Australia Drug Delivery Devices Market Size and Share - Growth Analysis Report and Forecast Trends (2026-2035)

Market Overview

The Australia drug delivery devices market is being reshaped by the move of high-value injectable therapies from hospital to home. Pens, autoinjectors and prefilled syringes now carry biologics and weight management medicines, while inhalers remain the everyday workhorse of respiratory care.

Three forces are shaping the market: subsidy decisions that determine which presentations reach patients, biosimilar competition that multiplies device formats, and a clinical shift towards less frequent dosing that rewards simple, reliable self-administration devices.

In December 2025, Celltrion received approval for ustekinumab biosimilar pre-filled pens. In April 2026, Eli Lilly said it would not list Mounjaro on the PBS for type 2 diabetes, and in July 2026 GSK registered a twice-yearly asthma biologic supplied in a pre-filled pen or syringe.

Key Market Trends and Insights

• Self-injection biologics: GSK's depemokimab, registered in July 2026, is dosed 100 mg every six months by pre-filled pen or syringe, and patients or trained caregivers may administer it.
• Weight management pens: Health Minister Mark Butler said in January 2026 that over 400,000 Australians already pay privately for weight loss medicines, which sets the commercial scale for incretin pen supply.
• Biosimilar device choice: Celltrion's 90 mg/1 mL ustekinumab pre-filled pen won approval in December 2025, showing how biosimilars add pen presentations that compete with syringe formats.
• Respiratory device pipeline: AstraZeneca's Breztri Aerosphere, a pressurised inhaler with 120 doses per pack, was submitted for PBS listing in severe asthma, with consumer comment closing in May 2026.

Australia Drug Delivery Devices Market Size and Forecast

The market is shifting from commodity syringes and legacy inhalers towards prefilled, patient-operated systems that carry biologics and incretin therapies. Injectable devices lead on revenue and advance fastest, while inhalation devices remain the broad, stable base of everyday respiratory care. Autoimmune and inflammatory conditions are the fastest-growing therapeutic area, and home administration gains share against hospitals. Queensland grows quickest, with New South Wales the largest state. Subsidy settings, biosimilar launches and less frequent dosing underpin a durable, multi-year outlook.

Key Takeaways: Australia Drug Delivery Devices Market

Home Administration Anchors Long-Term Demand

Revenue is on course to expand by about 99% across the decade, from AUD 1,050.00 million in 2025 to AUD 2,084.89 million in 2035 at a 7.1% CAGR. Chronic therapies, recurring device refills and steady biosimilar launches make demand repeat-driven.

Injectables and Autoimmune Therapies Lead Growth

Inhalers remain widely used, but injectable devices grow at an estimated 8.6% CAGR and autoimmune and inflammatory conditions at an estimated 9.2% CAGR through 2035. Home and self-administration is expected to rise at 8.1% as therapies move out of hospitals.

Twice-Yearly Biologics Reshape Respiratory Devices

GSK announced the Australian registration of Exdensur in July 2026, and the PBAC recommended its Highly Specialised Drugs listing. Attention turns to how rare, high-value doses are supported by training and pen design.

• Registered for severe eosinophilic asthma from age 12
• Dosed 100 mg every six months by pen or syringe
• Not yet listed on the PBS as of October 2026

Australia Drug Delivery Devices Market Report Summary

Key Insight

Subsidy decisions, biosimilar competition and a shift to home treatment shape the outlook. Injectable devices lead on revenue and growth, while inhalers hold the broad base of everyday respiratory care.

Key Trends in the Australia Drug Delivery Devices Market

The Australia drug delivery devices market is being reshaped by subsidy decisions, new self-injection biologics and the gradual move of pen-based therapies into routine home care.

September 2026 - Wegovy Returns to the PBAC With a Revised Proposal

• The PBS website shows Novo Nordisk's Wegovy pre-filled pens, from 0.25 mg to 2.4 mg, under review for adults with established cardiovascular disease and obesity, with a revised submission set for the November 2026 PBAC meeting.
• Consumer comment ran from 22 July to 16 September 2026, and the medicine remained unlisted as at 1 October 2026.
• The outcome decides whether a subsidised pen supply reaches a large patient group.

July 2026 - GSK Registers Exdensur for Severe Asthma

• GSK Australia announced on 28 July 2026 that the TGA had registered Exdensur (depemokimab) for severe eosinophilic asthma and nasal polyps.
• The PBAC recommended listing at its 8 July 2026 meeting, judging it as effective as mepolizumab with two doses a year instead of thirteen.
• It is given by pre-filled pen or syringe and may be self-administered.

April 2026 - Lilly Declines PBS Listing of Mounjaro for Type 2 Diabetes

• Eli Lilly Australia said on 28 April 2026 that it would not list Mounjaro on the PBS for type 2 diabetes, citing unacceptable funding caps.
• The company said it made four reimbursement submissions and that up to 450,000 Australians could have benefited.
• Private prescription remains the main route for the KwikPen.

March 2026 - PBAC Recommends Yuflyma Prefilled Syringe as Adalimumab Biosimilar

• At its March 2026 meeting the PBAC recommended Celltrion's Yuflyma 20 mg/0.2 mL pre-filled syringe on a cost-minimisation basis against Humira.
• The 40 mg and 80 mg Yuflyma presentations were already listed as both pre-filled syringes and pre-filled pens.
• The PBAC advised that the syringe should not be substituted for any adalimumab pen.

Key Insight

Policy and product cycles now move together. Subsidy rulings, biosimilar listings and longer dosing intervals push care towards pens and syringes used at home, while pricing disputes can slow access.

Recent Market Developments in the Australia Drug Delivery Devices Market

Recent developments, presented from the most recent, show the Australia drug delivery devices market moving through regulatory milestones, supplier showcases and format transitions.

May 2026- AstraZeneca Seeks PBS Listing for Breztri Aerosphere in Severe Asthma

• Consumer comment on AstraZeneca's submission for Breztri Aerosphere closed on 20 May 2026, ahead of the PBAC's July 2026 meeting.
• The 120-dose pressurised inhalation combines budesonide, glycopyrronium and formoterol for adults not controlled on an inhaled corticosteroid and long-acting beta agonist.
• The PBAC outcome had not been published as at 1 October 2026.

January 2026 - BD Previews Large-Volume and Wearable Injection Systems at Pharmapack

• BD exhibited at Pharmapack in Paris on 21 and 22 January 2026, featuring its Libertas wearable injector and Neopak glass prefillable syringe.
• The company stressed high-viscosity biologics, GLP-1 therapies and large-volume subcutaneous delivery as patient self-administration grows.
• Such platforms are the building blocks Australian sponsors draw on for local launches.

December 2025 - TGA Approves Celltrion Ustekinumab Biosimilar Pre-Filled Pens

• The TGA approved Celltrion's Steqeyma in 90 mg/1 mL and 45 mg/0.5 mL pre-filled pens on 16 December 2025.
• The pens add to the syringe and vial presentations already approved for the same biosimilar.
• Pen formats let patients with psoriasis and bowel disease inject at home.

June 2025 - Lilly Completes Mounjaro Move to the Multi-Dose KwikPen

• On 30 June 2025 Eli Lilly confirmed that Mounjaro vial presentations were exhausted after its transition to the multi-dose pre-filled KwikPen.
• Lilly told the TGA that vial stock had run out.
• The change ended single-dose vials and made the pen the only way to supply the medicine.

Key Insight

Recent events show format transitions and regulatory steps more than capacity additions. Suppliers are retiring vials, adding pen presentations and showcasing wearable platforms, while subsidy decisions remain the gating step.

Australia Drug Delivery Devices Industry Segmentation

The Expert Market Research’s report on the Australia Drug Delivery Devices Market offers a detailed analysis of the market based on the following segments.

Market Breakup by Product Type

• Injectable Devices
• Inhalation and Respiratory Devices
• Infusion Pump Systems
• Transdermal and Implantable Devices
• Others

Injectable Devices lead revenue and grow fastest at an estimated 8.6% CAGR through 2035, as the TGA approved Celltrion's Steqeyma pens on 16 December 2025 and Eli Lilly completed its KwikPen transition in June 2025. Inhalation and Respiratory Devices cover inhalers, spacers and nebulisers, where AstraZeneca's Breztri Aerosphere reached consumer comment in May 2026. Infusion Pump Systems span hospital and ambulatory pumps, including the mylife CamAPS FX app that Ypsomed and CamDiab introduced in Australia in June 2025. Transdermal and Implantable Devices include patches and depot systems. Others covers needle-free devices and accessories.

Market Breakup by Application

• Respiratory Diseases
• Diabetes, Obesity and Metabolic Disorders
• Autoimmune and Inflammatory Conditions
• Oncology and Pain Management
• Others

Autoimmune and Inflammatory Conditions grow fastest at an estimated 9.2% CAGR, because the PBAC recommended Yuflyma's 20 mg syringe in March 2026 while adalimumab pens were already listed. Respiratory Diseases remain the broadest therapeutic base, and GSK's twice-yearly Exdensur was registered in July 2026. Diabetes, Obesity and Metabolic Disorders rely on pens, with Wegovy back before the PBAC in November 2026 after Lilly declined a type 2 diabetes listing in April 2026. Oncology and Pain Management use infusion and injectable devices in clinics. Others covers vaccines and hormone therapies.

Market Breakup by End User

• Home and Self-Administration
• Hospitals
• Clinics and Specialist Centres
• Others

Home and Self-Administration grows fastest at an estimated 8.1% CAGR, since GSK states Exdensur may be self-administered or given by a trained caregiver, and BD described growing patient self-administration at Pharmapack in January 2026. Hospitals remain a large buyer of syringes, infusion pumps and nebulisers, and supply pressure on Ventolin Nebules, which GSK reported to Asthma Australia in an April 2026 update, shows their dependence on reliable consumables. Clinics and Specialist Centres supervise first doses and training for biologics. Others includes aged care and community nursing services.

Market Breakup by Region

• New South Wales
• Victoria
• Queensland
• Western Australia
• South Australia
• Others

New South Wales dominates through the largest population and hospital network, growing at an estimated 6.8% CAGR through 2035. Victoria follows at 6.9%, and GSK Australia issued its July 2026 Exdensur announcement from its Abbotsford office, with media contacts in Melbourne and Sydney. Queensland is the fastest-growing state at an estimated 7.8%, ahead of Western Australia at 7.5%, as faster population growth lifts home therapy demand. South Australia grows at 6.6%. Others covers Tasmania, the ACT and the Northern Territory at 7.2%, where remote patients gain most from self-administered pens.

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Competitive Landscape in the Australia Drug Delivery Devices Market

Competition combines therapy owners that control device choice, device specialists that supply platforms and biosimilar sponsors that add formats. Entry barriers include TGA registration, PBS listing outcomes, combination-product validation and clinician training.

Novo Nordisk

Novo Nordisk, headquartered in Bagsværd, Denmark, supplies semaglutide pens in Australia through Novo Nordisk Pharmaceuticals Pty Limited. Its Wegovy pre-filled pens, in strengths from 0.25 mg to 2.4 mg, were recommended by the PBAC in November 2025 for adults with cardiovascular disease and obesity. A revised submission is set for the PBAC's November 2026 meeting, after the Health Minister committed to a listing in January 2026.

Eli Lilly

Eli Lilly, headquartered in Indianapolis, Indiana, markets tirzepatide as Mounjaro in Australia through Eli Lilly Australia. The company confirmed on 30 June 2025 that vials were exhausted after its move to the multi-dose KwikPen. On 28 April 2026 it said it would not list Mounjaro on the PBS for type 2 diabetes after four reimbursement submissions, leaving private prescriptions as the main access route.

GSK

GSK, headquartered in London, operates in Australia through GlaxoSmithKline Australia, whose registered office is in Abbotsford, Victoria. It announced on 28 July 2026 the TGA registration of Exdensur, a six-monthly biologic given by pre-filled pen or syringe. The PBAC recommended it on 8 July 2026. GSK also reported ongoing Ventolin Nebules supply constraints to Asthma Australia in an April 2026 update.

BD

BD, headquartered in Franklin Lakes, New Jersey, supplies prefillable syringes, disposable autoinjectors, pens and the Libertas wearable injector to drug sponsors worldwide, including those serving Australia. At Pharmapack in Paris on 21 and 22 January 2026 it highlighted biologics, GLP-1 therapies and large-volume subcutaneous delivery, and previewed dual-injection systems in development.

Other players operating in the Australia drug delivery devices market include AstraZeneca, Ypsomed, Celltrion, Amgen, and Terumo, alongside hospital suppliers, pharmacy wholesalers, specialist pump distributors and respiratory device makers supporting injectable, inhaled and infusion therapy across Australia.

Key Insight

Competition rests on therapy ownership, device usability, reliable supply and subsidy outcomes rather than price alone. Pharmaceutical sponsors control device choice, while specialists compete through platforms and partnerships.