Biopharmaceutical Contract Manufacturing Market Size, Share, Opportunities, And Trends By Source (Mammalian, Non-mammalian), By Product Type (Biologics, Biosimilars), By Service (Process Development, Fill & Finish Operations, Analytical And QC Studies, Packaging And Labeling), By Scale Of Operation (Commercial Operation, Clinical Operations), By Therapeutic Area (Oncology, Autoimmune Diseases, Metabolic Diseases, Cardiovascular Diseases, Neurology, Infectious Diseases, Others), And By Geography - Forecasts From 2024 To 2029

The biopharmaceutical contract manufacturing market is anticipated to expand at a high CAGR over the forecast period.

Biopharmaceutical contract manufacturing is the process of outsourcing the production of biopharmaceuticals, including vaccines, therapeutic proteins, and monoclonal antibodies, to specialist third-party manufacturers. These contract manufacturing organizations (CMOs) provide expertise, facilities, and equipment for the production, purification, and packaging of biopharmaceutical products on behalf of biotechnology and pharmaceutical firms.

Companies can use the CMO's capabilities to accelerate product development, decrease costs, and manage risks associated with manufacturing difficulties and regulatory compliance. This collaborative approach allows biopharmaceutical companies to focus on R&D and commercialization activities while leveraging CMOs' manufacturing knowledge to bring novel medicines to market efficiently and effectively.

This sector provides a variety of services, including cell line development, upstream and downstream processing, formulation, fill-finish, and packaging, among others. The growing complexity of biologics, the necessity for cost-effective manufacturing solutions, and biopharmaceutical companies' desire to focus on core capabilities such as research and development are all key drivers of market expansion. Furthermore, the market is seeing consolidation and strategic partnerships as businesses attempt to extend their skills, geographic reach, and service offerings to satisfy the changing demands of the healthcare industry.

Market Drivers

• Increasing demand for biopharmaceuticals is expected to propel the biopharmaceutical contract manufacturing market.

The global demand for biopharmaceuticals is expanding due to several causes, including the rising frequency of chronic diseases, advances in biotechnology, and an aging population. Biopharmaceuticals, which include monoclonal antibodies, recombinant proteins, and vaccinations, provide focused and effective therapies for a wide range of medical diseases, resulting in their widespread adoption by healthcare practitioners and patients.

Furthermore, an increasing understanding of disease mechanisms at the molecular level has resulted in the development of novel biologics with better therapeutic outcomes and fewer adverse effects than traditional small-molecule medications. As a result, pharmaceutical companies are diversifying their biopharmaceutical portfolios and investing in R&D to capitalize on this enormous market opportunity. This growth in demand is driving the need for greater manufacturing capacity, resulting in pharmaceutical businesses seeking outsourcing solutions from specialist contract manufacturing organizations to meet market demand efficiently and cost-effectively.

According to NCBI, in 2022, biopharmaceutical product sales have increased during the last three years. For example, total sales in 2018 were 26.28 billion yuan, with a slight increase in 2019 (30.34 billion yuan), and sales income soared to nearly 67.91 billion yuan in 2020 (a 123.8% increase). In 2020, the top three biopharmaceutical goods sold were Camrelizumab (5.14 billion yuan), human albumin (4.56 billion yuan), and human immunoglobulin for injection (3.78 billion yuan). In both 2019 and 2018, the top three products with the highest sales were recombinant human thrombopoietin injection (2.4 billion yuan in 2019 vs. 2 billion yuan in 2018), and human albumin (1.97 billion yuan in 2019 vs. 2.1 billion yuan in 2018).

• Robust biopharmaceutical pipelines are anticipated to drive market growth in the biopharmaceutical contract manufacturing industry

Cell and gene treatments are emerging as one of medicine's most dynamic sectors, with a growing number of ongoing research and development initiatives. Many companies and research groups are involved in the development of cell and gene treatments. The leading vendors are increasingly conducting clinical trials to get regulatory approval in the United States, where there is significant untapped potential.  

According to NCBI in 2021, The pipeline for biosimilars continues to grow, with the FDA approving 30 biosimilars and 21 biosimilars set to emerge in the United States by July 2021. The number of biosimilars in the pipeline database increased by 208% in 2020. In the last seven years, the number of biosimilars that have been marketed has climbed by 226%. The current number of biosimilars in the preclinical phase in 2020 versus 2013. has risen equally by 200%. By 2018, the European Union had approved over 40 biosimilars, several of which were successfully commercialized in Australia, Canada, Japan, and South Korea. In the coming years, contract manufacturing for biopharmaceuticals will play an increasingly important role in the worldwide market.

• Surge in manufacturing capacity expected to boost the biopharmaceutical contract manufacturing market.

The globalization of biopharmaceutical supply chains has gained prominence in the sector due to a variety of variables. Pharmaceutical businesses are diversifying their manufacturing locations across multiple geographies to reduce the risks associated with geopolitical instability, natural disasters, and supply chain disruptions. This trend includes not only outsourcing manufacturing to CMOs but also setting up manufacturing plants in strategic places across the world.

Furthermore, rising demand for biopharmaceuticals in emerging regions needs a worldwide approach to production and delivery. Furthermore, advances in transportation and logistics have made cross-border transit of biopharmaceutical products more efficient. Overall, the globalization of biopharmaceutical supply chains strengthens pharmaceutical businesses' resilience, flexibility, and market access, allowing them to better serve worldwide patient populations while effectively managing risks.

Only 37% of the Indian population has health insurance coverage, and the high level of out-of-pocket spending forces families into poverty. Still, India's increasing middle class seeks access to high-quality healthcare and cutting-edge pharmaceuticals, making the country an appealing, emerging market for the creative biopharma sector. India takes pride in being the "pharmacy of the world," producing 20% of the world's generic pharmaceuticals and more than half of its vaccines. The Indian government welcomes investment from global biopharma companies and sees potential for top Indian companies to advance up the value chain and achieve world-class innovation.

Asia Pacific region is expected to grow significantly.

Asian countries are poised to become increasingly attractive destinations for outsourcing the biomanufacturing of large molecules, such as monoclonal antibodies and recombinant proteins. Factors driving this trend include the region's growing expertise in bioprocessing technologies, skilled workforce, and competitive cost structures. Additionally, many Asian countries offer favorable regulatory environments and government incentives to attract foreign investment in the biopharmaceutical sector.

Countries like China, India, South Korea, and Singapore have been investing heavily in building state-of-the-art biomanufacturing facilities and infrastructure, further enhancing their appeal to pharmaceutical companies seeking outsourcing partners. Furthermore, the proximity to rapidly growing markets in Asia-Pacific and the ability to navigate complex supply chain challenges make these countries strategic choices for biopharmaceutical manufacturing outsourcing. As a result, Asian countries are expected to play an increasingly significant role in the global biopharmaceutical contract manufacturing market in the coming years.

According to NCBI, in 2022, China and other developing countries, particularly India, lead the globe in the production of generic medications, making affordable medication available in the majority of low-income countries. In terms of biopharmaceuticals, biosimilars are the generic equivalent.

Market Restraints

• Regulatory compliance leading to constraints in the biopharmaceutical contract manufacturing market.

In the biopharmaceutical contract manufacturing business, regulatory compliance is a critical limitation on operations and strategies. To assure the safety and efficacy of biopharmaceutical medicines, government agencies such as the FDA and EMA establish high-quality standards and regulatory criteria. Contract manufacturers must strictly adhere to these requirements throughout the whole manufacturing process, from raw material procurement to final product release. Failure to comply can lead to serious consequences such as product recalls, regulatory punishments, and reputational harm.

Market Developments

• January 2024: FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines, advanced therapies, and oncolytic viruses, announced today that it will expand its finished goods autoinjector services through a non-exclusive strategic partnership agreement with SHL Medical (SHL), a global solutions provider of advanced drug delivery systems.
• October 2023: Samsung Biologics will offer de-risking, development, manufacturing, and smooth transitions for biologics from early stages to large-scale commercialization. The alliance will streamline the gene-to-IND process, accelerating lead candidate selection and advancing CMC through clinical development. The multi-year agreement aims to promote the biopharmaceutical industry's long-term growth and strengthen Samsung Biologics' presence in the European market.

Segmentation

• By Source
  • Mammalian
  • Non-mammalian
• By Product type
  • Biologics
  • Biosimilars
• By Service
  • Process Development
  • Fill & Finish Operations
  • Analytical and QC studies
  • Packaging and Labeling
• By Scale of operation
  • Commercial Operation
  • Clinical Operations
• By Therapeutic area
  • Oncology
  • Autoimmune Diseases
  • Metabolic Diseases
  • Cardiovascular Diseases
  • Neurology
  • Infectious Diseases
  • Others
• By Geography
  • North America
    • USA
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Taiwan
    • Thailand
    • Indonesia
    • Others