Contract Biomanufacturing Services Global Market - Forecast to 2028
Biologics manufacturing or Biomanufacturing is primarily a recombinant DNA technology based complex process of manufacturing biopharmaceuticals using engineered or natural living expression platforms like the mammalian and insect cell cultures, unicellular microbials or the multicellular transgenic plants and animals. The biologics manufacturing is a complex process involving huge capital and sound technical expertise. Many large and small biopharmaceutical companies are turning to outsource their bioprocessing or biomanufacturing activities to reduce capital investments, to accelerate the speed to market of their innovative products and to gain a cost-effective and timely access to flexible and scalable, most appropriate biomanufacturing facilities and technologies along with skilled and technical expertise. The outsourcing process enables large pharmaceutical companies to focus on their core competencies while for small companies and virtual start-ups, it is the only way to get their innovative biological products into the market without making huge investments on building the internal manufacturing capabilities. Contract manufacturing organizations, particularly for R&D and clinical trials, are making product manufacturing process more efficient and often less costly. Also, the use of single-use bioreactors is effectively reducing the manufacturing facility cost.
The biologics contract manufacturing services global market is expected to reach $57.1 billion by 2028 growing at a low teen CAGR from 2020 to 2028. There is a continued growth of the biopharmaceutical market which is expected to nearly double in the next 10 years. This is attributed to continued new product approvals, expansion of indications for current products, increasing awareness and adoption of these advanced biological products in the less-developed countries and increasing efficient therapeutic products demand from the aging population burdened with various kinds of chronic diseases like cancer, arthritis and genetic diseases in the U.S. and other major pharmaceutical markets. Many blockbuster drugs in the verge of patent expirations is also giving room for many biosimilar (and bio-better) companies to enter into the global biopharmaceuticals market subsequently involving many CROs, CDMOs, and CMOs to enter into the picture to meet the huge volume demand of these biological products. 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 to meet the increasing demand for the clinical and commercial supply of biologics. These bioservice providers have become an integral part of the rapidly expanding biopharma industry as they are equipped with the latest technological capabilities and expanded manufacturing capacities. By expanding manufacturing capacities or acquiring new facilities and thus adding novel, advanced and complementary capabilities, increased production capacities and expanded geographical reach to their services portfolio, CDMO’s focus on becoming the single, strategic partner to their customers by providing cost-effective end-to-end biologics development and manufacturing services. In September 2020, Catalent Inc. has invested $130 million for the addition of five additional suites to enhance their late phase clinical to commercial gene therapeutic manufacturing. In August 2020, Samsung Biologics had invested approximately $2 billion to build a fourth Super Plant with an additional 256KL production capacity to offer multi-scale manufacturing services. In January 2020, Cognate BioServices had acquired Cobra Biologics, a leading CDMO specialized in plasmid DNA and viral vector development and manufacturing services to enhance its capabilities in gene therapeutics.
The contract biomanufacturing global market is dominated by North American region which commanded the largest revenue in 2020 and is expected to grow at a low teen CAGR during the forecasted period according to IQ4I estimation. The Asia Pacific region is witnessing huge growth opportunities in terms of biologics outsourcing and many of the local CMOs are leading the way to make the region the most preferred destination for biologics outsourcing. Some of the reasons for countries like China, South Korea and India becoming the favourite destinations for biologic outsourcing projects include the lower labor cost, availability of high technical expertise and huge manufacturing facilities and favorable, supportive government regulations related to contract biomanufacturing in these regions. Asia-Pacific region is the fastest growing region in the contract biomanufacturing global market in 2020 and is expected to grow at high teen CAGR during the forecasted period.
According to IQ4I analysis, even though in-house biomanufacturing capacities still hold a major share of 67.8% in the biomanufacturing market, their capacity utilization rate is less compared to that of CMO’s with a utilization rate of 65.5%. Most of the CMO’s are currently utilizing mammalian culture techniques for the commercial, GMP production of biotherapeutics. Most of the CMO based biomanufacturing capacity is consolidated with major players like Samsung Biologics, Boehringer Ingelheim, Fujifilm and AbbVie. The global medium penetration range of CMO biomanufacturing capacity is expected to increase immensely in the coming years attributed to the vast opportunity in the space and various capacity expansion projects being executed by the CMO’s in response to the elevating biomanufacturing capacity demand.
The global bio-manufacturing outsourcing market is driven by factors such is driven by the increasing trend of outsourcing among the biopharmaceutical companies, availability of advanced bioprocessing capabilities among the contract bioservice providers and the escalating approval and adoption of biologics and the cost effective biosimilars among the value centric global patient pool leading to huge volume demand for biologics. Emergence of advanced biotherapeutics, increasing R&D investments by the biopharma companies, development of precision and orphan indication therapies and the persistently increasing prevalence of chronic, communicable and autoimmune diseases are also boosting contract biomanufacturing market growth. There are certain restraints and threats as well which could potentially hamper the biomanufacturing outsourcing market. These include requirement of huge capital investment for capacity expansion, setting of cGMP compliant facilities and technology up-gradation, need to be compliant with intellectual property protection rights of biopharma companies, development and expansion of in-house biomanufacturing capacities, the trend of low volume biomanufacturing outsourcing and competition from the established and local CDMO’s and stringent regulatory guidelines to be followed during the biomanufacturing.
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