The parenteral compounding industry is valued at USD 1.85 billion in 2025. As per FMI's analysis, the industry will grow at a CAGR of 9.1% and reach USD 4.45 billion by 2035.The global parenteral compounding industry is expected to experience robust growth over the next decade, driven by the increasing prevalence of chronic diseases, rising geriatric population, and greater demand for patient-specific injectable therapies.
In 2024, the industry witnessed a notable shift toward automation in sterile compounding. Regulatory bodies strengthened oversight of compounding standards, emphasizing contamination prevention. Key players engaged in strategic partnerships to scale production capacities and improve service accessibility.
Technological advancements in sterile compounding techniques and the automation of compounding processes are improving the accuracy and safety of medication preparation, further propelling industry adoption across healthcare institutions. Additionally, regulatory support for outsourcing sterile preparations and a push toward minimizing medication errors are encouraging healthcare providers to invest in parenteral compounding services.
By 2035, the industry will likely be shaped by integrated compounding systems, AI-based quality control mechanisms, and enhanced traceability protocols, ensuring regulatory compliance and patient safety. The expansion of home infusion therapy and personalized medicine is also anticipated to significantly bolster industry demand.
| Metric | Value |
|---|---|
| Industry Value (2025E) | USD 1.85 billion |
| Industry Value (2035F) | USD 4.45 billion |
| CAGR (2025 to 2035) | 9.1% |
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The parenteral compounding industry is on a sustained growth trajectory, driven by rising chronic disease prevalence and increased demand for personalized sterile medication. Regulatory shifts favoring outsourcing and stricter quality control are compelling healthcare providers to adopt advanced compounding services. Stakeholders investing in automation and strategic partnerships will gain a competitive edge, while laggards in compliance and innovation risk being outpaced.
Accelerate Automation in Sterile Compounding
Invest in robotic and software-driven compounding systems to reduce human error, improve consistency, and scale output safely.
Align with Personalized Healthcare Trends
Develop capabilities around patient-specific formulations and support services tailored to home infusion and chronic care management.
Expand Strategic Collaborations and Capacity
Engage in M&A, R&D alliances, and regional capacity expansions to meet rising demand and address regulatory challenges efficiently.
| Risk | Probability - Impact |
|---|---|
| Regulatory Non-compliance in Sterile Standards | Medium - High |
| Supply Chain Disruptions for Critical Ingredients | High - Medium |
| Technological Obsolescence of Compounding Systems | Medium - Medium |
| Priority | Immediate Action |
|---|---|
| Adopt Next-Gen Compounding Systems | Run feasibility study and ROI analysis for automated sterile systems |
| Strengthen Regulatory Readiness | Launch internal audit and compliance alignment program |
| Explore Regional Expansion | Evaluate demand hubs for new facility placement or partner tie-ups |
The parenteral compounding industry is entering a critical phase where growth will be dictated by precision, scale, and regulatory alignment. Boards should prioritize funding for automation, reinforce regulatory engagement strategies, and explore inorganic expansion through acquisitions or strategic partnerships.
This intelligence reshapes the roadmap by pushing compounding from a peripheral support function to a core differentiator in patient-centered care and operational efficiency. Act now to future-proof operations and lead in quality-assured, customized medication services.
(Surveyed Q4 2024, n=480 stakeholder participants evenly distributed across hospital administrators, compounding pharmacists, regulators, and outsourcing facility executives in North America, Western Europe, Japan, and South Korea)
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| Countries /Regions | Policy & Regulatory Impact |
|---|---|
| United States | The FDA’s Drug Quality and Security Act (DQSA) mandates registration and compliance for 503B outsourcing facilities. Regular inspections and CGMP adherence are required for commercial-scale production. |
| Canada | Governed by NABP standards and Health Canada ’s Guidance on sterile preparation. Provinces may require compliance with Model Standards for Pharmacy Compounding (NAPRA). Certification through ISO cleanroom classification and internal SOP validation is often necessary. |
| Germany | Regulated under EU GMP Annex 1 , which guide sterile compounding within pharmacies. Facilities must comply with CE-marked equipment usage and aseptic protocols. Certification from local pharmacy boards is mandatory. |
| France | Follows ANSM regulations and EU GMP standards . Parenteral preparations in hospital pharmacies must comply with sterility assurance levels (SAL) and environmental control criteria. Audits are frequent under national pharmacovigilance programs. |
| United Kingdom | Regulated by the MHRA and guided by Royal Pharmaceutical Society (RPS) compounding guidelines. Must comply with EU GMP Annex 1 and ISO 14644 cleanroom standards. Batch certification by a Qualified Person (QP) is required for commercial release. |
| Japan | Governed by the Pharmaceutical and Medical Device Act (PMDA) and the Japanese Pharmacopoeia . Less stringent enforcement compared to the US/EU. Facilities may follow JP-GMP , but few mandatory certifications exist unless exporting. Focus is more on internal quality systems and SOPs. |
| South Korea | Regulated by the Ministry of Food and Drug Safety (MFDS) . Hospital compounding is lightly regulated, but commercial sterile compounding must meet KGMP (Korea GMP) standards. Certification for cleanroom operations and sterility validation is required for scaling production. |
| Australia | Overseen by the Therapeutic Goods Administration (TGA) . Follows PIC/S GMP Guide and requires mandatory licensing for compounding facilities producing high-risk sterile products. TGO 91 & 92 guidelines apply for parenteral formulations. |
| India | Regulated by CDSCO and Schedule M of the Drugs and Cosmetics Act . While sterile manufacturing requires GMP certification, hospital-based compounding lacks uniform regulation . Growing push for CGMP adoption in outsourcing units. |
| China | Managed by the National Medical Products Administration (NMPA) . Follows Chinese GMP (2010 Revision) . Stringent for commercial compounding, especially for exports. Facilities need certification for Grade A/B cleanrooms , sterility, and environmental monitoring systems. |
In March 2024, Baxter International announced the completion of its spinoff of the BioPharma Solutions business into a new independent entity, named SimtraBioPharma Solutions. While the spinout primarily focused on contract manufacturing, analysts suggest this restructuring will allow Baxter to sharpen its focus on core hospital and pharmacy offerings, including parenteral compounding [Source: Baxter Press Release, March 2024].
Fresenius Kabi expanded its sterile injectable and compounding manufacturing footprint in the United States with the launch of a new facility in Melrose Park, Illinois, in Q2 2024. The site is expected to strengthen its USA supply chain and reduce reliance on overseas production [Source: Fresenius Kabi Newsroom, April 2024].
Omnicell Inc. reported in its Q1 2024 investor call that it had expanded deployment of its IVX Workflow and IVX Station technologies across several large USA hospital networks. These systems integrate real-time barcode scanning, gravimetric checks, and pharmacist alerts for aseptic IV preparations [Source: Omnicell Earnings Call, Q1 2024].
The hormone replacement therapy (HRT) is dominating the parenteral compounding market industry with a market share of 49.7% in 2025. The therapeutic focus of the parenteral compounding industry will continue to be shaped primarily by evolving clinical needs in pain management, hormone replacement therapy, and other specialized treatment areas. Pain management remains a dominant driver due to the high demand for rapid, targeted analgesic interventions, particularly in surgical recovery, oncology, and palliative care.
Compounded preparations allow providers to personalize dosages and combinations for better pain control while minimizing adverse effects. Hormone replacement therapy is also gaining traction, especially among aging populations and patients with endocrine disorders requiring precise hormonal balance, which is often unavailable in off-the-shelf formulations.
Other therapeutic areas include critical care, oncology, and infectious diseases, where compounded solutions are necessary to manage complex cases or navigate drug shortages. Across all these areas, the need for sterility, dosing accuracy, and flexibility supports a steady shift toward compounded parenteral formulations in both inpatient and outpatient settings.
The adults to dominate the parenteral compounding market with a market share of 54.0% in 2025. The application-based segmentation of the parenteral compounding industry will see consistent demand across adult, pediatric, geriatric, and veterinary patient groups. Adult applications will dominate in volume, particularly in chronic disease management and acute care scenarios, where customized intravenous therapies ensure faster recovery and improved drug efficacy.
Pediatric compounding will gain attention due to the necessity of precise, weight-based dosing and formulations that address sensitivities or incompatibilities in children. Geriatric applications will also rise steadily as this demographic often requires tailored drug regimens to manage polypharmacy, organ function decline, and altered drug metabolism.
Veterinary demand, while smaller in scale, continues to grow, driven by rising pet healthcare standards and the need for species-specific sterile preparations. Across all groups, safety, dosage accuracy, and administration efficiency are critical, prompting healthcare providers to rely more on parenteral compounding to fill gaps left by mass-produced pharmaceuticals.
This industry in the USA is projected to grow at a CAGR of 9.6% from 2025 to 2035. The growth would be supported by a well-established regulatory framework, increased adoption of 503B outsourcing facilities, and increased demand for sterile compounding in hospitals and ambulatory surgical centers. The United States is still confronted with regular drug shortages, driving up using compounded alternatives by health care providers.
Deterrents in the form of stringent USP and guidelines are luring compounding pharmacies to domicile a lot of their capital investment to advanced cleanroom infrastructure and automation technologies. Moreover, the increase in the geriatric population and prevalence of disorders like cancer and endocrine diseases is leading to sustained demand for patient-centric parenteral medications. M&A activity and investments in workflow efficiency are set to further fuel the growth across states, metros to emerge as healthcare hubs, predicts the report.
This industry in UK is projected to grow at a CAGR of 8.4% from 2025 to 2035. Demand for parenteral compounding is being driven by the National Health Service's (NHS) progression toward personalized medicine and the extensive incorporation of compounding services in hospital pharmacies. The MHRA's regulatory reforms and a focus on compounding safety has shaped compounding operations, especially post-Brexit.
On the other hand, centralized compounding is much less common in the USA than in the UKIn the UK., specialty compounding units within NHS trusts are expanding rapidly. Growing interest in biologics and hormone therapies, as well as an aging population and consolidation in hospitals, will continue to fuel industry growth over the next 10 years.
This industry in France is projected to grow at a CAGR of 8.6% from 2025 to 2035. With public hospitals dominating the healthcare landscape and demand for personalized IV therapies increasing, the role of sterile compounding in them is taking a more prominent position. Compounding safety and strict quality led by French National Authority for Health (HAS) also encouraging adoption of automated sterile compounding systems.
Although private outsourcing is still small, hospital compounding is being updated. A major driver is the increasing demand for therapies that treat oncology or provide palliative care, as well as governmental initiatives that promote pharmaceutical autonomy due to globally fragile supply chains exposed by recent health crises.
This industry in Germany is projected to grow at a CAGR of 9.0% from 2025 to 2035. The development of hospital pharmacy services in the German healthcare system serves as a solid foundation, and as a result, demand for parenteral compounding is rising, especially as oncology services are being expanded and personalized hormone therapies are increasingly being used.
The (BfArM) regulatory oversight upholds rigorous benchmarks which support investments in sterile compounding - infrastructure. Its focus on safety and pharmaceutical accuracy has spurred greater automation in compounding units. In addition, reimbursement models favor in-house preparations over outsourced options, reinforcing hospital-centric compounding. The availability of advanced technologies for geriatric care and neurology is further encouraging innovation and specialization in this segment.
This industry in Italy is projected to grow at a CAGR of 8.9% from2025 to 2035. A major contributor to this shortage of essential oncology and pain management medications is the increasing number of Italian public hospitals investing in sterile compounding units. Budget constraints in some regions prevent quicker adoption of advanced automation systems. The Italian Medicines Agency (Agency of the Italian Medicines-AIFA) imposes strict sterility and quality standards that drive hospital pharmacies to improve their facilities.
Centralized compounding is still limited and there is increasing demand for patient-specific therapies, including in oncology, intensive care and endocrinology. Need for personalized medicines and a growing geriatric population is also driving the surge growth of customized IV therapies coupled with the pressure to reduce drugs wastage. Domestic outsourcing players may find opportunities in initiatives to make the country self-sufficient in pharmaceuticals.
New Zealand is projected to grow at a compound annual growth rate of 7.8% from 2025 to 2035, reflecting a more conservative expansion pace due to industry size and public health funding limitations. The country’s centralized healthcare system favors hospital-based compounding, particularly for oncology and critical care patients. Regulatory oversight is managed by Medsafe, and compliance with sterile preparation standards is increasingly prioritized.
Smaller population size and limited outsourcing infrastructure restrict rapid expansion, but growing focus on personalized therapies and veterinary care is slowly broadening the application of compounded injectables. Investment in regional hospital upgrades and increased interest in hormone replacement therapy are likely to contribute modestly to industry growth. The veterinary segment is also emerging as a niche opportunity for compounding pharmacies.
South Korea will see a compound annual growth rate of approximately 9.4% between 2025 and 2035, driven by rapid hospital modernization and growing demand for precision therapies. The country’s technologically advanced healthcare infrastructure facilitates integration of automated compounding systems within tertiary hospitals. Regulatory enforcement by the Ministry of Food and Drug Safety (MFDS) ensures stringent adherence to sterile preparation standards.
Demand for parenteral therapies is rising in oncology, critical care, and hormone therapy, with patient safety and dosing precision becoming critical focal points. Moreover, the aging population and increasing burden of non-communicable diseases are accelerating the need for custom formulations. As South Korea pushes toward health tech innovation, sterile compounding is gaining importance as part of integrated care delivery models in major urban centers.
Japan is forecasted to register a compound annual growth rate of 8.2% between 2025 and 2035, marginally below the global benchmark, largely due to regulatory rigidity and industry conservatism. However, rising chronic illness prevalence and the world's most aged population create consistent demand for tailored parenteral therapies.
Hospital pharmacies, rather than commercial compounding services, dominate sterile preparation activities, largely driven by institutional protocols and strict oversight from the Pharmaceuticals and Medical Devices Agency (PMDA). The government’s efforts to contain healthcare spending may limit outsourcing expansion, but automation and workflow improvement within large hospitals are supporting incremental growth. Oncology, geriatrics, and endocrinology are key focus areas, while veterinary compounding remains limited but slowly emerging.
China is anticipated to grow at a compound annual growth rate of approximately 10.2% from 2025 to 2035, outperforming the global average due to rapid healthcare infrastructure development and increased pharmaceutical localization. The Chinese government is heavily investing in hospital modernization, which includes integration of sterile compounding facilities for oncology, infectious disease, and pain management therapies.
Regulatory upgrades by the National Medical Products Administration (NMPA) are pushing hospitals and private entities to comply with sterility and dosing safety standards. Demand is further supported by the country’s vast aging population and increasing incidence of chronic diseases. As shortages of critical drugs continue to occur, compounded injectables are becoming essential to bridge therapeutic gaps. A growing number of private compounding companies and tech-enabled hospitals are leading innovations in workflow and automation.
Australia will experience a compound annual growth rate of around 8.8% between 2025 and 2035, supported by its robust healthcare infrastructure and regulatory clarity. The Therapeutic Goods Administration (TGA) enforces stringent guidelines that govern both hospital-based and outsourced compounding, particularly in sterile environments.
Hospitals remain the main centers of parenteral compounding activity, especially for oncology, hormone therapies, and palliative care. Interest in advanced compounding automation and cleanroom technologies is increasing as facilities aim to reduce human error and meet growing demand for individualized care. Rural and remote healthcare facilities are increasingly depending on centralized compounding services to manage critical patient needs. Additionally, growing veterinary applications and an expanding geriatric population are contributing to demand for tailored injectable therapies across the country.
North America leads in expansion due to advanced healthcare infrastructure, while Asia-Pacific is witnessing rapid growth due to rising healthcare investments and awareness of personalized therapies.
Outsourcing facilities help hospitals and clinics access high-quality, sterile compounded medications without needing on-site compounding capabilities, reducing risk and cost.
Regulations require facilities to comply with good manufacturing practices, ensure sterility, and maintain detailed records, which can influence operating models and investment decisions.
Yes, automation in sterile compounding, advanced cleanroom technologies, and real-time environmental monitoring are improving operational safety and throughput.
The industry is poised for sustained growth due to expanding therapeutic applications, ongoing drug shortages, and the increasing push for customized treatment regimens.
the industry is segmented into Pain Management, Hormone Replacement Therapy, and Others.
the industry is segmented into Adults, Pediatric, Geriatric, and Veterinary.
the industry is segmented into North America, Latin America, Europe, East Asia, South Asia, Oceania, and the Middle East & Africa.
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Parenteral Compounding Market
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