The global biosimilars market is estimated to reach USD 3,288.0 million by 2026 from USD 2,001.6 million in 2019. The market is expected to register a significant growth rate of 6.3%.
Biosimilars are basically biological products which are similar to some other already approved biological medicines. These biosimilars are approved as per the same standards of pharmaceutical safety, efficacy, and quality that are applicable to all other medicines.
Factors such as increasing demand for biosimilars owing to their cost effectiveness and rising prevalence of various chronic diseases are expected to drive the market growth. According to Amgen’s annual report published in 2019, 17 biosimilars were approved by the US Food and Drug Administration (FDA) as of January 2019. Other factors responsible for market growth include the strategic developments by major market players.
However, risk of patient safety & efficacy of the drug and stringent government regulations are expected to negatively impact the market growth during the forecast period.
Patent expiry for certain biologic products and new indications for which treatment options need to be developed are expected to provide lucrative opportunities for market growth.
The global biosimilars market has been segmented into product, manufacturing, and indication.
On the basis of product, the global biosimilars market is divided into insulin, rhGH, granulocyte colony-stimulating factor, interferon, erythropoietin, etanercept, monoclonal antibodies, follitropin, glucagon, calcitonin, teriparatide, and enoxaparin sodium. Monoclonal antibodies segment is expected to account for the largest market share owing to the rising number of product launches related to monoclonal antibodies and growing RD activities in the segment.
By manufacturing, the global biosimilars market is classified into in-house and contract. The in-house manufacturing segment held the largest market share as it is preferred most by the major players in the market as it eliminates the potential hindrance that can be caused by the external factors in a company’s manufacturing as well as distribution process. Moreover, the method is considered cost-effective by many major players.
Based upon the indication, the market is categorized into offsite treatment, oncology, chronic disease, blood disorder, autoimmune disease, blood disorders, infectious disease, and others. The oncology segment is anticipated to hold the largest market share owing to the increasing prevalence of cancer.
By region, the global biosimilars market is segmented into the North America, Europe, APAC, and RoW.
Europe region is expected to lead the market owing to the presence of many major players in the region. These include Boehringer Ingelheim, Fresenius Kabi, Gedeon Richter, Mabxience, Stada Arzneimittek AG, and Sandoz, among others. North America is estimated to be the second largest market in 2019, owing to the strong product pipeline. According to a data published by an independent source, over 40 biosimilars are in the developmental phase and a significant number of biosimilars are in pipeline. The biosimilars market is the APAC region is anticipated to grow at the fastest CAGR owing to the rising research & development activities by major players in the region and increasing prevalence of chronic diseases. According to a data published by the Institute for Health Metrics & Evaluation (IHME), most of the deaths in Japan were due to Alzheimer’s disease in 2017, followed by Ischemic Heart disease. The biosimilars market in RoW is expected to slowly grow owing to the developing healthcare infrastructures of countries in the Latin American region and Middle East region.
Key market players covered in the report include Probiomed (Mexico), Boehringer Ingelheim (Germany), Apotex (Canada), Fresenius Kabi (Germany), Gedeon Richter (Hungary), Mabxience (Spain), Amega Biotech (Argentina), Biocad (Moscow), Coherus Biosciences (US), Stada Arzneimittel AG (Germany), Dr.Reddy’s Laboratories (India), Mylan (US), Samsung Biologics (South Korea), Amgen (US), Biocon (India), Celltrion (South Korea), Teva Pharmaceutical (Israel), Eli Lilly and Company (US), Pfizer (US), Sandoz (Germany), and others. These companies are involved in product approvals and investments in research & development to manufacture technologically advanced anesthesia machines. For instance, in November 2018, Teva Pharmaceutical Industries received US FDA approval for Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin used for the treatment of HER2-overexpressing breast cancer. With this, the company expanded its product portfolio. Furthermore, in October 2018, Sandoz (Novartis) received US FDA approval for Hyrimoz (adalimumab-adaz) for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. With this, the company enhanced its market presence in the biosimilars market. In September 2016, Humira by Amgen Inc. was approved by the US FDA. Humira is the first adalimumba biosimilar. The company also received recommendations by the European Union (EU) in January 2017 to launch 2 European versions of Humira, named Amgevita and Solymbic in the region.
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