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Biosimilars and Follow-On Biologics Market Report 2023: Regulatory Hurdles Slowing Down Access to Biosimilars
Research and Markets
5 min read
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Dublin, June 14, 2023 (GLOBE NEWSWIRE) -- The "Biosimilars and Follow-On Biologics Market Report 2023-2033" report has been added to ResearchAndMarkets.com's offering.

World revenue for the Biosimilars and Follow-on Biologics Market surpassed US$19,668 million in 2022.

Even in mature areas where regulations for standard generics have been in place for some time, there are still certain challenges, particularly with regard to sophisticated generics. Product categories like respiratory and some long-acting injectables, for instance, still require a large amount of evidence production, which drives up costs and restricts the availability of generics in these markets. This is frequently accompanied by intellectual property (IP) disputes and legal actions, wherein originators are granted prolonged protection periods beyond the initial time intended for the submitted innovation, delaying Generics access.

In a similar vein, clinical trial expenses continue to be exorbitant despite the fact that the regulatory pathways for biosimilars have been well delineated. Even if it is predicted that improvements in regulatory science and characterisation abilities would lessen the necessity for such restrictions, this places researchers and producers at a high degree of risk.

Some emerging nations are still having trouble establishing the proper regulatory environment to facilitate quicker product development. While these variables have an impact on the development of generics and biosimilars, they have a stronger influence when players attempt to build a more inventive pipeline. It will be important to further simplify regulatory requirements to speed up market access while ensuring adequate quality and efficacy.

Emerging Economies Continues to Pose Challenges for Building Presence for Generics and Biosimilars Companies

While emerging nations provide a substantial development potential and an essential playing field for greater access to medicines, they also present major structural and competitive market challenges for generics and biosimilars enterprises. While fierce local competition makes it challenging for players to establish a presence in these markets, additional factors like unstable economic conditions, price controls, the push for local manufacturing in some markets, and shifting regulatory requirements across geographies are all affecting players' ability to successfully focus on these markets. It may also be less enticing for international firms to join in and assist the development of these markets due to currency repercussions in certain of the countries. Past partnerships and acquisitions have had varying degrees of success, which has limited overall growth performance for players in these fields.

In these conditions, local players who are familiar with the dynamics of their own marketplaces may have an even greater potential to grow developing economies. International players will need to concentrate on careful selection of target nations (e.g., markets with legislative requirements that are comparable to other markets, such as the US and EU) and implement a tailored portfolio approach to avoid costly expansion initiatives with little immediate return.

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