The global biosimilars market size was exhibited at USD 25.12 billion in 2022 and it is expected to surpass around USD 126.01 billion by 2032, poised to grow at a compound annual growth rate (CAGR) of 17.6% during the forecast period 2023 to 2032. North America biosimilars market was valued at USD 5.50 billion in 2022.
The cost-effectiveness of the biosimilars in the treatment of various chronic diseases prevalent among the global population is driving the growth of the global biosimilars market. The rising prevalence of chronic diseases among the population and recent approvals of numerous biosimilars in various nations by the regulatory authorities is expected to rapidly boost the adoption of the biosimilars across the globe. The rising awareness regarding the availability of biosimilar drugs and its effectiveness in the treatment of various disorders is boosting the demand for the biosimilars across the globe. The rising prevalence of chronic diseases such as cardiovascular diseases, diabetes, cancer, and kidney failure can be treated effectively using biosimilars, which is expected to drive the market growth in the upcoming years. According to the International Agency for Research on Cancer, around 19.3 million new cancer cases and around 10 million cancer related deaths were reported in the year 2020, across the globe. Moreover, the rising prevalence of diabetes is boosting the growth of the biosimilars market. According to the World Health Organization, diabetes is the major cause of kidney failure, heart attacks, blindness, and stroke.
The regulatory reforms in the nations like US, China, and Japan are expected to increase the adoption of biosimilars in the forthcoming years. Europe has already approved over 60 biosimilar brands and accounts for around 50% of the market value. In 2018, the FDA has approved seven biosimilars in US. Therefore, the regulatory reforms in the major markets is expected to positively impact the market growth and present a lucrative growth opportunities to the market players in the foreseeable future.
Furthermore, the rising investments by the key market players in the research and development activities is driving innovations in the global biosimilars market. The expiry of patents of the earlier biosimilar drugs is offering new opportunities. However, the complexities involved in the manufacturing of the biosimilars is a major challenge to the market players. Further the high cost associated with the production of biosimilars may hamper the market growth in the forthcoming years.
| Report Highlights | Details |
| Market Size | USD 126.01 Billion by 2032 |
| Growth Rate | CAGR 17.6% From 2023 to 2032 |
| Largest Market | Europe |
| Fastest Growing Market | North America |
| Base Year | 2022 |
| Forecast Period | 2023 to 2032 |
| Segments Covered | Product, Application, Region |
| Companies Mentioned | Synthon Pharmaceuticals, Inc., Novartis, TevaPharmaceutical Industries Ltd., LG Life Sciences, Celltrion, Biocon, GenentechHospira, Merck Serono, Biogen idec, Inc. |
Based on region, Europe dominated the global biosimilars market in 2022, in terms of revenue and is estimated to sustain its dominance during the forecast period. The increased adoption of the biosimilars in Europe has boosted the market growth. Moreover, the regulatory authorities have played a crucial role in the adoption of biosimilars by makes appropriate and favorable changes towards the approval of the biosimilar drugs.
On the other hand, North America is estimated to witness a significant growth rate during the forecast period. The growing popularity of the biosimilars in the North America and the presence of numerous market players in the region are investing heavily in the research of the biosimilars, which arew expected to drive the growth of the market in this region. The FDA in US approved around 20 biosimilars in the year 2020. In 2020, Pfizer obtained the FDA approval for its Nyvepria, which is used for lowering the infection incidences. All these factors are anticipated to drive the growth of the biosimilars market in North America, during the forecast period.
Based on product, the monoclonal antibodies segment accounted largest revenue share in 2022. Monoclonal antibodies are extensively used in the treatment of diseases such as cancer, rheumatoid arthritis, cardiovascular diseases, and multiple sclerosis. Monoclonal antibodies targets the specific infected cells in the treatment and hence is extensively used in the treatment of cancer, which led this segment to become the most dominant segment.
The erythropoietin segment is estimated to be the fastest-growing segment during the forecast period. The erythropoietin helps in the production of red blood cells in the bone marrow. Moreover it also treats the anemia effectively. The rising number of kidney related diseases are expected to propel the growth of this segment.
Based on application, the oncology segment dominated the global biosimilars industry in 2022, in terms of revenue and is estimated to sustain its dominance during the forecast period. This is attributed to the availability of biosimilars at lower prices for the treatment of cancer and the rising prevalence of cancer among the global population. According to the International Agency for Research on Cancer, around 19.3 million new cancer cases and around 10 million cancer related deaths were reported in the year 2020, across the globe. Prevalence of breast cancer in the female population is surging, accounting for around 11.7% of the new cancer cases followed by the lungs cancer that accounted for 11.4% and colorectal cancer accounted for 10.0% in 2020. Hence, the growing demand for the biosimilar drugs for the treatment of cancer is boosting the segment growth.
On the other hand, the growth hormonal deficiency segment is expected to be the fastest-growing segment during forecast period. The rising chances of kids getting affected with rare growth hormone deficiency during pregnancy is expected to drive the market. According to the National Organization for Rare Disorders, there are 50% chances of getting growth hormone deficiency to the child during pregnancy.
The market is moderately fragmented with the presence of several local companies. These market players are striving to gain higher market share by adopting strategies, such as investments, partnerships, and acquisitions & mergers. Companies are also spending on the development of improved products. Moreover, they are also focusing on maintaining competitive pricing.
In May 2020, Fresenius Kabi acquired approval for its MSB11455, a pegfilgrastim biosimilar, from both the FDA and EMA.
The various developmental strategies like acquisition, partnerships, mergers, and government policies fosters market growth and offers lucrative growth opportunities to the market players.
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