Challenges and opportunities for the innovation of novel drugs

An analysis of R&D collaborations within the sectoral innovation system of the Indian pharmaceutical industry

Master's Thesis , 2016 , 157 Pages , Grade: 1,6

Medicine - Pharmacology, Pharmacy

This paper investigates whether, and to what extent, external sourcing activities and R&D collaborations between Indian pharmaceutical firms and their partners in the sectoral innovation system constitute a viable option for them to upgrade into the development of new, enhanced drugs. This was achieved through conducting an analysis of the pharmaceutical industry‘s sector innovation system and R&D collaboration modes between Indian pharmaceutical firms and their external partners.

The Indian pharmaceutical industry is the country’s leading science-based industry with wide ranging capabilities in the complex field of drug technology and manufacturing. Expanding at a compound annual growth rate of 23.9 per cent, the Indian pharmaceuticals market is anticipated to reach USD 55 billion by 2020. Among the pharmerging markets, it is highly ranked in terms of quality and the extensive range of manufactured drugs.

India signed the Agreement on Trade Related Intellectual Property Rights in 1995. This agreement aimed at harmonizing intellectual property rights and patent protection worldwide. India's decision to sign was disputed since civil society campaigners believed it would prevent access to low cost drugs and many Indian generics drug firms susptected to lose their right to reverse-engineer products, which were patent-protected abroad. Most small-scale generics firms remained resistant, while the majority of large-scale firms welcomed the possibility of entering higher-income markets, fuelled by their visions of becoming innovators themselves.

Signing the Agreement on Trade Related Intellectual Property Rights necessitated amendments to the Patents Act, 1970. This Act had previously offered Indian firms equivalent protection to that of their foreign counterparts, encouraging them to produce new chemical entities instead of generic drugs. The new institutional framework has resulted in a search for novel drugs and new markets, leading to an increase in collaborations on research and development.

Inhaltsverzeichnis (Table of Contents)

• 1. Introduction
  • 1.1. Background
  • 1.2. Objective, research gaps and research question
  • 1.3. Definitions and concepts
  • 1.4. Delimitation
  • 1.5. Outline of the thesis
• 2. Methodology
  • 2.1. Analytical framework
  • 2.2. Methodological approach
    • 2.2.1. Research philosophy
    • 2.2.2. Research perspective
    • 2.2.3. Research strategy
  • 2.3. Data collection
    • 2.3.1. Surveys
    • 2.3.2. Secondary data
    • 2.3.3. Design of the field phase
    • 2.3.4. Reliability
    • 2.3.5. Validity
  • 2.4. Summary
• 3. Theoretical framework
  • 3.1. The sectoral innovation system
  • 3.2. The innovation value chain and open innovation
  • 3.3. Learning and idea generation through R&D collaborations
  • 3.4. Summary
• 4. Research context
  • 4.1. Self-reliance policy: Amendment of the patent law and introduction of the New Drug Policy (1947-1991)
  • 4.2. The phase of liberalization, de-control and product patent (1991- today)
  • 4.3. Summary
• 5. Key components of the SIS of the API sector in India
  • 5.1. Descriptive Analysis
  • 5.2. The Government of India
    • 5.2.1. Overall policy framework
    • 5.2.2. The patent regime
    • 5.2.3. Product and quality regulations
  • 5.3. The academia
  • 5.4. The industry
    • 5.4.1. Balance of Trade
    • 5.4.2. Production of APIs
    • 5.4.3. R&D intensity
    • 5.4.4. R&D stages and skills to develop NCES
  • 5.5. Summary
• 6. R&D collaboration strategies
  • 6.1. Sources of innovation information
  • 6.2. Prime motives for R&D collaborative projects
  • 6.3. Collaborative R&D projects aimed at early stage drug development
    • 6.3.1. Invention stage of early stage R&D collaboration projects
    • 6.3.2. Most important objectives of early stage R&D collaboration projects
    • 6.3.3. The contribution to success of early stage R&D collaboration projects
    • 6.3.4. Problems related to early stage R&D collaboration projects
  • 6.4. R&D collaboration cases
    • 6.4.1. In-licensing
    • 6.4.2. Out-licensing
    • 6.4.3. Contract research and manufacturing services
    • 6.4.4. Collaborative research projects
    • 6.4.5. Public private R&D partnerships
  • 6.5. Summary

Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)

This work provides an in-depth analysis of R&D collaborations within the sectoral innovation system (SIS) of the Indian pharmaceutical industry. The research aims to identify the challenges and opportunities that this system faces in developing novel drugs.

• The role of R&D collaborations in the innovation process
• The impact of the Indian patent regime on R&D collaborations
• The key components of the SIS, including government, academia, and industry
• The challenges and opportunities for developing novel drugs in India
• The strategies for successful R&D collaboration in the Indian pharmaceutical sector

Zusammenfassung der Kapitel (Chapter Summaries)

• Chapter 1: Introduction This chapter provides an overview of the research topic, outlining the background, objectives, research gaps, and research question. It also defines key concepts and delineates the scope of the study.
• Chapter 2: Methodology This chapter details the research methodology employed in the study, including the analytical framework, research philosophy, perspective, and strategy. It also describes the data collection methods, reliability and validity considerations, and summarizes the methodological approach.
• Chapter 3: Theoretical framework This chapter presents the theoretical foundation for the study, exploring the concepts of the sectoral innovation system, the innovation value chain, open innovation, and the role of R&D collaborations in learning and idea generation.
• Chapter 4: Research context This chapter examines the historical context of the Indian pharmaceutical industry, focusing on the evolution of the patent regime and the impact of liberalization policies on the SIS.
• Chapter 5: Key components of the SIS of the API sector in India This chapter analyzes the key components of the SIS, including government policies, the role of academia, and the structure of the industry. It also explores the industry's Balance of Trade, production of APIs, R&D intensity, and the skills required for developing novel chemical entities.
• Chapter 6: R&D collaboration strategies This chapter examines various R&D collaboration strategies employed by pharmaceutical companies in India. It analyzes the sources of innovation information, prime motives for collaborations, and the challenges and opportunities associated with different types of collaborative projects.

Schlüsselwörter (Keywords)

The primary focus of this work lies in the analysis of R&D collaborations within the Indian pharmaceutical industry. Key terms and concepts include sectoral innovation system, open innovation, R&D intensity, patent regime, API production, novel drug development, and collaborative research strategies. The research delves into the impact of these factors on the development of novel drugs and the challenges and opportunities for innovation within the Indian pharmaceutical sector.

• College: Copenhagen Business School
• Grade: 1,6
• Author: Elise Siebenbruck (Author)
• Publication Year: 2016
• Pages: 157
• Catalog Number: V324120
• ISBN (eBook): 9783668237049
• ISBN (Book): 9783668237056
• Language: English
• Tags: pharmaceutical industry, India, R&D collaborations, Innovation System, knowledge sharing, drug discovery