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The PAT market is developing and evolving rapidly as pharmaceutical firms strive to implement the framework set in place by the regulators. As with all new markets, people will engage at different times, at differing rates, and for different reasons. This editorial seeks to treat PAT in classical marketing terms, describing four phases of the PAT market evolution and discussing how the PAT market will likely mature.
This editorial is about the process analytical technology (PAT) market — which doesn't exist!
Markets, in general, exist for products and/or services, and can be described in terms of the concepts of market evolution and development. However, PAT is not a product or service. It is a concept, a working principle or a framework for operating, depending on your point of view and how you implement it.
It is not an analytical system, which is only a small part of PAT. Nor is it something you can go out and buy. You can purchase the tools and technologies that make up the framework, you can buy the services and capabilities that you need to implement and it is these that have a market that exists and is growing. But you can't go out and buy 'PAT' even though some people believe they have!
Saying this, the following editorial will discuss PAT in marketing terms as though it is a product and has a product marketing life cycle. I will attempt to describe how PAT is evolving in the pharmaceutical industry from the perspective of a product and service provider.
In marketing terms the most appropriate way to look at how PAT is evolving is through the analogy of a product life cycle adoption curve. Here, a product or market is described in terms of uptake phases through its life from introduction, through maturity and into its decline. Figure 1 illustrates the typical four phases of a market evolution.
Innovators have existed for many decades, well before the inception of PAT. In many areas and companies within the pharmaceutical industry, groups of innovative scientists and engineers struggled to apply measurement and even control techniques to pharmaceutical processes.
Figure 1 The PAT ÃÂ´marketÃÂ´ adoption curve.
Often these innovations were stopped or stifled by the then current regulatory regime, but once the PAT initiative kicked in many of these groups blossomed into well funded and internally supported PAT groups. Although now encouraged by the regulators to be innovative they found that the necessary measurement and control tools, technologies or methodologies didn't exist and set about developing them themselves. From necessity, these groups often had to set out and develop instrument and control systems before they could apply them to PAT applications, taking nascent measurement technologies and creating bespoke systems. This was an expensive and time consuming exercise for groups whose core competency was pharmaceutical product development, engineering or analytics.
This period of PAT development is almost over, vendors awakened to the fact that a gap in the supply market existed and a raft of technologies were developed that are now available for purchase. Innovators are realizing their core competencies should be applied to their products and processes rather than emulating vendors.
As time moves on, each generation of vendor-supplied technology needs less and less customization to fit the PAT needs. Innovators are now moving into exploiting available technologies and moving their innovation into application, not inventing measurement systems.
The more progressive innovators have realized that deep, mutually beneficial partnerships with their vendors offer them a fast track to getting the tools they need.
As the early innovators move application of PAT tools into the mainstream they are realizing that tackling the standardization of analytical, engineering and data infrastructures is the next hurdle to embedding PAT into their organizations.
Unfortunately, from a marketing point of view, the innovators, although powerful and necessary advocates of PAT, don't actually represent a large percentage of the pharma industry but they are the leaders, they set the trends.
Early adoptors follow the innovators once the product market begins to develop and stabilize; PAT uptake is not different. Seeing the support from the regulators and the evidence from the innovators that PAT can work and bring more consistent product quality and business benefits, these people are now beginning to implement PAT. The realization that a well thought-through PAT strategy can be implemented without the establishment of large and expensive internal groups and that commercial measurement and control systems are available off-the-shelf from vendors, with full after-sale services if needed has given these early adoptors the confidence to engage in PAT.
It is vital that these implementations succeed because the majority of the pharma industry, yet to engage with PAT, will be watching to see how these more practical and pragmatic projects fare with respect to regulatory scrutiny and the creation of real and tangible business benefits for the pharma company. The market is currently at the beginning this phase.
The majority of pharma companies are sitting on the fence, deciding if or when to jump into PAT. Not necessarily the industry leaders or the largest of companies, this majority group contains the greatest number of individual pharma companies i.e., the middle- to small-size research-based companies, generic manufacturers and contract manufacturing companies. It is likely that the engagement of this community will bring the explosion in the use of PAT that will be necessary for its success.
Typically this market group is highly pragmatic, very risk averse and very financially aware of return on investment. Therefore, they are likely to wait to see the results of the early adoptors and how easy it becomes to purchase the necessary technologies and services to implement a successful PAT project. To this end, it is important that vendors invest in creating goods and services that provide a high chance of success, good return on investment and low-risk implementation.
In marketing terms the 'laggards' are those that, for whatever reason, follow late in the adoption life cycle. Typically these are highly conservative, risk-averse organizations that need to see rock-solid reasons to change and engage. In pharma company terms it is unclear who these will be.
Perhaps companies that cannot create internal cultures that respond to commercial and regulatory pressures will lie in this group or those with products and processes so well understood that PAT will bring little or no benefit?
However, it's likely there will be laggards. The regulators have made it clear where regulatory scrutiny will be focused; at companies that chose not to understand the scientific and engineering aspects of their products and processes and cling to the 'old' three batch validation paradigm.
It is clear that PAT is evolving and maturing and that the pace is quickening. It is driven by the twin forces of regulatory encouragement and a pharma industry that has an increasingly more profound understanding of the potential business benefits of PAT. It is also being fuelled by the vendor community through an ever increasing number of off-the-shelf PAT technologies, tools and services.
However, looked at across the whole pharma industry, uptake of PAT remains patchy and hesitant in 2006. Typically it is some combination of fear, uncertainty and doubt that stops people from engaging in change, even one such as PAT with its clear benefits to the industry and its patients. Understanding and removing these barriers to PAT uptake will require the close-working partnership of the regulators, the pharma industry and the vendors. For all of these parties the development of a large and strong PAT 'market' is a common cause.
In marketing terms, the Innovators will show the way to the Early Adaptors who in turn will prove to the Majority that investing in PAT can be done with a high degree of success and low risk.
The Majority must be engaged if PAT is to become a way of life in the pharma industry and a success, the earlier and faster the better.
Of course, if the market adoption analogy is applied strictly to PAT, it like all 'products' or 'markets' has a finite lifetime before it goes into decline and is replaced by the 'next generation'. What this next generation of PAT will be and look like will depend on the success of this first generation. No doubt the next generation of regulatory, industry, and vendor Innovators are thinking about this already.
Brian Davies is director of PAT at Thermo Electron Corporation, USA.