Pharma Market in Chile 2025: Growth, Regulation & Opportunities for Global Manufacturers

Pharmaceutical business in Chile is a crucial participant in health facilities of the country and the economy. Despite its small size in comparison with the size of regional giants like Brazil or Mexico, the pharmaceutical market of Chile has shown its relatively steady growth over time, good regulation, and the high level of access to healthcare services. A strong regulatory authority (Instituto de Salud Publica - ISP), a growing middle-income society, and an increasing demand of cheap medicines, biosimilars as well as curing treatments has made Chile an appealing but competitive target of global pharmaceutical investors.

By 2025, Chile can be distinguished by the stable market growth, which is predetermined by the following factors: the ageing population, government programs focused on providing the population with universal health coverage, and increased spending on healthcare innovation. The high level of trade openness and Free Trade Agreements (FTAs) that the country has gives it an extra edge of making foreign manufacturers and exporters seek to establish a presence in Latin America. Moreover, there is a rise in demand of contract manufacturing,  APIs (Active Pharmaceutical Ingredients), and digital healthcare solutions which, again, is a sign of gradual shift of Chile towards modern and value-driven healthcare delivery.

Nonetheless, to do business in the Chile pharmaceutical industry, one must know its peculiarities, such as stringent regulatory demands, small market size, price regulations and high generics competition. A clear strategy of entry incorporating a combination of local joint ventures, regulatory readiness, and cost-effective business is the key to unlocking the growth potential of Chile in the long term to foreign entrants, multinational pharma companies, and export-oriented firms.

For a broader view of Latin America’s evolving pharma industry, explore our in-depth country reports on the Argentina Pharma Market, Mexico Pharma Market, Venezuela Pharma Market.

• In 2024 the overall pharmaceuticals market of Chile will be US $2.45 billion with a prediction of approximately US $3.12 billion in 2028 - representing a 6.24% CAGR over 2024-28.
• According to another source another domestic market is reported at about US $1.8 billion (approximately 0.73% of the GDP of Chile) in the recent past.
• In the case of sub-segments: the market of active pharmaceutical ingredients (API) in Chile was worth US $481.2 million in 2023 and US $759.1 million in 2030 is a 6.7% CAGR between 2024 and 2030.
• The contract manufacturing and research services market in Chile are projected at US $343.8 million in 2023 with a projected growth of US $ 572.6 million in 2030 (CAGR = 7.6).
• Conversely, there are also data that indicate slower total sales growth: e.g., pharmaceuticals sales in Chile per capita USD PPP increases by 331.3 in 2024 to 334.8 in 2028 (i.e. very low growth of around 0.3-0.4%).

Implication to the Global Buyer

Chile is not a huge market in the global perspective, but it provides a stable growth and opportunities in APIs, contract manufacturing and specialty therapies. Chile has trade agreements with other countries and export oriented companies can consider Chile as a gateway to Latin America.

Chile is a country with healthcare in which almost all the citizens are insured on both public and private plans, which are called FONASA (public) and ISAPRE (private).

Key dynamics include:

• Generics & biosimilars gaining market share through government substitution policies.
• Multi-channel distribution — retail pharmacies, hospital procurement, and digital health platforms.
• Growing demand for chronic-disease, oncology, and biologic therapies driven by an aging population.

What foreign businesses are supposed to know:

• It is also essential to have a local distributor or partner to be registered, tender and navigate the public procurement bids.
• Generics and similar drugs (so-called branded generics) are expanding quicker than innovators - global firms must weigh between innovative therapies and generics/biologics.
• ​​​​​​​The company strategy should consider the multi-channel distribution (retail pharmacies, full hospital procurement, outpatient clinics) and a comparatively fragmented pharmacy retail market.

Ageing population: The proportion of the population in Chile aged 65 and above is on the rise, which is boosting the demand of chronic disease therapies, biologics, oncology.

Generics/biosimilars: The policies of generic substitution are being driven by the desire of governments to contain costs and the need to have affordable medicines.

Digital health, logistics & warehousing: Digital health is also shaping the logistics, the pharmaceutical warehousing market is being influenced by tougher distribution demands (Good Distribution Practices, cold-chain, GDP compliance) and is contributing to demand of specialised logistics.

Implication for buyers

In the case of innovative drug companies: expansion in the areas of chronic/oncology/biologics offers this growth but competitive generics climate suggests that high-quality products must be persuasive.

In the case of generics/ API/contract manufacturing: high potential given that Chile has trade-linkages to re-export to Latin America.

The Ministry of Health has a competent regulatory authority over human pharmaceuticals, medical devices, vaccines etc., the Instituto de Salud Publica de Chile (ISP).

• Registration: Before marketing/importing, manufacturers (local or foreign) have to seek sanitary registration/market authorisation through ISP.
• Policy of generic substitution: Chile had introduced substitution policy since 2014 to increase access and utilization of generics.

Bioequivalence: Generic drugs of some active ingredients in Chile have to show bioequivalence.

The opportunities in case of global buyers / multinational pharma / export-oriented players are:

A) Exports / Contract Services and manufacturing.

As the market of the contract manufacturing and research services is projected to expand (~CAGR 7.6) to US 572.6 million in 2030, Chile may provide the Latin American export base.

API manufacturing: The API market will experience US $759.1 million by 2030 (~ 6.7 percent CAGR).

In the case of the Indian/Asian API suppliers: The "Guide to Key Pharma Markets in LATAM" reveals Chile as the possible generics and ingredients destination.

B) Generics & Biosimilars

Expansion of generics due to the government policy and the aging population. Potential to license generics by the global companies, launch biosimilars or collaborate with local generics players.

Specialty generics (oncology, biologics) can have greater potential of higher margin.

The major risks to global buyers / foreign investors venturing into Chile pharma market are:

Regulatory & Approval Delays

• The fact that ISP is at Level IV NRA on the PAHO/WHO rating is not without fault; it has been reported that the company has bottlenecks in approval times and the generic substitution policy.
• Local dossiers, bioequivalence data, occasionally local studies may also be required to register it; process times may take more time than elsewhere in the market.

Scale / Size Constraint on Market.

• Chile market is small (~US $2-3 bn) relative to major markets in Latin America, and it can only yield returns when it is export-oriented.
• ​​​​​​​Some metrics are poor in terms of per-capita growth (see per-capita sales growth ~0.3-0.4%).

Competition & Price Pressure

• Intense generic competition implies that branded innovators could have their margins being tightened. The research discovered that branded generic entry reduced prices by a lot.
• ​​​​​​​Reforms in the public procurement process can exert strain on prices and reimbursements.

Intellectual Property and access to the market.

• Although Chile does have good regulatory systems, newer specialty therapies might still have problems with enforcement of IP; local generics/generic entry can destroy prices.
• ​​​​​​​To the export oriented players, there is exchange rate volatility (Chilean Peso) and local economic cycles.

The following are tactical recommendations classified in terms of buyer-type:

Multinationals / Innovative-Therapy Players

• Entry Strategy: Launch in Chile via a Latin America platform - flagship product registered in Chile and then expand either through exports or local associates.
• Pricing: Be ready to deal with cost-containment pressure; create value-differentiation (unmet need, specialty segment, biologic) and take into account tiered pricing.
• Regulatory: Early interactions with ISP on dossier strategy; local bioequivalence planning where necessary; local legal/regulatory counsel.
• Distribution: Negotiate with large pharmacy chains (Salcobrand, Cruz Verde) and hospital tenders; find a good local partner to do the logistics.
• Risk-Mitigation: Local legal entity/ reputable distributor; currency risk in hedging; advertising/promotion regulations.

In the case of Generics / Biosimilars / Licensing Players.

• Partnering: Evaluate the idea of entering into a licensing agreement with local generic manufacturers in order to gain quicker market penetration in the local market.
• Regulatory: Focus on bioequivalence dossiers; strategise generics as cheaper substitutes; keep a check on the environment of the substitution policy.
• Export Orientation: Leverage Chile to be export center of Latin America through free trade accords; create contract-manufacturing or fill/ finish situations on the ground.
• Efficiency in Cost: Localise Chile/Latin America packaging, labelling; cooperate with local warehouses and logistics which meet the GDP.

Overall, Chile is an attractive yet small pharmaceutical industry to international purchasers and export oriented companies. Its advantages are a steady high-income health sector, well-developed regulatory agency (ISP), a rising demand of generics/specialty treatment and expanding contract manufacturing/ API. On the other hand, it is not as large, competition and price pressures are not as imaginary, and regulatory/registration schedules are to be dealt with proactively.

To a global buyer, Chile must probably be viewed as a part of a larger Latin American strategy and not a business big-bet. The most successful entry strategies will be those that can capitalize on export opportunities, domestic alliances, less costly productions and differentiated products (i.e., biosimilars, niche medicines, digital distribution, etc.). The ability to convert opportunity to sustainable growth will depend on being operationally ready; distribution, regulatory, warehousing, and local partner.

-Development of Chile’s Pharma & OTC Market (Chameleon-Pharma) – forecast US$5.32 bn by 2035, CAGR ~5.32%.
-ReportLinker: Pharmaceutical Goods Market Size in Chile – 2023 value US$315.21 m, 2028 forecast US$333.72 m
- Grand View Research – Chile API market: US$481.2 m in 2023 → US$759.1 m by 2030 (CAGR ~6.7%)
-Baker McKenzie / PMPG – registration & advertising overview in Chile.
-Indian Embassy Santiago (Pharmexcil) report – generics opportunities for Indian exporters