The pharmaceutical market is growing at a rapid rate. 2018 produced a hive of sector activity with record-breaking FDA approvals and private investment in Biotech, all contributing to the growth of new medicines to meet unmet clinical needs.
Data shared by EvaluatePharma indicates the launch of novel therapies, including gene and cell therapies, as well as increased access to medicines globally are set to fuel growth in the market with total prescription drug sales expected to reach $1.2trn in 2024.
With significant scientific advances in large molecular weight therapeutic development and major developments in therapeutic areas such as immunotherapies and oncology, to name a few, we've curated a set of insightful articles covering key pharmaceutical trends we saw in 2018 and things to look out for in 2019.
1. A thriving Biotech industry
The number of biopharmaceutical companies with active development pipelines has increased significantly - over 4,000 companies in 2018, as seen below. A portion of this figure is attributed to Biotech companies who continue to drive research and development (R&D) growth. This is supported by robust Biotech funding in 2018 where, private investment reached $13.5 billion in venture capital in the first 10 months and subsequently led to a record-breaking year in FDA approvals.
FierceBiotech recently highlighted that for more than 20 years, 1996 has stood out as the high watermark for drug approvals. Now, there is a new peak on the chart of FDA approvals: 2018. The total for this year has edged past the 53 FDA approvals from 1996, a year when the new user fee program led to the processing of a backlog of submissions.
In a recent article, Binder Dijker Otte (BDO) state confidently that: “for Biotech, the time for innovation has never been better.” BDO point to a number of factors behind this optimism, including:
- over 25 patent expirations coming up from 2018-19
- the FDA’s drive to encourage competition
- a focus on breaking down silo-ed thinking and behaviours
It's fair to say the Research and Development (R&D) in the industry is booming and Biotech's continue to play their part in finding revolutionary treatments for disease.
2. Biologics - why a case-by-case approach is vital
Biologics are becoming increasingly more complex. The scientific and technological advancements mean it’s no longer a one-size-fits-all solution. As a result, packages of work are more bespoke and a case-by-case approach must be implemented. The reasoning behind why a case-by-case approach makes good scientific sense was examined at our Modern Drug Development Roadshow, which we held in Cambridge and London earlier this year.
As an extension of this, the roadshow discussed predicting human toxicity and how using animal models for the nonclinical evaluation of biologics offers some real challenges. To overcome them, Dr Kirsty Harper, Head of Biologics at Envigo, told the audience:
- Understanding pharmacology is a must
- Species selection is critical, especially for biologics
- Assess the safety of your biologic at all times
Are you looking for greater detail on the importance of taking a case by case approach when developing biologics? You'll find it in this 2010 paper 'Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models.'
If Biologics is your area of interest, you may be aware that we’ve hosted an Annual Biologics Symposium (ABS) for the last eight years. The event brings together top industry experts and thought leaders, to discuss their latest ideas and share their insights. Some of the topics covered this year included:
- Advanced therapies and novel peptides - a new approach
- Gene therapies - challenges and safety considerations
- Antibodies - library construction and potential re-investigation
- Vaccines - exciting developments
- Biologics - some special considerations
3. Immunotherapies - why you need to know your biology
There are many new immunotherapy treatments available now with the potential to prolong life and treat disease. CAR T cells and checkpoint inhibitors are just two examples that have received a lot of traction this year. In fact, 2018 saw the first ever EU marketing authorisation of CAR T therapies for the treatment of blood cancer. Rival treatments developed by Novartis and Gilead/Kite Therapeutics each got the nod from European authorities. Both treatments have come to fruition after many years of research.
The development of therapeutic products to treat human disease is becoming ever more sophisticated. So, it’s increasingly vital that we understand fully the biological mechanisms of disease, and the effects of therapeutic intervention. Traditionally, immunologists have used rodents in their studies. But with the advent of better targeted therapies, scientists constantly need to explore new models.
A deeper understanding of biology is opening the way for additional progress in immunotherapy. Improving our understanding of drug safety will lead to more efficacious, and targeted therapeutic products.
4. The continually evolving oncology R&D environment
The prospects for the oncology market seem stronger than ever. Throughout the world, patient demand for treatments is booming - as is the global spending on cancer treatments.
It's clear competition in the oncology market is as fierce as ever with companies in a race to engage patients, providers and regulators more effectively. In 2019, the smartest pharmaceutical businesses will prove their value in an evolving landscape that demands transparency and will adopt a strategic, comprehensive and integrated approach. To see what such an approach involves in practice, we recommend PwC’s article 'New dynamics of the pharmaceutical oncology market: Five questions to shape your strategy.'
5. Big data - promises and pitfalls for our industry
Imagine a world where we could build personalized treatments based on the genomic make-up of individual patients. A world in which traditional R&D funding is channeled into smaller studies with far higher impact. A place were powerful AI spot patterns unlock the door to revolutionary new treatments. Sounds too good to be true?
The pharmaceutical industry is a complex business environment with many types and volumes of available data. The big data opportunity is a way to effectively utilize these data to better identify new potential drug candidates and develop them into effective medicines.
These golden benefits - and the revolution in healthcare they could bring - are exactly what some proponents of big data are promising the pharmaceutical industry and sector giants like GSK are funnelling millions of dollars into data-driven solutions.
Of course, it’s not as simple as putting in extra cash in and waiting for your profits to come cascading out. To be effective, big data solutions often require significant shifts in both attitudes and behaviours across large organizations. Then there are the possible implications of even closer regulatory oversight that come with a big data approach.
Management consultancy McKinsey & Company have been looking at this issue closely. You can read their thoughts on big data and the pharmaceutical industry in their article 'How big data can revolutionize pharmaceutical R&D.'
6. Looking forward to 2019
As we’ve seen in our pharmaceutical industry overview 2018, the market is strong and growth prospects for 2019 are encouraging. A thriving Biotech industry, significant scientific advances in large molecular weight therapeutic development and major developments in areas such as immunotherapies and oncology all augur well for the future. And big data offers us a tantalising glimpse of a world where R&D can zero in on patient needs like a laser beam.
In addition, the role a CRO plays in the drug development process continues to attract attention and it's expected that they'll play an even more significant role in the wider pharmaceuticals ecosystem in 2019 and beyond, according to PharmaTimes. The primary shift is in CROs taking a more strategic role and the best relationships will take these considerations into account:
- Plan early and promote transparency with your CRO
- Think about creating a win-win relationship with your CRO
- Define your respective roles and responsibilities
- Ensure you and your CRO communicate regularly
- Don't save all your lessons learned for the end of the project
- Aim to create a strategic partnership based on trust and collaboration
Explore more about 'How to get the most out of your preclinical contract research organization'