Pharmaceutical Contract Manufacturing Market

Global Pharmaceutical Contract Manufacturing Market Report: By Service (pharmaceutical manufacturing services (pharmaceutical FDF manufacturing services, and pharmaceutical API manufacturing services), biologics manufacturing services (biologics FDF manufacturing services, and biologics API manufacturing services), and drug development services), End User (Big Pharma, Small & Medium-sized Pharma, Generic Pharma), and Region (North America, Europe, Asia-Pacific, Latin America, Middle-East and Africa) Global Industry Analysis, Size, Share, Growth, Trends, Regional Analysis, Competitor Analysis and Forecast 2024-2032.

Pharma & Healthcare | March 2024 | Report ID: EMR00653 | Pages: 253

Global Pharmaceutical Contract Manufacturing market is predicted to reach approximately USD 229.75 billion by 2032, at a CAGR of 6.95% from 2024 to 2032.

The Global Pharmaceutical Contract Manufacturing market refers to the outsourcing of pharmaceutical production processes by pharmaceutical companies to third-party organizations specializing in manufacturing. This practice allows pharmaceutical firms to focus on core competencies such as research, development, and marketing, while leveraging the expertise and infrastructure of contract manufacturing organizations (CMOs) to produce drugs efficiently and cost-effectively.

The market encompasses a wide range of services including formulation development, API synthesis, manufacturing, packaging, and labeling. It serves various segments of the pharmaceutical industry including small biotech firms, generic drug manufacturers, and large multinational pharmaceutical companies. The increasing complexity of drug development, stringent regulatory requirements, cost pressures, and the need for flexible manufacturing capacity have fuelled the growth of the global pharmaceutical contract manufacturing market.

The demand for biologics, specialty medications, and generic drugs has all increased significantly in recent years, and the complexity of pharmaceutical formulations has also increased. These factors have contributed to the strong growth of the global pharmaceutical contract manufacturing market. The pharmaceutical industry's globalisation, the development of new technologies, and outsourcing trends that maximise operational effectiveness and cut manufacturing costs all contribute to market expansion. Furthermore, the COVID-19 pandemic has highlighted the significance of robust and flexible supply chains, leading pharmaceutical companies to collaborate with contract manufacturers to guarantee continuous drug supply and minimise the hazards linked to interruptions in manufacturing processes.

 

 

Global Pharmaceutical Contract Manufacturing report scope and segmentation.

Report Attribute

Details

Estimated Market Value (2023)

USD 125.53 billion

Projected Market Value (2032)

USD 229.75 billion

Base Year

2023

Forecast Years

2024 – 2032

Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment- Based on By Services, By End-User, & Region.

Segments Covered

By Services, By End-User, & By Region.

Forecast Units

Value (USD Billion or Million), and Volume (Units)

Quantitative Units

Revenue in USD million/billion and CAGR from 2024 to 2032.

Regions Covered

North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Countries Covered

U.S., Canada, Mexico, U.K., Germany, France, Italy, Spain, China, India, Japan, South Korea, Brazil, Argentina, GCC Countries, and South Africa, among others.

Report Coverage

Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, market attractiveness analysis by segments and region, company market share analysis.

Delivery Format

Delivered as an attached PDF and Excel through email, according to the purchase option.

 

Global Pharmaceutical Contract Manufacturing dynamics

Pharmaceutical companies are finding it more and more necessary to outsource their manufacturing processes to contract manufacturing organisations (CMOs) with specialised infrastructure and expertise in order to cut costs and increase operational efficiency. Furthermore, the need for CMOs with advanced manufacturing skills and technological know-how is being driven by the increasing complexity of drug development, which includes the emergence of biologics and specialty medicines. Additionally, as the pharmaceutical industry becomes more globalised, contract manufacturing organisations (CMOs) are extending their reach geographically by setting up shop in emerging markets in order to take advantage of the rising demand for pharmaceutical products.

Furthermore, the evolving regulatory landscape, characterized by stringent quality standards and compliance requirements, is shaping the competitive dynamics of the pharmaceutical contract manufacturing market. CMOs must continuously invest in regulatory compliance, quality assurance, and risk management to maintain market competitiveness and meet the evolving needs of pharmaceutical clients. Additionally, technological advancements such as automation, robotics, and digitalization are transforming manufacturing processes, enabling CMOs to enhance operational efficiency, reduce production costs, and accelerate time-to-market for pharmaceutical products.

 

Global Pharmaceutical Contract Manufacturing drivers

  • Increasing Demand for Outsourcing Services:

The growing need from pharmaceutical companies to outsource manufacturing processes to specialised contract manufacturing organisations (CMOs) is driving the pharmaceutical contract manufacturing market. Pharmaceutical companies can concentrate on their core skills, like marketing, R&D, and production, by outsourcing. At the same time, they can take advantage of CMOs' infrastructure and experience to expedite time-to-market, cut costs, and streamline manufacturing processes. Furthermore, the need for CMOs with advanced manufacturing capabilities and experience managing complex formulations and production processes is being driven by the growing complexity of drug development, which includes the introduction of biologics and specialty medicines. As pharmaceutical companies continue to look for strategic partnerships with CMOs to maximise operational efficiency and boost competitiveness in the global pharmaceutical market, this trend is anticipated to fuel market growth.

  • Technological Advancements and Innovation:

Innovation in pharmaceutical contract manufacturing is being driven by technological advancements like automation, robotics, and digitalization. These advancements allow CMOs to lower production costs, improve product quality, and increase operational efficiency. Robotics and automation improve production throughput, reduce human error, and streamline manufacturing processes, which boosts productivity and lowers costs for CMOs and their pharmaceutical clients. Additionally, digitalization makes data analytics, predictive maintenance, and real-time monitoring easier. This helps CMOs find possible bottlenecks, optimise production schedules, and enhance overall manufacturing performance. Furthermore, CMOs can now provide creative solutions for customised medications, novel therapies, and intricate drug delivery systems thanks to developments in formulation technologies and manufacturing processes. This opens up new avenues for CMO growth and differentiation in the global pharmaceutical contract manufacturing market.

 

Restraints:

  • Regulatory Challenges and Compliance Requirements:

The global regulatory authorities have imposed strict compliance standards and requirements on the pharmaceutical contract manufacturing market. In order to guarantee product safety, effectiveness, and quality throughout the manufacturing process, CMOs are required to abide by Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and other regulatory guidelines. For CMOs, complying with regulatory requirements means making large investments in technology, infrastructure, and employee training, which raises operational costs and complicates operations. Furthermore, CMOs face difficulties in maintaining regulatory compliance and adjusting to new regulatory requirements due to regulatory uncertainties, shifting guidelines, and evolving compliance standards. This could potentially delay product approvals and have an impact on pharmaceutical clients' access to the market.

  • Intellectual Property Protection and Confidentiality Concerns:

Intellectual property (IP) protection and confidentiality concerns pose significant restraints to the pharmaceutical contract manufacturing market. Pharmaceutical companies are increasingly reliant on CMOs to manufacture proprietary formulations and specialty medicines, raising concerns about IP theft, unauthorized replication, and data breaches. Protecting confidential information, trade secrets, and proprietary technologies is paramount for pharmaceutical companies and CMOs to safeguard their competitive advantage and maintain trust and confidence in their business relationships. However, ensuring robust IP protection measures, implementing secure data management systems, and enforcing stringent confidentiality agreements require substantial investment in cybersecurity infrastructure and compliance mechanisms, increasing operational costs and complexity for CMOs and their pharmaceutical clients. Additionally, navigating IP disputes, contractual breaches, and legal challenges related to confidentiality breaches can disrupt business operations, damage reputations, and undermine market competitiveness, highlighting the importance of proactive risk management strategies and effective IP protection mechanisms in the pharmaceutical contract manufacturing market.

 

Opportunities:

  • Diversification of Service Offerings:

Diversifying service offerings presents another key opportunity for CMOs to enhance competitiveness, expand market reach, and capture new revenue streams in the pharmaceutical contract manufacturing market. With the increasing complexity of drug development and evolving customer demands, there is growing demand for integrated services and end-to-end solutions encompassing formulation development, process optimization, analytical testing, packaging, and regulatory support. CMOs can differentiate themselves by offering specialized expertise in niche therapeutic areas, innovative drug delivery technologies, and value-added services such as supply chain management, inventory optimization, and post-marketing surveillance. Moreover, strategic investments in advanced manufacturing technologies, such as continuous manufacturing, personalized medicine platforms, and biopharmaceutical manufacturing, enable CMOs to address unmet needs, accelerate innovation, and capitalize on emerging trends shaping the future of the pharmaceutical industry.

 

Segment Overview

  • By Services

In terms of services, the market encompasses pharmaceutical manufacturing services, including finished dosage form (FDF) manufacturing and active pharmaceutical ingredient (API) manufacturing, biologics manufacturing services covering both FDF and API manufacturing, and drug development services. Pharmaceutical manufacturing services involve the production of finished pharmaceutical products and active ingredients, catering to the formulation and synthesis needs of pharmaceutical companies across various therapeutic areas. Biologics manufacturing services specialize in the production of biological drugs, including monoclonal antibodies, recombinant proteins, and cell therapies, which require specialized facilities and expertise in bioprocessing technologies. Drug development services encompass a range of activities from preclinical research and formulation development to clinical trial manufacturing and regulatory support, facilitating the development and commercialization of pharmaceutical products.

  • By End-Use

In terms of end-users, the pharmaceutical contract manufacturing market serves a wide spectrum of clients, including big pharmaceutical companies, generic pharmaceutical companies, small and medium-sized pharmaceutical companies, and others. Big pharmaceutical companies represent established multinational corporations with extensive product portfolios, global market presence, and significant R&D investments. These companies rely on contract manufacturing services to optimize manufacturing capacity, reduce production costs, and accelerate time-to-market for new drug candidates. Generic pharmaceutical companies specialize in the production of off-patent drugs and generic equivalents, leveraging contract manufacturing partnerships to enhance production efficiency, maintain competitiveness, and meet regulatory requirements in diverse markets. Small and medium-sized pharmaceutical companies encompass a diverse group of companies ranging from startups and biotech firms to mid-sized enterprises, which often lack the resources and infrastructure to establish in-house manufacturing capabilities. These companies partner with contract manufacturers to access specialized expertise, scale manufacturing capacity, and navigate regulatory complexities, enabling them to focus on core competencies such as research, development, and commercialization.

 

Global Pharmaceutical Contract Manufacturing Overview by Region

North America dominates the market, fuelled by a robust pharmaceutical industry, strong regulatory standards, and a significant presence of large pharmaceutical companies outsourcing manufacturing activities to contract manufacturing organizations (CMOs). The region benefits from a mature healthcare system, advanced manufacturing capabilities, and a favourable business environment conducive to innovation and collaboration.

Europe follows closely, characterized by stringent regulatory requirements, technological advancements, and strategic partnerships between CMOs and pharmaceutical firms. The region's established pharmaceutical market, coupled with increasing investments in biologics and specialty medicines, drives demand for contract manufacturing services. Asia-Pacific emerges as a rapidly growing market, driven by factors such as rising healthcare expenditure, expanding pharmaceutical industry, and favourable government initiatives promoting outsourcing and investment in healthcare infrastructure.

Countries like China and India offer cost-effective manufacturing solutions, skilled workforce, and growing expertise in biopharmaceuticals, positioning the region as a key hub for pharmaceutical contract manufacturing. Latin America and the Middle East & Africa regions present untapped potential, driven by increasing healthcare spending, improving regulatory environments, and growing demand for affordable and accessible medicines. These regions offer opportunities for CMOs to expand market presence, forge strategic alliances, and capitalize on emerging trends shaping the global pharmaceutical contract manufacturing market. However, regional disparities in regulatory compliance, intellectual property protection, and infrastructure development pose challenges to market growth and require tailored strategies to navigate market complexities and unlock growth opportunities effectively.

 

 

Global Pharmaceutical Contract Manufacturing market competitive landscape

Leading contract manufacturing organizations (CMOs) such as Lonza Group AG, Catalent, Inc., and Patheon Inc. (a part of Thermo Fisher Scientific Inc.) dominate the market with their extensive manufacturing capabilities, global presence, and diversified service offerings spanning pharmaceuticals, biologics, and drug development services. These market leaders leverage their technological expertise, regulatory compliance, and economies of scale to cater to the evolving needs of pharmaceutical clients, drive innovation, and maintain competitive positioning in the market. Additionally, mergers, acquisitions, and strategic alliances are prominent features of the competitive landscape, enabling key players to expand market reach, enhance service capabilities, and capitalize on emerging opportunities in the pharmaceutical contract manufacturing market.

Moreover, niche CMOs specializing in specific therapeutic areas, dosage forms, or manufacturing technologies carve out distinct market niches, offering customized solutions, flexibility, and agility to meet the diverse needs of pharmaceutical clients. Emerging players in regions like Asia-Pacific and Latin America are gaining traction, driven by factors such as cost advantages, regulatory harmonization, and increasing investments in healthcare infrastructure. These players focus on technology adoption, quality assurance, and customer-centric strategies to gain market share, build brand reputation, and establish long-term partnerships with pharmaceutical companies.

 

Global Pharmaceutical Contract Manufacturing Recent Developments

  • Oct 2023, Samsung Biologics (KRX: 207940.KS), a leading global contract development and manufacturing organization (CDMO), has entered into a strategic partnership with Kurma Partners, a prominent European venture capital firm specializing in healthcare and biotechnology. The collaboration aims to facilitate the development and manufacturing of biologics for companies within Kurma Partners' portfolio.
  • Oct 2023, Quotient Sciences, a leading pharmaceutical company, has significantly expanded its sterile fill/finish capabilities at its Alnwick, UK facility through a major investment. This strategic initiative will augment the existing capacity of the Annex 1 compliant facility, allowing it to effectively address the rising industry demand for comprehensive drug development programs.

 

Scope of Global Pharmaceutical Contract Manufacturing report

Global Pharmaceutical Contract Manufacturing report segmentation

ATTRIBUTE

DETAILS

By Services

  • pharmaceutical manufacturing services (pharmaceutical FDF manufacturing services, and pharmaceutical API manufacturing services),
  • Biologics manufacturing services (biologics FDF manufacturing services, and biologics API manufacturing services),
  • Drug development services

By End-User

  • Big pharmaceutical companies
  • Generic pharmaceutical companies
  • Small & medium-sized pharmaceutical companies
  • Others.

By Geography

  • North America (USA, and Canada)
  • Europe (UK, Germany, France, Italy, Spain, Russia and Rest of Europe)
  • Asia Pacific (Japan, China, India, Australia, Southeast Asia and Rest of Asia Pacific)
  • Latin America (Brazil, Mexico, and Rest of Latin America)
  • Middle East & Africa (South Africa, GCC, and Rest of Middle East & Africa)

Customization Scope

  • Available upon request

Pricing

  • Available upon request

 

Objectives of the Study

The objectives of the study are summarized in 5 stages. They are as mentioned below:

  • Global Pharmaceutical Contract Manufacturing size and forecast: To identify and estimate the market size for Global Pharmaceutical Contract Manufacturing market segmented by Services, By End-User, and by region. Also, to understand the consumption/ demand created by consumers between 2024 and 2032.
  • Market Landscape and Trends: To identify and infer the drivers, restraints, opportunities, and challenges for Global Pharmaceutical Contract Manufacturing
  • Market Influencing Factors: To find out the factors which are affecting the market of Global Pharmaceutical Contract Manufacturing among consumers.
  • Company Profiling:  To provide a detailed insight into the major companies operating in the market. The profiling will include the financial health of the company's past 2-3 years with segmental and regional revenue breakup, product offering, recent developments, SWOT analysis, and key strategies.

Research Methodology

Our research methodology has always been the key differentiating reason which sets us apart in comparison from the competing organizations in the industry. Our organization believes in consistency along with quality and establishing a new level with every new report we generate; our methods are acclaimed and the data/information inside the report is coveted. Our research methodology involves a combination of primary and secondary research methods. Data procurement is one of the most extensive stages in our research process. Our organization helps in assisting the clients to find the opportunities by examining the market across the globe coupled with providing economic statistics for each and every region.  The reports generated and published are based on primary & secondary research. In secondary research, we gather data for global Market through white papers, case studies, blogs, reference customers, news, articles, press releases, white papers, and research studies. We also have our paid data applications which includes hoovers, Bloomberg business week, Avention, and others.

Data Collection

Data collection is the process of gathering, measuring, and analyzing accurate and relevant data from a variety of sources to analyze market and forecast trends. Raw market data is obtained on a broad front. Data is continuously extracted and filtered to ensure only validated and authenticated sources are considered. Data is mined from a varied host of sources including secondary and primary sources.

Primary Research

After the secondary research process, we initiate the primary research phase in which we interact with companies operating within the market space. We interact with related industries to understand the factors that can drive or hamper a market. Exhaustive primary interviews are conducted. Various sources from both the supply and demand sides are interviewed to obtain qualitative and quantitative information for a report which includes suppliers, product providers, domain experts, CEOs, vice presidents, marketing & sales directors, Type & innovation directors, and related key executives from various key companies to ensure a holistic and unbiased picture of the market. 

Secondary Research

A secondary research process is conducted to identify and collect information useful for the extensive, technical, market-oriented, and comprehensive study of the market. Secondary sources include published market studies, competitive information, white papers, analyst reports, government agencies, industry and trade associations, media sources, chambers of commerce, newsletters, trade publications, magazines, Bloomberg BusinessWeek, Factiva, D&B, annual reports, company house documents, investor presentations, articles, journals, blogs, and SEC filings of companies, newspapers, and so on. We have assigned weights to these parameters and quantified their market impacts using the weighted average analysis to derive the expected market growth rate.

Top-Down Approach & Bottom-Up Approach

In the top – down approach, the Global Batteries for Solar Energy Storage Market was further divided into various segments on the basis of the percentage share of each segment. This approach helped in arriving at the market size of each segment globally. The segments market size was further broken down in the regional market size of each segment and sub-segments. The sub-segments were further broken down to country level market. The market size arrived using this approach was then crosschecked with the market size arrived by using bottom-up approach.

In the bottom-up approach, we arrived at the country market size by identifying the revenues and market shares of the key market players. The country market sizes then were added up to arrive at regional market size of the decorated apparel, which eventually added up to arrive at global market size.

This is one of the most reliable methods as the information is directly obtained from the key players in the market and is based on the primary interviews from the key opinion leaders associated with the firms considered in the research. Furthermore, the data obtained from the company sources and the primary respondents was validated through secondary sources including government publications and Bloomberg.

Market Analysis & size Estimation

Post the data mining stage, we gather our findings and analyze them, filtering out relevant insights. These are evaluated across research teams and industry experts. All this data is collected and evaluated by our analysts. The key players in the industry or markets are identified through extensive primary and secondary research. All percentage share splits, and breakdowns have been determined using secondary sources and verified through primary sources. The market size, in terms of value and volume, is determined through primary and secondary research processes, and forecasting models including the time series model, econometric model, judgmental forecasting model, the Delphi method, among Flywheel Energy Storage. Gathered information for market analysis, competitive landscape, growth trends, product development, and pricing trends is fed into the model and analyzed simultaneously.

Quality Checking & Final Review

The analysis done by the research team is further reviewed to check for the accuracy of the data provided to ensure the clients’ requirements. This approach provides essential checks and balances which facilitate the production of quality data. This Type of revision was done in two phases for the authenticity of the data and negligible errors in the report. After quality checking, the report is reviewed to look after the presentation, Type and to recheck if all the requirements of the clients were addressed.

Frequently Asked Questions

Global Pharmaceutical Contract Manufacturing forecast period is 2024 - 2032
According to Global Pharmaceutical Contract Manufacturing research, the market is expected to grow at a CAGR of ~ 6.95% over the next eight years.
The possible segments in Global Pharmaceutical Contract Manufacturing are based on by Services, By End-User, & by region.
The expected market size for Global Pharmaceutical Contract Manufacturing is USD 125.53 billion in 2023.
The major players in the market are Lonza Group AG, Catalent, Inc., Thermo Fisher Scientific Inc., Patheon N.V., Evonik Industries AG, AbbVie Contract Manufacturing, Boehringer Ingelheim GmbH, Recipharm AB, Jubilant Life Sciences Limited and Dr. Reddy's Laboratories Ltd.