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Orphan Drug Market Overview.

The orphan drugs market is growing annually at roughly 7%. Total orphan drug sales will rise from $127bn for 2017 to $217bn in 2022.
An orphan drug can be defined as an agent specifically designed to treat rare (orphaned) diseases.
Prior to 1983 R&D of orphan drugs was limited but a US orphan drug act at that time gave incentive to the new development of these medicines.
NORD (The National Organization for Rare Disorders), one of the backers of the original act estimates 30 million Americans suffer from thousands of rare diseases.
The 1983 act paved way for other countries to follow suite, notably the European Union in 2000 and Japan a decade earlier.

The Pharma14, monthly updated, platform tracks and lists all marketing authorizations, including orphan drugs across 41 countries.

Sample data: Orphan drug Nitisinone in German market. 2 mg, 5 mg, 10 mg, 20 mg capsules.

Nitisinone in german market

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Saudi Arabia medicine data and pricing are newest addition to Pharma14.

Saudi Arabia's deep commitment to health care should bring it's pharmaceutical spending to the average developed market expenditure by 2020.
Saudi Arabia with a population of 33 million people will spend roughly $300 per person on pharmaceuticals by 2020.
Pharma14 is happy to announce the addition of Saudi Arabia to its global medicine database.
This is just the latest addition to our platform that now comprises close to 2,000,000 registered medicines across 41 countries.
As in all other countries, Saudi Arabia's monthly updated medicine knowledge base includes pricing, reimbursement information and much more.
Pharma14's robust and accurate medicine data, as well as its industry leading drug pricing and reimbursement information give its members the tools required to compete in today's market.
Key pricing drivers such as generics, parallel trade, biosimillars, niche markets and more provide unique industry insight.
 
Sample Saudi Arabia data: Lenalidomide competitive landscape.  5 mg, 10 mg, 15 mg, 25 mg capsules. Ex-factory, wholesale and retail pricing. Revlimid and Lenalidomide spc.
 
Saudi Arabia Lenalidomide competitive landscape.  5 mg, 10 mg, 15 mg, 25 mg capsules. Ex-factory, wholesale and retail pricing. Revlimid and Lenalidomide spc.
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Silodosin (Rapaflo) analysis. Competitive landscape.

Silodosin (Rapaflo) is prescribed for the treatment of benign prostatic hyperplasia (BPH), or enlarged prostate.
Allergan's Rapaflo lost patent protection in the US on December 1, 2018. It was approved by the FDA in October 2008.
The drug is available in capsule formulation of 4 mg and 8 mg dosages with over $300 million in US and European sales in 2018.
In Europe where the drug was developed by Recordati, the patent expired in 2018 as well (inc.SPC) with clinical data exclusivity until 2020.
Pharma14’s proprietary Market Opportunity Locator indicates that outside the US market (Lupin, Amneal and Sandoz) no generic marketing authorizations of Rapaflo have been approved.
Pharma14's "Market opportunity locator" is a live proprietary platform that tracks all registrations in 40 countries giving members of our platform direct insight when new generics are registered as well as when they appear on the market.
 
Sample data: Silodosin. Competitive landscape.
 
Silodosin competitive landscape
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Turkey medicine data and pricing are newest addition to Pharma14.

Pharma14 is happy to announce the addition of Turkey to its global medicine database.
This is just the latest addition to our platform that now comprises close to 2,000,000 registered medicines across 40 countries.
The new data is updated on a monthly basis and covers all the registered Rx and OTC medicines in Turkey.
As in all other countries, Turkey's full medicine data includes pricing, reimbursement information and much more.
Pharma14's robust and accurate medicine data, as well as its industry leading drug pricing and reimbursement information give its members the tools required to compete in today's market.
Key pricing drivers such as generics, parallel trade, biosimillars, niche markets and more provide unique industry insight.
 
Sample Turkish data: Humira (Adalimumab) Information and ex-factory, wholesale and retail pricing.
 
Turkey Humira and Adalimumab prices ex-factory wholesale retail
 
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Gefitinib analysis. Competitive landscape.

Looking at Gefitinib (Iressa), Pharma14’s proprietary Market Opportunity Locator indicates that this oncological medicine has generic registrations in various European countries and Canada.
Although Gefitinib has seen recent generic marketing launches, there still remain quite a few European countries and in the US where Astra Zeneca's Iressa is the only competitor on the market.
Countries' such as Belgium, Brazil, Greece, Italy, US and UK to name a few, still have not seen any generic launch in Gefitinib.
Pharma14's "Market opportunity locator" is a live proprietary platform that tracks all registrations in 39 countries giving members of our platform direct insight when new generics are registered as well as when they appear on the market.
 
 
Sample data: Gefitinib. Competitive landscape.
 
gefitinib competitive landscape
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Business tool #1: Locate medicines with the least possible competition.

Besides world class medicine data Pharma14 strives to give it member's cutting edge business tools.
In this fast paced and competitive landscape these tools will give Pharma14 members a clear advantage over their peers.
Pharma14's Market Opportunity Locator:
While looking for business opportunities or optimal product launch pricing it is vital to get a clear picture of the competition that may exist for a medicine in question.
Live tracking markets, Pharma14 members can view the number of competing MA holders that exist for each type of molecule in the 39 countries covered.
Furthermore our advanced features give members a picture of all registered MA's in question, whether they are marketed or not, current and historical pricing as well as reimbursement information. Niche markets and older niche products can be located with ease saving your team countless hours of research.
 
 
Sample data: Molecules with a single MA holder in Belgium market. 
 
market opportunity locator
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Tigecycline analysis. Competitive landscape.

Looking at Tigecycline, Pharma14’s proprietary Market Opportunity Locator indicates that this antbiotic drug has generic registration in various European countries including the USA and Canada.
Although Tigecycline has seen recent generic marketing launches, there still remain quite a few European countries where Pfizer's Tygacil is the only competitor on the market.
Countries' such as Cyprus, Denmark, Estonia, Iceland, Ireland, Latvia, Lithuania, Norway and Switzerland still have not seen any generic competition in Tigecycline.
Pharma14's "Market opportunity locator" is a live proprietary platform that tracks all registrations in 39 countries giving members of our platform direct insight when new generics are registered as well as when they appear on the market.
 
 
Sample data: Tigecycline. Competitive landscape.
 
Tigecycline competitive landscape
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Pharma14 tracking of new cancer drug market authorizations.

2018 has seen a record number of new medicines approved by the FDA. 
59 new novel drugs and biologics have been approved.
Combining 2017 and 2018, the FDA has approved well over 30 new cancer drugs.
As the number of new cancer drugs coming onto market is increasing each year, Pharma14 has undertaken a specific program to track and list these new products immediately as they become registered MA’s among the 39 countries we cover.
 
Sample data: Opdivo, Nivolumab 10 mg/ml. Ex-factory prices in selected markets.
 
Opdivo Nivolumab 10mg per ml
 
 
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Australia consumption and sales information added to the Pharma14 global medicine platform database.

Pharma14 has been working diligently to grow its consumption and sales information and is pleased to announce the latest addition to this tool.
Beginning February 2019 the data for Australia been included for all Pharma14 members.
This new addition to our database includes over 4,500 medicines with their consumption and sales data for medicines sold in Australia.
Our Australia consumption and ex-factory sales data include information on medicine consumption as well as total yearly sales figures, plus year to year movement. 2018 vs. 2017 figures.
 
Sample data: Amlodipine. 2018 vs. 2017 5 mg and 10 mg tablets. Ex-factory prices and consumption in packs.
 
Australia Amlodipine
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Pharma14 brings its members all European parallel imported drug information.

The European parallel pharmaceutical trade started in the Netherlands in the 70's and is estimated to be worth approximately  € 5.5 billion (value at 2017 ex-factory prices) and between 2 - 3 % of total European medicine sales.
The trade is an arbitrage between medicine prices in different countries which are negotiated between governments and the pharmaceutical industry.
The medicine is sold on the same conditions as the original manufacturer’s normal packaging. All imported pharmaceuticals have to be approved by the local medical authority - or the EMA.
Pharma14 data includes all European parallel imported drugs and relevant information such as prices and reimbursement status.
 
 
Sample Clopidogrel parallel importers in Germany. January 2019 data.
 
Clopidogrel parallel importers in Germany
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Track first generic medicine registrations with Pharma14's Market Opportunity Locator.

One of the most important needs of business development pharmaceutical managers is the ability to track the transition a medicine makes from its patented to its generic counterpart position.
As patent expiry dates differ from country to country, keeping track of many medicines across various markets becomes a very large undertaking that requires pharmaceutical companies to spend substantial resources of time and money.
 
The cycle of a medicine going generic has two parts:
First, the generic medicine obtains the Marketing Authorization and secondly is when the medicine is launched to the market.
Pharma14 has created a unique tool, that captures the information of both cycles at hand, for your business development team’s needs.
 
Our "Market Opportunity Locator" tracks all medicine registrations letting you detect where and when a patented drug has gone off patent and new competitor generic medicines have entered into the market.
 
Ambrisentan example.
Ambrisentan is a drug indicated for use in the treatment of pulmonary hypertension developed by GSK and Gilead.
Ambrisentan is commercialized by Gilead in the US as Letairis and by GSK outside the US as Volibris
Patent expiration for this medicine will become relevant in the coming years in many countries.
 
Pharma14’s “market opportunity locator” indicates that as of January 2019 the Canadian market is the single market where a generic version exists for this medicine.
The Apotex generic version APO-Ambrisentan is in Canada with registration date of April 2018.
 
UK Apotex
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Italy consumption information added to the Pharma14 global medicine platform database.

Pharma14 is continuing to diligently grow its consumption and sales information and is pleased to announce the latest addition to this tool.
Beginning January 2019 the reimbursed medicines consumption data for Italy has been added to the Pharma14 platform.
This information is available to all Pharma14 members at no additional cost.
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Pharma14 is glad to announce consumption and sales data coverage for 15 countries and counting.

The database is a comprehensive annual summary on the use, consumption and costs of reimbursed medicines in these 15 markets.
Data is based on the past full two years with movement trends shown in total units and dollar value.
Pharma14 is working to add more markets to this database and we will keep you posted as we bring additional countries on board in the coming months.
Of our 41 country medicine and pricing database the current list of 15 markets we cover for consumption and sales data are as follows:
USA, UK, Germany, France, Italy, Czech Republic, Norway, Sweden, Finland, Denmark, Netherlands, Australia, Estonia, Latvia and Lithuania.
 
Sample data: Amlodipine consumption and sales in France.
 
france amlodipine consumption
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France consumption and sales information added to the Pharma14 global medicine platform database.

Pharma14 has been working diligently to grow its consumption and sales information and is pleased to announce the latest addition to this tool.
Beginning December 2018 the data for France has been included for all Pharma14 members.
This new addition to our database includes over 12,000 medicines with their consumption and sales data for medicines sold in France.
Our France consumption and sales data includes information of brand pack consumption as well as total yearly sales figures.
 
Sample data: Atorvastatine consumption and sales in France.
 
france atorvastatine consumption and sales
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Pharma14 adds UK Specials and Drug Tariff Special information. Pricing, consumption and sales data added to platform.

As Drug Tariff Specials are an important tool for reducing prescribing costs, it is important for companies working in the UK health sector to be able to keep track of price movements, consumption and sales data.
Pharma14's UK data now includes both Drug Tariff Specials and non-Tariff Special order items.
Data includes prices, consumption and sales values.
 
Sample data: Perindopril Drug Tariff Special Order prices. 100 ml and 150 ml 800 mcg/ml solutions.
 
uk special order perindopril
 
 
uk special order amlodipine
 
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Revlimid first generic versions registered.

Keeping track of first generic medicine registrations of originator molecules is an important part of market intelligence for any pharmaceutical company.
Looking at Celgene’s blockbuster drug Revlimid for example, Pharma14’s proprietary Market Opportunity Locator tool can live track all first generic registrations for Lenalidomide across 39 markets in Europe, North America and more.
The pace of generic registrations can be extremely fast across many markets.
In the case of Lenalidomide we can say that the first generic version registered in Europe was in Latvia by Alvogen in May of this year.
Since this date generic versions of Lenalidomide have been registered in 11 more countries in Europe, primarily by Teva, Accord and Sandoz.
 
Sample data: Marketed Celgene Revlimid and generic Lenalidomide registrations by Teva, Sandoz and Helm in Denmark
 
denmark lenalidomide
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Japan's pharmaceutical market.

Japan has a tradition of patented drug consumption and the local authorities are targeting an 80% generic penetration by 2020.
The Japanese health authorities are encouraging generic drug makers to penetrate the local market to bring down high branded prices.
Pharma14 sees this as an opportunity for European and American generic companies to act and start examining this market as a serious future customer base.
The fact that Japan is the third largest pharmaceutical market in the world speaks for itself as a great opportunity in the waiting.
Pharma14’s medicine database coverage of Japan can be an excellent tool for companies looking at this market.
Our monthly updated platform covers all registered MA’s in Japan including pricing and reimbursement information.
Pharma14’s MARKET OPPORTUNITY LOCATOR is a proprietary system that lets you know when first generic versions of molecules appear in markets on a live basis.
For example, according to our system, TADALAFIL and PREGABALIN are still not sold in a generic version in Japan but have many generic competitors in other countries.
 
 
Sample data: Tadalafil competition. USA 7 registered MA holders. Japan 1 MA holder.
 
 
japan ma holders

 

Sample data: Japan Tadalafil still sold exclusively by Eli Lilly.

 

Japan Tadalafil

 

Sample data: Japan Pregabalin still sold exclusively by Pfizer.

Japan Pregabalin

 

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Pharma14 is your reimbursement specialist.

Is one of your data needs and requirements the reimbursed status of medicines across Europe and other regulated markets?
Pharma14 is happy to announce the total coverage of reimbursed data of all medicines in our database.
As you know reimbursed information is one of those illusive data sets that can change on a constant basis.
Our monthly updated platform will give you total reimbursed information for over 500,000 marketed medicines across 41 countries.

France reimbursed Amlodipine

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