According to the latest research by nova one advisor, the global Biosimilars market size was exhibited at USD 22.19 billion in 2022 and it is expected to hold around USD 97.05 billion by 2032, growing at a CAGR of 15.9% from 2023 to 2032.
According to the latest research by nova one advisor, the global Biosimilars market size was exhibited at USD 22.19 billion in 2022 and it is expected to hold around USD 97.05 billion by 2032, growing at a CAGR of 15.9% from 2023 to 2032.
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Key Takeaways:
- North America dominated the market with the largest revenue share of 40.22% in 2022
- Asia Pacific is expected to grow at the fastest CAGR of 18.5% over the forecast period.
- The recombinant non-glycosylated proteins segment accounted for the largest revenue share of 54.19% in 2022
- The recombinant glycosylated proteins segment is expected to grow at the fastest CAGR of 14.9% over the forecast period.
- The chronic and autoimmune disorders segment accounted for the largest revenue share of around 21.16% in 2022
- The oncology application segment is estimated to grow at the fastest CAGR of 17.1% over the forecast period.
The growth of this market can be attributed to their cost effectiveness for both patients & manufacturers and the increasing prevalence of chronic & non-communicable diseases, such as cancer and anemia. According to the World Health Organizationestimates, 40% of children below five years of age, and 30% of women between the age group of 15 and 49 years are suffering from anemia. Moreover, biosimilar drugs offer almost similar results and are considered a more affordable alternative to their reference biologics.
Since they are almost similar, the producers of biologics also have to lower their prices to compete with biosimilars, which reduce the cost of the overall treatment. For instance, a report published by Biosimilars Forum in April 2021 suggests that increasing competition from biosimilars has resulted in lowering the prices of biologics by an average of 56% to up to 150%. Furthermore, biologics have patents to protect them from competing with biosimilars. These patents restrict the production of biosimilars for a period of 8 to 20 years depending on the regulations in different countries. However, patents of many lifesaving biologics are expected to expire during the forecast period, which can boost growth.
According to an article by Congressional Budget Office published in April 2021, the U.S. Food and Drugs Administration (FDA) had approved 29 biosimilar drugs by 2020, and some of them were yet to be introduced in the market. Furthermore, an article by Generics and Biosimilars Initiative suggests, the entry of Amgen’s biosimilar Soliris was delayed till 2025. The outbreak of the COVID-19 pandemic had a negative impact on the global market. Since the supply chains of different products including pharmaceuticals were disrupted and most of the sources were dedicated to fighting COVID-19, the production of biosimilars experienced a shortage of raw materials.
For instance, according to a report published by Johns Hopkins Bloomberg School of Public Health, as a result of the lockdown, a shortage was observed in the supply of Active Pharmaceutical Ingredient (API), which is an important raw material used in producing drugs. These shortages directly affected the production and supply of biosimilars and other drugs during the pandemic. However, due to the increasing demand, several market players are significantly investing in the research & development of biosimilars, which can further add to the market growth. For instance, a key player offering advanced biotechnology solutions, Amgen Inc., has invested USD 2 billion in the development of 10 biosimilar medicines.
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Biosimilars Market Dynamics
DRIVER: Launch of novel biosimilars
Various key market players operating in the market have a strong emphasis on the development of biosimilars. As of December 2022, FDA has approved 40 biosimilars, and 25 have launched in the US. During the COVID-19 pandemic, FDA approvals slowed significantly; however, approvals rebounded in 2022, with seven new biosimilar approvals. All seven biosimilars approved in 2022 referenced products with previously approved biosimilars; no biosimilars were approved in 2022 referencing new reference products. 2022 also registered four new product launches, including the first two Lucentis (ranibizumab) biosimilars. Additionally, in 2022, FDA designated two new interchangeable biosimilars: Rezvoglar (referencing Lantus (insulin glargine)) and Cimerli (referencing Lucentis (ranibizumab)). Although there was an overall decline in approvals during the 2020 to 2021 timeframe, the number of development programs participating in the FDA’s Biosimilar Development Program has continued to rise. As of April 2023, there are around 60–70 biosimilars under pipeline studies. (Clinical.gov); half of them will be launched in three to four years. Growing approvals of biosimilars will ensure access to a greater pool of therapeutics and drive market growth.
RESTRAINT: Complexities in Manufacturing
Developing biosimilars is a highly complex and costly process that requires significant investments, technical capabilities, clinical trial expertise, scientific standards, and quality systems. Unlike the development of generic medicines, biosimilar manufacturers must invest in clinical trials and post-approval safety monitoring programs similar to that of the original innovator companies. Developing a biosimilar is a complex process. Biosimilars, like all biologics, are produced through an intricate, multistep process using living cells. However, the cell line and manufacturing process of the reference product are proprietary and belong to the original manufacturer.
For new entrants, the cost of developing biosimilars ranges from USD 100–250 million, including the cost of constructing a plant capable of producing biosimilars on a large scale. Besides this, the estimated timeframe for setting up a biosimilar/biological production capacity is anywhere from five to seven years; the cost can vary based on the location. The requirement for such high investments extends the time for companies to break even or to get sufficient returns on investment. In addition, companies with manufacturing experience (especially in biologics), such as Amgen and Biogen Idec, will have a considerable advantage over new companies with no such manufacturing experience. Hence, large pharmaceutical companies are expected to dominate the market as they bring marketing, sales, R&D, and manufacturing expertise.
OPPORTUNITY: Emerging markets
Markets across the Asia Pacific, Latin America (LATAM), and the Middle East offer significant growth opportunities to biosimilar manufacturers primarily due to the presence of less-stringent regulatory guidelines in developing countries. They differ from established markets regarding regulatory pathways, payer perceptions, pricing, affordability, and competitive landscapes. China and India are considered attractive destinations for R&D outsourcing for global biosimilar development and manufacturing companies, mainly due to their low labor & laboratory setup costs and the availability of skilled resources. This has drawn significant attention from key market players.
The market in Asia Pacific is a dynamic and rapidly evolving industry, with several key players leading the way: Celltrion (South Korea), Samsung Bioepis (South Korea), Dr. Reddy’s Laboratories (India), Biocon, and Shanghai Henlius Biotech (China). These companies have been instrumental in developing and commercializing biosimilars in the region and are expected to continue driving innovation and growth in the coming years..
CHALLENGE: Excess competition and regulatory challenges
Competition in the market is among biosimilar manufacturers and from originator biologic manufacturers. Upon the entry of new biosimilar products in the market, the originator biologic manufacturer may defend using various means such as the launch of second-generation products, reformulations, dosing improvements, supporting devices, and competing on prices.
Regional Insights
North America dominated the market with the largest revenue share of 40.22% in 2022 owing to a strong regulatory framework for biosimilars and the presence of major players in the region. Moreover, the region has relatively easy access to biosimilars. According to the U.S. Generic Biosimilars Saving Report 2021, 31 biosimilars had been approved and 20 have been launched in the U.S., which has resulted in an increment of nearly 10 million days of therapy. The 20 biosimilars launched in the U.S. are priced 30% lesser than the biologics and have resulted in lowering the cost for both biosimilars and biologics. This cost reduction is expected to provide a further boost for biosimilars in this region.
Asia Pacific is expected to grow at the fastest CAGR of 18.5% over the forecast period. The presence of key players, such as Dr. Reddy’s Laboratories, Biocon, Pfizer Inc., and Celltrion, has helped in the development and commercialization of biosimilars in this region. For instance, in August 2019, Dr. Reddy’s Laboratories launched a biosimilar of Roche’s Avastin in India, which facilitates the treatment of various types of cancers. Similar developments in the market coupled with increased health expenditure are expected to propel the growth of biosimilars in this region. According to the World Bank data retrieved in April 2023, health expenditure in China as a percentage of GDP has increased from 4.98% in 2015 to 5.59% in 2020.
Some of the prominent players in the global biosimilars market include:
- Amgen Inc.
- F Hoffman-La Roche Ltd.
- Sandoz International GmbH
- Dr. Reddy’s Laboratories Ltd.
- Teva Pharmaceutical Industries Ltd.
- Pfizer Inc.
- Samsung Biopis
- Biocon
- Viatris Inc.
- Celltrion Healthcare Co.,Ltd.
- AbbVie Inc.
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2020 to 2032. For this study, Nova one advisor, Inc. has segmented the global Biosimilars market.
By Product
- Recombinant Non-glycosylated Proteins
- Recombinant Glycosylated Proteins
By Application
- Oncology
- Blood Disorders
- Growth Hormonal Deficiency
- Rheumatoid Arthritis
- Chronic and Autoimmune Disorders
- Others
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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