Orphan Drug Market Entry
The global orphan (and “Ultra –Orphan”) drug market is currently valued at $123 Billion and expected to rise to $ 200 Billion by 2020 and represent 19% of all prescription drug sales. 30% of all industry drug approvals for Orphan Drugs.
It is estimated that the number of patients suffering with rare diseases is 30 Million in Europe and 350 Million people worldwide with a direct result of specialist Biopharmaceutical companies investing significantly to develop novel but generally expensive treatments. Payers, stakeholders and regulatory decision makers are becoming concerned by the potential budgetary impacts of these innovative Orphan drugs and the widening gap between clinical value and pricing.
Otago Healthcare recognises the challenges and risks presented to Specialist Pharma companies developing Orphan drugs for commercialisation in the United Kingdom, Europe and Middle East.
We work by becoming the commercial partner in Europe (and/or Middle East) from early clinical development to market approval stage. We work integrally developing strategic business plans, pre-marketing disease awareness campaigns, working on EMEA and COMP submissions pricing strategies, reimbursement through regulatory bodies, supply chain and business development.
Our primary objective is for all stakeholders, decision makers and customers endorsing the clinical value in the use of the Orphan Drug and importantly for the patient to have access to these life changing specialist medicines.
What are the challenges entering the United Kingdom and Europe?
- High costs to set up infrastructure (hiring and recruiting key personnel during the pre-launch and launch phase, setting up offices which expensive leases).
- Access to the complex network of stakeholders, decisions makers and payer groups evaluating Orphan Drugs with a view to reimbursement.
- Regulated price sensitive market.
- Identifying and understanding the process of introducing a new Orphan Drug with the relevant bodies which will endorse adoption such as:
- National Institute of Clinical Excellence(NICE),
- Scottish Medicines Consortium(SMC),
- All Wales Medicines Group(AWMG),
- Rare Diseases Advisory Group (RDAG),
- Health Technology Assessment (HTA)
- European Union Committee of Experts on Rare Diseases (EUCERD),
- Committee for Orphan Medicinal Products(COMP).
- Knowledge of the user base for the clinical indications of the Orphan Drug.
- Access to key clinicians, Key Opinion Leaders and decision makers in Secondary Care.
- Mapping out exactly where the patients are located, their existing treatment and treatment pathways
- Developing sales and ensuring return on investment for the Orphan Drug.
What is our strategy for United Kingdom & European entry?
- We represent you as your commercial arm in the United Kingdom and Europe by having an existing infrastructure which is “ready to go”
- Our office will become your UK /European operational office.
- Otago team will absorb your name and represent you during pre-launch through to launch by strategic activities with key opinion Leaders, customers, key stakeholders, decision makers, government bodies, payers and advisory groups.
- Our team will carry out a detailed analysis of the market to establish the potential, where the patients are located, how they are being treated and identify their treatment pathways.
- We will utilize our knowledge, expertise and experience of working with all the relevant Government appointed bodies for product endorsement and reimbursement of Orphan Drugs by working closely through our market access specialist.
- Our medical affairs and regulatory team will work closely with you to support disease awareness campaigns pre-marketing approval across Europe ensuring all signatory approvals are in line with European regulations.
- We become the “commercial and operational face” for you in the United Kingdom (and Europe).
What are the advantages using Otago?
- Existing infrastructure across Europe and Middle East – “ready to go” team.
- Working with a team who are highly experienced and successful in commercializing Orphan drugs across Europe.
- Rapid and successful penetration into the United Kingdom and Europe using our expertise, experience and established customer base in the hospital and government sector.
- We can work with you from early to late clinical stage phases to develop market awareness of the rare disease treatment across Europe.
- Significant reduction of costs in setting up infrastructure for your company in the United Kingdom and Europe.
- A proven team ready to work with you from early clinical stage development through to full commercialization on all aspects from regulatory, marketing, sales and supply chain.
- Faster return of investment.
- Fixed costs agreed by both client and Otago to ensure cost containment but long-term profitability during the commercialization of the Orphan Drug.