Rituximab biosimilar (Henlius Biotech)

Oncology Enabling Development of Improved Biologic Products Advancements in oncology settings are improving patient quality of life. Due to effective biosimilars, healthcare providers are able to receive better outcomes in several cancer patients who can opt for convenient treatments such as a painless injections rather than receiving a lengthy chemotherapy session. Patent expiry of biologic drugs for the treatment of cancer are creating a scope for incremental opportunities. As such, oncology indication segment of the biosimilars market is estimated to reach a value of ~US$ 21.1 Bn by the end of 2030. Download Sample @ Since the oncology segment is likely to witness aggressive growth during the forecast period, companies in the biosimilars market are increasing efforts to introduce improved formulations of biologic products. Apart from biosimilars, companies are increasing the production of epoetins and filgrastims for the treatment of chemotherapy-induced neutropenia. Healthcare companies are also developing biosimilars to Rituximab, since the novel drug is FDA-approved. Biologic drugs similar to Rituximab are creating incremental opportunities for companies, as these drugs are being increasingly used in the treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. Innovations in mAbs Increase Cancer Treatment Options Innovations in monoclonal antibodies (mAbs) are expected in the biosimilars market landscape in the near future. Healthcare companies are increasing their efficacy in hybridoma-based technology to develop improved mAbs with the help of genetic engineering. Monoclonal antibodies are a key source of revenue in the recombinant glycosylated proteins segment. As such, among product types, the recombinant glycosylated proteins segment of the biosimilars market is estimated to reach a value of ~US$ 23.5 Bn by 2027. Hence, manufacturers are aiming at the integration of humanized mAbs based on grafting the murine complementary regions into the human immune globulin backdone. Monoclonal antibodies are being pervasively used for the treatment of cancer, diabetes, and autoimmune diseases. Manufacturers in China are facing fierce competition to gain approvals for biosimilar mAbs. For instance, in December 2019, Shanghai Henlius Biotech – a producer of advanced mAb products, announced the approval of China’s first-of-its-kind Rituximab biosimilar HLX01 for the treatment of non-Hodgkin’s lymphoma. Companies Seek Approval for Orphan Biosimilars Companies in the biosimilars market are tapping into opportunities in orphan biosimilars. Biosimilars are gaining popularity as affordable treatment options for patients in need of biologics. Due to the high prevalence of rare diseases, companies have a renewed purpose to steer innovation in biosimilars. Thus, manufacturers are increasing efforts to fulfill unmet needs of patients with rare diseases by increasing the availability of low-cost biosimilars. Get a glimpse of the in-depth analysis through our Report Brochure Development of new orphan biosimilars is in the pipeline for most healthcare companies. They are increasing efforts to gain approvals on new biologic products. For instance, Amgen – a U.S. multinational biopharmaceutical company, revealed that the company has gained approval for its biosimilar medicine, which is a version of Johnson and Johnson/MRK’s Remicade (infliximab). Manufacturers in the biosimilars market are commercializing orphan biosimilars for the treatment of rare blood diseases involving blood clotting and impaired bone marrow function. Hence, companies are increasingly focusing on the development of biosimilars for blood disorders, since the segment is anticipated for exponential growth during the forecast period. Low-cost Biosimilar Insulin in Offing The global biosimilars market is largely consolidated with five major players accounting to more than ~50% of the market share. This poses as a challenge for emerging players to gain prominence in the biosimilars market. Moreover, unfavorable regulatory landscape as suggested by the FDA in the U.S. poses as a challenge for drug manufacturers. Currently, the biosimilars market in North America is projected for exponential growth during the forecast period. The U.S. being one the most developed economies in North America is faced with several restraints in the current developmental programs for protein products, including insulin, due to stringent and time-constrained regulatory norms imposed by the FDA. Hence, manufacturers in the biosimilars market are increasing R&D activities to produce affordable biological products before the 2020 deadline issued by the FDA. Insulin is an important recombinant non-glycosylated protein that is creating incremental opportunities for companies in biosimilars market, due to high prevalence of diabetic patients. Analysts’ Viewpoint The biosimilars market is expected to expand at a high CAGR of ~23% during the forecast period. Manufacturers are gaining business stability by increasingly innovating in biosimilars catering to cancer patients and are driving down costs of medicines. One of the biggest barriers in the growth of orphan biosimilars is the long clinical development pathway due to evidence requirements for rare disease drugs. Hence, manufacturers are focusing on analytical similarity with originators to develop approval-worthy biosimilars. Companies should invest in developing economies of Asia Pacific such as India, since the country is an emerging hub for biologics and biosimilars. India’s biopharma sector is aiming to emulate the global standard in generic drugs and is increasing efforts to improve access to affordable biosimilar products. Biosimilars Market: Overview The global biosimilars market was valued at ~US$ 8 Bn in 2021 and is projected to expand at a high CAGR from 2019 to 2027. The growth of the market can be attributed to various factors, including significant product pipeline, focus of market players on expanding their presence in emerging markets, rise in prevalence of non-communicable diseases, cost savings offered by biosimilars, patent expiries of major biologics, and increase in adoption rate of biosimilars. Biosimilars can be defined as a biologic medical product, which is considered to be similar to already approved biologic. These biosimilars are approved based on their efficacy, quality, safety, and the same standards of pharmaceutical quality that apply to all biologic medicines. Biosimilars are the copy versions of biologics, which have reached the end of patent protection. The patent expiries of major biologics are expected to contribute to the growth of the biosimilars market. As a result of increasing approvals and sales of biosimilars, biologics, which had a steady or growing demand, witnessed a strong decline in their sales. The global burden of chronic diseases has been increasing globally. Aging population and changing societal behavior are the key factors contributing to the increase in prevalence of chronic diseases. Major chronic diseases include diabetes, hypertension, stroke, respiratory diseases, oral diseases, obesity, arthritis, and cancer. The approvals of biosimilars have been increasing globally, owing to changing regulations and increasing pressure on the healthcare system to facilitate treatment to all patients. Biosimilars or copy biologics are being increasingly adopted by physicians, authorities, and patients, owing to much-needed improvements to access therapeutically-viable treatments for various diseases. Biosimilars Market: Segmentation The global biosimilars market has been segmented based on product, indication, and region In terms of product, the biosimilars market has been categorized into recombinant glycosylated proteins, recombinant non-glycosylated proteins, and recombinant peptides. Recombinant glycosylated proteins segment has been further divided into monoclonal antibodies, erythropoietin, and others. The recombinant non-glycosylated proteins segment has been sub-segmented into insulin, granulocyte colony stimulating factor, recombinant human growth factor, and interferons. Based on indication, the biosimilars market has been divided into chronic diseases, oncology, autoimmune diseases, infectious diseases, blood disorders, growth hormone deficiency, and others. The oncology segment dominated the market in 2018. It is anticipated to remain dominant during the forecast period, owing to increase in prevalence of cancer and significant pipeline of biosimilars focused on the treatment of cancers. Biosimilars Market: Regional Segmentation In terms of region, the global biosimilars market has been divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa Europe dominated the global biosimilars market in 2018, and is likely to remain dominant during the forecast period. Europe is considered the global pioneer in the biosimilars market with the first approved biosimilar in 2006. This region accounts for over 70% of the global biosimilar spending, as it is the most developed biosimilar market. In addition, Europe has over 60 approved biosimilars currently, contributing significantly to the growth of the biosimilars market in the region. The global biosimilars market in Asia Pacific is anticipated to expand at a high CAGR during the forecast period. The robust growth of the market in the region can be attributed to increase in manufacturing of biosimilars in India and Korea. In addition, there are over 300 biosimilars under development in Asia, which would help Asia position itself as the center for global biosimilars manufacturing and adoption. Biosimilars Market: Major Players Key players operating in the global biosimilars market include Pfizer, Inc. Intas Pharmaceuticals Ltd. Biocon Dr. Reddy’s Laboratories Ltd. Teva Pharmaceutical Industries Ltd. Sandoz International GmbH (A Novartis Division) Celltrion Inc. Amgen, Inc. STADA Arzneimittel AG Apotex Inc. (Apobiologix) These players are focused on adopting organic growth strategies to strengthen their product portfolio. These companies have adopted strategies such as collaborations, investment in research & development, strengthening their biosimilars pipeline, and product launches in order to stay competitive in the biosimilars market. Key Questions Answered in Biosimilars Market Report What is the sales/revenue generated by biosimilar products across all regions during the forecast period? What are the key trends in the biosimilars market? What are the major drivers, restraints, and opportunities in the market? In which region is the biosimilars market set to expand at the fastest CAGR during the forecast period? Which segment will have the highest revenue globally in 2027 and which product segment will expand at the fastest CAGR during the forecast period? Biosimilars Market – Segmentation Product Recombinant Glycosylated Proteins Monoclonal Antibodies Erythropoietin Others Recombinant Non-glycosylated Proteins Insulin Granulocyte Colony Stimulating Factor Recombinant Human Growth Factor Interferons Recombinant Peptides Indication Chronic Diseases Oncology Autoimmune Diseases Infectious Diseases Blood Disorders Growth Hormone Deficiency Others Region North America Europe Asia Pacific Latin America Middle East & Africa TABLE OF CONTENT 1. Preface 1.1. Market Definition and Scope 1.2. Market Segmentation 1.3. Key Research Objectives 1.4. Research Highlights 2. Assumptions and Acronyms 3. Research Methodology 4. Executive Summary: Global Biosimilars Market 5. 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China has seen a significant surge in biosimilar approvals over the last three years, with 13 new biosimilars approved during 2018–2021, bringing the total biosimilars approved in China to 20. With China’s large biosimilar pipeline, this trend looks set to continue into the future. Currently, China has a large generics market, as approximately 90% of all marketed drugs in China are generics. In comparison, biosimilars only account for 0.002% of all marketed drugs. To date, the biosimilars market in China has been limited, trailing behind other Asia-Pacific (APAC) markets such as Japan and South Korea. Japan currently has 26 approved biosimilars and South Korea has 18 approved biosimilars. Prior to this recent surge, which began in 2019, China had no official biosimilars available on the market. China stimulated its biosimilars market through the implementation of new legislation and regulations by the Chinese regulatory authority, the National Medical Products Administration (NMPA). In 2015, the NMPA released the first guidelines for an established biosimilar pathway within China, ten years after the EU implemented the first-ever regulatory pathway for biosimilars in 2006 and nearly six years after South Korea and Japan implemented their own frameworks in 2009. This new regulatory pathway created standardised regulations for the development and evaluation of biosimilars, clarifying the definition of biosimilars and setting standards for preclinical R&D, clinical trials and manufacturing. Additionally, the NMPA made multiple regulatory changes to reduce the costs and barriers for companies performing biologics R&D. This, alongside the increasing reimbursement of biologic drugs, is helping to drive biosimilar growth in China. In February 2019, China’s first official biosimilar was approved. The rituximab biosimilar HLX01 was developed by Shanghai Henlius Biopharmaceutical for the treatment of Non-Hodgkin’s Lymphoma (NHL). Three more biosimilars were approved in China in 2019, and seven biosimilars were approved in 2020, at an increase of 75% between 2019 and 2020. There have been already been two biosimilar approvals in China in H1 2021. A bevacizumab biosimilar by Luye Pharma Group Ltd was approved in May 2021 for non-small cell lung cancer, and an infliximab biosimilar by Mabpharm Ltd was approved in July 2021 for ankylosing spondylitis (Bekhterev’s Disease). This surge in Chinese biosimilars looks set to continue into the future, with 11 biosimilar drugs currently in pre-registration and awaiting approval by the NMPA, as well as approximately 100 biosimilars in the pipeline. This recent surge in biosimilars has helped China become one of the leading biosimilar markets in only three years, overtaking South Korea to reach second place behind Japan according to a number of approvals. China’s strong biosimilar pipeline and the latest regulation changes by the NMPA are likely to drive China’s biosimilar markets to new heights. Related Report Healthcare Get the Report Latest report from Browse over 50,000 other reports on our store. Visit GlobalData Store