The Biotech Boom: Making Light Work of Market Access

Ensuring timely, cost-effective and profitable market access for new pharma products has never been more challenging. Rates of next-generation drug launch are increasing year on year, creating strong competition. Products are becoming more tightly targeted too, giving companies a smaller market to go after. And of course biologic drugs are increasingly complex and expensive to research and develop – which must be justified in patient benefits to ensure profitable returns.

This article outlines a five-step plan to help biotechs and biological pharma companies cut through the market complexities to get their new products to market swiftly and cost-efficiently.

The global biotech industry is booming currently. In 2021, the number of new launches was significantly higher than in 2020, and in 2022 the volume will rise again. Many of these exciting new products are being developed by biotechs, which must vie with the bigger and more established pharma names for recognition and a place in the market, if they want to secure market access and optimize pricing and reimbursement terms – in spite of their limited resources.

There are a number of very real challenges facing biotech teams, both practically and commercially. Compared to the blockbuster drugs of old, next-generation drugs are much more tightly targeted, giving companies a smaller target market to go after. Biopharma products, being both novel and complex, also require extensive, deeply involved research, making them more expensive – costs that must be justified by the benefit to patients if producers are to generate profitable returns.

All of this means that developers and marketing authorization holders of novel treatments need a strong strategy and carefully thought-out approach, to ensure that they optimize market access and are able to compete effectively in target countries.

Accessing Europe

Europe is the second largest market globally for new drugs after North America, yet today is only the third largest to register new drugs. For external drug producers this makes Europe an attractive market commercially. Yet it is also a market that is highly diverse and fragmented, each country having its own appetite for new treatments, and its own regulatory nuances – requirements which are evolving all the time.

So how can young biotechs and biological pharma companies cut through the market complexities to get their new products to market swiftly and cost-efficiently?

Below are five steps to success.

1.       Develop a fit-for-purpose market access strategy.

As blockbuster drug development gives way to more targeted and personalized medicines involving living cells and genes, the parameters involved in assessing, vetting and commercializing these products will inevitably bear little resemblance to those used to review traditional pharmaceuticals.

Carrying out a finely tuned pharmacoeconomic impact study on the community and communicating the benefits of innovative new therapies and treatments to the authorities, to the different commissions, to payers/insurers and to potential financial backers needs specific expertise. When seeking help with devising and executing the optimum market access strategy, it is important that such support is tailored to the particular company and its area of focus, to maximize success and secure the best pricing and reimbursement terms.

This will involve understanding which countries to target first for the particular treatment, and what it will take to get a dossier to the top of a fast-growing pile within a particular authority, so that it is investigated as a priority.

2.       Maximize efficiency with a joined-up strategy for registration & market access.

The process of applying for marketing authorization for a new product inevitably involves collating a lot of valuable detail, so it makes sense that this activity should seamlessly feed into market access strategy, processes and content. Aligning the two streams of activity and working on them in parallel rather than sequentially will focus thinking, strengthen the narrative, accelerate progress and save duplication of effort.

3.       Start with a core dossier which serves 80 percent of all market needs.

Although ultimately European market access will be approached by country, successful attack will combine a blend of central, regional knowhow/preparation and local application. We propose devising a core set of benefits and a core dossier, with around 80 percent of agreed messaging and content which will be the same for all markets. This can be developed in parallel with marketing authorization preparations, ensuring close alignment and optimal potential for resource and content sharing.

4.       Select your initial target market, based on maximum opportunity.

With the most critical building blocks in place, commercial strategy teams can start to build out the market access dossier for the primary target market – in other words, the country identified as having the best potential for optimal pricing/reimbursement for the particular product.

A knowledgeable partner will be able to help pinpoint this based on:

·         The size of the given market, in particular its target population of patients with the particular condition/demand for the new treatment;

·         The attitude of the local authority towards innovative treatments, and any policies or ”fast-track” processes designed to accelerate market access and/or more generously compensate drug developers;

·         Current competition – what’s already in the market, what room there is for a new entrant; and

·         The biopharma company’s existing activity or relationships (affiliates/partners) in that market, including any plans to manufacture the product locally.

5.        Complete the dossier using this target country as a template.

With the core 80 percent of the dossier already developed, the final finessing can be done with the primary market in mind, drawing on local knowledge of that country and the particular priorities and preferences of the local authority’s key decision-makers. A service partner with local in-country expertise as well as central regional knowledge will be well placed to find that sweet spot between general appeal and applicability and targeted messaging for each specific market.

Once the dossier has been completed and approved for the preferred/primary country, it can serve as a template for other markets – minimizing the amount of rework each time. Again, local experts will be able to help adapt the final 20 percent of input that is market specific, boosting the chance of success in accessing each country with the most beneficial terms.

Additional considerations

Local market knowledge and connections are essential to remove potential blocking points, smoothing the way and ensuring that dossiers have a strong narrative that clearly ”sells” the unique benefits of each proposed new treatment, in the terms that matter most to that population and its overseeing authority.

Yet, even so, the path to market access may not be straightforward, particularly if this is dependent on the outcome of ongoing clinical studies or if dossiers are especially complex.

Navigating the options will require specialist expertise, whether to advocate the best clinical trial objectives or to propose and help provide access to alternative funding mechanisms or equivalents. These might include risk/benefit-sharing (with the authorities or a hospital or health centre, perhaps), to bring a new drug to market – so seek out advice on the complete spectrum of options.

Certainly, when surveying the market for a prospective consulting or full-service partner, companies will need to consider to what extent each provider simplifies the process of market access for advanced therapy medicinal products (ATMPs) – whether the treatments in question are completely new, or have already enjoyed success in the United States or Asia.

The right strategy and approach, tailored to the needs of biopharma – particularly one that spans and connects regulatory/registration and market-access support (and bridges strategy, governance, financials, HR and more) – could be critical in obviating regional market complexity, and in streamlining the delivery of vital new treatments to the patients who need them.