Understanding long-listed pharmaceutical products without competition in South Korea: policy implications in managing generic entrants and pharmaceutical expenditures

ABSTRACT

Background

The nature of competition within the pharmaceutical sector has received a great deal of attention from policymakers and researchers. This is the first study to comprehensively analyze long listed single-source products within the South Korean market.

Methods

Long listed single-source products are defined as pharmaceutical drugs that are available in the market for at least 8 years, without competition. We analyzed the determinants that lead to long listed single-source products in the market, and then evaluated their impact on health systems by examining the subsequent price responses of manufacturers.

Results

Based on the number of drugs and their market values, pharmaceuticals categorized as long listed single-source products constitute a substantial portion of the market. Characteristics of the market are closely associated with generic entrants. In particular, the market size of a substance is associated with generic entrants, while the price of a brand-name drug is related to being long listed single-source products.

Conclusions

Our analysis supports the creation of a regulatory and/or reimbursement system in order to support robust and effective competition within the marketplace. The first step toward rationalizing the system is to provide widespread information on drugs with limited competition or no competition.

KEYWORDS:

• Market competition
• pharmaceutical drug branding
• off-patent drugs
• generic drugs
• South Korean pharmaceutical industry

Expert Opinion

• Drugs categorized as long listed single-source products constitute a substantial portion of the market in South Korea.

• A regulatory system that can provide information on drugs with limited competition should be devised in order to encourage robust and effective competition.

• However, many long listed single-source products are not candidates for generic entrant due to the complexity of their production.

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Author contributions

KS designed the study, collected and analyzed data, and wrote the manuscript. The author read and approved the final manuscript.

Notes

1. Available at https://www.hira.or.kr/bbsDummy.do?pgmid=HIRAA030014050000

2. Available at https://biz.kpis.or.kr/kpis_biz/index.jsp

3. Available at http://www.motie.go.kr/motie/py/sa/companyGuide/companyguide.jsp

Additional information

Funding

This work was supported by the Ministry of Education of the Republic of Korea and the National Research Foundation of Korea(NRF-2019S1A5A8032445).