Breakingthrough FDA

As women all across the world grapple with cancer, the oncology space is getting competitive with companies coming up with new breakthrough treatments to usurp the other By Shalini Gupta

The past two months have seen the US FDA approve two new breakthrough treatments for cancer in women. First being Lynparza, marketed by Astra Zeneca, used to treat advanced ovarian cancer with the genetic BRCA mutation and in women in whom three or more lines of therapy do not work.

Pfizer’s breast cancer drug Inbrance is the latest in line, released in February, marketed along with Letrozole to treat postmenopausal women for a certain type of breast cancer that has spread. Both Lynparza and Inbrance were granted accelerated approvals as a step to release a ‘breakthrough therapy’ sooner into the market than expected. The oncology market is sure to heat up with both these developments. Two analysts help understand the dynamics of the breast cancer and ovarian cancer market from their individual perspectives.

Ovarian cancer: Japan rules; India and China to lead the future

Japan accounts for more than half of the APAC market, with its high Annual Cost of Therapy (ACoT), good healthcare access, and high treatment rates. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.5 per cent by 2020 driven predominately by the approval of potential pipeline candidates such as Amgen’s Trebananib and AstraZeneca’s Olaparib, which has recently already gained approval in the US and EU.

The country’s incidence rate stands at 8.1 cases per 100,000 population and has become increasingly stable over the past two decades, a trend expected to continue throughout the forecast period and reflected in the stabilised prevalence population. The effect of drug-price inflation rates is minimal in Japan as the inflation rate for pharmaceuticals is almost equal to the consumer price index, which itself is very low due to strong controls on drug pricing. The factors driving the market have not changed drastically, with the key factor being the approval of potential pipeline drug candidates.

However, even as Japan rules, India and China, are expected to post higher growth rates between 2013 and 2020 despite the modest cumulative growth rate of the ovarian cancer therapeutics market in APAC.

Says Sravanthi Addapally, Associate Analyst, GBI Research, “This is largely due to their growing prevalence populations and drug-price inflation rates. Contextually, the APAC prevalence population will increase by approximately 27,000 ovarian cancer patients by the end of 2020, 95 per cent of which will come from India and China.”

China has the second-highest market share due to a larger prevalence population although the actual cost of treatment is lower than that of Japan. “While the prevalence rate in India is 5.4–8.0 cases per 100,000 population (according to location), China stands at 7.73 cases per 100,000 population and 5.19 cases per 100,000 population (in urban and rural areas respectively). However, currently India has the smallest share, accounting for only 10.4 per cent of the APAC market revenue which is contributed by its lowest actual cost of treatment coupled by a low treatment rate,” Addapally adds.

The Asia Pacific market shows a lower incidence rate as compared to developed countries.

However, unlike developed western countries, the incidence rate is not expected to decrease during the forecast period, except in Australia which has a high ACoT and low prevalence rate of 10.4 cases per 100,000 of its population. All said and done, however, North America dominates the global market for ovarian cancer due to a large number of aging population. Asia is the dark horse of the future, expected to show high growth rates in the next five years.

Breast cancer: Newer treatments, first to market approach

GlobalData in their latest report estimates that the global breast cancer market for HER 2 (excluding APAC) is set to increase to $6.12 billion by 2023 growing at a rate of 15.5 per cent. US would lead the pack occupying close to $4 billion of the projected market followed closely by five EU countries combined (France, Germany, Italy, Spain and the UK) with $2 billion. This would be led by newer treatment options coming in the market namely, the CDK4/6, PI3K inhibitors in the HR (hormone receptor) positive setting, and the PARP inhibitors in the niche and highly underserved triple negative breast cancer (TNBC) setting.

According to Shabaaz Ali, GlobalData’s analyst covering oncology, “Sales from these drug classes alone are expected to account for $5.1 billion (84 per cent) of the global HER2-negative breast cancer sales in 2023. The collective sales from CDK4/6 and PI3K inhibitors will account for $3.6 billion clocking 79 per cent of the global sales in the HR+ setting in 2023. The collective sales from all of the PARP inhibitors will account for $1.02 billion i.e 94 per cent of the global sales in the TNBC setting.”

Implementation of nationwide breast cancer screening programmes in several countries will contribute to an increase in the diagnosis of early-stage disease. This along with increasing worldwide aging population remains the biggest driver. This is especially the case in urban China, where, over the forecast period, the incident cases are expected to increase faster than in any other market, at an Annual Growth Rate (AGR) of 6.4 per cent.

Adjuvant setting is a lucrative space for companies given the sheer size of the adjuvant population and the high number of treatment cycles that can be administered in this setting. “By 2023, Lynparza sales across the 8MM in TNBC are expected to reach $926 million, with 79 per cent from sales in the adjuvant TNBC setting at $731 million. NeuVax (nelipepimut-S/E75) is also set to enter the adjuvant setting (HR+) in the US and 5EU, and even with relatively low patient shares (<10 per cent), it will score comparatively high global sales of $567million,” adds Ali. However, it will remain relatively untapped, even after the forecast period.

While hormonal agents such as CDK 4/6 and PI3K inhibitors will be more in demand in the HR+ setting extending the time patients spend on these agents, PARP inhibitors will stand out in the TNBC setting. However, these can only be used in the subgroup of patients who are BRCA mutation positive (around 30 per cent). For these BRCA+ patients, the PARP inhibitors will create a new treatment paradigm altogether. However, this does not apply for the majority of TNBC patients (who don’t have a BRCA mutation).

To sum up, the oncology market is getting crowded and competitive taking away the luxury of time from companies when it comes to their drug gaining approval. There is no approach but the first to market approach. GlobalData believes that when it comes to some of the drugs that demonstrate extraordinary efficacy, such as Palbociclib, special regulatory pathways (such as the FDA’s breakthrough designation pathway), are greatly accelerating the time needed for those drugs to reach the market. Ali adds that the oncology space is going to experience a trend towards filing on Phase II data.

“We are now seeing very large Phase II trials with over 150 patients which are also adopting surrogate endpoints such as PFS (progression free survival). Another tactic is to jump straight from Phase I to Phase III (as exemplified by Abemaciclib). The tell-tale signs of such strategies are the sheer size of these early stage trails, which are often multi-centre and multinational,” concludes Ali.

Overall the breast cancer therapeutics market in the four Asia-Pacific (APAC) countries of India, Australia, China and Japan is expected to grow at a CAGR of 7.6 per cent to $2.5 billion by 2020. Japan had the largest market in 2013 with a value of $872 million, or a share of 58 per cent, followed by China with $320 million or 21 per cent, and Australia with $234 million or 16 per cent. India had the lowest market share and value at five per cent and $81 million, but is expected to witness the fastest growth over the forecast period with a CAGR of 13.8 per cent, compared to Australia at 7.8 per cent and China and Japan both at 7.7 per cent.

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