The global biosimilars market size was USD 15.54 Billion in 2021, and is expected to register a revenue CAGR of 21.3% during the forecast period. Termination of patent period of previous reference biologics, increasing prevalence of inflammatory and immune-mediated chronic diseases, and rising demand for biosimilar drugs due to their cost-effectiveness are major factors expected to drive market revenue growth. Furthermore, increasing acceptance and approval of biosimilars by regulatory bodies for treatment of different cancers is another factor expected to drive revenue growth of the market from 2022 to 2030.
Biosimilars are biological formulations that are very similar to previously-approved and commercialized biologic products, such as vaccines, plasma and other blood components, tissues, and proteins; specifically, monoclonal antibodies and cell signaling proteins. Biosimilars exhibit high levels of similarity with original patented drugs and accomplish same therapeutic and clinical results while being cheaper than their branded counterparts, which is creating high demand in the market. Although they display similar efficacy, potency, and safety as original drug and are patented and approved in same way, biosimilars may have slight structural differences as compared to their biologics due to difference in their active ingredients. Regulations mandate that safety and efficacy of biosimilar must not be affected compared to originator biologics due to change in ingredients. Some biosimilars, such as monoclonal antibodies are used for treatment of multiple diseases. These slight notable differences are creating high demand for biosimilar drugs over generics.
Biopharmaceutical products are steadily gaining focus from market players owing to reduced span of time for clinical development. Recent laws have accelerated approval process of biosimilars by eliminating phase II clinical trials and focusing on determination of ‘biosimilarity’ of new formulation to the reference originator biologics. This brings down healthcare costs for patients consuming biosimilars over original biologics.
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Drivers: End of patent period of previous reference biologics and low cost of biosimilars is driving biosimilars market revenue growth
Biologic drugs are pharmaceutical formulations that are either produced from living organisms, such as bacterial and fungal cultures and mice animal models, or contain components that have been acquired from them. These drugs are extensively used by medical practitioners for treatment of patients. In terms of clinical efficacy, biosimilars produce same therapeutic effects as their reference biologics, and are administered to patients in the same way. However, their composition is different from original drug, as original composition is patented by pharmaceutical company and cannot be reproduced by other manufacturers during the patent period. A patent provides protection to biologic formulations for 20 years from the date of patent filing, implying that products that have been patented two decades will now lose protection. This provides opportunity to biosimilar manufacturers to reproduce and improve these formulations and sell them at a cheaper price. Commercial biologic medications that are prescribed to patients are expensive, adding to cost of healthcare. Biosimilars are generally priced around 20-30% lower than their parent or branded counterparts due to lower costs of development in Research and Development (R&D) process as compared to original biologics. This reduces cost and provides better access to effective treatments of patients. In addition, low-cost biosimilars impart a downward effect on the cost of original biologic formulations through competitiveness among manufacturers for price.
Environmental pollution, climate change, exposure to Ultraviolet (UV), chemical and biological contamination in water and food, and genetic and epigenetic factors are increasing cases of cancer globally. Medical advancements have enabled complete recovery of cancer patients even from later stages of diagnosis, although the procedure is expensive and therapeutic options are limited. Certain targeted and immunotherapy drugs have been used in recent years to treat different types of cancer, while other formulations are receiving approval of regulatory bodies such as the Food and Drug Administration (FDA) for treatment of cancer, and to help manage side effects of inflammatory or immune-mediated diseases. This is increasing use of biosimilars in the healthcare and oncology research sectors, and is expected to drive market revenue growth.
The biosimilars market is dynamic and in an emerging state, with a large number of pharmaceuticals giants as well as emerging players operating across the globe. Additionally, emerging players have a good opportunity to enter the biosimilars market, owing to availability of a number of original formulations whose patent period will terminate in the next few years and favorable regulatory scenario that is projected to support revenue growth of the market from 2022 to 2030.
Restraints: Manufacturing complications and variation in composition are some factors restraining market revenue growth
Developing biosimilar formulations is an expensive and complicated process that involves collaboration of various domains for expertise in clinical and preclinical trials, standardization of quality check systems and biopharmaceutical composition, technical assistance as well as for major investments, in terms of revenue. Biosimilar products have to be passed through clinical trials and monitoring programs after approval to note efficacy and observe long term side effects, even after amendments to accelerate approval process.
Another factor restraining revenue growth of market is variation in composition while manufacturing biosimilars, so that novel formulation is similar to original biologic. In order to set apart new product from patented product, manufacturers change active ingredients, which often results in deteriorated efficacy of the biosimilar. Standardization of product quality and regulation of ingredients that can be used for each product is a possible solution. Additional rounds of clinical and preclinical trials to demonstrate robustness of efficacy of new product to regulatory bodies is another factor hampering market revenue growth. Furthermore, although cheaper than commercialized biologics, biosimilars are more expensive than generic medicinal alternatives, due to complex biological manufacturing processes, which is expected to discourage patients from switching to biosimilars.
The COVID-19 pandemic adversely affected market revenue growth. Previously due to lockdowns globally, healthcare community was oriented towards tackling this virus and collaborate together to end this pandemic. Pharmaceutical industries were working on R&D to develop a vaccine and to keep necessary stock of medicines to treat the illnesses caused by this virus. Hospitals were converted into specialized COVID-19 hospitals as cases were increasing significantly. Biomedical community concentrated on providing ventilators and other equipment to ensure that patients received adequate oxygen. Successful rollout of vaccination, after its approval, has helped patients suffering from other diseases to get themselves diagnosed and treated. Medicine supplies for other diseases also grew, eventually at a rapid pace across the world. Raw materials for such medicines were supplied without any hustle to the developing nations. Underdeveloped countries also received the required doses of medicines and vaccines under the global program campaign headed by World Health Organization (WHO). It is projected that biosimilar drugs will eventually grow at a rapid pace during the forecast period.
Product Type Insights:
Based on product type, global biosimilars market is segmented into recombinant peptides, recombinant glycosylated proteins, recombinant non-glycosylated proteins, and others.
Recombinant glycosylated proteins segment is expected to account for significant revenue share during the forecast period. Glycosylation is the reaction between a hydroxyl or other functional group of a molecule with a carbohydrate in order to form a glycoconjugate. It is an enzyme-catalyzed reaction and is most extensive post transitional modification made in proteins by eukaryotic cells. Majority of recombinant proteins manufactured for human therapy are glycoproteins derived from animal cells, and it is essential to fully characterize and if possible, control the glycosylation profile of these products. These products are generally used for making drugs for cancer treatment, as glycosylation greatly influences biological activity of recombinant proteins, regulates their function, modulates clearance of the protein from circulation system of the patient, and is a determining factor of antigenicity of the product. Regular demand for these medicines across the world for treatment of cancer is expected to drive market revenue growth.
Disease Type Insights:
Based on disease type, global biosimilars market is segmented into oncology, blood disorders, chronic disease, infectious disease, and others.
Oncology segment is expected to register rapid revenue CAGR during the forecast period. Biosimilars have several potential advantages in cancer treatment, as they introduce competition into drug development process. Biosimilars help save a huge amount of money for the patients who need to pay for the original products. Biologics include a wide variety of products such as blood & blood components, hormones, vaccines, and allergens or anti-allergy medications. Oncology accounts for a significant share of the segment in this market owing to emergence of novel chemical and biological carcinogenic substances that are increasing cases of cancer. Developments in the field of medical science have enabled doctors to treat patients who have been diagnosed at later stages and recover them to normalcy. However, with increasing stages cancer metastasizes to the entire body, limiting therapeutic options. Treatment with biosimilars cuts down cost of treatment for a large number of cancer patients, making it more accessible and affordable.
Blood disorders segment is projected to register steady growth rate from 2022 to 2030. Erythropoietins (EPOs) and Granulocyte Colony Stimulating Factor (GCSF) were some of the first biosimilar formulations used for hematology-oncology applications. These products found applications in treatment of neutropenia, as they were observed to stimulate proliferation of neutropenic progenitor cells and activate mature neutrophils. With increasing global population, cases of patients suffering from the disease is increasing, thereby increasing adoption of biosimilars as a cost-effective treatment method.
Biosimilars markets in the Europe is expected to account for largest revenue share in the global market during the forecast period. Termination of patent period of previous reference biologic products, development of new biosimilars by drug developers present in countries in this region, and rising incidences of inflammatory and immune-related chronic disorders are major factors expected to drive market revenue growth. Enactment of laws to accelerate the drug approval process and robust presence of market players in Europe are some other factors expected to drive revenue growth of the market. 39 biosimilar drugs have been approved in European Union until May 2022, which can be used for oncology treatment.
Asia-Pacific biosimilar market is expected to register rapid revenue CAGR during the forecast period due to presence of various emerging players in the region. Increasing geriatric population in Asia-Pacific is associated with a high healthcare expenditure burden, and the market segment demands lower cost alternatives such as biosimilars, which can drive revenue growth. Increasing number of cancer patients in this region and lack of medical infrastructure especially for cancer patients, are creating opportunity for the private players in this region to engage themselves and invest with the help of government support and provide cheaper medicines to patients for their treatment. These factors are expected to drive revenue growth of market in the region during the forecast period.
Competitive landscape of global biosimilar market is moderately fragmented with several key players operating on global and regional levels. Key players are engaged in platform development and strategic alliances to expand their respective portfolios and gain a robust footing in global market. Major companies in the global market report include Pfizer Inc., Dr. Reddy’s Laboratories Ltd., Novartis AG., Amgen Inc., Biocon Ltd., Samsung Biologics, Celltrion, Teva Pharmaceuticals Industries Ltd., F. Hoffmann-La Roche Ltd., and Biogen Idec Inc.
- On 22 December 2021, Novartis announced that the company entered into to acquire all of the outstanding share capital of Gyroscope Therapeutics, which is a U.K.-based ocular gene therapy company. Geographic atrophy, which is an advanced form of age-related macular degenerative retinal disease which leads to progressive and irreversible vision loss. Gyroscope also has several additional assets in its pipeline in early discovery for retinal diseases. This acquisition is expected to add GT005, which is an investigational, one-time gene therapy, to the Novartis portfolio. Currently, the therapy is in phase II for the treatment of people living with GA.
- On 04 February 2021, Biocon Biologics Ltd., which is a fully integrated ‘pure play’ biosimilar company and a subsidiary of Biocon Ltd., signed an agreement with the Clinton Health Access Initiative to expand access to lifesaving cancer biosimilar in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership. The partnership is a significant step in delivering advanced cancer therapies to patients who need them the most and ensures equitable access to high-quality biosimilar in low and middle-income countries.
Segments Covered in the report
This report offers historical data and forecasts revenue growth at a global, regional, and country-level, and provides an analysis of market trends in each of sub-segments from 2022 to 2030. For the purpose of this report, Reports and Data has segmented the global biosimilars market based on product type, disease type, and region:
Biosimilars Market Report Scope
Segments covered By Product Type Outlook, Disease Type Outlook, Regional Outlook
By Product Type Outlook
Recombinant Non-Glycosylated Proteins
Recombinant Glycosylated Proteins
By Disease Type Outlook
Middle East & Africa
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