Biopharmaceutical Contract Manufacturing Market

Biopharmaceutical Contract Manufacturing Market Size

The size of the global biopharmaceutical contract manufacturing market was worth USD 7.79 billion in 2024. The global market is anticipated to grow at a CAGR of 9.10% from 2025 to 2033 and be worth USD 17.06 billion by 2033 from USD 8.50 billion in 2025.

Biopharmaceutical is a complicated field that combines both pharmaceuticals and healthcare requirements. Formulating, getting approvals, and distributing drugs made for human consumption is difficult, as it has many steps. The manufacturing, research and development, clinical trials, FDA approvals, and logistics/retail and marketing are all critical for the success of a biopharmaceutical company. Therefore, the work and management on multiple fronts can get quite complicated; this is where biopharmaceutical companies hire contract manufacturing agencies to do their work. In addition, contract tract manufacturing companies can help clear the strict regulations of drug manufacturing so that the companies can focus on more research and development. 

MARKET DRIVERS

The global biopharmaceutical contract manufacturing market is majorly driven by the faster pace of production with contract manufacturing organizations, less cost compared to their own manufacturing facilities, and entry-level pharmaceutical production companies looking for investors. In addition, faster approvals for patent sharing, intellectual property copyright rules, higher demand for the drugs by the people, less production capacity, and others are expected to promote the growth rate of the biopharmaceutical contract manufacturing market. Any big pharma giant cannot manufacture every single drug on its own, so they opt for contractual obligations with small companies to produce drugs by entering into an MOU or by investing in the production. The growing adoption of CMOs by biopharmaceutical manufacturers is one of the significant factors propelling the market growth.

There have been a lot of budding entries in the field of CMOS in recent years. This has allowed critical pharmaceutical manufacturers to independently reduce the burden of manufacturing every new drug. Pharma industries see this as an opportunity to reduce their investments in manufacturing by going for outsourcing to these organizations. Due to this, the amount spent on manufacturing can be diverted to the R&D division for efficient drug inventions. For CMOs, there is an opportunity with the biopharmaceutical contract manufacturing market expansion in the form of Mergers, acquisitions, and joint ventures with big companies. These actions make the CMOS realize the opportunities to make their organizations financially stable and technologically capable.

MARKET RESTRAINTS

There are a few restraints for the global biopharmaceutical contract manufacturing market to expand, as the small companies lack specialized experience in biopharmaceutical manufacturing, abuse of patent sharing details, easy reverse engineering of the drug composition formula, etc., are restraining the market from further expansion. These factors provoke the pharma giants to install their production facilities with huge investments, undermining the efficacy of contract manufacturing organizations (CMOS).

Significant challenges faced by the key market players are the lack of technological capabilities of small companies, the lack of strategic management of resources, and the lack of quality oversight. Due to these factors, many big companies opt for in-house production facilities to manufacture biopharmaceutical products. This poses a threat to the expansion of CMOs for further expansion, the lack. Furthermore, the lack of intellectual property rules in many countries and unbridled patent rights in some countries also challenge the market growth of contract manufacturing organizations.

REPORT COVERAGE

SEGMENTAL ANALYSIS

By Product Type Insights

Of all these segments, the vaccines and insulin segments lead the way as these are used in inhibiting diabetes and other seasonal flu cases. Diabetes is a rising problem with growing prevalence worldwide. According to WHO statistics, around 422 million people worldwide have diabetes, further promoting the segment. Additionally, the rising spread of infectious diseases is leading to more vaccines. For instance, the COVID-19 pandemic led to rising demand for vaccination against the disease. According to WHO, as of November 2022, 12,959,275,260 vaccine doses have been delivered worldwide. 

By Therapeutic Area Insights

Out of all these segments, oncological and cardiovascular disease-related segments lead the market, as many pharma companies outsource their oncological drug production to different companies. Additionally, rising cancer and cardiovascular problems worldwide support the growth of the segments. For instance, according to WHO statistics, nearly 10 million deaths, or nearly one in six deaths, were caused by cancer in 2020, making it the leading cause of death globally. On the other hand, with 17.9 million deaths per year, cardiovascular diseases (CVDs) are the leading cause of death worldwide.

By Application Insights

The clinical application market segment registers the highest growth in biopharmaceutical pharma production based on the application. Clinical trials to produce new drugs are essential to determine their capacity in market potential. These trials also help to clear the FDA guidelines for life-saving drugs. Therefore, the entire investment in the research and development of a drug relies heavily on clinical trial procedures. Therefore, the segment is gaining traction because of its importance. 

However, the commercial segment is also expected to show significant growth during the forecast period due to the heavy emphasis on earning revenue from pharma companies. In addition, commercial contract manufacturing companies help large enterprises properly invest and distribute their revenues to earn more profits, driving the segment. 

REGIONAL ANALYSIS

Geographically, the North American biopharmaceutical contract manufacturing market is the leading market for the contract manufacturing of biopharmaceutical products. This can be attributed to the large-scale investments in CMOS and better intellectual property rights-related laws. The North American region takes over the global market primarily based on market collaborations and agreements, as key business strategies lead to growth and expansion worldwide. Such large organizations also buy small-scale biopharmaceutical companies in the Asia Pacific to reinforce their market presence. The Oncology area is witnessing significant growth owing to an increase in cancer-related diseases. The market has also observed growth in R&D and a surge in innovative developments in manufacturing.

The biopharmaceutical contract manufacturing market in Europe had a considerable share of the global market in 2023 and is anticipated to hold a substantial share of the global market during the forecast period.

The APAC biopharmaceutical contract manufacturing market is expected to showcase a promising growth rate with countries such as China, India, Japan, Korea, etc., due to Low operating and manufacturing costs, a desirable location for outsourcing, increasing demand for biologics, partnerships with regional and international organizations, increased consolidation, and the presence of pharma and biopharma companies are all positive factors supporting the growth of the market in the region. 

KEY MARKET PARTICIPANTS

Noteworthy companies operating in the global biopharmaceutical contract manufacturing market profiled in this report are Patheon N.V., Rentschler Biotechnologie GmbH, AbbVie Contract Manufacturing (An AbbVie Company), Biomeva GmbH, Boehringer Ingelheim GmbH, WuXi Biologics, Abzena Plc, Lonza Group AG, Probiogen AG, Sandoz International GmbH, Fujifilm Diosynth Biotechnologies, KBI Biopharma, Inc., Cytovance Biologics, Inc., Baxter Biopharma Solutions, Vetter Pharma International GmbH, Catalent, Inc., Samsung Biologics Co., Ltd., and Ajinomoto Althea, Inc.

Growing pharmaceutical development offers lucrative opportunities for contractual manufacturing organizations to prosper. Recently, the AstraZeneca vaccine for COVID-19 has partnered with Serum Institute of India to manufacture the vaccine; SII has entered into three other Indian firms for manufacturing the vaccine in addition.

In addition, the Russian vaccine giant Gamaleya Research Institute partnered with Dr. Reddy's Laboratories to manufacture the Sputnik vaccine. These agreements are taking place on a large scale due to the increase in the usage of biologics in the field.

RECENT MARKET DEVELOPMENTS

• In November 2022, AstraZeneca agreed to sell its West Chester, Ohio, facility to busy biomanufacturing startup National Resilience. In conjunction with the sale, the pharmaceutical companies reached a "long-term" biomanufacturing agreement, as part of which Resilience will continue to produce "selected AstraZeneca medicines."
• In November 2022, A 15-million-euro ($14.6 million) facility expansion for ReiThera, an Italian biotech and contract manufacturing company, was opened with a focus on large-scale viral vectors for vaccines and gene therapies. According to a November 3 company release, the debut came after operational approval from the Italian Medicines Agency.
• In November 2022, after learning that Fosun Pharma would try to sell off its $3.8 billion company, Gland, the Indian pharmaceutical company, went to the Bombay Stock Exchange to react. Bloomberg News was the first to disclose that Chinese company Fosun consulted an adviser to assess interest in its majority position in Gland. This M&A shock led to a rise in Gland Pharma's shares early on Tuesday. Industry players and buyout firms are evaluating Gland's business, according to people familiar with the situation who spoke with Bloomberg.
• In November 2022, two prominent contract manufacturers from Europe are joining the action amid a wave of CEO changes in the biopharma industry. After seven years as the head of the German CDMO, Frank Mathias, Ph.D., announced Monday that he would be leaving Rentschler.

MARKET SEGMENTATION

This research report on the global biopharmaceutical contract manufacturing market has been segmented and sub-segmented into the following categories.

By Product Type

• Insulin
• Monoclonal Antibodies  
• Growth Factors  
• Interferons  
• Recombinant Proteins
• Vaccines
• Others   

By Therapeutic Area

• Infectious Disease
• Cardiovascular Disease
• Oncology 
• Metabolic Disease
• Respiratory Disorder
• Autoimmune Disease  
• Neurology
• Ophthalmology  
• Others 

By Application

• Clinical
• Commercial

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa