Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Improve the Competitiveness of Japanese Players

Friday 3 May 2013, Amsterdam

The Declining and Rapidly Aging Population Presents Significant Challenges to the Healthcare System and Economy as a Whole

Japan had a population of 127,817,277 in 2011, making it the 10th most populated country in the world (The World Bank, 2012). However, since 2005, as the number of deaths exceeded that of births, the population has declined. Without significant government intervention, the depopulation process is expected to continue. The proportion of people aged 65 or over is 23.3% and projected to reach 29.1% by 2020 and almost 40% by 2050 (Statistical Research and Training Institute, 2012).
These demographic changes will present further challenges to a stagnating economy, which, as the data in this report confirms, is already struggling with reduced economic growth. A diminishing workforce and falling productivity levels will likely add to the economic difficulties Japan is experiencing. The associated increase in disease burden has also had implications for the healthcare system. Healthcare expenditure has risen, and is set to rise further as the population continues to age
Japan’s universal healthcare system may therefore prove unsustainable as the government looks to control spending. A combination of pro-generic policies, government initiatives to prevent lifestyle diseases, and higher copayments should help to keep healthcare expenditure under control.

Regulatory Reform will Continue to Attract Foreign Pharmaceutical Companies

The ongoing deregulation of the Japanese pharmaceutical industry has made it an attractive market for big pharma. Improvements to the new drug approval process have significantly shortened the approval time. Consultation services provided by approval bodies have been expanded and improved, approval standards have been clarified and the number of trained personnel involved in the review process has increased. Many of these changes have occurred following the introduction of a number of plans and government policies. Plans are currently being implemented to shorten the review period and improve cooperation with other countries, particularly Western and other Asian nations, such as the Second Medium Range Plan (2009–2014), which includes the International Strategic Plan.

In April 2007, the government introduced the 5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices, which contributed towards the reduction in lag time associated with new product approvals.

In addition to attracting foreign investment, deregulation has also improved the competitiveness of Japan’s pharmaceutical companies. The market now consists of multinational players such as Takeda and Daiichi Sankyo, who market leading products globally.