Global Specialty Pharmacy Market Outlook, 2031

The global specialty pharmacy industry covers pharmacies that dispense and manage specialty medicines, which are typically high-cost drugs used to treat complex, chronic or rare conditions and that require special handling, administration, monitoring or patient support. Specialty drugs include treatments for cancer, rheumatoid arthritis, psoriasis, inflammatory bowel disease, multiple sclerosis, HIV, hepatitis C, cystic fibrosis, haemophilia, rare genetic diseases, and increasingly obesity and cardiometabolic disease. Specialty pharmacies provide services such as insurance benefit verification, prior authorisation support, financial assistance coordination, cold-chain shipping, injection training, adherence monitoring, side effect management and data reporting to manufacturers and payers. In the United States, specialty drugs account for only a small share of prescriptions but around half of total pharmacy drug spending. The largest US specialty pharmacies are owned by pharmacy benefit managers and insurers: CVS Specialty, part of CVS Health; Accredo, part of Cigna's Evernorth; and Optum Specialty Pharmacy, part of UnitedHealth. Other major players include Walgreens Specialty Pharmacy and AllianceRx, Shields Health Solutions, Humana's CenterWell Specialty Pharmacy, Elevance's CarelonRx, Kroger Specialty Pharmacy, and health system-owned specialty pharmacies. Distributors such as McKesson, Cencora and Cardinal Health operate specialty distribution and oncology networks, while in Europe and Asia hospitals and specialised home care companies often perform similar roles.

The specialty pharmacy market has grown rapidly as the pharmaceutical pipeline has shifted toward biologics, targeted cancer drugs, rare disease therapies and injectable treatments, and the arrival of high-priced drugs for obesity and other chronic conditions has blurred the line between specialty and traditional pharmacy. At the same time, the market has become a focus of policy scrutiny. The Federal Trade Commission's interim reports in 2024 and January 2025 alleged that the three largest pharmacy benefit managers marked up specialty generic drugs dispensed through their affiliated pharmacies by billions of dollars, and it sued them in 2024 over insulin rebating practices. In February 2026, Congress enacted federal PBM reform that delinks PBM compensation from drug prices in Medicare Part D, requires rebate pass-through and addresses pharmacy network practices, with most provisions taking effect in 2028. Biosimilars have reshaped specialty pharmacy economics: in April 2024, CVS Caremark removed Humira from major formularies in favour of adalimumab biosimilars, including one marketed by its own subsidiary Cordavis, while Express Scripts and Optum launched their own private-label biosimilars, and ustekinumab biosimilars arrived in 2025. Health systems have expanded their own specialty pharmacies to capture patients treated in their clinics, and Walgreens, owner of AllianceRx and Shields Health Solutions, was taken private by Sycamore Partners in August 2025.

Market Dynamics Market Drivers • Growth of Specialty Drug Pipelines and SpendingMost new drugs approved in recent years are specialty medicines, including biologics, targeted oral cancer drugs, cell and gene therapies, rare disease treatments and injectable therapies for immunology and neurology. Existing specialty drugs are gaining new indications and treating more patients. Specialty drug spending is growing faster than overall drug spending, and specialty pharmacies benefit from handling these high-value products and the services they require.
• Need for Patient Support and Adherence ServicesSpecialty medicines often require complex dosing, injections, monitoring for side effects and coordination with physicians and insurers. Patients may need help with prior authorisation, copay assistance and financial support. Manufacturers and payers rely on specialty pharmacies to provide these services, collect outcomes data and support adherence, which improves results and justifies high drug costs. Limited distribution networks chosen by manufacturers reward pharmacies with strong clinical capabilities.

Market Challenges • Regulatory Scrutiny of PBM-Owned PharmaciesThe dominance of specialty pharmacies owned by the largest PBMs has attracted criticism from regulators, lawmakers, employers and independent pharmacies, who argue that PBMs steer patients to their own pharmacies and inflate prices. FTC reports, state laws restricting PBM practices and federal PBM reform enacted in 2026 may change reimbursement and network rules. Arkansas passed a law banning PBMs from owning pharmacies in the state in 2025, although it was blocked by a court.
• Biosimilar Transition and Margin PressureThe shift from high-priced biologics to lower-priced biosimilars reduces the revenue specialty pharmacies earn from each prescription, although private-label biosimilar strategies allow some PBMs to capture value. Payer pressure on reimbursement, manufacturer copay accumulator and maximiser programmes, and competition from health system pharmacies squeeze margins. Handling cell and gene therapies and other ultra-high-cost products carries financial risk.

Market Trends • Private-Label Biosimilars and Formulary ManagementPBMs have created subsidiaries that co-brand biosimilars with manufacturers, such as CVS's Cordavis, Express Scripts' Quallent and Optum's Nuvaila, and they use formulary decisions to move patients to these products. CVS Caremark's removal of Humira from major formularies in 2024 moved most of its adalimumab patients to biosimilars within months. This model is being applied to ustekinumab and other biologics as they lose exclusivity.
• Health System and Integrated Specialty PharmacyHospitals and academic medical centres are building their own specialty pharmacies to serve patients treated by their oncologists, rheumatologists, neurologists and gastroenterologists, integrating pharmacists into clinics to improve access and outcomes. Companies such as Shields Health Solutions help health systems run these pharmacies. Integrated models can shorten time to treatment and improve adherence, although PBM networks sometimes restrict access.



Segment Analysis Oncology and inflammatory and autoimmune conditions account for the largest shares of specialty pharmacy revenue, while metabolic diseases, rare diseases and neurology are fast-growing therapeutic categories. Oncology is one of the largest specialty categories, including oral targeted cancer drugs such as kinase inhibitors, PARP inhibitors and CDK4/6 inhibitors, and supportive care medicines, many dispensed by specialty pharmacies and medically integrated oncology practices. Inflammatory and autoimmune conditions, including rheumatoid arthritis, psoriasis, psoriatic arthritis, inflammatory bowel disease and atopic dermatitis, generate very large revenues through self-injected biologics such as Dupixent, Skyrizi, Stelara, Cosentyx and adalimumab products and oral drugs such as Rinvoq. Multiple sclerosis drugs, including injectable and oral therapies, are another important category. HIV and hepatitis C medicines are dispensed widely by specialty pharmacies, though hepatitis C volumes have fallen. Rare diseases, including cystic fibrosis, haemophilia, spinal muscular atrophy and lysosomal storage disorders, involve high-cost therapies with limited distribution. Metabolic diseases, including obesity and diabetes, have become significant, with GLP-1 drugs sometimes managed through specialty channels because of their cost and prior authorisation requirements. Neurology and psychiatry, pulmonary hypertension, fertility, growth hormone, transplant, cardiology including amyloid and cardiomyopathy drugs, and cell and gene therapies form additional categories.

PBM and insurer-owned specialty pharmacies account for the largest share of the US market, while health system, independent, retail and distributor-affiliated specialty pharmacies compete for the remainder. PBM and insurer-owned specialty pharmacies, including CVS Specialty, Accredo and Optum Specialty Pharmacy, together dispense a large majority of specialty prescriptions in the United States, supported by their parent companies' control of pharmacy networks and formularies. Health system-owned specialty pharmacies, operated by hospitals and academic medical centres, have grown rapidly, integrating pharmacists into specialty clinics and often achieving strong adherence and outcomes. Independent specialty pharmacies, including companies focused on particular diseases or limited distribution drugs, compete through clinical expertise and service, although they face challenges accessing PBM networks. Retail chain specialty pharmacies, such as Walgreens Specialty and AllianceRx, Kroger Specialty and grocery-affiliated pharmacies, combine specialty services with retail footprints. Distributor-affiliated specialty businesses, such as McKesson's specialty and oncology networks, Cencora's specialty distribution and Cardinal Health's specialty solutions, supply physician offices and oncology practices and sometimes operate specialty pharmacies. Home infusion pharmacies, such as Option Care Health, provide infused specialty drugs at home. Outside the United States, hospital pharmacies and homecare providers dispense most specialty medicines.

Self-administered specialty drugs dispensed to patients' homes account for the largest share of specialty pharmacy revenue, while provider-administered and infused therapies form another major channel. Self-administered specialty drugs, including oral medicines and injectables that patients take or inject at home using pens, syringes or autoinjectors, account for the largest share of specialty pharmacy dispensing. Specialty pharmacies ship these medicines, often in temperature-controlled packaging, and provide training and support. Provider-administered drugs, such as intravenous biologics, chemotherapy and some injectables, are given in physician offices, hospital outpatient departments or infusion centres, and they are bought either by providers directly under a buy-and-bill model or dispensed by specialty pharmacies to the provider through white bagging or brown bagging arrangements, which payers sometimes require. Home infusion, where nurses administer intravenous or subcutaneous drugs in patients' homes, provides a lower-cost alternative to hospital infusion for suitable patients. Cell and gene therapies require specialised handling and are usually managed directly between manufacturers, treatment centres and payers. The shift of many biologics from intravenous to subcutaneous forms increases the share dispensed for home use, while payer policies on site of care influence where infused drugs are given.

Commercial insurance funds the largest share of specialty pharmacy spending in the United States, while government programmes and manufacturer assistance programmes also play important roles. Commercial insurance, including employer-sponsored plans managed by pharmacy benefit managers, funds the largest share of US specialty drug spending, and employers face rising costs from specialty medicines and GLP-1 drugs, leading them to adopt utilisation management, biosimilar preferences and specialty carve-out programmes. Medicare Part D covers self-administered specialty drugs for older adults, and the Inflation Reduction Act's cap on out-of-pocket costs, which took effect in 2025, and Medicare drug price negotiation affect specialty spending. Medicare Part B covers many provider-administered drugs. Medicaid covers specialty drugs for low-income patients with significant rebates. Manufacturer patient assistance programmes and copay cards help commercially insured patients afford high out-of-pocket costs, although insurers' copay accumulator and maximiser programmes have changed how these funds are applied. Charitable foundations provide assistance for patients with government insurance. In other countries, national health systems and social insurance pay for specialty medicines, often dispensed through hospitals, with prices negotiated centrally.

Regional Analysis North America dominates the specialty pharmacy market because of the United States' high specialty drug spending, the distinct specialty pharmacy model built around PBMs and payers, and rapid growth in specialty medicines. North America, led by the United States, accounts for the vast majority of global specialty pharmacy revenue. The US model, in which specialty pharmacies dispense high-cost drugs to patients' homes and provide clinical and reimbursement services, is highly developed, and specialty drugs account for about half of US pharmacy drug spending. The market is dominated by PBM-owned pharmacies, CVS Specialty, Accredo and Optum Specialty, and is shaped by the adoption of private-label biosimilars since 2024, FTC scrutiny of specialty generic markups and federal PBM reform signed in February 2026. Health system specialty pharmacies and companies such as Shields Health Solutions continue to grow. Canada has a smaller specialty pharmacy sector, with private and public drug plans and growing biosimilar switching policies. Europe has a different structure, in which specialty medicines are mostly dispensed by hospital pharmacies or delivered by homecare companies under contract with national health systems, such as homecare providers in the UK and Germany, and biosimilar adoption is advanced. Asia-Pacific is growing as specialty drug use expands in Japan, China, South Korea, Australia and India, with hospital pharmacies and emerging direct-to-patient pharmacy models, including specialty drug platforms and designated pharmacies in China that dispense innovative drugs covered by national reimbursement. Latin America, led by Brazil and Mexico, and the Middle East, particularly Saudi Arabia and the UAE, are developing specialty pharmacy and homecare services as access to biologics increases.

Key Developments February 2026: The Consolidated Appropriations Act, 2026 introduced PBM reforms including delinking compensation from drug prices in Medicare Part D and requiring rebate pass-through, with most provisions effective from 2028.
August 2025: Walgreens, owner of Walgreens Specialty Pharmacy, AllianceRx and a majority of Shields Health Solutions, was taken private by Sycamore Partners.
January 2025: The Federal Trade Commission reported that the three largest PBMs marked up specialty generic drugs dispensed by their affiliated pharmacies by billions of dollars between 2017 and 2022.
January 2025: Biosimilars to Stelara entered the US market, giving specialty pharmacies and PBMs new lower-cost options for psoriasis and inflammatory bowel disease.
September 2024: The FTC filed an administrative complaint against CVS Caremark, Express Scripts and Optum Rx and their group purchasing organisations over insulin rebate practices.
April 2024: CVS Caremark replaced Humira with adalimumab biosimilars, including one co-marketed by its subsidiary Cordavis, moving most patients to biosimilars within months.

Considered in this report
• Historic Year: 2020
• Base Year: 2025
• Estimated Year: 2026
• Forecast Year: 2031

Aspects covered in this report
• Global Specialty Pharmacy Market with its value and forecast along with its segments
• Various drivers and challenges
• Ongoing trends and developments
• Top profiled companies
• Strategic recommendation

By Therapeutic Area
• Oncology
• Inflammatory and Autoimmune Conditions
• Multiple Sclerosis
• HIV and Hepatitis
• Rare Diseases
• Metabolic Diseases
• Other Specialty Conditions

By Pharmacy Type
• PBM and Insurer-Owned Specialty Pharmacies
• Health System Specialty Pharmacies
• Independent Specialty Pharmacies
• Retail Chain Specialty Pharmacies
• Home Infusion Pharmacies

By Administration Type
• Self-Administered Drugs
• Provider-Administered Drugs
• Home Infusion

By Payer
• Commercial Insurance
• Medicare
• Medicaid and Other Government Programmes
• Patient Assistance Programmes