Biosimilars Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Filgrastim & Peg-filgrastim, Monoclonal Antibodies, and Others), By Disease Indication (Cancer, Autoimmune Diseases {Arthritis, Psoriasis, and Others}, and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2023-2030

The global biosimilars market size was valued at USD 20.44 billion in 2022 and is projected to grow from USD 23.96 billion in 2023 to USD 73.03 billion by 2030, exhibiting a CAGR of 17.3% during the forecast period.

Biosimilars are safe, effective, and highly similar versions of approved and authorized biologics. A biological drug is a large and complex protein produced from living cells through complex manufacturing processes. A generic drug is a copy of a chemical drug. A biosimilar is similar to the original biologic, however, it is not identical. Once a patent on an authorized biologic has expired, a biosimilar may enter the market. Approval for a biosimilar is only granted after its efficiency and similarity compared to its biologic has been established. Obtaining approval for a biosimilar is easier compared to a biologic.

Earlier, when the patents on biologics expired, only a small number of biosimilars were authorized due to the lack of clear product guidelines, regulatory uncertainty, and physician caution. However, with more precise guidelines, the rate at which these products are developed and approved has increased significantly. For instance, a total of 43 biosimilars were approved by the U.S. Food and Drug Administration (FDA) by the end of September 2023, with the most recent biosimilar approval being Tofidence (tocilizumab-bavi) on September 29, 2023.

Regulators, such as the European Medicine Agency (EMA), the U.S. Food and Drug Administration (FDA), and Health Canada (HC) have developed stringent regulatory guidelines for the assessment and approval of these products in terms of their physical characteristics, chemical composition, and clinical characteristics. This has enabled rapid drug development and approval, as well as increased market access and cost-effectiveness.

Moreover, the growing prevalence of chronic diseases and expensive treatment costs are increasing the demand for cost-effective solutions to reduce the economic burden of the patient population. The growing demand for a comparatively easier approval process has influenced the market players' focus on introducing novel drugs that are similar to biologics, available at comparatively lower rates and intended to treat a wide range of diseases. Such initiatives are anticipated to gradually shift the preference of the patient population toward these products, which is anticipated to drive the demand for these drugs during the forecast period.

COVID-19 IMPACT

Increase in Regulatory Approval During the COVID-19 Pandemic Positively Impacted

The outbreak of the COVID-19 pandemic introduced new challenges in the pharmaceutical industry, including the manufacturers of biosimilars industry in 2020. As the pandemic continued, there were concerns related to the availability of active pharmaceutical ingredients (API) required by drug manufacturers. On the demand side, patients delay seeking treatment, particularly less convenient administration, such as infusions, leading to lower patient volume and ultimately affecting the overall demand.

In response to this, regulatory bodies, such as the Food and Drug Administration (FDA), continuously monitor the supply chains. They diverted their focus on the product pipelines to provide a cost-effective solution to the growing population's needs.

• For instance, the European Medicine Agency (EMA) approved 58 biosimilars by April 2020. The pandemic and the inevitable economic constraints brought these products front and center.


• Moreover, 2020 marked the end of many blockbuster biologics patents in the U.S., such as Truvada, Chantix, Forteo, Ciprodex, and Afinitor, which created an expansion opportunity for the growth of this market.

This positive impact was witnessed in the revenues of market players due to increased sales of their products post-pandemic. For instance, the biosimilar segment of Pfizer Inc. recorded a revenue of USD 1,527.0 in 2020, which exhibited a growth of 67.6% from 2019. This growth continued in 2021 as well, with a year-on-year growth of 53.4% in 2021 from 2020.

Similarly, the biosimilar segment of Biocon exhibited a year-on-year growth of 61.2% from 2021 to 2022. The growth was attributed to its recent acquisition of Viatris to expand its biosimilar business footprints in 70+ countries. Moreover, the availability of these products as an alternative treatment option to prohibitively expensive initial biologic products is anticipated to drive their adoption rate.

By 2023, biosimilar competition is expected to grow due to an increase in medical expenditure over the following years. As a result, these products that treat a variety of cancer and autoimmune conditions are an attractive business proposition for the pharmaceutical industry and an important public health issue due to the increasing demand for biotechnological drugs. Cumulatively, all these factors will surge the demand for innovative drugs and drive global market growth at a steady rate during the forecast period.

LATEST TRENDS

Patent Expiration of Biologics and Introduction of Biosimilars to Propel Market Growth

One of the key global biosimilar market trends witnessed is the expiration of biologics patents, which is likely to create new opportunities for companies in this market. A patent typically lasts around 20 years from the moment a company files an application. This period gives exclusive rights to the drug inventor, after which competing companies can launch a biosimilar. Already, these products have been developed for blockbuster biologics, such as Lantus, Rituxan, Herceptin, Remicade, Enbrel, Neulasta, Avastin, and Humira.

• For instance, in September 2023, Johnson & Johnson Services, Inc. disclosed the patent expiration of its Stelara (ustekinumab), a biologic used for psoriasis and Crohn’s disease. Moreover, the biologic is set to lose its European patent in July 2024.

Furthermore, many companies are making strategic alliances with biologics manufacturers to reserve an early entry into this market.

• In August 2023, South Korean biopharmaceutical company Celltrion Inc. signed an agreement with Johnson & Johnson in relation to the biosimilar drug Stelara (active ingredient: Ustekinumab) used for autoimmune diseases within the U.S. As a result of this agreement, Celltrion's Stelara biosimilar, known as CT-P43, will be able to enter the market starting from March 7, 2025, following its approval in the U.S.

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DRIVING FACTORS

Low Healthcare Expenditure is Likely to Drive Market Expansion

Biologics have yielded improved clinical outcomes for patients, yet they are costly to develop and produce due to their high development and manufacturing costs. On the other hand, biosimilars are cost-effective alternatives to biologics that have been clinically evaluated and proven to be effective and safe. The utilization of these products could potentially lead to a decrease in the cost of care while still offering the same advantages as the original biologic treatment.

• According to a study published by RAND Corporation in January 2022, Biosimilar drugs are expected to drive down prices for expensive medicines used to treat cancer and rheumatoid arthritis, with savings estimated to be USD 38.4 billion of projected total U.S. expenditure on biologics from 2021 to 2025.

The cost difference is one of the critical factors influencing the treatment preference of the patient population toward the uptake of these products over biologics, which is driving the market's growth.

• According to GoodRx.com, a single 100-mg vial of Remicade (infliximab) treatment can cost USD 1600 retail, vs USD 500 for Avsola, as recorded in January 2021. Further, it stated that this leads to savings with biosimilars ranging from 44% to 69% compared to the price of the reference drug.

Such instances provide significant cost savings and increased patient access to treatment, subsequently surging the uptake and driving the market growth.

Growing Emphasis of Key Players on R&D of Novel Drugs to Boost Market Growth

Market players are strengthening their product portfolio to meet the growing demand of the patient population suffering from various chronic conditions. These players are focusing on strategic collaborations and acquisitions to expand their product presence in emerging countries and strengthen their position in the market.

• In September 2023, Abbott signed an agreement with Spain-based global biotech leader mAbxience Holdings S.L. to commercialize several biosimilars focusing on oncology, women's health and respiratory diseases in emerging markets.

Such strategic initiatives to accelerate the R&D and product presence are likely to expand the range of treatment options for the patient population. This is projected to surge the demand for medications, citing the comparatively lower cost of medications, especially from emerging countries.

RESTRAINING FACTORS

High Manufacturing Costs and Complexity of Production Process May Hinder Market Growth

One of the critical impediments to market growth is that the development of these products is a highly complex and costly process. They must be produced at low costs in order to remain competitive and profitable, even in the face of substantial price discounts offered by reference product manufacturers. This is due to the fact that reference product manufacturers typically have more than two decades of experience in product manufacturing and benefit from economies of scale resulting from supplying the global market. Moreover, these companies typically have the most extensive stainless steel-based facilities that have been paid for and continuously improved over time (in line with the latest technology).

Furthermore, the companies often market a subsequent product. Hence, the established presence of certain large pharmaceutical companies and high manufacturing costs are anticipated to limit the biosimilars market growth during the forecast period.

SEGMENTATION

By Drug Class Analysis

Drive Monoclonal Antibodies Segment Growth is Driven by its High Number of Regulatory Approvals

Based on product, the market is segmented into filgrastim & peg-filgrastim, monoclonal antibodies, and others.

The monoclonal antibodies segment dominated the market in 2022. These are classes of therapeutics that are rapidly gaining traction for treating a wide range of chronic diseases, especially cancer. The growing focus of market players in getting regulatory approvals for their products for multiple indications is driving the segment’s growth. For instance, in September 2023, Samsung Bioepis Co., Ltd. signed an agreement with Sandoz to commercialize SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara (ustekinumab). The reference medicine Stelara (ustekinumab) is a monoclonal antibody (mAb) treatment indicated for autoimmune disorders, including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

The filgrastim & peg-filgrastim segment held the second-largest market share in 2022. The drug class decreases the risk of infection in patients with non-myeloid cancers. These products offer longer half-life and slower elimination rates, which reduces the need for frequent dosing. This ultimately reduces the treatment cost and increases the uptake of these drugs, subsequently driving the segment’s growth.

The other segment includes TNF blockers, insulins, human parathyroid hormones, and others, which are projected to exhibit steady growth over 2023-2030.

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By Disease Indication Analysis

Autoimmune Diseases Segment Leads Due to Approval of Broad Range of Drugs for Autoimmune Disease

By disease indication, the global market is classified into cancer, autoimmune diseases, and others.

The autoimmune diseases segment accounted for the largest biosimilars market share in 2022. The segment includes prevalent diseases, such as arthritis, psoriasis, and others. The growing geriatric population with autoimmune diseases is surging the demand for cost-effective solutions to continue the treatment regimes. According to 2021 data from the Center for Disease Control and Prevention (CDC), among the age of 65 years and older, 50% of the population have been diagnosed with arthritis. Therefore, the market players are focusing on getting regulatory approvals for these indications in order to meet the growing demand, which is driving the segment’s growth.

The cancer segment held the second-largest market share in 2022.  A large number of pipeline candidates are under clinical trials for various cancers, which is one of the critical factors that is likely to augment the segment’s growth during the forecast period. The others segment includes retinal diseases and kidney conditions, among others.

By Distribution Channel Analysis

Hospital Pharmacies Segment’s Growth Led by Rising Awareness among Patient Population

Based on distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.

The hospital pharmacies segment dominated the global market in 2022. The increasing awareness about these products among the patient population through healthcare professionals in terms of cost and efficacy is surging its procurement rate in hospital settings. Moreover, the reimbursement policies offered by certain countries are surging their uptake in these settings. Hence, all these factors are anticipated to augment the segment’s growth cumulatively.

The retail pharmacies segment held a considerable share in 2022. The segment’s growth is attributed to the growing focus of market players in distributing their products through these retail chains in order to increase product presence.

The online pharmacies segment is expected to grow with the highest CAGR during the forecast period due to the benefits it offers over other segments, such as ensuring timely delivery of drugs at the doorstep, which is majorly contributing to the segment's growth.

REGIONAL INSIGHTS

In terms of region, the global market is segmented into North America, Europe, Asia Pacific, Latin America and the Middle East & Africa.

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North America is expected to grow with the highest CAGR during the forecast period. The U.S. FDA has developed a regulatory approval pathway for these products. The number of approved products is estimated to substantially increase in future years, accompanied by an increasing loss of exclusivity of biological reference products, especially in oncology. By providing more affordable treatment options and introducing price competition to the market, biosimilar medicines may reduce the economic burden. Savings derived from the market entry can relieve burdened healthcare budgets and open up budgetary room for new treatment options, subsequently driving market growth across the region.

Europe was valued at USD 10.31 billion in 2022 and is likely to dominate the market throughout the forecast period. Europe represents an attractive market for manufacturers as it has recently updated guidance on the interchangeability of these medicines with the aim to eliminate uncertainties among stakeholders on the use of these products in clinical practice. As recorded on September 1, 2022, 86 biosimilars have been approved by the European Medicines Agency (EMA) since 2006, mainly in the therapeutic areas of cancer, diabetes, and rheumatoid arthritis. Moreover, these products are appealing to payers since they offer the same clinical benefit as the originator drug at a lower price, leading to savings that may be allocated elsewhere in the healthcare system. Cumulatively, all these factors led to the dominance of this region in the global market.

Asia Pacific is projected to grow with the second-highest CAGR during the forecast period. The growth in this region is primarily attributed to the cost benefits offered by the generic drugs, spurring their demand among the patient population. The market players are focused on making strategic alliances with an aim to expand their footprints in other emerging markets. For instance, in October 2022, Biocon Ltd. entered into a strategic out-licensing agreement with Yoshindo Inc. for commercializing two of its pipeline biosimilar products, ustekinumab and denosumab, in the Japanese market. Such strategic initiatives are anticipated to increase the accessibility of these products, which is likely to surge its uptake among the patient population, subsequently contributing to market growth across the region.

Latin America and the Middle East & Africa are expected to grow at a slower rate during the forecast period. However, the rising expenditure on chronic conditions coupled with the availability of drugs at cheaper rates are anticipated to drive market growth in these regions.

KEY INDUSTRY PLAYERS

Novartis AG, Amgen Inc., Pfizer Inc., and Samsung Bioepis Together Held Notable Market Share Due to Strong Product Offerings

In the competitive scenario, the global market is highly competitive due to the presence of many established and emerging market players, such as Novartis AG, Amgen Inc., Pfizer Inc., and Samsung Bioepis, which have established their presence in the market. These companies have a considerable advantage over emerging players due to the significant investment, technical capabilities, and clinical trial expertise they hold in manufacturing these complex medications at low cost. Moreover, these companies are strongly focusing on getting regulatory approvals for their product for multiple indications across various countries.

Some other emerging market players include Celltrion, Biocon, and Coherus BioSciences, among others. These companies are expanding their product presence by making strategic alliances to expand their R&D capabilities and distribution network in order to increase their market shares and product availability in key countries.

LIST OF KEY COMPANIES PROFILED:

• Celltrion Inc. (South Korea)


• Pfizer Inc. (U.S.)


• Novartis AG (Switzerland)


• Amgen Inc. (U.S.)


• Biocon (India)


• Biogen (U.S.)


• Coherus BioSciences (U.S.)


• Samsung Bioepis (South Korea)


• Shanghai Henlius Biotech, Inc. (China)

KEY INDUSTRY DEVELOPMENTS:

• October 2023: Pfizer’s Abrilada (adalimumab-afzb) received approval from the U.S. FDA as the second interchangeable Humira biosimilar. An interchangeable designation is granted by the FDA to only those biosimilars that meet additional data requirements. This data demonstrates that patients who alternate between the reference product and the biosimilar exhibit the same clinical result as patients who are being treated with the reference product alone.


• July 2023: Boehringer Ingelheim launched the first interchangeable branded version of Humira, Cyltezo (adalimumab-adbm), in the U.S. market. Cyltezo reinforces the ultimate goal of providing a more affordable and accessible treatment option across the U.S.


• January 2023: The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorization for Ximluci, a ranibizumab biosimilar developed in partnership with STADA Arzneimittel and Xbrane Biopharma. The marketing authorization will broaden patient access to ranibizumab in the U.K.


• August 2022: Teva Pharmaceutical Industries Ltd. received marketing authorization from the European Commission for Ranivisio (ranibizumab), an ophthalmology biosimilar of Lucentis. Ranivisio (ranibizumab) is approved for treatment for all five Lucentis indications in adults and is to be commercialized in Europe.


• June 2022: The U.S. FDA approved Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Neulasta, developed by Amneal Pharmaceuticals and Kashiv Biosciences.

REPORT COVERAGE

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The global biosimilars market research report provides qualitative and quantitative insights on the global market and a detailed analysis of the market size and growth rate for all possible segments in the market. It also provides an elaborative analysis of the market dynamics and competitive landscape. Various key insights presented in the report are the prevalence of key chronic diseases by key countries, pipeline analysis, key industry developments by key players, and the impact of COVID-19 on the global market.

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