CAGR: 12%Current Market Size: USD 220 MillionFastest Growing Region: APAC
Largest Market: North AmericaProjection Time: 2023-2030Base Year: 2022
The global monoclonal antibodies market is expected to grow from USD 220 million in 2022 to USD 544.7 million by 2030, at a CAGR of 12% during the Projection period 2023-2030. The growth of the monoclonal antibodies market is mainly driven by the rising cases of chronic diseases.
Monoclonal antibodies, a kind of immunotherapy, are generated in a lab by making many copies of a single antibody. Many monoclonal antibodies have been approved by the FDA for the treatment of inflammatory, malignant, and other disorders. The rising prevalence of chronic diseases such as cancer, heart disease, and others is a major factor driving the monoclonal antibody market (mAbs). More people are likely to employ mAb treatments for targeted therapies, which will aid in market expansion. Furthermore, the COVID-19 pandemic has resulted in the development of many mAbs that combat the SARS-CoV-2 virus, making market expansion simpler. Because of their safety and effectiveness, mAbs may be used to treat COVID-19. Many of these antibodies have emergency use authorizations (EUAs) from the US Food and Drug Administration. For example, in February 2022, the US Food and Drug Administration granted Eli Lilly's bebtelovimab a EUA (European Union Authorization) to treat COVID-19 patients at risk of serious illness or who may require hospitalisation (FDA). The US Department of Health and Human Services has also stated that at least 600,000 free courses of bebtelovimab will be distributed. They may also purchase 500,000 more doses in the near future. This will allow monoclonal antibodies (mAbs) and related companies to expand in novel ways.
Sample Request: - Global Monoclonal Antibodies Market
Market Dynamics:
Drivers:
More monoclonal antibodies are projected to be approved by regulatory agencies, making it easier for novel drugs to be developed for treatment. This is projected to aid market expansion throughout the Projection period. For example, in 2018, Chugai Pharmaceutical Co., Ltd., now a subsidiary of Roche Holding AG, reported that the US Food and Drug Administration had granted Breakthrough Therapy Designation to its drug, Satralizumab. Darzalex (daratumumab), a monoclonal antibody developed by Johnson & Johnson, was approved by the US Food and Drug Administration (FDA) in May 2018 for use in combination with Velcade (bortezomib), melphalan, and prednisone to treat newly diagnosed multiple myeloma patients who are not candidates for autologous stem cell transplantation (ASCT).
Restraints:
The high price of monoclonal antibodies is projected to stifle market growth. The high expense of producing monoclonal antibodies is the primary reason why they are still employed primarily in developed countries rather than emerging or poor ones. Loss of patents by firms also limits market expansion.
Opportunities:
Over the Projection period, the rising emphasis on research and development activities is expected to give attractive growth prospects for the market. Coupled with rising government financing for the development of the monoclonal antibody sector, market participants have raised their expenditure on novel pharmaceutical research and development, as well as clinical trials, providing prospects for market expansion throughout the Projection period.
Challenges:
The market's expansion is being hampered by stringent regulatory issues linked to drug licencing and drug testing. Furthermore, several nations prohibit drug testing on humans prior to formal authorisation, posing a hindrance to the market's growth. The ability of monoclonal antibodies market products to treat previously incurable diseases has paved the way for the release of ground-breaking treatments on the market; nevertheless, these drugs are subject to a number of regulatory requirements, which provide a hindrance to the market's growth.
Segmentation Analysis:
The global monoclonal antibodies market has been segmented based on source, production type, application, and region.
By Source
The source is human, murine, humanized, and chimeric. The human segment led the largest share of the monoclonal antibodies market with a market share of around 38.56% in 2022. Human mAbs modulate effector functions efficiently and are less immunogenic than chimeric or humanised mAbs. These antibodies can be created in transgenic mice using phage display and hybridoma methods. As a result of recent advances in genetic engineering technology, the creation of fully human mAbs is expected to gain pace in the near future.
By Production Type
The production type segment is in vivo and in vitro. The in vivo segment led the largest share of the monoclonal antibodies market with a market share of around 62.67% in 2022. Because of its economic feasibility in lengthy manufacturing runs and lesser proclivity for contamination with foreign antigens. Furthermore, the development of serum-free culture media and semi-permeable membrane-based systems has boosted the viability of biomanufacturing activities and is expected to speed up segment expansion.
By Application
The application segment is neurological diseases, oncology, infectious diseases, autoimmune diseases, and others. The oncology segment led the largest share of the monoclonal antibodies market with a market share of around 35.67% in 2022. Since they bind to the proteins on the surface of cancer cells, monoclonal antibodies elicit an immune response. Cancer monoclonal antibodies may have a significant market position in the global monoclonal antibodies market due to the increased prevalence of cancer cases worldwide. Cancer is affecting an increasing number of people worldwide. According to the World Health Organization's (WHO) February 2022 estimate, cancer was responsible for roughly 10 million deaths globally in 2020. In terms of new cancer diagnoses in 2020, the most prevalent were breast (2.26 million cases), prostate (1.41 million cases), skin (non-melanoma) (1.20 million cases), lung (2.21 million cases), colon and rectum (1.93 million cases), and stomach (1.20 million cases) (1.09 million cases).
Global Monoclonal Antibodies Market - Sales Analysis.
The sale of the monoclonal antibodies market expanded at a CAGR of 11.1% from 2016 to 2022.
The rising frequency of chronic diseases such as cancer, cardiovascular disease, and others is raising demand for biologics, which is expected to drive the monoclonal antibodies (mAbs) market. Similarly, expanding applications of mAb treatments for targeted therapies, as well as rising awareness of such medicines among patients and clinicians, are likely to contribute significantly to market growth. Additionally, the COVID-19 pandemic has fueled the development of many mAbs directed against the SARS-CoV-2 virus, which has improved market expansion potential. Since mAbs are a viable alternative for COVID-19 mitigation because to their safety and effectiveness, the U.S. FDA has granted several such antibodies emergency use authorizations (EUA).
For example, the US FDA awarded an EUA to Eli Lilly's bebtelovimab in February 2022 for the treatment of COVID-19 patients who are at risk of developing severe disease or who may require hospitalisation. Furthermore, the US Department of Health and Human Services announced the provision of at least 600,000 free bebtelovimab courses, with an option to acquire 500,000 further doses in the future, creating fresh potential for mAb/immunoglobulin growth. The key advantages of mAb treatments over earlier therapies in terms of specificity, efficacy, and convenience of administration have resulted in a slew of new product launches and approvals in this field.
Thus, owing to the aforementioned factors, the global monoclonal antibodies market is expected to grow at a CAGR of 12% during the Projection period from 2023 to 2030.
By Regional Analysis:
The regions analyzed for the monoclonal antibodies market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. North America region dominated the monoclonal antibodies market and held a 38.2% share of the market revenue in 2022.
Global Monoclonal Antibodies Market - Country Analysis:
Germany's monoclonal antibodies market size was valued at USD 15.8 million in 2022 and is expected to reach USD 39.4 million by 2030, at a CAGR of 12.1% from 2023 to 2030. Because there is a well-established healthcare system, a high degree of patient awareness, and an increase in cancer research opportunities. The market is also predicted to expand as a result of major competitors such as Pfizer Inc., Amgen Inc., Merck & Co., and others. The government putting more money on cancer research is also likely to aid market growth in the region.
China’s monoclonal antibodies market size was valued at USD 17.6 million in 2022 and is expected to reach USD 44.8 million by 2030, at a CAGR of 12.4% from 2023 to 2030. More people can employ monoclonal antibody cancer therapy as people have more money to spend, and medical care is getting more attention in the region.
India's monoclonal antibodies market size was valued at USD 13.2 million in 2022 and is expected to reach USD 33.38 million by 2030, at a CAGR of 12.3% from 2023 to 2030. The rising frequency of chronic diseases such as cancer, cardiovascular disease, and others is raising demand for biologics, which is expected to drive the monoclonal antibodies (mAbs) market in the region.
Key Industry Players Analysis:
To increase their market position in the global monoclonal antibodies market business, top companies focus on tactics such as adopting new technology, mergers & acquisitions, product developments, collaborations, partnerships, joint ventures, etc.
Latest Development:
Report Metrics
Report Attribute |
Details |
Study Period |
2022-2030 |
Base year |
2022 |
CAGR (%) |
12% |
Market Size |
220 million in 2022 |
Projection period |
2023-2030 |
Projection unit |
Value (USD) |
Segments covered |
By Source, By Production Type, By Application, and By Region. |
Report Scope |
Revenue Projection, competitive landscape, company ranking, growth factors, and trends |
Companies covered |
Novartis AG, Pfizer Inc, Amgen Inc., GlaxoSmithKline plc, Daiichi Sankyo Company, Limited, Merck & Co., Inc., AstraZeneca plc, Abbott Laboratories, Bayer AG, Eli Lilly And Company, Johnson & Johnson Services, Inc., Viatris Inc., Bristol Myers Squibb, F. Hoffman-La Roche Ltd., Thermo Fisher Scientific, Inc., Biogen Inc., Sanofi S.A., Novo Nordisk A/S, and Merck KGaA. |
By Source |
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By Production Type |
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By Application |
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Regional scope |
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Scope of the Report
Global Monoclonal Antibodies Market By Source:
Global Monoclonal Antibodies Market By Production Type:
Global Monoclonal Antibodies Market By Application:
Global Monoclonal Antibodies Market By Region:
Global monoclonal antibodies market is expected to reach USD 544.7 million by 2030.
The monoclonal antibodies market is projected to have a CAGR of 12%.
Based on the production type, the monoclonal antibodies market is segmented into in vivo and in vitro.
More monoclonal antibodies are projected to be approved by regulatory agencies, making it easier for novel drugs to be developed for treatment. This is projected to aid market expansion throughout the Projection period.
Based on the application, the global monoclonal antibodies market has been segmented into neurological diseases, oncology, infectious diseases, autoimmune diseases, and others.
Leading market players active in the global monoclonal antibodies market are Novartis AG, Viatris Inc., Pfizer Inc, Amgen Inc., Merck & Co., Inc., AstraZeneca plc, Daiichi Sankyo Company, Limited, Abbott Laboratories, GlaxoSmithKline plc, Eli Lilly And Company, Johnson & Johnson Services, Inc., Bayer AG, F. Hoffman-La Roche Ltd., Biogen Inc., Thermo Fisher Scientific, Inc., Bristol Myers Squibb, Novo Nordisk A/S, Sanofi S.A., Merck KGaA among others.
Political Factors- As a government change, new government policies are implemented. Countries with a lack of political stability may have a negative influence on Pfizer's activities in that country since freshly formed governments may have an impact on Pfizer's operations. The absence of regulatory organizations can also be viewed as a significant political element affecting the expansion of a pharmaceutical corporation such as Pfizer. In the absence of regulatory authorities, the process would become more fragmented, and the company's operations would suffer as a result. A similar scenario occurred when Pfizer agreed to manufacture their COVID-19 vaccine with South Africa's Biovac Institute.
Economic Factors- The exchange rate is a critical component in determining whether a currency appreciates or depreciates. As a result, a fluctuating exchange rate can have an impact on Pfizer's investment plans because the currency value will not be consistent. Economic downturns can have a negative impact on the success of any organization. The Great Recession in the United States from 2007 to 2010 harmed every industry. Although the pharmaceutical business suffered less damage because it only produces critical pharmaceuticals, Pfizer and other leading pharmaceutical companies saw limited growth during the recession. Aside from that, high labor expenses have an impact on company operations since an increase in labour wages puts pressure on product prices. Prices rise as a result.
Social Factors- Social issues have a considerable impact on the performance of a corporation. As a result, before investing in a country, a corporation like Pfizer must conduct a demographic analysis of that country. According to the WHO, the chance of being unwell rises with age. Based on this data, Pfizer should invest more in countries with a higher proportion of elderly people, such as Japan. Pfizer can thus provide care to those in need while increasing its revenue. Before investing in a country, any multinational corporation should understand its norms. Commercial and social practices vary from one country to the next. A lack of understanding of a country's traditions and values can get a firm in hot water.
Technological Factors- People expect Pfizer to meet their expectations as technology advances. To be competitive, Pfizer must embrace new technology and fully utilize the internet and social media. Recognizing the importance of its internet presence, Pfizer developed its website, which contained detailed information about its goods as well as rare insights into the firm. Another technological issue influencing Pfizer would be competitors getting a technological advantage over Pfizer through innovation. If competitors invest more in research and development, Pfizer may be forced out of the market. To combat this threat, Pfizer has spent a considerable amount of its revenue on research and development. Pfizer spent more than 22% of their revenue on research and development in 2020.
Environmental Factors- One of the environmental issues that have a big impact on companies is climate change. Because climate change has increased the frequency of natural disasters around the world, Pfizer should ensure that its supply chain remains flexible so that there is no disruption in supplies. An increasing proportion of greenhouse gases are regarded as a major hazard to the environment. Pfizer might deploy renewable technologies in the medicine production process to reduce greenhouse gas emissions. Another environmental element influencing Pfizer's sales is the use of environmentally friendly materials in manufacturing and packaging processes. With the UN's presentation of sustainable development goals, eco-friendly items were given special consideration.
Legal Factors- Laws are implemented and applied differently in different countries, therefore Pfizer should analyze the legal concerns that would affect the company before entering a new market. Lawsuits are usually a disgrace to the company's reputation and should be avoided at all costs. Violations of the legislation can result in a lifetime ban and severe penalties. Pfizer's future depends on several legal concerns, including anti-discrimination legislation. Anti-discrimination legislation is held in high regard around the world. To avoid issues, Pfizer should ensure that there is no discrimination at Pfizer. Pfizer understands how critical it is for the corporation to follow the rules.
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