The Pharmaceuticals market in Chile is projected to generate a revenue of US$2,446.00 million in 2024. Among the various markets, Oncology Drugs is anticipated to be the largest, with a projected market volume of US$471.90m in the same year. The industry is expected to witness a steady annual growth rate of 6.24% from 2024 to 2028, resulting in a market volume of US$3,116.00m by 2028. However, in a global context, United States is expected to generate the highest revenue, reaching US$636.90bn in 2024. Chile has seen a surge in investment and research in the pharmaceutical sector, positioning the country as a key player in the Latin American market.
The Chilean pharmaceutical market is mainly dominated by generic drugs. Due to the economic slowdown in recent years, consumer preference for cheaper drugs (generics) will continue to increase. On the other hand, Cenabast, the public agency responsible for the procurement of medicines in public hospitals, will increase the direct import of medicines, which can avoid the higher costs of paying local suppliers.
- Population - 1.96 crores (2022)
- Capital City - Santiago
- Language - Spanish
- Currency - Chilean Peso
- 923 = 1.00 US Dollars (June 2024)
- Gross Domestic Product Per Capita in USD : 16,616.23 USD
- International Borders: -Peru to the north, Bolivia to the northeast, Argentina to the east, and the Drake Passage to the south.
- Largest Port: - San Antonio.
- Structure of the Market
- Public Sector: Cenabast, Public Hospitals, Municipalities
- Private Sector: Wholesalers, Pharmacies, Private Hospitals
- Regulator: The Agencia Nacional de Medicamentos (ANAMED)
- Registration period: 6-18 months
- Registration fee: $2500, depending on the variety
- Whether factory inspection is required: no
THE REQUIREMENTS THAT ARE REQUIRED TO REGISTER PRODUCTS IN CHILE:
The applications for registration of pharmaceutical products with the Sanitary Registry, which has the nature of an affidavit, should be filled according to an established procedure. In general terms, they should include general data, technical information, pharmaceutical quality information and safety and efficacy information.
There is a simplified registration procedure in the following cases:
Products containing the same active ingredients, in the same quantity and using the same route of administration than already registered products (not benefiting of exclusivity period)
Products, which active ingredients are sufficiently known and which efficacy, safety of usage and adverse reactions are described in the scientific literature.
Products that are pharmaceutically equivalent to another already registered, which active ingredients are part of a list of ingredients having specific norms to follow to demonstrate their therapeutic equivalence (bioequivalence).
Products manufactured in Chile for the sole purpose to be exported.
The registration process and the information and document submission to the Institute of Public Health (ISP), as well as the payment of the involved fees, is done online using the Institute´s on line system called GICONA23.
BIOEQUIVALENT PRODUCTS
According to current Chilean regulations, to be considered as therapeutically bioequivalent compared to a reference medicine, a drug must:
- Have a sanitary registration in force.
- Comply with Good Manufacturing Practices (GMP) and quality management.
- Submit a pharmacokinetic study of comparative bioavailability, proving to have the same efficacy and safety than the reference product.
- Studies intended to demonstrate therapeutic equivalence should be submitted to the Institute of National Health (ISP) and follow a pre-established procedure. They could be Import of pharmaceutical products.
- Laboratories, drug wholesalers, drugstores, public health entities and, in general any natural person or legal entity are authorized to import pharmaceutical products previously registered with the Institute of Public Health.
- Pharmaceutical ingredients can be imported only by drugstores and manufacturing laboratories. Semi-finished products can be imported only by laboratories (devoted to manufacturing, repacking and/or fractioning).
- The import and commercialization of pharmaceutical products is subject to two authorizations granted by the Institute of Public Health:
- Custom Destination Certificate (“Certificado de Destinación Aduanera”), authorizing to move the products from Customs area to the establishment (meeting the requirements established by the law) where they will be stored. This authorization is requested for Customs clearance.
- Resolution for Usage and Disposition (“Resolución de Uso y Disposición), which authorizes the usage and distribution of the imported pharmaceutical products.
- Both authorizations can be requested at the same time and using the same form through the GICONA on-line system. This can be done before the arrival or the goods to Chile.
- Products cannot be used, commercialized or processed in any way until the Resolution for
- Usage and Disposition is granted.
SWOT ANALYSIS
The following SWOT Analysis is intended to be a useful technique for understanding the Strengths and Weaknesses of pharmaceutical producers, and for identifying both the Opportunities open to them and the Threats they face in the Chilean market.
STRENGTH
- Good Quality of pharmaceutical products.
- Competitive prices wide variety of products.
- Existence of experienced procedures and exporters.
- General good image of products
OPPORTUNITIES
- Total market is expected to continue growing in years to come.
- Opportunities for generics with demonstrable bioequivalence.
- Increase in government purchase for social programs.
WEAKNESS
- Relatively low experience of drug exporter in the Chilean market.
THREATS
- Limited number of potential importers/Distributors
- Strict sanitary and health requirements according to Chilean regulation.
- High competition for internation laboratories
