Pharmaceutical manufacturing is one of the most regulated industries in the world. The price of error here is patient health, so compromises are unacceptable. Good Manufacturing Practice (GMP) standards have become the only global language understood by regulators and doctors.
The PHARMPROM team analyzed the dataset of the Unified Register of Drug Manufacturers and identified non-obvious trends that are shaping the landscape of the Russian pharmaceutical market right now.
Trend #1. Record Regulator Activity
Data analysis for the five-year period (2021–2025) shows an unambiguous picture: the market has not just recovered from pandemic shocks; it has gained unprecedented momentum. We see a manifold increase in inspectorate activity and the number of issued documents.
- Explosive Growth: While 145 certificates were issued in 2021, this figure rose to 865 by 2025. A nearly 6-fold increase!
- Peak Activity: 2025 became the absolute record holder for the entire observation period.
- Stability: After a sharp jump in 2022 (505 certificates), the industry reached a consistently high plateau, updating maximums in 2024 (623) and 2025.
This indicates that the transition to EAEU standards and production localization are in full swing.
Trend #2. Geography: The Balance of Power Shifts
Who guarantees the quality of medicines for Russian patients today? The data shows an interesting market structure: with the dominance of domestic sites, international presence remains critically important.
| Category | Details | Share |
|---|---|---|
| Russia (Leader) | 1,316 certificates | 50.8% |
| Top Foreign Partners | Germany (186), India (149), Italy (121), USA (108) | 40.2% |
Crucial Point: Market concentration is high — the top 10 countries account for 88.5% of all issued documents.
Trend #3. Certificate Lifecycle
A GMP certificate is not a permanent document. It is a “living” record that is regularly updated, reissued, or ceases to be valid. Analyzing the ratio of active to archived records reveals the “pulse” of regulatory work.
Currently, the database records:
- ✅ Active: 1,597 certificates (61.6%)
- ❌ Inactive: 994 certificates (38.4%)
The high share of inactive documents (almost 40%) should not be alarming. In most cases, the “inactive” status is accompanied by notes on “Amendments”. This is a positive signal: manufacturers are not leaving the market but are actively updating their dossiers, expanding production lines, and reissuing documents in accordance with new requirements.
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