Biosimilar Market exhibiting CAGR of 26.1% by 2032, due to expiring patents for blockbuster biologic | insightSLICE
The global Biosimilar market size was estimated to be US$ 29.5 billion in 2021 and is expected grow at a CAGR of 11.5% between 2023 to 2032.
A biosimilar is a biological product that is substantially comparable to an existing FDA-approved reference product and contains no biologically meaningful changes. The function and structure of both the reference product and the biosimilar are carefully examined and verified by the company to develop a biosimilar.
Properties such as purity, chemical identity, and bioactivity are compared to licensed pharmaceutical formulations to characterize biosimilars.
The maker uses these comparison tests, together with clinical testing data, to demonstrate that the biosimilar is extremely comparable to the reference standard and may thus be used in combination or as a replacement. When an existing approved drug’s patent expires, producers seek authorization from regulatory authorities to start the production of biosimilars.
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Global Biosimilar Market Key Segments:
By Product
- Monoclonal Antibodies
- Infliximab
- Trastuzumab
- Rituximab
- Adalimumab
- Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
- Insulin
- Granulocyte Colony-Stimulating Factor
- Erythropoietin
- Recombinant Human Growth Hormone
- Etanercept
- Follitropin
- Teriparatide
- Interferons
- Enoxaparin Sodium
- Glucagon
- Calcitonin
By Indication
- Oncology
- Inflammatory & Autoimmune Disorders
- Chronic Diseases
- Blood Disorders
- Growth Hormone Deficiency
- Infectious Diseases
- Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)
By Geography
- North America
- United States
- Canada
- Rest of North America
- Europe
- Germany
- United Kingdom
- Italy
- France
- Spain
- Rest of Europe
- Asia Pacific
- Japan
- India
- China
- Australia
- Rest of Asia Pacific
- Middle East & Africa
- UAE
- Saudi Arabia
- South Africa
- Rest of the Middle East & Africa
- South America
- Brazil
- Rest of South America
Because biosimilars have lower R&D expenses than novel biologic drugs, the cost of biosimilars is lower, allowing cost savings and increased accessibility to particularly successful treatment for patients. Cheaper biosimilars tend to lower the prices of reference biologics due to price rivalry among producers.
As developing and poor countries are seeing a rising demand for treatments and therapies against critical diseases, biosimilars will play a critical role in satisfying them. Due to their significant cost-to-benefit ratio, it is predicted that the global biosimilar market will have increased growth within the forecast period.
The key players of the Global Biosimilar Market are:
The major players covered in this biosimilar market report are Amgen Inc., Amega Biotech, Apotex Inc., Biocad, Boehringer Ingelheim, Biocon Limited, Coherus BioSciences, Celltrion, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Fresenius SE & Co., Intas Pharmaceuticals Ltd., Novartis AG, Pfizer Inc., Kashiv Biosciences, Teva Pharmaceutical Industries Ltd., STADA Arzneimittel AG, Gedeon Richter PLC, Samsung Biologics, Viatris Inc., mAbxience, Probiomed S.A. De C.V., Fujifilm Kyowa Kirin Biologics Co Ltd., Thermex, Reliance Life Sciences, and others.
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Driving factors for the growth of Global Biosimilar Market
The majority of today’s best-selling biologics will expire their patent rights in the coming years, opening up new chances for biosimilar pharmaceuticals. Nearly 20 cancer biologics’ patents might expire by 2023, potentially paving the way for new biosimilars in cancer.
Similar cases of patent expiration across various domains of biological treatments will propel the growth in the biosimilar drugs market for the next decade.
Advancements in biomedical technology, production and qualitative testing of newly formulated biosimilars, optimization of drugs, and reduction in side effects have ensured a faster adoption of biosimilar drugs. The companies involved in biosimilar production are also being benefited by the scale of economies of well-established treatments.
There is also an increase in investment for marketing purposes by these companies which ensures better sales and revenue growth for biosimilar products. All of these factors have resulted in an increase in the commercialization of the biosimilars market in the last few decades.
Government regulatory framework reforms and lower healthcare expenses are predicted to propel the global biosimilar market throughout the projected timeline. Fast-tracking of clinical trials, the use of bioinformatics tools for potential interactions, and better production methods have enabled a positive outlook toward biosimilar drugs by governmental agencies.
The use of immunotherapies to treat COVID-19 has opened up new opportunities to explore in the biosimilars sector. The increased availability of biosimilar healthcare insurance is also having a favorable influence on the market.
Public and clinicians’ perception of biosimilar drugs is also changing and thus ensuring a faster adoption and subsequent growth of the biosimilar market across the globe.
The increased prevalence of chronic illnesses, as well as the increasing need for their cost-effectiveness, are driving the expansion of the biosimilar industry. Regulations encouraging biosimilar use in many countries, especially in Asia and Africa, as well as simplified regulatory clearance processes, are important drivers driving biosimilar market development.
Biosimilars are used to treat a variety of ailments, notably type 1 and type 2 diabetes, hormone abnormalities, postmenopausal osteoporosis, anemia, renal disease, cancers, autoimmune diseases, infectious diseases, and psoriasis. Cancer, inflammatory diseases, hypertension, and hepatitis are among the primary target therapy categories for which numerous biosimilars are in development.
Aside from these, biosimilars for additional chronic diseases such as meningitis, prostate cancer, adult T-cell leukemia, obesity, hypertension, and hepatitis E are available and achieved significant growth in the past few years.
Future R&D investments in novel diseases where existing treatment is costly or drugs with complex manufacturing processes will increase the outreach of the biosimilar drugs market globally.
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Challenges of Global Biosimilar Market
Even if biosimilar research expenses are minimized, producing biosimilars remains a very difficult and costly procedure that necessitates large expenditures, clinical trial experience, process improvement, maintaining technical regulations, and technical skills.
Unlike in the creation of generic drugs, biosimilar producers are also expected to spend on clinical studies and post-approval safety control procedures comparable to those of original patent-holding firms.
Controlling the variability of expected developed products is another key challenge in the manufacturing of biosimilars. The manufacturing variations of end products that are exactly similar to their reference products can lead to difficulties.
Regulatory authorities may additionally demand preclinical and clinical evidence to demonstrate that the manufacturing procedure had no effect on the product’s effectiveness or safety and that there was no inconsistency between the biosimilar and the original biologic.
Biosimilar producers must compete not just with other biosimilar producers, but also with the original biologic producer and generic drugs manufacturer. As new biosimilar goods hit the market, the initial biologic company can compete by launching reformulated pharmaceuticals, second-generation treatments, dose enhancements, and economical manufacturing processes.
Biosimilars still have an unfavorable perception from physicians which impacts their prescription to a certain degree. Other factors like patent extensions and lower price differences compared to generic drugs are also prohibiting the growth of the global biosimilars market.
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