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Vol 22, No. 01, January 2018   |   Issue PDF view/purchase
What lies ahead
Experts give their insights on the health landscape and key trends for the year ahead.

The epidemiology of lung cancer has changed over the past decade in Singapore as well as worldwide. Lung cancer incidence is declining among the males but has remained fairly constant among females. The proportion of never-smokers among patients with non-small-cell lung cancer (NSCLC) has risen. If this trend continues, the typical future lung cancer patient, particularly in East Asian countries, will no longer be a male chronic smoker, but a never smoking female in her fifth or sixth decade.

Both the diagnosis and treatment of lung cancer, especially NSCLC, has also advanced with the times. It is no longer sufficient to diagnose a patient with small-cell-lung cancer (SCLC) or NSCLC. It is standard practice to do molecular profiling on NSCLC to look for molecular aberrations for which targeted therapies are available. For those NSCLC patients with molecular aberrations, they will be treated with targeted therapies. For those NSCLC without molecular aberrations, they will be treated with chemotherapy or immunotherapy, or a combination of both. Thus, treatment of NSCLC has moved beyond chemotherapy to targeted therapy and immunotherapy. The future trend will look at how best to incorporate various combinations of immunotherapy, chemotherapy or targeted therapy, as well as focus on resistance mechanisms to treatment. The future of lung cancer is starting to look brighter.

"NSCLC treatment has moved beyond chemotherapy to targeted therapy and immunotherapy."

2018 is shaping up to be a year of challenge for those working with patients who have osteoporosis in APAC. This is because osteoporosis and fragility fractures – a precursor to future breaks and further disability – are becoming more common due to our ageing population and the region’s increasing tendency toward urbanisation. In fact, our region is on track to becoming the epicentre for hip fractures as early as 2040, if we fail to act now.

Approximately one in four patients who sustain a hip fracture die within a year, and less than a quarter of those who survive regain their previous levels of function. Moreover, about 20 percent of people who sustain a hip fracture will be admitted to a care home in the year following fracture.

Alarmingly, this emerging public health crisis is neither being currently recognised, or addressed.

We can improve the diagnosis and treatment of osteoporosis, particularly among those patients who have already broken a bone. We can more frequently diagnose osteoporosis among those at high risk of fracture, by measuring bone mineral density. However access to bone densitometry is limited in several APAC countries, presenting another barrier to diagnosis and treatment.

Another solution to the problem is a systems-based approach. Fracture liaison services (FLS) have to date proven to be the most effective systems-based approach for osteoporosis management. FLS identify patients aged over 50, who present to the healthcare system with a fracture. As the fracture is most often due to osteoporosis, these patients must be investigated and treated. If left untreated, they will have more than double the risk of sustaining a further fracture in 12 months.

FLS is more developed in some APAC countries than others. For instance, Taiwan and Singapore have implemented FLS as a national health policy. Even in Australia, apart from the State of NSW, FLS have been under-developed, and remain a major healthcare initiative for Osteoporosis Australia.

The International Osteoporosis Foundation (IOF) will hold a regional meeting in Sydney in November 2018 to highlight the growing epidemic of osteoporosis in the region, and to identify solutions.

"We have a rapidly approaching public health crisis, and the time to act is now. We need regional, multi-stakeholder collaborations to prioritize fracture prevention and initiate systematic, long-term treatment plans for those with broken bones. We must approach individual Governments throughout APAC with these data to avoid a future tsunami of hip fractures."

2018 – Are we entering a healthcare conundrum?

Since the completion of the human genome sequencing in 2003, and after the successful animal cloning of Dolly, the term precision medicine has become a reality as we see an emerging new generation of targeted drugs. With rapid advancements in cloning technology and improved understanding of cell development and genetics, our approach to healthcare and medicines has greatly evolved.

All of this is good news in the world of healthcare where we try to fight fatal diseases, reduce the morbidity of chronic ailments and avoid or delay debilitating neurological conditions that strangle the golden years as we age. But, with every good turn, we find a new conundrum – or so it seems.

New players, new rules

Silicon Valley’s entry into healthcare has boosted the funding and technology resources available to scientists and academics involved in research and development. Better still, many have joined the life sciences arm of the Silicon Valley giants such as Google and Apple.

“Samsung, LG and SK, 3 major chaebol conglomerates in South Korea, have completed preparations to make full-fledged investments in the biotech industry through stock market listing, mergers or stake acquisitions,” says Sang-Eun Ju, Visiting Professor at Sungkyunkwan University, Seoul and Associate at Vital Signs. “Given their domestic dominance, MNCs such as Roche and BMS have entered supply contracts with these companies. Samsung Biologics is poised to become the world's top-ranked biopharmaceutical CMO in 2018.”

Innovation is more central to the DNA of tech-savvy companies like Apple & Samsung compared to the traditional biotech/pharma players – hence, they enter the space knowing that it is hungry for disruption and innovation. Soon, the traditional marketing manager of a biotech or pharma company will face a quandary – who are my competitors.

Keeping up with precision medicine

As David Crow writes in his article, Decoding Cancer (Financial Times, October 2007), the amount of research by cancer treatment centers worldwide can be mind boggling.

Enter the makers of next-generation diagnostics such as Foundation Medicine – described in the article as the ‘Bloomberg for cancer’ – where real time information will enhance the selection of the appropriate treatment for the individual patient.

In a few years, there will be a plethora of decision support tools, genetic testing services, individualized options and potentially, a re-writing of how diseases are treated. So, how will doctors cope and keep up with these advances? Until we find a way of integrating these advances into daily practice care, it may be a hard road for the busy doctor who went to medical school before the human genome was sequenced.

Cybersecurity in healthcare

Disruptive and innovation may soon become inevitable vocabulary in any discussion that revolves around strategy and business models. The medical device industry is regarded as the ‘hottest’ sector in terms of adopting disruptive technology and creating innovative new services. Driven by economic need and growing demand from the burgeoning middle class, China and India are making significant inroads in creative solutions in biotech and medical devices. Private fundraising in China is pushing the shift from cheap generics to high-end products.

So, while the Internet of Things (IOT), remote monitoring and wireless connectivity transform how healthcare can be delivered, it exposes a new vulnerability in the form of security as we saw in the WannaCry ransonware outbreak. Safety of healthcare delivery takes a new meaning as the risk of hackers and the security of the devices, including the responsibility of the manufacturers, are now being scrutinized with many questions unanswered.

As regulators and policy makers work with various stakeholders to solve these questions, these genomic, technological and disruptive advances are largely positive for the healthcare space. Health insurance and pricing aside, the largest beneficiary may be the patient as their ability to understand, comprehend and make decisions will strengthen – so long as it does not create a new problem – inundating patients with so many options that they are not able to decide!

"China and India are expected to make significant inroads in creative solutions in the biotech and medical devices"

APAC is a diverse area. What are the main characteristics for the leading markets in APAC? My answer is India, because of its growth, potential, and speed. The opportunity comes from the growing population (13 billion people) and the steady growth of GDP (7.1% in 2016). Especially since the middle-class GDP will be drastically increasing.

Of course, there are challenges in emerging countries. One is country risk (political complexity, Currency, and Economy). The other is operation risk (Law, regulation, and tax). PM Modi says, “Make in India” and encourages the investment from foreign companies into India. MedTech companies will face the impact of regulation and tax. The price control is now a hot topic for medical technology industry. It is a temporarily set-back. Nothing is impossible. The operation risk can be overcome. The MedTech companies based in the developed countries need to change their strategy from the high-end products with high price to local needs products with competitive prices, if they want to get the benefit of the growing Indian market. They can learn from some successful companies in India. Daikin and Panasonic are successful by their local design, local development, and local production. The return of investment will come in the long run. It is time to invest to India for the future. As mentioned above, India has attractive characteristics of “Growth, Potential, and Speed”.

At the disease fields, cardiovascular diseases, cancer, respiratory diseases will continue to increase. The aging society will bring about new opportunities such as Information Technology and Innovation for life-style diseases. As for the business model innovation, digital health will be really changing the landscape in healthcare. One of the challenges are government regulation, so the industry needs to convince the Government by showing the desired outcomes.

"It is time to invest to India for the future."

Major changes for bio supply forecast in 2018

Integration of supply chain a critical issue as industry globalises, with a resurgence in European manufacturing and biotech markets forecast

Industry experts from bioLIVE predict that 2018 will usher in a new age of increased integration and collaboration across the large and small molecule supply chain. Additionally, next year will also see a continued rise in the European bioprocessing and biomanufacturing sectors, along with a resurgence in European biotechs.

One of the key factors identified is the relative states of maturity of the supply chains. The small molecule space has nearly 50 years of history behind it, coupled with a highly mature contract services sector, whereas for newer biologicals, such as cell and gene therapies, the potential development and commercialisation challenges that lie ahead are only starting to emerge.

“One of the consistent problems in bio for the last year has been getting the right level of skilled workers, as well as building a global and stable partners base. This is an area that small and large molecule will likely collide in 2018 – particularly as more CDMOs, and pharma companies begin to diversify their capabilities,” commented Rutger Oudejans, Brand Director Pharma at UBM.

Overall, the biologics market in Europe is experiencing fairly robust growth and there is a resurgence of activity in the European bio hubs, but the supply chain will be a key area of focus to ensure that products make it to market quickly and securely. Another consideration is that, at present, the USA and Europe dominate manufacturing, but China and India are widely acknowledged to be fast growing bio markets albeit from a small base. As seen with small molecules 30 years ago, biosimilars development will gradually move East. However, this will happen on an even faster timeline due to the greater sizes of the domestic markets here now – which are far more developed than when the generics industry was evolving.

UBM research amongst the potential supplier base is showing that 2018 will be a critical year for the bio industry. There is a clear duality in the market as the industry tries to incorporate increasing demand for biosimilars (often large mammalian capacity demand), coupled with the unique development challenges of the newer smaller cohort drugs – single-use tech is another major growth area. Collectively, this means there are potentially two distinct types of supply chain developing – and in multiple geographic locations.

Next year there is likely to be an increased internationalisation of the market as Asian companies will move to work with more western partners, and in- and out- licensing of newer more efficient technologies will proliferate in order to help lower overall costs.

“In the past few years we have seen the supply chains of bio and small molecule coming together, particularly as you have seen more and more CDMOs transferring their skills into bio. There is a growing issue of availability of resource, and undoubtedly there are learnings and contacts that can be shared, since there is a global shortage of skills and manufacturing,” added Oudejans.

Finally, 2018 – as highlighted by the CPhI Annual Report – could also be the year we see the development of new, bio specific excipients. These new excipients are likely to be developed in conjunction with a bio active and there will be a focus on characterising excipients by surface interaction. However, biosimilars are not predicted to drive down costs of these new excipients for biologics, since biologics will still have superior pharmaceutical equivalence.

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