Innovative and responsible governance of nanotechnology for societal development

Abstract

Governance of nanotechnology is essential for realizing economic growth and other societal benefits of the new technology, protecting public health and environment, and supporting global collaboration and progress. The article outlines governance principles and methods specific for this emerging field. Advances in the last 10 years, the current status and a vision for the next decade are presented based on an international study with input from over 35 countries.

Appendix. Examples of achievements and paradigm shifts

Regional partnerships in nanotechnology

Skip Rung, Oregon Nanoscience and Microtechnologies Institute (ONAMI)

Since the establishment of the NNI in 2001, numerous state, regional, and local partnerships have arisen, dedicated completely or in part to the advancement of nanotechnology. These partnerships may be grouped into seven major categories:

• State-backed organizations to enhance nanotechnology research capacity and state-funded programs to grow startup companies, with significant, but not exclusive, focus on nanotechnology (e.g., ONAMI and the Oklahoma Nanotechnology Initiative)

• State-funded programs to grow startup companies, some exclusive (e.g., Albany Nanotech) and other with significant, but not exclusive, focus on nanotechnology (e.g., Ben Franklin Technology Partners)

• Academically oriented infrastructure investments by states, including cost-share support from private sources (e.g., California NanoSystems Institute)

• Member-funded state/local trade associations (e.g., Colorado Nanotechnology Alliance)

• Member-funded national/international nanotechnology trade associations (e.g., NanoBusiness Alliance and the Silver Nanotechnology Working Group)

• Industry-sponsored academic-industry consortia (e.g., Western Institute of NanoElectronics)

• Industry-inspired fundamental research for an industry sector (e.g., Nanoelectronics Research Initiative involving NSF since October 2003 and NIST since 2007)

Funding, sustainability, and operational success for these kinds of partnerships can only occur in strong alignment with important stakeholder objectives that are able to out-compete other initiatives seeking public or voluntary private support. In the case of state investment (the majority of cases), the sole motive is economic development, requiring credible results in terms of jobs (ideally) or at least financial leverage. There is increasing pressure for such initiatives to become “self-supporting” (although with private and Federal funds), even in the case of activities for which the state economy is the primary beneficiary.

In the next 10 years, as the NNI increases its emphasis on commercialization, two regional/state initiative models can be expected to grow in importance. The first model, “High Tech Extension” (Fig. 6) is the direct connection of nanotechnology infrastructure to existing businesses, helping them improve existing products, develop new products, and expand employment. Easy and economical access to resources such as nanoscale materials characterization can expand the impact of nanoscience to a broader swath of the economy.

Fig. 6

Nanoscience facilities and equipment can best benefit technology development when they are conveniently located and easy to use by businesses. Such access is especially important to the small and medium size enterprises that are critical for early-stage commercialization. State and regional economic development field staff can serve as “high-tech extension” agents

The second model, known as “Gap Funding,” is accelerated commercialization assistance to entrepreneurial ventures (e.g., SMEs, university and/or corporate spinouts) in the form of technology transfer and early-stage funding on favorable terms. While SBIR and STTR awards are vital tools in this regard, locally managed capital with an emphasis on launching growth companies is a necessary addition to the portfolio of commercialization programs, and one which lends itself well to Federal partnerships with state/regional initiatives. Federal and state partnerships for the “gap funding” of new ventures that commercialize NNI-funded technology R&D could accelerate commercialization by 2–4 years and ensure a focus on economic returns and job creation. The “gap” to be traversed with proposed short-term funding assistance is also known as the “valley of death” between business startup and commercial profitability.

Examples of research projects on societal implications established by NSF

Mihail C. Roco, National Science Foundation

Table 4 lists the many projects established by the National Science Foundation through 2010 to support research on societal implications of nanotechnology research, development, and commercialization. (A number of these projects also support outreach to inform the American public regarding nanotechnology issues and involve them in governance discussions.)

Table 4 Examples of NSF-sponsored projects supporting social implications inquiry, 2001–2010

Center for nanotechnology in society at ASU

David Guston, Arizona State University

The Nanoscale Science and Engineering Center/Center for Nanotechnology in Society at Arizona State University (NSEC/CNS-ASU; http://cns.asu.edu) was established on October 1, 2005, with funding from the National Science Foundation. CNS-ASU combines research, training, and engagement to develop a new approach to governing emerging nanotechnology. The center uses the research methods of “real-time technology assessment” (RTTA) and guides them by a strategic vision of anticipatory governance. The anticipatory governance approach consists of enhanced foresight capabilities, engagement with lay publics, and integration of social science and humanistic work with nanoscale science and engineering research and education (Guston 2008; Wetmore et al. 2008). Although based in Tempe, Arizona, CNS-ASU has major partnerships with the University of Wisconsin–Madison and the Georgia Institute of Technology, plus a network of other collaborators in the United States and abroad.

CNS-ASU has two types of integrated research programs, as well as educational and outreach activities (which are themselves integrated with research). Its two thematic research clusters, which pursue fundamental knowledge and create linkages across the RTTAs, are “Equity, Equality and Responsibility” and “Urban Design, Materials, and the Built Environment.” The Center’s four RTTA programs are:

• Research and Innovation Systems Assessment, which uses bibliometric and patent analyses to understand the evolving dynamics of the NSE enterprise

• Public Opinion and Values, which uses surveys and quasi-experimental media studies to understand changing public and scientists’ perspectives on NSE

• Anticipation and Deliberation, which uses scenario development and other techniques to foster deliberation on plausible NSE applications

• Reflexivity and Integration, which uses participant-observation and other techniques to assess the center’s influence on reflexivity among NSE collaborators

The center’s major conceptual-level achievement has been validating anticipatory governance as a richly generative strategic vision. Its three major operations-level achievements are: (1) completing the “end-to-end” assessment to create novel insights in a study of nanotechnology and the brain; (2) deepening the integration of NSE researchers into CNS-ASU; and (3) building collaborations for informal science education (ISE) on the societal aspects of NSE. Programmatic achievements include establishing an internationally adopted definition of nanotechnology to assemble and mine bibliographic and patent databases; conducting two national public opinion polls and a poll of leading nano-scientists; conducting the first National Citizens’ Technology Forum on nanotechnology for human enhancement (Fig. 7); demonstrating that interactions between NSE researchers and social scientists can generate more reflexive decisions; sustaining an international research program on NSE and equity; and laying the foundations for a new research program in urban design, materials, and the built environment.

Fig. 7

Participants in the first National Citizens’ Technology Forum on Nanotechnology and Human Enhancement, conducted by CNS-ASU in March 2008 (courtesy of David Guston)

Center for nanotechnology in society at UCSB

Barbara Harthorn, University of California, Santa Barbara

The Center for Nanotechnology in Society at the University of California, Santa Barbara (CNS-UCSB), promotes the study of societal issues connected with emerging nanotechnology in the United States and around the globe. It serves as a national research and education center, a network hub among researchers and educators concerned with innovation and responsible development of nanotechnology, and a resource base for studying these issues in the United States and abroad. The work of the CNS-UCSB is intended to include multiple stakeholders in the analysis of nanotechnology in society and in discussion through outreach and education programs that extend to industry, community, and environmental organizations, policymakers, and diverse publics.

The intellectual aims of CNS-UCSB are twofold: to examine the emergence and societal implications of nanotechnology with a focus on the global human condition in a time of sustained technological innovation; and to apply empirical knowledge of human behavior, social systems, and history to promote the socially and environmentally sustainable development of nanotechnology in the United States and globally. These aims motivate research from many theoretical and methodological perspectives, provide the basis for industry–labor–government–academic–NGO dialogues, and organize the mentoring of graduate, undergraduate, and community college students and postdoctoral researchers.

CNS-UCSB researchers address a linked set of social and environmental issues regarding the domestic U.S. and comparative global creation, development, commercialization, consumption, and regulation of specific nano-enabled technologies for energy, water, environment, food, health, and information technology. The center addresses questions of nanotechnology-related societal change through research that encompasses three linked areas:

• Historical context of nanotechnology

• Nanotechnology and globalization, with an emphasis on East and South Asia

• Nanotechnology risk perception and social response studies among experts and publics; media framing of nanotechnology risks; and methods for engaging diverse U.S. publics in upstream deliberation about new technologies

CNS-UCSB has close ties with the internationally prominent nanoscience researchers at UCSB who are connected with the university’s California NanoSystems Institute, Materials Research Laboratory, and National Nanotechnology Infrastructure Network; with ecotoxicology researchers in the UC Center for Environmental Implications of Nanotechnology (UC CEIN); and with social science research centers focused on relations among technology, culture, and society. U.S. collaborators are based at UC Berkeley, Chemical Heritage Foundation, Duke University, Quinnipiac University, Rice University, State University of New York (SUNY) Levin Institute, SUNY New Paltz, University of Washington, and University of Wisconsin. Collaborators abroad are based at Beijing Institute of Technology, Cardiff University, Centre National de la Recherché Scientifique, University of British Columbia, University of East Anglia, University of Edinburgh, and Venice International University.

CNS-UCSB’s novel graduate educational program co-educates societal implications and nanoscale science and engineering students. UCSB graduates in nanoscale science and engineering participate in CNS-UCSB research on, for example, science policy analysis, media coverage analysis, public deliberation, expert interviews on risk and innovation, Chinese patent analysis, and comparative state R&D policies.

Governance toward sustainable nanotechnology

Jeff Morris, U.S. Environmental Protection Agency

One objective of U.S. EPA’s Nanomaterial Research Program is to shift thinking and behavior from managing risk to preventing pollution. Preventing pollution is one of main themes in the EPA Nanomaterial Research Strategy (http://www.epa.gov/nanoscience), while other themes directly support EPA research to understand what properties of different nanoscale materials may cause them to be, among other things, mobile, persistent, and/or bioavailable. This and other exposure-related information, together with research on what specific nanomaterial properties may influence toxicity, can inform the use of green chemistry and other approaches to foster the responsible design, development, and use of nanomaterials, including nanotechnology uses that directly or indirectly advance environmental protection. In addition to ensuring that existing nanomaterials are environmentally sustainable, EPA also needs to look for creative ways to develop nanomaterials in a sustainable manner.

The environmentally friendly research by EPA seeks to demonstrate how toxic chemicals can be avoided while producing nanoparticles and has been applied to one promising application: technology for cleaning up pollution that uses nanoscale zero valent iron (NZVI) to promote the breakdown of contaminants in ground water. The EPA team began by making NZVI by mixing tea with ferric nitrate. This process did not use any hazardous chemicals, such as sodium borohydride, which is commonly used to make nanoparticles. Not only did the process eliminate the use of hazardous chemicals, but the nanoparticles showed no significant signs of dermal toxicity. The researchers next used grape extract to make high-quality nanocrystals of gold, silver, palladium, and platinum (Nadagouda et al. 2010). The message behind this example is that moving toward sustainable nanotechnology means incorporating new thinking into materials research and development. The EPA research may or may not lead to “green nano” materials that can be commercialized. Nevertheless, it demonstrates that it is feasible to synthesize nanoparticles using nontoxic inputs, and that the real limits to the development and application of green chemistry approaches for nanotechnology lie in our own ingenuity.

Public participation in nanotechnology debate in the United States

David Berube, North Carolina State University

Public participation in science and technology debate has been convincingly shown to matter for normative, instrumental, and substantive purposes, and indeed this “participatory turn” is now evident in many countries (Harthorn 2010). In particular, effective public participation can serve a vital instrumental role in development of trust—essential in the nanotechnology case given the uncertainties about safety, extent of benefits, and longer term social risks. The NNI, through the NSF, has supported a number of efforts to include the public in science and technology policy decision making through a number of different formats and programs (see Guston 2010a). Activities range from informal science outreach at museums (NISEnet), to science café–type informal community discussions at a number of sites, to longer-term informal “citizen schools” (e.g., at the University of South Carolina), and to multi-sited national engagement consensus conferences (CNS-ASU) and comparative cross-national public deliberations (CNS-UCSB). CNS’s Public Communication of Science and Technology is conducting engagement activities on public perception of risks of nanoscience and on nanotechnology and food.

CNS-ASU’s National Citizens’ Technology Forum was modeled after Danish consensus conference but distributed across six U.S. locales. The NCTF on “nanotechnology and human enhancement” demonstrated that a high-quality deliberative activity can be organized at a national scale in the United States, and that a representative selection of lay citizens can come to discerning judgments about nanotechnology developments while they are still emergent (Hamlett et al. 2008). CNS-UCSB’s 2007 comparative U.S.-UK public deliberations were modeled on UK upstream deliberation efforts and included a between-groups design to compare deliberations on nanotechnology applications for energy and for health in the two countries (Pidgeon et al. 2009a, b). More recently CNS-UCSB in 2009 conducted an additional set of workshops, in deliberative groups, to examine more closely the role of gender differences, a consistent factor in diverging public views on risks.

About 53% of the public in the United States perceives little to no risk from nanotechnology (Berube et al. 2010). The only nanotechnology applications to which the public regularly applies high negative EHS footprints are food-related. Important variables determining public perceptions of risk seem to be educational levels and socioeconomic categories more than cultural or religious identifiers, though culture and religion can be correlated to education and socioeconomic status.

There is a growing population of “newsless” Americans who do not seek out news from either traditional sources or digital media sources. Also, there is a growing body of Americans known as “net-newsers” who get most of their news information from Internet resources (Pew Research Center for the Public and the Press 2010). While some net-newsers clearly draw from traditional news that has migrated to the web, a growing number are turning to resources associated with the term “Web 2.0.” These two phenomena pose special challenges for engaging the public in effective nanotechnology governance discussions. We must find new and creative ways to reach the newsless, and we must find creative ways to use social media engagement platforms to reach those individuals who are net-newsers. The swing toward net-newsing also means that much of what social science knows about the amplification of risk, which traditionally has been drawn from newspapers and television, will likely need to be reexamined.

Scenarios approach: the nanofutures project

Cynthia Selin, Arizona State University

The future of nanotechnology is not preordained and can therefore not be predicted. There are critical uncertainties surrounding both the technological pathways and the societal implications of discoveries on the nanoscale. The development of nanotechnology depends on choices made today, choices that occur throughout society in the boardroom, within the laboratory, in the legislature, and in shopping malls. There are numerous complex, interrelated variables that impinge upon what nanotechnology will ultimately look like in 10 years’ time.

Future-oriented methods like scenario planning provide a means to structure key uncertainties driving the coevolution of nanotechnology and society (Selin 2008). These critical uncertainties range from the health of the U.S. economy, to regulatory frameworks, to public opinion, to the actual technical performance of many of nanotechnology’s projected products. Anticipation and foresight, as opposed to predictive science, provide means to appreciate and analyze uncertainty in such a way as to maximize the positive outcomes and minimize the negative outcomes of nanotechnology (Barben et al. 2008; Youtie et al. 2008). The value of scenario development in particular is to rehearse potential futures to identify untapped markets, unintended consequences, and unforeseen opportunities.

Three application areas are important to assess the prospective benefits and risks of nanotechnology:

• Health and medicine: Nanotechnology promises many breakthroughs in cancer treatment, drug delivery, and personalized medicine. The CNS has looked systematically at emerging diagnostic technologies and determined that critical choices revolve around the reliability and security of the data produced by the device and how well the device is managed and integrated within the larger medical system. If portable, fast, and reliable medical diagnostics are to yield positive societal benefits, questions regarding access must be adequately addressed.

• Climate and natural resources: Nanotechnology’s development can be directed towards overcoming many of the planet’s most urgent ills by generating products and processes that focus on conserving, protecting, and extending natural resources. One CNS-ASU scenario focused on generating drinkable water from air, which could enable off-the-grid survival and begin to address global demands for clean water.

• Energy and equity: Nanotechnology has much to offer towards producing greater efficiencies and cost savings in the energy domain. One particular scenario examined using nanotechnology-enhanced coolants to boost nuclear power generation. Describing such a future technology as a scenario provides a means to assess the broader barriers to and carriers of the innovation.

These anticipation and foresight approaches may take a variety of forms from traditional scenario planning to experiments with virtual gaming, simulation modeling, deliberative prototypes, and training modules. Such tools enable the scientific enterprise to become more responsive to shifting societal, political, and economic demands to produce more robust and relevant discoveries that address contemporary and future needs proactively.

Large nanotechnology firms as the primary source of innovation and under-commercialization

Nina Horne, University of California, Berkeley

A small number of large multinational firms are responsible for a significant portion of nanotechnology patenting activity, yet competitive strategies artificially reduce their ability to commercialize products. New policies can change this trend.

Since 2000, nanotechnology discovery and innovation have flourished; nanotechnology has now reached the broad diffusion point of a general-purpose technology (Graham and Iacopetta 2009). Large multinational enterprises (LMEs) remain the locus of most nanotechnology innovation relative to small and medium enterprises (SMEs) and universities, with moderate relative change over time (Table 5). Innovation occurs within LMEs due to the clustering of capital, including equipment and technically proficient labor, combined with deep market knowledge that maximizes application development.

Table 5 Top nanotechnology patent holders

Patenting is more concentrated in 2010 as compared to 2000, with over a quarter of all U.S. nanotechnology patents issued held by only twenty entities. And as of 2008, private R&D investment is now larger than public R&D investment. Moreover, LMEs now represent the largest source of capital annually, with less than 5% of total funding coming from the generally recognized source of innovation, venture capital. While this balance of relatively higher private funding is desirable, it further underscores the dominance of LMEs and the importance of ensuring high commercialization efficiencies for broader economic good.

Private firms are both effective commercialization drivers and a significant source of commercialization inefficiency. In all technology areas, at least one-third of technology products fully vetted through technical and market testing are not launched to market. Consistent findings of significant suppression rates emerge from empirical data across multiple applied nanotechnology market sectors sharing similar characteristics in the overall nanotechnology market, including longer exit periods and high initial capital investment requirements. The percentage of technically and market-ready products not released to the market is on average between 40 and 50 percent (for technology products, see Cooper 2001; for pharmaceutical products, see Carrier 2008). The impact of regulatory review on pharmaceutical suppression is higher, of course, than for technology products. Policies to drive out sleeping patents are common in many industrialized nations via compulsory licensing and march-in clauses. These policies have been shown empirically to be ineffective due to significant underuse; firms do not use licenses because first-moving firms bear the costs, whereas subsequent firms would benefit financially (Carlton and Perloff 2000).

The implications for 2020 are significant. Under current trends, continued government investment in basic and applied R&D combined with general economic recovery will create continued patenting and spin-out growth over the mid-term, despite a short-term shortage of venture capital funding. At the same time, a significant number of nanotechnology patents will be concentrated to a smaller set of actors. As a result, a limited number of large firms will continue to serve as both a significant source of intellectual property and under-commercialization in the near- and mid-terms. New policies to effectively drive out sleeping patents can increase nanotechnology’s broader economic impact. Specifically, auctions across multiple-sector firms will offset the underuse of compulsory licensing; auctions should be carefully constructed to avoid distortions.

The goal of nanotechnology patent auctioning is to incentivize firms to release unused intellectual property (IP) by providing short- and mid-term profit for patents. With compulsory licensing, the number of potential bidders, and therefore the short-term valuation of intellectual property, are lower as compared to an open-auction market. Auctioning eliminates the weakness of compulsory licensing, as first-moving firms assume both the costs and the financial rewards of IP reassignment. Two factors determine the type of auction that would create the greatest efficiency: private value, in which bidding firms may have relevant IP that would significantly increase the value of an auctioned IP, and information asymmetry, in which bidding firms may have knowledge of the auctioned IP that would affect valuation. Given that nanotechnology products generally require many patents to create a final product, the withholding of a single patent critical to the success of a product could produce artificially high bids relative to the real value of the patent, simply due to timing. Concurrent rather than subsequent auctioning would prevent the overvaluation of such critical patent technology. Therefore, a uniform-price auction, otherwise known as a second-price sealed bid or Vickrey auction of multiple nanotechnology patents, would produce the most efficient reallocation of patents.

Decision making with uncertain data

Jeff Morris, U.S. Environmental Protection Agency

The history of regulation of industrial chemicals shows that regulatory agencies such as EPA have been unable to keep pace, in terms of acquiring and evaluating risk-related information, with the introduction of chemicals into society.³ Yet it seems to be accepted by many government, industry, and NGO stakeholders that the appropriate path for nanotechnology governance is to follow the regulatory science model that has been used for decades for industrial chemicals.⁴ This acceptance has important implications for the U.S. regulatory agencies under whose mandates nanotechnology risk issues fall. Christopher Bosso (2010) has identified institutional capacity as a major issue arising from nanotechnology stakeholders’ agreements that large amounts of data will be needed to inform decisions related to nanotechnology’s environmental implications. Given the inability of regulatory agencies to adequately address the assessment needs of traditional industrial chemicals, it seems unlikely that regulators will have the capacity to keep up with nanotechnology’s regulatory demands unless they adopt new approaches to governing the introduction of new substances, including but not limited to nanoscale materials, into society.

Related to institutional capacity is another issue raised by Bosso (2010), the trade-off between taking action to anticipate risks and acquiring sufficient information to make defensible decisions about risks. Regulatory agencies traditionally have needed a large body of evidence to make decisions on chemical risks. It will take years, if not decades, to develop hazard and exposure databases as large as currently exist for such substances as asbestos.⁵ The dilemma, therefore, is how to instill anticipatory, risk-preventative behavior in governance institutions when little regulatory science data exist. If those responsible for environmental decision making embrace the existing chemical assessment model as the principal approach to nanotechnology governance, the balance between being anticipatory and generating robust risk-information databases likely will become increasingly difficult and contentious.

The idea of anticipatory technology evaluation for nanomaterials fits within a larger national and global movement toward sustainable chemical, material, and product development and use. The people who invent, design, synthesize, fabricate, incorporate into products, use, regulate, and dispose of or recycle chemicals and other materials—including nanoscale materials—in many cases do not have adequate information (including but not limited to physical–chemical and/or material properties, life cycle, hazard, fate, exposure) to make decisions that lead to those chemicals or materials being designed, created, and managed in an environmentally sustainable manner. Nor do they often have information on the inputs (e.g., energy, starting materials) that go into, and the emissions that are released from, the fabrication of these substances. Without such information, environmental decision makers will not be able to overcome the current backlog of unassessed chemicals (including, increasingly, nanomaterials), let alone address the impacts of new materials from emerging technologies, such as nanoscale materials. The recent introduction of a TSCA reform bill in the United States, together with the European Community’s progress toward implementing REACH, adds impetus to the need for innovative solutions to assessment approaches oriented toward the green design of chemicals, materials, and products.

Penetration of nanotechnology in therapeutics and diagnostic

Mostafa Analoui, The Livingston Group, New York, NY

The past decade has witnessed a strong surge in research and product development around utilization of nanotechnology in life sciences. During 2000-2010, nanotechnology publications and patents have shown a steady growth, while for nanobiotechnology the trend is showing a much faster growth, reflecting additional scientific investment both by public and private sectors (Delemarle et al. 2009). This steady increase in scientific output and creation of intellectual properties, however, has not been matched with a similar pattern in investment, product development and commercialization (Business Insights 2010). This discrepancy in evolution of knowledge and market introduction is a common characteristic of innovative and emerging technologies.

An overwhelming level of investment is currently focused on reformulation and novel delivery of existing chemical and molecular entities. Consistently, more than 60% of nanomedicine R&D is allocated to this segment. There are several outstanding and successful developments. Perhaps the hallmark of such activities can be summarized in the journey that Abraxis took for development of nano-albumin formulated of paclitaxol (product known as Paclitaxel), one of the most cytotoxic agents. Abraxane has promised a safe therapy at much higher doses. Abraxane received FDA clearance for metastatic breast cancer in January of 2005. Since then, Abraxane has been prescribed to an increasing number of patients, with expanding indications. This product had more than $350 million sales in 2009 and was cornerstone for acquisition of Abraxis by Celgene for $2.9 billion. This is the largest merger and acquisitions deal to date in the nanomedicine field.

Examples of nano-formulated drugs approved and in the market are listed in Table 6, showing a market size of more than $2.6 billion in nanotechnology-based therapeutics in 2009, with no product in the market in 2000.

Table 6 Selected nano-based therapeutics and their 2009 sales

With more than $120 billion pharmaceutical products losing their patent protection between 2009 and 2014, this has started an avalanche of R&D and investment, which should come to fruition for patients and investors during 2010–2020. Perhaps the most promising products yet to come or new chemical/molecular entities based on a rational nanoscale-design addressing major chronic diseases such as Alzheimer’s disease (AD), osteoarthritis and rheumatoid arthritis (OA/RA) and major improvement therapeutics for ophthalmic diseases such as Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME). With current pipeline and increased R&D investment, some landscape-shifting management of such diseases via nanomedicine products is anticipated.

Nanotechnology-based diagnostics has gone through a significant landscape shift since 2000, when key promising areas (as a combination of ongoing research and blue-sky thinking) included nano-based contrast agents, nano-arrays for label-free sequencing, highly sensitive and specific assays and passive sensors. Quantum dots (QDs) received broad attention as a promising optical contrast agent for in vitro and in vivo biological imaging. Despite significant progress in R&D on QDs, concerns with toxicity have prevented utilization of this product for human imaging. Nevertheless, there has been a significant program in enhancing several in vivo contrast agents (for CT and MR imaging), as well as in the introduction and validation of new class of agents that is expected to find their ways in clinical practice in next decade. Additionally, nano-based arrays and assays are gradually coming out of research laboratories into clinical markets. More than 50 companies are developing nanoparticle-based medicines for treating, imaging and diagnosing cancer in 2010 in the U.S. alone (Service, 2010).

An example of such development is ultrasensitive detection of protein targets, using nanoparticle probe technology developed by Nanosphere, Inc. Nanosphere is using its patented gold nanoparticle probe technology to develop rapid, multiplexed clinical tests for some of the most common inherited genetic disorders, including certain types of thrombophilia, alterations of folate metabolism, cystic fibrosis, and hereditary hemochromatosis. Also, it must be noted that Nanosphere is a recent, pure-play nanodiagnostic company, which went public through IPO in 2007.

Currently nanodiagnostics concepts focus around utilization of nanoscale properties for:

• Ultrasensitive biomarker development/measurement

• Multi-assay for real-time in vitro assessment

• Clinical nano-tracers and contrast agents for establishing disease stage, drug PK/PD and monitoring therapy

Successful development of such ensembles of therapeutics and diagnostics for drug development will eventually lead to more effective utilization in clinical practice, with the promise of moving toward “personalized medicine.” Figure 8 compares historical and future market size for therapeutics and diagnostics products.

Fig. 8

Historical and projected markets for nanotherapeutics (Tx) and nanodiagnostics (Dx) (baseline data and compounded annual growth rates are based on BCC Research 2010)

While we are not at a stage to claim availability of “personalized medicine” today (although depending on a chosen definition, one may claim this has been practiced in medicine for quite some time), we have certainly come a long way since 2000. In the next 10 years, nanotechnology is projected to make even greater contributions compared to the past 10 years (Table 7). Convergence of nanodiagnostics and nanotherapeutics, along with better understanding of the etiology of diseases, should provide game-changing solutions for prevention of disease, more effective patient management, and enhancing quality of life globally.

Table 7 Major trends and projection in nanotherapeutics and nanodiagnostics 2000–2020

Products enabled with nanotechnology generated $254 billion in 2009

Jurron Bradley, Lux Research

Since the U.S. National Nanotechnology Initiative sparked a boom of interest in the early 2000 s, nanotechnology has enticed entrepreneurs, financiers, and corporate leaders with its potential to create value in a wide range of products and industries. For example, in 2009 businesses generated $254 billion in revenue from products touched by emerging nanotechnology, which is defined as the purposeful engineering of matter at scales of less than 100 nm to achieve size-dependent properties and functions.

There are three stages of the nanotech value chain, including nanomaterials (raw materials that make up the base of the nanotechnology value chain), nanointermediates (intermediate products—neither the first nor the last step in the value chain—that either incorporate nanomaterials or have been constructed from other materials to have nanoscale features) and nano-enabled products (finished goods at the end of the value chain that incorporate nanomaterials or nanointermediates). About 88% of 2009 revenue came from nano-enabled products, which are in big ticket markets like automobiles and construction (Fig. 9). The nanomaterials and nanointermediates portion of the value chain supplied the other 12%, namely nanomaterials like zinc oxide, silver, and carbon nanotubes and nanointermediates like coatings and composites.

Fig. 9

Products touched by nanotechnology generated $254 billion in 2009

In terms of sector, the manufacturing and materials sector—which includes industries like chemicals, automotive, and construction—accounted for 55% of the revenue in 2009, and the electronics and IT sector—which is dominated by computer and consumer electronics—contributed 30%. The healthcare and life sciences sector—primarily made up of pharmaceuticals, drug delivery, and medical devices—and the energy and environment sectors—comprised of energy applications like solar cells and alternative batteries—contributed 13% and 2%, respectively. In terms of region, the U.S. and Europe provided 67% of the revenue, followed by 37% from Asia and the remainder from the rest of the world (Fig. 9).

Venture capital funding increased steadily until 2008, but it experienced a significant decline during the 2009 economic crisis (Table 8).

Table 8 Venture capital funding for nanotech totaled $792 million in 2009