Heterogeneity in learning processes and the evolution of dynamic managerial capabilities as a response of emergence of biosimilar market: evidence from the Indian pharmaceutical industry

ABSTRACT

This paper examines heterogeneity in the response of Indian firms to the emergence of a new segment in the pharmaceutical generics market – biosimilars. The necessary diversity of the knowledge base and regulatory requirements underlying biosmilar products have created significant technological capability and market access challenges for Indian firms. This is but the latest development which adds to an existing catalogue of challenges including the decline of the traditional generics markets, regulatory hurdles in advanced country markets and failures in managing new drug development. Using case studies of three Indian firms we show that dynamic managerial capability is a key driver of heterogeneity in learning processes involved in acquisition of technological capabilities for biosimilars and market access strategies. It further highlights the important role of pre-existing capabilities in enabling and constraining the development of new biosimilar capabilities.     

The Indian Challenge: The Evolution of a Successful New Global Strategy in the Pharmaceutical Industry

UK and European public policy has sought to encourage young biotechnology firms adopt American-inspired strategies. The venture-backed start-up associated with Silicon Valley and Route 128 in Boston, has been the preferred model. These policies have had limited success thus far. Indian companies are evolving indigenous business models that are achieving success within the pharmaceutical industry. Some Indian pharmaceutical firms, established initially as low cost suppliers, are investing in building innovative capabilities. This paper analyses the strategies and trajectories of a number of Indian pharmaceutical companies that are expanding successfully in Western markets. It assesses the local and international contextual factors that have underpinned the strategies and discusses relevant conceptual frameworks.     

Regulation and efficiency in European insurance markets

With a series of directives completed in 1994 the European Commission tried to open and harmonize national European insurance markets. This has led to considerable deregulation in several countries. This paper surveys pre-1994 regulation in Germany and the UK and the Commission's policy. It argues that it is unlikely that the policy will have a significant impact on direct international competition between European insurance markets, until there is standardization of insurance law. However, the tightly regulated markets will become more like the loosely regulated UK market. The paper evaluates this outcome and concludes that the European Commission's policy may thereby have improved the welfare of insurance buyers in the previously highly regulated countries such as Germany. The paper also uses efficiency-frontier estimation to compare the dispersion of firm efficiencies in the German and British life insurance market. The results support the hypothesis that tighter solvency regulation allows the survival of a larger proportion of higher-cost firms.     

The Impact of Patents on Innovation,Technology Transfer and Health: A Pre- and Post-TRIPs Analysis of India's Pharmaceutical Industry

The debate surrounding the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement indicates that patents matter for development. Yet literature on the geography of knowledge transfer shows that knowledge is spatially sticky, suggesting that the impact of patents can be exaggerated. Using interview evidence, this paper explores how Indian pharmaceutical firms have responded to changes in patent law, including the introduction of more extensive patent protection in 2005 as a condition of TRIPs. A regime of limited patent protection for over three decades prior to TRIPs facilitated informal knowledge transfer and the emergence of a pharmaceutical industry with significant domestic capabilities. Contrary to some expectations, the Indian pharmaceutical industry has continued to grow post-TRIPs, with large domestic firms becoming involved in more formal technology transfer as part of an increasingly collaborative relationship with multinationals. This trend is also driven by a focus on the markets of developed countries, raising questions for the future sustainability of India's low-priced medicines. While changes in patent law can facilitate or inhibit a variety of aspects of development, the adaptation of the Indian pharmaceutical industry suggests that their impact must be related to the broader institutional setting, particularly the underlying domestic capabilities.     

Building Technological Capabilities In A Liberalising Developing Economy: Firm Strategies And Public Policy

As a consequence of economic reforms, the Indian manufacturing sector faces a variety of technology related challenges. It not only has to quickly develop world-class manufacturing capabilities, but also gear up to develop new products and processes. In this paper we analyse the technology strategies of six Indian firms in different product groups which are trying to build competitive manufacturing and technology capabilities. The linkages between corporate, technology, and manufacturing strategies are explored and the role of complementary assets is studied in order to identify patterns through which these firms are building capabilities of various kinds. Specifically, we evaluate the extent to which firms use supply chains to develop product and process technologies. Some links between public policy and firm level technological capabilities are also explored to identify a few key priorities in the current context     

Return of industrial policy?

For the sake of freedom, economic growth and poverty reduction the state in market economies should limit itself to regulating markets and (sometimes) correcting ‘market failures’. This neoliberal conception has been the near-consensus for the past two to three decades in the West and in western-led international organizations such as the World Bank. But as of recently, the consensus has been challenged by circumstances with which it cannot contend. This article spells out key ideas behind the consensus – in particular, its rejection of industrial policy. It then argues that the US government has long practised – to good effect – a hitherto little noticed type of industrial policy focused neither on the individual firm nor on the geographic region but on networks of firms, and that a (small) change in the American normative climate has occurred post 2008 in favour of a government steering role in markets. Moreover, some middle-income countries, with manufacturing sectors shrinking in the face of East Asian competition, have recently shown renewed interest in industrial policy. Finally, parts of the World Bank have recently begun to operationalize industrial policy, under the banner of ‘building competitive industries’ (industrial policy by another name), as has not been the case since the mid 1980s. The combination of these several forces may herald the emergence of new global norms in favour of a more ‘developmental’ role of the state.     

Sunk Costs,Firm Heterogeneity,Export Market Entry and Exit: Evidence from India

This paper analyses the role of sunk costs and firm heterogeneity in firm decision to enter and exit export markets. Employing rich firm-level data on Indian manufacturing firms, the study points out that sunk costs in terms of previous export experience significantly explain entry and exit decisions of firms in the export market. The first set of analysis involves estimation of dynamic discrete choice model using random effects probit correcting for initial conditions problem. We find evidence that previous export experience (sunk costs) matters for export decision. However, importance of sunk costs is found to depreciate rapidly. Further, analysis across sub-sample of firms accounting for firm heterogeneity factors like size and product level information supports the hypothesis of sunk costs. Second set of analysis involving firm survival in export markets using discrete-time hazard models shows evidence of negative duration dependence. We observe that those firms which continue to export for few years are less likely to exit from export markets.

     

Informative advertising by heterogeneous firms

This paper introduces a model to analyze the role of the cost of information dissemination in large markets where firms have varying degrees of intrinsic efficiency reflected in their marginal costs. Firms enter a market and discover how efficient they are. Those firms with high enough efficiency stay, others exit. Remaining firms then compete to attract consumers by disseminating information about their existence and their prices using a common advertising technology. The properties of the model’s equilibrium are analyzed. The model is then used to study the effect of the cost of information dissemination on the competitiveness of the market and key industry aggregates, such as price distribution and the distribution of firm value.     

Product sophistication and spillovers from foreign direct investment

Foreign direct investment (FDI) in developing countries is often associated with higher economic growth due to knowledge and technology spillovers to local firms. One way that FDI speeds up growth is by facilitating the manufacturing of more sophisticated products by local firms. So far, there is a lack of firm‐level evidence how the presence of multinational firms affects the product sophistication of firms in a developing country. The aim of this paper is to fill this gap. We compile an extensive firm–product‐level data set of Indian manufacturing firms, which we complement with information on product sophistication and spillovers from FDI. We then explore different channels through which spillovers from multinationals to local Indian firms foster the manufacturing of sophisticated products. We find evidence that spillovers through supplier linkages strongly increase the manufacturing of sophisticated products in India.     

Trade and productivity: Self-selection or learning-by-exporting in India

Recent literature tried to explain the Indian growth miracle in different ways, ranging from trade liberalization to industrial reforms. Using data on Indian manufacturing firms, this paper analyzes the relationship between firm's productivity and export market participation during 1991–2004. While it provides evidence of the self-selection hypothesis by showing that more productive firms become exporters, the results do not show that entry into export markets enhances productivity. The paper examines the explanation of self selection hypothesis for total factor productivity differences across 33,510 exporting and non-exporting firms. It uses propensity score matching to test the learning-by-exporting hypothesis. In line with the prediction of recent heterogeneous firm models of international trade, the main finding of the paper is: more productive firms become exporters but it is not the case that learning by exporting is a channel fuelling growth in Indian manufacturing.     

TRADE POLICY AND MARKET POWER: FIRM‐LEVEL EVIDENCE

This article identifies the effect of trade policy on market power through new data and a new identification strategy. We identify market power by observing how exporting firms price discriminate across markets following variations in bilateral exchange rates. Pricing‐to‐market is prevalent in all countries in our sample, even among small firms, although it is increasing in firm size. More importantly, we find that the effect of nontariff measures (NTMs) is not isomorphic to that of tariffs. Whereas tariffs reduce the market power of foreign firms through rent‐shifting effects, NTMs reinforce the market power of nonexiting firms, domestic and foreign alike.     

Human resource management for learning through knowledge exploitation and knowledge exploration: Pharmaceuticals in Mexico

This paper investigates the influence of human resource management practices on the likelihood that a firm performs in-house R&D. R&D is broadly interpreted as learning—a mechanism promoting absorptive capacity and supporting technology capability-building. Firms can choose between two learning strategies: they can exploit existing knowledge, or perform more complex explorations and acquire new knowledge. Different knowledge requirements associate with distinct R&D outcomes with varying degrees of novelty for the firm. Findings are supported with evidence from the pharmaceutical industry in Mexico. The analysis reveals positive linkages between human resource management practices and learning at firm level. The relationship is contingent on factors such as expected R&D outcomes, or the novelty of the knowledge required by the firm. The provision of training revealed the more consistent, positive influence on the likelihood that pharmaceuticals firms perform R&D in Mexico.     

Why does China protect its labour‐intensive industries more?*

China's tariff structure favours labour‐intensive sectors, and this is at odds with traditional theory of comparative advantage. The paper argues that tariffs in China are a mechanism for protecting technology‐backward domestic – especially state‐owned enterprises (SOEs) from competition technology‐advanced foreign enterprises producing in China. With relatively integrated labour markets and cross‐firm technology differences, SOEs’ subsistence is supported by subsidized credit and limited access of foreign firms’ local production to tariff‐protected domestic markets. Labour market integration and capital subsidies increase the relative cost of labour in SOEs compared to their foreign competitors, hurting more domestic firms in industries that use labour more intensively. Restrictions to FIEs’ (foreign‐invested enterprises) access to tariff‐protected product markets, which protect more labour‐intensive industries, compensate for the greater cost disadvantage of SOEs in labour‐intensive sectors.     

Harnessing the Firm-specific Knowledge of the Maintenance Workforce for Organizational Competitiveness

This paper argues, with the support of the empirical data from five case-study firms, that maintenance workers can play a key role in advancing technology used by their firm and contributing to its long-term competitiveness. Maintenance workers can contribute their firm-specific knowledge which they gain from their experience of working with the equipment in two ways: by providing feedback on asset performance to other departments/firms who design, select or install new technology/equipment; and by making the newly introduced and/or existing technology more suitable to the working environment. Yet, this valuable potential of maintenance employees is rarely appropriated by firms, of which many are enthusiastically seeking additional competitiveness. If 'learning by doing' is an important way for firms to learn and to compete, then this wider role of the maintenance workforce should be harnessed by firms that seek long-term competitiveness.     

Financialization and Manufacturing Firm Profitability under Uncertainty and Macroeconomic Volatility: Evidence from an Emerging Market

Using semi-annual data from 1993 to 2003 for all publicly traded manufacturing firms in Turkey, this paper explores the impacts of macroeconomic uncertainty and external shocks on profitability of real sector firms in the presence of multiple investment options in both real and financial sectors. The paper argues that increasing availability and accessibility of investment opportunities in the financial markets help real sector firms sustain profit margins despite market rigidities, increasing goods market competition, or higher levels of risks. The empirical results based on dynamic panel estimations show that increasing macroeconomic uncertainty and volatility have a significantly negative effect on firm profitability. In contrast, increasing the share of financial investments in total assets is found to be reducing such negative effects at a statistically and economically significant level.     

Harnessing the Firm-specific Knowledge of the Maintenance Workforce for Organizational Competitiveness

This paper argues, with the support of the empirical data from five case-study firms, that maintenance workers can play a key role in advancing technology used by their firm and contributing to its long-term competitiveness. Maintenance workers can contribute their firm-specific knowledge which they gain from their experience of working with the equipment in two ways: by providing feedback on asset performance to other departments/firms who design, select or install new technology/equipment; and by making the newly introduced and/or existing technology more suitable to the working environment. Yet, this valuable potential of maintenance employees is rarely appropriated by firms, of which many are enthusiastically seeking additional competitiveness. If 'learning by doing' is an important way for firms to learn and to compete, then this wider role of the maintenance workforce should be harnessed by firms that seek long-term competitiveness.     

Innovation or imitation? The effect of spillovers and competitive pressure on firms’ R&D strategy choice

In this paper a firm’s R&D strategy is assumed to be endogenous and allowed to depend on both internal firm characteristics and external factors. Firms choose between two strategies, either they engage in R&D or abstain from own R&D and imitate the outcomes of innovators. This yields three types of equilibria, in which either all firms innovate, some firms innovate and others imitate, or no firm innovates. Firms’ equilibrium strategies crucially depend on external factors. We find that the efficiency of intellectual property rights protection positively affects firms’ incentives to engage in R&D, while excessive competitive pressure has a negative effect. In addition, smaller firms are found to be more likely to become imitators when the product is homogeneous and the level of spillovers is high. Regarding social welfare our results indicate that strengthening intellectual property protection can have an ambiguous effect. In markets characterized by a high rate of innovation a reduction of intellectual property rights protection can discourage innovative performance substantially. However, a reduction of patent protection can also increase social welfare because it may induce imitation. This indicates that policy issues such as the optimal length and breadth of patent protection cannot be resolved without taking into account specific market and firm characteristics.     

From Imitation to Innovation: The Evolution of R&D Capabilities and Learning Processes in the Indian Pharmaceutical Industry

Since the mid 1990s the Indian pharmaceutical industry has emerged as a leading supplier of generic drugs to both developing and developed countries.The movement of the Indian pharmaceutical industry along the R&D value chain represents a remarkable shift from an importer to an innovator of drugs. The Indian government's industrial and technology policies along with changes in regulation of intellectual property rights played a crucial role in shaping this development of R&D capability. Using the 'capability creation model' this paper discusses the learning processes and stages involved in this dramatic accumulation of technological capability. This analysis shows that the Indian pharmaceutical industry has followed a trajectory from duplicative imitation to creative imitation to move up the value chain of pharmaceutical R&D. Finally as a result of changes in patent law the industry is learning to develop capabilities in innovative R&D. The basic and intermediate technological capabilities gained from imitative learning gave these firms a solid base for development of competence in advanced innovative R&D. These findings have implications for government policies as well as firm strategies in other developing countries albeit with some limitations due to global harmonisation of patent laws being promoted by the World Trade Organization.