Biosimilars Market Scenario
Biosimilars Market Size is expected to register a CAGR of 7.5% during the forecast period of 2019 to 2025, with a market value of USD 13,460 Million in 2018.
A biosimilar is a biologic medical product highly similar to another already approved biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines. The global biosimilars market is driven by factors such as rising demand for biosimilars due to their cost-effectiveness and growing prevalence of chronic diseases. Additionally, rising pressure to reduce healthcare expenditure coupled with patent expiry of various blockbuster drugs and the increasing number of biosimilar drug approvals by the FDA is anticipated to fuel the market growth.
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For instance, according to the biosimilars update report by Amgen in 2019, As of January 2019, the US Food and Drug Administration (FDA) approved 17 biosimilars, out of which 7 products launched in 4 therapeutic areas. On the other hand, patient safety and medical efficacy are projected to hamper the growth of the market during the assessment period. Moreover, major companies in the market are involved in strategic acquisitions, collaborations, and mergers to sustain their position in the market.
For instance, in October 2018, Sandoz, a Novartis division received the US Food and Drug Administration (FDA) approval for its biosimilar, HyrimozTM (adalimumab-adaz) for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PSA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, ulcerative colitis (UC), ankylosing spondylitis (AS), adult Crohn's disease (CD), and plaque psoriasis (Ps)
Biosimilars Market Segmentation
Global Biosimilars Market has been segmented based on product, applications, end users, and region.
The market, based on product, has been bifurcated into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides.
The recombinant non-glycosylated proteins are further divided into human growth hormone (RHGH), granulocyte colony-stimulating factor (filgrastim), insulin, and interferons. Similarly, the recombinant glycosylated proteins segment is further bifurcated into erythropoietin (EPO), monoclonal antibodies (MABS), and follitropin. The recombinant peptides segment has been subdivided into glucagon and calcitonin
The recombinant non-glycosylated proteins segment is expected to hold a major share in the market due to an increase in the number of incidences of chronic diseases, diabetes also growth hormone deficiency-related disorders. Thus, the therapeutic use of recombinant non-glycosylated proteins is broadening as their increased availability and lowered price.
For example, according to the International Diabetes Federation (IDF), in 2017, approximately 425 million adults aged between 20 to 79 years suffered from diabetes, and this number is expected to rise to 629 million by 2045.
On the basis of applications, the global biosimilars market has been divided into oncology, chronic diseases, autoimmune diseases, blood disorders, growth hormone deficiency, infectious diseases, and others. Blood disorders segment is expected to grow with high growth rate due to increased prevalence of blood disorders and adoption of biosimilars as its low cost in comparison to biologics reduces the treatment cost.
For example, according to the Centers for Disease Control and Prevention in the US, hemophilia A affects 1 in 5,000 male births, and about 400 babies are born with hemophilia A each year.
Based on end user, the market has been divided into hospitals and clinics is expected to hold the largest share in the market as easy availability for treatment with expert faculties.
Based on region, the global biosimilars market has been divided into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The biosimilars market in the Americas has further been segmented into North America and Latin America; the North American market has been further divided into the US and Canada.
The European biosimilars market has been sub-divided into Western Europe and Eastern Europe. Western Europe has further been classified as France, the UK, Germany, Italy, Spain, and the rest of Western Europe. The biosimilars market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The biosimilars market in the Middle East & Africa has been divided into the Middle East and Africa.
Biosimilars Market Key Players
The key players in the Global Biosimilars Market are Pfizer (US), Sandoz International (Germany), Teva Pharmaceuticals (Israel), Amgen, Inc. (US), Biocon (India), Dr. Reddy’s Laboratories (India), Celltrion (South Korea), Samsung Biologics (South Korea), Eli Lily & Company (US), Hospira Inc.(US), Actavis, Inc.(US), Cipla Ltd (India), Stada Arzneimittel AG (Germany), and Mylan, Inc.(US).
Regional Market Summary
The market in Europe is expected to dominate the global biosimilars market due to the increasing biosimilar product approvals and the emergence of new market participants in the region. The growing prevalence of chronic diseases in the US and Canada is expected to drive the market growth. Furthermore, there has been an increase in the expenditure in research by healthcare bodies; this is expected to fuel the growth of the market in this region. For example, according to Amgen, in 2019, Europe has an advanced biosimilar market, with 53 approved biosimilar products. The market in Asia-Pacific expected to show a considerable amount of growth. This can be attributed to the patent expiry of biologic products, introduction of new biosimilars, adoption of biosimilars to reduce the treatment cost, and the involvement of key companies. For instance, according to the National Center for Biotechnology Information, in 2019, Many key biologics are scheduled to lose their patent by the year 2020, which will provide the opportunity to other biopharmaceutical companies to develop similar biologics. Already there are more than 100 Indian biopharmaceutical companies are engaged in manufacturing and marketing of biosimilar. The market in Americas is projected to have a steady growth rate during the forecast period owing to an increase in chronic diseases and well-developed healthcare system. The market in the Middle East & Africa is projected to account for the least share of the global market due to low disposable income in the region.
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