Ultra Market Research | Global Biopharmaceutical CMO and CRO Market
Biopharmaceutical CMO and CRO market growth – Outsourcing services driving innovation in drug development

Global Biopharmaceutical CMO and CRO Market

  • Report ID : 593

  • Category : Pharmaceuticals

  • No Of Pages : 140

  • Published on: July 2024

  • Status: Published

  • Format : Power Point PDF Excel Word

Key Question Answer

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Global Market Outlook

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In-depth analysis of global and regional trends

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Analyze and identify the major players in the market, their market share, key developments, etc.

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To understand the capability of the major players based on products offered, financials, and strategies.

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Identify disrupting products, companies, and trends.

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To identify opportunities in the market.

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Analyze the regional penetration of players, products, and services in the market.

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Comparison of major players financial performance.

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Evaluate strategies adopted by major players.

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Recommendations

Global Biopharmaceutical CMO and CRO Market 

The global biopharmaceutical CMO and CRO market was valued at US$ XX billion in 2023 and is anticipated to reach approximately US$ XX billion by 2033, growing at a CAGR of XX% from 2024 to 2033. The increasing reliance on outsourced services in the biopharmaceutical sector has driven demand for Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). CROs offer comprehensive research and development services throughout clinical trials, while CMOs focus on the large-scale production of drugs, including the primary synthesis of drug substances and the secondary formulation into various dosage forms. This trend toward outsourcing has led to a greater emphasis on talent acquisition within CROs and CMOs, fostering specialized expertise and operational efficiency. By leveraging these external partnerships, pharmaceutical companies can better manage internal resources and costs, transforming the relationship between CROs and CMOs into a strategic alliance. This collaborative approach not only supports industry growth but also enhances flexibility and innovation in biopharmaceutical development and manufacturing.

 

Market Overview
The biopharmaceutical CMO and CRO market is rapidly expanding as pharmaceutical and biotechnology companies increasingly rely on outsourced services for research, development, and manufacturing. Contract Research Organizations (CROs) provide essential support throughout the phases of clinical trials, offering expertise in clinical research, regulatory affairs, and trial logistics. Meanwhile, Contract Manufacturing Organizations (CMOs) facilitate the efficient production of drug substances, ensuring compliance with stringent quality standards and regulatory requirements. This outsourcing trend enhances cost-effectiveness by providing access to advanced facilities and skilled personnel, and it accelerates drug development timelines, positioning CMOs and CROs as crucial partners in the industry's growth and innovation efforts.

  • In April 2024, Parexel and Palantir expanded their collaboration to accelerate clinical data delivery and improve clinical outcomes for patients.
  • In October 2023, Anju welcomed Atherion Bioresearch as its newest CRO partner.
     

Key Insights
North America held the largest market share globally.
The Asia-Pacific region is expected to expand at the highest CAGR.
The contract manufacturing segment held the largest market share by service.
The contract research segment is anticipated to grow at the fastest rate.
The mammalian segment led the market by source.
The non-mammalian segment is projected to expand at the fastest CAGR over the forecast period.
The biologics segment generated the largest market share by product type.
The biosimilars segment is estimated to grow at the fastest CAGR over the forecast period.
 

Regional Stance
North America continues to dominate the pharmaceutical market, maintaining the largest share throughout the forecast period. The U.S. pharmaceutical industry leads in developing innovative drugs, which, although often expensive, significantly contribute to healthcare costs for both private sectors and federal agencies. In Canada, the focus of Contract Research Organizations (CROs) on histopathology and genomics services highlights growing capabilities in advanced medical research. For example, CellCarta in Canada offers diverse biomarker platforms and services, including antigen presentation, bioanalytical solutions, and immune profiling, which enhance capabilities in biologics characterization and data mining. Mexico's evolving healthcare sector, with recent reforms in procurement and distribution systems, positions it as a critical market for various healthcare products and services. These regional dynamics underscore North America's pivotal role in pharmaceutical innovation and healthcare advancements.

In September 2023, Canadian CRO Cirion Biopharma was acquired by French diagnostic group Cerba HealthCare.
The Asia-Pacific region emerges as a highly promising market during the forecast period, driven by shifting dynamics in pharmaceutical outsourcing and strategic location decisions. Beyond being a manufacturing hub, Asia is increasingly recognized as pivotal in global drug discoveries. Pharmaceutical companies are expanding their presence in Asia to capitalize on its growing significance as both a consumer market and a hub for manufacturing and human capital. India, in particular, is gaining traction as a preferred destination for biotechnology outsourcing, attracting global biopharmaceutical firms seeking cost efficiencies in development and manufacturing. This trend reflects a strategic move by "Big Pharma" to optimize operational costs while leveraging Asia's expanding capabilities in biopharmaceutical innovation and production.

 

Market Segmentation
By Service
The contract manufacturing segment continues to lead the market in revenue share, driven by its ability to help pharmaceutical companies enhance productivity and efficiency while ensuring quality products. Partnering with contract manufacturing organizations (CMOs) allows pharmaceutical firms to achieve significant cost savings and access specialized services that optimize manufacturing processes. This strategic collaboration boosts productivity and improves overall quality control, making CMOs preferred partners in the pharmaceutical industry. The key benefits include operational efficiencies, cost-effectiveness, and enhanced capabilities in delivering high-quality pharmaceutical products to meet market demands.

The contract research segment is poised to gain momentum in the forecast period as contract research organizations (CROs) play a critical role in providing specialized research services to the biotechnology, pharmaceutical, and medical device industries, along with academic institutions. Whether offering comprehensive full-service capabilities or specialized services, CROs are pivotal partners for pharmaceutical companies in advancing research and development initiatives. Their contributions are instrumental in shaping advancements in life sciences and healthcare, facilitating innovation and efficiency across the sector. This growing reliance on CROs underscores their significance in driving research excellence and supporting pharmaceutical companies in achieving their scientific and commercial objectives.

 

By Source
The mammalian segment has emerged as the leader in the market, commanding the largest share due to the burgeoning potential of biopharmaceuticals. This segment focuses on producing medicinal products through mammalian cell cultures, encompassing a wide array of therapeutic substances such as hormones, enzymes, cytokines, clotting factors, antibodies, and fusion protein therapeutics. The utilization of mammalian cell cultures offers significant commercial opportunities for drug developers by enabling the production of complex biologics that meet diverse medical needs. This growth underscores the pivotal role of mammalian sources in advancing biopharmaceutical research and expanding therapeutic options in the healthcare sector.

The non-mammalian segment is anticipated to experience growth in the forecast period, driven by efforts to overcome historical challenges in producing biologically active whole antibodies through systems like yeast or bacteria cultures. Previous limitations related to achieving proper folding and glycosylation have posed hurdles. Advancements in biotechnology and genetic engineering are enhancing the potential of non-mammalian sources to produce complex biologics more effectively. These developments are poised to expand the scope of non-mammalian cell culture systems in biopharmaceutical production, offering new opportunities for innovation and commercialization in the healthcare industry.

 

By Product Type
The biologics segment has emerged as the leader in the market, commanding the largest share. Biologics, also known as biological drugs, are manufactured using living organisms such as microorganisms, plant cells, or animal cells. They have long been integral to medical treatments, particularly in oncology, where they are used to combat cancer by slowing tumor growth and aiding recovery from other anti-cancer therapies. The growth of biologics underscores their therapeutic importance and increasing adoption in diverse disease treatments, driven by advancements in biotechnology and the demand for targeted and personalized medicine solutions. This trend highlights biologics as pivotal drivers of innovation and growth in the pharmaceutical and healthcare sectors.

The biosimilars segment is poised for growth in the forecast period as these biologic products are designed to replicate FDA-approved reference biologics with high similarity in safety, purity, and potency. Biosimilars undergo rigorous testing and trials by manufacturers to demonstrate their equivalence to the reference product, ensuring they meet stringent regulatory standards. This segment offers significant opportunities by providing cost-effective alternatives to expensive biologics, thereby enhancing patient access to essential treatments. As healthcare systems worldwide seek to contain costs while maintaining treatment efficacy, biosimilars play a crucial role in expanding therapeutic options and fostering competition in the biopharmaceutical market. The anticipated growth of biosimilars underscores their potential to drive innovation and affordability in biologic therapies, benefiting both patients and healthcare providers.

 

Market Dynamics

Driver
The Role of CROs and CMOs in Biopharmaceutical Development
The demand for cost-effective development and manufacturing of biopharmaceutical products is escalating amidst global healthcare systems' efforts to enhance efficiency and curb costs. In response, industries are reassessing and optimizing their internal processes. Outsourcing to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) has emerged as a pivotal trend, facilitating streamlined operations and expanding market opportunities. This strategic shift supports industry adaptability and fosters growth in the biopharmaceutical CMO and CRO market, driven by the need for specialized expertise and enhanced operational efficiency.

In May 2024, BioConnection and AGC Biologics formed a strategic partnership.
 

Restraints
Risk Management Challenges
Pharmaceutical companies engaged in outsourcing agreements must prioritize risk management, especially given the critical nature of supply chain strategies. The sector faces significant risks associated with logistics outsourcing, influenced by internal and external factors. To navigate these challenges effectively, organizations require a systematic and disciplined approach to identify and mitigate risks. Factors such as market dynamics, competitive pressures, technological advancements, evolving client demands, reduced response times, and strategic global outsourcing pose continuous risks that can hinder the growth of the biopharmaceutical CMO and CRO market. Addressing these complexities is essential to sustain operational resilience and foster growth in an increasingly dynamic industry environment.

 

Opportunities
The Evolution of Biopharmaceutical Outsourcing in CMOs and CROs
Outsourcing has become indispensable in the biopharmaceutical industry, with contract manufacturing organizations (CMOs) playing a critical role in meeting high-volume production demands for vaccines and therapies. Beyond capacity, outsourcing offers pharmaceutical companies essential benefits such as cost control, resource optimization, and expedited market entry. CMOs are poised to expand outsourcing across analytical and toxicity testing and fill/finish operations, driven by increasing demands and the need for advanced services. Simultaneously, pharmaceutical firms are outsourcing research activities to maintain competitiveness amidst rapid technological advancements and economic uncertainties. This strategic shift toward outsourcing creates substantial growth opportunities for both biopharmaceutical CMOs and contract research organizations (CROs), fostering innovation and flexibility in a dynamic industry landscape.

In January 2023, Agilent and Akoya Bios

 

Key Players in the Cell and Gene Supply Chain Services Market

Lonza

JRS Pharma

Samsung Biologics

CMC Biologics

TOYOBO Co. Ltd.

Rentschler Biotechnologies

FUJIFILM Diosynth Biotechnologies

WuXi Biologics

Patheon

Boehringer Ingelheim

PRA Health Sciences

LabCorp

 

Market Segmentation

By Service

  • Contract Manufacturing
  • Process Development
  • Upstream
  • Downstream
  • Fill & Finish Operations
  • Analytical & QC studies
  • Packaging
  • Contract Research
  • Inflammation & Immunology
  • Cardiology
  • Oncology
  • Neuroscience
  • Others

 

By Source

  • Mammalian
  • Non-Mammalian

 

By Product

  • Biologics
  • Vaccines
  • Monoclonal antibodies (MABs)
  • Recombinant Proteins
  • Antisense, RNAi, & Molecular Therapy
  • Others

 

By Geography

North America

  • U.S.
  • Canada
  • Europe
  • Germany
  • France
  • United Kingdom
  • Rest of Europe

Asia Pacific

  • China
  • Japan
  • India
  • Southeast Asia
  • Rest of Asia Pacific

Latin America

  • Brazil
  • Rest of Latin America

Middle East & Africa (MEA)

  • GCC
  • North Africa
  • South Africa
  • Rest of Middle East & Africa

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