In January 2023, Amgen Inc. launched AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab) in United States

Northbrook, IL 60062 -- (SBWire) -- 06/26/2023 --Biosimilars Market in terms of revenue was estimated to be worth $29.4 billion in 2023 and is poised to reach $66.9 billion by 2028, growing at a CAGR of 17.8% from 2023 to 2028 according to a new report by MarketsandMarkets™. Major factors driving the market growth at significant CAGR are rising incidence of chronic diseases and increasing demand of biosimilars. Furthermore, increased number of approvals and investment in research and development of biosimilars is likely to upsurge the market growth in coming years.
The biosimilars industry is poised for significant growth and innovation in the near future. Biosimilars, which are highly similar and interchangeable versions of approved biologic drugs, offer several advantages such as increased patient access to affordable treatments, cost savings for healthcare systems, and enhanced competition in the pharmaceutical market. With the expiration of patents on several high-revenue biologic drugs, the biosimilars market is expected to expand rapidly as more companies enter the space. Advances in manufacturing technologies, analytical techniques, and regulatory frameworks will drive the development and commercialization of a broader range of biosimilars across therapeutic areas. This increased competition will further drive down prices, making life-saving biologic treatments more accessible to patients worldwide. Additionally, collaborations between biosimilar manufacturers, healthcare providers, and regulatory authorities will help build confidence in the safety, efficacy, and quality of biosimilars, fostering their widespread adoption. As the biosimilars industry matures, it will not only reshape the pharmaceutical landscape but also play a pivotal role in addressing the growing healthcare demands and improving patient outcomes on a global scale.

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Monoclonal Antibodies accounted for the largest share of the drug class segment in the biosimilars market in 2022.

Based on the drug class, the biosimilars market is segmented into monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, anticoagulants and other drug class. The monoclonal antibodies product segment accounted for the largest share. It is expected to dominate the market throughout the forecast period. Declining of the monoclonal antibodies biosimilars owing to increased competition is likely to have positive impact on the market growth. Rising prevalence of cancer is also one of the major factor increasing demand of mabs is boosting growth of the segment.

The oncology segment accounted for the largest share of the indication segment in the biosimilars market in 2022.

Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases; chronic diseases, blood disorders; growth hormone deficiency; infectious diseases and other indications. Oncology accounted for the largest share of the market in 2022. Rising incidence of cancer coupled with increased demand for the cost effective biosimilars is driving the segmental growth. Furthermore, increased research and huge number of products under clinical trials is further expected to project growth at faster pace.

Asia Pacific is likely to grow at the highest growth rate during the forecast period.

Based on the region, the global biosimilars market is segmented into North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. Europe is the largest regional segment followed by Asia Pacific. The Asia Pacific region is estimated to grow at the highest CAGR in the biosimilars market during the forecast period. The emergence of new players the market, increased approvals for biosimilars in the region and loss of patent exclusitivity are some of the major factors propelling the market in Asia Pacific region.

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Biosimilars Market Dynamics:

Drivers:
1. Increasing demand for biosimilars
2. Launch of novel biosimilars
3. Rising geriatric population and chronic disease incidence
4. Abbreviated regulatory approval process and interchangeability

Restraints:
1. Complexities in manufacturing

Opportunities:
1. Emerging markets
2. Patent expiries of blockbuster biologics and research into new indications

Challenges:
1. High competition and regulatory challenges

Key Market Players:
Some of the prominent players in the biosimilars market are Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy's Laboratories Ltd. (India), Amgen, Inc. (US), Eli Lilly and Company (US), and among others.

Report Link: Biosimilars Market

Recent Developments:

- In January 2023, Amgen Inc. launched AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab) in United States

- In October 2022, Biocon and Yoshindo Inc., entered into an agreement for commercializing Biocon's pipeline products ustekinumab and bDenosumab in Japan

Biosimilars Market Advantages:

- Increased Access to Affordable Treatment: Biosimilars provide a more cost-effective alternative to expensive biologic drugs. By offering comparable efficacy and safety profiles at a lower price, biosimilars expand patient access to essential treatments. This is particularly significant in the case of chronic diseases where biologics play a vital role but may be financially burdensome for patients and healthcare systems.
- Cost Savings for Healthcare Systems: The introduction of biosimilars creates competition in the pharmaceutical market, leading to reduced prices for both biosimilars and reference biologics. This drives down healthcare costs and allows for more efficient allocation of resources within healthcare systems. The cost savings generated by biosimilars can be redirected towards improving access to other medical interventions or expanding healthcare services.

- Market Competition and Innovation: Biosimilars foster competition among pharmaceutical companies, encouraging innovation and the development of new therapeutic options. As more manufacturers enter the biosimilars market, it stimulates research and development efforts to improve manufacturing processes, enhance product quality, and explore novel therapeutic applications. This competition ultimately benefits patients by expanding treatment options and promoting continuous advancements in biologic therapies.
- Regulatory Framework and Quality Standards: The biosimilars market is supported by robust regulatory frameworks that ensure the safety, efficacy, and quality of these products. Stringent regulations guide the development, manufacturing, and approval processes of biosimilars, ensuring they meet rigorous standards and are comparable to reference biologics. This provides healthcare professionals and patients with confidence in the reliability and performance of biosimilars.

- Healthcare Sustainability and Patient Outcomes: The increasing adoption of biosimilars contributes to the long-term sustainability of healthcare systems. By reducing the financial burden associated with expensive biologic drugs, biosimilars enable healthcare providers to allocate resources more efficiently, ensuring that patients have access to vital treatments. This, in turn, can lead to improved patient outcomes, better disease management, and enhanced overall healthcare effectiveness.

The biosimilars market's advantages, including increased access to affordable treatment, cost savings, market competition and innovation, robust regulatory frameworks, and improved healthcare sustainability, make it a promising sector that can address unmet medical needs and drive positive change in healthcare systems globally.