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📦 Somatotropin, its derivatives and structural analogues

Somatotropin, its derivatives and structural analogues

HS Code:

📦

Overview

Somatotropin, its derivatives, and structural analogues (HS Code: 2937.11) belong to the category of hormones, specifically growth hormones used primarily in medical and veterinary applications. Somatotropin, also known as human growth hormone (HGH), is utilized for treating growth disorders in children and adults, as well as in research and biotechnology. Its derivatives and analogues are often synthesized for enhanced efficacy or specific therapeutic purposes. This category is a niche but high-value segment in global trade due to the specialized nature of production and stringent regulatory requirements.

Total Trade Volume

USD 2.5 billion

Data from 2022

Source

United Nations Comtrade Database, World Trade Organization (WTO)

Tariff Analysis

Average Rate

5.2%

Highest Rate

12% (applied by certain developing countries)

Lowest Rate

0% (under free trade agreements like EU-US agreements)

Common Restrictions

  • Strict import licensing due to medical use
  • Compliance with Good Manufacturing Practices (GMP)
  • Restrictions on non-approved therapeutic uses
  • Mandatory clinical trial data for imports

Market Trends

Rising demand for recombinant human growth hormone (rHGH)

Increased production and export from biotech hubs like the US and Switzerland due to growing prevalence of growth hormone deficiencies and aging populations.

2021-2022

Advancements in biosimilar growth hormones

Reduction in costs and increased accessibility in emerging markets, driving trade volume growth in countries like South Korea.

2020-2022

Regulatory harmonization in major markets

Simplified approval processes in the EU and US have boosted cross-border trade while maintaining high safety standards.

2019-2022

Recent Developments

EU Approval of New Somatotropin Biosimilar

The European Medicines Agency (EMA) approved a new biosimilar for somatotropin, increasing competition and potentially lowering prices in the EU market.

March 2023

Expected to increase trade volume within the EU by 10-15% over the next two years.

US FDA Tightens Regulations on HGH Imports

The US Food and Drug Administration (FDA) introduced stricter guidelines for imported somatotropin products to combat counterfeit drugs.

January 2023

May temporarily reduce import volumes from non-compliant countries while increasing scrutiny on supply chains.

South Korea Expands Production Capacity

A leading South Korean biotech firm announced a new manufacturing facility for somatotropin derivatives, aiming to double export capacity.

September 2022

Likely to position South Korea as a key exporter in the Asia-Pacific region, impacting global trade dynamics.