Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
Contract biomanufacturing is a widely used term to describe the manufacture of biologic molecules for various stages of drug development right from pre-clinical stage to commercial supply. The biologic drug manufacturing is a complex process involving huge capital and sound technical expertise. Many large and small pharmaceutical companies are turning to outsource the drug manufacture process to reduce capital investments on capacities and focus more on their core competencies.
The Contract biomanufacturing global market is expected to grow at a CAGR of 15.5% to reach $48.8 billion by 2027. This will be a result of continued new product approvals, expansion of indications for current products which include less-developed countries becoming more affluent and increased drug demand of the aging population in the U.S. and other major pharmaceutical markets. Aging populations are at high risk of developing chronic diseases such as cancer and arthritis and these diseases are being precisely targeted using biopharmaceuticals.
Factors affecting the biologics contract manufacturing market include drivers such as globalization of outsourcing for biomanufacturing, increased in expansion, mergers, and acquisitions, the emergence of the latest technologies such as single-use bioreactors. However, there are certain restraints that are hindering the growth of the market. These include high requirements for capital investments in setting up huge manufacturing facilities, the risk of product contamination and maintenance of production efficiency.
Contract biomanufacturing is rapidly growing in biologics outsourcing global market. Due to the high demand for biologics and customized and integrated services that the contract manufacturing organizations (CMOs) provide, the manufacturing of biologic drugs in a contracted manner is being highly adopted. The latest and cutting-edge technologies that have been installed by CMOs which include single-use bioreactors are creating huge potential for outsourcing market. The use of single-use bioreactors can reduce not only the capital cost for plant construction and commissioning but also reduces the risk of cross-contamination and the need for cleaning validation. These bioreactors also ensure rapid changeover. Examples include, In April 2018 Wuxi Biologics plans to invest $381 million to open new biomanufacturing facility in Ireland, the new facility will use multiple single-use bioreactors for commercial biomanufacturing and it is designed to be able to run continuous bioprocessing. The company intends to install a total of 48,000L fed-batch and 6,000L perfusion bioreactor.
The current situation in the biopharmaceutical industry is exciting with new technologies and market, such as continuous processing, cellular and gene therapies. For example, KYMRIAH and Yescarta are recently approved CAR T- cell therapies, which clear cancer from the patient body by killing cancer cells by using genetically modified T cells and other new technologies are creating opportunities in emerging markets.
The most of contract biomanufacturing companies have been engaged in active facility expansion. There are some key factors driving the capacity increase are a huge upcoming pipeline of biosimilar/ biobetters, and therapeutic MAbs by companies. The advancement in technology is driving the market for ADCs, the rising case of cancer are some key driving factors for the market, According to ADCs society more number of ADCs are developed in Breast cancer, Myeloma followed by Lung. There are close to 130 cancer ADCs in preclinical and Phase I stage, where newer approaches to generating ADCs with new technologies include novel conjugation and modified linkers and payload is the future potential of this evolving market. In January 2019 Lonza plans to invest 14 CHF million to expand antibody-drug conjugate (ADC) manufacturing capacity in Visp, Switzerland. This expansion shows the ADCs are one of the fastest growing segments of the pharma and biotech industry and the deployment of ADCs targeted therapies has intensified in recent years.
According to IQ4I estimation, Major Contract Biomanufacturing market players are Lonza, Boehringer Ingelheim, Catalent, and Samsung Biologics, Patheon (Thermo Fisher Scientific), Fujifilm Diosynth Biotechnologies, JSR Corporation Etc.,
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