**1. Introduction**

Nanotechnology-enabled drug delivery systems (NDDS) are associated with high expectations regarding their economic and societal value. NDDS are expected to contribute to important issues in healthcare such as enabling novel pharmaceutical therapies which only target the site of the disease and help to reduce costs of healthcare. To date, more than two dozen NDDS have been developed into marketed products and many more are under development [1]. Market forecasts have estimated that the market for these technologies will grow from US\$ 1 billion in 2010 to US\$ 136 billion in 2021 [2, 3].

The pronounced expectations surrounding nanotechnology-enabled drug delivery applica‐ tions and its claimed market potential suggest that the path toward market introduction is clear. This is however not the case, as is often with newly emerging technologies. While for instance claims have been made about NDDS contributing to a reduction of undesirable side effects of drugs (compared to conventional delivery systems), to date limited clinical data is available to actually support such claims. Uncertainties about the application of regulatory regimes and which methodologies to apply in order to assess novel nanotechnology-enabled drug carriers have created further challenges for firms to introduce new products on the market.

Making promises is almost inevitable in order to attract attention and mobilize resources. However, too broad promises may make sponsors such as large pharmaceutical companies and venture capitalists reluctant. Uncertainties about the performance of specific future drug delivery systems, the demand for such technologies and how they will be evaluated by

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regulatory authorities have contributed to impasses, 'waiting games' as we have called them [1, 4] which constrain development and potential market introduction of NDDS.

new technologies become embedded is difficult in itself, due to uncertainties regarding how new products will eventually look like and their impacts. Anticipation of how other involved actors perceive and cope with parts of the embedding process and what this means for individual actors' strategies then introduces further complexities. Yet, taking into account these perspectives and strategies is exactly what is important in the case of the drug delivery sector, which consists of an intersection of different value chains with a large number of mutually dependent actors. Then how to anticipate future market introduction and embedding of nanotechnology-enabled drug delivery systems? How to support articulation of anticipa‐ tory strategies and decision making of, say academic and business entrepreneurs, taking into

Anticipating Market Introduction of Nanotechnology-Enabled Drug Delivery Systems

http://dx.doi.org/10.5772/57180

503

The question of anticipation of future introduction and embedding of NDDS is a common challenge of emerging technologies. Within the field of technology assessment a number of approaches have been developed to deal with uncertainties of emerging technologies empha‐ sizing interactive anticipatory approaches such as real-time technology assessment [7], anticipatory governance [8], interaction research in lab-settings [9] and constructive technol‐ ogy assessment [10]. Such approaches are devised to support stakeholders in their anticipatory competences and to support strategies and decision making. These approaches differ in terms of scope, i.e. which dynamics and actors are taken into account, and in their main target

In this chapter I will focus on the approach of Constructive Technology Assessment (CTA) which has a particular emphasis on exploring future developments with stakeholders in a domain and feeding insights back to researchers and technology developers. This approach is by now well established and has been applied for different nanotechnologies and their applications. I will describe the methodology of CTA scenario workshops and demonstrate the approach by offering the results of a study [11] where this approach was used to map and support anticipation of opportunities and challenges of nanotechnology-enabled drug

In section 2 I will start with offering a general perspective on how different types of actors perceive and assess emerging technologies. This is important to recognize when interacting with a variety of involved actors and forms the backdrop against which I position the meth‐ odology and approach of Constructive Technology Assessment and its scenario workshops. I will describe the CTA methodology and discuss how to organize and prepare for such interactive workshops. In section 3 I will set the scene for the workshops by briefly describing the main actors involved in the drug delivery sector and the promises of NDDS. In section 4 I will report on the preparation of the workshops and discuss in detail the main lines of discussion in the workshop and participants' assessments of the situation in which the drug delivery sector finds itself regarding emerging nanotechnologies. In section 5 I will conclude by summarizing main findings and reflecting on the merits of the CTA approach for antici‐ pating, and supporting anticipation of, market introduction of nanotechnology-enabled drug

account other actors' perspectives in the domain of drug delivery systems?

audience, i.e. whose strategy articulation and assessment is actually supported.

delivery technologies.

delivery systems.

In such uncertain and ambiguous situations actors need to make sense of what is happening already and what might happen [5], before taking a specific course of action. There are two main strategies available to developers of NDDS to handle this challenging situation. Aca‐ demic entrepreneurs and firms interested in developing and introducing NDDS on the market may view uncertainties regarding performance and value inevitable and/or postpone such discussions until a later stage and wait for the 'invisible hands' of the market to do its proverbial work. Or, they can anticipate reception of new products and interact with the broader environment to work towards the market introduction of what they consider to be desirable products.

Pro-active interactions will have to go beyond the promotion of promises of nanotechnologyenabled drug delivery systems in anticipation of the opening up of new markets. Market success of newly introduced NDDS products involves more than attractive sales figures. Deuten et al. [6] argued for broadening the notion of market success by thinking in terms of what they call 'societal embedding'. They characterized societal embedding by three dimen‐ sions (p. 132): (1) Integration: new technologies need to be integrated in industries and markets; that is, within business practices and repertoires of users, in this case clinicians and patients. (2) Admissibility: new products need to be acceptable according to rules and standards within the sector or set by the government. Think for instance of good manufacturing practices, preclinical testing and clinical trials. (3) Acceptance: new products have to be accepted by the public. That is, societal concerns should not be too strong, there should be sufficient articulation in order to make well-informed choices by clinicians and patients, and the product should actually be used.

Pro-active action then requires taking a broader perspective than that of a single actor, saying an academic researcher or a start-up firm with a patent in the field of NDDS. Societal embed‐ ding involves a variety of issues which create openings for different actors - who have different interests in, and perspectives on, emerging NDDS - to engage in strategic actions and interac‐ tions. In the drug delivery sector, firms, governmental bodies, health insurers, scientists, clinicians and patient organizations are all more or less involved in interactions with respect to one or more dimensions of societal embedding. Thus, important dynamics related to the market introduction of NDDS exist at the level of the drug delivery sector rather than at the level of individual academic or business entrepreneurs. Put differently, for the market introduction of NDDS entrepreneurial individuals and organizations are dependent on interactions with other players in the sector which is beyond their full control. Pro-active action then requires understanding of what happens at the level of the domain and feeding back such insights into individual or collective strategies to further development and market introduc‐ tion of NDDS.

Anticipation on future market introduction and embedding may seem the wiser option compared to trial-and-error strategies, but is also difficult and precarious. Anticipation on how new technologies become embedded is difficult in itself, due to uncertainties regarding how new products will eventually look like and their impacts. Anticipation of how other involved actors perceive and cope with parts of the embedding process and what this means for individual actors' strategies then introduces further complexities. Yet, taking into account these perspectives and strategies is exactly what is important in the case of the drug delivery sector, which consists of an intersection of different value chains with a large number of mutually dependent actors. Then how to anticipate future market introduction and embedding of nanotechnology-enabled drug delivery systems? How to support articulation of anticipa‐ tory strategies and decision making of, say academic and business entrepreneurs, taking into account other actors' perspectives in the domain of drug delivery systems?

regulatory authorities have contributed to impasses, 'waiting games' as we have called them

In such uncertain and ambiguous situations actors need to make sense of what is happening already and what might happen [5], before taking a specific course of action. There are two main strategies available to developers of NDDS to handle this challenging situation. Aca‐ demic entrepreneurs and firms interested in developing and introducing NDDS on the market may view uncertainties regarding performance and value inevitable and/or postpone such discussions until a later stage and wait for the 'invisible hands' of the market to do its proverbial work. Or, they can anticipate reception of new products and interact with the broader environment to work towards the market introduction of what they consider to be desirable

Pro-active interactions will have to go beyond the promotion of promises of nanotechnologyenabled drug delivery systems in anticipation of the opening up of new markets. Market success of newly introduced NDDS products involves more than attractive sales figures. Deuten et al. [6] argued for broadening the notion of market success by thinking in terms of what they call 'societal embedding'. They characterized societal embedding by three dimen‐ sions (p. 132): (1) Integration: new technologies need to be integrated in industries and markets; that is, within business practices and repertoires of users, in this case clinicians and patients. (2) Admissibility: new products need to be acceptable according to rules and standards within the sector or set by the government. Think for instance of good manufacturing practices, preclinical testing and clinical trials. (3) Acceptance: new products have to be accepted by the public. That is, societal concerns should not be too strong, there should be sufficient articulation in order to make well-informed choices by clinicians and patients, and the product should

Pro-active action then requires taking a broader perspective than that of a single actor, saying an academic researcher or a start-up firm with a patent in the field of NDDS. Societal embed‐ ding involves a variety of issues which create openings for different actors - who have different interests in, and perspectives on, emerging NDDS - to engage in strategic actions and interac‐ tions. In the drug delivery sector, firms, governmental bodies, health insurers, scientists, clinicians and patient organizations are all more or less involved in interactions with respect to one or more dimensions of societal embedding. Thus, important dynamics related to the market introduction of NDDS exist at the level of the drug delivery sector rather than at the level of individual academic or business entrepreneurs. Put differently, for the market introduction of NDDS entrepreneurial individuals and organizations are dependent on interactions with other players in the sector which is beyond their full control. Pro-active action then requires understanding of what happens at the level of the domain and feeding back such insights into individual or collective strategies to further development and market introduc‐

Anticipation on future market introduction and embedding may seem the wiser option compared to trial-and-error strategies, but is also difficult and precarious. Anticipation on how

[1, 4] which constrain development and potential market introduction of NDDS.

products.

502 Application of Nanotechnology in Drug Delivery

actually be used.

tion of NDDS.

The question of anticipation of future introduction and embedding of NDDS is a common challenge of emerging technologies. Within the field of technology assessment a number of approaches have been developed to deal with uncertainties of emerging technologies empha‐ sizing interactive anticipatory approaches such as real-time technology assessment [7], anticipatory governance [8], interaction research in lab-settings [9] and constructive technol‐ ogy assessment [10]. Such approaches are devised to support stakeholders in their anticipatory competences and to support strategies and decision making. These approaches differ in terms of scope, i.e. which dynamics and actors are taken into account, and in their main target audience, i.e. whose strategy articulation and assessment is actually supported.

In this chapter I will focus on the approach of Constructive Technology Assessment (CTA) which has a particular emphasis on exploring future developments with stakeholders in a domain and feeding insights back to researchers and technology developers. This approach is by now well established and has been applied for different nanotechnologies and their applications. I will describe the methodology of CTA scenario workshops and demonstrate the approach by offering the results of a study [11] where this approach was used to map and support anticipation of opportunities and challenges of nanotechnology-enabled drug delivery technologies.

In section 2 I will start with offering a general perspective on how different types of actors perceive and assess emerging technologies. This is important to recognize when interacting with a variety of involved actors and forms the backdrop against which I position the meth‐ odology and approach of Constructive Technology Assessment and its scenario workshops. I will describe the CTA methodology and discuss how to organize and prepare for such interactive workshops. In section 3 I will set the scene for the workshops by briefly describing the main actors involved in the drug delivery sector and the promises of NDDS. In section 4 I will report on the preparation of the workshops and discuss in detail the main lines of discussion in the workshop and participants' assessments of the situation in which the drug delivery sector finds itself regarding emerging nanotechnologies. In section 5 I will conclude by summarizing main findings and reflecting on the merits of the CTA approach for antici‐ pating, and supporting anticipation of, market introduction of nanotechnology-enabled drug delivery systems.
