The global biosimilar market was valued at USD 4.49 billion in 2017 and is anticipated to reach USD 22.43 billion by 2023 at a CAGR of 30.9%.
Biosimilar is a biologic medical product, which is similar to the originator biologic products. As per the European Medicines Agency (EMA), a biosimilar is biomedicine that has the same characteristics as the biomedicines licensed in the European Union (EU). For the record, early biologics, erythropoietin (EPO), insulin, and growth hormones have been invaluable for the treatment and medication of major illnesses, such as anemia, renal diseases, and diabetes. However, complex biologics, such as monoclonal antibodies (mAbs), cytokines, and therapeutic vaccines, are successfully revolutionizing cancer treatment, autoimmune disorders, and other difficult-to-treat diseases, which is further boosting the market growth. The market is majorly driven by the use of analytical and real-world data to improve biosimilar acceptance among prescribers and end-users without the need for any therapeutic equivalence tests.
The participation of the insurers, purchasers, integrated delivery networks, and physicians in quality- and outcomes-based payment structures is fueling the adoption of biosimilars. Additionally, the integrated health systems are encouraging more patients to take a paradigm shift towards the adoption of biosimilars for the treatment of several diseases.
The healthcare companies are arduously working to retain their market position by developing innovative products. The companies are also providing a number of services, including patient education, mobile apps, and financial assistance, to create a brand identity and increase the consumer base.
The global biosimilars market is segmented into product, disease, and manufacturing.
In terms of product, the biosimilars market has been categorized into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant glycosylated proteins segment has been further divided into erythropoietin, monoclonal antibodies, and others. The recombinant non-glycosylated proteins segment has been sub-segmented into insulin, granulocyte colony-stimulating factor, recombinant human growth factor, and interferons.
The recombinant glycosylated proteins segment is grabbing the highest shares in the biosimilars market. However, non-glycosylated proteins are expected to witness significant growth in the years to come.
By diseases, the market is segmented into oncology, chronic diseases, autoimmune diseases, blood disorders, growth hormone deficiency, infectious diseases, and other diseases. The blood disorder segment registered the largest share in the biosimilars market on account of the growing prevalence of blood disorders, availability of low costs biosimilars, and increasing healthcare expenditure.
By type of manufacturing, the market is bifurcated into in-house manufacturing and contract manufacturing. The in-house manufacturing segment is grabbing the largest share in the biosimilar market. This can be attributed to the growing adoption of the in-house method of manufacturing by several biosimilar manufacturers.
The U.S. is witnessing significant growth in the biosimilars market on account of increasing FDA approvals, rising healthcare expenditures, and the growing presence of leading players. In March 2015, the USFDA approved Zarixio developed by Sandoz, a biosimilar version of Amgen’s blockbuster Neupogen. On the other hand, about 19 pipeline biosimilar molecules are still in the development stage. Additionally, pending legislative decisions on data exclusivity period, naming conventions, and interchangeability are likely to impact the market growth to some extent. Some of the factors hindering the market growth include regulatory obstacles that persist along with FDA, unclear rules and regulations regarding the manufacturing of biosimilars and the need for up-gradation in therapeutic areas for the development and manufacturing of biosimilars.
Mexico is backed with the support of the government that is actively working to accelerate the biosimilars market growth. It was witnessed that demand spurred by high out-of-pocket health care spending (estimated at +90%).
The EU is dominating the biosimilars market and will continue the same during the forecast period. The region has one of the most matured biosimilars markets on account of increasing product approvals, rising R&D activities, and increasing investments in the field of biosimilars. Recently, about 19 biosimilar products got approved in four molecule classes: human growth hormone, erythropoietin, G-CSF, and tumor necrosis factor (TNF)-inhibitors and about 29 pipeline biosimilars molecules are in the clinical stage. Some of the factors driving the market include the patent expiry of biologic products, the launch of new biosimilars, surge in the incidence of chronic disorders, increasing geriatric population, and the presence of emerging players.
The EU biosimilar market was valued at around USD 2.5 billion in 2017, and it reached around USD 4 billion by 2018.
Brazil is dominating the biosimilar market in Latin America. This can be attributed to the favorable regulatory environment and the rising presence of domestic and international manufacturers. The companies are engaging in a number of mergers and acquisitions to sustain in the cut-throat competition. For instance, Sanofi’s acquired Medley and Merck’s for expanding their product portfolio. Currently, around 5 biosimilar pipeline molecules are in the clinical stage. Additionally, the low costs of medicines and favorable policies for the expansion of the pharmaceutical industry is adding fuel to the market growth.
Russia aims to boost its domestic pharmaceutical industry and increase its market share by 50% in 2020 from 20% in 2012. The increase in preferences for local producers will require full-time participation by international companies in cooperative partnerships with the Russian companies. Currently, about eight biosimilar molecules are in the pipeline clinical stage.
The Asia Pacific is the fastest growing biosimilars market and will continue the same during the forecast period. The region is backed with the presence of major contributors to the market, i.e., India, China, and Japan. In India, the biosimilar guidelines were introduced in the year 2012. The Indian pharmaceutical companies hold extensive experience in the field of generics and have successfully expanded their reach in a number of countries across the globe. Currently, around 19 biosimilars are in the pipeline development stage. Other factors driving the market include the long-standing partnerships between global pharmaceutical and domestic companies for developing innovative biosimilars of the highest quality in India.
Whereas, China lacks a bit behind in the biosimilars market due to stringent rules guarding the way of biosimilars. However, once the biosimilars receive the approval, the country is projected to witness one of the fastest growth. Additionally, the country has the presence of leading players that are actively working to develop advanced biosimilar and are engaging in several strategic mergers, collaborations, and acquisitions for the same.
South Africa is considered one of the most sophisticated markets in biosimilars on account of increasing investment from the government and key players in the field of generics, including biosimilars.
South Korea is considered as the most mature biosimilar market. The country is staying at the forefront in the biosimilars market in such a high risk and complex environment. It is backed with the immense support of the government, which is heavily investing in the field of biosimilars. In 2012, the South Korean government invested about 35% of the national medical R&D budget in the production of biosimilars. The set targets for domestic biopharmaceutical companies are projected to win around 22% of the global biosimilar market by 2020. To date, about 12 biosimilars have been approved and 36 biosimilars are still in the pipeline, including f monoclonal antibody (mAb) biosimilars with 17 mAbs.
The market for global biosimilar market is highly fragmented, with different market players operating in local regions. Some of the key players are engaging in acquisitions, collaborations, and partnerships to gain a competitive edge. On 26th September 2017, Amgen and Simcere Pharmaceutical Group announced the implementation of an agreement to co-develop and commercialize four biosimilars in China. The collaboration involves undisclosed biosimilars in the areas of oncology and inflammation. The agreement further reveals that Amgen possesses rights for the co-development, manufacturing of biosimilars, and marketing approvals applications.
On 19th December 2018, Sandoz entering into a commercialization and supply agreement with Gan & Lee that aims to bring market biosimilars versions of lispro, apart, and glargine to meet the rising demand of biosimilars. Under the terms of the agreement, Sandoz will be responsible for commercializing the medicines in the US, Switzerland, the EU, Canada, South Korea, Japan, New Zealand, and Australia.
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