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How to ‘ACE’ geographical expansion in Europe
Biotech-in-a-box™️ aims to provide a ‘one-stop shop’ for small to medium size life sciences companies to de-risk the scaling-up journey by leveraging Deloitte’s whole portfolio of capabilities.
Biotech companies are now at the forefront of innovation in the search for new cures and hope for patients – they are responsible for ~70% of global clinical trials (of which 42% are in partnership) and for the development of nearly half of 2018 FDA approved medicines. However, they face significant challenges related to navigating the business life cycle, including securing IP, managing R&D, raising funds (including IPO), launching product/portfolio and expanding geographically. Next generation therapies (such as gene and cell therapies) also add another layer of complexity in managing regulatory, supply chain and patient journey.
Geographical expansion into Europe
Typically, Biotech companies focus their limited resources on the US market or their market of origin. A critical first step for global expansion is market entry in Europe, which accounts for over 20% of the global pharmaceutical market. Europe is however a complex market with distinct healthcare systems and reimbursement processes at the individual country level. Thriving in such an intricate environment means going beyond traditional thinking on geographical expansion and requires a clear understanding of the unique requirements from a development, manufacturing, distribution, commercial and operational perspective.
‘ACE framework’ – a three-step game plan
Based on our experience helping biotech companies navigate geographical expansion, we have defined three steps to effectively:
- Assess potential: Agree on the guiding principles for the European business, and assess the commercial opportunity, route-to-market options and associated costs across the European markets
- Consider options: Select the most appropriate go-to-market options using a set of strategic criteria (e.g. investment required, time to value, complexity to manage, resources required), align on the priority factor(s) for decision-making and define the cut-off points for a go/no-go decision
- Establish presence: Choose the best route to successfully establish presence in Europe, which could either be via a partnership or licensing route, or the company choosing to go-it-alone
- Partnership or licensing-out route: Important to understand the value of the assets, potential tax implications, different partnering models and aligning incentives
- Go-it-alone: Necessary to map out the commercial and launch strategy, as well as identify the capabilities required to manage the successful build-up and implementation in Europe (incl. medical, commercial, regulatory, supply chain, legal and compliance, finance / Tax, HR, IT, etc.)
What is required to scale successfully?
Biotech’s presence in overall biopharma research and development has been increasing in recent years with a leading role in developing COVID-19 vaccines or treatments today. As they attract investment, they have to scale up in order to deliver innovative medicines to patients.
European Entry ‘must haves’
Before making a decision on which go-to-market route to follow, it is important to understand what is required to launch products in Europe alone (i.e. without a partner), including the ‘must-haves’ for commercialisation in the European market, associated costs, required investment for business activities (such as running marketing campaigns) and hiring FTEs. It is also critical to consider all the business’ organisational functions and determine what contribution will be required from each when it comes to the build-up of the European operation.
Commercial and medical
- Commercial (including marketing and market access) and medical management team with strategy and plans in place
- Commercial and medical materials and field force to engage with consumers
Regulatory and safety
- Market Authorisation (including requirements such as pharmacoviligance system to support safety management)
Supply chain and quality
- Manufacturing and Importation Authorisation to import product into EEA
- Local Wholesale and Distributions Authorisations (WDA) to own, purchase, sell, store or transport the product
- Quality management system and SOPs to meet EU/local requirements
Legal and Compliance
- Local legal entity registration
- Compliance management for EU (e.g. General Data Protection Regulation, GDPR)/ local market requirements
Finance and tax
- International tax compliance and intracompany agreements
- Financial and management accounting to meet the accounting and reporting requirements
- Local VAT registration
- Hiring, on-boarding and training (including SOPs)
- Payroll and compensation management
Infrastructure and IT
- Office infrastructure to support basic business operations
- IT system to support business activities (e.g. CRM) and in accordance with regulatory requirements (e.g. EUdraVigilance, EMVS)