institutions as well as improving user interfaces to accommodate scientists with little IT background. Instrument companies are developing new applications, and independent software vendors are creating software to keep up with increased demands for better throughput and compatibility and to capitalize on opportunities in these new markets for IT vendors.

Gene Expression Analysis Products

The ever-expanding universe of applications for gene expression analysis products has made these technologies some of the most enticing and promising systems in recent times. Companies in this closely-watched category have had to be versatile and visionary, while still delivering results based upon their core functionality. The focus of this category was on products used for measuring mRNA levels to determine the expression level of genes. DNA microarrays, target labeling reagents, standard and real-time PCR kits and reagents, cloning and expression reagents have enabled great leaps in scientific discovery. The tremendous attention and money directed towards microarrays is likely to continue attracting both new customers and suppliers to the field. In this competitive market, successful companies have been carefully positioning their products to appeal to the extremely diverse needs of their customers. Additionally, qPCR has had a host of potential applications, some of which include comparing gene expression levels in normal and diseased tissues, determining viral and bacterial loads, and genotyping. From basic researchers wanting to elucidate cellular processes to infield detection of infectious agents, the potential market for qPCR technology continues to grow.

High-throughput Screening & Analysis Systems
The more rapid pace of scientific progress, made possible by the industrialization of biological discovery, has put more power in the hands of each researcher than many would have imagined 15 years ago. The category of High-throughput Screening & Analysis Systems is dedicated to automated systems employing miniaturized assays formats (e.g., 96-, 384- or 1536-well plates) used for conducting multiple experiments simultaneously. While many scientists were adept with their pipettes and traditional techniques, technologies such as microplate-based systems, microplate readers, liquid handling systems and lab robotics have greatly increased one’s productivity in the lab. Microplate assays, for example, provided the advantages of reducing labor time, raw material costs and sample volume. Critical to the pharmaceutical industry, microplate technology allowed both miniaturization and high-throughput to merge in an effort to streamline the drug discovery process. Today, microplate readers allow researchers to perform a variety of different assays efficiently and precisely as a result of their high-throughput adaptability and robotics. This product category continues to grow in order to meet the demands for greater scalability and quality.

Image Analysis Systems
The human eye became privy to never before seen spectacle when van Leeuwenhoek first used a light microscope to discover red blood cells in 1677. Today, scientists need much more than any single technique can provide and thus depend on many different image analysis systems. This category includes systems used for measuring or visualizing experimental results, which typically include functions for image editing, annotation, enhancement and archiving. Such systems can be configured for fluorescent microscopy, intracellular ion imaging, automated image stitching, fluorescence and dynamic fluorescence imaging, gel/blot analysis, grain counting and 3-D reconstruction. With hundreds of ways to appreciate the microscopic world, the van Leeuwenhoeks of today use gel documentation systems, CCD cameras, scanners and recorders made by the more than 95 companies in this category.

Instrumentation for Genomic Analysis
Understanding the role of genetic variation is expected to profoundly change our perspective on human disease and the practice of medicine in the years to come. Genotyping, the process of analyzing the particular genetic variations (i.e., polymorphisms) existing in an individual DNA sample, can be used to identify the susceptibility of genes. Researchers face alternatives at every step of the process, from the selection of which molecular technique to use, to a myriad of choices for labeling, detection and scoring. Life science suppliers are positioning themselves to support SNP genotyping with a broad spectrum of products and services, especially in the pharmaceutical segment. Given their power, sensitivity and high-throughput capabilities, DNA microarrays play a vital role in drug discovery, development and evaluation. Manufacturers with the help of end-users are currently trying to identify and optimize combinations of genes to be arrayed, in addition to developing the best tools for data acquisition and analysis. This mix has created a dynamic and fluid marketplace. This category, defined as equipment used to manipulate nucleic acids, determine genetic sequences, or monitor gene expression levels, includes sequencers, DNA microarray scanners, genotyping or fragment systems and equipment for PCR and real-time PCR.

Instrumentation for Protein Analysis

Just when we were celebrating the milestone that was the completion of the Human Genome Project, scientists asked the next fundamental question: “What does the sequence really mean?” The quest to uncover the functional application of genes as expressed in the proteome created a new frontier and the need for new technology. With recent advances in ionization technology, for example, mass spectrometry has facilitated protein identification and characterization by using techniques such as digestion analysis, peptide sequencing and chemical synthesis verification. Other specialized applications of the technology include studying protein conformational changes, multi-protein complex formations and posttranslational modifications. Researcher demands for increased efficiency and productivity have accelerated the development of mass spectrometers with fully automated processing and high-sample throughput capabilities. Advances in software technology have created products that track the sample and integrate its processing. These automated systems, capable of high-throughput protein identification, are leading the way in freestanding instrumentation. In this category, defined as capital equipment used for detecting and quantifying proteins, the products in addition to mass spectrometry include HPLC and chromatographic instruments.

Laboratory Plasticware
Plasticware is an essential part of every life science laboratory.  Plastics offer a combination of lightweight, strength, flexibility, safety and convenience that has supplanted glass in most lab applications including tissue and cell culture.  Plasticware manufacturers are responding to the needs of life scientists in many innovative ways including product size, handling, and coatings to support automation, as well as in the areas of ease-of-use and ergonomics.  In this highly competitive category where brand strength can often be as important as price, 46 different suppliers were named with Eppendorf, Fisher and VWR leading the group

Nucleic Acid Purification Products
The process of purifying DNA has come a long way since the early days of cesium chloride gradients and phenol chloroform extractions. Timesaving discoveries such as anion exchange and silica-based columns have decreased the need for long centrifugations and working with harmful substances, literally catapulting the founders of these technologies to the forefront of the DNA purification market. An expected increase in the number of DNA purification preps that are performed per year, as well as room to increase customer satisfaction levels, represent opportunities for companies to increase market share. These factors made competition among the 35 nominees particularly dynamic. The category, which encompassed products used for the isolation and analysis of DNA or RNA, included products such as kits and reagents for isolation and purification of DNA and RNA, as well as nucleic acid markers and DNA gels.

Protein Separation Products
To gain a comprehensive understanding of protein function and regulation, researchers must separate proteins, then identify and characterize the expressed proteins. 1-D or 2-D gel electrophoresis, and occasionally single- or multi-dimensional liquid chromatography, have been the predominant techniques for separating proteins. To meet the demands of scientists, companies are developing new innovations that aspire to be inexpensive and reliable, generate high-resolution protein separation and yield good visual detection of subtle differences. Today gels are available as homogeneous, pre-cast products, which are combined with automated equipment and imaging analysis software for improved quantitative results and reduced workload. Products used for the purification and/or analysis of peptides or proteins are the focus of this category-one that includes kits, reagents, pre-cast gels, protein and antibody arrays, and apparati for protein electrophoresis.

RNAi Products
The phenomenon of RNA interference (RNAi) has rapidly evolved into a powerful technique to silence gene expression in eukaryotic cells. From an evolutionary perspective, RNAi helps protect cells from viruses and transposable genetic elements in addition to carrying out more routine cellular tasks essential to development and growth. Much of the technique’s popularity comes from allowing researchers to study the molecular effects of modulating expression at the level of individual genes. This amazing degree of precision can now be accomplished without the tedious and time consuming efforts previously dedicated to the construction of single gene knock-outs or dominant negative expressing cell lines. The diversity of its applications has quickly made RNAi an indispensable tool for both academic and industrial scientists interested in gene function characterization, signaling pathway analysis and target validation. This category focuses on products used to study the phenomenon of RNA interference, including siRNA vectors, pre-validated siRNA complexes, custom-made chemically synthesized siRNA, enzymes and reagents.