Lessons from the South Korean IVD Market

The Indian and South Korean in-vitro diagnostics (IVD) industries have grown significantly and compete directly in the global market. Despite its significantly small size and population, the South Korean IVD industry fares much better than the Indian IVD industry.

• The Indian IVD market was valued at approximately USD 1.69 billion in 2023 and is projected to reach USD 2.56 billion by 2030. On the other hand, South Korea's IVD market is estimated at USD 1.99 billion in 2024 and is expected to grow to USD 2.59 billion by 2029.
• The Growth rates forecast for India and South Korea until 2030 are 6.25% and 5.42%, respectively, indicating a significant disparity given their size. This underscores the urgent need for India to learn from South Korea's strategies to achieve robust growth in the IVD segment.
• India is considered an emerging IVD manufacturing hub, while South Korea is regarded as a more mature and favorable market for IVDs. It is known for its efficient regulatory processes and openness to foreign investments.

Government Initiatives Impacting the IVD Market in South Korea

1. Cancer screening and control programs: The South Korean government has implemented initiatives to control cancer cases by assisting with cancer testing, contributing to the growth of the IVD market, particularly in the cancer/oncology segment.
2. Infectious disease control: Government efforts to control infectious diseases, especially during the COVID-19 pandemic, have increased demand for IVD testing.
3. Public-private partnerships: The government is collaborating with private entities to increase innovation, efficiency, and service delivery in the IVD sector.

Which South Korean Aspects Should We Emulate?

For India to attain robust growth in the IVD segment, we must learn from some of South Korea’s key drivers and best practices:

1. Streamlined Regulatory Process: South Korea is known for having a favorable regulatory process for the IVD industry. India must urgently work on simplifying and expediting its regulatory procedures to attract more foreign investments and facilitate faster product approvals. The need for these regulatory improvements is crucial and should be felt by the audience.
2. Fast-Track Procedures: In 2020, South Korea initiated a fast-track procedure for international patients with severe illnesses. India must implement similar fast-track approval processes for critical IVD products, especially those addressing urgent healthcare needs.
3. Designated Testing Institutions: South Korea has designated IVD clinical performance testing institutions (107 as of November 2023). India must similarly establish a testing, validating, and accreditation network to upgrade our adherence to quality standards.
4. Supportive Foreign Investment Policies: India must modify its policies and procedures to attract global foreign investors in line with South Korean policies. We must also encourage technology transfer to upgrade the existing domestic IVD setups.
5. Global Outreach: To drive growth, the Indian IVD industry must tap all established and emerging markets. Exposure to high-quality Indian IVD products at a global level is a prerequisite for creating the preferred imagery and global customer acceptance.
6. Focus on Advanced Technologies: South Korea is acknowledged for its prowess in molecular diagnostics and PoCT. India must similarly identify niche areas for innovation, technology transfers, and extensive R&D and establish itself as a champion in certain niche areas.
7. Quality Standards Alignment: India’s IVD quality standards - ICMED must align with international standards to create a positive impact and acceptance of Indian IVD products in global markets. 
8. Public-Private Partnerships: India must emulate this collaborative model based on public-private partnerships, stitching together the best government and private entities to drive innovation and efficiencies, resulting in a win-win situation.
9. Regulatory Support for Domestic Manufacturing: While India has initiatives like "Make in India" and PLI, much more needs to be done to create an optimal regulatory environment that fosters domestic manufacturing.
10. Cybersecurity Guidelines: South Korea has recently updated its IVD regulations to include cybersecurity guidelines. India must develop and implement regulatory frameworks to address the growing importance of data security in IVD devices and systems. We must guard against any negative impacts from this new-age threat.
11. Crisis Management & Quick Response Mechanism: South Korea has a robust, highly structured, and efficient crisis management system. Its Central Disaster and Safety Countermeasure Headquarters (CDSCH), headed by the PM, managed its response during the COVID-19 pandemic. In contrast, India’s NDMA is bogged down by the country's vast size, diverse population, and a federal system that promotes decentralization. Proper coordination between central and state authorities is critical for more effective crisis management.

India's burgeoning population and growing healthcare sector have the potential to propel the IVD industry to new heights. India will improve its global standing in the IVD market through focused innovation, improving regulatory processes, and targeting specialized segments. These initiatives will benefit the industry, drive growth, increase investments, and enhance international competitiveness. 

Written By – Jatin Mahajan Secretary Association of Diagnostics Manufacturers of India (ADMI)

https://jmitra.co.in/