The global pharmaceutical market is expected to overcome $1.5 trillion by 2023, from the $1.2 trillion of 2018, at an annual growth rate of 3-6%. This increase should be paralleled by the increase in the number of launched products, that might reach 54 in 2023. Competition in biosimilars is also expected to increase by three times, while specialty share of total medicine spending will reach 50% by 2023 in most developed markets. These scenarios are illustrated by the recent IQVIA Institute of Human Data Science “The Global Use of Medicine in 2019 and Outlook to 2023”.
Emerging trends and technologies
The digital revolution and the availability of newer and improved biotechnological technologies is going to change profoundly the way medicine is practiced. IQVIA experts have identified ten emerging sectors to be monitored in the next five years, as they might provide a great amount of innovation.
Nine next generation biotherapeutics (NGB) have been launched already. Induced pluripotent stem cells (iPSC), CRISPR/Cas9 and other cells or gene-modifying techniques might be used to treat selected patient cohorts. The modalities to determine costs and accessibility for these treatments still need to be fine-tuned to allow for their broader sustainability. Bioethics considerations are also needed to better determine the allowed use of technologies such as CRISPR/Cas9. On the other hand, competition in the field is limited by the complexity of the manufacturing and distribution process.
Prescription digital therapeutics (DTx) might represent a completely new way to think about a pharmaceutical product. They are devices claimed to provide new treatment modalities and carrying indications and disease-specific treatment effectiveness claims in their prescribing labels. The number of mobile apps of this category submitted to the FDA for clearance or approval (under the De Novo pathway) is increasing. Areas of intervention include cognitive pathways and behavioural drivers of health, attention deficit hyperactivity disorder (ADHD), major depressive disorder and schizophrenia. Developers of these IT solutions often collaborate with pharmaceutical companies to complement their respective expertise towards the development of innovative approaches to cure.
The area of neglected tropical diseases has been traditionally covered by the activities of many philanthropic organisations, those research programmes are in many cases close to reach regulatory approval. Five to ten products are expected by IQVIA experts to be launched in the next ten years. Priorities in funding of this type of research should be based on WHO’s assessment, and it might be shifted to non-drug approaches or root causes identification.
Artificial intelligence, machine and deep learning will continue to be major areas of interest for investments, as they may support the identification and development of new breakthrough treatments, particularly in the areas of pre-clinical validation, target identification and efficiency of clinical development.
Real world evidence will be increasingly used to generate additional information to support the approval of new indications for already marketed medicinal products. Apps for remote monitoring and new study designs for site-less clinical trials are prerequisites to achieve this objective.
IQVIA expects health and patient senior advocacy roles – internal to pharmaceutical companies – to be present by 2019 in the most of the top 20 pharma companies, in order to better support the patient-centric approach to healthcare. These roles should bring clinical and commercial efforts together, to support patient engagement and clinical trial design.
Biopharma companies are expected to contribute to more than one-third of launches of new medicines in the next five years, but they might suffer pressures from payers to keep under control the high prices of this kind of products. Big, traditional pharma companies may continue to pursue M&A policies to acquire emerging biopharmas, or might prefer the way of partnership agreements to mitigate R&D risks.
Specific to the US are the monitoring of the outcomes of the reforms proposed by the government to deal with high prices of medicines and that of policies to control the prescription and use of opioids, a theme that will remain a complex and challenging topic to be addressed according to IQVIA’s report.
The current trends of the market
The US market is expected to evolve faster (4–7%) compared to the top 5 European countries (1–4%) and Japan; emerging countries should also play an important role (5–8%). Among these last ones, Chinese market should reach a value of $140–170 billion, even if its growth is declining to 3–6%. Turkey, Egypt and Pakistan are expected to experience the greatest growth in the next five years, while China, Brazil and India maintain by now the greater medicine spending.
The launch of new, innovative medicinal products shall be the main driver for developed markets, coupled to improved access for the emerging ones. Biosimilars will gain an increasingly important role especially in the US, while the European scenario is dominated by policies to contain the costs for healthcare systems.
Pricing still remains a hot issue in the ongoing US debate, and it is subject to complex dynamics involving different phases of negotiations between manufacturers, the government and public and private payers. Innovative medicinal products are being launched with very high prices since many years; IQVIA expects it could reach a median price of $100,000 per year by 2023 for orphan and oncological drugs. Price competition, independent review of prices and decline in the number of breakthrough approaches (i.e. CAR-T therapies or immune checkpoint inhibitors) compared to last five years might help, according to the report, to reduce such price increase. Pressures are also made in the US to reduce list price increases for established branded medicines. Net prices for manufactures increased at an estimated 1.5% in 2018 and are expected to rise at 0–3% over the next five years.
Trends for new products
Average spending level on new products launched in 2019-2023 is expected to reach $45.8 billion, slightly greater that the $43.4 billion observed for products launched in 2014-2018. This year and the next one are expected to show the bigger number of new launches, especially in the specialty, orphan, biologics and oncology areas, thus confirming the trend towards an increasing role of precision medicine where a new treatment is supposed to reach fewer patients. Stratification using specific biomarkers is an add-on characteristic of such approach.
IQVIA expects the launch of some 70-90 new oncology products in the next five years, out of the more than 700 currently in late clinical development. Other emerging therapeutic areas that might see the launch of new products include nonalcoholic steatohepatitis (NASH), migraines, neuromuscular diseases, autism and other developmental disorders, and a range of molecular targets for cell and gene therapies.
The patent cliff of 2019
The current year will see the loss of exclusivity for many branded products, leading to the launch of the corresponding generic or biosimilar versions of the drug. The impact on the market for small molecule-based products is expected to exceed $121 billion in the next five years (+15%) in the developed areas, and to reach $17.0 billion in 2023 for biologics. Among the main products interested is adalimumab (Humira), which is already available as biosimilar in Europe, while it will maintain exclusivity in the US up to 2023. By this year nivolumab (Opdivo) and pembrolizumab (Keytruda) will be the only brands not be facing generic or biosimilar competition. The US is expected to present the greater growth of the biosimilar market, even if introduction of new biosimilars should continue to occur more rapidly in Europe. The introduction of incentives for this sort of medicinal products and an improved communication of their benefits to patients and providers are also envisaged by the report.
Specialty medicines to treat chronic disease
Ageing has a great impact on the increasing number of patients suffering for chronic diseases. This area, together with those of complex and rare diseases, is the target of specialty medicines. A market that will represent around 50% of the total in 2023, when spending for specialty products is expected to reach $475–505 billion. Oncology, autoimmune, immunology, HIV and multiple sclerosis are the most interesting therapeutic areas, says IQVIA, covering 74% of the expected growth in developed countries.