Top Driving Factors Behind Biosimilars Growth
RELEASE DATE: Oct 2024 Author: Spherical Insights Request Free Sample
What is Biosimilars?
A biosimilar (also known as a follow-on biologic or subsequent entry biologic) is a biologic medical product that is nearly identical to the original product manufactured by another company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the patent expires. Unlike generic drugs of the more common small-molecule type, biologics have high molecular complexity and can be very sensitive to changes in manufacturing processes. Regardless of heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle. Unlike generic drugs of the more common small-molecule type, biologics have high molecular complexity and can be very sensitive to changes in manufacturing processes. Regardless of heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.
Major Challenges Facing Biosimilars Today
- Increased competition and regulatory challenges
The biosimilar market is becoming more competitive among manufacturers and biologic originators. When new biosimilars hit the market, originator biologic manufacturers may respond with second-generation products, reformulations, dosage improvements, supportive devices, and competitive pricing strategies to maintain their market share.
- High manufacturing costs and the complexity of the production process
One of the most significant barriers to market growth is the highly complex and expensive process of developing these products. They must be manufactured at a low cost in order to remain competitive and profitable, even in the face of significant price discounts offered by reference product manufacturers.
This is because reference product manufacturers typically have more than two decades of product manufacturing experience and benefit from economies of scale gained by supplying the global market. Also, these companies typically have the most extensive stainless steel-based facilities that have been paid for and continuously improved over time (in line with cutting-edge technology). Additionally, companies frequently market a subsequent product. Hence, the established presence of certain large pharmaceutical companies and high manufacturing costs are expected to limit the growth of the biosimilar market.
The Growth Potential of Biosimilars: Key Opportunities for Market Expansion
- Markets are emerging
Asia Pacific, Latin America (LATAM), and the Middle East offer significant growth opportunities for biosimilar manufacturers due to less stringent regulatory environments than established markets. These regions have distinct regulatory pathways, payer perceptions, pricing, affordability, and competitive landscapes, making them ideal for biosimilar development. China and India, with their low labor and laboratory setup costs and abundant skilled resources, are especially appealing for global biosimilar R&D outsourcing. Leading companies such as Celltrion, Samsung Bioepis, Dr. Reddy's Laboratories, Biocon, and Shanghai Henlius Biotech are driving biosimilar innovation and commercialization in the Asia Pacific, resulting in rapid industry growth.
- Technological Advancements
Advances in scientific technology have significantly accelerated biosimilar research and development, allowing for improvements to biologics developed approximately 15 years earlier. Biosimilars are a rapidly growing drug class that is intended to be used interchangeably with biologics, which are complex proteins produced in living cells and have a wide range of therapeutic applications, including the treatment of inflammatory bowel diseases, cancers, and endocrine disorders. The primary goal of biosimilar development is to lower treatment costs while retaining nearly identical efficacy, safety profiles, and immunogenicity to the reference biologics. Biosimilars require fewer clinical trials than reference products but still involve production within living cells, so the expiration of biologic patents represents a significant opportunity for expanding the biosimilars market. Continued production of new biosimilars as patents expire is poised to drive market growth and increase accessibility to these cost-effective treatment options.
Top Driving Factors Fueling the Rapid Growth of the Biosimilars Market
1. The launch of novel biosimilars
All approved biosimilars in 2022 referred to previously approved products; none introduced new reference products. The year also saw four new product launches, including the first two Lucentis biosimilars. In addition, the FDA approved two new interchangeable biosimilars, Rezvoglar (for Lantus) and Cimerli (for Lucentis). Although approvals decreased between 2020 and 2021, the number of biosimilar development programs participating in the FDA's Biosimilar Development Program has steadily increased. As of April 2023, approximately 60-70 biosimilars were in pipeline studies, with half expected to launch within the next three to four years, driving market expansion.
2. Low healthcare expenditures are likely to drive market expansion.
Biologics have resulted in better clinical outcomes for patients, but they are expensive to develop and produce due to their high manufacturing costs. Biosimilars, on the other hand, are less expensive versions of biologics that have been clinically tested and proven to be effective and safe. The use of these products could potentially reduce the cost of care while providing the same benefits as the original biological treatment.
3. Rising competition and innovation boost biosimilars growth
Many companies are competing to enter the biosimilars market, which has the potential to significantly drive market growth due to improved access to treatments. Furthermore, technological advancements in the recombinant glycosylated proteins segment have led to the emergence of several therapies, such as modified proteins and soluble receptors, which can further contribute to the growth of this market.
Global Perspectives: Key Insights into the Biosimilars Market by Region
The U.S. Food and Drug Administration has established a regulatory approval pathway for these products. The number of approved products is expected to grow significantly in the coming years, accompanied by an increasing loss of exclusivity for biological reference products, particularly in oncology. Biosimilar medicines have the potential to reduce the economic burden by making treatment options more affordable and introducing price competition to markets. Savings from market entry can relieve burdened healthcare budgets and free up budgetary space for new treatment options, thereby driving market growth across the region. The number of approved products is expected to grow significantly in the coming years, accompanied by an increasing loss of exclusivity for biological reference products, particularly in oncology. Biosimilar medicines have the potential to reduce the economic burden by making treatment options more affordable and introducing price competition to markets. Savings from market entry can relieve burdened healthcare budgets and free up budgetary space for new treatment options, thereby driving market growth across the North America region.
Conclusion
The biosimilar drug market is poised for significant growth. This is driven by a number of factors including the launch of new biosimilar medicines, increased competition, and technological advances that increase research and development capabilities. As the healthcare situation evolves Emerging markets in Asia Pacific, Latin America, and the Middle East currently Unique opportunity for biosimilars the market expansion at the end of this period is greater. The rising prevalence of chronic diseases, combined with high treatment costs, is driving demand for cost-effective solutions to reduce the patient population's economic burden. The growing demand for a more straightforward approval process has influenced market players' focus on introducing novel drugs that are similar to biologics, available at lower costs, and intended to treat a wide range of diseases. Such initiatives are expected to gradually shift the patient population's preference toward these products. Additionally, biosimilars offer a cost-effective alternative to traditional biologics. Improve patient access to needed care and reduce healthcare costs with an increasing number of certified products and good feedback. Regulatory environment. The future of the biosimilar market looks bright offering a path to increased patient care and economic sustainability in the system.
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