If you are an emerging biopharma company, your next best opportunity may not be in your backyard. Expanding product launches globally can be more effective and efficient, particularly when you optimize potential revenue through partners with a true global footprint and experienced in overcoming common pharmaceutical commercialization challenges.

You spend less, earn more, help more patients, and sustain growth in launching your product in potentially high-revenue countries through an integrated global commercialization services partner. Together, you can develop a comprehensive plan to overcome reimbursement, market access, and regulatory requirements and fulfill local requirements in new markets.

“Emerging biopharma companies often first think about the United States as a market to launch in, which makes sense because it often represents 60 percent of the global market for innovative products. However, they tend to forget the rest of the world, and the rest of the world is still 40 percent of the market,”

- Marc-Olivier Bévierre, partner and life science practice leader at Vintura, a strategy and organization consultancy arm of Cencora specializing in healthcare and life sciences.

“So, if you are a U.S. biotech that applies the Pareto Principle or the 80-20 rule, you will not consider other markets because 80 percent of your business would come from 20 percent of your market according to the principle and rule. That’s a pity because it’s a loss of many patients you could help and much revenue you could earn internationally,” he continued.

For example, Europe represented more than 20 percent of the global pharmaceutical market in 2021. However, accessing its 400 million patients can be a challenge because its fragmented and country-specific healthcare systems differ in regulatory requirements, health technology assessment (HTA) processes, and health system funding policies. 

Similarly, Asia increasingly offers opportunities for growth and innovation, but it is also highly complex, particularly in terms of the access environments and competitive landscape. Therefore, you must understand local market requirements to grow successfully when building a global commercial stage biopharma organization.

“Smaller biopharmaceutical companies often go to the markets they are familiar with or where they have their own direct commercial footprint. However, there is a much larger revenue opportunity to explore beyond their comfort zone,” said Gert Jan Van Der Hulst, vice president, international commercialization at Cencora.

Expanding into high-revenue markets

Although potential high-revenue countries generally include, Japan, France, Germany, the United Kingdom, Spain, and Italy, the potential for emerging biopharmaceuticals varies by factors like market size and product type. 

"For example, some countries may be good for patient enrollment in clinical trials; however, they may not be best positioned to commercialize an asset," Van Der Hulst said. 

Van Der Hulst suggests identifying global launch opportunities at an early stage, ideally when clinical trials are still ongoing. A future commercial footprint will be mainly driven by an in-depth understanding of local market access and reimbursement requirements including ever-changing regulatory landscapes.

Areas and examples of local requirements to understand include:

• Commercial - Business license and permits, pricing and reimbursement process, and payer structure
• Finance and legal - Asset transfer timelines, valuation requirements, and audit reporting
• Regulatory - Artwork approval times, production grace periods, and post-marketing studies
• Supply chain and quality - Import license timelines, local manufacturing and release requirements

Also, countries may be interlinked. “You have to be careful when and where to launch first because the price in one country might drive the prices in other countries,” Bévierre said, noting the so-called “international reference pricing arrangements between countries such as Canada and the United Kingdom. 

“You want to make sure that you go in the right order so that you don’t leave money on the table,” he continued. “These are all the things you have to consider.”

A well-defined plan is essential when expanding into a new market. “A comprehensive plan means that you don’t forget anything. That’s key because when launching internationally execution is the biggest challenge due to the complexity. The cost of forgetting can be high,” Bévierre said.

If, for example, you don’t collect data required by payers in your clinical trial design, then you will not be able to get dosages approved later. “What may seem like a little mistake at one point of the launch preparation might have dramatic consequences later,” Bévierre said.

Key components of a plan include:

• Market assessment
• Competitive landscape analysis
• Pricing strategies
• Early data generation strategies
• Regulatory compliance considerations

Bévierre begins by helping a biopharma client identify countries where they could optimize their revenue potential. Then he addresses market access and regulatory hurdles associated with those markets.

More formally, Cencora customizes clients’ launch plans with its Commercialization Blueprint tool, which maps out different scenarios and sequences. Doing so accelerates launches and keeps them on budget.

Partnering with Cencora

Emerging biopharmas increasingly ally with commercialization services partners like Cencora to launch products in new markets. In 2022, pharma deals reached $132.1 billion, the third highest in the past decade, as companies chose to access innovation through alliances and partnerships rather than acquisitions.

Cencora is uniquely positioned to help emerging biopharmas expand globally as they combine strategic advice with the actual operational execution of commercial launches.  It also has the breadth and depth of local expertise necessary for navigating individual country requirements that other consulting firms lack.

With deep understanding of the local landscape, competition, and considerations for global market access requirements, Cencora's consulting professionals develop and implement effective global market access plans for new therapies. From outcome research to economic modeling, evidence generation and strategically navigating each country’s review processes, Cencora has the path to global market access covered.

“Strategy is just the beginning of the story. Ninety percent of the work is in execution, which is often very difficult,” Bévierre said.

Cencora’s experts facilitate market access, regulatory, pharmacovigilance, and quality expertise worldwide. In acquiring PharmaLex, Cencora expanded its global footprint, adding capabilities to provide strategic guidance and operational execution in numerous markets. 

“If we do not have our own people in specific countries or regions, we have experts available through our highly qualified global partner network. This allows clients to work with a local market access experts just about anywhere,” Van Der Hulst said.

“If an emerging biopharma company is looking at 20 to 25 different countries, we would centralize the relevant market access and regulatory insights coming from our local experts in each of those countries and streamline it in an easy-to-absorb manner for our business partners,”

In that example, our business partners could then decide which markets to prioritize based on information provided by Cencora’s local experts. All of our expert teams frequently  interact with local health authorities and payers from a market access perspective. In many cases our functional and executive leaders are former regulators and have worked at leading pharma companies. 

Making innovative therapies available to patients, caretakers, and physicians through a global distribution solution is another ‘must have’ for successful commercialization.

Cencora can build on the legacy of AmerisourceBergen as leader in pharmaceutical distribution services. While some other U.S.- based companies have decided to pull out of Europe, we have done the opposite. Cencora has made significant investments in acquiring both specialty- and wholesale distribution organizations in Europe. The addition of World Courier brings a fully integrated global distribution solution.

That local expertise and presence is one of the key factors for commercial success of the asset(s) our business partners are bringing to market.

Many emerging biopharma companies share their experiences with us how challenging it has become to obtain fair licensing deals. Upfront payments could help them navigate towards a short-term key inflection point; however, you give away control and lose value in the mid- and longer term.

“In partnering with Cencora, our business partners retain all the rights over their asset(s) and keep more of the asset NPV when it is commercialized,” Van Der Hulst said. 

The client also minimizes financial exposure before FDA/EMA approvals by leveraging Cencora’s infrastructure instead of building its own. “It would be much more expensive because it would be a fully dedicated organization that costs more and is less flexible,” Bévierre said.

“For example, if you had a problem with distribution and eventually decided not to launch your product or you wanted to withdraw it after, you would have already spent money on infrastructure,” Bévierre said. “You would also mitigate risk because otherwise, you would have to get up the learning curve for the market.” 

For emerging biopharmas, an integrated commercialization services partner like Cencora can make launches in new markets both effective and efficient. Together, we can optimize revenue by overcoming common pharmaceutical commercialization challenges through a comprehensive plan formed and executed through collaboration.

More recently, also midsize- to big pharma organizations are engaging with Cencora experts. Leading pharma organizations involve us to help think through and operationalize strategies as they consider strategic solutions for their specialty brands globally.