Biologics Contract Manufacturing Market
Number of pages: 100 | Report Format: PDF | Published date: April 05, 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$ 13.6 billion |
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Revenue Forecast in 2031 |
US$ 31.5 billion |
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CAGR |
9.8% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023-2031 |
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Historical Year |
2021 |
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Segments Covered |
Product, Indication, 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 Biologics Contract Manufacturing market was valued at US$ 13.6 billion in 2022 and is expected to register a revenue CAGR of 9.8% to reach US$ 31.5 billion by 2031.
Biologics Contract Manufacturing Market Fundamentals
A biological drug is created using a living structure, such as a plant, animal, or microbial cell. The majority of biologics are composed of multiple, extremely complicated molecules. Recombinant DNA technology is used to create a large number of biologics. Cancer, autoimmune conditions, and viral diseases are just a few of the many illnesses that are frequently treated with biologics. Several biopharmaceutical contract manufacturing organizations provide services ranging from drug production to drug manufacturing for proteins/peptides, antibodies, vaccines, and other biological substances. Nanoparticles, rDNA, synthetic vaccines, fusion proteins, soluble receptors, immunoconjugates, and immune therapeutics are some new biologic products. In addition, vaccines, cell/tissue treatments, growth factors, interferon, liposomes, antibodies, coagulation proteins, fusion proteins, enzymes, hormones, interleukins, and peptides are other commonly available biologic drugs.
Biologics frequently cost higher than conventional small-molecule medications and need specialized facilities and tools to produce them. As a result, pharmaceutical companies may find it more cost-effective to outsource biologics manufacturing to skilled contract manufacturing organizations. These organizations have the knowledge and know-how to guarantee that biologics are created, managed, and stored by regulatory requirements. By undertaking this, pharmaceutical firms can ensure the quality and safety of their biological products while concentrating on other key competencies.
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Biologics Contract Manufacturing Market Dynamics
The global biologics contract manufacturing market revenue is driven by the rising use of cutting-edge biological production technologies, increased R&D activities by pharmaceutical and biopharma businesses, and supportive laws for clinical trials in developing countries. According to the 19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production 2022, biopharmaceutical contract manufacturing became a US$ 14 billion business since 86.9% of biopharmaceutical companies outsource at least some of their operations. By spending resources to develop unique skills, biopharmaceutical contract developing and manufacturing organizations are implementing cutting-edge technology.
Biologics frequently cost more than typical small-molecule medications because they must be produced in specialized centers with specialized technologies. As a result, pharmaceutical companies opine that hiring competent contract manufacturing companies to produce their biologics is more economical. Pharmaceutical companies can also avoid costly capital investments in biologics facilities and equipment by outsourcing biologics production to contract manufacturing organizations. Due to this strategy, they can concentrate on other areas of drug development, such as research and clinical trials, which allows them to utilize their resources more effectively.
Previously, only a few businesses could in-house manage the entire biologics manufacturing process. This has significantly altered in recent years due to the proliferation of biologics-manufacturing businesses on the market. Researchers now have many opportunities to examine hybrid structures that combine biologics with clearly defined chemical entities, which have also altered how diseases are treated. Biologics have become very successful owing to the quick advancements in biotechnology. Because biologics can interact with difficult-to-reach targets that small molecules have been able to avoid, the future growth potential looks lucrative.
Osteoarthritis, tendon injuries, and chronic wounds are just a few diseases that human biologics have shown promise in addressing. Using autologous biologics may lessen the requirement for intrusive procedures and long-term drug use. According to the statistics from the IQVIA Institute, biological drugs made up 2% of all prescriptions written in the United States in 2017 but 37% of all net drug spending. Small molecules used in traditional remedies have comparatively straightforward chemical structures. Biologic drugs (or big molecules), like monoclonal antibodies, are complex proteins made in living cells and are more expensive to produce. Therefore, during the forecast period, the high cost of biological drugs is expected to restrain the global market. Despite this, biological drugs are gaining popularity due to their success in treating difficult-to-treat conditions like cancers and autoimmune diseases. Additionally, many biologics' patent protection has already lapsed or will do so soon, opening the door for developing biosimilars, which are anticipated to lower prices and broaden access to these life-saving treatments.
Biologics Contract Manufacturing Market Ecosystem
The global biologics contract manufacturing market is analyzed from three perspectives: product, indication, and region.
Biologics Contract Manufacturing Market by Product
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Based on the products, the global biologics contract manufacturing market is segmented into recombinant proteins, monoclonal antibodies, vaccines, biosimilars, and others.
The biosimilars segment accounted for the largest revenue share of the global biologics contract manufacturing market in 2022. Due to their affordability, biosimilars are a common option for treating many chronic and uncommon diseases worldwide. Therefore, cost-effectiveness is a major factor boosting product demand in this industry. Additionally, biosimilars could broaden patient access to therapies that could save their lives, particularly in low- and middle-income nations where the price of biologics is often prohibitive.
It is expected that competitive rivalry will further drive down costs and increase accessibility as more biosimilars hit the market. Some market segments are expected to expand profitably depending upon how the products are implemented currently and how they are expected to expand. Monoclonal antibodies are seen to have high market penetration in the present market compared to other market segments. The variety of products can explain this large share in this category and the ongoing investments made by market participants to enhance the efficacy of monoclonal antibodies in various disease-treating modalities.
On the other hand, since greater resources are being spent on research and development to improve vaccines, this segment is expected to generate more revenue in the future. A wide range of possibilities has been made possible by collaborations and ongoing research projects that seek to produce biological products like recombinant proteins, antisense, RNAi, molecular therapy, etc.
Biologics Contract Manufacturing Market by Indication
Based on the indications, the global biologics contract manufacturing market is segmented into oncology, immunology, cardiology, hematology, and others.
The oncology segment accounted for the largest revenue share of the global biologics contract manufacturing market in 2022. The worldwide oncology segment is expanding due to the rising cancer burden caused by rising alcohol and tobacco use. According to the World Health Organization, cancer is one of the leading causes of death worldwide, projected to increase by 50% in the next two decades. This growth is expected to fuel demand for oncology drugs and therapies. Therefore, it is anticipated that the rising incidence of cancer would encourage the use of effective and affordable treatments everywhere, thereby fostering the expansion of the global biologics contract manufacturing market.
The increasing demand for personalized medicine and targeted therapies is also expected to drive the revenue growth of the biologics contract manufacturing market. Moreover, the growing trend of outsourcing biologics manufacturing by pharmaceutical and biotechnology companies to reduce costs and focus on core competencies is further expected to boost market revenue growth. The market revenue is also expected to grow due to increased government and non-profit initiatives to raise awareness about early cancer treatment. Technological advancements in biologics research will likely lead to the development of new and innovative therapies, further fueling biologics contract manufacturing market revenue growth. However, stringent regulatory requirements and high capital investments may somewhat challenge market revenue growth.
Biologics Contract Manufacturing Market by Region
Based on the region, the global biologics contract manufacturing market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounted for the largest revenue share of the global biologics contract manufacturing market in 2022. This revenue growth is primarily due to increased outsourcing operations in North America. Several key regional players compete for higher market revenue shares by introducing cost-effective and high-quality products. Furthermore, the increasing adoption of advanced technologies such as artificial intelligence and machine learning in outsourcing services is expected to drive regional market revenue growth. This trend will likely generate lucrative opportunities for market participants in the coming years. In the years to come, it is also expected that the research and production of advanced therapies will accelerate market growth in North America.
On the other hand, during the forecast period, the Asia Pacific market is anticipated to experience the fastest growth rate. The regional expansion can be attributed to the regulatory agencies for biologics changing the criteria for clinical trial assessment in accordance with international standards. Additionally, Asia Pacific has lower clinical trial costs compared to other areas. Therefore, these factors are expected to boost regional market revenue expansion during the forecast period.
Competitive Landscape of Biologics Contract Manufacturing Market
Notable players in the global biologics contract manufacturing market include:
Strategic Development in Biologics Contract Manufacturing Market
Biologics contract manufacturing companies offer manufacturing services for biological and medical products to pharmaceutical and biopharmaceutical companies.
The increased prevalence of different chronic diseases and increased demand for advanced therapeutics are the key factors driving the revenue growth of the global market.
The high cost and manufacturing complications are restraining the revenue growth of the global biologics contract manufacturing market.
Key companies operating the global biologics contract manufacturing market are Lonza Group, Samsung Biologics Co. Ltd., Patheon, Cambrex Corporation, and Siegfried Holding AG.
The global biologics contract manufacturing market is expected to grow at a revenue CAGR of 9.8% during the forecast period from 2023 to 2031.
*Insights on financial performance are subject to the availability of information in the public domain