As 3D printing drugs in rural hospitals becomes a reality, what are the opportunities and threats for AstraZeneca?

In rural hospitals, critical drugs are often not in stock. Desperate patients and their families are further pushed into prolonged suffering. Feeling they have nothing to lose, some resort to DIY solutions.

As additive manufacturing is applied to drug production at patients’ closest point of sale, we can imagine a world where rural patients purchase out-of-stock drugs within a few hours of visiting a local hospital. What if the hospital had a 3D printer? What if CAD files from global pharmaceutical companies like AstraZeneca were available?

On the same day Alibaba’s ‘Singles’ Day’ sales took China by storm, The New York Times ran an article describing an unusual online transaction taking place in rural China – a son with a cancer-stricken mother was purchasing raw materials from e-commerce sites like Alibaba to make a version of AstraZeneca’s Tagrisso, a lung cancer drug [1].

Cancer drugs manufactured by large pharmaceutical companies such as AstraZeneca go through stringent regulation and a complex global supply chain to eventually reach a local hospital where patients can purchase them. In rural hospitals, these critical drugs are often not in stock. Desperate patients and their families are further pushed into prolonged suffering. Feeling they have nothing to lose, some resort to DIY solutions. Perhaps due to lack of access to drugs, rural cancer patients in China are 30% more likely to die than urban cancer patients after a diagnosis [1].

As additive manufacturing is applied to drug production at patients’ closest point of sale, we can imagine a world where rural cancer patients purchase out-of-stock drugs within a few hours of visiting a local hospital. What if the hospital had a 3D printer? What if CAD files from AstraZeneca were available?

Additive manufacturing of drugs

Drugs containing API such as acetaminophen and guaifenesin have been successfully 3D printed between 2006 to 2015 [2]. In July 2017, researchers at GlaxoSmithKline and the University of Nottingham demonstrated that a combination of inkjet printing and UV curing can produce oral dosage forms of drugs to treat Parkinson’s [3].

Patient demand for increased access to life-saving drugs at lower unit costs of production have led biohackers such as Michael Laufer to debut 3D-printable drug makers this summer. Laufer used his 3D-printed ‘Apothecary Microlab’ to synthesize pyrimethamine, a drug better known by its trade name Daraprim. Pharmaceutical company CEO Martin Shkreli had bought the patent for Daraprim and raised the price by 5,500 percent to $750 a pill. Laufer wanted to make the point that with his 3D-printed Microlab, a layperson could essentially make Daraprim for $2 a pill [4].

Opportunities and Threats for AstraZeneca

For AstraZeneca, additive manufacturing presents an opportunity to improve its supply chain by outsourcing production to the point of sale. In the long term, AstraZeneca would be able to save costs by relying less on supply chain intermediaries in charge of shipping, transport, and quality maintenance. 3D printing at local hospitals would not replace all of its supply chain system but it would be useful for solving out-of-stock problems for rural areas where AstraZeneca faces a last mile problem.

Even more important is preparing for potential disruptions, such as becoming disintermediated by desperate and underserved patients who may take drug manufacturing into their own hands. China already has large online forums dedicated to DIY cancer drugs, such as “Dances with Cancer” and “I Want Miracles” with over 440,000 members [1]. Another downside is losing an edge to competitors such as GlaxoSmithKline that are conducting projects to provide more use cases of 3D drug manufacturing.

Recommendations for AstraZeneca

AstraZeneca is beating competitors in China, and saw a 32% increase in the region for the past quarter [5]. However, winning in a geography and winning in terms of new drug development does not exempt it from taking on projects to disrupt its supply chain and improve access to rural markets. Because so many of China’s cancer patients live in rural areas, it is critical for AZ’s China division to improve access to drugs and 3D printing at local hospitals and pharmacies is one way of addressing this problem.

AstraZeneca should pay close attention to what competitors are doing to simplify their supply chain through inkjet 3D printing. According to GSK Director of Technology Martin Wallace, “Inkjet 3D-printing methods are of particular interest to the pharmaceutical industry because they have many parallels with current manufacturing processes, and may offer a more efficient longer-term printing solution.” [6]

Uncertainties to resolve

AstraZeneca will have to figure out how to be adequately compensated for the drugs produced in local, rural hospitals. Is there a way to configure the 3D printing machines so that only designated, qualified individuals with purchasing accounts can use it?

It will also need to protect itself from liability issues, because they will be giving more drug quality control to the rural hospitals. How will AstraZeneca protect itself from quality issues?

Later, as 3D printing of drugs in local hospitals becomes more common, AstraZeneca and other drug manufacturers will need to reconcile 3D printer – company drug formula compatibility issues. Will there be a different printer for every brand, or will all companies be allowed to make their drug through one printer?

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References

[1] Wee, S. (2018). In China, Desperate Patients Smuggle Drugs. Or Make Their Own.. [online] Nytimes.com. Available at: https://www.nytimes.com/2018/11/11/business/china-drugs-smuggled-homemade.html.

[2] Prasad, L. and Smyth, H. (2015). 3D Printing technologies for drug delivery: a review. Drug Development and Industrial Pharmacy, 42(7), pp.1019-1031.

[3] 3D Printing Industry. (2018). Scientists 3D print Parkinson’s medicine for first time with UV inkjet 3D printing – 3D Printing Industry. [online] Available at: https://3dprintingindustry.com/news/scientists-3d-print-parkinsons-medicine-first-time-uv-inkjet-3d-printing-117695/.

[4] Rosenblatt, S. (2018). Biohacker’s latest answer to health care hurdles: Homebrew meds – The Parallax. [online] The Parallax. Available at: https://www.the-parallax.com/2018/07/20/biohacking-homebrew-meds-hope/.

[5] BioPharma Dive. (2018). AstraZeneca at ‘inflection point’ in turnaround, predicts CEO. [online] Available at: https://www.biopharmadive.com/news/astrazeneca-at-inflection-point-in-turnaround-predicts-ceo/541756/.

[6] Redshift EN. (2018). GlaxoSmithKline and the Future of 3D-Printed Pharmaceuticals. [online] Available at: https://www.autodesk.com/redshift/3d-printed-pharmaceuticals/.

 

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Student comments on As 3D printing drugs in rural hospitals becomes a reality, what are the opportunities and threats for AstraZeneca?

  1. I don’t think it would be too hard to limit the 3D printers so only doctors for example can use them. The system could work with ID’s that have to be set up before hand. The more troublesome part is the quality control. And also, how much will a 3D printer cost? We are assuming they would be cheaper and drugs supplied the traditional way. Is this actually true?

  2. Absolutely fascinating. This would be a use case for 3D printing that could save lives if it can be implemented in a safe way. I think there are a few questions AZ should think about
    1) How does patent protection come into play in such a setting? I don’t see this as too different from generics companies producing drugs before the patent expires, so there may be a question of whether the scope of protection or the legal action that AZ can take differs depending on whether the generics are made for sale (generic companies mass producing) or individual consumption (presumably, 3D printing)
    2) How it can differentiate itself, from a quality standpoint. Again, I see 3D printing as very similar to generic companies (or other non-reputable companies) making copies of AZ’s drugs and selling it. AZ has an advantage over DIY 3D printed drugs in that it’s quality-assured.

    Additionally, 3D printing may be more applicable for chemical compounds. However there is a trend for biologics and personalized medicine being developed for new treatments, which from my limited understanding seems like less of a good fit for 3D printing since the production of biologics and personalized medicine is more complicated than the current 3D printing technologies. The question thus becomes, does it make sense for AZ to try and do something super high tech (i.e. print medicines) to solve a rather low-tech distribution problem?

  3. Great article! You certainly raise some interesting questions. Your second question concerning quality really resonated with me – it could absolutely cause considerable problems if the drugs being produced had quality issues. This is further exacerbated by the fact that these machines would be in remote and rural areas – for example, AstraZeneca wouldn’t be able to send out an expert to operate the printer each time drugs were needed. I think that one way to combat the issue ties into your first point – ensuring that only trained individuals can access these products. Perhaps there is a way to innovate the technology so that local operators must collaborate with an AstraZeneca expert remotely so that AstraZeneca can still retain a portion of control over the production. If the local operators must communicate with company-employed experts to execute the printing process, the process could be remotely overseen and controlled by AstraZeneca to ensure that quality and access issues are being addressed.

  4. Thanks for writing this article! I used to do development work in rural China training village doctors, and the issues raised in this blog post rings close to heart. While additive manufacturing is innovative in context of printing drugs, I don’t think the best use case will be in China’s rural hospitals. Patients in developing countries are dealing with more fundamental issues around misdiagnosis of disease (e.g. improper response procedures for infectious illnesses like tuberculosis) and the over-prescription of antibiotics, which is leading to anti-microbial resistance in rural communities. I view giving access to this kind of technology at the rural-healthcare-level in China as dangerous, unless the more fundamental issues around culture and training is solved.

  5. Such a fascinating topic – and a great article! This technology has the potential to truly disrupt the pharmaceutical industry. But I think the problem of how to scale this is very real. While the actual production of the drugs may be cheaper (in some cases, like that of Daraprim, drastically so), distributing 3D printers to local hospitals in rural areas could prove a mammoth task in and of itself. This also raises the question of how companies can monetize this technology and ensure that they are adequately compensated, while also keeping in mind the vast social good that comes from providing a cheap supply of life-saving drugs in rural areas.

  6. Fascinating topic, even though I think it might still take a while for this idea to become feasible economically – I imagine investment/fixed costs of these machines would be pretty high. Maybe one potential near term application could be pharmaceutical R&D – since those already incur huge investments, 3D printing might be able to turn the process more efficiently. What do you think?

    To your questions:
    – Quality control and responsibility: I might be completely off, but I tend to think those risks are very similar to those a pharmaceutical company faces today. Therefore, I think there might be ways to reduce or accommodate those risks.

    – Usage of the machine by different brands: Due to the high investment I mentioned earlier, I would assume that for this idea to work on hospitals/care centers in rural areas one single machine would have to print a wide variety of medicines from different companies. As one of the comments mentioned earlier, it would be important to achieve a revenue sharing model that could protect patents while still providing a financial benefit for the 3D printing company.

  7. Great read! I’ve never heard about 3D-printing drugs before. The caution I have is with regards to quality control and in turn liability. At least in the US, there is a ton of quality control and testing in drug manufacturing to make sure that its API, formulation, etc. is precisely as is in the approved label. Without adequate quality control, one can imagine the safety and efficacy of a 3-D printed drug be very different and have costly consequences.

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