In 2024, North America continues to lead the global biosimilars market, driven by favorable regulatory environments, robust research and development capabilities, and an increasing number of product approvals. The U.S. and Canada have been at the forefront of biosimilar innovations, with regulatory agencies such as the U.S. Food and Drug Administration (FDA) and Health Canada playing pivotal roles in shaping the market.

New Product Launches and Regulatory Support in North America

North America accounted for the largest share of the biosimilars market in 2024, largely due to proactive regulatory frameworks and supportive policies. The FDA’s approval of six new biosimilars in the first half of 2024 alone reflects the dynamic landscape for biosimilar therapies in the United States. In Canada, Health Canada approved six biosimilars in 2023 across a range of diseases, bringing the total number of approved biosimilars in the country to 59 by March 2024. This approval trend indicates the growing acceptance and integration of biosimilars into the North American healthcare system.

The region’s cutting-edge research and development (R&D) facilities further bolster biosimilar innovation. According to IQVIA, biosimilar spending is projected to rise sharply, with estimates indicating a range between $20 billion and $49 billion by 2027. Furthermore, cumulative biosimilar sales over the next five years are expected to reach $129 billion, underlining the pivotal role of North America in driving the global biosimilars market forward.

The global biosimilar market size is also set for substantial growth, estimated to expand from USD 34.75 billion in 2024 at a 17.6% compound annual growth rate (CAGR) through 2034. By 2034, the market is projected to reach an estimated USD 175.79 billion. This remarkable growth is driven by the rising prevalence of cancer and the cost-effectiveness of biosimilars, making them a viable treatment option for a wide range of diseases.

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Asia-Pacific: The Fastest-Growing Market for Biosimilars

On the other side of the globe, the Asia-Pacific (APAC) region is poised to experience the fastest growth in the biosimilars market during the forecast period. This surge can be attributed to several factors, including the rapid expansion of research and development activities, escalating healthcare expenditure, and an increasing number of patent expirations.

China, a leader in biosimilars innovation within the APAC region, has emerged as a key player in the market. As of March 2024, China had filed an impressive 67 new biologic patents. The country has also been proactive in introducing biosimilars to the market, with more than 20 biosimilars approved by China’s National Medical Products Administration (NMPA) as of February 2023. This trend signifies a growing interest and commitment to biosimilars as a cost-effective alternative to traditional biologic therapies.

India, recognized as the “Pharmacy of the World,” has become a central hub for biosimilar production and exports, particularly in the vaccine sector. India’s pharmaceutical industry plays a crucial role in the global supply chain, supplying more than 60% of the world’s vaccine demand. Additionally, India ranks 6th globally in terms of patent filings, with 64,480 patent applications recorded in 2023. This patent activity is fueling further advancements in biologic and biosimilar research, ensuring the country’s continued prominence in the sector.

Market Dynamics and Future Outlook

The biosimilars market in Asia-Pacific is benefiting from a combination of local expertise, growing demand for biologics, and increasing regulatory support. The rising prevalence of chronic diseases, including cancer, diabetes, and cardiovascular conditions, is further contributing to the expansion of biosimilar use in the region. As more patents for original biologics expire, the entry of biosimilars into these markets provides an opportunity for affordable treatments, improving accessibility to essential medicines.

In summary, while North America remains the dominant force in the biosimilars market, Asia-Pacific is rapidly gaining ground, driven by increasing patent activity, strong R&D efforts, and the rising demand for affordable healthcare solutions. As both regions continue to innovate, the global biosimilars market is expected to evolve into a more competitive and accessible sector, with significant growth prospects over the next few years. The global biosimilar market’s impressive growth trajectory—from USD 34.75 billion in 2024 to an estimated USD 175.79 billion by 2034—highlights the increasing importance of biosimilars in addressing the global healthcare challenges of the future.

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