What Are Some 2024 Trends in the Dossier Industry?
Industry-wide portfolio reassessments
Many specialty and originator companies are reevaluating where they play. Do they stay in generics or jettison those products off to subsidiaries? And generic companies themselves are also reevaluating how they can maximize their returns with the infrastructure they have. As we know, no one has an unlimited infrastructure. They're actively looking at where they source their products, and which products to continue with.
Here at Medis, we're trying to maximize our product lifecycle and add value back to customers via our VIP (volume improved products) projects. Here we’re talking about trying to consolidate different volumes across often multiple SKUs of the same molecule, essentially bringing dossiers up to date. By promoting some older molecules, we can obtain volumes for our customers at better prices.
Demand has bounced back
Across the board, demand has steadily increased following the quiet COVID years. We're typically seeing increased demand from customers across the globe, and we assume customers are seeing this trend among their portfolios.
And this means there's greater competition now to supply that demand. When you have a bump up in demand, but you don’t have the bump up yet in terms of infrastructure, everybody is playing catch up. It takes time and it's not something to dismiss lightly.
Environmental, social and governance (ESG) is obviously a growing area of importance for the pharmaceutical industry.
As in every industry now, investors, employees, customers, consumers and regulators all are demanding firms be more transparent about their plans for tackling environmental, social and governance issues from global warming and pollution to discrimination and forced labor. The risks for companies that are seen as moving too slowly are high.
Medis, as part of Teva, has expended increased efforts in 2023, and will continue to do so going forward, to make an impact – both internally and externally – on these 3 areas.
The company's focus on environmental, social and governance (ESG) is part of our DNA. It strengthens our business, serving as a fundamental platform that helps drive long-term sustainability and guides all that we do to reach patients with our quality medicines.
There are many examples. Teva inherently helps patients get lower cost treatments, without compromising quality, and leverages its global reach and wide range of affordable medicines to help address health challenges. Last year, the company's generic medicines contributed to $44 billion in savings across 21 countries, and it continued to develop innovative treatments for unmet health needs.
Five access to medicines programs have also been implemented to date, four of which were launched in 2022 (of eight committed by 2025). Through these programs, treatment is provided to patients who wouldn’t otherwise have access to them, including in countries where Teva doesn’t have business operations.
Teva further supports the health of people by protecting the health of our environment. In 2022, we reduced our absolute scope 1 and 2 greenhouse gas (GHG) emissions by 24% (vs. 2019), putting us ahead of schedule to meet our 2025 target (25% reduction), and reduced our absolute scope 3 GHG emissions by 12% (vs. 2020).
Serialization as a regulatory change
In early 2019, the Delegated Regulation 2016/161 came into force by the European Commission, setting out a track and trace system where the identification and the authentication of medicinal products is guaranteed by an end-to-end verification of all products bearing the safety features to help secure the safe supply chain and combat counterfeiting of medicinal products.
This Regulation is known as Serialization and involves assigning a unique identifier to each finished product pack to trace it from the beginning of the supply chain to the point it reaches the consumer's hands. All information is then kept in a unique database, using unique identifiers for authenticity.
While 36 European countries and some additional non-European countries such as Russia, Saudi Arabia, Egypt, China, Uzbekistan, and UAE have pharmaceutical serialization implemented, the rest of the world has not yet. The United States of America implemented serialization requirements by the end of 2023 and will see it in full force during 2024 for the first time. In many other countries, legislation for pharmaceutical serialization and track and trace systems are being drafted or are in the planning stage for implementation in the near future.
Growing interest in specialty & biosimilar products
Although worldwide demand for generic drugs continues to grow as payers and consumers seek ways to cut healthcare costs, the future of the generics market will certainly continue to face, and be impacted by, the significant challenges of increased competition, price erosion, and government-driven legislation.
Generic drugs will remain an integral part of the medicines business given the significant number of patent expirations over the coming years, but changes in strategy will inevitably be required to combat the challenges.
One such strategy, for those generic players with the means, capability, or access, will be to complement their existing generic portfolios with differentiated, high-value products such as specialty and biosimilar products.
The introduction of these higher-value generics will reduce generic companies' risk and exposure to price sensitive vanilla generic portfolios. Specialty generics, value-added generics, and biosimilars typically offer better profit potential and lower levels of competition. Such drugs are being increasingly used to treat rare and chronic diseases and reflect a growing percentage of prescription-drug spending globally.
There is already significant branded specialty drug penetration in many markets across the globe. The higher level of expertise required creates a significant entry barrier but can help specialty generics manufacturers differentiate their portfolios and improve profitability.
The risk of these complex and costly developments is also being increasingly mitigated through strong partnerships between small biopharma companies with their technical expertise and generic companies with their prowess in marketing, sales, and distribution networks. Portfolio diversity is key to the future success and sustainability of today's key generic players.