Global Biosimilars Market Size By Product (Monoclonal Antibodies, Insulin, Erythropoietin), By Indication (Oncology, Inflammatory And Autoimmune Diseases, Chronic Diseases), By Geographic Scope And Forecast

Biosimilars Market Size And Forecast

Biosimilars Market size was valued at USD 14.7 Billion in 2022 and is projected to reach USD 109.2 Billion by 2030, growing at a CAGR of 24.9% from 2023 to 2030.

The rising prevalence of chronic diseases, as well as the increasing demand for biosimilars due to their cost-effectiveness, are driving market growth. Regulatory approvals and other regulations in various countries that encourage biosimilar adoption are also major driving factors in the Biosimilars Market. The Global Biosimilars Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market.

Global Biosimilars Market Definition

A biosimilar is defined as a biological medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved copies of original “innovator” products that can be created after the original product’s patent expires. The approval includes a reference to the innovator’s product. Unlike generic drugs of the more common small-molecule type, biologics have a high level of molecular complexity and may be extremely sensitive to changes in manufacturing processes. Regardless of their differences, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.

Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and Health Canada’s Health Products and Food Branch have their guidelines on the requirements for demonstrating the similarity of two biological products in terms of safety and efficacy. Despite minor differences in clinically inactive components, animal studies, and clinical study or studies, they claim that analytical studies show that the biological product is highly similar to the reference product. They are sufficient to establish the safety, purity, and potency of the reference product in one or more relevant conditions of use for which the reference product is licensed and intended to be used, as well as for which biological product licensure is sought.

In 2009, the World Health Organization (WHO) issued “Guidelines for the evaluation of similar biotherapeutic products (SBPs).” The goal of this guideline is to establish an international standard for evaluating biosimilars. Since 2006, the EMA has approved approximately 50 biosimilars for marketing. The first biosimilar of a monoclonal antibody to be approved globally was an infliximab biosimilar in the EU in 2013. On March 6, 2015, the FDA approved the first biosimilar product in the United States, Sandoz’s filgrastim-sndz (trade name Zarxio).

Global Biosimilars Market Overview

The major drivers for the growth of the Biosimilars Market are the Increasing demand for biosimilar drugs due to their cost-effectiveness, the rising geriatric population and the increasing incidence of chronic diseases, the abbreviated regulatory approval process, and Growing Strategic Partnerships and Agreements. Biosimilars are typically priced 20–30% lower than their parent/branded counterparts. This results in both cost savings and patient access to highly effective treatments. When compared to innovator biologics, biosimilars have lower R&D costs. Biosimilars are less expensive because R&D costs are lower.

Through price competition among manufacturers, lower-priced biosimilars tend to have a downward effect on the prices of reference biologics. Biosimilar drugs’ significant cost-to-benefit ratio is expected to increase their demand in the coming years. The rapid adoption of these drugs around the world has the potential to reduce direct spending on biologics. Various pharmaceutical companies are forming strategic alliances, collaborations, and acquisitions to gain a competitive advantage in the development, manufacturing, or commercialization of their products. The collaborations aim to make high-quality, low-cost therapies available to patients.

The market is thought to be fairly flat and is developing at a slower pace as a regulatory framework is put in place. As a result of the collaborations, competing companies can strengthen their ability to deliver next-generation drugs and improve their accessibility. As a result, the Biosimilars Market is expected to grow during the forecast period. The restraints for the market growth are Manufacturing complexities and biologics manufacturers’ resistance. Whereas, the opportunities are Emerging markets, the expiration of patents on blockbuster biologics, and research into new indications.

Global Biosimilars MarketSegmentation Analysis

The Global Biosimilars Market is Segmented on the basis of Product, Indication, And Geography.

Biosimilars Market, By Product

• Monoclonal Antibodies
• Insulin
• Granulocyte Colony-Stimulating Factor
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Enoxaparin Sodium
• Glucagon
• Calcitonin

Based on Product, the market is segmented into Monoclonal Antibodies, Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Enoxaparin Sodium, Glucagon, and Calcitonin. The majority of the market is dominated by Monoclonal Antibodies. Monoclonal Antibodies and Insulin are expected to be the fastest-growing segments during the forecast period, owing to the widespread use of Monoclonal Antibodies in the treatment of cancer, autoimmune disorders, and osteoporosis, as well as rising incidences of insulin-dependent diabetes worldwide and rising demand for cost-effective treatment options.

Biosimilars Market, By Indication

• Oncology
• Inflammatory And Autoimmune Diseases
• Chronic Diseases
• Blood Disorders
• Growth Hormone Deficiency
• Infectious Diseases
• Other Indications

Based on Indication, the market is segmented into Oncology, Inflammatory And Autoimmune Diseases, Chronic Diseases, Blood Disorders, Growth Hormone Deficiency, Infectious Diseases, and Other Indications. Oncology is the market’s largest segment, owing to the availability of biosimilars at a lower cost than innovative biologics and a large number of cancer patients. The availability of biosimilars in Oncology has reduced prices, making cancer treatment more affordable and accessible. Furthermore, due to the high incidence and prevalence of cancer, healthcare systems all over the world are focusing on reducing the burden of cancer by implementing cost-effective treatment options. In this scenario, biosimilar drugs could see widespread use in major markets such as the United States, Europe, and the Asia Pacific. Given these factors, as well as the looming competition from biosimilars, many major biologic pharmaceutical companies are investing heavily in the development and approval of biosimilar drugs.

Biosimilars Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the world

On the basis of Regional Analysis, The Global Biosimilars Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. The Biosimilars Market is dominated by Europe, followed by the Asia Pacific and North America. Several factors are driving growth in these markets, including the impending patent expiration of biologic products and the launch of new biosimilars, the rising incidence of chronic disorders, the emergence of new players, and early market entry.

Key Players

The “Global Biosimilars Market” study report will provide valuable insight with an emphasis on the global market including some of the major players such as Pfizer Inc., Sandoz (Germany), Amgen Inc., Biocon (India), Celltrion (South Korea), Samsung Biologics (South Korea), Novartis AG, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd, Fresenius Se & Co. KGaA, Stada Arzneimittel AG, Boehringer Ingelheim, Gedeon Richter Plc.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Key Developments

• September 2021, BYOOVIZ (ranibizumab-Nuna), a biosimilar of LUCENTIS (ranibizumab), was approved by the Food and Drug Administration (FDA) for the treatment of myopic choroidal neovascularization, macular edoema following retinal vein occlusion, and neovascular age-related macular degeneration. The first ophthalmology biosimilar to be authorized in the US was BYOOVIZ.

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• Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors• Provision of market value (USD Billion) data for each segment and sub-segment• Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market• Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region• Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled• Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players• The current as well as the future market outlook of the industry with respect to recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions• Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis• Provides insight into the market through Value Chain• Market dynamics scenario, along with growth opportunities of the market in the years to come• 6-month post-sales analyst support

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