Economics of the Pharmaceutical Industry

2018 ◽  
Vol 56 (2) ◽  
pp. 397-449 ◽  
Author(s):  
Darius N. Lakdawalla
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Pharmaceutical Products ◽  
Pharmaceutical Firms ◽  
Economics Literature ◽  
The Us ◽  
Pharmaceutical Prices ◽  
Normative Implications

The pharmaceutical industry accounts for a substantial chunk of the US economy's research and development investments, which have resulted in significant medical breakthroughs. At the same time, the costs of pharmaceutical products continue to rise, as does pressure to adopt direct or indirect controls on pharmaceutical prices. We review the economics literature on the pharmaceutical industry, focusing particularly on its positive and normative implications for the innovation, pricing, and marketing decisions of pharmaceutical firms. We discuss the major achievements of, and persistent gaps in, the literature, along with lessons for policy. (JEL I11, L11, L65, M31, M37, O31, O34)

Strategic Research and Development Investment Decisions in the Pharmaceutical Industry

2020 ◽  
Vol 39 (3) ◽  
pp. 564-586
Author(s):  
Anita Rao
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Development ◽  
Research And Development ◽  
Investment Decisions ◽  
Strategic Research ◽  
Pharmaceutical Firms

Do pharmaceutical firms respond to the actions of their competitors in R&D, and if so, what implications does this have for policies aimed at incentivizing drug development?

The Economics of the Biopharmaceutical Industry

2011 ◽  
pp. 519-554 ◽  
Author(s):  
Patricia M. Danzon
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Future Research ◽  
Neglected Diseases ◽  
Market Demand ◽  
Global Issues ◽  
Insurance Reimbursement ◽  
Development Costs ◽  
The Us ◽  
Differential Pricing

This article summarizes the literature, and considers the issue of paying for research and development. It reviews research and development costs, regulation, productivity and incentives for innovation. It discusses market demand and pricing, effects of insurance, reimbursement regulation, alternatives to patents, and generics. Further, it reviews trends in promotion, regulation of promotion and its effects. It discusses global issues, including differential pricing and R&D for neglected diseases. The focus is on the US, as the home of the largest number of multinational pharmaceutical and smaller biotech companies. This article notes the important differences in regulatory and reimbursement systems in other countries. Finally it suggests that although there is large and growing literature on the pharmaceutical industry that has produced valuable information, important issues remain for future research.

R&D investment behavior of US pharmaceutical firms

2017 ◽  
Vol 9 (2) ◽  
pp. 205-219 ◽  
Author(s):  
Michal Jirásek
Keyword(s):  
Pharmaceutical Industry ◽  
Random Effect ◽  
Investment Behavior ◽  
Theoretical Assumption ◽  
Industry Studies ◽  
Content Type ◽  
Pharmaceutical Firms ◽  
The Us ◽  
Single Industry ◽  
D Investment

Purpose The behavioral theory of the firm (BTOF) has been used to explain the research and development (R&D) investment behavior of firms in numerous multi industry studies. However, their partially contradictory results point to the possible need for a single industry perspective that would reduce heterogeneity of business trends, models and other characteristics. This study aims to test this theoretical assumption within the challenging context of the US pharmaceutical industry. Design/methodology/approach The research uses data from 20 firms, which number among the largest in the US pharmaceutical industry, over the period 2002-2014. These data are analyzed using fixed- and random-effect panel models. Findings The findings generally support the need for a thorough understanding of the industry under study and its specific characteristics. The firms analyzed in this research behave slightly differently from theoretical assumptions, and it is argued that this is caused by industry specific factors. Moreover, the use of two separate aspiration measures – for historical and social aspirations – is supported as it provides more in-depth insight into the firms’ behavior. Originality/value This paper, which is based on research presented at the 4th International Conference on Innovation and Entrepreneurship, represents the first inquiry into the R&D investment behavior of pharmaceutical firms using the BTOF. It also represents an argument for conducting single-industry rather than multi industry studies when using this theory.

A Comprehensive Review on Strategies for New drug Discovery and Enhanced Productivity in Research and Development: Recent Advancements and Future Prospectives

2020 ◽  
Vol 17 ◽  
Author(s):  
Adity Sharma ◽  
Karan Mittal ◽  
Daisy Arora ◽  
Subrahmanya Sarma Ganti
Keyword(s):  
Research And Development ◽  
Cost Effective ◽  
Pharmaceutical Products ◽  
Lean Six Sigma ◽  
Health Care Facilities ◽  
Substantial Impact ◽  
Pharmaceutical Firms ◽  
Diffusion Of Knowledge ◽  
Pharmaceutical Industries ◽  
On Chip

: At present, due to increased costs, decreased productivity, and lack of breakthrough technologies many pharmaceutical firms face various challenges in their research and development projects. A variety of environmental concerns have also been gradually placing pressure on the pharmaceutical industry, including substantial profit losses due to patent expiration, more expensive health care facilities, and more stringent regulatory requirements. A system-oriented approach to finding innovative solutions is essential to this complicated problem. In our opinion, the key to solving these challenges is to increase the quality and number of creative and cost-effective new pharmaceutical products without incurring excessive R&D expenses, both for the future profitability of pharmaceutical industries and developments in healthcare. Our main emphasis is to highlight the strategies and models like Quality by Design, Lean Six Sigma, Organ-on-Chip, Chorus, AI, and so on in delivering innovations, which can be a good positive change for industries as to increase productivity in terms of time efficiency and innovation as well. These models focus on the creation and diffusion of knowledge internal to the firms. The major focus points should include critical investigation in innovations where the risk is high, as this can lead to the safer side of the development. We then propose specific strategies that could have the most substantial impact in improving R&D productivity. Besides this, the selection of strategy and models at the same point is as important as its implementation and its accurate selection can assist pharmaceutical companies to improve R&D organizations and their productivity.

Creative and Innovative Statistics in Clinical Research and Development

2005 ◽  
Vol 44 (04) ◽  
pp. 551-560 ◽  
Author(s):  
W. Maurer
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Clinical Research ◽  
Development Process ◽  
Critical Path ◽  
Clinical Development ◽  
Compound A ◽  
The Us ◽  
The Right ◽  
Reduced Time

Summary Objectives: The aim of this paper is to show that even in a highly regulated area such as clinical research and development in pharmaceutical industry, there are needs and ample opportunities for statisticians and other medical informatics professionals to further creatively develop and implement methods in order to support the collection, analysis and interpretation of clinical data. Methods: The recently published “Critical Path” initiative of the US Food and Drug Administration discusses the decline in new drug submissions in the last decade and illustrates potential causes in the present clinical development process. Areas where statisticians can and have begun to look for new innovative ways to overcome these shortcomings are presented and examples of such novel approaches that have been developed by statistical methodologists in the pharmaceutical industry together with statisticians in academia are given. Results: In Early Development, i.e., in the first studies in man with a new compound, a combination of Bayesian methods and modeling approaches is particularly promising to increase the efficiency of decision making whereas in later phases (IIb and III) a marriage of modeling and classical frequentist approaches together with novel adaptive designs is expected to help to chose the right dose regimen and to perform the trials more efficiently in reduced time. Conclusions: The combination of known statistical methods and thinking and the development of new approaches are in line with the present paradigm of “learning and confirming” in regulated clinical development while increasing the efficiency of both.

Problems Facing the Arab Pharmaceutical Industry: A Case Study from Yemen

2016 ◽  
Vol 2 (4) ◽  
pp. 234-241
Author(s):  
Mohammed Al-Shakka ◽  
Ebtesam Abood ◽  
Adel Al-Dhubhany ◽  
Sami Abdo Radman Aldubai ◽  
Khaled Said ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Low Income ◽  
Well Being ◽  
Pharmaceutical Products ◽  
Domestic Market ◽  
Raw Material ◽  
Political Crisis ◽  
Pharmaceutical Manufacturer ◽  
University Graduates ◽  
Pharmaceutical Drugs

Because of the almost-instant connection with the welfare and well-being of individuals, pharmaceutical industry stands prominently as a very important factor for the improvement and progress of a healthy productive nation. These days, pharmaceutical industry thrives as one of the largest and exponentially expanding global industries. Nonetheless, millions of people in low income developing countries, have to suffer from the fatal consequences of the inaccessibility and non-availability of essential drugs. This is also happening in Yemen, where the pharmaceutical manufacturers sector have to face up to many challenges. The Yemen Drug Company (YEDCO) was founded in 1964 by the Yemeni government as it collaborated with private investors. It was endorsed as a company with the expertise in the medicinal drug marketing. YEDCO started its work by taking in drugs from foreign companies and then locally marketing and distributing them. In 1982, YEDCO built the first medicinal factory for drugs in Sana’a. Since then, seven companies were set up to manufacture medicines in Yemen. The expanding population has led to the need to have more pharmaceutical products. It may be understandable that pharmaceutical manufacturer companies are also hit by the political crisis in the country. Inadequate amount of fuel and raw material as well as low security status were some of the underlying factors behind these ill-effects in Yemen. Imported drugs make up about nearly 90% % of the pharmaceutical market compared to 10% drugs from the domestic market. This situation has led to an additional burden being shouldered by the national economy, where Yemen spends about US$263 million annually on pharmaceutical drugs, in reference to the national Supreme Drugs Authority. Although there is a very quick growth in the population and drugs consumption, the pharmaceutical industry has not been very active, where global pharmaceutical products play their role dominantly on the domestic market. The pharmaceutical production necessitates skilled human resources like university graduates. By contrast, the government and the private sector should also motivate the pharmaceutical industry and make use of the local employment

Translational medicine

2011 ◽  
Vol 152 (47) ◽  
pp. 1894-1902
Author(s):  
János Antal ◽  
Attila Timár
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Patient Care ◽  
Computer Modeling ◽  
Translational Medicine ◽  
Scientific Discipline ◽  
Laboratory Research ◽  
Basic Sciences ◽  
Industry Research ◽  
Underlying Basis

Translational medicine is the emerging scientific discipline of the last decade which will set the benchmark for the pharmaceutical industry research and development, integrates inputs from the basic sciences of computer modeling and laboratory research through the pre-clinical and clinical phases of human research to the assimilation of new therapies and treatments into everyday practice of patient care and prevention. With this brief insight authors tried in their humble way to summarize the underlying basis, the present and the potential future of this emerging view, to draw attention to some of the challenges and tasks it faces and to highlight some of the promising approaches, trends and model developments and applications. Orv. Hetil., 2011, 152, 1894–1902.

Actual issues of hygienic regulation and creation of safe working conditions at pharmaceutical manufacturing enterprises

2020 ◽  
Vol 60 (10) ◽  
pp. 640-644
Author(s):  
Vadim M. Vasilkevich ◽  
Ruslan V. Bogdanov ◽  
Elena V. Drozdova
Keyword(s):  
Pharmaceutical Industry ◽  
Working Conditions ◽  
Experimental Studies ◽  
Pharmaceutical Products ◽  
Laboratory Animals ◽  
Production Environment ◽  
Basic Principles ◽  
Toxicological Studies ◽  
Health Disorders ◽  
Safe Working

Introduction. The working conditions of pharmaceutical industry workers are characterized by the combined effect of unfavorable factors of the production environment, among which the leading one is chemical. The aim of study is to substantiate the basic principles and criteria for hygienic regulation of pharmaceutical products in their production to ensure safe working conditions for employees based on the results of their own research and existing requirements of technical regulations. Materials and methods. Analysis of working conditions and the prevalence of health disorders in pharmaceutical workers (according to literature data), toxicological studies of pharmaceutical substances on laboratory animals, scientific justification of hygiene standards in the air of the working area. Results. Among employees of the pharmaceutical industry, the predominant forms of production-related health disorders are diseases of the respiratory system, as well as skin dermatitis of allergic origin, liver and biliary tract diseases. Based on the results of experimental studies of domestic pharmaceutical products for the treatment of cardiovascular, oncological and mental diseases that have priority socio-economic significance, the basic principles and features of the practice of justifying the hygienic standards of medicines in the air of the working area are developed and systematized. Conclusions. During hygienic rationing of medicines, it is necessary to use a differentiated approach that allows, based on the analysis of information about the chemical structure, physical and chemical characteristics, production conditions, pharmacotherapeutic activity, and the results of studying the toxic effect in an experiment on laboratory animals, to determine the maximum permissible content in the air of the working area of medicines or to justify the prohibition of isolation with reasoned recommendations for their safe production.

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