Biosimilars Market Size, Share & Trends Analysis Report By Product (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins), By Applications (Oncology, Blood Disorder, Growth Hormonal Disorders, Rheumatoid Arthritis, Chronic and Autoimmune Diseases), By Manufacturing Type (In-house manufacturing, Contract Manufacturing) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global biosimilars market size valued at USD 17.02 billion in 2022. It is estimated to reach an expected value of USD 84.12 billion By 2031, it will be growing at a CAGR of 19.4% over the forecast period (2023–2031). The growing emphasis on reducing healthcare expenditures fuels market expansion. The European region has approved the highest number of biosimilars worldwide.

Biosimilars, or follow-on biologics, are almost identical copies of an original product but are manufactured by another company. Biosimilars are used to treat various chronic and acute diseases and disorders. Biosimilars are used to record the electrical action produced by the human brain. A biosimilar, often a follow-on biologic, is a biotherapeutic product strikingly similar to a reference biologic drug. It comprises living organisms, or cells, and has a complex molecular structure. Manufacturers depend on regulatory authority approval to commence production of biosimilars when the patent on a biologic medicine expires. The term "biosimilar" is applied to a class of biological drugs that are thought to be structurally and functionally similar to an existing medicine.

Market Dynamics

Biosimilars Market Drivers

Increasing Prevalence of Chronic Diseases

Cancer is considered one of the major causes of illness and has social and economic impacts on individuals. According to a report published by WHO in 2018, over 9.6 million deaths were caused by cancer globally. The same source estimated that about 1 in 6 deaths are caused by cancer. Cancer is estimated to cost more than USD 4.5 billion in direct health system costs. This increased the investments by various countries. For instance, Australia improved its cancer research and related initiatives with the help of USD 252 million in financing from 2016 to 2018. Similarly, the United States government increased spending on medical research by USD 2.6 billion in December 2019. The government also provided an increase of USD 296 million for cancer research funding.

Moreover, the rise in Medicare caps for the U.S. territories and Puerto Rico for two years has been critical in helping various cancer patients receive treatment and follow-up care. As per a report published by the Australian Bureau of Statistics, around 47.3% of the population in Australia was diagnosed with at least two chronic conditions during 2017–18. The prevalence of chronic diseases is high in the geriatric population, with approximately 80% of those aged 65 and above diagnosed with two or more chronic diseases. All such factors drive segment growth.

Increasing Emphasis on Cutting Down Healthcare Expenditures

Healthcare costs have risen owing to highly priced pharmaceuticals, especially biological drugs. Governments all over the world are emphasizing the production of cost-effective drug synthesis. According to estimates from the Centers for Medicare and Medicaid Services, healthcare spending climbed by 4.3% in 2016, reaching over USD 3.3 trillion. These facts indicate the rising healthcare expenditure in the country, and in the recent past, the government has been emphasizing reducing healthcare expenditure. The implementation of Obamacare in 2010 was beneficial in accelerating market potential by reforming U.S. healthcare at large.

Various initiatives undertaken by national governments are expected to further expel market growth in the near future. Japan ranks second in the pharmaceutical market, following closely after the U.S. and various strategies undertaken by the government to evade the Asian economic crisis. Therefore, price regulations in Japan and price cuts formulated in India's health budget have raised large cost-containment demands in the healthcare industry. The current financial and economic crisis and the many aging people are the key reasons for imposing cost containment in healthcare systems. This highlights the need to develop new, improved, cost-effective methods for synthesizing these drugs. Thus, the emphasis on bringing down healthcare expenditure is expected to boost the biosimilar market.

Biosimilars Market Restraint

High Manufacturing Complexities and Costs

Biologics are complex and large molecules that have specific effects. In many cases, they are antibodies or proteins such as G-CSF. One of the main concerns to be observed is that some modifications might occur during the manufacturing process that are mostly undetectable and lead to altered immunogenicity, efficacy, or toxicity. As a result, numerous physicians express concerns about prescribing biosimilars instead of biologics to their patients, as they cannot determine the suitability of the biosimilar until the drug's efficacy abruptly diminishes or the patient experiences toxicity caused by the biosimilar.

Furthermore, the cost of development of biosimilars is much higher than that of generics that are chemical based. Due to the cost efficiency of chemical-based generics, patients would prefer using generic medications rather than biosimilars if the disease requires regular usage of drugs for its treatment. Biosimilars are also comparatively less stable than generics that are chemical based; therefore, they require cold chain distribution to maintain their stability for a longer time. Moreover, the required capital investment in plant, property, equipment, and manufacturing costs will be comparatively higher for biosimilars than for chemical-based generics.

Biosimilars Market Opportunities

Cost-Effectiveness of Biosimilar Drugs

The rapid growth of the biotechnology industry has created the demand for safe and cost-effective medicines to curtail the existing healthcare expenditure. Due to cost-effective manufacturing processes, biosimilars are cheaper than comparators' (originators') drugs. Various studies indicate that biosimilars, derivatives of living organisms, fit the cost-effectiveness ratio. Biosimilars have been proven to be of slightly lower or almost equal effectivity in comparison to their respective reference biopharmaceuticals.

Reduced biologics unit cost and greater biosimilar medicine volume are two major healthcare sector expectations brought about by the introduction of biosimilars. The necessity to produce biosimilars cost-effectively is crucial as the pharmaceutical industry competes with originator products. Thus, manufacturers are engaged in the development of cost-effective. Processes facilitating increased profit margins for the company. Thus, biosimilars being cheaper and more cost-effective than originator drugs is a key market driver in the biosimilar market.

Regional Analysis

Europe Dominates the Global Market

Region-wise, the global biosimilars market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

Europe is the most significant global biosimilars market shareholder and is estimated to exhibit a CAGR of 13.5% during the forecast period. Europe has held the largest market share due to the existence of a well-defined regulatory framework for biosimilars and major biopharmaceutical companies such as Johnson & Johnson, Novartis, AstraZeneca, Pfizer, Merck, Sanofi, and GlaxoSmithKline. Moreover, a well-developed healthcare infrastructure and a growing number of product launches have fueled regional market growth. Since Europe approved the first biosimilar drug in 2006, the region has pioneered the regulation of biosimilars. Over the past ten years, the region has approved the highest number of biosimilars worldwide.

Similarly, Celltrion and Teva Pharmaceuticals' biosimilar Truxima (rituximab-abbs) was approved in Europe in 2017 and was launched in the U.S. in 2019. The adoption of Truxima in Europe was over 60%. The EU has set the standard for biosimilar pharmaceutical regulation by developing a strong framework for their approval and influencing biosimilar development globally.

North America is estimated to grow at a CAGR of 25.9% during the forecast period. This is due to rising efforts from manufacturers to tap growth opportunities in the U.S. and Canada. Since the establishment of the U.S. biosimilar regulatory pathway in March 2009, the region has experienced substantial growth, bringing with it both new potential and problems. The U.S. FDA approved the first biosimilar product, Zarxio (filgrastim-sndz), in March 2015. A rise in the number of approvals is anticipated to boost the adoption of biosimilars in the region in the near future. For instance, in December 2019, Amgen received FDA approval for AVSOLA (infliximab-aq). The biosimilar was approved for all the indications of chronic inflammatory conditions. The total cost of healthcare has increased because of the copyrighted pharmaceutical medications, particularly biologics, which are quite expensive. Affordable medication synthesis is a priority for the governments of various nations.

Furthermore, the U.S. is known as the country with the highest health expenditure. It has recently emphasized cutting healthcare expenditures. The healthcare savings from biosimilars are estimated to range from USD 24 billion to USD 150 billion between 2018 and 2027. Therefore, the need for R&D of cost-effective treatment options is expected to upsurge the usage of biosimilars in the near future. Moreover, the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Government of British Columbia have taken significant steps to enhance the use of biosimilar drug products across Canada. A growing number of product approvals is also one of the factors anticipated to boost market growth. According to Health Canada's annual report, Health Canada approved 11 biosimilar submissions in the 2018-2019 fiscal year from April 1, 2018 to March 31, 2019. Therefore, a rise in product approvals is also a major factor expected to boost market growth.

In Asia-Pacific, the rising need for more affordable therapeutic treatments and the increasing incidence of chronic diseases drove the region's market share. The growing interest in product development in nations like South Korea, China, and India is among the most important things driving this region's market. In addition, non-communicable diseases such as diabetes, cancer, and autoimmune disorders have become more common in Asia due to factors such as an aging population, changing lifestyles, and increased urbanization. South Korea has been more aggressive in the development of biosimilars. Moreover, China has been providing generous funding for developing the biotechnology industry, including biosimilars, and an additional USD 11.8 billion was funded from 2015 through 2020 to advance innovations in the biotechnology sector. Thus, initiatives undertaken by the government are anticipated to fuel market growth.

Segmental Analysis

The global biosimilars market is segmented by product, application, and manufacturing type. 

Based on product, the global biosimilar market is divided into recombinant non-glycosylated proteins and recombinant glycosylated proteins.

The recombinant non-glycosylated proteins segment dominates the global market and is anticipated to exhibit a CAGR of 18.7% during the forecast period. G-CSF, a naturally occurring growth factor, specifically targets hematopoietic cells. A biosimilar medicine is said to be given more frequently than the original drug. The insulin market is projected to experience the most rapid growth among the sub-segments of the recombinant non-glycosylated protein industry. The market expansion is due to the increasing prevalence of diabetes and the accessibility of biosimilars at a more affordable price than branded insulins. Therefore, rising cognizance, cost-effectiveness, and various benefits of biosimilar drugs are anticipated to fuel market growth during the forecast period.

Based on application, the global biosimilars market is segmented into oncology, growth hormonal deficiency, blood disorders, rheumatoid arthritis, and chronic and autoimmune disorders. 

The chronic and autoimmune disorders segment owns the highest market share and is estimated to grow at a CAGR of 19.7% during the forecast period. The most commonly occurring autoimmune disorders that biosimilars can treat are rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn's disease, and macular degeneration. The most popular treatment for autoimmune illnesses is biologics, which include adalimumab and etanercept, which are used to treat such conditions.

Autoimmune illnesses can be treated with the human monoclonal antibody adalimumab biosimilars, which works by blocking Tumor Necrosis Factor (TNF). Many other large pharmaceutical firms have been authorized to produce biosimilar forms of adalimumab, including Boehringer Ingelheim, Momenta Pharmaceuticals, Pfizer, Sandoz, Zydus Cadila, and numerous others. The segment is expected to experience growth driven by an uptick in arthritis and related issues.

Based on manufacturing type, the global biosimilars market is segmented into in-house manufacturing and contract manufacturing. 

The in-house manufacturing segment dominates the global market and is anticipated to exhibit a CAGR of 18.8% during the forecast period. This growth can be attributed to the fact that the product makers are the key players in this market. Moreover, the increasing demand resulting from the drug's efficacy in various applications is projected to increase throughout the analysis period, fueling this segment's growth.

Recent Developments

• June 2023: Bio-Thera Solutions obtained approval from the Food and Drug Administration for Avzivi (bevacizumab-tnjn), a biosimilar version of Avastin.