The global oncology biosimilar market size was valued at USD 2.92 billion in 2022. It is projected to reach USD 15.62 billion by 2031, growing at a CAGR of 20.5% during the forecast period (2023-2031). Oncology Biosimilar is the identical copy of oncology biologics used for the treatment of cancer. Oncology biosimilar works against specific proteins and prevents cancer cells from growing further, assists the body in producing more blood cells to replace those lost during other cancer treatments, and enhances the body's immune system's ability to recognize and kill cancer cells. A biosimilar is based on a biologic medication that has already undergone extensive research, development, clinical testing for safety and efficacy, and FDA approval (FDA). Because the biosimilar is based on the approved drug, the biologic medication is frequently referred to as a "reference drug." The FDA must also approve the biosimilar for it to function similarly to its reference medication. Although they are not exactly the same, a biosimilar and a generic version of a biological drug are similar in some ways. The same active ingredients are used in both.
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Growing Prevalence of Cancer
Cancer develops when normal cells undergo a multi-stage process that typically progresses from a pre-cancerous lesion to a malignant tumor. In addition to the general risk accumulation, aging people tend to have less efficient cellular repair mechanisms. The risk of cancer is increasing due to smoking, drinking alcohol, unhealthy diet, sedentary lifestyle, and air pollution. Cancer risk factors can include some chronic infections; low- and middle-income nations are particularly affected by this. Globally, carcinogenic infections such as Helicobacter pylori, human papillomavirus (HPV), hepatitis B, hepatitis C, and Epstein-Barr virus were linked to 13% of cancer diagnoses in 2018. About 40% of deaths occur from cancer in developing countries and the middle-class population due to an unhealthy lifestyle. Furthermore, in 2018, lung, liver, stomach, colorectal, and prostate cancers are five types of cancers that kill men more frequently than other cancer types across the globe.
Cost Effectiveness of Oncology Biosimilar Drugs
Advances in the diagnosis and treatment of cancer have been made possible by new diagnostic technologies, such as molecular profiling. This has greatly improved clinical outcomes, such as survival rate. However, the high cost of biologic medications might make it difficult for some patients to get the best care possible. Adding less expensive biosimilar agents to the therapeutic toolbox can potentially reduce the burden on healthcare expenditure and improve access to cancer treatments. Oncology biosimilars have demonstrated comparable efficacy and safety based on clinical evidence, physicochemical quality data, and real-world settingsy.
High Sensitivity of Biosimilar
The biosimilar has higher sensitivity, due to which the temperature fluctuation can degrade the efficacy of oncology biosimilars for cancer treatment. Oncology biosimilars must be distributed with a cold chain network for theirproper maintenance. Moreover, difficulty in anticipating differences in protein folding may exist. As a result, even though the biosimilar may have the same peptide chain, its effects might differ. This makes the process of creating biosimilars difficult and potentially problematic. Thus, these factors can restrain the market growth over the forecast period.
Development of Biologics
The development of biologics—drugs derived from living organisms- is increasing, encouraging the use of biosimilars, a less expensive substitute for biologics with similar efficacy. The focus of pharmaceutical companies is quickly shifting toward creating competitive biosimilar drugs and original biologics. The shift towards biologics has been caused by a sharp decline in the rate of innovation in the field of small molecules, which has historically been the focus of pharmaceutical companies. Additionally, increased research and development (R&D) activities have improved clinical trial and new product launch success rates. For instance, the US Food and Drug Administration (FDA) authorized Amneal Pharmaceuticals, Inc.'s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar to the Roche/Genentech drug Avastin, in April 2022.
The global oncology biosimilar market is segmented by types of cancer, drug type, and distributional channels.
Based on types of cancer, the global market is bifurcated into breast cancer, colorectal cancer, blood cancer, neutropenia cancer, and non-small cell lung cancer.
Breast cancer is the highest contributor to the market and is expected to grow at a CAGR of 21.7% during the forecast, due to the highest share of breast cancer cases worldwide out of all cancers. According to the world cancer research fund international, breast cancer accounted for the majority share of 12.5% of all cancers in 2020. Ageing, obesity, alcohol abuse, family history of breast cancer, radiation exposure history, reproductive history, tobacco use, and postmenopausal hormone therapy are some factors that raise the risk of breast cancer.
Based on drug type, the global market is bifurcated into mAb, immunomodulators, hematopoietic agents, and G-CSF.
The G-CSF segment is the highest contributor to the market and is expected to grow at a CAGR of 19.3% during the forecast period. The larger share is due to the high prevalence of cancer worldwide and the adoption of G-CSF after chemotherapy to help recover white blood cells after cancer treatment. Different types of granulocyte colony-stimulating factors (G-CSF) are lenograstim, filgrastim, long-acting filgrastim, and lipegfilgrastim. The body produces growth factors as proteins. Some of them stimulate blood cell production in the bone marrow. An example of a growth factor is G-CSF, which increases the production of white blood cells in the bone marrow to lower the risk of infection following some forms of cancer treatment. Additionally, G-CSF causes some stem cells to circulate in the blood from the bone marrow. Early cells called stem cells give rise to red blood cells, white blood cells, and platelets.
Based on distribution channels, the global market is bifurcated into retail pharmacies, hospital pharmacies, and online retailers.
The hospital pharmacy segment is the highest contributor to the market and is expected to grow at a CAGR of 20.5% during the forecast period. The larger share is linked to the higher penetration of hospital pharmacies worldwide and the trust factor revolving around it.
The global oncology biosimilar market is bifurcated into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.
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North America Dominates the Global Market
North America is the most significant shareholder in the global oncology biosimilar market and is expected to grow at a CAGR of 19.7% during the forecast period. The larger share is due to the increasing prevalence of cancer in the USA due to changing lifestyles, increasing obesity, higher alcohol consumption, and smoking. According to CDC, in the year 2019, 1,752,735 new cases of cancer were reported, and 599,589 people died. Behind every 100,000 people, 439 cancer cases were reported, out of which 146 people died. The FDA has shown a dedication to assisting the United States in building and maintaining a robust biosimilar market that encourages competition between original creator biologics and biosimilars on an even playground. Current U.S.A regulatory requirements for creating and approving biosimilars, and determining interchangeability, are stringent and scientifically sound to safeguard patient safety and maintain the trust of payers and providers.
Europe's oncology biosimilar market is expected to grow significantly. The increasing prevalence of breast cancer in the U.K. and the registration of over 55,000 breast cancer cases each year in the U.K. and around 4,700 in Scotland are some of the factors expected to support the market growth in the region. The rise of breast cancer cases due to unhealthy lifestyles such as less physical activity, increasing alcohol consumption, and obesity is fuelling the growth of the oncology biosimilar market. Similarly, approximately 350 men are diagnosed with cancer each year in the U.K., escalating the market growth further.
Asia Pacific is expected to be the fastest-growing oncology biosimilar market during the forecast period 2023-2031. Breast cancer is widely spread in Asian countries owing to unhealthy lifestyles and increasing obesity, increasing demand for the oncology biosimilar market.
Furthermore, according to the World Health Organization (WHO) Cancer Report, in India, rising new cases of lung, oral, lip, throat, and neck cancers are most common in men while increasing the prevalence of cervix, breast, and ovarian cancers in women. Along with this, the increasing prevalence of cancer such as kidney, intestine, and prostate cancer in the geriatric population in China due to the rise in the smoking population is influencing the market growth.
LAMEA is expected to grow steadily owing to the undeveloped healthcare infrastructure. A lack of awareness about a healthy lifestyle is slowing cancer treatment in this region. In the Middle East and Africa, improving healthcare infrastructure and rising government initiatives in healthcare contribute to the market's growth. According to a study at the University of Sharjah, The risk of cancer in young adults in UAE is five times higher than U.K., USA, China, India, and Canada.
List of top key global oncology biosimilar market companies profiled
|Market Size||USD in 15.62 billion By 2031|
|Forecast Units||Value (USD Billion)|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
|Segments Covered||by Types of Cancer (Breast Cancer, Blood Cancer), Drug Type (mAb, G-CSF)|
|Geographies Covered||North America, Europe, Asia-Pacific, LAME and Rest of the World|
|Key Companies Profiled/Vendors||Teva Pharmaceutical Industries Ltd., Biocon, STADA Arzneimittel AG, Sandoz International GmbH, Intas Pharmaceuticals Ltd., Celltrion Inc., Pfizer Inc., Apotex Inc., Dr. Reddy’s Laboratories Ltd., and BIOCAD,|
|Key Market Opportunities||Development of Biologics|