South Korea Orphan Drugs Market Size, Share, and COVID-19 Impact Analysis, By Drug Type (Biological, Non-Biological), By Disease Type (Oncology, Hematology, Neurology, Cardiovascular, and Others), and South Korea Orphan Drugs Market Insights, Industry Trend, Forecasts to 2035.

South Korea Orphan Drugs Market Insights Forecasts to 2035

• The South Korea Orphan Drugs Market Size was estimated at USD 3.9 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of around 10.76% from 2025 to 2035
• The South Korea Orphan Drugs Market Size is Expected to Reach USD 12.0 Billion by 2035

According to a research report published by Spherical Insights & Consulting, the South Korea Orphan Drugs Market Size is anticipated to reach USD 12.0 Billion by 2035, growing at a CAGR of 10.76% from 2025 to 2035. The main factor propelling the regional market is the implementation of advantageous policies by governmental entities to prevent the spread of infectious diseases.

Market Overview

The South Korean orphan drugs market pharmaceutical products created to identify, prevent, or treat rare diseases affecting fewer than 20,000 individuals in the nation make up the South Korean orphan drugs market. These illnesses are frequently degenerative, progressive, chronic, disabling, and life-threatening. High development costs, specialized treatment needs, and small patient populations are common characteristics of orphan drugs. Additionally, The Rare Disease Management Act, passed by South Korea in 2016, has played a significant role in promoting the creation and availability of orphan medications. This law offers a number of incentives, such as tax breaks for R&D, expedited approval procedures, exemptions from some data submission requirements, and longer periods of market exclusivity. The act also permits risk-sharing arrangements and flexible pharmacoeconomic evaluations to improve patient access to orphan medications.

Report Coverage

This research report categorizes the market for the South Korean orphan drugs market based on various segments and regions and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the South Korean orphan drugs market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the South Korean orphan drugs market.

Driving Factors

The number of patients eligible for orphan drug treatments has increased as such of the quick development of diagnostic technologies, which has also increased the identification of rare diseases. Additionally, this development has made it easier to diagnose patients more quickly and accurately, which has improved patient outcomes and increased demand for specialized treatments.

Restraining Factors

the South Korean orphan drug market, mostly because of the limited patient pool for rare diseases and the high development costs. The financial feasibility of creating and promoting orphan medications is impacted by these difficulties, as well as regulatory barriers and restrictions on market exclusivity.

Market Segmentation

The South Korea orphan drugs market share is classified into drug type and disease type.

• The biological segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The South Korea orphan drugs market is segmented by drug type into biological and non-biological. Among these, the biological segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. Monoclonal antibodies and gene therapies are examples of biological orphan drugs that are widely used because of their efficacy in treating rare diseases and the growing emphasis on personalized medicine.

• The oncology segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The South Korea orphan drugs market is segmented by disease type into oncology, hematology, neurology, cardiovascular, and others. Among these, the oncology segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. The rising incidence of rare cancers and the emphasis on targeted treatments have led to a high demand for oncology orphan drugs. Biotechnology developments and government funding for rare disease therapies are driving the market.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the South Korea orphan drugs market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Samsung Biologics
• Celltrion Inc.
• LG Chem Life Sciences
• Hanmi Pharmaceutical Co., Ltd.
• GC Pharma
• SK Biopharmaceuticals
• Others

Recent Developments:

• In May 2025, For the first time in six years, compensation for South Koreans who had suffered from drug side effects declined in 2024. Due to fewer cases and a lack of public awareness, the government's national drug side effects relief fund had received 4.75 Billion won (USD 3.5 Million), but payouts had decreased.

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at South Korea, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the South Korea orphan drugs market based on the below-mentioned segments:

South Korea Orphan Drugs Market, By Drug Type

• Biological
• Non-Biological

South Korea Orphan Drugs Market, By Disease Type

• Oncology
• Hematology
• Neurology
• Cardiovascular
• Others