Biopharmaceuticals Contract Manufacturing Market By Product (Biologics [Monoclonal Antibodies (MABS), Proteins/Peptides, Vaccines, And Others], Biosimilars), By Source (Mammalian And Non-Mammalian), by geography, is expected to grow at a noteworthy CAGR forecast till 2027 owing to the increase in the outsourcing volume by key manufacturers and expansion in the services offered by CMOs

The global biopharmaceuticals contract manufacturing market estimated to advance at a 7.38% CAGR during the forecast period from 2022 to 2027. The rise in the biopharmaceuticals contract manufacturing market is primarily owing to the growing R&D investments for the development of various biologics and biosimilars, the rise in the volume of outsourcing by the key biopharma giants, various advantages associated with contract manufacturing such as reductions in the overall investment for introducing a new drug in the market, and others. Also, the robust pipeline of biologics is likely to be responsible for driving the global biopharmaceuticals contract manufacturing market during the forecasted period from 2022 to 2027.

Biopharmaceuticals Contract Manufacturing Market Dynamics:

The biopharmaceuticals contract manufacturing market is witnessing lucrative growth at present owing to the rise in the outsourcing volume to the contract manufacturing organizations by the leading biopharma manufacturers as well as by the start-up companies. This is because the process of introducing a new biopharma drug into the market can be lengthy, requiring significant R&D, specialized manufacturing equipment, and the expertise to navigate regulatory concerns whereas working with a contract manufacturing organization can help avoid some of these costly start-up expenses. For instance, on November 17, 2020, Samsung Biologics partnered with Eli Lilly and Company to accelerate the global supply for Lilly's COVID-19 antibody therapies through a long-term manufacturing agreement.

Moreover, various contract manufacturing organizations are expanding their business operations to enable end-to-end manufacturing of biological drug substances and product supply which in turn could increase the dependency of key players on CMOs for drug production and supply, thereby leading to the biopharmaceutical CMOs market growth. For instance, on July 27, 2021, Abbvie expanded its global CMO operations by increasing manufacturing capacity & services such as biologics fill-finish, topical creams and ointments, sterile ophthalmic ointments, and custom API. The expansion added AbbVie contract manufacturing’s end-to-end capability for CMO clients.

Additionally, the rising focus of the CMOs on providing safe drug products for patients could also increase their demand among biopharmaceutical manufacturers. Thus, augmenting the growth of the biopharma CMO market. For instance, recently in September 2021, ADMA Biologics received FDA approval for its in-house aseptic fill-finish machine VanRx and related operations. The VanRx fill-finish machine utilizes a state-of-the-art closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients. The VanRx machine has the capability of rapidly switching between different container and closure formats, enabling aseptic filling in a variety of different fill volumes and presentation sizes, and is expected to allow ADMA to bring its products to market faster.

Hence, all the aforementioned factors are anticipated to boost the global biopharmaceuticals contract manufacturing market during the forecasted period.
However, the high cost of setting up a production facility for biopharmaceuticals and regulatory hurdles for CMOs in gaining product approval are some of the factors likely to impede the biopharmaceuticals contract manufacturing market growth.

Although the unprecedented COVID-19 pandemic has devastated the healthcare facility in the initial phases and had affected the overall healthcare market as well as manufacturing facilities, the biopharmaceuticals contract manufacturing market observed a significant growth during the pandemic. This is because biopharmaceutical companies shifted their focus on the development of safe and effective vaccines for the management of COVID-19 infection and have also partnered with various contract manufacturing organizations to increase the manufacturing process and make treatments more globally accessible for patients. For instance, on March 08, 2021, Baxter BioPharma Solutions, one of the largest contract manufacturing organizations (CMO) entered into an agreement with Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of the Moderna COVID-19 Vaccine in 2021.

Biopharmaceuticals Contract Manufacturing Market Segment Analysis:

Biopharmaceuticals Contract Manufacturing Market By Product (Biologics [Monoclonal Antibodies (MABs), Proteins/Peptides, Vaccines, and Others], Biosimilars), By Source (Mammalian and Non-Mammalian), and By Geography (North America, Europe, Asia-Pacific, and Rest of the World).

In the product segment of the biopharmaceuticals contract manufacturing market, monoclonal antibodies from the biologics sub-segment is projected to hold a considerable market share in the year 2021. This is because monoclonal antibodies (MABs) based biologics & biosimilars enhance and suppress immune responses in various medical conditions and are used to treat a variety of chronic disorders such as cardiovascular disorders, cerebrovascular disorders, and cancers, among others.

Furthermore, due to the rise in demand and sales of monoclonal antibody-based drugs, key pharma manufacturers have increased their investment in collaborations and contract manufacturing to meet the high needs thereby augmenting the market growth for the segment. For instance, as per the report published by Regeneron Pharmaceuticals, Inc. in 2020, the company’s investment in the cost of collaboration and contract manufacturing was USD 115 million in the fourth quarter and USD 420 million for the full year of 2019, compared to USD 73 million in the fourth quarter and USD 254 million for the full year 2018 which was primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent (Dupilumab).

Additionally, the rising partnership between various biopharma CMOs and pharma giants to accelerate the manufacturing of monoclonal antibody-based drugs is likely to bolster the segmental market growth. For instance, on June 18, 2021, Lonza and ValenzaBio entered into a clinical manufacturing agreement where the former will provide drug substance and drug product manufacturing under accelerated timelines for monoclonal antibody treatment at the Guangzhou facility.

Moreover, a rise in approval for MABs based biologic drugs by regulatory bodies could also be a factor responsible for propelling the market. For instance, in August 2021, FDA granted Emergency Use Authorization (EUA) to REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19.

Hence, all the above-mentioned factors are anticipated to contribute to the monoclonal antibodies product segment in the biopharmaceutical contract manufacturing market in the upcoming years.

North America is expected to dominate the overall Biopharmaceuticals Contract Manufacturing Market:

Among all the regions, North America is expected to occupy a major share in the overall biopharmaceuticals contract manufacturing market in the year 2021. This domination is owing to the presence of a large number of CMO manufacturing organizations in the region that are continuously expanding their capacity. Moreover, the high prevalence of various disorders, the presence of a large number of companies involved in developing biologics, and the increase in the number of contracts between the CMOs and biopharmaceutical companies in the region are likely to exhibit an increased market growth for biopharmaceuticals CMOs.

For instance, in April 2018, Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products completed a USD 5.5 million expansion program at its 200,000+ square foot Philadelphia, Pennsylvania, site to provide additional clinical packaging and storage capacity.

Also, in October 2017, Lonza acquired a clinical-stage mammalian manufacturing site in the US from Shire plc. The plant is equipped with single-use bioreactors of 1,000L and 2,000L capacities, coupled with downstream purification capabilities.

Thus, a rise in activities by the large CMO players to maintain their position in the market could potentially increase the market for biopharmaceutical CMOs in the region.

Furthermore, a robust pipeline of biologics in the region is also expected to increase the outsourcing of these drugs by the key players in the upcoming years ultimately augmenting the market growth. For instance, as per the FDA 2020 data, the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs) in the year 2020.

Additionally, to combat the COVID-19 pandemic various companies in the region are collaborating with CMOs to increase the production scale of the vaccine which is also expected to surge the demand for contract manufacturing organizations in the region. For instance, in January 2021, Novartis signed an initial agreement to provide manufacturing capacity for the Pfizer-BioNTech COVID-19 vaccine.

Thus, the interplay of all the above-mentioned factors is likely to propel the biopharmaceutical contract manufacturing market growth in the region during the forecasted period.

Biopharmaceuticals Contract Manufacturing Market Key Players:

Some of the key market players operating in the Biopharmaceuticals Contract Manufacturing market include Boehringer Ingelheim International GmbH, Lonza, Rentschler Biopharma SE, BINEX Co., Ltd., INCOG BioPharma Service, FUJIFILM Diosynth Biotechnologies U.S.A. Inc, Novartis AG, ProBioGen AG, TOYOBO CO., LTD., Samsung Biologics, Thermo Fisher Scientific, Inc., AbbVie, Inc., WuXi Biologics, AGC Biologics, ADMA Biologics, Inc., Baxter BioPharma Solutions (Baxter), iBio., Catalent, Inc, Cambrex Corporation, Pfizer Inc., and others.

Recent Developmental Activities in the Biopharmaceuticals Contract Manufacturing Market:

• On August 31, 2020, PharmAbcine, a biotech company focusing on the development of antibody therapeutics signed a contract manufacturing organization(CMO) agreement with Binex, a leading biologics CDMO (Contract Development and Manufacturing Organization) company in Korea to produce olinvacimab at its new 5,000L production line.

• On August 28, 2020, iBio and Planet Biotechnology entered into an exclusive worldwide license agreement for the development of a COVID-19 therapeutic.

Key Takeaways from the Biopharmaceuticals Contract Manufacturing Market Report Study

● Market size analysis for current market size (2021), and market forecast for 5 years (2022-2027)

● The effect of the COVID-19 pandemic on this market is significant. To capture and analyze suitable indicators, our experts are closely watching the

Biopharmaceuticals Contract Manufacturing market.

● Top key product/services/technology developments, mergers, acquisitions, partnerships, joint ventures happened over the last 3 years

● Key companies dominating the Global Biopharmaceuticals Contract Manufacturing Market.

● Various opportunities available for the other competitor in the Biopharmaceuticals Contract Manufacturing Market space.

● What are the top-performing segments in 2021? How these segments will perform in 2027.

● Which are the top-performing regions and countries in the current market scenario?

● Which are the regions and countries where companies should have concentrated on opportunities for Biopharmaceuticals Contract Manufacturing market growth in the coming future?

Target Audience who can be benefited from the Biopharmaceuticals Contract Manufacturing Market Report Study

● Biopharmaceuticals Contract Manufacturing providers

● Research organizations and consulting companies

● Biopharmaceuticals Contract Manufacturing-related organization, association, forum, and other alliances

● Government and corporate offices

● Start-up companies, venture capitalists, and private equity firms

● Distributors and Traders in Biopharmaceuticals Contract Manufacturing

● Various End-users who want to know more about the Biopharmaceuticals Contract Manufacturing Market and the latest technological developments in the Biopharmaceuticals Contract Manufacturing market.

Frequently Asked Questions for the Biopharmaceuticals Contract Manufacturing Market:

1. What is Biopharmaceuticals Contract Manufacturing?

Biopharmaceuticals Contract Manufacturing is a term used when a pharmaceutical company outsources the manufacturing process or a part of the process of products to a third party or manufacturing organization.

2. What is the market for Global Biopharmaceuticals Contract Manufacturing?

The global Biopharmaceuticals Contract Manufacturing Market is estimated to advance at a 7.38% CAGR during the forecast period (2022-2027).

3. What are the drivers for Global Biopharmaceuticals Contract Manufacturing?

The major factor driving the demand for Biopharmaceuticals Contract is the growing R&D investments for the development of various biologics and biosimilars, the rise in the volume of outsourcing by the key biopharma giants, various advantages associated with contract manufacturing such as reductions in the overall investment for introducing a new drug in the market, and others. Also, the robust pipeline of biologics is likely to be responsible for driving the global biopharmaceuticals contract manufacturing market during the forecasted period from 2022 to 2027.

4. What are the key players operating in Global Biopharmaceuticals Contract Manufacturing?

Some of the key market players operating in the Biopharmaceuticals Contract Manufacturing market include Boehringer Ingelheim International GmbH, Lonza, Rentschler Biopharma SE, BINEX Co., Ltd., INCOG BioPharma Service, FUJIFILM Diosynth Biotechnologies U.S.A. Inc, Novartis AG, ProBioGen AG, TOYOBO CO., LTD., Samsung Biologics, Thermo Fisher Scientific, Inc., AbbVie, Inc., WuXi Biologics, AGC Biologics, ADMA Biologics, Inc., Baxter BioPharma Solutions (Baxter), iBio., Catalent, Inc, Cambrex Corporation, Pfizer Inc., and others.

5. Which region has the highest share in the Biopharmaceuticals Contract Manufacturing market?

Among all the regions, North America is expected to occupy a major share in the overall biopharmaceuticals contract manufacturing market in the year 2021. This domination is owing to the presence of a large number of CMO manufacturing organizations in the region that are continuously expanding their capacity. Moreover, the high prevalence of various disorders, the presence of a large number of companies involved in developing biologics, and the increase in the number of contracts between the CMOs and biopharmaceutical companies in the region are likely to exhibit an increased market growth for biopharmaceuticals CMOs.