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Top Autoinjector Companies in Australia & New Zealand: Company Analysis 2026

Company Analysis | Medical Devices | Australia & New Zealand

By Global Data Route Analytics Research Team · Published 26 September 2026 · 12 min read

The Australia and New Zealand autoinjectors market has changed more in the last two years than in the previous twenty. Anapen left the Australian market, leaving EpiPen as the only adrenaline autoinjector for about a year. A new competitor, Jext, arrived on the PBS in June 2026, a needle-free adrenaline nasal spray followed, and CSL launched the world's first prefilled pen for hereditary angioedema (HAE) prevention with an Australian world-first approval.

In this Australia and New Zealand autoinjectors market company analysis, we profile the key companies behind these changes: their background, product portfolio, recent developments, financial snapshot and contact details. We then map the vendor landscape, competitive environment, M&A activity, strategy and a competitive heat map.

Key findings

  • Adrenaline autoinjectors are the core of the market. Australia has one of the highest food allergy rates in the world, with about 10% of Melbourne infants showing challenge-confirmed food allergy in the HealthNuts study.
  • Competition is returning. After Anapen's exit in 2024–2025, Biocelect's Jext joined the PBS on 1 June 2026, ending EpiPen's period as the only PBS-listed autoinjector.
  • CSL leads on innovation. Its ANDEMBRY (garadacimab) prefilled pen won a world-first TGA approval in January 2025, a PBS listing on 1 April 2026 and a Medsafe approval in New Zealand.
  • New Zealand is a narrower market. EpiPen is the only Pharmac-funded adrenaline autoinjector (since February 2023), and Jext has no Medsafe registration yet.

~10%

Melbourne infants with food allergy (HealthNuts)

1 Jun 2026

Jext adrenaline autoinjector PBS listing

1 Apr 2026

CSL ANDEMBRY pen PBS listing

US$15.6 bn

CSL FY25 total operating revenue

Who Are the Key Autoinjector Companies in Australia and New Zealand?

The key autoinjector companies and brands in Australia and New Zealand are:

  1. CSL Limited: Australian biotech leader; ANDEMBRY prefilled autoinjector pen for HAE
  2. Biocelect Pty Ltd: Australian sponsor of the Jext adrenaline autoinjector (PBS-listed 2026)
  3. SciGen Australia Pty Ltd: sponsor of the Nemera-made SciTropin A reusable growth hormone pen
  4. Allergy Life Australia: patient-support charity and Anapen information channel
  5. Viatris (EpiPen): long-standing market-leading adrenaline autoinjector in both countries
  6. Arrotex Pharmaceuticals (Anapen): former Anapen supplier; all doses withdrawn by mid-2025

Adrenaline Autoinjector Market Snapshot

Adrenaline (epinephrine) autoinjectors for anaphylaxis are the largest and most visible part of the ANZ autoinjectors market. This table shows the status of each device as of September 2026.

Device Sponsor / Supplier Doses Australia (TGA / PBS) New Zealand 2026 Status
EpiPen / EpiPen Jr Viatris 300 mcg / 150 mcg PBS-listed Pharmac-funded since Feb 2023 Available
Jext / Jext Jnr Biocelect (made by ALK-Abelló) 300 mcg / 150 mcg TGA 14 Nov 2025; PBS 1 Jun 2026 Not registered New 2026
Anapen 500 / 300 / Jr 150 Arrotex Pharmaceuticals 500 / 300 / 150 mcg PBS-listed from Sep 2021 Not confirmed Withdrawn
neffy (nasal spray) Needle-free alternative 2 mg / 1 mg TGA 8 Dec 2025; PBS 1 Jul 2026 Not registered Alternative

Anapen 300 and Anapen Jr 150 were discontinued in July and September 2024 for lack of demand, and Anapen 500 went out of stock from July 2025 because of a global supply shortage.

Company Overview at a Glance

The four companies profiled in this analysis come from the company links reviewed for this study; figures marked * are third-party or self-reported estimates.

Company HQ Founded Positioning Scale indicator
CSL Limited Melbourne, VIC 1916 Global biotech; ANDEMBRY prefilled pen FY25 revenue US$15,558M; ~29,000 staff
Biocelect Pty Ltd Sydney, NSW + Christchurch, NZ 2014* Specialty medicines sponsor; Jext autoinjector Private; ~12–14 staff*
SciGen Australia Pty Ltd NSW (group HQ Singapore) 1992 (AU) Growth hormone + Nemera reusable pen Private; owned by YiFan International
Allergy Life Australia Australia (national, online) Not disclosed Allergy patient-support charity; Anapen listing Registered charity (DGR)

Product Mapping Analysis

This matrix maps each company across the main autoinjector and self-injection categories in Australia and New Zealand.

Company Adrenaline autoinjector Biologic prefilled pen Growth hormone pen Reusable device PBS-listed device product NZ presence Patient education & support
CSL Limited – ✓ – – ✓ ✓ –
Biocelect ✓ – – – ✓ ✓ –
SciGen Australia – – ✓ ✓ – – –
Allergy Life Australia Listing – – – – – ✓

✓ Offers / applies   Listing Information or listing channel only   – Not offered. NZ presence for CSL reflects Medsafe approval of ANDEMBRY; for Biocelect, its Christchurch office.

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Detailed Company Analysis

Each profile covers the company background, products, recent developments, financials and contact details, with links to the official sources.

1. CSL Limited

Global biotech leader · ANDEMBRY prefilled pen · Melbourne, Victoria

About Us Analysis

Founded in 1916 as the Commonwealth Serum Laboratories and listed on the ASX since 1994, CSL is Australia's largest biotechnology company. It employs almost 29,000 people and serves patients in more than 120 countries through CSL Behring (plasma and specialty therapies), CSL Seqirus (vaccines) and CSL Vifor (iron and nephrology). It manufactures in Australia, Germany, Switzerland, the UK and the US, and runs the world's largest plasma fractionation facility at Broadmeadows, Victoria.

Product Portfolio Analysis

  • ANDEMBRY (garadacimab): a first-in-class anti-Factor XIIa monoclonal antibody that prevents attacks of hereditary angioedema (HAE) in patients aged 12 and over.
  • Device: a 200 mg / 1.2 mL prefilled autoinjector pen, described by CSL as the first prefilled pen for HAE treatment, with the dose delivered in about 15 seconds.
  • Dosing: a 400 mg loading dose, then 200 mg once a month by subcutaneous self-injection.
  • Other lines: immunoglobulins, albumin, haemophilia and other HAE therapies, influenza vaccines and Australia's antivenoms.

Recent Developments / M&A

  • 14 Jan 2025: TGA approves ANDEMBRY, a world-first regulatory approval.
  • Feb–Jun 2025: approvals follow in the UK, EU, Japan (launched 18 Apr 2025), Switzerland and the US.
  • 2 Dec 2025: CSL Seqirus opens a $1 billion-plus vaccine and antivenom manufacturing facility in Melbourne.
  • 12 Mar 2026: Medsafe approves ANDEMBRY in New Zealand.
  • 1 Apr 2026: ANDEMBRY is listed on the PBS, giving Australian patients subsidised access to a once-monthly preventive pen.
  • Earlier M&A: CSL acquired Vifor Pharma in 2022, creating the CSL Vifor division.

Financial Snapshot

FY25 (year to 30 June 2025): total operating revenue of US$15,558 million and net profit attributable to shareholders of US$3,002 million (Annual Report 2025). FY26 revenue was reported at about US$15.8 billion, in a year CSL described as a reset, with large one-off impairments.

Contact Us

655 Elizabeth Street, Melbourne VIC 3000, Australia · Tel: +61 3 9389 1911 · csl.com

Company Links (Official Sources)

Analyst view: CSL brings the scale, manufacturing base and regulatory strength that no other company in this group has. ANDEMBRY shows how autoinjector pens are moving beyond emergency use into long-term biologic therapy, and CSL is the local leader in that shift.

2. Biocelect Pty Ltd

Specialty medicines sponsor · Jext adrenaline autoinjector · Sydney & Christchurch

About Us Analysis

Biocelect is a privately held company that sources, in-licenses and commercialises medicines for Australia, New Zealand and the South Pacific. Its portfolio spans infectious disease and travel medicine, vaccines, specialty care and allergy. It has a head office in Sydney and an office in Christchurch, New Zealand.

Product Portfolio Analysis

  • Jext 300 (300 mcg / 0.3 mL): adrenaline autoinjector for patients weighing 20 kg or more.
  • Jext Jnr 150 (150 mcg / 0.15 mL): for children weighing 7.5–20 kg.
  • Device features: two-step use, colour-coded ends, a yellow safety cap and an automatically retracting needle; can be used through clothing.
  • Origin: Jext was developed and is manufactured by ALK-Abelló of Denmark and has been sold in Europe since about 2010.
  • Other lines: travel and infectious disease medicines (including a malaria treatment), vaccines and specialty products.

Recent Developments / M&A

  • 14 Nov 2025: Jext and Jext Jnr registered with the TGA.
  • 1 Jun 2026: Jext listed on the PBS and launched in Australia, becoming the second PBS-listed adrenaline autoinjector alongside EpiPen.

Financial Snapshot

Private company; financials not publicly disclosed. Third-party data sites carry revenue estimates, but these are not reliable for a company with a national PBS-listed product.

Contact Us

Level 4, 143 Macquarie Street, Sydney NSW 2000 · NZ: Level 5, 47 Hereford Street, Christchurch 8013 · Tel: 1300 907 411 · Email: info@biocelect.com · biocelect.com

Company Links (Official Sources)

Analyst view: Biocelect is the company to watch in adrenaline autoinjectors. Jext gives prescribers and patients a PBS-listed alternative to EpiPen for the first time since Anapen left, and the next step is New Zealand registration and funding.

3. SciGen Australia Pty Ltd

Growth hormone & reusable pen injector · New South Wales

About Us Analysis

SciGen Australia is the local arm of the SciGen group, founded in Singapore in 1988, with the Australian subsidiary set up in 1992. The group sells biopharmaceuticals across Singapore, Korea, Australia, China and Southeast Asia, with partners in Europe, Brazil and New Zealand. It was formerly ASX-listed and has been owned by YiFan International Pharmaceutical since 2018.

Product Portfolio Analysis

  • SciTropin A Pen: a reusable pen injector made by Nemera for SciTropin A (somatropin, recombinant human growth hormone), approved by the TGA in February 2022.
  • SciTropin A cartridges: 10 mg/1.5 mL and 15 mg/1.5 mL listed on the ARTG, used with the reusable pen.
  • Other lines: insulin (Gensulin/SciLin) and Gensupen 2 insulin pen in other markets, Zometa (zoledronic acid) in Australia and New Zealand, and oncology supportive care products.

Recent Developments / M&A

  • Feb 2022: TGA approval of the Nemera-made SciTropin A reusable pen injector.
  • Aug 2018: YiFan International Pharmaceutical completed its acquisition of SciGen Ltd from Bioton S.A. for about $28 million.
  • 2019: SciGen acquired rights to Zometa from Novartis.

Financial Snapshot

Not publicly available. SciGen was taken private in 2018 and now reports within the YiFan group.

Contact Us

Group HQ: 150 Beach Road, #32-05/08 Gateway West, Singapore 189720 · scigen.com

Company Links (Official Sources)

Analyst view: SciGen shows how specialty sponsors use proven device partners like Nemera to bring pen-based hormone therapy to Australia. Its niche is small but loyal, since growth hormone patients inject regularly for years.

4. Allergy Life Australia (AllergyLife)

Patient-support charity · Anapen information channel · National

About Us Analysis

Allergy Life Australia is a national, community-run charity with DGR (deductible gift recipient) status. It supports people living with allergies through more than 150 online support groups, the My Allergy Card app, cost-assistance programs and a healthcare directory. It is not a device manufacturer or sponsor; its link to the autoinjector market is through patient education and its Anapen product listing.

Product Portfolio Analysis

  • Anapen 500 listing: 500 mcg / 0.3 mL adrenaline autoinjector for patients weighing 50 kg or more, supplied in Australia by Arrotex Pharmaceuticals.
  • Programs: Allergy Life Aid (cost help), My Allergy Card app, Allergy Life Health directory, My Safe Program and online support groups.

Recent Developments / M&A

  • Jul–Sep 2024: Anapen 300 and Anapen Jr 150 discontinued in Australia for lack of demand.
  • Jul 2025: Anapen 500 goes out of stock due to an unresolvable global supply shortage, with no resupply date.
  • 2025–2026: AllergyLife adds an Allergy Notes app feature, passes 150 support groups and launches Allergy Life Aid.

Financial Snapshot

Not publicly available (registered charity).

Contact Us

Email: contact@allergylife.com.au · allergylife.com.au

Company Links (Official Sources)

Analyst view: AllergyLife matters as a voice of the patient. Supply shocks such as the Anapen withdrawal hit its community first, and patient groups shape awareness, training and demand for new devices like Jext.

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Recent Developments Timeline

Sep 2021

Anapen is listed on the PBS in Australia.

Feb 2022

TGA approves SciGen's Nemera-made SciTropin A reusable growth hormone pen.

Feb 2023

Pharmac begins fully funding EpiPen in New Zealand.

Jul–Sep 2024

Anapen 300 and Anapen Jr 150 are discontinued in Australia.

Jan 2025

TGA grants CSL's ANDEMBRY a world-first approval.

Jul 2025

Anapen 500 goes out of stock, leaving EpiPen as the only adrenaline autoinjector in Australia.

Nov 2025

TGA registers Biocelect's Jext and Jext Jnr.

Dec 2025

CSL opens a $1 billion-plus vaccine and antivenom facility in Melbourne.

Mar 2026

Medsafe approves ANDEMBRY in New Zealand.

Apr 2026

ANDEMBRY is listed on the PBS.

Jun 2026

Jext is listed on the PBS and launched.

Jul 2026

neffy adrenaline nasal spray is listed on the PBS as a needle-free alternative.

Competitive Landscape Analysis

The ANZ market is small and concentrated, and most devices are imported. Companies compete through regulatory approvals, PBS and Pharmac listings, and supply reliability rather than local manufacturing. The players fall into three groups:

Tier 1: Global innovator with local manufacturing

CSL Limited (with Viatris’ EpiPen as the established adrenaline leader)

Large-scale companies with strong regulatory records and reimbursed products. CSL leads in biologic prefilled pens; EpiPen remains the default adrenaline device in both countries.

Tier 2: Specialist sponsors and distributors

Biocelect, SciGen Australia

Lean companies that in-license proven devices from global makers (ALK-Abelló, Nemera) and win share through PBS listings and focused marketing.

Tier 3: Patient ecosystem

Allergy Life Australia

Charities and patient groups that shape awareness, training and device choice, and feel supply shocks first.

What will decide the winners?

  • Reimbursement: PBS listing in Australia and Pharmac funding in New Zealand decide which devices patients actually get.
  • Supply reliability: the Anapen withdrawal showed that one supply failure can remove a brand from the market.
  • New Zealand entry: Medsafe registration and Pharmac funding are the next frontier for Jext and other challengers.
  • Needle-free alternatives: nasal adrenaline (neffy) will push autoinjector makers to improve ease of use and training.

Vendor Landscape

The vendor landscape groups each company by business model, core offering, therapy area, geographic reach and credentials.

Company Vendor Type Core Offering Therapy Area Geographic Reach Credentials
CSL Limited Global Innovator ANDEMBRY prefilled autoinjector pen Hereditary angioedema; plasma therapies; vaccines Australia, NZ and 120+ countries TGA, PBS, Medsafe, FDA, EMA approvals
Biocelect Specialty Sponsor Jext / Jext Jnr adrenaline autoinjectors Anaphylaxis; travel medicine; vaccines Australia, NZ, South Pacific TGA registered; PBS listed
SciGen Australia Device-Partnered Sponsor SciTropin A + Nemera reusable pen Growth hormone deficiency Australia; Asia-Pacific group TGA approved pen (2022)
Allergy Life Australia Patient Ecosystem Anapen listing, support programs Allergy and anaphylaxis Australia (national) Registered DGR charity

Competitive Environment

Using Porter's Five Forces, the table below shows how intense competition is in the Australia and New Zealand autoinjectors market and why.

Force Intensity Market Evidence Strategic Implication
Competitive Rivalry Medium
 
Only two PBS-listed adrenaline autoinjectors (EpiPen and Jext) in 2026; rivalry is rising after years of near-monopoly. Compete on training, device features and supply reliability.
Threat of New Entrants Low-Medium
 
TGA registration, PBS listing and Pharmac funding are slow and costly for a small population. Partner with global device makers to shorten the path.
Bargaining Power of Buyers High
 
The PBS and Pharmac act as powerful single buyers that set prices and funding terms. Build strong cost-effectiveness cases for reimbursement.
Bargaining Power of Suppliers Medium-High
 
Most devices are made overseas (ALK-Abelló, Nemera, Viatris); the Anapen shortage showed supply risk. Secure multi-source supply and local stock buffers.
Threat of Substitutes Medium
 
neffy nasal adrenaline spray was PBS-listed in July 2026 as a needle-free option. Differentiate with ease of use, clear dosing and patient trust.

Merger & Acquisition Analysis

Deal activity in the ANZ autoinjectors space is mostly about licensing, acquisitions by parent groups and large capital investment, rather than frequent local mergers.

Date Deal / Parties Type Value Strategic Rationale Market Impact
2022 CSL acquires Vifor Pharma Acquisition Approx. US$11.7 bn Adds iron and nephrology franchise; creates CSL Vifor. Strengthens CSL's global specialty portfolio and scale.
Aug 2018 YiFan International Pharmaceutical acquires SciGen Ltd from Bioton Acquisition Approx. $28 M Takes SciGen private and adds its Asia-Pacific biopharma network. SciGen continues as sponsor of growth hormone pens in Australia.
2025–2026 Biocelect brings ALK-Abelló's Jext to Australia In-licensing / Distribution Undisclosed Adds a proven European autoinjector to Biocelect's allergy portfolio. Restores competition to EpiPen on the PBS from June 2026.
Dec 2025 CSL Seqirus opens Melbourne facility Capital Investment $1 bn+ Local vaccine and antivenom manufacturing capacity. Reinforces Australia's sovereign biologics manufacturing.
2024–2025 Arrotex withdraws Anapen Market Exit n/a Low demand for 300/150 doses; global supply failure for 500 mcg. Leaves a gap now being filled by Jext and neffy.

Outlook: expect more in-licensing deals that bring proven overseas autoinjectors and needle-free devices to ANZ, especially for New Zealand, where only one adrenaline autoinjector is currently funded.

Strategy Framework

The framework below shows each company's main strategy, growth levers, key strength and the main risk to watch.

Company Core Strategy Growth Levers Key Strength Watch-out
CSL Limited Innovation-led Global Scale World-first approvals; PBS and Medsafe access for ANDEMBRY; local manufacturing investment Scale, R&D, manufacturing and regulatory strength FY26 reset and impairments; HAE is a niche indication
Biocelect In-licensing & Reimbursement PBS listing of Jext; potential NZ registration; allergy portfolio growth Agile sponsor with a PBS-listed autoinjector Small team competing against EpiPen's brand strength
SciGen Australia Device Partnership Niche Nemera pen platform; growth hormone patient base; group portfolio Proven device partner and ARTG-listed products Limited public data and narrow indication
Allergy Life Australia Community & Advocacy Support groups, apps, cost-assistance programs Direct reach into the allergy community Depends on donations; not a supplier

Heat Map Analysis

The heat map scores each company from 1 (low) to 5 (high) on seven competitive factors. These are analyst scores based on the public information in this blog; darker cells mean a stronger position.

Company Autoinjector Portfolio PBS / Pharmac Access Regulatory Track Record Local ANZ Presence Financial Strength Innovation Patient Engagement Total /35
CSL Limited 3 4 5 5 5 5 3 30
Biocelect 4 4 4 4 2 3 3 24
SciGen Australia 3 3 4 3 2 3 2 20
Allergy Life Australia 1 1 1 4 1 2 5 15
Scale: 5 High 4 3 2 1 Low

Reading the heat map: CSL leads on regulatory strength, financial scale and innovation. Biocelect has the strongest adrenaline autoinjector position among the specialist sponsors thanks to Jext's PBS listing. SciGen holds a focused niche in growth hormone pens, while Allergy Life Australia scores highest on patient engagement.

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Frequently Asked Questions

What is the Australia and New Zealand autoinjectors market?

It covers devices that let patients self-inject a pre-measured dose of medicine, including adrenaline autoinjectors for anaphylaxis, prefilled pens for biologics such as CSL's ANDEMBRY, and pen injectors for hormones such as growth hormone.

Which adrenaline autoinjectors are available in Australia in 2026?

EpiPen (Viatris) and Jext (Biocelect) are the PBS-listed adrenaline autoinjectors in 2026. Anapen was withdrawn between 2024 and 2025, and neffy, a needle-free nasal adrenaline spray, was PBS-listed in July 2026.

Which adrenaline autoinjector is funded in New Zealand?

EpiPen is the Pharmac-funded adrenaline autoinjector in New Zealand, fully funded since 1 February 2023. Jext and neffy do not yet have Medsafe registration or Pharmac funding.

When was Jext listed on the PBS?

Biocelect's Jext adrenaline autoinjector was registered with the TGA on 14 November 2025 and listed on the PBS on 1 June 2026, in 300 mcg and 150 mcg (Jext Jnr) doses.

What is CSL's ANDEMBRY autoinjector?

ANDEMBRY (garadacimab) is a once-monthly prefilled autoinjector pen that prevents hereditary angioedema attacks. The TGA approved it in January 2025 as a world first, and it was listed on the PBS on 1 April 2026.

Why was Anapen withdrawn from Australia?

Anapen 300 and Anapen Jr 150 were discontinued in 2024 because of low demand, and Anapen 500 went out of stock from July 2025 because of an unresolvable global supply shortage.

How can I get the full Australia and New Zealand autoinjectors market report?

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Conclusion

The Australia and New Zealand autoinjectors market is small but important, driven by one of the world's highest allergy rates and a growing shift to self-injected biologics. After the Anapen withdrawal, Biocelect's Jext has brought competition back to adrenaline autoinjectors, while CSL's ANDEMBRY shows the next wave of long-term, pen-based therapies. Specialist sponsors such as SciGen and patient groups such as Allergy Life Australia complete the ecosystem. For manufacturers, investors and healthcare buyers, reimbursement decisions, supply reliability and New Zealand market access will define the next few years.

Research Methodology & Sources

This analysis is based on each company's official website, annual reports, TGA, PBS, Medsafe and Pharmac information, and announcements from ASCIA (the Australasian Society of Clinical Immunology and Allergy), reviewed in September 2026. Third-party estimates are marked as such.

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