What is the Drug Formulation Market Size?
The global drug formulation market size is calculated at USD 1.96 trillion in 2025 and is predicted to increase from USD 2.08 trillion in 2026 to approximately USD 3.50 trillion by 2035, expanding at a CAGR of 5.97% from 2026 to 2035.
Drug Formulation Market Key Takeaways
- North America contributes the highest share in 2025.
- By geography, the Asia Pacific is expected to experience the quickest growth from 2026 to 2035.
- By formulation, the tablets segment dominated the market in terms of revenue in 2025.
- By routes of administration, the oral segment dominated the market in 2025.
- By therapy area, the other illnesses segment dominated the market and would continue to hold the top spot from 2026 to 2035.
- By end-user, the retail segment held the maximum revenue share in 2025.
What is a Drug Formulation?
Introducing new technology and more economical, effective manufacturing techniques have drastically altered the pharmaceutical industry. An increase in investment flow in this sector has positively impacted the market growth. Robotics and artificial intelligence are used to decrease product waste and manufacturing floor downtime (AI).
Additionally, single-use disposable products have gained popularity in this sector and have supplanted open-transfer manufacturing methods. The paradigm changes towards integrated, intelligent, and data-rich paperless operations have led to accurate and error-free production. Drug production has accelerated as a result of these continuous developments.
A pharmaceutical formulation combines active chemical ingredients (APIs) mixed with suitable excipients and technological processes to create a pharmaceutical product. Each inactive component employed to develop the formulation serves a specific function. The increasing need for biologics to treat chronic diseases like cancer, Alzheimer's, diabetes, arthritis, and dementia will be responsible for the market's investment trend.
How is AI contributing to the Drug Formulation Industry?
The application of Artificial Intelligence in the whole process involved in drug formulation is very vast, as it impacts not only the cost and time taken during the drug's research but also the quality of the final product. Predicting or even simulating the solubility, stability, interaction of the excipients, and the release behavior is all part of AI's vast analytical capabilities.
These days, it is very common for AI to be used in the process of selecting the best dosage forms, determining the most efficient delivery systems, and providing the best patient-specific formulations all at once via the incorporation of genetic and clinical data.
Market Growth
The advent of cutting-edge technologies and more accessible and economical manufacturing techniques has resulted in a significant shift in the pharmaceutical sector. To reduce production waste and downtime on the factory floor, robotics and artificial intelligence are rapidly being deployed in the pharmaceutical business.
By providing several opportunities to treat a wide range of medical diseases, personalized medicine ongoing advancements have also made it possible to create patient-centric models. Additionally, the prevalence of chronic diseases in the population is rising, and the amount of investment flowing into this industry is increasing, which is helping to fuel market expansion. The growing global population, which recently has aided the drug formulation industry's growth, is also impacting the consumption of medicines.
Market Outlook
- Industry Growth Overview: Biopharmaceuticals, delivery platforms, and global demand for effective therapies are the three factors that the market growth is relying on.
- Sustainability Trends:Green chemistry, renewable materials, and biocatalysis, along with continuous manufacturing technology, will be the key drivers of the formulation processes' sustainable practices.
- Global Expansion:The prevalence of chronic diseases and the adoption of personalized medicine in healthcare systems all around the world are the main reasons for global expansion.
- Major investors:The investments and strategic growth of the companies Pfizer, Johnson & Johnson, AstraZeneca, Novartis, and Sun Pharmaceutical Industries will not go unnoticed.
- Startup Ecosystem:Young companies gain more benefits by means of government support, research with a focus on innovation, and collaboration with academic and scientific institutions worldwide.
Market Scope
| Report Coverage | Details |
| Market Size in 2025 | USD 1.96 Trillion |
| Market Size in 2026 | USD 2.08 Trillion |
| Market Size by 2035 | USD 3.50 Trillion |
| Growth Rate from 2026 to 2035 | CAGR of 5.97% |
| Base Year | 2025 |
| Forecast Period | 2026 to 2035 |
| Segments Covered | Formulation, Routes of Administration, Therapy Area and End-User |
| Regions Covered | North America, Europe, Asia-Pacific, Latin America and Middle East & Africa |
Market Dynamics
Drivers
The trend of critical pharmaceuticals' patent protection expiring more frequently and the rise in pharmaceutical and biopharmaceutical businesses outsourcing their services are the two main drivers of the market's expansion. The expansion of the market is being driven by the rising trend of essential medications' patent protection expiring.
For instance, the Korean Ministry of Food and Drug Safety (MFDS) announced that 158 pharmaceutical product patents were anticipated to expire in 2021, in accordance with a 2021 update by the Generics and Biosimilar Initiative, as part of ongoing action to improve the quality of generics and ensure an effective and competitive generics market.
According to the same source, 44 patents are listed suitable for rapid generics entrance. They do not have any additional patents on the items in question on the MFDS's Green List, comparable to the FDA's (US Food and Drug Administration) Orange Book. This consequently drives up the need for formulation development outsourcing among emerging candidates, fueling market expansion.
Restraints
Pharmaceutical compositions are currently created through trial and error methods. This approach is labor-intensive, expensive, and takes a lot of time. It also requires a lot of labor to develop and maintain. However, the complexity of adhering to regulatory values would influence the medication development process, as repeating the drug development process would have a significant negative economic impact on the pharmaceutical business.
The pharmaceutical industry is under pressure to provide new active pharmaceutical ingredients and reduce healthcare expenses (APIs). As a result, this issue is anticipated to limit the involvement of pharmaceutical firms in the medication development process, which is expected to hamper market expansion. Another factor that is anticipated to restrain the growth of the drug formulation market is supply-chain complexity.
Most pharmaceutical companies have a convoluted supply chain that needs to be more utilized or efficient. The supply chain's cost-effectiveness or lack of flexibility is to blame for its complexity. The profitability of major players has been hurt, though, and this tendency is anticipated to persist over time.
Opportunities
The amount of money pharmaceutical companies invest in research, and development depends on several factors, including the anticipated revenue from a new drug, the predicted cost of developing that drug, and legislation influencing the drug supply and demand (R&D). For instance, pharmaceutical companies spent, on average, roughly 25% of their revenue on research and development, according to Federal Government Statistics.
Top R&D spenders in 2019 allocated nearly one-fifth of their income to R&D in 2021. The pharmaceutical sector is international; even if companies with US headquarters sometimes spend the most on R&D. over the projected year, such circumstances are predicted to produce profitable opportunities for local businesses to strengthen their positions and boost their market shares.
Segment Insights
Formulation Insights
In 2025, tablets dominated the market in terms of revenue, holding a share owing to the availability of various tablets available, including film- and enteric-coated, effervescent, and orally disintegrating ones. Introducing 3D-printed pills created for specific requirements is another factor driving market expansion.
The injectables segment is expected to expand during the projected period at the second-fastest CAGR. The expansion of the market is linked to an increase in the number of prefilled syringes and auto-injector approvals. Additionally, a movement in consumer preferences toward larger dosage quantities has led to a rise in demand for 2.25-mL needle syringes, which considerably boosts the segment's income.
Subcutaneous injections have become incredibly popular recently among patients, device manufacturers, and medicine developers. These injections have the following advantages: self-administration, simplicity, dependability, accuracy, prefilled syringes used for fixed doses, small design, compliance, and excellent patient comfort. The introduction of subcutaneous injections is anticipated to boost the injectables market's growth further.
Routes of Administration Insights
In 2025, the oral segment dominated the global market. Oral dose forms are inexpensive, simple, and accommodating to patients. Orally given medications are now more widely available on the market because of developments in drug delivery technology like sustained-release dose formulations and tailored drug delivery.
The parenteral category is anticipated to grow at the quickest CAGR over the projected period due to a significant increase in automated systems, barrier systems, including controlled access barrier systems, and isolators being used in parenteral manufacturing. Many package designs, including ready-to-fill syringes, cartridges, and vials, have significantly changed the parenteral manufacturing industry.
The growing desire for novel medication delivery systems that better suit patients' "mobile lifestyles" paves the way for the widespread use of pens and auto-injectors, further accelerating the segment's growth. Additionally, a rise in drug developers' outsourcing of fill-finish manufacturing services increases the parenteral market's income creation.
Therapy Area Insights
In 2025, the other illnesses category dominated the market, which would continue to hold the top spot over the forecasted years. For R&D spending in this sector, the COVID-19 pandemic is expected to be the primary motivator. Additionally, the development of medicines to treat essential illnesses in women, like irregular menstruation, has attracted much operational player attention due to increased awareness of women's health.
According to several studies, the cost of cancer treatment in the healthcare system has increased by half recently. Additionally, the segment is growing due to the massive number of immuno-oncology clinical trials being conducted worldwide. There are several potential opportunities for the diabetes industry due to an increase in the incidence rate of diabetes worldwide and the number of marketed branded anti-diabetic treatments.
End-User Insights
The highest revenue share in 2025 came from the retail sector. More people choose self-medication as a treatment for minor health conditions since medical costs and health insurance have increased. OTC medications have also become more well-liked as a convenient and affordable alternative. These reasons cause a high rate of drug purchases through retail outlets, which raises the segment's market share. Specialty pharmaceuticals are now widely available at retail pharmacies as a result of specialty pharmacies' tremendous rise in recent years, contributing to the segment's growth.
To improve clinical outcomes and compete with other businesses in the market, retail pharmacists also engage in partnerships and collaboration models with healthcare providers and facilities. Due to the introduction of electronic information transfer, there will likely be a wide range of opportunities in primary care. By doing this, difficulties with poor communication between primary and secondary care can be resolved.
Regional Insights
How is North America leading in the Drug Formulation Market?
North America is at the forefront of the market due to its high healthcare expenditures, excellent research facilities, and a very supportive regulatory framework. There is a growing demand for biologics, biosimilars, personalized medicine, and gene therapy development, as well as the challenges of high R&D costs and reliance on imported pharmaceutical ingredients.
U.S. Drug Formulation Market Trends
The U.S. is in the forefront mainly because of its innovative pharmaceutical companies, quick approvals of drugs, and a large population suffering from chronic diseases. Strong research ecosystems and regulatory support are the main factors that enhance the development of formulations, which allows the quick adoption of the latest delivery technologies and therapeutic solutions personalized for the different disease areas.
The US market contributes significantly to the support of the global pharmaceutical industry. FDA approvals have accelerated owing to rising R&D expenditures, and they are anticipated to stabilize through 2022. The government approved 50 novel pharmaceuticals in 2022, roughly on par with the approval of 53 drugs the previous year. Due to the ongoing global immunization campaign and the need for necessary and elective medical treatments in 2023, US pharmaceutical output and sales are anticipated to remain high.
What are the driving factors of the Drug Formulation Market in Europe?
Europe is in a good position because of the very strong research ecosystem, the high-quality regulatory standards, and the demand for generic drugs, which is increasing. The advanced drug delivery systems, the development of new treatments for chronic diseases, and the outsourcing of formulation development services are the main areas of opportunity that will support the efficient and compliant practices in pharmaceutical manufacturing.
Germany Drug Formulation Market Trends
Germany is the European leader due to its strong presence of multinational pharmaceutical companies, innovative biotechnology firms, and the large amount of money invested in research and manufacturing. Government policies that support the industry and public funding make the position of Germany even stronger, and thus the country can develop high-value formulations and upgrade its pharmaceutical technology across therapeutic segments.
How is Asia-Pacific performing in the Drug Formulation Market?
Asia-Pacific is the region that is expected to show the most rapid growth over time. This will be mainly due to the increased spending on healthcare, the presence of large patient populations, and the supportive government policies. The benefits the region will gain from the above-mentioned factors will be the quick and inexpensive clinical development, the expansion of biosimilars, and the digital health technologies, which are going to be widely used and will enhance the efficiency of drug formulation and development.
Due to its sizable customer base, rising healthcare costs, increasing disease incidence, and supportive legislative frameworks, Asia Pacific is expected to experience the quickest growth among all regions throughout the projection period. The area has also undergone a digital revolution to provide sustainable patient care in recent years.
China Drug Formulation Market Trends
China is the leader in the region as it moves to become a pharmaceutical industry that relies more on innovation. The quick drug approval process, huge government support, and the nice being for big patient population make the cancer and rare diseases treatment area especially strong in producing and research-driven pharmaceuticals.
Several national-level programs have encouraged the use of big data and artificial intelligence (AI) in Asia. The Chinese State Council released guidelines to promote the growth of big data and AI in healthcare, focusing on its use in that field. Additionally, several western businesses are building new facilities in this region because of the lower costs.
Drug Formulation Market-Value Chain Analysis
R&D: Research and Development aim at discovering and developing new drug candidates through scientific research and preclinical testing processes.
- Key Players: Pfizer, Roche, Moderna, Amgen
Clinical trials and regulatory approvals: Clinical trials and regulatory approvals assess drug safety, efficacy, and performance to obtain authorization for commercial market entry.
- Key Players: IQVIA, Covance
Formulation and final dosage: Formulation and final dosage conversion turn the API into stable, usable dosage forms that are ready for patient administration.
- Key players: Johnson & Johnson
Packaging and serialization: Packaging and serialization of the finished products, application of the identifiers, and making sure of compliance with traceability, safety, and regulations.
- Key Players: West Pharmaceutical Services, Amcor
Distribution of drug formulation to hospitals and pharmacies: Distribution of drug formulation to hospitals and pharmacies manages logistics, ensuring healthcare providers and retail outlets are delivered efficiently.
- Key players: McKesson, AmerisourceBergen, Cardinal Health
Top Companies in the Drug Formulation Market & Their Offerings
- Bristol-Myers Squibb: Bristol-Myers Squibb brings to life and markets cutting-edge medications that are aimed at curing serious diseases like cancer, immunology, and heart diseases all over the world.
- Eli Lilly and Company: Eli Lilly dedicates itself to the whole process of discovering, developing, producing, and selling pharmaceutical products with a strong focus on diabetes and obesity treatment.
- Gilead Sciences, Inc.: Gilead Sciences is committed to finding, designing, and selling new medications that cater to the needs of those patients who have no other options, such as those suffering from HIV or liver diseases.
Other Major Companies
- Merck & Co., Inc.
- Novartis AG
- Pfizer Inc.
- AbbVie Inc.
- Boehringer Ingelheim International GmbH
- F. Hoffmann-La Roche AG
- Johnson & Johnson
- 3M Company
- Bayer AG
- Teva Pharmaceuticals Industries Ltd.
- Amgen, Inc.
- Sanofi SA
- GlaxoSmithKline plc
- Boston
Recent Developments in the Drug Formulation Industry
- In May 2025, Christine Allen, cofounder of Intrepid Labs, highlights the critical yet undervalued role of drug formulation in drug discovery. Her Toronto-based start-up has raised $11 million to innovate in this area using robotics and artificial intelligence technologies. (Source: cen.acs.org)
- In May 2025, Persist AI launched its Cloud Lab platform for pharmaceutical formulation development after securing $12 million in Series A funding. This platform enhances drug development speed and efficiency using advanced robotic lab facilities via a website. (Source: prnewswire.com)
- On June 20, 2022,Bristol Myers Squibb and Turning Point Therapeutics inked a definitive merger agreement. Because Turning Point Therapeutics is a precision oncology firm still in clinical development, this acquisition will increase BMS's selection of oncology medications.
- On March 20, 2022, AstraZeneca made the Evusheld long-acting antibody combination available to the general population. It has been authorized in Europe for a substantial population's pre-exposure prophylaxis (prevention) of COVID-19.
Segments Covered in the Report
By Formulation
- Tablets
- Capsules
- Injectable
- Sprays
- Suspensions
- Powders
- Other Formulations
By Routes of Administration
- Oral
- Topical
- Parenteral
- Inhalations
- Other Routes of Administration
By Therapy Area
- Cardiovascular Diseases (CVDs)
- Pain
- Diabetes
- Cancer
- Respiratory Diseases
- Other Diseases
By End-User
- Retail
- Non-retail
ByGeography
- North America
- Europe
- Asia-Pacific
- Latin America
- The Middle East and Africa
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