2023-2029 is the forecast period in the market report.
Biologics are genetically modified proteins derived from human genes. Biologic drugs target specific parts of the human immune system. Biologics are fundamentally different from chemically synthesized drugs. There is a wide range of biological products, including blood components, somatic cells, recombinant gene therapies, vaccines and allergens. Biological products consist of nucleic acids, proteins and tissues from living organisms. These products are isolated from sources such as animals, humans and microbes using biotechnological methods. This product is very sensitive to contamination, so the development of biological contracts shows a strong demand from pharmaceutical companies. Also, an increase in funding for research and development in biotechnology, increase in in outsourcing of R&D activities by pharma and biopharma companies are key factors that are anticipated to provide ample new growth opportunities for the market in the upcoming years.
Factors such as the increasing adoption of advanced technologies for organic production, growth in mergers and acquisitions activity, an increase in the outsourcing of R&D activities by pharmaceutical and biopharmaceutical companies and a favourable regulatory environment for clinical trials in developing countries are important factors that are expected to drive the growth of the market.
The prevalence of diseases such as neurological diseases, gynaecological diseases, cancer, eye diseases and cardiovascular diseases is steadily increasing. For example, according to the WHO, cancer is one of the leading causes of death worldwide and will be responsible for more than 10 million deaths in 2020. According to Cancer Tomorrow, the number of cancer cases is expected to increase in the coming years. Cancer Tomorrow estimates that over 19.3 million cancer cases were reported in 2020 and that number is expected to reach 30.2 million by 2040. In these cases, the healthcare contract development and manufacturing organizations (CDMOs) play a vital role in patient care as many biopharmaceutical companies seek to develop new therapies or first-class products for the treatment of disease. This is expected to boost the growth of the market in the upcoming years.
The market is expected to have new lucrative opportunities with the technological advancements, innovations and ongoing R&D activities involved in the biologics contract development sector, which is expected to provide ample new growth opportunities for the market during the forecast period. Also, a growing number of mergers and collaborations have spurred pharmaceutical and biopharmaceutical outsourcing as major industry players expand into developing regions and this factor is expected to provide different new growth opportunities for the market over the projected time period.
The market has major restraining factors like certain side effects associated with biologics such as respiratory infections, pneumonia, urinary tract infections, skin infections etc. Also, the high cost associated with biologics production methods and lack of awareness regarding the use of these products are expected to act as a hurdler for the market’s growth over the forecast period. Besides, the shortage of resources in underdeveloped nations is another factor that is expected to restrain market growth.
The cost of biopharmaceuticals and biomedical products is quite high as they require extensive research and development procedures and their manufacture is a very complex process that requires highly skilled scientists. Also, the lack of skilled work force in low-income countries is expected to be a major challenge for the market’s growth over the forecast period.
The report provides an in-depth analysis of the global Biologics Contract Development market, market size, and compound annual growth rate (CAGR) for the forecast period of 2022-2028, considering 2021 as the base year. With increasing demand for biologics contract development in various applications has led to increasing demand and is expected to witness growth at a specific CAGR from 2021-2028.
The global Biologics Contract Development market comprises of different market segments like source, product, indication and geography.
By source, the Biologics Contract Development market includes the key segments of
The mammalian source segment is expected to witness a high CAGR during the forecast period. This is because using mammalian cells for protein expression has the main advantage of producing mammalian proteins with correct post-translational modifications that provide native structure. Mammalian cells such as Chinese Hamster Ovary (CHO) cell lines are among the most preferred and approximately 70.0% of therapeutic proteins are developed from CHO cells.
The microbial sources segment is expected to witness significant growth over the estimated time period. Microbial systems are widely used to produce recombinant therapeutic proteins. To date, approximately 650 protein drugs have been approved worldwide, of which approximately 400 are derived from recombinant microbial technologies. Additionally, approximately 48.0% of biologics approved for manufacturing are made from microbial sources, which are primarily used by contract development and manufacturing organizations to manufacture cytokines, hormones, enzymes, and monoclonal antibodies. These factors are expected to support the growth of the segment.
By product, the Biologics Contract Development market is segmented into
The cell line development segment is further segmented into microbial, mammalian and others. The process development segment is further segmented into upstream, downstream, by product and others. The upstream sub-segment is further classified into microbial, mammalian and others. The downstream sub-segment is further classified into Impurity, isolation, and identification, physicochemical characterization, pharmaceutical analysis and others. The by-product sub-segment is further classified into monoclonal antibodies, recombinant proteins and others.
The process development segment is expected to lead the development market over the forecast period. The upstream followed by the downstream development sub-segment is expected to grow at a high rate. Upstream process development primarily involves selecting the correct cell line, culture medium, bioreactor systems and operating parameters. Upstream process development services are provided by most organic production organizations and are very specific to customers' business needs, legal constraints and project timing.
The cell line development service is expected to have a significant growth over the projected time period. According to NCBI, cell lines are rigorously used to test vaccine production, drug metabolism and cytotoxicity, generate artificial tissues (e.g., artificial skin), study gene function, produce antibodies, and synthesize biological compounds. . The use of cell lines has revolutionized scientific research. The development of efficient cell lines is needed as they can be used to study expected clinical outcomes. Producing an efficient cell line affects productivity and product quality. The different characteristics of the cell line also improve process development to achieve targeted productivity and quality.
The Biologics Contract Development market has major indications like
The oncology segment is expected to dominate the market over the forecast period. Because cancers are formed by a malfunctioning immune system, biological therapy is said to re-establish, stimulate, or amplify the immune response, which is why many pharmaceutical and biopharmaceutical companies are willing to invest in new cancer-related treatments. Cancer can spread to any organ in the body, so there is a great need for treatment, which in turn drives investments in research and development and outsourcing by various companies.
The immunological diseases segment is expected to grow at the fastest rate during the forecast period. Immunological diseases or conditions caused by immune system dysfunction include diseases such as asthma, allergies, autoimmune diseases, and others. According to the NCBI, autoimmune inflammatory diseases affect approximately 7.6% to 9.4% of the world's population, particularly young and middle-aged women. Biological products have gained significant importance in the treatment of diseases such as arthritis, rheumatological diseases and others. The high efficacy and safety of these drugs are likely to increase the demand for biologics to treat immunological diseases, which is expected to have a positive impact on the market.
The global Biologics Contract Development market is studied for the following regions
North America is expected to grow at a high growth rate over the forecast period. This is attributed to the increase in investment in research and development and the local presence of global players and their efforts to obtain new patents. The growth of contract development organizations (CDOs) is mainly attributable to growing outsourcing activities and the increase in the number of clinical trials in the region.
In Asia Pacific, the market is expected to record the highest growth over the forecast period. Various regulatory changes aimed at modifying the standards for the evaluation of clinical trials in line with global requirements are attracting biotech companies to invest in the Asia-Pacific region. Asia-Pacific countries have a large pool of patients and potential for advanced medical expertise. These factors mentioned above are expected to contribute to the growth of the market in the region.
The exclusive COVID-19 impact analysis report by Axiom MRC provides a 360 degree analysis of micro and macro-economic factors on the global Biologics Contract Development market. In addition, complete analysis of changes on the global Biologics Contract Development market expenditure, economic and international policies on supply and demand side. The report also studies the impact of the pandemic on global economies, international trade, business investments, GDP and the marketing strategies of key players present in the market.
The demand for medical supplies to treat the infected population has increased. Respiratory support devices such as nebulizers, life support devices, oxygen generators, and monitors are among the most commonly used medical devices in primary care settings. Additionally, COVID-19 has led to a surge in demand for medical supplies such as personal protective equipment such as masks, gloves, and goggles. Due to the increasing number of COVID-19 cases around the world, the need for medical care is increasing, both from medical professionals and from the civilian population for preventive measures. Manufacturers of these products have an opportunity to take advantage of this increased demand for medical supplies to ensure an adequate and continuous supply of the personal protective equipment market. Therefore, COVID-19 is expected to have a significant impact on the biologics contract development market.
The competitive landscape analysis of Biologics Contract Development market is primarily focused on expanding the global growth of biologics contract development with new product innovation, business expansion, increasing presence of a range of manufacturers operating in Biologics Contract Development market has led to growing demand for the market. Besides, the market offers a range of products in different application to fulfil the required demand of consumer which is further contributing healthy growth in the market.
The key players studied in market are
July 2022: CRO Novotech had expanded its presence in the U.S. by acquiring a US-based CRO, NCGS, which provided research services in hematology, infectious disease, oncology, and the CNS.
April 2022: Labcorp had collaborated with, Xcell Biosciences, in order to support the company in developing cell and gene therapies for treating Parkinson’s, cancer, and other rare diseases.
By source, the Biologics Contract Development market includes the key segments of microbial, mammalian and others. The mammalian segment is expected to dominate the market over the forecast period. By product, the Biologics Contract Development market is segmented into Cell Line Development and Process Development. The cell line development segment is further segmented into microbial, mammalian and others. The process development segment is further segmented into upstream, downstream, by product and others. The process development segment is expected to lead the market for software development over the forecast period. By indication, the Biologics Contract Development market is segmented into oncology, immunological disorders, cardiovascular disorders, haematological disorders and others. The oncology segment is expected to lead the Biologics Contract Development over the estimated time period. The global Biologics Contract Development market is studied for the following region North America, Europe, Asia-Pacific and Rest of the world (RoW). North America is expected to grow at a high growth rate over the forecast period.
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Mode of Operation
|Market Players and its Competitors:
Siegfried Holding AG
Fujifilm Holding Corporation
Thermo Fisher Scientific, Inc.
Samsung Biologics Co., Ltd.
Bionova Scientific, Inc.
What would be forecast period in the market report?
2023-2029 is the forecast period in the market report.
Which is the leading indication segment for Biologics Contract Development market?
Oncology segment has accounted the major market share, and is expected to witness the growth at highest pace during the forecast period.
Which region is gaining majority of market share during the forecast period (2023-2029)?
North America is expected to gain major market share during the forecast period (2023-2029).