Market brief · Pharmaceuticals · 2026
Colombia is open to your medicines: the pharmaceutical market entry guide
A US$6 billion pharmaceutical market growing close to 8% a year, and a regulator (INVIMA) that lets foreign manufacturers hold their own registrations. Here is what the numbers say, and how to enter while keeping your molecule, your brand and your registration under your control.
The essentials
Key findings
- 01US$6.0Bin projected Colombian pharmaceutical sales for 2026.1See it
- 02~8%average yearly growth of the pharmaceutical market since 2014.1See it
- 0385%+of the US$388M in 2025 pharmaceutical exports went to Latin America.1See it
- 0477%of the US$1.77B medical device market was covered by imports in 2025.2See it
- 05+25%growth of the device market between 2025 and 2030, to US$2.22B.2See it
- 06US$874in projected health spending per person in 2030, up from US$650 in 2025.3See it
- 07Level IVis INVIMA's rating from PAHO/WHO, among the highest in the region.1See it
- 085 yearsof validity for a medicine registration under Decree 677 of 1995, renewable.See it
- 09In your namethe INVIMA registration can stay, even if the manufacturer is foreign.See it
Chapter 1 of 6
A growing market with a hub position in Latin America
Colombia combines a sizable domestic market with a manufacturing base that already exports across the region. Fitch Solutions (BMI) projects pharmaceutical sales close to US$6 billion in 2026, after growth near 8% a year since 2014.1
- Sustained demand. Pharmaceutical sales have grown close to 8% a year since 2014, driven by wider health coverage and an aging population.1
- A regional export platform. Over 85% of Colombia's US$388M in pharmaceutical exports went to Latin American markets in 2025.1
- A broad life sciences market. Beyond medicines, a US$1.77B medical device market (77% imported) heading to US$2.22B by 2030, plus cosmetics and food, all under INVIMA.2
- A predictable regulator. Medicines are registered under Decree 677 of 1995, with 5-year renewable registrations, online filing and pharmacovigilance after launch.
Where Colombia's pharmaceutical exports go
Share of 2025 pharmaceutical exports by destination. ProColombia reports more than 85% went to Latin America.
More than 85% of Colombian pharmaceutical exports stay in Latin America: a product made or registered here already travels the region.
See the data
| Share of exports | |
|---|---|
| Latin America | 85% |
| Rest of the world | 15% |
Chapter 2 of 6
Beyond medicines: a life sciences market that runs on imports
The same regulator covers medical devices, and that market tells a clear story: demand is growing faster than local supply. ProColombia expects the device market to rise from US$1.77B in 2025 to US$2.22B in 2030, while domestic production goes from US$346M to US$495M.2
Medical device market vs. domestic production
US$ millions. The gap between the two bars is what imports cover today.
The device market grows by about US$444M to 2030, while domestic production adds about US$150M.
See the data
| Total market | Domestic production | |
|---|---|---|
| 2025 | US$1,773M | US$346M |
| 2030 (projected) | US$2,217M | US$495M |
How much of the device market is imported
US$ millions, 2025. Imports reached US$1,374M of a US$1,773M market.
About three of every four dollars spent on medical devices in Colombia go to imported products.
See the data
| 2025 | |
|---|---|
| Imports | US$1,374M |
| Rest of the market | US$399M |
Health spending per person keeps rising
US$ per capita. Over the same period, health spending moves from 8.2% to 9.3% of GDP.
Spending per person rises by about a third between 2025 and 2030.
See the data
| Health spending per capita | |
|---|---|
| 2025 | US$650 |
| 2030 (projected) | US$874 |
Chapter 3 of 6
The decisive advantage: own your INVIMA registration
SPI structures the local representation so the registration stays in your name. If a commercial relationship ends, your product does not leave the market with it.
Chapter 4 of 6
A predictable regulator
INVIMA was recognized by the Pan American Health Organization and the World Health Organization as a level IV regulatory authority, one of the highest ratings in the region. That recognition makes it easier to use a Colombian registration as a reference in other Latin American markets.1
- Medicines are registered under Decree 677 of 1995.
- Registrations last 5 years and can be renewed.
- Filings are submitted online before INVIMA.
- Pharmacovigilance obligations start after launch.
Chapter 5 of 6
Your route into Colombia, in four steps
- 01 · DiagnoseFree initial assessmentProduct category, applicable filing, timeline and fees for your portfolio, before you commit.
- 02 · RegisterINVIMA health registrationMedicine dossiers under Decree 677, amendments and renewals, labeling review and pharmacovigilance. Also devices, cosmetics and food.
- 03 · ProtectPatents, trademarks and dataPatents (PCT) and trademarks (Madrid Protocol) before the SIC, test-data protection for new molecules, and defense against infringement.
- 04 · Operate & growLegal base and partnersCompany formation, distribution and licensing contracts, compliance, and distributor search for Colombia and the region.
Chapter 6 of 6
Your partner: one point of contact, from dossier to resolution
- 1993
- founded in Bogotá
- +15,000
- permits, trademarks and patents
- +120
- countries via partners
- 1
- point of contact
Built for life sciences companies. A Regulatory Affairs team filing medicines, devices, cosmetics and food before INVIMA, and coordinating filings across Latin America.
What we file
- Medicines
- Medical devices
- Cosmetics
- Food
- Pharmacovigilance
- 5-year renewals
Above all, their deep knowledge of INVIMA procedures. Second, their high level of organization and attention to detail.
Sources
- ProColombia, "Mercado farmacéutico colombiano abre espacio para nueva inversión extranjera en manufactura y biotecnología" (17 Mar 2026), citing DANE and Fitch Solutions/BMI.
- ProColombia, "Dispositivos médicos: Colombia tiene mercado y espacio para nueva inversión extranjera" (6 Oct 2026), citing sector analysis and DANE.
- ProColombia, "Inversión y exportación: por qué Colombia interesa al capital global de dispositivos médicos" (2 Mar 2026), citing BMI.
Market values include estimates and forecasts from the cited sources.
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Considering Colombia or Latin America?
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