Biopharmaceuticals Contract Manufacturing - Market Insights, Competitive Landscape, and Market Forecast - 2030

Biopharmaceuticals Contract Manufacturing Market by Product (Biologics [Monoclonal Antibodies (MABs), Proteins/Peptides, Vaccines, and Others], Biosimilar), Source (Mammalian and Non-Mammalian), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2030 owing to the increasing prevalence of chronic diseases such as cancer, diabetes, and other autoimmune disorders, growing research and development investments for the development of various biologics and biosimilar, the rise in the volume of outsourcing by the key biopharma giants, and the advantages associated with biopharmaceuticals Contract Manufacturing Organization (CMOs) in streamlining the drug development & manufacturing process across the globe.

The biopharmaceuticals contract manufacturing market is estimated to advance at a CAGR of 7.38% during the forecast period from 2024 to 2030. This rise in chronic conditions such as cancer, diabetes, and other autoimmune diseases are driving the demand for innovative treatments and therapies, particularly biopharmaceuticals, which offer targeted and effective solutions thereby escalating the market. In the dynamic pharmaceutical industry, biopharmaceuticals contract manufacturing is essential for driving innovation and expediting the development of life-changing therapies. It offers seamless access to specialized expertise and state-of-the-art facilities, critical for high-quality and compliant clinical trials. Efficient procurement and management of raw materials by contract manufacturers ensure a streamlined supply chain, allowing pharmaceutical companies to concentrate on core R&D efforts and accelerate the development of groundbreaking therapies. This collaboration reduces time-to-market, enhances product quality, and ensures regulatory compliance, advancing healthcare outcomes and patient well-being. Contract Research Organizations (CROs) further support this ecosystem by providing specialized R&D services, including clinical trials, regulatory consulting, and data management. By partnering with CROs, pharmaceutical companies can focus on core research while ensuring regulatory compliance, streamlining drug development, and accelerating the delivery of innovative therapies to patients worldwide, during the forecast period from 2024 to 2030.

Biopharmaceuticals Contract Manufacturing Market Dynamics:

According to recent data provided by GLOBOCAN, in 2022 estimated new number of cancer cases was 20 million, and the projection is estimated to increase to 32.6 million by 2045.

Additionally, according to the recent update provided by the International Diabetes Federation, in 2021, approximately 537 million adults aged 20-79 were living with diabetes. This number was projected to rise to 643 million by 2030 and 783 million by 2045.

Furthermore, according to recent data provided by the British Heart Foundation, in 2021, around 620 million people globally were living with heart and circulatory diseases, equivalent to about 1 in 13 individuals. Each year, nearly 60 million new cases of these diseases are diagnosed worldwide, a figure almost matching the UK's population. Coronary (ischemic) heart disease remained the most prevalent, affecting an estimated 200 million people, including 110 million men and 80 million women.

Thus, as the prevalence of these chronic conditions rises, there is an escalating demand for innovative biologic therapies, which are often complex and require specialized manufacturing processes. Biopharmaceutical companies are increasingly outsourcing production to contract manufacturers who possess the necessary expertise, advanced technologies, and regulatory compliance capabilities. This outsourcing allows biopharma companies to focus on research and development while ensuring high-quality, scalable, and efficient production of biologics. Consequently, the surge in chronic diseases is driving the growth of biopharmaceutical contract manufacturing, enabling faster development and delivery of critical therapies to patients.

Additionally, the biopharmaceuticals contract manufacturing market is witnessing lucrative growth at present owing to the rise in the outsourcing volume to the contract manufacturing organizations (CMO) 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 (CMO) can help avoid some of these costly start-up expenses. 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 stringent regulatory hurdle for CMOs in gaining product approval and difficulty in managing the supply chain, balancing manufacturing capacity, and maintaining state-of-the-art manufacturing facilities with advanced technologies requires substantial capital investment may hinder the biopharmaceuticals contract manufacturing market during the forecasted period.

Biopharmaceuticals Contract Manufacturing Market Segment Analysis:

Biopharmaceuticals Contract Manufacturing Market by Product (Biologics [Monoclonal Antibodies (MABs), Proteins/Peptides, Vaccines, and Others], Biosimilar), Source (Mammalian and Non-Mammalian), and 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 are projected to hold a considerable market share in 2023. 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, in May 2024, Sanofi announced an investment of more than €1 billion to create new bio-production capacity at its sites in Vitry-sur-Seine, doubling the site's monoclonal antibody production capacity.

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, in February 2024, AbbVie and OSE Immunotherapeutic announced a partnership to develop a novel monoclonal antibody for the treatment of chronic inflammation.

Moreover, a rise in approval for monoclonal antibodies-based biologic drugs by regulatory bodies could also be a factor responsible for propelling the market. For instance, in February 2024, Chugai Pharmaceutical Co., Ltd. announced that crovalimab, a humanized complement inhibitor C5 monoclonal antibody was approved by the National Medical Products Administration (NMPA) of the People's Republic of China for treating adults and adolescents (12 years and above) with Paroxysmal Nocturnal Hemoglobinuria (PNH).

Therefore, owing to the above-mentioned factors, the monoclonal antibody category is expected to generate considerable revenue thereby pushing the overall growth of the global biopharmaceuticals contract manufacturing market during the forecast period.

North America is expected to dominate the overall biopharmaceuticals contract manufacturing market:

North America is expected to account for the highest proportion of the biopharmaceuticals contract manufacturing market in 2023, out of all regions. This can be ascribed to the increasing prevalence of cancer, diabetes, and other autoimmune diseases across the region. Additionally, 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 increased market growth for biopharmaceutical contract manufacturers across the region.

According to recent data from the GLOBOCAN, in 2022, North America saw an estimated 2.67 million new cases of cancer, with forecasts indicating a rise to 3.83 million by 2045. As per the same source, in Canada, the number of new cancer cases was around 292,000 in 2022, projected to reach 449,000 by 2045. Meanwhile, in Mexico, there were approximately 207,000 new cases of cancer in 2022, expected to increase to 360,000 by 2045. Thus, as the incidence of cancer continues to increase globally, there is a growing demand for advanced biologic therapies tailored to target specific cancer types and genetic profiles. Biopharmaceutical companies are increasingly turning to contract manufacturers to leverage their specialized expertise in bioprocessing and manufacturing across the region thereby boosting the market of biopharmaceutical contract manufacturers.

Additionally, the rise in activities by the large biopharmaceutical contract manufacturer players to maintain their position in the market could potentially increase the market for biopharmaceutical CMOs in the region. For instance, in July 2023, AstraZeneca and Sanofi announced FDA approval for Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season, and up to 24 months of age for continued protection into their second RSV season. Beyfortus is the sole monoclonal antibody approved for passive immunization, ensuring safe and effective protection for all infants during this critical period.

Additionally, 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, in June 2024, the FDA approved three biosimilar products Ahzantive a biosimilar of Eylea (aflibercept), Nypozi a biosimilar of Neupogen (filgrastim), and Pyzchiva a biosimilar of Stelara (ustekinumab).

Therefore, the above-mentioned factors are expected to bolster the growth of the biopharmaceuticals contract manufacturing market in North America during the forecast 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:

• In April 2024, BioInvent announced the new clinical trial collaboration and supply agreement with MSD to evaluate BI-1910, the company's second anti-TNFR2 antibody in combination with KEYTRUDA(R) (pembrolizumab)
• In March 2024, Gilead and Merus announced the collaboration to discover novel antibody-based trispecific T-cell engagers
• In September 2023, The U.S. Department of Health and Human Services (HHS) announced the new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen.

Key Takeaways From the Biopharmaceuticals Contract Manufacturing Market Report Study:

• Market size analysis for current biopharmaceuticals contract manufacturing size (2023), and market forecast for 6 years (2024 to 2030)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years
• Key companies dominating the biopharmaceuticals contract manufacturing market.
• Various opportunities available for the other competitors in the biopharmaceuticals contract manufacturing market space.
• What are the top-performing segments in 2023? How these segments will perform in 2030?
• Which are the top-performing regions and countries in the current biopharmaceuticals contract manufacturing 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 This Biopharmaceuticals Contract Manufacturing Market Report Study:

• Biopharmaceuticals contract manufacturing product providers
• Research organizations and consulting companies
• Biopharmaceuticals contract manufacturing -related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing 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 are 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 biopharmaceutical contract manufacturing?

The biopharmaceuticals contract manufacturing market is estimated to advance at a CAGR of 7.38% during the forecast period from 2024 to 2030.

3. What are the drivers for the biopharmaceuticals contract manufacturing market?

This rise in chronic conditions such as cancer, diabetes, and other autoimmune diseases is driving the demand for innovative treatments and therapies, particularly biopharmaceuticals, which offer targeted and effective solutions thereby escalating the market. In the dynamic pharmaceutical industry, biopharmaceutical contract manufacturing is essential for driving innovation and expediting the development of life-changing therapies. It offers seamless access to specialized expertise and state-of-the-art facilities, critical for high-quality and compliant clinical trials. Efficient procurement and management of raw materials by contract manufacturers ensure a streamlined supply chain, allowing pharmaceutical companies to concentrate on core R&D efforts and accelerate the development of ground-breaking therapies. This collaboration reduces time-to-market, enhances product quality, and ensures regulatory compliance, advancing healthcare outcomes and patient well-being. Contract Research Organizations (CROs) further support this ecosystem by providing specialized R&D services, including clinical trials, regulatory consulting, and data management. By partnering with CROs, pharmaceutical companies can focus on core research while ensuring regulatory compliance, streamlining drug development, and accelerating the delivery of innovative therapies to patients worldwide, during the forecast period from 2024 to 2030.

4. Who are the key players operating in the biopharmaceuticals contract manufacturing market?

Some of the key market players operating in the biopharmaceuticals contract manufacturing market include Boehringer Ingelheim International GmbH, 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., Lonza, and others.

5. Which region has the highest share in the biopharmaceuticals contract manufacturing market?

North America is expected to account for the highest proportion of the biopharmaceuticals contract manufacturing market in 2023, out of all regions. This can be ascribed to the increasing prevalence of cancer, diabetes, and other autoimmune diseases across the region. Additionally, 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 contract manufacturers across the region.