The state of the ELN market in 2007
By Michael Elliott, Atrium Research
The year 2007 has been strong for suppliers of electronic laboratory notebooks (ELNs). Demand continues unabated, resulting in a year-over-year market expansion of more than 35 per cent. Domain-specific products, particularly those designed for chemistry and quality, continue to dominate product sales. However, in the past 12 months there has been a significant increase in interest from biology, a discipline with typically less well-defined workflows. Atrium Research predicts the 30-plus ELN suppliers will receive US$75m from software and services in 2007.
More than 40 per cent of biopharmaceutical research chemistry departments have ELN active projects. The ten largest companies have fully deployed or are in the process of implementing systems in their medicinal chemistry units. These systems are frequently integrated with chemical registration, chemical naming, inventory, and supplier databases. Requesting assays from the chemistry ELN page is also becoming popular to reduce the number of individual systems a scientist must navigate.
In the past year, biology departments began to take a serious interest in ELNs, primarily for lead optimisation and development processes in medicinal chemistry. Late-stage discovery and early development groups studying pharmacology, DMPK, and toxicology are now considering ELNs as a flexible alternative to LIMS products traditionally used in GLP development. These groups require a highly configurable environment for ever-changing protocol workflows, something not provided by most LIMS.
The overuse of MS Excel spreadsheets in biology for data translation, storage and analysis has also prompted companies to consider ELNs as a tool to improve data quality and efficiency. Biologists typically spend close to 50 per cent of their time manipulating data1, so organisations are trying to increase the effectiveness of their scientific resources to provide more time for insightful analysis and experimentation.
The diversity of biological sciences can create data management complexities not typically found in chemistry that can complicate the installation of an ELN. In biology, most data tends to be structured (e.g. assay results), whereas in medicinal chemistry most data is unstructured (e.g. experimental write-up). In lead optimisation existing repositories, such as screening databases, must also be taken into consideration.
Does a department look to augment databases used for high-volume, repeatable experiments with an ELN for exploratory assays? Is the ELN just a repository for static data contained in PDFs and spreadsheets or is it used dynamically for data analysis and reporting? Or do they look at the entire informatics ecosystem? These are among the many questions organisations are asking themselves. Best-practice companies are looking at their inter- and intra-departmental processes to develop an informatics strategy – one in which the ELN is a critical component.
The past year has seen most ELN installations migrating away from the ‘hybrid’ model that used printed and hand-signed pages for intellectual property protection. A fully electronic installation is now standard in the vast majority of large biopharmaceutical companies. PDF renditions are electronically signed and stored in a content management archive for long-term retention.
However, the movement to an electronic environment raises a number of policy issues regarding record management, particularly in light of the changes to the US Federal Rules of Civil Procedure (FRCP) enacted in December 20062. The modification to FRCP now treats electronic records with the same weight as paper records in legal discovery with the caveat that they must be proven to be authentic and trustworthy.
Companies now require proven and established record management practices, as well as technology for record authentication.
Nearly 50 per cent of organisations prefer to purchase their informatics products from one vendor if they could3. Suppliers are trying to tap into this market by promoting a more ‘holistic’ approach with new product revisions and mergers and acquisitions. Innovative features and add-on modules will further grey the line between traditional definitions of ELNs, scientific data management systems, and LIMS.
References
1. Atrium Research 2004 and 2005 market research
2. Elliott, Michael H; The Rules have Changed, Scientific Computing; May 2007
3. Elliott, Michael H; Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management Edition III; Wilton, CT
