Biopharmaceutical Contract Manufacturing Market Report by 2028

[Research Report] The biopharmaceutical contract manufacturing market is projected to reach US$ 27,868.50 million by 2028 from US$ 15,735.04 million in 2021; it is expected to grow at a CAGR of 8.5% from 2021 to 2028.

The rising outsourcing by pharmaceutical companies is one of the most key factors driving the growth of the market. A few years ago, the contract manufacturing industry was a niche service market offering additional manufacturing capacity or specific services to pharmaceutical companies. The rise of CMOs was fueled by the increasing number of drug manufacturing failures. In the past, pharmaceutical companies had undertaken manufacturing facilities to develop innovative drugs. However, to reduce the risk of overcapacities, the demand for manufacturing outsourcing has continuously risen. Recently, Revolo Biotherapeutics entered into a partnership with contract development and manufacturing organization (CDMO)—Northway Biotech—to manufacture Revolo’s binding immuno-regulatory protein 1805. The partnership included services from cell line development to manufacturing protein with quality assurance and regulatory compliance support. Similarly, Gland Pharma has been manufacturing Remdesivir for four companies, including Mylan, since 2021. Also, the organization increased its manufacturing quotas due to high demand from the companies. In 2019, Samsung Biologics and GI Innovation signed a contract for immunochemotherapy. Under this agreement, Samsung Biologics was providing services ranging from f-cell lines development to production of Phase-I drug substances. The increasing number of contracts between biopharmaceutical companies and contract manufacturing companies shows an increasing market size for the biopharmaceutical contract manufacturing market.

North America is likely to continue its dominance in the biopharmaceutical contract manufacturing market during 2021–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period. Increasing demand for clinical trials, growing pharmaceutical and medical device industries, increasing healthcare expenditure, high R&D spending, and the presence of key market players in the region that offer manufacturing, storage, logistic, and other services is likely to enhance the market growth in the country. For instance, Alderley Analytical, Almac, and among others are well-known manufacturing organizations that offer a wide range of integrated services to more than 600 pharmaceutical and biotech companies. The presence and significant impact of biopharmaceutical companies in the region in terms of revenue, technology, and employment opportunities are expected to aid the growth of the market in the region.

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Biopharmaceutical Contract Manufacturing Market: Strategic Insights

Market Size Value in	US$ 15,735.04 million in 2021
Market Size Value by	US$ 27,868.50 million by 2028
Growth rate	CAGR of 8.5% from 2021 to 2028.
Forecast Period	2021- 2028
Base Year	2021

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Lucrative Regions for Biopharmaceutical Contract Manufacturing Market

Market Insights

Increasing Demand for Biologics Drives Market Growth

The contract manufacturing market for biologics is growing at an unprecedented rate owing to increasing biologics pipeline, manufacturing complexity, and companies shifting their focus towards core activities. Presently, many pharmaceutical and biotechnology companies outsource varied services from early-stage drug development to commercial-scale manufacturing. Outsourcing is required to expedite research and development, speed up market entry, give access to novel technologies, regulatory expertise, and reduce risks at a competitive cost. Complexities in biologics development and production and increasingly stringent quality standards have driven drug manufacturers to prefer contract manufacturer services. Moreover, many companies are opting CMOs services to speed up the development process and lower production costs. For instance, Sanofi has outsourced manufacturing of its biologics pipeline to Boehringer Ingelheim. Moreover, TaiMed Biologics Ibalizumab (the FDA-designated orphan drug) is manufactured by CMO WuXi PharmaTech. Also, in 2021, Samsung Biologics expanded its collaboration with AstraZeneca from 2020. The contract included the production of a drug substance, AstraZeneca’s COVID-19 long-acting antibody combination, and manufacturing of a cancer immunotherapy product started from 2022.

Product-Based Insights

Based on product, biopharmaceuticals contract manufacturing market is segmented into biosimilar and biologics. The biologics segment held the largest share of the market in 2021 owing to increasing demand for biologics, increasing research, and development activities to develop new drugs for chronic indications in the forecast period. The segment is further segmented into monoclonal antibodies, recombinant proteins, vaccines, and others. The market for biosimilar is expected to register the highest CAGR in the market during the forecast period due to patent expiration of blockbuster drugs and increasing pipeline.

Biopharmaceutical Contract Manufacturing Market, by Product– 2021 and 2028

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Service Insights

The biopharmaceuticals contract manufacturing market, by service, is segmented into process development, fill and finish operations, analytical and quality control studies, and packaging. In 2021, the process development accounted for the largest market share in the global biopharmaceuticals contract manufacturing market owing to higher focus on pilot to commercial scale-up process development, cell line development, and other processes. However, analytical and quality control studies are expected to grow at a significant CAGR in the forecast period owing to stringent regulatory regulation and complex manufacturing requirements for biologics.

Companies operating in the biopharmaceutical contract manufacturing market adopt product innovation strategy to meet the evolving customer demands across the world, which also permits them to maintain their brand name in the global market. Also, the companies in the market create partnerships, collaborations, and contracts with biopharmaceutical companies to further drive the revenue of the market.

Biopharmaceutical Contract Manufacturing Market – Segmentation

Based on the product, the biopharmaceutical contract manufacturing market is segmented into biologics and biosimilar. The biologics segment is further segmented into monoclonal antibodies, recombinant proteins, vaccines, and others.

By service, the biopharmaceutical contract manufacturing market is segmented into process development, fill and finish operations, analytical and quality control studies, and packaging.

Based on the source, the biopharmaceutical contract manufacturing market is segmented into mammalian and microbial-based biologics/non-mammalian.

Biopharmaceutical Contract Manufacturing Market – by Geography

Based on geography, the biopharmaceutical contract management market is primarily segmented into North America, Europe, Asia Pacific, the Middle East and Africa, and South and Central America. The market in North America is further segmented into the US, Canada, and Mexico. The European biopharmaceutical contract management market is sub-segmented into Germany, France, the UK, Spain, Italy, and the Rest of Europe. The market in the Asia Pacific is sub-segmented into China, India, Japan, Australia, South Korea, and the Rest of Asia Pacific. The biopharmaceutical contract management market in the Middle East and Africa is further segmented into Saudi Arabia, the UAE, South Africa, and the Rest of the Middle East and Africa. The market in South and Central America is sub-segmented into Brazil, Argentina, and the Rest of South and Central America.

Company Profiles

• Lonza AG
• Boehringer Ingelheim Biopharmaceuticals GmbH
•  Inno Bio Ventures Sdn Bhd
• Thermo Fisher Scientific, Inc.  
• AbbVie, Inc.
• WuXi Biologics, Inc.
• General Electric Co.
• Samsung Biologics Co. Ltd.
• Merck KGaA
• Ajinomoto Co. Inc.