The introduction of the first biotechnology drug, recombinant insulin, in 1982 marked the turning point in the commercial viability of biotechnology innovation, and its potential to address some of the major global problems of healthcare, food security, energy sufficiency, renewable resources and environmental sustainability (Ahn and Meeks, 2007; Ahn et al., 2010a; Ahn et al., 2010b; Battelle/Biotechnology Industry Organisation, 2010; Ahn and York, 2011; Ahn et al., 2012; Dunham 2012). Within the context of entrepreneurship, biotech-nology entrepreneurship is relatively new (Meyers, 2012), research-driven and requires the collaboration of human talent, capital and institutions to achieve economic and social development, job creation, poverty alleviation, skills development and technology transfer. These benefits have captured the interest of the developed and developing economies in programmes and activities aimed at promoting biotechnology entrepreneurship, in order to capitalise on what has been termed the “biocentury” (Battelle/Biotechnology Industry Organisation, 2010).

This study explored the dynamics of biotechnology entrepreneurship in the developing economies of South Africa and Brazil with the aim of understanding the practical realities of biotechnology entrepreneurship in these economies. Although, this research was based on the organizing framework of the individual-opportunity nexus of entrepreneurship (Shane, 2003), the results show that the individual-opportunity nexus of entrepreneurship does not entirely hold for biotechnology entrepreneurship in South Africa and Brazil. Instead, there is a nexus of research and development; and a government-incentivised environment that is conducive for biotechnology entrepreneurship. The main empirical and theoretical contributions of this research include conducting this research in South Africa and Brazil and the development of a proposed theoretical framework of biotechnology entrepreneurship, respectively.

Methodologically, the use of a qualitative multiple case study approach constitutes a methodological contribution. Current studies in biotechnology entrepreneurship make use of a nomothetic philosophical approach and employs quantitative methods within one developing economy context. The policy implications of these dynamics in South Africa and Brazil; as well as implications for the other stakeholders in the biotechnology industry are articulated as being linked to the control of the factors that influence biotechnology entrepreneurship by the various stakeholders. Hence, the implications for government are predominantly linked to regulation and infrastructure; and the implications for the other stake-holders are predominantly linked to funding and skills.

Assumption underpinning the research

There is one assumption that underpins the proposed research. In spite of the difficulties of measuring entrepreneurship in a cross-national context (Carree and Thurik, 1998), it is assumed that the developing economies of South Africa and Brazil are good candidates for the study of biotechnology entrepreneurship in developing economies. There are other countries that could easily be considered for inclusion into this research, such as Malaysia and Indonesia. However, within the context of biotechnology entrepreneurship there are clear similarities that make Brazil and South Africa good candidates for this research. Both countries are classified as efficiency-driven economies in the GEM study (Bosma and Levie, 2010; Kelley et al., 2012) and are seen as ideal emerging market partners for biotechnology alliances with developed economies (Veilleux et al., 2010). In addition, they have fairly developed economy, government institutions, educational institutions, regulatory  environment   and  markets  according  to  the standard of developing countries (Veilleux et al., 2010). On the basis of patent publication, both have fairly good representation of patent publications according to the standard of developing economies (Bound, 2008; United States Patent and Trademark Office, 2009) and are often included in the Organisation for Cooperation and Development (OECD) analysis and reports on biotech-nology (Organisation for Economic Cooperation and Development, 2013d). On the basis of the stage of their biotechnology industry, both have abundant biodiversity and advanced agricultural biotechnology (Cloete et al., 2006; Bound, 2008) and are considered as viable partners for direct foreign investment in biotechnology (Ernst and Young, 2010b). In terms of government policy on biotechnology entrepreneurship, both have high level of government involvement and clearly defined policies on biotechnology development (Department of Science and Technology, 2001; da Silveira and de Carvalho Borges, 2005; Marques and Gonçalves Neto, 2007; Bound, 2008; Technology Innovation Agency, 2010; Ernst and Young, 2010b).

The literature on general entrepreneurship recognises the role of the individual in the process of entrepreneurship (Kenney, 1986) in developed and developing economies. The psychological attributes necessary for the individual to function effectively as an entrepreneur include higher levels of cognitive functioning, motivation, leadership qualities, propensity to take risk, action-orientation, self-efficacy, preference for autonomy, self-direction, and differential access to scarce and expensive resources (Shane and Venkataraman, 2000; Eckhardt and Shane, 2003; Shane, 2003). In addition to the psychological attributes, the requisite non-psychological factors such as education and career experience (Barro and Lee, 2000) are necessary for biotechnology entrepreneurship. Studies also recognise the role of the environment or “external forces” (Tushman and Anderson, 1986; Hannan and Freeman, 1987; Ács and Audretsch, 2003) in the process of entrepreneurship in developed and developing economies. In addition, the process of biotechnology entrepreneurship in the developed economies has been seen to be driven primarily through collaboration of stakeholders (Müller et al., 2004), which is similar to having a system of biotechnology entrepreneurship. The literature on the determinants for researchers’ choice to engage in commercialisation (Nilsson, Rickne and Bengtsson, 2010) highlights four factors: the perceived role of the university, supportive infrastructure, industrial actor set-up, and networks. The details of these factors include university culture, university infrastructure such as the technology transfer office (TTO), national infrastructure for commercialisation of research, large companies    that have receiver capabilities, and collaboration among key stakeholders. Another component of the literature is the addition of the role of entrepreneurial opportunities (Shane and Venkataraman, 2000). The integration of the individual, environmental and entrepreneurial opportunities (Cunningham and Lischeron, 1991; Shane and Venkataraman, 2000) in exploring the dynamics of biotechnology entrepreneur-ship has the prospect of providing an in-depth understanding of the key aspects of biotechnology entrepreneurship in South Africa and Brazil.

Biotechnology entrepreneurship

Biotechnology is situated at the boundary of the fields of biology and engineering. It is a combination of science (medical science, biochemistry, molecular biology, cell biology) and industrial production (medical, food, forest industries) (Kivinen and Varelius, 2003). Hence, similar to entrepreneurship, biotechnology has been defined differently by scholars affiliated to either of the underlying fields (Bud, 1991). This contributes to the confusion about what a single unifying definition for the field in the early stages of development should be. However, 21st century biotechnology has been defined as “the use of cellular and biomolecular processes to solve problems or make useful products” (Biotechnology Industry Organisation, 2008). 20th century biotechnology evolved from an emphasis on population problems and agriculture to a focus on areas such as pharmaceuticals, agricultural chemicals, food production, waste disposal and chemical manufacture (Bud, 1991). In the 21st century, biotechnology has assumed global importance in the areas of healthcare, environmental protection, agriculture, chemistry, and material science (Biotechnology Industry Organisation, 2008), with significant commercial potential (Dibner, 1986; Muller and Fujiwara, 2002; Müller and Herstatt, 2004; Ahn and Meeks, 2007; Ahn et al., 2010a; Ahn et al., 2012).

Biotechnology entrepreneurship in developed economies

In developed economies, the United States (US) leads the chart in biotechnology.  The US has more companies, employs more people, invests more in research and development, and earns more than all of Europe combined (Kettler and Casper, 2001). This may be as a result of the early-mover advantage, which the US gained by embracing biotechnology and actively encouraging the development of the industry decades before Europe took the same route. In 2010, the bioscience industry was estimated to have directly created 1.6 million jobs in the US and to be indirectly responsible for about 3.4 million jobs in total (Battelle/Biotechnology Industry Organisation, 2012), with a net income of $3.7  billion  for publicly traded biotech companies in 2009 (Ernst and Young, 2010b). Owing to globalisation and through international collaboration, there is extensive interaction between the American and European biotechnology industry through the big multinational biotechnology corporations (Dibner, 1986) and research scientist networks. At a governmental level, many European countries, and an Asian country such as Japan, implement similar policy initiatives to America in order to fast-track their biotechnology industries. The existence of similar policy initiatives to those of America has been confirmed in the biotechnology industries of Finland (Kivinen and Varelius, 2003); the United Kingdom, Germany and Japan (Dibner, 1986; Müller, 2002; Muller and Fujiwara, 2002; Müller et al., 2004); and Sweden (Nilsson, 2001). The combination of American and European biotechnology industries, under the banner of developed economies, constitutes a near total domination of the entirety of the global biotechnology industry, with the developing economies having very little or no current impact. It is difficult to make a direct comparison between the biotechnology industry in the developed and developing economies, except in cases such as the biofuel industry in Brazil, owing to the general lack of empirical research and data, and the undeveloped nature of the industry in most developing economies. However, the GEM report provides a basis of comparison for general entrepreneurial activities across these two types of economies (Herrington et al., 2008; Bosma and Levie, 2010), which is assumed to provide a similar comparative basis for biotechnology entrepreneurship.

The GEM report has categorised the national conditions of the developed economies under “innovation-driven” as shown in Table 1. For developed economies, the basic requirements (institutions, infrastructure, macroeconomic stability, health and primary education) and efficiency enhancers (higher education and training, goods market efficiency, labour market efficiency, financial market sophistication, technological readiness and market size) are in place and are maintained. Nevertheless, the key focus is on the entrepreneurial conditions (Bosma and Levie, 2010) such as entrepreneurial finance, government policies, government entrepreneurship programmes, entrepreneurship education, R&D transfer, commercial and legal infrastructure for entrepreneurship, internal market openness, physical infrastructure for entrepreneurship, and cultural and social norms. The prevalence of entrepreneurial activities in the US attests to the availability of basic requirements and efficiency enhancers. About 4 to 6% of America’s working population take action to start a new business annually, and about 40% experience bouts of self-employment in their lifetime (Ács and Audretsch, 2003:5). The result of this is that an estimated 761,000 new corporations, the number of which increases to 4.5 million with the inclusion of all forms of business, are started per year in America as at 1998 (Ács and Audretsch, 2003:28).

The trend for the rest of the developed economies is expected to be similar to America, although not to the same magnitude. Some of the differences linked to the national conditions for the developed and developing economies (Phan, Venkataraman and Velamuri, 2008) are shown in Table 2. Biotechnology entrepreneurship activities are currently entrenched in the developed economies, and are continually being improved as biotechnology is expected to be the economic growth engine of the 21st century Battelle/Biotechnology Industry Organisation, 2010). As might be expected, most of the published literature on biotechnology entrepreneur-ship is based in the developed economies, where industry statistics have been tracked for decades. The empirical studies on biotechnology entrepreneurship for the developing economies are still at the exploratory stage and the industry has not developed to a stage where statistics are readily available and tracked.

Biotechnology entrepreneurship in emerging economies

In developing economies, biotechnology entrepreneur-ship holds the tantalising prospect of significantly contributing to food security, improved agricultural output, sustainable environmental development practices, improved healthcare, job creation, poverty alleviation and economic development (Clarke, 2002). The achievement of all, or any, of these benefits depends on the national conditions that exist in the developing economies. The “bigger” economies of the developing world, such as BRIC (Brazil, Russia, India and China), South Africa and possibly Nigeria (Department of Science and Technology, 2001), may be in a better position to exploit the benefits of biotechnology in a globalised world, whether through technology transfer, innovative development of the industry, development of particular niches within the biotechnology industry or a combination of these and other options. These bigger economies represent a vital link between the developing and the developed economies as the basic requirements already exist in these economies (Fontes 2001). The GEM report (Kelley, Singer and Herrington, 2012) classifies South Africa and Brazil as efficiency-driven and as such the key focus is on the efficiency enhancers such as higher education and training, goods market efficiency, labour market efficiency, financial market sophistication, technological readiness, market size. While, these efficiency enhancers are fundamental to the development of entrepreneurial culture in general, the developing economies still need to develop the entrepreneurial conditions necessary for an innovation-driven industry such as biotechnology (Herrington et al., 2008; Bosma and Levie, 2010).

The global issues of human health, food security, renewable resources and environmental sustainability (Battelle/Biotechnology Industry Organisation, 2010) that are addressed by biotechnological solutions are more prevalent in developing economies as are the issues of economic  and  social  development,  unemployment  and global competitiveness. These issues highlight the importnce of understanding and developing entrepreneurship in general, and specifically biotechnology entrepreneurship, in the emerging economies.

Research question

The research question explored in this study is:

Question 1

How do bioscientists carry out biotechnology entrepreneurship in the developing economies of South Africa and Brazil?

Organising framework

The individual-opportunity nexus framework of entrepreneurship (Shane, 2003:11) (Figure 1) was used as the organising framework for this research, which guided the exploration of the dynamics of biotechnology entrepreneurship in the developing economies of South Africa and Brazil. Shane’s (2003) framework considers the existence of entrepreneurial opportunities as independent of the actors and as needing to be discovered by enterprising individuals. The individual attributes needed to exploit these opportunities effectively include psychological factors, such as cognition and motivation and non-psychological factors such as education and career experience. In the environment of entrepreneurship, the three categories of factors believed to influence productive entrepreneurial activity are the economic, political and cultural environments (Shane, 2003). There are marked differences between the developed and developing countries in all three categories of environmental factors. While, the four aspects of the economic environment: wealth, economic stability, capital availability and taxation, are all at advanced levels and favourable for productive entrepreneurship in the developed economies, the developing economies face issues of poverty, economic instability, lack of capital and restrictive tax laws (Herrington et al., 2008; Bosma and Levie, 2010). Similarly, political instability in developing economies and low levels of a national culture of innovation and entrepreneurship hamper productive entrepreneurial activity (Herrington et al., 2010).

Shane (2003) individual-opportunity nexus framework for entrepreneurship is able to explain the process of biotechnology entrepreneurship as the literature on biotechnology entrepreneurship aligns to the components of the individual-opportunity nexus framework (Pisano 1990; 1991). This makes this framework useful for understanding the process of biotechnology entrepreneurship in South Africa and Brazil. The process of biotechnology entrepreneurship in South Africa and Brazil is then compared to the literature on the process of biotechnology entrepreneurship in developed economies, in order to identify similarities and differences.

This research was conducted in the idiographic philosophical tradition. The rationale for using this is the complex nature of the social interactions involved at the individual, organisational, institutional and national levels which underlie the dynamics of biotechnology entrepreneurship. These interactions are non-linear and have multiple overlapping meanings, and are suitably studied through the case study method. Primary data from a case study design was used for this study. Multiple cases, comprising South Africa and Brazil, were investigated in order to achieve literal and theoretical replication (Eisenhardt, 1989, 1991; Yin, 2009). The individual cases were holistic within the multiple-case study. The case study was carried out at country level of analysis with interviews conducted with individuals associated with the biotechnology industry in various capacities. Environmental and institutional factors have key influences on the dynamics of biotechnology entrepreneurship at a country level. The use of a country level of analysis was expected to embody these environmental factors and be broad enough to provide a true understanding of the dynamics of biotechnology entrepreneurship in the developing economy context. In addition, conducting interviews with individuals within the biotechnology industry ensured that the lived dynamics of biotechnology entrepreneurship within its original context were adequately captured (Creswell, 2009; Yin, 2009).

Data analysis

The qualitative data analysis for this research was conducted in the tradition of building theory from case studies in order to understand the “how” and “why” of contemporary events (Eisenhardt and Graebner, 2007; Yin, 2009:8; Klonoski, 2013). The dynamics of biotechnology entrepreneurship in South Africa and Brazil were examined in detail to generate theoretical insights (Welch, Piekkari, Plakoyiannaki and Paavilainen-mäntymäki, 2011), understand their peculiarities (Stake, 2006), and the structures and contexts (Klonoski, 2013) in which observed behaviours were analysed. A Computer Aided Qualitative Data Analysis Software (CAQDAS) package called Atlas.ti version 7.1.6 was used for the data analysis. The use of Atlas.ti was meant to aid rapid, consistent and rigorous qualitative data analysis (Weitzman, 1999; Rambaree, 2007; Hwang, 2008), and extended the researcher’s ability to organise, remember and be systematic (Zdenek, 2008).

The cross-case analysis is an aggregate view (Stake, 2006) of the research on the dynamics of biotechnology entrepreneurship in South Africa and Brazil. The patterns that emerged from the peculiarities of the individual case studies are aggregated to themes and contrasted with the literature on biotechnology entrepreneurship to enable an accurate interpretation towards developing theory. The patterns identified from the within-case analyses of South Africa and Brazil are presented in Table 3 below. The patterns that emerged from within the case analyses of South Africa and Brazil (Table 3) resulted in 14 areas of alignment between South Africa and Brazil, from which the emerging themes were derived. The patterns referred to the same concept but not necessarily with the same experience or outcome. Hence, there were instances of positive versus negative experiences across the patterns.

The methodological approach for this research was designed to achieve an in-depth understanding of the process of biotechnology entrepreneurship in South.

Africa and Brazil in their original contexts. The empirical, methodological and theoretical contributions, as well as the implications for the different stakeholders are articulated below.

Empirical contributions to the literature

The main empirical contribution of this research to the literature is the contribution to the body of knowledge, which addresses the gap created by the paucity of empirical research on biotechnology entrepreneurship in the context of developing economies. Few empirical research studies are specific to biotechnology entrepre-neurship (Schoemaker and Schoemaker, 1998; Müller et al., 2004; Audretsch et al., 2008; Carsrud et al., 2008; Oliver, 2008; Gunn et al., 2013). Furthermore, the empirical research that is specific to biotechnology entrepreneurship, most studies are specific to the developed economies and few are specific to the developing economies (Onyeka, 2011). The paucity of empirical research on biotechnology entrepreneurship in the developing economies’ context creates a gap that this research addressed.

Methodological contributions to the literature

The few studies on biotechnology entrepreneurship, in developing economies, employ mostly survey methodology and single case studies within one developing economy. The use of qualitative multiple case studies, in the idiographic philosophical tradition, in two developing economies, is deemed to enrich the discourse in biotechnology entrepreneurship and hence make a contribution to the knowledge of biotechnology entrepreneurship in developing economies.

A qualitative multiple case study method was used for this study, at a country level of analysis. The use of a holistic multiple case study approach provided the opportunity for literal and theoretical replication (Yin, 2009). The case selection was purposefully aimed at good candidates for biotechnology entrepreneurship in the developing economies with sufficient similarity, and variability, to provide a suitable context for this research (Yin, 2009).

Theoretical contributions to the literature

The main theoretical contribution of this research is the development of a theoretical framework of biotechnology entrepreneurship, which defines the dynamics of biotechnology entrepreneurship in South Africa and Brazil (Figure 2). The research followed the idiographic tradition, defining themes that are tested against literature. The proposed theoretical framework of biotechnology entrepreneurship is based on the themes that emerged from the cross-case analysis of the process of biotechnology entrepreneurship in South Africa and Brazil. The within-case analysis of each case incorporated the lived experiences of the bioscientists, bioentrepreneurs, and subject matter experts SMEs in biotechnology entrepreneurship in South Africa and Brazil. At the time of this research, there is no known theoretical framework of biotechnology entrepreneurship, especially from a developing economies’ context. Although this theoretical framework cannot be generalis-ed to all developing economies, it provides the means to study the process  of  biotechnology  entrepreneurship  in other developing and developed economies.

Policy and other implications for the government

One of the themes identified through the cross-case analysis is “the government plays an important role in biotechnology entrepreneurship in South Africa and Brazil”. In addition, the policy and regulatory environment was among the top challenges identified for the development of biotechnology entrepreneurship in the developing economies.

The role of government in providing a favourable environment for the development of biotechnology entrepreneurship includes legislation on the national biotechnology strategy, policies on public research institutions, policies related to research funding, intellectual property policies, regulations on university-industry technology transfer, regulations on taxation, labour laws, policies on the acquisition of scarce skills, policies on science and mathematics in the education curriculum, and policies related to regional and international collaboration on biotechnology entrepreneurship.

The availability of the relevant policies and regulations; the effectiveness of implementing these policies by the government agencies; and the leadership and direction provided by government were highlighted as some of the differences between the developed and developing economies.

Furthermore, the government plays the roles of facilitator, buyer of biotechnology products and solutions, and funder, in addition to the role of providing a favourable policy and regulatory environment. The facilitation role of the government includes the provision of leadership, infrastructure, capacity, research institutions and platforms for local and international collaborations among key stakeholders. The role of government as a buyer is necessitated by the social obligation of government to provide improved healthcare, food security, energy sufficiency and sustainable environmental practices. The role of the government as a funder includes the funding of R and D, infrastructure funding and project funding. It is recommended that the government of South Africa, in particular, find effective ways of delivering on these roles to create a conducive environment for the development of biotechnology entrepreneurship.

Implications for the other stakeholders

The empirical contribution of this research has implications for the other stakeholders involved in the biotechnology industry, such as the research institutions, venture capitalists, large biotechnology companies and bioentrepreneurs. A clearer understanding of the dynamics  of   biotechnology  entrepreneurship  in  developing economies is expected to aid decision making related to the biotechnology entrepreneurship by these stake-holders. There are multiple points of stakeholder collaboration and strategic alliances in the proposed theoretical framework for biotechnology entrepreneurship. These are in the environment for biotechnology entrepreneurship; R and D; opportunity exploitation; and commercialisation of research. The research institutions need to review their policies on intellectual property and the transfer of technology from the university to the industry, in alignment with similar policies by the government. This was highlighted as one of the gaps in the development of biotechnology entrepreneurship in these developing economies. Furthermore, the culture of the universities and research institutions needs to be changed from prioritising publication to being focused on commercialisation of research to realise economic and social value. The understanding of the dynamics of biotechnology entrepreneurship in these developing economies, especially in South Africa where there is a lack of a developed venture capital industry, will aid the venture capitalists in understanding the peculiarities of the environment, the challenges and gaps, the role of the government and the opportunities that can be exploited. Importantly, the lessons from the success of the venture capital market in Brazil can be implemented in South Africa, given an enabling regulatory environment.

The absence of large biotechnology companies was highlighted as one of the gaps in South Africa. Given the involvement of the large biotechnology companies in major R and D; their role as cooperation partners, customer and competitor; and the availability of good research universities and skilled researchers in South Africa, there is an opportunity for the large biotechnology companies to seek out collaboration opportunities in South Africa, provided the enabling environment expected to be provided by the government is in place. Similarly, they can use their expertise in Brazil to enter the South African biotechnology industry.

The author(s) have not declared any conflict of interests.