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. Contract manufacturing organizations, particularly for R&D and clinical trials, are making product manufacture, more efficient and often less costly. In addition to that, the use of single-use bioreactors is effectively reducing the manufacture facility cost. This option is more viable for smaller and low-funded companies for their in-house candidate product manufacturing needs, whereby, the companies can avoid $50-$150 million facility costs for construction of fixed, dedicated stainless steel bioreactor-based bioprocessing systems and outsource their manufacturing requirements to CMOs which use single-use facilities which typically cost $25-$40 million for commercial manufacture.
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There is a continued growth of the biopharmaceutical market which is expected to nearly double in the next 10 years. 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 a high risk of developing chronic diseases such as cancer and arthritis and these diseases are being precisely targeted using biopharmaceuticals. Many blockbuster drugs losing their exclusivity are also giving room for many biosimilar (and bio-betters) companies to enter into the world’s biopharmaceuticals market subsequently attracting many CROs, CDMOs, and CMOs to enter into the picture. Hence, there is every reason to assume that future growth in biopharmaceutical outsourcing will continue at a minimum of 14% in western countries to about 18% in Asian countries.
Nowadays CMOs are gaining much prominence due to increased demand for the clinical and commercial supply of biologics. Such prominence is achieved mainly through capacity expansions or more easily through mergers and acquisitions. In October 2018, Boehringer Ingelheim, is one of the worlds’ largest manufactures of biopharmaceutical, completed the expansion of biopharmaceutical facility by increasing capacity of bioreactor to 290,000L, now company is well positioned to manufacture future biopharmaceutical medicines, both from its own research pipeline and as contract manufacturer for other pharmaceutical and biopharmaceutical companies. Contract manufacturing services are mainly benefitting the small-scale companies, which lack the facilities for the bio-manufacturing and also intend to not invest in fixed assets like steel bioreactors and bioprocessing facilities thus giving an opportunity for the CMOs to gain market presence.
The contract biomanufacturing global market is dominated by North American region commanded the largest revenue in 2018 and expected to grow at a double digit CAGR according to IQ4I estimation. The Asia Pacific region is witnessing huge growth opportunities in terms of biologics outsourcing and many local contract manufacturing organizations are taking the lead in making this region the most sought after destination for biologics outsourcing. Some of the reasons why countries such as China and India are favourite destinations for such projects include the lower cost of labour, higher technical expertise and favourable government regulations in countries such as China. The Asia-Pacific is expected to grow at highest double digit CAGR from 2018 to 2027.
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The global bio-manufacturing outsourcing market is driven by factors such as globalization of bio-manufacturing facilities, increased funding from private venture capitals and government organizations, increasing outsourcing budgets and the emergence of latest technologies such as single-use bioreactors. An example of such investment includes WuXi Biologics, a contract development and manufacturing organization invested $240 million in a 25-acre site which is located in Shijiazhuang for the development of labs, as well as clinical manufacturing capabilities with a 5,000L bioreactor and 48,000L bioreactor for commercial manufacturing. There are restraints and threats as well which could potentially hamper the biomanufacturing outsourcing market. These include unequal distribution of biomanufacturing capacities around the globe which could pose capacity constraints in future, Stringent regulatory affairs and mandatory cGMP certifications which could make the drug manufacture process to further low down, outsourcing being restricted to only small and mid-sized companies are another major restraint where large companies are looking for CMOs as an option only when there are insufficient capabilities internally.
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