Biosimilars Market Scope

According to Market Research Future (MRFR), the biosimilars market trends report has valued the industry size USD 23.97 billion in 2022 and is projected to grow from USD 29.70 Billion in 2023 to USD 161.95 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 23.90% during the forecast period (2023 - 2032).

Biosimilars Market: Latest News and Developments

·        The FDA has approved the first Humira biosimilar. Adalimumab-bwwd (Cyltezo), a Humira biosimilar, received FDA approval in January 2023 for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

·        Rising use of biosimilars in the treatment of cancer. A growing number of biosimilars are being used to treat cancer. The FDA authorised filgrastim-sndz (Zarxio), pegfilgrastim-jmdb (Onpro), and trastuzumab-dkst (Herzuma) as three biosimilars for the treatment of cancer in 2022.

Major Drivers and Impediments

Overall healthcare costs are rising owing to the high-priced pharmaceutical drugs, particularly biologics. Government bodies worldwide are concentrating on lower-priced drug synthesis. The United States spends the most on healthcare and is therefore, working on cutting down on the same. Likewise, price regulations in India and Japan for reducing the health budget have bolstered the demand for cost containment. This scenario has thrown light on the requirement for new affordable and effective therapeutics, which can be favorable for the biosimilars industry in subsequent years.

Popular biological drugs are edging towards patent cliff and this can mean substantial profits for the global market. Cost effectiveness of biosimilars, especially compared to the patented biologics and successful outcomes during clinical trials should also benefit the global market. The expanding pharmaceutical sector focused on developing biosimilar drugs can be another key growth booster in the near future.

Market Segmentation

Biosimilars industry can be considered with respect to product, applications, and end users.

The products based on which the market has been split into are recombinant glycosylated proteins, recombinant peptides, and recombinant non-glycosylated proteins. Recombinant non-glycosylated proteins are the biggest segment in the global market, thanks to the soaring cases of chronic disorders ranging from growth hormone deficiency to diabetes. As a result, recombinant non-glycosylated proteins are therapeutically used as they are readily available and are cost-effective.

Application-wise, the biosimilars market caters to chronic diseases, oncology, blood disorders, autoimmune diseases, infectious diseases, growth hormone deficiency, and more. Blood disorders have emerged as the top segment, as a result of the rising burden of the condition worldwide and the increased use of biosimilars by virtue of their low cost and the overall reduction in the treatment cost.

Major end users in the global market are hospitals and clinics as well as research institutes. Hospital and clinics are healthcare settings where treatment options and skilled professionals are easily available, and therefore, have emerged as the leading segment in the global industry.

Regional Status

Europe, MEA or Middle East & Africa along with the Americas, APAC or Asia Pacific are the primary markets for biosimilars.

Europe has taken the lead in the global market, as the region houses a vast elderly pool, with close to one fifth of the overall EU population aged more than 65 years. This has given way to several lifestyle-related disorders such as oncology, autoimmune diseases, diabetes, to name a few. Presumably, the scenario has raised the demand for biosimilars and can mean higher market growth over the next few years. In addition to this, numerous blockbuster biologics are on track to lose patent in the coming years, which should present lucrative opportunities to the biosimilar manufacturers.

The North American market displays a bright outlook and can emerge quite lucrative in the coming years, in view of the surging burden of chronic ailments in Canada and the United States. The rising spending on research activities by the healthcare agencies also fuels the market expansion in the region. Favorable reimbursement landscape in the region, especially in the US, encourages healthy competition as it results in lower incentives for the players to compete based on price.

The APAC market is slated to witness considerable growth, with China, South Korea and India offering a host of lucrative opportunities for drug development as well as commercialization. These are generics-driven countries and are known for frequently launching new and advanced manufacturing platforms, which has brought down the costs associated with biosimilar production. In the coming few years, majority of the patent expiries is touted to be in biosimilars, which is deemed as a profitable aspect by leading manufacturers and can translate into substantial market growth.

Eminent Vendors

Top global key players listed by biosimilars market outlook report include Stada Arzneimittel AG (Germany), Teva Pharmaceuticals (Israel), Biocon (India), Pfizer (US), Sandoz International (Germany), Eli Lily & Company (US), Actavis, Inc. (US), Dr. Reddy’s Laboratories (India), Cipla Ltd (India), Amgen, Inc. (US), Samsung Biologics (South Korea), Hospira Inc.(US), Mylan, Inc.(US), Celltrion (South Korea), to mention a few.

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