Thesis (MBA)--Stellenbosch University, 2004. / ENGLISH ABSTRACT: In the history of the world, technological change has always played a central role in the advancement of the global economy. Every now and then a technological development comes along that causes a quantum leap in the technological progress of the world. Such were the mechanical developments that led to the industrial revolution, or the electronic developments that led to the more recent information technology revolution. A characteristic of these developments is its profound impact on the world economy. An explosion of new product and production possibilities typically follows such landmark technological developments. So fast and intense are the technological and resulting economic changes, that it can truly be described as a revolution. Recently, the rapid advances in molecular biology have caused such a multitude of new product and production possibilities in biological sciences that it can be described as a biotechnology revolution. Modern biotechnological techniques like recombinant DNA techniques have made the genetic manipulation of organisms possible. This creates possibilities of new production techniques and products previously unimaginable. The centre stage of the biotechnology revolution is in the US and Europe. South Africa and other developing countries have lagged behind in adopting and extracting economic value from modern biotechnology. This study investigates the issues in modern biotechnology and how the South African economy can benefit from modern biotechnology. It was found that modern biotechnology has tremendous economic potential and that already many overseas companies are generating huge profits from modern biotechnology products in all fields of biotechnology. However, some concerns about the safety of modern biotechnology point at the necessity for a proper global regulatory framework to ensure the consumer acceptance of biotechnology products required to continue to extract value from new biotechnology developments. Various cost factors need to be considered in the biotechnology industry and in South Africa the importance of these cost factors is much more pronounced due to the small scale of the South African economy. South Africa and many other developing countries will most definitely benefit from adopting modern biotechnology and expanding national biotechnology capacity. However, analyses like cost-volume-profit, economic potential, and production factor gap analyses need to be executed, preferably up to product level, to determine the appropriate biotechnology areas or products with the biggest economic potential and on which South Africa should focus its biotechnology efforts. Government stimulation of the South African biotechnology industry is welcomed by the industry. The expansion of South African biotechnology capacity will result in sustainable long-term economic benefits, not only to South Africa, but also to other developing African countries. It is concluded that the large-scale adoption of modern biotechnology in South Africa is appropriate and that the exploding biotechnology product developments, combined with increased market acceptance of modern biotechnology products, will create significant economic benefits in the South African economy. / AFRIKAANSE OPSOMMING: Sedert die vroegste tye in die geskiedenis van die wereld het tegnologiese ontwikkeling 'n sentrale rol in die vooruitgang van die wereldekonomie gespeel. Elke nou en dan vind daar 'n tegnologiese ontwikkeling plaas wat 'n kwantumsprong in die vooruitgang van die wereld tot gevolg he!. Voorbeelde hiervan is die meganiese ontwikkelinge wat tot die industriele revolusie gelei het, of die meer onlangse elektroniese ontwikkelinge wat die informasietegnologierevolusie tot gevolg gehad het. 'n Kenmerk van hierdie ontwikkelinge is die geweldige impak wat dit op die wereldekonomie gehad het. 'n Ontploffing in produkte en produksietegnieke is tipies die gevolg van hierdie landmerk tegnologiese ontwikkelinge. Die tegnologiese- en gevolglik ekonomiese veranderinge is so vinnig en intens dat dit waarlik as 'n revolusie beskryf kan word. Die onlangse vinnige vooruitgang in molekulere biologie het so 'n ontploffing in nuwe produkte en produksietegnieke in die biologiese wetenskappe veroorsaak, dat dit as 'n biotegnologiese revolusie beskryf kan word. Moderne tegnieke, soos rekombinante-DNS-tegnieke, maak die genetiese manipulasie van organismes moontlik. Dit lei tot die ontwikkeling van nuwe produkte en produksietegnieke wat voorheen ondenkbaar was. Die fokuspunt van die biotegnologie-revolusie is in die VSA en Europa. Suid-Afrika en ander ontwikkelende lande het agtergeraak in die toepassing en ekonomiese aanwending van moderne biotegnologie. Hierdie studie ondersoek spesifiek die kwessies in moderne biotegnologie en hoe Suid-Afrika voordeel daaruit kan trek. Die studie het bevind dat moderne biotegnologie geweldige ekonomiese potensiaal het en dat daar reeds baie buitelandse maatskappye is wat groot winste in alle velde van biotegnologie genereer. Daar is egter sekere bekommernisse oor die veiligheid van moderne biotegnologie. Dit dui op die noodsaaklikheid van 'n deeglike globale regulatoriese raamwerk. So 'n raamwerk sal die verbruikersaanvaarding verseker wat nodig is vir die suksesvolle ekonomiese toepassing van moderne biotegnologie. Verskeie kostefaktore moet in die biotegnologie-industrie in berekening gebring word en in Suid-Afrika is hierdie kostefaktore baie belangrik weens die klein skaal van die Suid Afrikaanse ekonomie. Suid-Afrika en baie ander ontwikkelende lande kan definitief uit die aanvaarding van moderne biotegnologie en uitbreiding van biotegnologie-kapasiteit voordeel trek. Analises soos koste-volume-wins-, ekonomiese potensiaal- en produksiefaktorgapinganalises moet egter uitgevoer word, verkieslik tot op produkvlak, om die geskikte biotegnologieveld met die grootste ekonomiese potensiaal vir Suid-Afrika te bepaal. 'n Paar sleutel marksuksesfaktore moet in die biotegnologiebedryf in gedagte gehou word. Die kernbeginsel van hierdie sleutel marksuksesfaktore is geidentifiseer as die vermoe van biotegnologieprodukte om so 'n goeie waarde-aanbieding aan die klient te bied, dat die mark bereid is om 'n premiumprys vir die produk teen ekonomies lewensvatbare vraaghoeveelhede te betaal. Stimulering van die Suid-Afrikaanse biotegnologiebedryf deur die regering word wyd deur die industrie verwelkom. Die gevolglike uitbreiding van die biotegnologiekapasiteit in Suid-Afrika sal langtermyn ekonomiese voordele vir SuidAfrika, asook vir ander ontwikkelende lande in Afrika inhou. Die gevolgtrekking van hierdie studie is dat grootskaalse aanvaarding van moderne biotegnologie gepas is in Suid-Afrika en dat die ontploffing in biotegnologieprodukontwikkelings, tesame met groter markaanvaarding van moderne biotegnologieprodukte, groot potensiele voordele vir die toekomstige Suid-Afrikaanse ekonomie inhou.

Mini-study project (MBA)--University of Stellenbosch, 2003. / ENGLISH ABSTRACT: This report reviews the global and South African pharmaceutical and biotechnology industries and provides an overview of the changes taking place within these two industries. It highlights the impact this relationship will have on a developing South African biotechnology industry. Since the 1980s the pharmaceutical industry has experienced phenomenal growth in sales and profits. By the mid 1990s drug sales exceeded USD250 billion. Today the pharmaceutical industry is dominated by multi-national corporations with extensive R&D budgets, widespread use of trademarks and patents and complex commercial process technology. However they face threats from depleted product pipelines, patent expiry on billion dollar drug products, generic competition, increases in drug approval times, costs and price pressures. The entrepreneurial biotechnology industry promises to solve a number of the pharmaceutical industry's problems. In recent years biotechnology companies proved more effective in the development of new molecular entities. They promise individualised therapeutics, novel and more efficacious drug discovery and development of preventative treatments. However the decrease in equity financing after 2001 left almost 40% of biotechnology companies with less than 1 year of R&D funding. The industry experienced losses again in 2002 and the world is divided over the ethical, environmental and economic implications of biotechnological applications. The biotechnology and pharmaceutical industries have a symbiotic but antagonistic relationship. The change in this relationship will hugely affect South Africa's ideals of developing a biotechnology industry. Various diseases plague South Africa including HIV/AIDS, TB, obesity, diabetes, hypertension and infective diseases. These diseases will have a huge impact on South Africa's society. Yet only 10% of global R&D funding is committed to third world diseases and existing drugs and treatments are either not effective or too expensive for developing countries. It is in this situation that biotechnology and the development of a biotechnology industry could playa major role in alleviating South Africa's health burden. South Africa is already capable in first generation biotechnology, but third generation applications holds the most promise. Developing countries face various obstacles and challenges, but all boast well for South Africa. The government has committed R400 million (over a three year period) to utilize South Africa's biotechnology potential. Further, the country has highly skilled researchers, indigenous plant and animal species, a diverse population and a favorable exchange rate (low R&D costs). / AFRIKAANSE OPSOMMING: Die projek ondersoek beide die globale en Suid Afrikaanse farmaseutiese en biotegnologie industrieë. Verder word die veranderinge wat plaasvind in die industrieë onder die soeklig geplaas. Die projek beklemtoon die impak wat die verhouding sal hê op 'n ontwikkelende biotegnologie industrie in Suid Afrika. Die farmaseutiese industrie het sedert die 1980s dubbel syfer groei getoon in omsete en wins. Teen die middel 90's het verkope van farmaseutiese middels US$250 miljard wêreldwyd oorskry. Vandag word die farmaseutiese industrie oorheers deur multi-nasionale korporasies met omvattende navorsing en ontwikkelings begrotings, algemene gebruik van handelsmerkte, patente en komplekse proses-tegnologieë. Ten spyte hiervan word die industrie bedreig deur leë produksie-lyne, verval van patente, miljard dollar farmaseutiese produkte, generiese kompetisie, verlengde produk-goedkeurings periodes en prys-mededinging. Die biotegnologie industrie met sy innoveerende eienskappe beloof om verskeie van die farmaseutiese industrie se probleme op te los. Onlangs het biotegnologie maatskappye getoon dat hulle meer effektief is in die ontwikkeling van nuwe molekulêre eenhede. Biotegnologie beloof nuwe en meer effektiewe produk-ontwikkeling asook beter individuele terapieë en voorkomende behandelings. Die industrie staar finansiële krisisse in die gesig. Slegs 40% van biotegnologie maatskappye het voldoende navorsing en ontwikkelings-kapitaal tot 2004. Dit is hoofsaaklik as gevolg van 'n afname in eienaars-finansiering na 2001. Die industrie as 'n geheel het weereens 'n verlies gelei in 2002 en die wêreld is verdeeld oor die etiese, omgewings en ekonomiese implikasie van biotegnologiese toepassings. Die biotegnologie en farmaseutiese industrieë het 'n simbiotiese maar tog vyandige verhouding. 'n Verandering in die verhouding gaan Suid Afrika se ideale om 'n biotegnologie industrie te skep grootliks beïnvloed. Suid Afrika gaan gebuk onder verskeie siektes insluitende MIVNIGS, TB, vetsugtigheid, diabetes, hipertensie en infeksie siektes. Hierdie siektes het 'n groot impak op Suid Afrika se samelewing. Tog word slegs 10% van die globale navorsings en ontwikkelingsfondse aangewend om 'n oplossing te vind vir derdewêreld siektes. Verder is bestaande produkte en behandelings oneffektief of onbekostigbaar vir ontwikkelde lande. Dit is in sulke gevalle waar biotegnologie en die ontwikkeling van 'n biotegnologie industrie 'n groot rol kan speel in die verligting van Suid Afrika se gesondheids-las. Suid Afrika is vaardig in eerste-generasie biotegnologie, maar wêreld wyd hou derde generasie biotegnologie die meeste belofte in. Die tegnologie is tot op hede onderbenut in Suid Afrika. Ontwikkelende lande staar verskeie uitdagings in die gesig, maar Suid Afrika het talle sterk punte. Die regering het R400 miljoen (oor 'n drie jaar periode) beskikbaar gestel vir die ontwikkeling van Suid Afrika se biotegnologie potensiaal. Die land beskik ook oor navorsers van hoogstande gehalte, onbenutte inheemse plante en dier spesies, 'n diverse populasie en 'n gunstige wisselkoers (lae navorsings en ontwikkelings kostes).

D.Comm. / The mission of the research is to design a South African biotechnology business model that could be widely embraced by various biotechnology enterprises. The business model advises biotechnology enterprises on the applicable strategy to follow and addresses both internal and external factors important to biotechnology enterprises. Contrary to common beliefs, biotechnology has been utilised for thousands of years. The biotechnology markets in the United States, Europe, Canada and Asia/Pacific are increasingly moving operations beyond country borders to achieve business efficiency. A South African biotechnology strategy has been drafted and various organisations have been established to assist with the development of the industry. Aligning the information technology and knowledge management strategy to the overall business and operational strategies is crucial. The model information technology infrastructure will integrate key administrative, clinical and financial data and make it available to all researchers during the life-cycle, but in such a way that the speed-to-market for the new products being developed is much faster. Information technology outsourcing and grid computing have emerged as key solutions to solve shortage of information technology skills and generate vast capacity in the industry. Knowledge management forms the foundation of biotechnology organisations. The biotech culture must foster knowledge transfer and sharing. Employees in return must foster the behaviour created by the culture, and must importantly work in groups such as communities of practice to achieve applicable goals. Technology is the enabler of the knowledge management process and the corresponding architecture must allow the people to follow the culture of a knowledge sharing and transfer culture. The strategic management process of a biotechnology organisation is critical. Collaboration activities in the biotechnology industry have increased substantially over recent years to represent a contemporary management issue that needs to be managed by the strategic management process. Innovative biotechnology organisations will stay ahead by introducing new products prior to their rivals and consolidate a strong market position by adopting corporate and collaborative growth strategies. The aim of the empirical research is to identify the respondents' views on a number of strategic factors crucial to a biotechnology organisation and how it will influence the business model. Externally, market conditions, biotech categories and regulatory conditions influence the market outlook for South African biotech enterprises. Internally, information technology, knowledge management, human resources, enterprise structure, customers, productivity and growth strategies influence the shape of the enterprise. Based on all of these factors, recommendations are made to the industry on the external and internal factors of a business model and on specific areas that require further research.

Thesis (PhD)--Stellenbosch University, 2014. / ENGLISH ABSTRACT: This study investigates the efforts of stakeholders in a regional innovation system (RIS) to reconstruct the system to enable the development of the nascent biotechnology industry in the Western Cape province of South Africa. Various institutions and organisations played a crucial role in effecting these changes. One of the most important changes involved legislation that altered the role that universities play in bridging the gap between research outputs and reaping commercial benefits from such outputs. Following the logic of the regional innovation system, the study focused on the institutional changes, the mechanisms employed to bridge this gap (from creating spin-off firms, and licensing technologies based on university research, to designing programmes to support the development of bio-entrepreneurs). For a comparative perspective from another region that arrived on the biotechnology scene relatively late, the study includes a section on university spin-offs in biotechnology from Hong Kong universities. Since all the efforts to effect the changes to the RIS that would enhance the growth of this promising industry are relatively new, the study faced the usual problems associated with pioneering developments, such as small samples, a complete lack of databases, etc. For this reason, the questionnaire survey and case study methods were used throughout the study. Starting from the general to the specific, the thesis is divided into four complementary parts. Part I comprises the general literature survey and rationale for the study, while Part II narrows the focus to the organisations and mechanisms that connect knowledge creation and knowledge exploitation in the regional context in the Western Cape, South Africa and Hong Kong, China. Part III evaluates early efforts at building a bridge from science to business in the form of bio-entrepreneurship programmes. Part IV takes a micro view, tracking the evolution of biotechnology spin-offs from Western Cape universities, and highlighting the role that institutional changes played in the genesis, growth and, unfortunately, demise of some biotechnology spin-offs. The last section concludes. Throughout the study a familiar refrain repeated itself with respect to the challenges faced by new spin-offs, namely the perennial culprits of a lack of appropriate skills, and funding. From our study, bearing in mind the small scale and the danger of generalisations, it would seem as if the reconstruction of the RIS and related changes in the national innovation system (NIS1) did not generate the results that the strategy hoped for (at least in the Western Cape, the focus of our study). A beam of light is the relative success achieved with the development and implementation of a bio-entrepreneurship training programme, which laid the foundation to build a more sustainable bridge between the science of biotechnology and the commercial world where the wealth creation opportunities reside.

The potential for private sector healthcare business in Africa has been forecasted to reach $35 billion by 2016, with South Africa being regarded as the most industrially advanced country on the continent. South Africa’s entry to modern biotechnology is fairly recent, though, with companies in the private sector still in a developmental phase, and most having limited bioproduct ranges. While considerable research has been conducted in the past to attempt to define the biotechnology environment of South Africa, as yet, a concise overview is lacking. In particular, a synopsis of the biomedical or commercial health technology environment has not been forthcoming for entrepreneurs to refer to as a ‘roadmap’. The purpose of this study was to perform a comprehensive study on the attributes that should be met for a successful, sustainable health technology venture (HTV) to be started in South Africa; while identifying the opportunities and threats that have existed in the South African market; thereby, affecting their success and sustainability to date. In this study, two phases of research were conducted. The first was a small-sampled mixed-methods (both qualitative and quantitative) study involving 21 medical devices, biogenerics, diagnostics, and contract services companies. The second was a quantitative study, involving 107 vaccines, biogenerics, therapeutics, nutraceuticals, reagents, diagnostics, medical devices, biotools, contract services and public services companies. Inferential statistical tests were conducted on the data, including Pearson’s Chi-Square, ANOVA, bivariate correlation, linear regression, logistic regression and multinomial logistic regression. From the study, the overall proportion of business sustainability for HTVs was found to be 66.7%, and at least 30% were unsustainable (or not yet at a level of sustainability). Variations were observed in the overall rate of sustainability for companies, based on their core functional classification, location, production type, size and start-up or R&D spending. By converting the observed frequencies of activity level, as an indication of sustainability, into a probability, it was possible to observe the company type that was most, and least likely to succeed in South Africa. Based on the statistical observations in this study, the HTV type most likely to succeed in South Africa, with a 63.7% probability of reaching sustainability, is a ‘vaccines’, ‘biotools’ or ‘public services’ company from Johannesburg with at least 20 employees; that has developed its goods or services internally, but manufactured externally and spent between R20 million–and–R30 million on its R&D or start-up. Conversely, least likely to succeed (3.2% probability) is a nutraceutical company from Cape Town with between six and 20 employees, that has developed and produced internally, and which has spent between R1 million–and–R10million on its start-up. / Life and Consumer Sciences / M.Sc (Life Sciences)

The potential for private sector healthcare business in Africa has been forecasted to reach $35 billion by 2016, with South Africa being regarded as the most industrially advanced country on the continent. South Africa’s entry to modern biotechnology is fairly recent, though, with companies in the private sector still in a developmental phase, and most having limited bioproduct ranges. While considerable research has been conducted in the past to attempt to define the biotechnology environment of South Africa, as yet, a concise overview is lacking. In particular, a synopsis of the biomedical or commercial health technology environment has not been forthcoming for entrepreneurs to refer to as a ‘roadmap’. The purpose of this study was to perform a comprehensive study on the attributes that should be met for a successful, sustainable health technology venture (HTV) to be started in South Africa; while identifying the opportunities and threats that have existed in the South African market; thereby, affecting their success and sustainability to date. In this study, two phases of research were conducted. The first was a small-sampled mixed-methods (both qualitative and quantitative) study involving 21 medical devices, biogenerics, diagnostics, and contract services companies. The second was a quantitative study, involving 107 vaccines, biogenerics, therapeutics, nutraceuticals, reagents, diagnostics, medical devices, biotools, contract services and public services companies. Inferential statistical tests were conducted on the data, including Pearson’s Chi-Square, ANOVA, bivariate correlation, linear regression, logistic regression and multinomial logistic regression. From the study, the overall proportion of business sustainability for HTVs was found to be 66.7%, and at least 30% were unsustainable (or not yet at a level of sustainability). Variations were observed in the overall rate of sustainability for companies, based on their core functional classification, location, production type, size and start-up or R&D spending. By converting the observed frequencies of activity level, as an indication of sustainability, into a probability, it was possible to observe the company type that was most, and least likely to succeed in South Africa. Based on the statistical observations in this study, the HTV type most likely to succeed in South Africa, with a 63.7% probability of reaching sustainability, is a ‘vaccines’, ‘biotools’ or ‘public services’ company from Johannesburg with at least 20 employees; that has developed its goods or services internally, but manufactured externally and spent between R20 million–and–R30 million on its R&D or start-up. Conversely, least likely to succeed (3.2% probability) is a nutraceutical company from Cape Town with between six and 20 employees, that has developed and produced internally, and which has spent between R1 million–and–R10million on its start-up. / Life and Consumer Sciences / M. Sc. (Life Sciences)