德勤全球-2019_Global_life_sciences_outlook_54页_4mb

2019 Global Life Sciences Outlook Summary

Core Content

The 2019 Global Life Sciences Outlook highlights the ongoing transformation in the industry driven by digital innovation, evolving market dynamics, and increasing regulatory scrutiny. It emphasizes the importance of Focus and Transform as key strategies for leaders to navigate the changing landscape. The report also explores growth trends, therapeutic focus, and challenges such as pricing pressures, supply chain disruptions, and the rise of personalized medicine and biosimilars.

Main Points

Digital Transformation

• Digital transformation in life sciences is not just about adopting technology, but using it strategically and symbiotically.
• Data is becoming the new currency in the industry, and digital enterprises are building new business models around it.
• Leaders should:
  • Focus on patients and regulators as partners.
  • Expand networked ecosystems through external innovation.
  • Mobilize data and collaborate with non-traditional partners such as startups and tech giants.
  • Outsource for advanced technologies and manufacturing and choose vendors with aligned values and risk profiles.

Economic Overview

• Global health spending is on the rise, with a CAGR of 5.4% for 60 countries (2018–2022).
• By 2019, health spending is expected to account for 10.5% of GDP.
• Per-person spending varies widely, from $11,674 in the US to $54 in Pakistan.

Growth Trends

• Life expectancy is rising globally, expected to reach 74.4 years by 2022, but the US saw a third consecutive decline to 78.6 years.
• Pharmaceutical spending is predicted to outpace overall health care spending.
• Worldwide prescription drug sales are expected to grow from $900 billion in 2019 to $1.2 trillion by 2024, with a CAGR of 6.4%.
• Orphan drugs and next-generation cell and gene therapies are expected to grow significantly, with the orphan drugs sector projected to almost double by 2024 and CAR-T therapy growing at over 51% annually (2018–2030).

Therapeutic Focus

• Oncology remains the dominant therapy segment, with projected sales reaching $233 billion by 2024.
• Immunosuppressants are expected to have the highest CAGR at 15.7%.
• Personalized medicine is growing at an 11% CAGR, driven by AI, blockchain, and health care analytics.
• 30% of personalized medicine is focused on oncology.

Medtech

• Medtech is projected to grow at 5.6% CAGR (2017–2024), with $475 billion in global sales in 2019 and expected to reach $595 billion by 2024.
• In Vitro Diagnostics is expected to be the largest medtech segment by 2024, with $79.6 billion in annual sales.
• Software-as-a-Medical Device (SaMD) is a growing area of innovation, with regulators aiming to de-risk and make it more agile.

Regulations

• FDA is launching a software precertification (Pre-Cert) program for SaMD in 2019 and updating its Medical Device De Novo Classification process.
• The EU is preparing for stricter regulations under the Medical Devices Regulations (MDR) and In Vitro Diagnostics Directive (IVDR).
• UK's NICE is setting new standards for digital health technology.
• Australia's TGA is reviewing SaMD regulations, and China's NMPA is focusing on data integrity in clinical trials.

Pricing Pressures

• Governments are increasing scrutiny of pharmaceutical pricing, driven by generic and biosimilar competition, patent expiries, and cost concerns.
• US is testing lower drug prices and increasing pricing transparency.
• UK has introduced a 2% cap on branded medicine sales to the NHS, potentially saving £930 million in 2019.
• France, Germany, and Japan are implementing price controls and HTA programs to ensure cost-effective treatments.

Geopolitical Uncertainty

• US-China trade war is a major concern for global pharmaceutical companies, with Chinese-made goods targeted for tariffs.
• Brexit is creating uncertainty for the UK and EU, with contingency plans to maintain access to medicines and medical devices.

Generics and Biosimilars

• Biosimilars are gaining traction, with the US approving its first in 2017 and India having over 50 approved biosimilars.
• Generics are expected to grow in demand, with $251 billion in revenues at risk from patent expiries.
• Civica Rx, a not-for-profit generic drug company, is disrupting the market by offering transparent pricing and manufacturing control.

Strategic Focus on Deal-Making

• Licensing is the most common type of deal, accounting for 93% of all biopharma deals.
• M&A and joint ventures are also key strategies for accessing new capabilities and technologies.
• The report outlines the strategic rationale, advantages, and disadvantages of different deal types.

Key Information

• Digital transformation is central to future success.
• Data is becoming a critical asset for value creation.
• Global health spending is rising, with North America expected to see a decline in its share of pharmaceutical spending.
• Oncology is the fastest-growing therapy area, and personalized medicine is gaining momentum.
• Regulatory changes are shaping the future of both pharmaceuticals and medical devices.
• Pricing pressures are a major challenge, with reforms and cost controls being implemented globally.
• Geopolitical factors such as trade wars and Brexit are affecting supply chains and market dynamics.