Biologics Outsourcing Global Market estimated to be worth $87.5 billion by 2028
Biologics are the therapeutic entities composed of sugars, proteins, or nucleic acids and made from natural sources such as human, animal or microorganisms. Biologics also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (for transplantation), cell and gene therapeutics. Similar to the conventional therapeutics, these drugs help in treating several diseases but are highly specific and more efficient in their disease healing mechanisms. The biologic entities like monoclonal antibodies and recombinant proteins target specific areas during their molecular mechanism of disease curing action.
Even though biologics are highly expensive when compared to the conventional small molecule drugs, these target specific therapeutics have proven to be very beneficial for patients and also ensure higher profit margins to the drug manufacturers. The escalating adoption of biologics and elevating demand for the highly efficient biotherapeutics from the value-centric patient population across the globe, increasing investments on research and developmental activities of biologics and advanced, next-generation biotherapeutics, a favorable and streamlined regulatory environment that is expediting the novel product approval process and the expansion of biosimilar market have all led to the rapid growth of the biopharmaceutical market. The number of novel drugs, meant to serve the hitherto unmet therapeutic needs and improve the survival chances of patients suffering from life threatening or debilitating medical conditions, that are getting approved has increased considerably in the recent years due to streamlining and fast tracking of the drug approval process by the regulatory authorities of the world. In 2019, 48 novel drugs received FDA approval, out of which 25.0% were biologic drugs. In the first six months of 2020, 25 novel drugs received FDA approval out of which 20% were biologic drugs. The increasing novel biologic drug approval statistics indicate that the pharmaceutical industry is gradually shifting its focus to the more advantageous biologics and that biotherapeutics, with their high selectivity and potency, are undoubtedly the ‘Drugs of Future’.
The multiple indication approval of these biologics and the ability of tailored biologics to treat previously immedicable diseases efficiently and selectively have increased their adoption rate, thereby expanding the target patient pool for these innovator drugs. The global list of blockbuster or top selling drugs has been populated with biologics for many years. In 2019, biologics occupied a major share among the top 10 selling drugs, with seven of them being biotherapeutics. The highest grossing biologic drug Humira, intended to treat rheumatoid arthritis, Crohn’s disease and ulcerative colitis had generated revenue of $19.1 billion in 2019 with around $14.9 billion revenue generated from U.S. alone.
Biosimilars, which are the equivalent versions of the licensed biologic products with slight differences in their clinically inactive components, are emerging as an effective substitute for these highly expensive biotherapeutics. These biosimilars that can be launched in the market only after the expiration of patents of the innovator drugs, increase the economical patient accessibility to the highly effective but expensive biotherapeutics by spurring stiff competition among the biopharmaceutical companies in the biologics market. Till February 2020, Europe had 58 biosimilars approved for use in the region while U.S. had 28 biosimilars approved to date. Asian countries like Japan, South Korea, India, China and other regions have been quick in embracing biosimilars due to their affordability and efficiency for their vast patient pool burdened with several autoimmune or non-communicable diseases and the continuous government support for their increased manufacturing and uptake to curb the healthcare expenditures.
This fast pacing biologic industry coupled with insufficient or lack of in house biologic development and manufacturing capabilities and capacities of biopharmaceutical companies has spurred these companies to outsource the different parts of biologic development and manufacturing process to highly efficient service provider organizations. To tap this market of high growth potential as the advantageous first movers or to increase accessibility in this rapidly growing market without making huge capital investments and by eclipsing the various risks associated with complex bio-molecule production, the large, medium, small or virtual biopharma companies are all increasingly adopting the trend of outsourcing so as to meet the accelerated biopharmaceutical development and production demand effectively. The Large Biopharma companies are coming up with strategies to cut down on their operational costs and concentrate more on their core competencies by outsourcing the biologic development and manufacturing processes to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). Thus the need to accelerate time to market of their novel biologic products and gain a competitive edge in the market by gaining economical and timely access to technologically advanced biologic development and biomanufacturing capabilities, flexible capacities and technical expertise of CDMOs is fuelling the biologic outsourcing market growth.
The biologics outsourcing global market is expected to reach $87.5 billion by 2028 growing at low teen CAGR from 2020 to 2028. Major drivers for the biologics outsourcing market include increasing trend of outsourcing among the biopharma companies for gaining an economical access to advanced biologics development and manufacturing capacities and capabilities, advanced bioprocessing capabilities of bioservice providers, increasing approvals and adoption of biologics, increasing R&D spend of biopharma companies and escalating approvals and uptake of biosimilars. Factors like emergence of next generation biotherapeutics, development of personalized and orphan indication therapies and the persistently escalating prevalence of chronic, communicable and autoimmune diseases are expected to boost the market growth.
The biologics outsourcing global market has been segmented based on the developmental phase, product, application end users and geography. Among the discovery, pre-clinical, clinical and commercial phases of biologics development, Commercial Phase outsourcing commanded the largest revenue in 2020 and is expected to grow at low teen CAGR during the forecasted period. The biological outsourcing market by product type is segmented into Antibody, Proteins, Vaccines, Gene therapy, cell therapy and others. Among these, antibody outsourcing segment accounted for the largest share of revenue in 2020 and is expected to grow at low teen CAGR during the forecasted period. Gene therapeutics segment is expected to be the fastest emerging market growing at low teen CAGR during the forecasted period. Among the various applications like research, bioproduction and diagnostics, bioproduction segment accounted for the largest revenue in 2020 and is expected to grow at low teen CAGR from 2020 - 2028. Based on end – users, biologics outsourcing market is segmented into Therapeutics, Diagnostics and Research. Therapeutics is the largest and fastest growing segment and is expected to grow at low teen CAGR from 2020 to 2028.
Geographically, North America dominated the biologics outsourcing market with the highest revenue in 2020 and is expected to grow at double digit CAGR from 2020 to 2028 due to the high quality and regulatory compliant biologics development and manufacturing services offered there and the utilization of sophisticated and leading edge bioprocessing technologies. Whereas Asia Pacific region is expected to be the fastest emerging market growing at mid teen CAGR during the forecasted period. The fastest growth rate of this region is due to the cost advantageous bioservices offered by the countries in the region, availability of skilled personnel and the favourable and supportive biologic development manufacturing related government initiatives and policies here. The countries of highlight in this region include China and India where the outsourcing market is on a boom and is expected to do better in coming years as well.
The biologics contract bimanufacturing 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.
The report specifically emphasizes on the rapidly evolving and high growth potential biologics contract manufacturing services market and cell line development services market. 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 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 is the fastest emerging segment growing at 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 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 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 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 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.
The cell line development service global market is expected to reach $1,702.2 million by 2028 growing at a double digit CAGR from 2020 to 2028. Increasing demand for monoclonal antibodies, recombinant proteins and vaccines, growing incidence rate of oncology, autoimmune disorders, infectious diseases & genetic disorders and growth in research activities related to the diseases and also recombinant cell lines for the production recombinant biopharmaceutical proteins are driving the market. Technological advancements in cell line engineering (gene editing tools) & cell line development technologies, screening technologies and process development are giving immense growth opportunities for the market. However, complexities in the development of stable cell lines and high risk of contamination due to complex purification methods are restraining the market. Furthermore, stringent and complex regulations and the high cost and technical requirement to adhere to accreditations such as GMP are posing threat to the industry.
Cell line development service global market is classified based on the expression system, cell line type, application and geography. Based on expression system, cell line development service global market is segmented into microbial, mammalian and others. Mammalian expression system is the largest & fastest growing segment and is expected to grow at a double digit CAGR from 2020 to 2028 due to utilization of mammalian cell lines for most of biologics development & production and also technological advancements in mammalian cell line development platforms for higher titer production.
Based on the cell line type, global cell line development service market is segmented into CHO, Mouse Myeloma (NS0; Sp2/0), Human Embryonic Kidney (HEK), Baby Hamster Kidney (BHK), Hybridoma, Human Embryonic Retina (PER.C6) and others. Among cell line type, CHO cell lines is the largest & fastest growing segment and is expected to grow at a low teen CAGR from 2020 to 2028 due its major advantageous like being versatile, relatively easy to work with, having well-understood glycosylation patterns and also increasing approvals of biologics which are produced from CHO cell lines. For instance, CHO is used in the manufacture of more than 65% of currently approved biologics.
Based on application, cell line development service global market is segmented into research, bio production and diagnostics. Bioproduction is the largest & fastest growing segment and is expected to grow at a low teen CAGR from 2020 to 2028 due to higher demand of biologics & biosimilars for therapeutic applications and increasing collaboration between the companies for the development & production of biotherapeutics using various advanced cell line development platforms.
Based on the geography, cell line development service global market is segmented into North America, Europe, Asia-Pacific and Rest of the world. North America accounted for the largest revenue in 2020 and is expected to grow at a double digit CAGR from 2020 to 2028. The Asia-Pacific is the fastest growing region in cell line development global market and is expected to grow at a low teen CAGR from 2020 to 2028.
According to IQ4I analysis, Cell banking service market generated the revenue of $xx million in 2020 and is expected to grow at a high teen CAGR reach $xx million by 2028. Proper cell line authentication is crucial to assure that inadvertent contamination of cell lines has not occurred during the regular cell culturing work. It is particularly important to authenticate the cell line during the drug development process to ensure the quality of the biopharmaceuticals produced from them. Cell line characterization service market generated the revenue of $xx million in 2020 and is expected to grow at a low teen CAGR to reach $xx million by 2028. Bioanalytical services market for biologics is estimated to exhibit exponential growth to reach $2,270.2 million during the forecasted period. Bioanalytical Outsourcing enables biopharmaceutical companies to cost effectively and quickly adapt to the ever evolving and highly taxing regulatory environment and the technological advancements in the field of bioanalytics. Through outsourcing, the biopharma companies can economically leverage the externally existing advanced and sophisticated analytical infrastructure, knowledge base and skilled and technical expertise of the CRO’s. The mandatory inclusion of bioanalyses data of biologics and biosimilars in the regulatory filings of countries across the globe for commercialization of products is also driving the biopharma companies to bioanalytical service providers who have a better understanding of the various regulatory aspects for product approval and are equipped with most sophisticated analytical equipments and specialized expertise. The cost and time advantages provided by the analytical service providers, the growth in the biosimilar and advanced biotherapeutics space, escalating adoption of quality by design (QbD) approach by biopharma companies and the need to replenish the pipeline of biopharma companies with strong, proven products before rolling out of the patents of their proprietary products are also fuelling the bioanalytical testing outsourcing.
The contract biomanufacturing services global market is fragmented with the top six players occupying only a meagre or modest share of the market and the remaining bulk share of the of the market being occupied by other players. The cell line development services global market is consolidated with the top six players occupying major share of the market of the market and the other players occupying only a modest share of the market.
The biologics outsourcing global market is fragmented with the top six players occupying modest share of the market and the remaining other players occupying the major part of the market. The top players in biologics outsourcing global 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.