Market Overview:
According to the latest research report published by DataM Intelligence, the Global Biosimilars Market was valued at US$ 30.1 billion in 2022 and is projected to reach US$ 76.7 billion by 2030. The market is expected to exhibit a CAGR of 12.8% during the forecast period 2023-2030. The global biosimilars market is segmented based on product, technology, application, distribution channel and region.
North America is expected to contribute significantly to the market growth because of the region’s aging population, improved healthcare infrastructure, FDA clearance for biosimilar medications and increased illnesses such as cancer. Major players in the market include Amgen Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc., Biocon, Samsung Bioepis, Mylan NV, Celltrion, Biogen and Intas Pharmaceutical Ltd among others.
Biosimilars are biological products that are clinically indistinguishable from authorized reference biologics. They are expected to perform similarly to the reference product regarding effectiveness, safety and quality. Biosimilars treat rheumatology, cancer, hematology, gastrointestinal and endocrinology.
Market Drivers:
An increase in the number of authorized biosimilars due to improved FDA (U.S. Food and Drug Administration) review processes and manufacturing and development methodologies is expected to boost biosimilar market growth. For example, Amneal Pharmaceuticals, Inc., a pharmaceutical firm, stated in March 2022 that the U.S. Food and Drug Administration approved the Biologics Licence Application (BLA) for filgrastim-you, a Neupogen biosimilar.
The item will be offered for purchase under the RELEUKO brand. Furthermore, as manufacturers have become used to the complicated regulatory and legal frameworks connected with submitting a biosimilar application, the number of biosimilar submissions has risen.
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Market Restraints:
The time and expense of developing biosimilar drugs is a big barrier for the Biosimilars business, threatening the industry’s growth and profitability. One of the major barriers to biosimilar pharmaceutical acceptability in impoverished and underprivileged nations is the high cost of research. According to recent research, a biosimilar takes 7 to 8 years to develop and costs between $100 million and $300 million. High biosimilar drug development costs will continue to hamper industry expansion during the forecast period.
Russia-Ukraine Conflict Analysis:
The Russia-Ukraine conflict may influence the Biosimilars industry since research cooperation, investment and finance may be hampered during the geopolitical upheaval and economic uncertainty. International research cooperation and information sharing are critical for advancing biosimilar development. The conflict between institutions, corporations and researchers in Russia, Ukraine and other nations may impede or limit scientific development and dissemination.
Artificial Intelligence Impact Analysis:
Artificial intelligence (AI) is rapidly being utilized in the biosimilar business to enhance many parts of the consumer experience. AI approaches like molecular docking and machine learning may help design biosimilars. These approaches allow for the prediction of protein structures, molecular interactions and binding affinities, which aids in creating better biosimilar molecules.
AI systems may examine massive datasets, including clinical trial data, patient records and genetic information, to detect trends, estimate treatment results and improve dosage strategies. This may aid in demonstrating biosimilarity and evaluating the safety and efficacy of biosimilars.
Recent Industry Developments:
- In May 2023, Gulf Pharmaceutical Industries PJSC (Julphar), one of the Middle East and Africa’s largest pharmaceutical producers, announced today that it had entered into a strategic licensing agreement with Sunshine Lake Pharma, a Chinese pharmaceutical firm, to become the region’s first manufacturer of modern Insulin biosimilars.
- Biocon Biologics and Viatris Inc. launched Abevmy, a bevacizumab medication, in Canada in May 2022. Abevmy is a Roche biosimilar of Avastin licensed by Health Canada for four cancer indications.
Segmentation Analysis:
As per the research analysis, the global biosimilars market is segmented by product into monoclonal antibodies, recombinant human growth hormone (rhGH), insulin, anti-coagulants, erythropoietin, fusion proteins, granulocyte colony-stimulating factor, follitropin and others; by technology into recombinant DNA technology (rDNA technology) and monoclonal antibodies (MAb) technology; by application into oncology, chronic and immune diseases, infectious diseases, growth hormone deficiency, blood disorders and others; and by distribution channel into hospital pharmacies, retail pharmacies and online pharmacies.
In 2022, the oncology segment had the largest market share, accounting for nearly 30.7% of the biosimilar market. Biologic-based drugs account for around one-fourth of the global pharmaceutical market and treat various illnesses. Cancer patients who use biological medications have shown significant advances in cancer therapy and supportive care.
The number of cancer cases in India in 2022 was computed using the predicted population and the age-specific incidence rate for each unique anatomical location of cancer, according to research published in the Indian Journal of Medical Research in 2022. The estimated number of cancer incidents in India for 2022 was discovered to be 14,61,427 (the crude rate was 100.4 per 100,000).
Geographical Analysis:
The global biosimilars market is segmented into North America, Europe, South America, Asia Pacific and Middle East & Africa.
North America Biosimilars Market:
North America is expected to occupy around 38.1% of the total market share throughout the projected period. Because of the region’s aging population, improved healthcare infrastructure, FDA clearance for biosimilar medications and increased illnesses such as cancer. The elements projected to drive regional development throughout the projection period include government actions to strengthen the healthcare system.
For example, in January 2023, Amgen, a biopharmaceutical firm, debuted the autoimmune disease medicine Humira in the United States, providing healthcare providers and patients with illnesses such as psoriasis, arthritis and Crohn’s disease with a lower-cost alternative to a therapy that is now priced at roughly $90,000 per year.
Competitive Landscape:
The major companies contributing to the global biosimilars market growth include Amgen Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc., Biocon, Samsung Bioepis, Mylan NV, Celltrion, Biogen and Intas Pharmaceutical Ltd among others.
Related Reports:
- Monoclonal Antibody Therapeutics Market
- Cancer Monoclonal Antibodies Market
- Recombinant Plasma Protein Therapeutics Market
- Anticoagulation Therapy Market
- Oncology Therapy Market
Additional Benefits Post Purchase:
1) Unlimited Analyst support for a period of 1 year.
2) Any query regarding the scope offered will be addressed within 24- 48 hours.
3) An Excel sheet with market numbers will be provided separately.
The Full Report has the below insights.
- The report offers a comprehensive evaluation of the market in terms of Market Value (US$) and Y-o-Y Growth Rates (%). It does so via in-depth qualitative insights, historical data (2020-2021) and verifiable market size projections (2022-2029).
- Visualize the composition of the global biosimilars market segmentation product, technology, application, distribution channel and region, highlighting the key commercial assets and players.
- By Product: Monoclonal antibodies, recombinant human growth hormone (rhGH), insulin, anti-coagulants, erythropoietin, fusion proteins, granulocyte colony-stimulating factor, follitropin and others
- By Technology: Recombinant DNA technology (rDNA technology) and monoclonal antibodies (MAb) technology
- By Application: Oncology, chronic and immune diseases, infectious diseases, growth hormone deficiency, blood disorders and others
- By Distribution Channel: Hospital pharmacies, retail pharmacies and online pharmacies
- By Region: North America, Europe, South America, Asia-Pacific and Middle East and Africa.
- Identify commercial opportunities in the global biosimilars market by analyzing trends and co-development deals.
- The report also covers data insights on various industry forces such as Porter’s five forces, regulations in each country, reimbursement scenario, technological advancements, PEST analysis and pricing analysis.
- Excel data sheet with thousands of the global biosimilars market-level 4/5 segmentation data points.
- PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study.
- Product mapping in Excel for the key product of all major market players.
- The report will provide access to approximately 50+ market data tables, 40+ figures and close to 180 pages.
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