How are Indian OTF Manufacturers gearing up to compete at global level?

According to a report by the Transparency Market Research, the global thin film drug manufacturing market is predicted to be worth US $15.9 billion by the end of 2024.The research report also suggests that the market will experience a CAGR of 9% from US$7.3 billion in 2015 to $15.9 billion by the end of 2024. The leading market share is said to be held by North America, accounting for 66.6% in 2016. The report states that the growing demand for efficient drug delivery systems has augmented the uptake of thin film drugs due to their efficiency and effectiveness. They are also easy to transport and store, encouraging patients to opt for these drugs.

The oral thin films (OTF) scenario in India

The OTF market in India is new and started gaining momentum only in the year 2012. Currently, it is fast gaining momentum because it is becoming popular among healthcare professionals and patients for the convenience it offers. It goes without saying that a number of opportunities lie for the enterprising pharma players in the OTF market in India. There are very few companies who are having their products but several big pharma companies have already started engaging in research, development and marketing of oral films in the market.

The market is yet to gain a competitive stand globally since several of the oral films approvals in India are very recent.

Oral Thin Film Market-global scenario

According to a report by the Transparency Market Research, the global thin films market is valued at $2,100 Mn in 2017 and is expected to reach a CAGR of 13.0% between 2018 and 2026. Experts believe that there will be a dramatic shift from oral tablets to oral thin films, owing to the convenience it offers to special need patient population, the treatment oferectile dysfunction, opioid dependence, nausea and vomiting, schizophrenia, and migraine.

Presently, there are close to 10 products available in the market, all of them in high demand due to exclusive benefits. Oral thin films are easy to take as compared to oral tablets as these are not required to be swallowed. They do not need water for administration, have a great taste, and improve the safety of medicine by reducing side effects. These are particularly helpful for patients who have difficulty in swallowing, such as the elderly, infants, children, and patients with neuron motor diseases.

How is India coping with the global market

Machineries: The machines used in India for slurry coating, roll slitting, packaging of oral film manufacturing in India is mostly indigenous, customized for the manufacturing process and the packaging system. Indian manufacturers are on the way to procure effective automated oral film manufacturing systems compliant to the global regulatory specifications which are highly priced and available mainly from European or Korean sources.

Adopting polyester-backed packaging: This form of packaging is also used for oral films. It is not yet applied in India because of the machineries involved. However, India is also working toward developing these machineries.

India- a feedback

The OTF market is India is emerging but is fast picking up pace with the global market. The oral films products has demonstrated good stability when stored for 3-4 years, thus gaining the acceptance of CDSCO-India. It is also noteworthy that the dossier submissions by the Indian OTF manufacturers in the semi-regulated markets have received good global acceptance and is increasingly on the rise.

To make it more acceptable among the general mass, the Drug Price Control Order has ordered revision of the prices of some of the most important medicines in India.

India is conducting research on techniques like solvent casting and aqueous slurry casting that are the most suitable for OTF manufacturing. They are not just inexpensive, but are also free from harmful solvents.

The OTF market in India is promising, just like its market in various countries in the APAC, North American, America and Europe. Following regulatory-compliance, the market is said for greater goals in the coming years.

About ZIM Laboratories

ZIM LAB is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for production and supply of innovative and differentiated generic pharmaceutical products to our customers globally. ZIM provides its customers with a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellets (sustained, modified, extended-release), taste-masked powders, suspensions, tablets, capsules and it’s recently developed Oral Thin Films (OTF).


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