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The biopharma revolution: navigating complexity
Within a decade, 85% of approved drugs and treatments are expected to come from biopharma companies. Yet across different global regions, there is wide variation in available funding and regulatory incentives for small and mid-sized biopharma companies. Ahmed Bouzidi, VP of biotech strategic development at ProductLife Group, provides some pointers to navigate the complexity.
While the ongoing Covid-19 pandemic may not fundamentally alter existing market trends, it will undoubtedly magnify and accelerate them – whether in regard to remote working, ecommerce and process digitalisation, or to the rise of the biopharmaceutical industry.
At first a frightening nightmare, with the rapid spread of the virus globally accompanied by significant morbidity and mortality, the Covid-19 pandemic quickly inspired great hope – through the unprecedented mobilisation of healthcare systems, including the regulatory authorities.
From initial identification of the virus, it took only a matter of weeks for the sequencing and the expression of the SARS-Cov-2 spike gene; just ten months to develop the first vaccines.
But the pandemic has also exposed some broader challenges and gaps in global capability, and the biopharma sector is both suffering the consequences, and in a position to be a potential solution. One of the challenges has been access to vaccines and treatments, compromised not by development or regulatory hurdles, but by uneven distribution of funding, geopolitical battles and sub-optimal supply chains.
The next supply-related challenge relates to anticipation. A second generation of vaccines must be designed, certainly using more conserved structural proteins of the virus in addition to the spike, to maximise efficacy against current and emerging variants of the coronavirus.
SME biopharma takes centre stage
The biopharmaceutical industry – in particular innovative SMEs and mid-size companies – has been centre stage in tackling Covid-19. While some of the candidates are traditional vaccines such as inactivated and attenuated products, most of the vaccine candidates being developed are advanced DNA, RNA, and protein sub-unit vaccines.
Smaller and more modest-size biopharma companies have a number of great advantages. They are flexible, adaptable and more geared to innovation. They are also experiencing greater acceptance than they ever have previously by global populations.
That is to say, confidence in more experimental/non-traditional products has soared during the pandemic, paving the way for biopharma SMEs to become major players in the global market.
Even back in 2017, about 65% of the drugs approved in the market were based on biotechnology, according to United Nations statistics, and this trend will accelerate in the coming years.
Confidence in more experimental/non-traditional products has soared during the pandemic.
The huge demand for biopharmaceuticals will be facilitated by an accelerating focus on research and related investment, fanned by the Covid-19 pandemic.
The ability of biopharmaceutical products to address previously untreatable conditions will fuel the introduction of innovative drugs to the market, bolstering the biopharmaceutical market over the next decade.
Biopharmaceutical companies are actively involved in the development of innovative molecules that fulfil the unmet needs of patients. With an increasing number of companies in the late-stage development of their biologics, it’s anticipated that the biologics market will witness substantial growth in the future.
The soaring number of product approvals, and increasing demand for targeted therapies, as well as the rise in the development of biosimilars, will contribute to this growth.
But the right conditions need to be aligned to realise the potential, and currently some regional markets are more favourable than others for the ambitious biopharma company.
Tomorrow, the market will be in part driven by the emergence of new diseases, triggering the need for effective vaccines and novel therapies.
This in turn will drive increasing demand for faster approval processes, a transformed regulatory landscape, and growth in emerging fields – such as specialty therapies, vaccines, orphan drugs, or personalised medicines for some indications in the fields of cancer, chronic diseases and emerging infectious diseases. All of this will attract increasing attention of investors and of Big Pharma.
And this is where things become interesting, and political. For all that biopharma has drawn rising interest and regulators have eased their path to market, the funding and proactive support available for bringing drugs to market varies internationally. This will have a bearing on biopharma companies’ strategies going forward.
The EU needs to address the current conservatism, sluggish timelines and regulatory complexity.
The EU has some work to do to create more conducive conditions in which biopharma innovators can thrive – certainly compared to the US and Asian markets.
This is evident from the differing approach taken by German SME BioNtech, which had to partner with the US big pharma Pfizer to develop its vaccine, and Moderna in the US, which was able to take its own product to market, thanks to the backing of substantial, risk-tolerant public financing.
In China, optimum conditions and the readily available funding in both Hong Kong and on the mainland, has led to three vaccines being produced in the last ten months, comparable with the US’s record.
If Europe wants to command a share of the biopharma revolution, the EU needs to address the current conservatism, sluggish timelines and regulatory complexity – not to mention the lack of adequate financial backing for smaller companies – which is preventing innovative SMEs from forging ahead with their developments and bringing them to market at speed.
The best of both worlds
In an ideal world, biopharma SMEs would be able to bring their own products to market, with the right support, retaining the benefits of those companies’ agility and maximising market competition, drug affordability, and global access to a choice of treatments.
Another option is to enter into partnership with large pharma – as the Oxford vaccine team did – thus combining the best of both worlds: innovation and speed with global contacts and supply chains, international regulatory and pharmacovigilance/safety experience and general market clout.
Certainly, pharmacovigilance will play an essential role in ensuring the safety of patients, especially as pharma branches out into more innovative treatments, and biopharma SMEs will need help with this.
Looking ahead, approval for newer biopharmaceutical products – not just branded but also biosimilar products (due to patent expiry of major pharmaceutical products) – will give rise to lucrative opportunities for market players, especially linked to low-cost alternatives to prohibitively expensive treatments for novel immuno-oncology products and the like.
To maximise their potential, biopharma innovators must ensure they are targeting the right markets with the right medicines. Strategies for product development must align with meeting regulatory obligations at all stages of development as well as pre and post-market. Key to this is timely access to funding at the right stages.
All of these factors combine to ensure safe delivery of much-needed treatments and the best patient outcomes. However, navigating through the complexities is a huge challenge and not one that smaller innovative businesses can usually tackle alone.