Biological APIs Market
Number of pages: 100 | Report Format: PDF | Published date: April 21, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
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Report Attribute |
Details |
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Market Size Value in 2022 |
US$ 60.10 billion |
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Revenue Forecast in 2031 |
US$ 122.97 billion |
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Growth Rate |
8.3% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023 to 2031 |
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Historical Year |
2021 |
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Segments Covered |
Product Type, Therapy Area, Application, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global biological APIs market was valued at US$ 60.10 billion in 2022 and is expected to register a revenue CAGR of 8.3% to reach US$ 122.97 billion by 2031.
Biological APIs Market Fundamentals
Biological APIs are the active ingredient, typically a large molecule, such as a protein or a nucleic acid, produced using biotechnology techniques. These techniques may involve genetically modifying cells, such as bacteria or mammalian cells, to produce the desired molecule. Other examples of biological APIs include insulin, which is used to treat diabetes, and erythropoietin, which is used to stimulate the production of red blood cells. Other examples include monoclonal antibodies, used to treat cancer and autoimmune diseases, and vaccines, which contain a biological API that stimulates the immune system to produce an immune response against a specific pathogen. The production of biological APIs is a complex process that requires careful control of many factors, including the culture conditions of the cells used to produce the molecule, the purification methods used to isolate the molecule, and the formulation of the final drug product. The biological API market is highly competitive and dominated by a few large players, including Roche, Sanofi, and Pfizer. The market is also highly regulated, with stringent quality and safety standards enforced by regulatory agencies such as the FDA and EMA.
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Biological APIs Market Dynamics
Chronic diseases such as cancer, diabetes, and cardiovascular diseases are rising globally, increasing the demand for biological drugs to treat these conditions effectively. The global prevalence of chronic diseases in 2021 is high and continues to rise. According to the World Health Organization (WHO), chronic diseases account for the majority of deaths worldwide, with an estimated 41 million deaths per year, or 71% of all deaths globally. Biological drugs are often used in personalized medicine, which involves tailoring treatments to individual patients based on their genetic makeup, lifestyle, and other factors. This trend drives the development of new biological APIs that can be used in personalized medicine. Advances in biotechnology have led to the development of new techniques for producing biological APIs, such as gene editing and synthetic biology. These advancements have made it easier and more cost-effective to produce biological drugs, which has led to an increase in their availability. Governments worldwide are investing in researching and developing new biological drugs to address public health challenges. This funding has led to the development of new biological APIs and increased the availability of funding for clinical trials. Emerging markets such as China and India have seen strong demand for biological drugs due to their large and growing populations, increasing healthcare spending, and rising prevalence of chronic diseases. Overall, the global biological APIs market revenue is expected to be driven by these factors during the forecast period.
However, there are a few factors that restrain the revenue growth of the global biological APIs market. The development and production of biological APIs are subject to rigorous regulations and guidelines, which can increase the time and cost required for bringing new products to market. This could limit the number of market players and slow innovation.
Biological APIs Market Ecosystem
The global biological APIs market is analyzed from four perspectives: product type, therapy area, application, and region.
Biological APIs Market by Product Type
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The global biological APIs market is segmented into proteins, antibodies, nucleic acids, and others based on product type.
The antibodies segment accounts for the largest global biological APIs market revenue share. Recently, there has been increasing interest in using antibodies as therapeutics to treat various diseases, including cancer, autoimmune disorders, and infectious diseases. The systems used to produce antibodies offer several advantages, including lower production costs and the ability to produce antibodies in enormous quantities. For instance, Adalimumab is a monoclonal antibody that binds to tumor necrosis factor-alpha (TNF-α), a protein that contributes to inflammation. It treats various inflammatory conditions, such as rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease.
Biological APIs Market by Therapy Area
Based on therapy area, the global biological APIs market is segmented into oncology, cardiovascular diseases, diabetes, autoimmune diseases, and others
The oncology segment accounts for the significant global biological APIs market revenue share. According to the World Health Organization (WHO), cancer is one of the leading causes of morbidity and mortality worldwide, with approximately 10 million deaths in 2020. In oncology, biological products are often used to target cancer cells specifically. These can include monoclonal antibodies, cytokines, and other biological molecules interacting with cancer cells and helping destroy or slow their growth. Biological APIs are also commonly used in combination therapies, which involve using multiple drugs or treatments simultaneously to improve efficacy and reduce side effects. Overall, the use of biological APIs in oncology has revolutionized cancer treatment and has led to significant advances in the field.
Biological APIs Market by Application
Based on application, the global biological APIs market is segmented into vaccines, interferon therapies, monoclonal antibody(mAb) therapies, insulin therapies, and growth hormones.
The monoclonal antibodies (mAb) segment accounts for a significant revenue share in the global biological APIs market. Monoclonal antibody therapy has become an important tool in treating many diseases, including cancer, autoimmune diseases, and infectious diseases like COVID-19. Biological APIs, including monoclonal antibodies, have revolutionized how we treat many diseases and significantly improved patient outcomes.
Biological APIs Market by Region
Based on region, the global biological APIs market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounts for the largest global biological APIs market revenue share. Chronic diseases such as cancer, diabetes, and cardiovascular diseases are major health concerns in North America. The prevalence of these diseases is increasing due to factors such as aging populations, unhealthy lifestyles, and genetic predisposition. Cardiovascular disease is a leading cause of death in North America, accounting for nearly 30% of all deaths. Also, cancer is North America’s second leading cause of death, accounting for approximately 21% of all deaths. The most common types of cancer in North America include breast, lung, prostate, and colorectal cancer. This has led to a growing demand for biological drugs that can effectively treat these conditions. Personalized medicine is an emerging field that tailors treatments to individual patients based on their genetic makeup, lifestyle, and other factors. Biological drugs are often used in personalized medicine, and the demand for such drugs is increasing in North America as healthcare providers seek to provide more targeted and effective treatments. Government bodies in North America provide significant funding for the research and development of new biological APIs. This funding supports the development of new drugs and technologies, as well as clinical trials to test the safety and efficacy of these drugs. The pharmaceutical industry in North America is a major consumer of biological APIs. Many pharmaceutical companies are investing in the development of biological drugs, which is driving the demand for biological APIs in the region. In 2020, in the United States, AbbVie launched Skyrizi (risankizumab), a biologic drug used to treat psoriasis. Overall, the biological APIs market revenue of North America is expected to continue to grow during the forecast period, driven by these and other factors.
Europe accounts for the second largest global biological APIs market revenue share. The prominent players in the area with increased financing for research programs are the factors driving the regional revenue growth. This revenue growth is expected to be significantly fueled by the expansion of R&D initiatives by pharmaceutical and biopharmaceutical firms. For instance, a report from the European Federation of Pharmaceutical Industries and Associations (EFPIA) claims that the value of Europe’s entire pharmaceutical production in 2019 was USD 344,837.0 million. These tendencies are expected to fuel the revenue growth of the global biological APIs markets in the area.
Asia Pacific is expected to record a significant revenue CAGR in the global biological APIs market. The region is expected to register significant revenue growth due to the increasing demand for drugs and medicines, a large population base, and a rise in chronic diseases. Countries like China and India are major players in this market, as they have established themselves as hubs for manufacturing generic drugs and APIs. Additionally, favorable government policies in these countries have encouraged foreign investments, further boosting the market revenue growth.
Biological APIs Market Competitive Landscape
The prominent players operating in the global biological APIs market with the largest revenue share are:
Biological APIs Market Strategic Developments
The expected size of the global biological APIs market in 2031 is US$ 122.97 billion.
The expected revenue CAGR for the biological APIs market is 8.3% during the forecast period.
Pfizer Inc., Sanofi SA, GlaxoSmithKline plc, AbbVie Inc., and Boehringer Ingelheim BioXcellence are key players in the biological APIs market.
The Asia Pacific region is expected to register a high revenue CAGR in the global biological APIs market.
The regulatory issues can limit the growth of the Biological APIs market revenue. Developing and approving new diagnostic tests can be lengthy and costly, and regulatory hurdles can slow the introduction of innovative technologies.
*Insights on financial performance are subject to the availability of information in the public domain