Asia has been witnessing increasing levels of Atopic Dermatitis (AD) over the previous few decades, with the Paediatric AD prevalence rates in various Asian ethnicities reaching as high as 20%.

Owing to its large population base, Asia may account for over 40% of the estimated global incidence of Follicular Lymphoma, with China, Japan and India collectively contributing to over a quarter of the cases.

With a high population density and over 45% of the global breast cancer incidence, Asia is expected to account for more than half of all TNBC cases, with a large TNBC patient pool, particularly in China and India.

Diabetes and hypertension are expected to drive the global prevalence of CKD, with much of this increasing burden observed in Asian locations of China and India.

The Asia-Pacific with an intermediate to high prevalence, represents three-quarters of chronic hepatitis B (CHB)-positive subjects worldwide.

Each year, there are over 300,000 new cases of Small Cell Lung Cancer globally, with Asia accounting for nearly 60% of the cases.

Asia ranks second in Prostate cancer incidence accounting for over a quarter of the global incident cases and has the world’s highest number of deaths due to Prostate cancer in 2020.

Asia accounted for over a third of the global bladder cancer incidence with over 200,00 newly diagnosed cases, with China having a higher prevalence of bladder cancer in 2020.

Asia accounted for almost 60% of the global incidence, mortality and five-year prevalence in 2020, with the highest incidence rates found in Australia and Eastern Asia for both sexes.

Asia accounts for almost 60% of the global incidence of cervical cancer, with India and China together contributing to more than a third of all cases and deaths.

The incidence of pancreatic cancer is rising in Asia-Pacific, with the region accounting for about half of new cases in 2020.

Nearly 75% of the new gastric cancer cases in the world are concentrated in Asia, with China showing the highest incidence and mortality.

The incidence of colorectal cancer cases is rapidly growing in Asia-Pacific and the region now accounts for more than half of all new cases diagnosed globally.

In Asia, lung cancer ranks as the most prevalent cancer and the primary cause of mortality, with the region accounting for almost 60% of the global incidence of lung cancer.

In Asia, EC is the sixth most common cancer, with the region constituting almost 80% of the new EC cases globally. The highest standardized incidence rate has been observed in East Asia.

CLL is one of the most common forms of leukaemia, with the Asia Pacific region showing increasing incidence. China and South Korea are among the Asian locations showing the greatest incidence.

According to the Globocan 2020 report, liver cancer is the fourth most frequent cancer in Asia, with the region accounting for over 70% of all new liver cancer cases worldwide. Hepatocellular carcinoma (HCC) and bile duct malignancies are highly prevalent in Asia, especially in China and South Korea where the prevalence rate is about five times higher than in Western countries.

Diabetes, which is endemic in most Western countries, is now seeing a surge in developing nations across Asia due to aging, urbanization, and changing dietary habits. It is estimated that about 80% of the people with diabetes now reside in developing countries, and mortality rates due to diabetes are higher in the Asia-Pacific compared to the rest of the world.

In 2020, Globocan reported over 400,000 new corpus uteri cases, with Asia accounting for about 40% of these new cases. China, where EC is the third most common female malignancy, accounted for nearly half of the new cases in Asia.

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common and the most aggressive subtype constituting nearly 70% of B-Cell Lymphomas in Asia.

T-cell lymphomas (TCLs) are types of non-Hodgkin’s lymphoma (NHL) that affect T lymphocytes.  About 10% of NHLs are TCLs, with this proportion reaching over 30% in certain Asian locations.

Cystic fibrosis is a rare autosomal recessive disease which primarily affects the lungs and digestive system due to a malfunction in the exocrine system responsible for producing saliva, sweat, tears and mucus.

AML is the most common form of leukemia in adults, accounting for approximately a third of all leukemia cases worldwide.

Ovarian cancer is the 7th most common cancer and 8th leading cause of cancer mortality among women globally.

Lymphoma, including Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL), is one of the most common cancers worldwide.

Cancer of the skin is by far the most common of all cancers. Melanoma accounts for only about 1% of skin cancers but causes a large majority of skin cancer deaths.

Head and neck cancer (HNC) is the sixth most common cancer globally, with the highest incidence being observed in the Asia region.

Breast cancer is the most frequent cancer, impacting 2.1 million patients each year, and causes the greatest number of cancer-related deaths.

With a streamlined regulatory environment, including no requirement for an IND, and the supportive R&D Government refund of up to 43.5% on clinical research spend, Australia has become a preferred destination for early phase clinical trials.

A growing number of biotechnology companies, both in the West and in Asia, are specializing in gene therapies and other regenerative treatments boosted by the approval of the first genetic therapy agent (tisagenlecleusel) by the FDA in 2017.

Over 600 sites across Asia-Pacific have been involved in the clinical development of now approved IO drugs, and hundreds more are experienced in managing clinical trials with immunotherapies for both monotherapy and combination therapies.

We have observed an unprecedented effort in the clinical development of Orphan drugs in the recent years. In fact, in 2018, the majority of new drugs approved by the FDA and EMA were Orphan medicines.

The objective of this report is to describe the Orphan drug development landscape and explain how the positioning of the Asia region has been evolving in the global picture.