Biosimilars Market Will Grow at Highest Pace Owing to Rising Demand for Cost-Effective Drugs
The global biosimilars market is estimated to be valued at US$ 33.87 Mn in 2024 and is expected to exhibit a CAGR of 5.9% over the forecast period 2024 to 2031.
Naufan Cmi
Biosimilars are biopharmaceutical drugs that are molecularly similar with equivalent therapeutic efficacy and safety as compared to corresponding reference biologics. Biosimilars provide a cost-effective alternate to expensive biologics and expand patient access. With patent expiry of large molecular biologics, biosimilars offer significant cost savings and enable more patients to access lifesaving treatments. Biosimilars are usually approved based on demonstrating analytical, preclinical and clinical similarity to an existing approved biologic.
The global biosimilars market is estimated to be valued at US$ 33.87 Mn in 2024 and is expected to exhibit a CAGR of 5.9% over the forecast period 2024 to 2031.
Key Takeaways
Key players operating in the biosimilars are U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA), Ministry of Environment, Forest and Climate Change (India), National Health Commission (China), Canadian Food Inspection Agency (CFIA), National Institute for Health and Welfare (THL) (Finland), Federal Institute for Risk Assessment (BfR) (Germany), National Institute of Food and Drug Safety Evaluation (KFDA) (South Korea), Ministry of Ecology and Environment (China), Environment Agency (United Kingdom), Ministry of Health, Labour and Welfare (Japan), Australian Government Department of Agriculture, Water and the Environment, Health Canada, Ministry of Health (Brazil).
The demand for Biosimilars Market Demand is growing rapidly owing to benefits like cost savings and expanded access to life-saving medicines. Multiple patent expirations of blockbuster biologics create opportunities for market players to launch affordable biosimilar versions. Several key biosimilars like adalimumab, bevacizumab and trastuzumab are seeing increasing adoption rates globally.
Technological advancements have improved characterization techniques, enabled robust comparability assessments and enhanced biosimilar efficacy, safety and immunogenicity profiles. Advanced analytics help establish high similarity to reference products and allay substitution concerns among physicians and patients.
Market Trends
There is an increased focus on expanding access to biosimilars in emerging markets like Asia, Africa and Latin America. Regulatory guidances are being developed to establish approval pathways and regulations in these markets to drive greater uptake. In the US, label extrapolation approvals are accelerating the ability to launch follow-on products across multiple therapeutic indications.
The market sees rising collaborations between originator companies and biosimilar developers to co-develop high volume blockbusters. Various partnerships help share commercialization capabilities and expand patient reaches through combined global footprints.
Market Opportunities
The patent expiry of blockbuster biologics like Humira, Revlimid and Enbrel creates multi-billion dollar market openings for biosimilars in the coming years. These provide huge revenue generation potential for both new entrants and established biosimilar makers.
Cell and gene therapies are revolutionizing chronic disease management. As the patent cliff arrives post 2030, cellular biosimilars would offer affordable treatment options in areas like cancer and rare genetic disorders.
Impact of COVID-19 on Biosimilars Market
The COVID-19 pandemic has had a significant impact on the growth of the global biosimilars market. Due to nationwide lockdowns imposed in various countries to curb the spread of the virus, production and supply chain activities were disrupted. This led to shortages and delays in the availability of biosimilar drugs. Moreover, many elective medical procedures and non-essential doctor visits were postponed during this period, which negatively impacted the demand for biosimilars used for chronic therapies. However, with COVID-19 patients requiring intensive care, the demand for certain biosimilars rose. For instance, the demand for biosimilar drugs used for treating autoimmune diseases increased as patients required continued treatment. Virtual mode of interaction between doctors and patients also supported the use of chronic disease biosimilars during the pandemic. Going forward, as lockdowns are gradually lifted and production resumes to pre-COVID levels, the market is expected to rebound. However, future virus outbreaks cannot be ruled out, which could pose challenges for market growth. Pharmaceutical companies will need to implement strategies to diversify their supply chains and develop stockpiles to ensure consistent supply even during healthcare emergencies.
In terms of regions, Europe accounted for the largest share of the global biosimilars market value in 2024, followed by North America. This is because the European Union was one of the early proponents of biosimilars. The region has a robust regulatory approval pathway and reimbursement policies in place, enhancing biosimilar adoption over branded biologics. On the other hand, the Asia Pacific region is expected to grow at the fastest pace during the forecast period. This is attributed to rising geriatric population, increasing healthcare expenditures, and growing acceptance of biosimilars among physicians and patients in the region. Countries like China, India, South Korea, and Japan will likely drive high market gains in the coming years.
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Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc.
