The global pharmaceutical market has experienced significant growth in recent years. For 2024, the total global pharmaceutical market was estimated at around *** trillion U.S. dollars. This is an increase of roughly *** billion dollars compared to 2023. Global pharmaceutical markets Globally, the United States is by far the leading market for pharmaceuticals, followed by other developed countries and emerging markets. Emerging markets can include middle and low-income countries such as Brazil, India, Russia, Colombia and Egypt, to name a few. Despite increasing revenues globally, the Latin American region accounts for the lowest share of the global pharmaceutical market’s revenues. Top pharmaceuticals globally The top pharmaceutical products sold globally include Humira, Eliquis and Revlimid. Oncology is the op therapeutic area for drug sales globally, and it is expected to show the largest growth over the next years. It is followed by drug spending for autoimmune diseases and diabetes. During the height of the COVID-19 pandemic, Comirnaty was the world's top revenue generating pharmaceutical product.

This statistic describes the global pharmaceutical sales in from 2020 to 2024, sorted by regional submarkets. For 2024, total pharmaceutical sales in the United States was estimated to reach around *** billion U.S. dollars. World pharmaceutical sales by regionThe pharmaceutical industry is best known for manufacturing pharmaceutical drugs which aim to diagnose, cure, treat, or prevent diseases. The pharmaceutical sector represents a huge industry, with the global market being worth around *** trillion U.S. dollars. Among the best known top global pharmaceutical companies are Pfizer, Merck and Johnson & Johnson from the U.S., Novartis and Roche from Switzerland, Sanofi from France, etc. Accordingly, North America and Europe are still among the largest global submarkets for pharmaceuticals. In 2024, the United States was still the largest single pharmaceutical market, generating more than *** billion U.S. dollars of revenue. Europe was responsible for generating around *** billion U.S. dollars. These two markets, together with Japan, Canada and Australia, form the so-called established (or developed) markets. The rest of the global pharmaceutical revenue is mainly from emerging markets, which include countries like China, Russia, Brazil and India. In fact, these emerging markets show the fastest increase in pharmaceutical sales. Latin America is the world region with the highest predicted compound annual growth rate until 2028.

Introduction

Global Specialty Pharmaceutical Market is poised for rapid expansion, projected to surge from US$ 68.3 billion in 2023 to approximately US$ 1532.8 billion by 2033, representing a CAGR of 36.5%.

The specialty pharmaceutical market is experiencing growth driven by key factors, such as continuous innovation and biopharmaceutical research. The industry's commitment to developing advanced treatment options is instrumental in achieving more precise disease targeting while minimizing side effects, which is especially relevant for complex conditions like autoimmune diseases and cancers.

Technological advancements, particularly Pharma 4.0, are reshaping pharmaceutical manufacturing through digitalization and automation. These innovations are crucial for enhancing production efficiency and flexibility, enabling real-time release testing and the implementation of digital twins to optimize manufacturing processes. Such technological shifts significantly boost productivity and ensure strict regulatory compliance within the industry.

Additionally, evolving regulatory policies are profoundly influencing the specialty pharmaceutical market. Changes in drug pricing and reimbursement models, with an increased emphasis on value-based and transparent pricing mechanisms, directly impact market dynamics. These regulatory adjustments are essential for determining pricing and reimbursement rates for specialty drugs, shaping overall market trends.

Recent regulatory approvals further highlight the sector's rapid development. Noteworthy approvals include Pfizer Inc. and BioNTech SE's COVID-19 booster targeting Omicron BA.4/BA.5, AbbVie Inc.'s Rinvoq for ulcerative colitis, and Amgen Inc.'s Enbrel for non-radiographic axial spondyloarthritis. These approvals exemplify the ongoing innovation within the specialty pharmaceutical industry, underscoring its essential role in advancing global healthcare standards and treatment options.

In 2023, Brazil was by far the Latin American country with the highest pharmaceutical market value, amounting to around **** billion U.S. dollars. Mexico ranked second, with a pharma market value of approximately **** billion U.S. dollars. As a whole, Latin America accounted for about *** percent of the global 2023 pharmaceutical market revenue. An industry driven by importsBrazil produced more than ** billion Brazilian reals worth of pharmaceutical products in 2020. Despite its significant role in the national economy, the pharmaceutical industry in this South American country relies mostly on imports. In 2021, Brazil had pharmaceutical imports for about ** billion U.S. dollars in 2021. Meanwhile, Brazil’s pharma exports have declined from **** billion U.S. dollars in 2014 to **** billion U.S. dollars in 2023. ACHE Laboratorios – a national market leaderDespite U.S companies such as Pfizer leading the global pharmaceutical industry, in Brazil Aché Laboratorios Farmacéuticos S.A. - a prominent 100-percent Brazilian pharmaceutical corporation – ranks first in the segment, with a revenue of over **** billion Brazilian reals in 2021. Focusing mostly on the production and sales of prescription drugs, the company invested more than **** billion reals in research, development, and innovation in 2018.

Overview

New York, NY – June 03, 2025 – Global Generative AI in Pharmaceutical Market size is expected to be worth around US$ 40.88 billion by 2034 from US$ 2.92 billion in 2024, growing at a CAGR of 30.2% during the forecast period 2025 to 2034.

The integration of Generative Artificial Intelligence (AI) in the pharmaceutical sector is revolutionizing drug discovery, formulation, and clinical development. As pharmaceutical companies seek faster, more efficient ways to bring therapies to market, generative AI models are emerging as vital tools in accelerating molecule design, predicting drug-target interactions, and optimizing trial outcomes.

By simulating complex biological interactions and generating novel molecular structures, generative AI algorithms are reducing the average drug discovery timeline by up to 30%, while significantly lowering R&D costs. These AI systems can process vast biomedical datasets, identify candidate compounds, and refine lead optimization with unmatched speed and precision.

Recent advancements in AI-driven de novo drug design, predictive modeling, and digital twin simulations are enabling pharmaceutical researchers to explore uncharted chemical spaces and repurpose existing drugs for new indications. Regulatory agencies, including the U.S. FDA and EMA, are actively engaging with industry stakeholders to establish ethical and safety frameworks for AI-enabled drug development.

The adoption of generative AI is gaining momentum across major pharmaceutical markets in North America, Europe, and Asia-Pacific. Strategic collaborations between AI technology firms, academic institutions, and biopharmaceutical companies are further accelerating this transformation. As the pharmaceutical industry embraces this technological shift, generative AI is poised to redefine innovation cycles, improve treatment outcomes, and deliver more personalized and affordable therapeutics worldwide.

In 2023, the North American region accounted for over half of the pharmaceutical market revenue worldwide. Since 2010, North America’s revenue share has increased by 11 percent, while Japan’s share has decreased by over six percent. Global pharmaceutical revenue The global pharmaceutical market made a grand total of around 1.6 trillion U.S. dollars in 2023. Worldwide pharmaceutical revenue had seen a steady increase every single year since 2001, when the market’s value was about two-thirds smaller. The largest submarket within this industry has been the United States recently. Pharma and biotech top companies The pharma industry is a large part of the healthcare branch and deals with the development and production of medical drugs. The leading pharmaceutical and biotechnological company according to the latest ranking, in terms of total revenue, was Johnson & Johnson, which generated over 85 billion U.S. dollars in revenue in 2023. Other large American companies in the top ten rankings included AbVie, Pfizer, and Merck & Co.

Brand name pharmaceutical manufacturers in the US are some of the most lucrative in the world. Consumers in the US use and spend more on prescription drugs than any other country, making manufacturers central to meeting this demand and supporting public health. This role was evident during the COVID-19 pandemic, as brand name pharma producers researched, produced and distributed vital vaccines in record time. Aside from vaccine development, domestic manufacturers can attribute rising spending on brand name drugs to several factors, including an aging population, expanding health coverage, new drug approvals and medical advances in expensive specialty areas like rare diseases and oncology. Still, mounting scrutiny facing brand name pharma makers focuses on pricing policies and patent protections, suggesting that the industry’s strong performance indicates monopolistic practices and price hikes rather than rising prescription drug use. In all, revenue has been growing at a CAGR of 5.8% over the past five years to an estimated $302.9 billion, including expected growth of 3.7% in 2025. One of the most notable pieces of regulation to date impacting brand name pharma producers is the Inflation Reduction Act (IRA). Passed in 2022, the IRA introduces multiple provisions impacting the industry, permanently reshaping how pharmaceutical manufacturers will operate. Key provisions of the IRA include Medicare’s ability to negotiate drug prices, rebates for excessive price increases and an out-of-pocket spending cap. While a substantial body of criticism and legal challenges surrounding the IRA exist, it marks the movement to lower drug spending for patients and the federal government. While brand name pharma manufacturers will navigate an evolving environment, the industry’s performance will remain robust. Ongoing R&D investments will yield new, innovative therapies to address unmet needs, bolstering product pipelines. At the same time, an increasing prevalence of chronic illness and a growing number of over 65 adults will support a steep demand for prescription drugs. Merger and acquisition activity seen in recent years won’t slow as incumbents look for ways to diversify pipelines, access new technologies or reach new markets as pressures from patent cliffs and the regulatory landscape mount. Still, revenue growth will be strong, increasing at a CAGR of 3.4% to an estimated $358.1 billion over the next five years

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Specialty Pharmaceuticals Market Size 2024-2028

The specialty pharmaceuticals market size is forecast to increase by USD 406.6 billion, at a CAGR of 13.64% between 2023 and 2028.

The market is experiencing significant growth, driven by the increasing demand for research and development due to escalating government healthcare expenditure. This investment in R&D is leading to the introduction of innovative therapies, catering to unmet medical needs and enhancing patient outcomes. However, the market is not without challenges. The stringent regulations imposed by regulatory bodies present a formidable hurdle, requiring companies to adhere to rigorous standards and lengthy approval processes. Moreover, the aging population is fueling the demand for specialty pharmaceuticals, as older adults often require complex and costly treatments for chronic conditions.
Companies seeking to capitalize on this market opportunity must navigate these regulatory obstacles and invest in research and development to stay competitive and meet the evolving needs of an aging population.

What will be the Size of the Specialty Pharmaceuticals Market during the forecast period?

Explore in-depth regional segment analysis with market size data - historical 2018-2022 and forecasts 2024-2028 - in the full report.
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The market continues to evolve, shaped by various market dynamics and applications across diverse sectors. Health economics plays a significant role, as contract manufacturing organizations optimize production costs and healthcare professionals navigate complex patient access issues. Drug interactions and adverse events necessitate robust safety monitoring and regulatory affairs. Pricing strategies for orphan drugs and infectious diseases are subject to ongoing debate, while targeted therapy and pharmaceutical research drive innovation in personalized medicine. Intellectual property rights and patent expiry impact market access and supply chain management. Formulation development, stability studies, and quality control are essential components of the drug development process.

Neurological, cardiovascular, and respiratory diseases are among the areas of focus in this dynamic industry. Precision medicine and value-based healthcare are emerging trends, while disease management and rare diseases remain critical areas of concern. Analytical chemistry, regulatory compliance, and packaging materials are integral to ensuring product efficacy and patient safety. The ongoing unfolding of market activities reveals evolving patterns in drug metabolism, clinical pharmacology, and regulatory landscapes.

How is this Specialty Pharmaceuticals Industry segmented?

The specialty pharmaceuticals industry 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.

Application

  Oncology
  Multiple sclerosis
  Inflammatory conditions
  Infectious diseases
  Others


Distribution Channel

  Offline
  Online


Geography

  North America

    US


  Europe

    Germany
    UK


  APAC

    China
    Japan


  Rest of World (ROW)

By Application Insights

The oncology segment is estimated to witness significant growth during the forecast period.

Oncology drugs, which target and destroy or inhibit the growth of cancer cells, are a crucial component of cancer treatment. These medications come in various forms, including chemotherapy treatment , targeted therapy, immunotherapy, and hormone therapy. The selection of the most effective drug and treatment plan depends on several factors, such as the cancer type and stage, the patient's overall health and medical history, potential drug interactions, and side effects. Healthcare professionals collaborate closely with patients and their families to determine the best treatment approach. Pharmaceutical research and development play a significant role in the creation of new oncology drugs, driven by intellectual property protections and advancements in fields like personalized medicine, disease management, and precision medicine.

The supply chain management of oncology drugs involves contract manufacturing, formulation development, and distribution networks. Quality control and regulatory affairs are essential components of the process, ensuring the safety and efficacy of these complex medications. Infectious diseases, such as HIV/AIDS and hepatitis, have also seen advancements in treatment through the development of targeted therapy and orphan drugs. Cardiovascular diseases, neurological diseases, respiratory diseases, and other conditions also benefit from ongoing pharmaceutical research and innovation. Value-based healthcare and pricing strategies are increasingly important considerations in the oncology drug market. Analytical che

The global pharmaceutical market is expected to grow at a CAGR of 5% during 2011-2017, exceeding sales worth US$ 1.1 Trillion by 2017. This market, however, is expected to undergo a number of transitions which would impact the course of its growth. These transitions include a shift of growth from the developed to the emerging markets, an increasing focus on biopharmaceuticals compared to small molecule drugs and an increasing preference for generics compared to their branded versions. As a result of these transformations; the need for a user friendly, robust and comprehensive pharmaceutical market intelligence has become imperative for investors, researchers, consultants, marketing strategists, and all those who are planning to foray into the pharmaceutical market in some form or the other.

IMARC Group, one of the world’s leading research and advisory firms, introduces a new and revolutionary way to understand and evaluate the global pharmaceutical market with its Microsoft Excel based report entitled “Global Pharmaceutical Market Report & Forecast: 2012-2017”. This report provides an analytical and statistical insight into the global pharmaceutical market. The study, which has been undertaken using desk based as well as primary market research has analyzed the following aspects of the global pharmaceutical market.

What We Have Achieved in This Report?

Regions Covered: Global, North America, Europe, Asia Pacific, Latin America & Caribbean and Middle East & Africa

Countries Covered in Each Region

North America: United States and Canada

Europe: Germany, France, Italy, Spain, United Kingdom, Russia, Turkey, Netherlands, Poland, Greece, Belgium, Switzerland, Austria, Sweden, Portugal, Hungary, Romania, Denmark, Czech Republic, Finland, Ireland, Norway, Slovakia, Bulgaria, Croatia, Slovenia, Lithuania, Latvia, Luxembourg and Estonia

Asia Pacific: Japan, China, South Korea, Australia, India, Taiwan, Indonesia, Thailand, Philippines, Pakistan, Vietnam, Bangladesh, Hong Kong, New Zealand, Malaysia and Singapore

Latin America & Caribbean:Brazil, Mexico, Venezuela, Argentina, Puerto Rico, Colombia, Chile, Ecuador, Peru, Dominican Republic and Uruguay

Middle East & Africa: South Africa, Egypt, Saudi Arab, Algeria, Morocco, United Arab Emirates Lebanon, Tunisia, Jordan and Kuwait

Focus of the Analysis:

• Historical sales performance (2007-2011) for each country
• Historical sales performance (2007-2011) for each region
• Sales forecast (2012-2017) for each country
• Sales forecast (2012-2017) for each region
• Sales performance of key manufacturers for each country (2007-2011)
• Sales performance of key therapeutic areas for each country (2007-2011)
• Country wise sales breakup for each region (2007-2011)
• Country wise sales breakup forecast for each region (2012-2017)

Key Questions Answered;

• What was the historical performance of the global pharmaceutical market?
• Which are the key regions and countries in the global pharmaceutical market?
• Which are the largest pharmaceutical markets in the world?
• Which are the fastest growing pharmaceutical markets in the world?
• Which markets are expected to witness the slowest growth in the coming years?
• Which countries represent the key markets for each region?
• What has been the performance of various therapeutic classes in each country?
• Who are the top pharmaceutical manufacturers in each country?
• What are the market shares of the top pharmaceutical manufacturers in each country?

Why You should Buy This Report?

• To gain a comprehensive understanding on the historical, current and future pharmaceutical market trends across 70 countries in 6 regions.
• To identify potential regions, countries, therapeutic areas, partners and competitors for market entry and expansion plans.
• As a tool for developing investment strategies by identifying the biggest winners and losers across various regions and countries.
• To ensure a successful M&A and partnership strategy by identifying therapeutic areas and companies with the most promising outlook.

Graph and download economic data for Employment for Manufacturing: Pharmaceutical and Medicine Manufacturing (NAICS 32541) in the United States (IPUEN32541W200000000) from 1987 to 2024 about medicines, pharmaceuticals, NAICS, IP, manufacturing, employment, and USA.

The U.S. Pharma E-commerce Market size was valued at USD 14.37 billion in 2023 and is projected to reach USD 50.89 billion by 2032, exhibiting a CAGR of 19.8 % during the forecasts period. The specific domain under consideration is the U.S. Pharma E-commerce market which represents the opportunities of goods and services sales through internet tools and services. It enables the consumer to buy prescribed drugs and other counter drugs, medical equipment and devices, and wellness products online. For the patient, it eliminates the time, effort and in many instances costs as the consumer, especially where the patient requires anonymity or convenience in acquiring medication. Use may encompass buying of medicines by consumers to hospitals and clinics acquiring medical essentials. Some trends are telemedicine, regulations to the online pharmacies, artificial intelligence for the personalized recommendations for healthcare and managing the medications. Thus, e-Commerce in the pharmaceutical industry has promising prospects and even greater potential for development in the context of the further advancement of digital health technologies.

The North America Pharmaceutical Logistics Market Report Segments by Service Type (Transportation, Warehousing & Storage and Value-Added Services and Others), by Mode of Operation (Cold-Chain Logistics and Non-Cold-Chain Logistics), by Product Type (Prescription Drugs, OTC Drugs, Biologics & Biosimilars, and More), by Country (United States, Canada and Mexico). The Market Forecasts are Provided in Terms of Value (USD).

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Pharmaceutical Contract Research And Manufacturing Market Size 2024-2028

The pharmaceutical contract research and manufacturing market size is forecast to increase by USD 141.3 bn at a CAGR of 10.87% between 2023 and 2028.

The market is experiencing significant growth, driven by several key factors. One of the primary drivers is the availability of cost-efficient resources in emerging markets, which has attracted numerous CMOs to set up operations In these regions. Another trend influencing the market is the increasing number of US FDA-approved manufacturing facilities, ensuring stringent quality control and regulatory compliance. However, the stereotypical nature of CMOs, which may hinder innovation and adaptability to new technologies, poses a challenge. Overall, the market is expected to grow steadily, driven by these factors and the increasing demand for outsourcing In the pharmaceutical industry.

What will be the Size of the Pharmaceutical Contract Research And Manufacturing Market during the Forecast Period?

Request Free SampleThe market encompasses a diverse range of services, from drug discovery and development to manufacturing and quality control. This market is characterized by its significant size and dynamic growth, driven by the increasing demand for cost-effective and efficient solutions in bringing new drugs to market. Key trends include the outsourcing of research and manufacturing processes, regulatory compliance, and the integration of advanced manufacturing technologies such as continuous manufacturing and artificial intelligence. Services in this market span from route scouting and bioprocess outsourcing to drug formulation and quality control. The market caters to both small molecule drugs and biologics, including biosimilars and active pharmaceutical ingredients (APIs).Pharmaceutical companies increasingly rely on specialized services providers to ensure regulatory compliance during clinical trials, reduce time-to-market, and optimize production costs. The market's focus on innovation and efficiency continues to evolve, with a growing emphasis on specialized services and the development of generic drugs and APIs.

How is this Pharmaceutical Contract Research And Manufacturing Industry segmented and which is the largest segment?

The pharmaceutical contract research and manufacturing industry 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. ServiceCMOCROEnd-userBig pharmaceuticalsSmall and medium-sized pharmaceuticalsGeneric pharmaceuticalsGeographyNorth AmericaUSAsiaChinaIndiaEuropeGermanyUKRest of World (ROW)

By Service Insights

The cmo segment is estimated to witness significant growth during the forecast period. The Contract Research and Manufacturing Organizations (CMO) segment dominates the global pharmaceutical market, driven by the increasing demand for specialized manufacturing processes for short-lived drugs and healthcare products. Advancements in medical sciences and the growing preference for specialty medicines, coupled with technological innovations like nanotechnology and stem cell research, are fueling the production of complex drugs. Pharmaceutical giants such as Pfizer, Johnson & Johnson, and GlaxoSmithKline are outsourcing their manufacturing activities to CMOs to optimize resource utilization. Additionally, the emergence of biologics, biosimilars, and targeted medication therapies is increasing the demand for cost-effective manufacturing services. CMOs offer a range of specialized services, including drug discovery, biologics manufacturing, clinical trial support, and regulatory compliance, among others.The pharmaceutical ecosystem comprises big pharma companies, academic institutes, CROs, and various service providers, all contributing to the drug development process. The integration of digitalization, personalized medicines, and advanced manufacturing technologies is further transforming the pharmaceutical landscape.

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The CMO segment was valued at USD 91.90 bn in 2018 and showed a gradual increase during the forecast period.

Regional Analysis

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 trends and drivers that shape the market during the forecast period.

For more insights on the market size of various regions, Request Free Sample

The Pharmaceutical Contract Research and Manufacturing (CRAM) market in North America experienced notable expansion in 2023 and is projected to continue growing during the forecast period. This growth can be attributed to the robust CRO (Contract Research Organizations) sector In

The United States Pharmaceutical Market size is valued at USD 598 billion in 2023, driven by market opportunities, industry trends, and top players. Explore insights on market dynamics, segmentation, and future outlook.

The Pharmaceutical Research and Manufacturers of America (PhRMA) trade group represents the leading biopharmaceutical research companies in the United States. In 2023, the research and development (R&D) expenditure of its member companies reached some 96 billion U.S. dollars worldwide. How much does the pharmaceutical industry spend on R&D relative to revenue? The development of a new drug costs around 2.6 billion U.S. dollars and can take up to 15 years. In relation to sales, the pharmaceutical sector invests more money in R&D than many other industries: PhRMA members spent 21 percent of their combined global revenues on R&D in 2023 – this share increased to nearly 23 percent when only considering the sales and R&D expenditure from the domestic market of the United States. Charting the rise of R&D expenditure Founded in 1958, PhRMA is headquartered in Washington, D.C. and has offices located around the United States. The group’s members collectively invested two billion U.S. dollars into the research and development of medicines worldwide in 1980, but by the start of the 21st century, this figure had increased to around 26 billion U.S. dollars.

The United States pharmaceutical intermediate market is expected to reach USD 6,591.4 million in 2025 and is projected to reach a total value of USD 9,052.8 million by 2035. This represents a compound annual growth rate (CAGR) of 3.2% during the forecast period from 2025 to 2035.

Graph and download economic data for Unit Labor Costs for Manufacturing: Pharmaceutical and Medicine Manufacturing (NAICS 3254) in the United States (IPUEN3254U100000000) from 1987 to 2024 about medicines, pharmaceuticals, unit labor cost, NAICS, IP, manufacturing, and USA.

The US pharmacy market is projected to grow at a CAGR of approximately 5-6% from 2024 to 2029, driven by increasing prescription drug usage, an aging population, and technological advancements. Despite robust growth, the market faces challenges such as regulatory complexities and rising operational costs, which require continuous innovation and adaptation. To learn more about […]

United States US: Pharmaceutical Industry: Total Exports data was reported at 80.256 USD bn in 2021. This records an increase from the previous number of 56.513 USD bn for 2020. United States US: Pharmaceutical Industry: Total Exports data is updated yearly, averaging 25.572 USD bn from Dec 1989 (Median) to 2021, with 33 observations. The data reached an all-time high of 80.256 USD bn in 2021 and a record low of 3.590 USD bn in 1989. United States US: Pharmaceutical Industry: Total Exports data remains active status in CEIC and is reported by Organisation for Economic Co-operation and Development. The data is categorized under Global Database’s United States – Table US.OECD.MSTI: Trade Statistics: OECD Member: Annual.

For the United States, from 2021 onwards, changes to the US BERD survey questionnaire allowed for more exhaustive identification of acquisition costs for ‘identifiable intangible assets’ used for R&D. This has resulted in a substantial increase in reported R&D capital expenditure within BERD. In the business sector, the funds from the rest of the world previously included in the business-financed BERD, are available separately from 2008. From 2006 onwards, GOVERD includes state government intramural performance (most of which being financed by the federal government and state government own funds). From 2016 onwards, PNPERD data are based on a new R&D performer survey. In the higher education sector all fields of SSH are included from 2003 onwards.

Following a survey of federally-funded research and development centers (FFRDCs) in 2005, it was concluded that FFRDC R&D belongs in the government sector - rather than the sector of the FFRDC administrator, as had been reported in the past. R&D expenditures by FFRDCs were reclassified from the other three R&D performing sectors to the Government sector; previously published data were revised accordingly. Between 2003 and 2004, the method used to classify data by industry has been revised. This particularly affects the ISIC category “wholesale trade” and consequently the BERD for total services.

U.S. R&D data are generally comparable, but there are some areas of underestimation:

1. i) Up to 2008, Government sector R&D performance covers only federal government activities. That by State and local government establishments is excluded;
2. ii) Except for the Government and the Business Enterprise sectors, the R&D data exclude most capital expenditures. For the Business Enterprise sector, depreciation is reported in place of gross capital expenditures up to 2014. Higher education (and national total) data were revised back to 1998 due to an improved methodology that corrects for double-counting of R&D funds passed between institutions.

Breakdown by type of R&D (basic research, applied research, etc.) was also revised back to 1998 in the business enterprise and higher education sectors due to improved estimation procedures.

The methodology for estimating researchers was changed as of 1985. In the Government, Higher Education and PNP sectors the data since then refer to employed doctoral scientists and engineers who report their primary work activity as research, development or the management of R&D, plus, for the Higher Education sector, the number of full-time equivalent graduate students with research assistantships averaging an estimated 50 % of their time engaged in R&D activities. As of 1985 researchers in the Government sector exclude military personnel. As of 1987, Higher education R&D personnel also include those who report their primary work activity as design.

Due to lack of official data for the different employment sectors, the total researchers figure is an OECD estimate up to 2019. Comprehensive reporting of R&D personnel statistics by the United States has resumed with records available since 2020, reflecting the addition of official figures for the number of researchers and total R&D personnel for the higher education sector and the Private non-profit sector; as well as the number of researchers for the government sector. The new data revise downwards previous OECD estimates as the OECD extrapolation methods drawing on historical US data, required to produce a consistent OECD aggregate, appear to have previously overestimated the growth in the number of researchers in the higher education sector.

Pre-production development is excluded from Defence GBARD (in accordance with the Frascati Manual) as of 2000. 2009 GBARD data also includes the one time incremental R&D funding legislated in the American Recovery and Reinvestment Act of 2009. Beginning with the 2000 GBARD data, budgets for capital expenditure – “R&D plant” in national terminology - are included. GBARD data for earlier years relate to budgets for current costs only.

US Pharmaceutical Contract Manufacturing Organization Market size was valued at USD 161.76 Billion in 2024 and is projected to reach USD 300.34 Billion by 2032, growing at a CAGR of 7.15% from 2025 to 2032.

Key Market Drivers: Expanding Drug Development Pipeline and FDA Approvals: According to the United States Food and Drug Administration (FDA), new drug applications (NDAs) grew by 32% in 2023, with 68 unique medications approved. According to the National Institutes of Health (NIH), the number of active clinical trials will reach 432,000 by 2023, with 65% requiring external manufacturing support, increasing demand for CMO services. Increasing Biologics and Complex Therapeutics Development: The FDA's Center for Biologics Evaluation and Research (CBER) announced that biologics license applications grew by 45% in 2023 over 2022. According to the National Center for Biotechnology Information (NCBI), biologics account for 38% of all pharmaceuticals in development, necessitating the specific manufacturing capabilities provided by CMOs, with investments in biologics manufacturing facilities expected to reach $12.8 billion by 2023. Cost Pressures and Manufacturing Efficiency Requirements: According to the US Department of Health and Human Services (HHS), pharmaceutical companies would invest $102 billion in R&D in 2023, with 42% outsourced to CMOs for cost efficiency. According to the Congressional Budget Office, pharmaceutical companies saved an average of 25% on costs through CMO agreements in 2023, leading to increased outsourcing of manufacturing activities.