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Growing regulatory pressure and competition from generics will drive adoption of product lifecycle management software and services in the pharmaceutical industry. Datamonitor estimates spending on product lifecycle management software by the pharmaceutical industry in Europe, North America, China and Japan to total $460.2 million by the end of 2007 and expects this to more than double by 2012.
Product lifecycle management (PLM) software and services solutions are still a nascent market for the pharmaceutical industry. Although the industry is starting to recognize the potential benefits of PLM in drug development, unless pharmaceutical companies adopt a strategic mindset about PLM, with all the process management changes and cultural adaptations it requires, PLM will remain a tactical solution whose potential is not maximized.
Pharmaceutical companies constantly strive to accelerate drug development processes, and decrease the time it takes to bring a drug to market, since the window from discovery to launch is both lengthy and costly. As competition from generic drugs grows, the industry has an additional motive to shorten the time it takes to bring a drug to market. Furthermore as mergers and acquisition activity continues, companies are in need of tools, such as PLM, to harmonize their product portfolios and enhance visibility across the entire pipeline.
PLM addresses the challenges of managing a portfolio of tens or hundreds of drug candidates, from disparate R&D facilities and manufacturing plants spread across the globe. Adding to the business drivers for investing in PLM is the increasing pressure by regulatory bodies that emphasize compliance to ensure drug safety. As a result, the industry is in need of sophisticated tools that automate research processes and create electronic trails that can help reduce non-compliance errors. PLM supports regulatory compliance by including applications that track adherence to regulation codes and identify risks of non-compliance.
In such a data-rich industry as Pharma, knowledge tends to be diluted quickly unless each organization adopts an effective methodology for transferring knowledge and for ensuring visibility and access to critical information when and where it is needed. Scientists, compliance staff, and engineers work with multiple protocols, materials, internal and external partners, constantly adapting their workflows according to experimental results. Although the degree of variability tends to decrease as the drug lifecycle progresses, a flexible PLM system that can keep up with this iterative process is crucial in supporting the development needs of the drug lifecycle.
Only an enterprise-wide system will maximize the value of PLM in a pharmaceutical company by offering the visibility, and flexibility the organization needs across its otherwise isolated functional departments. Furthermore, recognizing the value of an enterprise PLM solution indicates that the organization has a strategic view of PLM, rather than a tactical and merely technical view. In fact, a strategic approach to PLM necessitates an enterprise-wide system.
Today, PLM solutions have been slow in adoption by the pharmaceutical industry primarily because implementation takes anywhere between six months and two years. This indicates that current PLM products sold to pharmaceutical and biotechnology companies require tremendous amount of customization and configuration before they can be used within that type of environment. PLM technology for the pharmaceutical industry will be widely adopted once vendors are able to offer configurable packages rather than customized PLM projects or horizontal packaged solutions that may lack the necessary applications needed for the industry.
In the meantime, partnering with a vendor may be a necessary strategy for pharmaceutical companies. Some of the most successful and innovative pharmaceutical companies have partnered with a technology vendor to pursue a customized enterprise PLM implementation.
Partnerships provide technology vendors with a longer-term success than simply selling PLM products and services. By working collaboratively with the organization to develop the solution, vendors can gain the organization's loyalty, trust and business for years to come. Partnerships can be most successful when vendors fit the following four criteria: a long-term commitment to the project, a flexible and innovative mindset for conducting business, an efficient implementation strategy, and a track record of success.
PLM must begin earlier and be more comprehensive than it has been in the past. Only those PLM technologies that are aligned with business processes will maximize value within the organization. Organizations which do not make the necessary transition to PLM, either alone or through partnerships, will shortly find themselves lagging behind their more forward-thinking competitors who will be enjoying the benefits of their new knowledge-based centralized resources.
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