Pharmaceutical Contract Research And Manufacturing Market Size 2024-2028

The pharmaceutical contract research and manufacturing market size is estimated to grow by USD 141.3 billion at a CAGR of 10.87% between 2023 and 2028. The market is experiencing significant growth, driven by several key trends. One major factor is the availability of cost-efficient resources in emerging markets, particularly in Asia and Eastern Europe, which has attracted numerous pharmaceutical companies to outsource their research and manufacturing activities.  The expansion of biologics and biopharmaceuticals, as well as the growing demand for generic drugs, further contributes to the growth of the CRAM market.  Another trend is the increasing number of US FDA-approved manufacturing facilities in these regions, ensuring regulatory compliance and reducing the need for extensive inspections and approvals. However, the stereotypical nature of CMOs, which can include inconsistent quality, lack of transparency, and communication issues, poses a significant challenge to the market's growth. To mitigate these challenges, CMOs must focus on improving their operational efficiency, enhancing their regulatory compliance, and providing better communication and transparency to their clients. By addressing these challenges, CMOs can establish long-term partnerships with pharmaceutical companies and contribute to the continued growth of the market.

What will be the Size of the Market During the Forecast Period?

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Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

Boehringer Ingelheim International GmbH - The company offers the manufacturing of human pharmaceutical products, animal products, and biopharmaceuticals on a contract basis for other companies. 

The report also includes detailed analysis of the competitive landscape of the market and information about key companies, including:

Almac Group Ltd., Boehringer Ingelheim International GmbH, Cadila Pharmaceuticals Ltd., Catalent Inc., Charles River Laboratories International Inc., Cmic Holdings Co. Ltd, Dr Reddys Laboratories Ltd., ICON plc, IQVIA Holdings Inc., Laboratory Corp. of America Holdings, Lonza Group Ltd., Lupin Ltd., Novotech Health Holdings, OPTIMAPHARM d.o.o., Parexel International Corp., PCI Pharma Services, Recipharm AB, Samsung Electronics Co. Ltd., Syneos Health Inc., and Thermo Fisher Scientific Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Segmentation

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion " for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.

• Service Outlook 
  • CMO
  • CRO
• End-user Outlook
  • Big pharmaceuticals
  • Small and medium-sized pharmaceuticals
  • Generic pharmaceuticals
• Region Outlook 
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • APAC
    • China
    • India
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • Rest of the Middle East & Africa
  • South America
    • Argentina
    • Brazil
    • Chile

By Service Insights

The market share growth of the CMO segment will be significant during the forecast period.  The market is primarily driven by the outsourcing trend among Big Pharmaceutical Companies and biotechnology firms for manufacturing generic drugs, vaccines, antibiotics, and other healthcare products. The increasing focus on cost-effective manufacturing, regulatory compliance, and serialization to counteract counterfeiting in the pharmaceutical ecosystem has further fueled market growth. 

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The CMO segment was valued at USD 91.90 billion in 2018. CMOs (Contract Manufacturing Organizations) are the largest segment of the global CRAM market, providing services such as drug discovery, bioprocess outsourcing, drug development services, and manufacturing services for small molecule drugs, biologics, biosimilars, and active pharmaceutical ingredients (APIs). Advances in medical sciences and the emergence of targeted medication therapies have led to the development of drugs with short half-lives, necessitating advanced manufacturing technologies like continuous manufacturing and specialized services for drug formulation, quality control, and clinical trial support. Major pharmaceutical companies, including Pfizer, Johnson & Johnson, and GlaxoSmithKline, are outsourcing their manufacturing activities to optimize the use of their in-house resources and focus on core competencies. Academic institutes and CROs (contract research organizations) are also contributing to market growth by offering drug development services and clinical trial support. Artificial intelligence (AI) is increasingly being adopted in the CRAM industry for route scouting services, reducing the time and cost of drug development. In conclusion, the pharmaceutical CRAM market is expected to continue growing due to the increasing demand for cost-effective manufacturing, regulatory compliance, and advanced manufacturing technologies.

Regional Analysis

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Asia is estimated to contribute 46% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional market growth and trends will shape the market during the forecast period. The market encompasses clinical and commercial operations, driven by the digitalization trend in drug development processes.

Furthermore, clinical operations involve the planning, execution, and management of clinical trials to ensure patient safety and data integrity. Commercial operations focus on marketing, sales, and distribution of approved drugs. Digitalization facilitates streamlined production workflows, enhancing efficiency and reducing costs. Personalized medicines, a growing segment, require stringent quality standards to cater to unique patient needs. The drug development process involves various stages, from research and development to regulatory approval and commercialization. Adherence to quality standards and continuous innovation are crucial to meet evolving patient demands and regulatory requirements.

Market Dynamics and Customer Landscape

Our researchers analyzed the market research and growth data with 2023  as the base year, along with the key market growth analysis, trends, and challenges. A holistic analysis of drivers, trends, and challenges will help companies refine their marketing strategies to gain a competitive advantage. 

Key Market Drivers

Availability of cost-efficient resources in emerging markets is notably driving market growth. The market has experienced substantial growth due to the outsourcing trend in drug development processes by large and medium-sized pharmaceutical companies from developed countries. This trend is driven by the availability of skilled labor and advanced technological infrastructure at comparatively lower costs in countries like China, India, Brazil, and Mexico. The increasing number of US FDA-approved manufacturing facilities in these countries, such as India's over 100, further encourages outsourcing. The pharmaceutical ecosystem comprises various players, including Big Pharmaceutical Companies, Academic Institutes, Contract Research Organizations (CROs), and Biotech and Pharmaceutical Services Providers. The market encompasses a wide range of services, from drug discovery and development to manufacturing and regulatory compliance.

Furthermore, services offered include route scouting, clinical trials, bioprocess outsourcing, drug formulation, and quality control. Advanced manufacturing technologies, such as continuous manufacturing, serialization, and counterfeiting prevention, are also gaining popularity. The market caters to various drug categories, including small molecule drugs, biologics, biosimilars, and vaccines. The market provides cost-effective manufacturing solutions for active pharmaceutical ingredients (APIs), originator APIs, low potent APIs, and drug candidates. Specialized services, such as targeted medication therapies and drug delivery systems, clinical trial support, and contract manufacturing of oral solids, liquids, and emulsions, are also available. The market's growth is influenced by the increasing demand for cost-effective manufacturing, regulatory compliance, and the development of advanced manufacturing technologies. Artificial Intelligence is also playing an increasingly important role in drug discovery and development processes. Thus, such factors are driving the growth of the market during the forecast period.

Significant Market Trends

Increasing number of US FDA-approved manufacturing facilities is the key trend in the market. The market is experiencing significant growth, particularly in the area of generic drugs. One of the key drivers of this trend is the increasing number of US FDA-approved manufacturing facilities in emerging markets, such as China and India. India, which hosts approximately 400 such facilities, is a leading destination for outsourcing pharmaceutical manufacturing services. With around 230 approved Active Pharmaceutical Ingredient (API) facilities and 150 finished dosage form (FDF) facilities, India boasts the highest number of approved facilities in the world. Additionally, the country has approximately 147 formulation facilities.

Furthermore, the approval of manufacturing facilities in emerging economies like China, India, Mexico, and Brazil is on the rise, contributing to the expansion of the pharmaceutical ecosystem. This trend is especially significant for the production of small molecule drugs, antibiotics, vaccines, and biologics, including biosimilars and targeted medication therapies. Additionally, drug delivery systems and pharmaceutical packaging services play a crucial role in ensuring the safety and efficacy of medications.  Advanced manufacturing technologies, such as artificial intelligence, continuous manufacturing, and specialized services, are increasingly being adopted for cost-effective manufacturing of drug candidates. The market also prioritizes regulatory compliance, clinical trial support, and quality control to ensure the production of safe and effective drugs. The outsourcing of drug discovery, route scouting services, and bioprocess outsourcing to Contract Research Organizations (CROs) and academic institutes further fuels the growth of the pharmaceutical CRAM market. Thus, such trends will shape the growth of the market during the forecast period.

Major Market Challenges

Stereotypical nature of CMOs is the major challenge that affects the growth of the market. The market is witnessing significant growth, particularly in emerging economies like China and India. However, the industry encounters a major challenge with the limited advanced technology offerings from Contract Manufacturing Organizations (CMOs) in these regions. Although healthcare infrastructure in Asia has advanced, CMOs in the area predominantly utilize traditional manufacturing methods. They primarily focus on producing small molecule drugs, which can be mass-produced. However, CMOs in Asia face challenges in manufacturing biological drugs and vaccines at a large scale. This is primarily due to the intricate manufacturing processes of biological drugs, which necessitate advanced technologies.

Consequently, CMOs in the region offer services for drug development, including route scouting, regulatory compliance, and clinical trial outsourcing. They also provide drug discovery services, manufacturing services for active pharmaceutical ingredients (APIs), and drug formulation services. In addition, they offer specialized services such as clinical trial support, serialization, counterfeiting prevention, and drug delivery systems. Big pharmaceutical companies, academic institutes, and contract research organizations (CROs) increasingly outsource these services to ensure cost-effective manufacturing, quality control, and adherence to regulatory standards. Advanced manufacturing technologies like continuous manufacturing, biologics manufacturing, and biosimilars are increasingly being adopted to meet the demands of the pharmaceutical ecosystem. The market encompasses a wide range of offerings, from small molecule drugs to biologics, including targeted medication therapies, drug candidates, and active pharmaceutical ingredients (APIs) in various forms such as oral solids, liquids, emulsions, and drug delivery systems. Hence, the above factors will impede the growth of the market during the forecast period

Key Market Customer Landscape

The market forecast report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market forecasting and growth strategies.

 Customer Landscape

Market Analyst Overview

The market is a significant sector that caters to the needs of Big Pharmaceutical Companies, Academic Institutes, and CROs in the development and production of various pharmaceutical products. The market encompasses a wide range of services, including drug discovery, clinical trials, drug development services, biologics manufacturing, and outsourcing. Key areas of focus in the market are generic drugs, artificial intelligence, and route-scouting services. Generic drugs refer to cheaper versions of brand-name drugs, which are manufactured after the patent expires. advances in medical sciences and the growing adoption of specialty medicines, along with other developments such as nanotechnology and stem cell research, are leading to the emergence of drugs that have a short half-life.  Artificial intelligence plays a crucial role in drug development by analyzing vast amounts of data to identify potential drug candidates and accelerate the discovery process. The Pharmaceutical Ecosystem comprises various stakeholders, including Regulatory Compliance bodies, which ensure the safety and efficacy of drugs through stringent regulations. Clinical Trials are an essential part of the drug development process, and Contract Research Organizations (CROs) provide specialized services to manage and execute these trials.

Furthermore, the market also offers services for Bioprocess Outsourcing, Vaccines, Antibiotics, and Serialization to combat Counterfeiting. Advanced manufacturing technologies, such as Continuous Manufacturing and Specialized services, provide cost-effective manufacturing solutions for Small Molecule Drugs, Active Pharmaceutical Ingredients (APIs), and Drug Formulation. The market also caters to the production of Biosimilars, Biologics, and Drug Delivery Systems. Quality control is a critical aspect of the market, ensuring the production of high-quality products that meet regulatory standards. The demand for cell and gene therapies is driving the growth of integrated drug development services, which encompass the production of both finished dosage forms (FDF) and various active pharmaceutical ingredients, including generic API, originator API, high potent API (HPAPI), and low potent API, all supported by strong clinical operations. The market also offers Clinical Trial Support and services for Oral Solids, Liquids, Emulsions, and other drug forms.

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What are the Key Data Covered in this Market Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting of the market between 2024 and 2028
• Precise estimation of the market size and its contribution to the parent market
• Accurate predictions about upcoming market trends and analysis and changes in consumer behavior
• Growth of the market across Europe, North America, APAC, South America, and Middle East and Africa
• Thorough market growth analysis of the market's competitive landscape and detailed information about companies
• Comprehensive market analysis and report on the factors that will challenge the market research and growth of market companies