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2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends

Published: 1 March 2024

Some of the most sought-after human experiences are health and happiness. Although pharmaceutical companies cannot determine personal happiness, they are working to improve personal health outcomes that can tip the scale. The demand for personalised medicines, cell and gene therapies, hyperresponsive and patient-centric healthcare, real-world data fuelled by artificial intelligence (AI) platforms and stored in the cloud are just some examples of the personal touch that is driving the future of pharma.

Register your details to learn more about leveraging real-world data, the practical applications of AI and adopting configurable LC/NC solutions. Keep pace with the latest economic trends and identify opportunities for growth.

Technology trends

Current technology trends are influencing consumer behaviour and reshaping the way industry operates. Although pharma companies are working steadily to leverage the power of data and become more agile and resilient, there is still room for improvement.

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Adopting configurable LC/NC solutions

Highly configurable low-code/no-code (LC/NC) solutions are becoming popular because they invite innovation by giving quality and manufacturing professionals direct control over process design and data management. These applications provide “a close fit to business requirements, can be implemented quickly, and typically cost much less than systems developed in-house,” according to professionals.² One interesting offshoot of adopting configurable LC/NC solutions is to attract, or rather curate, the industry’s more technically competent talent to play the role of business developers – talent that is in short supply in biopharma, according to McKinsey & Company.³

Leveraging real-world data

The cloud, personal devices and apps are recording vast amounts of real‑world data (RWD). The US Food and Drug Administration (FDA) continues to prioritise methods to assess real-world data, develop advanced manufacturing approaches, and incorporate patient input.⁴ Currently, the FDA is looking for near real-time surveillance of stimulants via the ToxIC Registry programme and has also authorised the first medical devices to treat opioid use disorder (OUD).

Practical applications of artificial intelligence

A recent study found that small and large companies tend to use AI differently, but that AI solutions for pharma significantly increase efficiencies and the potential applications are promising.⁵ What will differentiate pharma manufacturers is how robustly they use modern tools like AI throughout their processes, including in production and quality control.⁶ Implementing novel technology will need to unfold strategically. The key is to start with low-risk, high-priority business cases, such as document management, for example, or predicting training lapses and gradually move on from there.

Regulatory trends

The key to pharma companies finding opportunities for growth is finding silver linings in regulatory challenges. Complementing regulatory efforts by promoting production and controls innovations will allow pharma leaders to improve patient outcomes and consequently extend their own reach.

The Drug Supply Chain Security Act

The Drug Supply Chain Security Act (DSCSA) was implemented in 2013 by the FDA to help protect consumers from counterfeit, stolen, contaminated, and otherwise harmful drugs.⁷ The FDA’s final guidance issued in September 2023 enables companies to more easily adopt secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain.⁸

Artificial intelligence legislation

The EU recently drafted the first legislation relating to the use of AI in the lifecycle of medicines.⁹ Members are hoping for agreement across the EU Council in preparation for discussions to establish the final form of the law. The new legislation seeks to outline levels of risk, transparency requirements, prevention of illegal content, and copyright infringement.¹⁰ There is no question that governing bodies are anticipating AI will play an integral part in future business models. Deloitte identifies one strategy to alleviate some of the legislator’s concerns of bias, overfitting, and data protection; namely applying low-code AI to common‑use cases rather than high‑stakes endeavours.¹¹

Learn more about transforming pharmaceutical manufacturing – the AI revolution.

Therapeutic trends

As the pharma industry strives to stay abreast of personalised patient needs, the number of holistic therapies dedicated to enhancing wellness – in addition to simply treating widespread disease – is rising.

Cell and gene therapies

Cell and gene therapy (CGT) has maintained a prominent space in the pharma landscape since 2021 and is projected to grow from $9 billion to $42 billion by 2030.^12,13 The regulatory framework, at least in the US, is poised to facilitate the development and approval of these therapies.¹⁴ KPMG reports that while the appetite for autologous cell therapies is diminishing, innovation therapies with simplified manufacturing processes and supply chain complexities are in favour.¹⁵

Wellness disrupters

According to Deloitte, sales volumes for drugs across disease areas are likely to decline over time with “more effective prevention, greater stratification of disease, better tailoring of drug regimens for patients, an increase in curative therapies, behavioural intervention, and advanced medical procedures.”¹⁶ Pharmaceutical companies may be pressed to adopt alternative therapies or find uses in concert with personalised devices and/or wellness regimens to meet consumers’ desires to stay healthy.

Obesity and addiction treatments

The demand for drugs to treat obesity, such as Wegovy and Ozempic, is currently exceeding demand, even prior to final indication approvals. This is one area where pharma is finding success shifting into broader wellness initiatives, but also relying on personalised technologies to target phenotypes. “In two to three years, we’ll have drugs for each of these categories … And there are lifestyle and diet interventions for each of the phenotypes that can also achieve results,” states Mark Bagnall, Phenomix Sciences CEO.¹⁷ Time will tell if this targeted approach may also support recent initiatives by the FDA to combat addiction and opioid use disorder (OUD), which continues to cause high mortality rates.¹⁸

Economic trends

Economic watchdogs report that there is slow overall deal activity due to tight capital, higher interest rates, inflation and pricing controls, and active enforcement by the Federal Trade Commission (FTC).¹⁵ However, others suggest the emergence of smaller partnerships and timely divesting and reacquisition strategies can redirect investment toward profitable outcomes.¹² Technology solutions are playing a more significant role in biopharma portfolios. The emergence of generative AI, for example, has “added some effervescence to the market” as companies seek to understand how to integrate it and are “compelled to acquire expertise,” according to PwC.¹⁹

Is localisation the answer for pharmaceutical supply chain resilience?

Inflation Reduction Act

The Inflation Reduction Act (IRA) establishes a process for price negotiations and drug pricing controls for 10 drugs available to Medicare beneficiaries. It also revises Medicare Part D to provide less expensive coverage. This comes in response to concerns about the financial stability and overall health of older Americans, who may often skip or ration prescriptions because they cannot afford them.²⁰ Although this act is primarily aimed at opening market access, widespread ramifications will impact pharma companies’ commercial strategies and may inhibit research and development.

Ongoing pharma supply chain management challenges

Backlogs in global supply chains are leading to more competition for the raw materials pharma companies need.²¹ Supply chain optimisation, including more careful selection of suppliers, is a central concern. However, one of the most critical causes of drug supply shortage is much closer to home.²² In a 2020 report published by the FDA, economists examined 163 drugs that went into shortage over a four-year period. Sixty‑two percent of them went into shortage only after supply was disrupted due to manufacturing and product quality problems.¹⁵

Reduced investment and increased oversight

Increased federal scrutiny limiting large M&A activity, IRA pricing concerns, delayed FDA approvals, and reduced investment in the biotech sector, are forcing the industry to redirect resources and evolve operationally to remain competitive. While large biopharmaceutical companies with equity and cash assets always have the advantage,¹⁵ smaller biotech companies are experiencing large‑scale layoffs and may need to confront reduced valuations in the near future.²³ Despite current cash scarcity, Ernst & Young is confident about the long term if biotech companies “can prioritise streamlining processes and the ongoing investment in organic innovation.”²⁴ Larger companies will continue to acquire early- to mid-stage assets, but are shifting their interest to areas where manufacturing and supply chain complexity is simplified.

Conclusion

While pharma has traditionally been characterised by costly and lengthy development cycles, ever-evolving demands, driven largely by needs for more personalisation, will require significant changes to pharmaceutical manufacturing and quality processes. The deeper digitalisation can go into these companies, the more personalised their products can become – more efficiently, and consequently less expensively. Reaching digital maturity remains imperative to enable companies to respond more quickly with flexibility and agility, while remaining compliant and competitive.

Digital transformation in pharma is only expected to grow over the next few years to keep pace with current trends. Configurable solutions and intelligent platforms are making it possible to harmonise unique business processes with changing regulations and market demands. Now is the time to leverage professional expertise, differentiate and expand your reach with a personal touch like never before.

Digital QMS in pharma

Only 29 percent of life science companies surveyed¹ by MasterControl have a digital quality management system (QMS) fully implemented at all facilities. Notable gaps in traditional quality management system offerings identified in the survey include:

– 22 percent of quality organisations point to limited quality system and/or process data visibility as a very significant pain point

– 20 percent of quality organisations confirm that existing processes are too rigid and/or complex

– In general, the more variable and situation-based a process is, the less often it is fully digitalised.

References

1. The State of Digital Quality Maturity in Pharma and Medtech [Internet]. MasterControl. [cited 2024 Feb]. Available from: https://www.mastercontrol.com/uk/resource-center/documents/the-state-of-digital-quality-maturity-in-pharma-and-medtech/
2. When low-code/no-code development works – and when it doesn’t [Internet]. 2021 [cited 2024 Feb]. Available from: https://hbr.org/2021/06/when-low-code-no-code-development-works-and-when-it-doesnt
3. Ahlawat H, Graves G, Hou T et al. The Helix Report: Is biopharma Wired For Future Success? [Internet]. McKinsey & Company; 2022 [cited 2024Feb]. Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/the-helix-report-is-biopharma-wired-for-future-success
4. FDA Today newsletter, AgencyIQ by Politico, Oct. 12, 2023.
5. Kulkov I. The role of Artificial Intelligence in Business Transformation: A case of pharmaceutical companies. Technology in Society. 2021 Aug;66:101629.
6. Bechtel M. Briggs B. Tech Trends 2023. 2023. Deloitte Insights.
7. FDA. Drug Supply Chain Security Act (DSCSA).FDA.gov. 2023.[cited 2023Sep]
8. FDA. DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry, FDA.gov. [cited 2023Sep].
9. Barrie R. Controlling the pharma machine: EMA conveys thoughts on AI use in industry [Internet]. 2023 [cited 2023Sep]. Available from: https://www.pharmaceutical-technology.com/news/controlling-pharma-machine-ema-ai/
10. EU AI act: First regulation on artificial intelligence: News: European parliament [Internet]. 2023 [cited 2023Sep]. Available from: https://www.europarl.europa.eu/news/en/headlines/society/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence
11. Grabowski B, et al. Low-code AI: Mission ready? 2023. Deloitte. [cited 2023Oct] Available at: https://www2.deloitte.com/content/dam/Deloitte/us/Documents/public-sector/us-low-code-ai-mission-ready-april-2023-vF.pdf
12. JP Morgan. Q2 2023 Biopharma Licensing and Venture Report. July 2023.
13. Pharma Voice. Inside the development of cell and gene therapies. [Internet] 2023. [cited2023Sep] https://www.pharmavoice.com/trendline/cell-gene-therapies/329
14. Cell And Gene Therapy Clinical Trials Market Size, Share & Trends Analysis Report Grand View Research. [Internet] 2023. [cited 2023Oct] Available from: https://www.grandviewresearch.com/industry-analysis/cell-gene-therapy-clinical-trials-market
15. Stoll J, et al. Biopharma Deal Trends Outlook for 2023. KPMG.
16. Yang T, et al. The Future of Biopharma: Reimagining traditional business models in 2040. Deloitte. 2020.
17. Gibney M. In the era of blockbuster obesity drugs, a personalized approach could boost outcomes. [Internet] PharmaVoice. 2023. [cited2024Feb] Available from: https://www.pharmavoice.com/news/blockbuster-obesity-drugs-Ozempic-Wegovy-Phenomix/690169.
18. FDA. FDA Continues Important Work on Substance Use and Overdose Prevention Efforts. FDA.gov. 2022. Available from: https://www.fda.gov/news-events/fdavoices/fda-continues-important-work-substance-use-and-overdose-prevention-efforts.
19. PwC. Next in Pharma: Thriving in 2023. 2023. [Internet] [cited2023Oct] Available from: https://www.pwc.com/us/en/industries/pharma-life-sciences/pharmaceutical-industry-trends.html
20. Luhby T. These are the first 10 drugs subject to Medicare price negotiations [Internet] CNN. 2023. [cited 2023Aug] Available from: https://www.cnn.com/2023/08/29/politics/medicare-drug-price-negotiations/index.html
21. Dukart H, et al. Emerging From Disruption: The Future of Pharma Operations Strategy. [Internet] 2022. McKinsey & Company [cited 2023Oct] Available from: https://www.mckinsey.com/capabilities/operations/our-insights/emerging-from-disruption-the-future-of-pharma-operations-strategy
22. FDA. Drug Shortages: Root Causes and Potential Solutions. 2020. Available from: https://www.fda.gov/media/131130/download
23. Buntz B. Pharma M&A trends in Q2 2023: Strategic acquisitions rise as deal-making holds steady. Drug Discovery and Development. 2023.
24. EY. Beyond Borders 2023: Biotech is facing a complex path forward, says EY report. [Internet] 2023.[cited 2023Jun] Available from: https://www.ey.com/en_us/news/2023/06/beyond-borders-2023-biotech-is-facing-a-complex-path-forward-says-ey-report

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2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends

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