فرایند توسعه محصول جدید و زمان ورود به بازار در صنعت داروسازی عمومی

Generic pharmaceutical companies tend to improve their market position by being first in the market when a patent on an original product elapses. The time-to-market of new products is an important source of their comparative advantages. In our study we investigate the organizational and managerial factors lying behind time-to-market in four generic pharmaceutical companies in Central and Eastern Europe. Our research also supports some results found in other studies on the lead-time of new product development. However, we find some factors specific to generic pharmaceutical companies. Our findings are incorporated into a diagnostic model of new product development in generic pharmaceutical companies, which is an important practical result of our research.

According to the Scrip Reports (2002) in the same period between 2000 and 2005 pharmaceuticals are expected to grow in value from USD 362 billion to USD 561 billion in constant prices — a rise of some 55%. In the same period around USD 100 billion worth of products face patent expiry (Cap Gemini Ernst & Young, 2002). This along with the severe budgetary problems of many governments represents an immense opportunity for generic companies, whose global market is today estimated at about USD 20 billion per annum. Moreover, the prevailing strategy is that generic companies with ‘first to market’ products capture the market, enjoy a high market share, create barriers to entry for the competition and create brand awareness for their products (Thomas, 1988 and Scrip Reports, 2002). The timing of introducing a new product and therefore the speed to market is a key issue for all manufacturers in this industry (Henderson, 2000). The formation of a generic company generally depends on its proximity to major markets and local prevailing conditions inviting generic production. For example, Canada's governmental support favoring generics and its geographical proximity to the US — the world's largest generics market — has dictated Canadian involvement. Germany, the largest European generics market, with government action actively favoring generics, expects German generic companies to dominate Europe. Teva from Israel is a unique example of a successful local company targeting the world in an aggressive fashion and thereby achieving its position as a top generics producer by acquisition (Scrip Reports, 2002). Despite the importance of the efficiency of new product development in the generic pharmaceutical industry and even though time-to-market has been extensively discussed in the literature, there is very little research directly relating to the generic pharmaceutical industry. Our research is the first in this area. For this we have collected data from four generic pharmaceutical companies from Central and Eastern Europe,2 where 34 new product development projects launched in 2002 have been included. This article presents some important factors impacting on the lead-time of new products, which can also be found in researches of other industries. In particular, we find a negative relationship between the incorporation of organizational tools and techniques, such as concurrent activities' management and time-to-market. Further, there is an appropriate negative relationship between the integration of new product development departments in particular phases of the new product development process and the cycle-time of those phases. Appropriate capacity management and project management also contribute to a shorter lead-time of a new product. However, there are also some particularities of generic pharmaceutical companies. We find that retargeted products (where an existing product is launched in a new market) have longer time-to-market than completely new products. The generic pharmaceutical industry depends very much on local market conditions and it is often easier to launch new products in already existing markets than to launch existing products in new markets. Further, we find that if the active pharmaceutical ingredient is sourced externally the time-to-market is shorter. The same is true of the external sourcing of the pharmaceutical formulation. Since generic companies often build their competencies in the market rather than on the technology used, strategic alliances and early supplier involvement in the new product development are important factors of their market success.

In a highly competitive industry such as the generic pharmaceutical industry time-to-market is a critical factor of any company's success. We analyzed the factors lying behind time-to market in four generic pharmaceutical companies in Central and Eastern Europe. We found that they are process-, organizationally- and measurement-related. In particular, concurrent activities and early supplier involvement were found to be important variables of new product development processes, and cross-functional teams, proper capacity management and proper project management to be important variables of organizational practices. Moreover, measurement practices as part of the reinforcing cycle to speed up lead-time performance have shown some weaknesses in the observed firms. The lack of this on the part of management reflects the fact that most companies in Central and Eastern Europe are still not so customer- and market-oriented as their Western peers. In addition, two findings are especially important for generic pharmaceuticals. First, since generic companies are usually more market—than technology—driven companies the early involvement of suppliers substantially increases the time-to-market. Strategic partnering is thus important to improve the process performance of such companies. Second, due to legal and administrative barriers, especially in Europe, generic companies face many difficulties when trying to enter new markets. By providing European generic producers with more favorable legislation, the time-to-market of retargeted products would increase. We are aware of the limits of our research due to the lack of data. Future research may pursue a real-time strategy of data collection to explore the nuances of projects or a longitudinal strategy of data collection to explore relationships to test for any time-lag effects. However, the expansion of research to generic pharmaceutical companies in other parts of the world is more than welcome.