IQ4I Research & Consultancy published a new report on “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 old paradigm, ‘process is the product’ is still relevant in biomanufacturing as the biomanufacturing process is solely responsible for the efficiency and safety of a biopharmaceutical product. An ideal biomanufacturing process should be able to deliver an efficient and safe biotherapeutic product economically, in a reproducible manner and should be able to traverse successfully the various efficacy and regulatory hurdles of biopharmaceutical commercialization.

The dynamically expanding biologics industry both in terms of revenue and volume outsource their biomanufacturing processes to Contract Manufacturing Organizations (CMOs) or Contract Development and Manufacturing Organizations (CDMOs) that provide the biopharmaceutical drug substance and drug product manufacturing services mostly on a fee-for-service basis. Biopharma companies outsource their bioprocessing or biomanufacturing activities 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. For instance, in September 2020, the Sweden based firm, CombiGene AB has signed agreement with Cognate Bioservices (Cobra Biologics) for the GMP production of two essential plasmids needed for the manufacturing of CG01, a gene therapeutic designed for the treatment of drug resistant focal epilepsy. In August 2020, the U.S. based, Novavax Inc. has signed a collaborative agreement with FUJIFILM Diosynth Biotechnologies, for the bulk drug substance manufacturing of their antigen component of NVX-CoV2373, a Novavax’ COVID-19 vaccine candidate. In July 2020, Editas Medicine (U.S.) had strategically partnered with Catalent Inc. for the development, manufacturing and clinical supply of their CRISPR medicines and engineered cell medicine while Humanigen Inc. of U.S. has partnered with the Catalent for the development, manufacturing and commercialization of their investigational COVID-19 therapeutic candidate Lenzilumab. In May 2020, Moderna Inc. of U.S. and Lonza have entered into a 10 year strategic collaboration for the large scale manufacturing of the Moderna’s mRNA vaccine against novel corona virus and other products in the future while in February 2020, WuXi Vaccines, subsidiary of WuXi Biologics, has signed a 20 year vaccine manufacturing contract valued at approximately $3 billion with a global vaccine leader.

The contract biomanufacturing services global market is expected to reach $57.1 billion by 2028 growing at a low teen CAGR from 2020 to 2028. The contract biomanufacturing global market 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. Some of the factors that are dampening the contract biomanufacturing market growth are 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, 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.

The contract biomanufacturing services global market is classified based on developmental phase, process, end users and geography. Based on the developmental phase, the contract Biomanufacturing global market has been segmented as contract clinical phase biomanufacturing and contract commercial phase biomanufacturing. Among these phases, the commercial phase contract biomanufacturing occupied the largest share in 2020 and is expected to grow at a low teen CAGR from 2020 to 2028 due to increasing approval of the highly specific and efficient biopharmaceuticals and adoption of these by the value-centric global population burdened with various kinds of chronic, infectious, genetic and autoimmune diseases with no effective conventional therapeutics till date. The clinical phase contract biomanufacturing revenue is the fastest emerging segment growing at a mid teen CAGR from 2020 to 2028. The fastest growth rate of this segment is mainly due to increasing number of clinical trials being carried out across the globe to prove the efficacy and safety of the novel biopharmaceuticals.

Based on the process of contract biomanufacturing, the global market has been grouped into mammalian contract biomanufacturing, microbial contract biomanufacturing and other contract biomanufacturing processes (plant or insect cell based). Among these, the mammalian market accounted for the largest share in 2020 and is expected to grow at a mid teen CAGR from 2020 to 2028. The largest market share and the fastest growth rate of this segment is due to the large scale implementation of this technology among the various contract biomanufacturers attributed to its various advantages like ability to produce more humanized, complex, large products with appropriate post-translational modifications and the ability to secrete the products.

The contract biomanufacturing services global market, by end users has been segmented into contract biomanufacturing for diagnostics, contract biomanufacturing for research reagents and contract biomanufacturing for therapeutics. Among these, contract biomanufacturing of therapeutics accounted for the largest share in 2020 and is expected to grow at a low teen CAGR during the forecasted period due to the huge volume manufacturing demand for these highly efficient biologics attributed to their increasing adoption by the value centric patient pool across the globe. Research reagents contract biomanufacturing segment is the fastest emerging segment and is expected to grow at low teen CAGR during the forecasted period. The high growth rate of this segment is attributed to the large number of researches being carried out across the globe for the development of efficient therapeutics based on the profound understanding of the disease pathology.

The contract biomanufacturing services global market based on geography is segmented into North America, Europe, Asia-Pacific and the Rest of the world (ROW). The major share of the contract biomanufacturing global market is occupied by North America in 2020 and is expected to grow at a low teen CAGR from 2020 to 2028 due to the high quality and regulatory compliant biomanufacturing services offered there and the utilization of sophisticated and leading edge biomanufacturing technologies. Asia-Pacific region is the fastest growing region in the contract biomanufacturing market in 2020 and is expected to grow at a high teen CAGR during the forecasted period. The fastest growth rate of this region is due to the biomanufacturing cost advantages offered by the countries in the region and the favourable and supportive biologic manufacturing related government initiatives and policies here.

Technological advancements have revolutionized the biomanufacturing landscape and the contract biomanufacturers are equipping themselves with the latest cutting edge technologies to streamline their bioprocessing activities, to increase their competitiveness and to ensure their growth in the new market avenues. The various innovations in the biomanufacturing processes have led to a more economical, flexible and qualitative production of the highly diverse biotherapeutics. The contract biomanufacturers are making huge investments to equip themselves with continuous biomanufacturing techniques to improve scalability and quality of the products produced, with novel process analytical tools to enhance process robustness and commercial bioproduction, with single use or disposable systems for economical elevation of flexibility and also reduction of production lead times and for the development of alternative and advanced downstream processing techniques to enhance production yields cost effectively. Some of the leading technologies adopted or incorporated by the contract biomanufacturers include robust, regulatory compliant, efficient and scalable mammalian and microbial proprietary expression platforms, automated monoclonality systems for fast track and high titer bioproduction, drug substance services like cGMP compliant continuous bioprocessing with the flexible perfusion technology for high volumetric production of various biotherapeutics, fit to purpose single use bioreactors and stainless steel bioreactors of multiple scales and capacities, cGMP compliant modular facilities, advanced downstream suites and purification suites equipped with chromatography skids, virus segregation skids and others, advanced drug product services like aseptic filling, lyophilization and storage conditions for a broad range of temperatures, implementation of Industrial Internet of Things (IIoT) and automated solutions for bioprocessing activities, capabilities like viral vector and plasmid DNA manufacturing to support the development of next generation or novel biotherapeutics, biosafety testing services consisting of bioburden (virus, mycoplasma) and endotoxin testing and others.

The consolidation of the installed Biomanufacturing capacities as product based or by the product or drug developer companies restricts their utilization by mid-size, smaller or virtual biopharma companies with limited or negligible biomanufacturing capacities. This signifies the need and opportunity for CMO based or external biomanufacturing capacity elevation to boost the biopharmaceutical industry and to avoid capacity constraint issues. According to IQ4I analysis, out of the estimated global biomanufacturing capacity of 8.5 million liters, the CMO based biomanufacturing capacity is xx million liters, indicating a penetration rate of xx% with an opportunity of xx% for CMO capacity expansion. According to IQ4I analysis, out of the estimated global microbial biomanufacturing capacity of 2.4 million liters, the CMO based biomanufacturing capacity is xx million liters, indicating a penetration rate of xx% with an opportunity of xx% for CMO capacity expansion. Microbial production capacity expansions offer numerous opportunities for CMOs due to the gradual evolution of the biopharmaceutical industry from the conventional antibody or protein based therapeutics to the next generation biotherapeutics. According to IQ4I analysis, out of the estimated global other expression system (plant cells, insect cells) based biomanufacturing capacity of 0.54 million liters, the CMO based biomanufacturing capacity is xx million liters, indicating a penetration rate of xx% with an opportunity of xx% for CMO capacity expansion. Other expression systems based capacity expansion also will offer immense opportunities for CMOs owing to the growing interest among the biopharmaceutical companies in the large scale bioproduction using these systems.

According to the changing landscape of diseases and trends of the biopharmaceutical industry, the CMOs are consistently enhancing their capabilities and service offerings by making huge investments in the more remunerative and high growth potential biologic service areas and by resorting to acquisitions to reduce competition and also gain specific technical or therapeutic expertise from the smaller, niche biological CDMO’s. For instance, in September 2020, Thermo fisher has opened its new Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri to accelerate innovation and enhance productivity for biopharma companies using the combined expertise from its bioproduction and pharma services businesses. In August 2020, to meet the escalating biomanufacturing demands, 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 July 2020, it had also commenced expanding its Drug Product (DP) capability by making strategic investments to build a flexible filling line and two additional lyophilizer units while in August 2019, the company expanded its commercial biomanufacturing capabilities by implementing N-1 Alternative Tangential Flow (ATF) perfusion system for achieving maximum cell densities at a shorter culture duration to ensure maximum productivity and reduced bioproduction timeline for their customers. In June 2020, FUJIFILM Diosynth Biotechnologies, a leading biologics CDMO has invested $928 million in its Denmark manufacturing site to double its biomanufacturing capacity and also to expand and enhance its capabilities infill or finish, labeling, assembly and packaging services while in February 2020, it expanded its Gene Therapy Manufacturing Capacity at Texas location through the $35 million expansion project to include the addition of cell culture and high throughput manufacturing suites. In March 2020, Sartorius Stedim Biotech had launched BIOSTAT STR Generation 3 single-use bioreactor and BIOBRAIN automation platform to make biopharmaceutical development and production faster, simpler and safer.

In August 2020, Charles River Laboratories acquired the U.S. based Cellero to enhance its capabilities in the discovery, development and manufacturing of cell therapeutics. In July 2020, AGC Biologics, acquired the Italian company Molecular Medicine S.p.A. ("MolMed") which offers GMP services for the development and production of cell and gene therapies to enhance its capabilities in cell and gene therapeutics. In January 2020, Charles River Laboratories had acquired the U.S. based HemaCare Corporation for approximately $380 million to enhance its capabilities in cell therapeutics development and manufacturing. To enhance their viral vector manufacturing capacity, in May 2019, Patheon of Thermo Fisher acquired Brammer Bio for $1.7 billion, while Catalent acquired Paragon Biosciences for $1.2 billion. In February 2020, Catalent, Inc., to perpetuate its leading position in the advanced biotherapeutics outsourcing market, also acquired MaSTherCell Global Inc., a company with a unique portfolio of autologous and allogeneic cell therapy capabilities, advanced technologies and associated analytical services for $315 million. Due to the remunerative and high growth potential of this market, many new firms are entering into this market. For instance, in January 2020, the collaboration between the investment firm, Deerfield Management Company and The Discovery Labs with an investment of $1.1 billion has led to the launch of Center for Breakthrough Medicine, a CDMO that aims to be the single solution provider for cell and gene therapeutics.

The contract biomanufacturing services global market is fragmented with the top six players occupying xx% of the market share and the remaining xx% of the market being occupied by other players. The top players in contract biomanufacturing market are Lonza Group Ltd. (Switzerland), Samsung Biologics Co. Ltd. (South Korea), Boehringer Ingelheim International GmbH (Germany), Thermo fisher Scientific Inc. (U.S.), Catalent Inc. (U.S.), WuXi Biologics (Cayman) Inc. (China), JSR Corporation (Japan), AGC Inc. (Japan), Rentschler Biotechnologie GmbH (Germany), Genscript Biotech Corporation (China), Cognate Bioservices Inc. (U.S.), Charles River Laboratories International Inc. (U.S.), Merck KGaA (Germany) and others.

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