Peru Pharma Market

Peru Pharma Market

The Peruvian pharmaceutical market is the 7th largest in the region, behind Mexico, Brazil, Argentina, Venezuela, Colombia & Chile. The Peruvian market value is approximately ????????????US$ 2.67Bn.

The Peru pharma market is unstructured with OTC market share 15% while Prescription based is 85%. Peru has been a traditional net importer of pharmaceutical products with largest suppliers are the United States, Germany and China with 44.7% of its domestic demand with imported drugs.?

Market Growth

5.22% CAGR

Population

Peru is the 4th most populous country in South America.

Approx 34 million

The 28% of Peruvians lives in rural areas

Life expectancy??????????

76.9 years

Official language

Spanish?is the official language of Peru

Currency

Peruvian Sol

Exchange Rate

100 Peruvian Sol = US $ 26.39

International Borders

Peru is bordered by Colombia & Ecuador to the North;

By Brazil in east

By Bolivia to the southeast ?

By Chile to the south.

It is also bounded by the South Pacific Ocean to the west.

Highly Demand Therapeutic Areas:

·??????Digestive system

·??????Metabolism

·??????Respiratory system

·??????Anti-infectives

Major Cities

Peru is divided into 24 regions across 3 distinct natural regions: Coastline, Highlands, and Jungle.

1.????Lima – Also National Capital

2.????Arequipa

3.????Trujillo

4.????Chiclayo

5.????Piura

Major ports in Peru

1.????Port of Callao

The Port of Callao is the main port in terms of traffic and storage capacity. Located in Lima.

2.????Shirt port

The port of Paita is the 2nd largest national port in Peru in terms of container traffic located in?Piura

3.????Port of Matalani

The Port of Matarani serves the southern region of Peru as well as several major cities in Bolivia, namely Santa Cruz, Cochabamba and Oruro.

?4.????Port Talara

The Port of Talara for national oil company , Refineries process different products such as motor gasoline, solvents, diesel , LPG, industrial oils and bitumen.

5.????Port of Salaverry

The port of Salaverry is actually an artificial port. It's basically a dock that's constantly exposed to surges and swells.

GDP

???????????2.8%

GDP Per Capita

Approx USD 6906

Healthcare Spending

???????????Approx. 5.22% of GDP

Approx USD 370

Ministry of Health

Also called - MINSA

FDA Name

DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)– General Bureau for Medicines, Inputs and Drugs of the Health Ministry.

Plant Audit

Yes.

For foreign manufacturers/ laboratories, GMP certificate is well accepted if already present for high surveillance countries or countries of mutual recognition with Peru. The Sanitary Authorization for registration as a laboratory fee is approx. USD $250. The regulatory regulations are very strict and is comparable to the EU or US standards.

Type of Dossier

CTD, generic drugs should undergo a bioequivalence test. As of now BE studies are required for drugs with narrow therapeutic index, drugs in which small variations in dosage may cause serious health risks to the patient. Other generics, however, keep on commercialized in absence of BE studies.

Registration Certificate

Also known as CRS – Certificado de Registro Sanitario.

Registration Validity

5 years

Timelines for Pharma Products

6 months

DIGIMED also provide Conditional Sanitary Registration of Medicines, Biological Products, & vaccines linked to emergency situations, such as the current COVID-19 pandemic. The regulation does not applicable to medical equipment.

This conditional registration will be granted within 90 days and, in the case of products approved by High Sanitary Surveillance Countries, for e.g. the USA then time limes are 30 calendar days.

Conditional Registration is valid for one year and renewable maximum upto four times.

Timelines for Medical Devices

Class I - 60 days

Class II - 90 days

Classes III, IV - 120 days

Registration Fees?

Regarding the commercialization authorization, the fees will depend on the product whose Sanitary Registration is being requested and range from $400 to $1,200, but usually its around US$ 758 per product.

API - approx US$ 753

Class I - approx. US$ 400

Class II - approx. US$ 460

Class III - approx. US$ 510

Class IV - approx. US$ 580

Registration Strategy

Registration application to be made electronically through a single window using the VUCE System.

Never appoint a distributor/importer as your country representative. Both aspects to be separated like commercial and regulatory interests,

Manufacturers must not allow the distributors to do the registrations of products, but always appoint their authorized representative to take care of the registration process.

So by adopting this strategy, registrations will remain in manufacture’s control. Suppose If you decide to end the relationship with your distributor at any point, then it would not be required to re-register your products.

Prices

“Free Market” for drugs – As there is no price control.

In the private retail sector, when comparing the medicine prices with the international reference prices representing bulk generic supply, the prices of originator brand products were about 28 times more expensive than the international reference price, while the lowest priced generics were typically about 6 times higher than the international reference price.

Prices of Few Products at Pharmacy of the Central Organism Minsa Headquarters

The medicines & devices used by patients in the national healthcare system are subsidized by the Government

·??????PREDNISONA - 5 mg/5 mL - 120 mL – Unit Price US$ 3.20

·??????CEFTRIAXONA SODICA - 1 g INYECT - Unit Price US$ 1.80

·??????FLUTICASONA + SALMETEROL - 120 DOSIS AEROSO – Unit Price US$ 17.70

·??????ITRACONAZOL - 100 mg TABLET – Unit Price Per Tablet US$ 0.50

·??????SULFADIAZINA DE PLATA 1% - 50 g CREMA –Unit Price US$ 4.00

·??????MEROPENEM - 500 mg - INYECT – INYECT – Unit Price US$ 8.80

·??????OMEPRAZOL 40 mg - INYECT – Unit Price US$ 2.20

Retail Prices of Few Pharma Products

Manufacturer -???Registration Holder – Product – Retail Price. ?????????????????????

·??????Scott-Edil - Drogueria Peru Sac - Methylprednisolone Sodium Succinate - $13.08

·??????Fdc Ltd - Drogueria Lipharma Sac – Gentamicin Eye Drop 5ml – $1.57

·??????Plethico Pharma Ltd - Intipharma Sac – Ceftriaxone 1g $3.90????????????????????????????????????????????????????????????????????????????????????????????????????

·??????Cipla - Biotoscana Farma De Peru - Fluticasona + Salmeterol MD Inhaler 120 Doses - $45

·??????Cadila - Sherfarma Sac – Tadalafil 20mg -?$ 4.5 Per Tab

·??????Msn Labs – Nordic Pharma – Pregabalin 300mg 30’s -$2.13

·??????Lupin Limited - Eske Corporation Sac – Cefalexina 250mg/5ml – 100ml - $4.24

Indian Pharma Companies and Distributors

·??????United Biotech (P) Ltd India - OQ Pharma S.A.C.

·??????Rusan Pharma Ltd - Sarmiento Ccoscco Agripino.

·??????Innova Captab Ltd - Ds Pharma Peru S.A.C.?

·??????Swiss Parenterals Ltd - Pharmagen S.A.C.

·??????Venus Remedies Limited - F & S Pharma E.I.R.L

·??????Lyka Labs Limited - Nordic Pharmaceutical Company S.A.C

·??????Lincoln Pharmaceuticals Ltd?- Corporacion Sarepta E.I.R.L

·??????Til Healthcare Pvt. Ltd - M K S Unidos S.A.

Major Players

Major generic producers are domestic and Latin American. Domestic producers include:

·??????Farmindustria,

·??????Marfan (from Medco Corporation)

·??????Magma (from Infarmasa Corporation).

Latin American producers include:

·??????the Colombian Genfar and

·??????the Chilean Newpharm (from Laboratorios Chile).

The companies control over 50% of the sector.

Few Importers in Peru

·??????Medifarma

·??????Laboratorios Induquimica

·??????Farmaceutica Otarvasq Sociedad Anonima Cerrada

·??????Laboratorios Portugal SRL

·??????Teva Peru SA

·??????Eurofarma Peru SAC

·??????Medrock Corporation Sociedad Anonima Cerrada

·??????Drocersa SA

·??????Grunenthal Peruana

·??????Banco De Credito Del Peru

Supply Chain:

In Peru there are huge logistical challenges. Its geography spreads from rugged Andes mountains to forests to subtropical desert. Most of the land is in rural area, while nearly one 4th of the population lives in Lima city (urban area).

InkaFarma Peru’s largest retail pharmacy chain had 60% of its stores in Lima, a typical ratio for businesses in the country.

Healthcare System / Insurance Provider / Tender Bodies:

Decentralized Healthcare system with 5 core entities.

4 Public and 1 Private service provider.

·??????Ministry of Health’s Health (MINSA) Insurance, Seguro Integral de Salud (SIS), - The largest insurance provider covering 60% of the population.

·??????Ministry of Labor’s Social Securit - EsSalud, 25% of the population.

·??????Armed Forces (FFFA), National Police (PNP or FNP), & the private sector covers remaining 10% of the population

Domestic producers tend to supply EsSALUD and MINSA while foreign producers FFAA & PNP. The Ministry of Health, EsSalud, and the national army buy medicines together annually in an attempt to improve prices, but local/domestic producers have challenges as they cannot compete in the prices offered by of Chinese or Indian in Peru.

Tender market share is 40% local manufacturer, 37% MNC and rest 23% Importers and Distributors.

Leading Suppliers of Raw Materials

·??????India

·??????China

·??????Belgium

·??????France

·??????Germany

·??????USA

Leading Destinations of Exports

·??????Ecuador

·??????Bolivia

·??????Argentina

·??????Venezuela

·??????Panama

·??????Colombia

·??????Guatemala

·??????Chile

·??????Costa Rica

Top domestic producers:

More than 80% of the produce pharmaceutical products, concentrated mainly in Lima.

·??????Farmindustria,

·??????Medifarma,

·??????Infarmasa

·??????Medco

Strength

·??????No Price Controls

·??????There are a relatively high number of domestic producers.

·??????Relatively young and growing population.

·??????Stable Political Climate

Weakness

·??????Local producers are reliant on raw materials imports

·??????Pharmaceutical export is low.

·??????Relatively Smaller Market.?

·??????Self-Medication is high.??

Opportunity ???

·??????More opportunity for generic drugs as compared to Patented or Branded

·??????In bidding local manufacturer are giving preference over foreign Supplies

·??????High Demand Chronic Diseases

·??????Scope of Teleconsulting is increasing specially post COVID. ?

Threat

·??????Moderate growth of Pharma market as compared to other countries like Brazil, Mexico

·??????Colombian local producers are aggressively challenging Peruvian producers

Thanks and Regards,

Dr. Palak Gupta

+91 9971140354

[email protected]

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