2015年-德勤全球_High_value_high_uncertainty_42页_735kb

报告摘要

Summary of "High value, high uncertainty: Measuring risk in biopharmaceutical research and other industries"

Core Content

This report examines the high value and high uncertainty that the biopharmaceutical industry faces in Europe, comparing it with other industries to understand the nature and impact of risk across sectors. It emphasizes the importance of sustainable innovation and the need for collaboration to address increasing challenges.

Main Viewpoints

The biopharmaceutical industry is a high-value sector that has significantly improved human health and quality of life, especially through the development of innovative medicines.
Despite its societal impact, the industry is facing growing challenges, including aging populations, stringent regulations, and rising costs of R&D.
The level of uncertainty in the biopharmaceutical industry is higher than in comparable industries, due to complex regulatory environments, increased R&D costs, and market access difficulties.
Collaboration is identified as a key strategy to reduce uncertainty and sustain innovation.
The business environment is evolving, and external factors such as regulations, market access, and R&D challenges are increasing the risk for biopharmaceutical companies.

Key Information

Biopharmaceutical Industry Overview

High societal value: Biopharmaceuticals have significantly increased life expectancy and quality of life, particularly for patients with acute and chronic diseases.
Investment in innovation: The industry invests heavily in R&D, with R&D intensity at 14.7%, far exceeding other sectors (e.g., consumer electronics at 5.3%).
Long development timelines: It takes the longest time to develop new products, and the attrition rate is high throughout the R&D process.
Regulatory complexity: The fragmented and complex regulation in Europe and globally poses a significant challenge.
Patent protection: While intellectual property is crucial, effective patent protection periods are often shorter due to the long R&D process.

Comparison with Other Industries

The report compares the biopharmaceutical industry with the following sectors:

Automotive manufacturing
Commercial aircraft manufacturing
Consumer electronics
Food manufacturing
Generic pharmaceuticals

These industries were selected based on similar R&D investment levels and market-oriented characteristics.

Main Trends Affecting the Biopharmaceutical Industry

Using a PESTLE analysis, the following trends are identified as major contributors to uncertainty in the biopharmaceutical sector:

PESTLE Category	Main Trends
Political	Aging demographic and chronic diseases; governments struggling with healthcare sustainability; health inequalities persist.
Economic	Stagnating R&D investment in Europe; global industry focus on emerging markets; large companies consolidating pipelines.
Social	More informed and empowered patients; increasing social responsibility towards developing countries.
Technological	Need for new scientific advancements; availability of electronic patient data is improving.
Legal	Increasingly stringent and uncertain regulations; trust in the industry is under threat.
Environmental	Stricter energy efficiency requirements; global infection outbreaks pose a constant threat.

Uncertainty Index and Metrics

An Uncertainty Index was developed to quantify the impact of three key uncertainties on the biopharmaceutical industry and other sectors:

Market access challenges
Fragmented and increasingly complex regulation
Costs and challenges of scientific advancement

The index was derived from seven metrics that were considered relevant and measurable across the selected industries. Metrics such as attrition rate, regulatory change, and patent life were excluded due to lack of data or difficulty in quantification.

Conclusion and Recommendations

The sustainability of biopharmaceutical innovation depends on reducing uncertainty, increasing collaboration, and adequately rewarding innovation.
Collaboration with external partners, including academic institutions and healthcare systems, is essential to maximise R&D investment and deliver high-quality medicines.
Government and industry alignment is needed to ensure healthcare systems remain sustainable and to support the future of innovation.
Strategic and executional risks can lead to positive business outcomes, while operational risks primarily affect compliance and regulation.

Conclusion

The biopharmaceutical industry is highly innovative and strategically important, but it is under increasing pressure due to uncertainty and risk. To ensure the future of innovation and healthcare sustainability, the industry must collaborate more, reduce uncertainty, and secure appropriate rewards for innovation. This report provides a comprehensive analysis of the business environment, uncertainty, and risk in the biopharmaceutical sector and highlights the need for systemic changes to support its continued growth and impact.