Drug molecules that help in treating specific genetic conditions that do not have any therapeutic intervention in the market are considered to be specialty pharmaceuticals.
These are more targeted drugs and are less toxic compared to traditional drugs. Blood-derived products, biopharmaceuticals, and complex molecules are a few examples of specialty pharmaceuticals. Also, expensive pharmaceuticals come under the category of specialty pharmaceuticals, and the cost threshold of these is around USD 600/month. Specialty pharmacy that had a very small place in the market once now forms a huge part of the pharmaceutical industry.
Some of the major trends for Specialty pharmaceuticals include:
Increased spending
One of the most significant trends that are grabbing everyone’s attention is the increased amount of spending which is being devoted to specialty pharmaceuticals. With much emphasis on the cost of healthcare, especially in developed countries across the globe, the expenditure on drugs is catching increased attention from the ones who are paying ever-increasing bills.
The growing product pipeline
When it comes to development, the pharmacy pipeline is bulging with specialty pharmaceutical products since there are six hundred plus specialty products in the pipeline, currently.
Targeted therapies to emerge
The move to targeted therapies is the next major trend in specialty pharma. Within the specialty pipeline, almost seventy percent of the drugs possess an identified biomarker associated with them. Although not all of these markers are yet to be turned into meaningful tests, it is highly expected that the personalized medicine will proliferate on the drug prescribing & managed care side as well as drug discovery side.
Personalized medicine
The growing interest in personalized medicine that is tailored according to a patient’s genomic makeup in order to help predict, diagnose as well as treat diseases are resulting in new investments in the Specialty drug segment.
Prevalence of complex, chronic conditions
Patients are suffering from more than a single chronic disease and this requires them to take numerous medications for many of them the latest treatments include specialty drugs. “The pharmaceutical manufacturing industry in India is continuously evolving owing to the introduction of newer technologies in the field along with the entry of newer players in the market thereby leading to greater innovation in the industry.
This has allowed the industry to enter the hitherto untapped areas of the market and provide a more inclusive cover-age of its customer base while dealing with previously neglected health issues,” says M. Rajarathinam, Managing Director, MMC Pharmaceutical Limited.
“The recent Production Linked Initiative scheme launched by the government has also provided the much-needed fillip to the manufacturers in the industry which would allow them to rise to the task at hand and meet India’s healthcare needs,” he adds.
Important Criteria to be met by Specialty drugs
Specialty drugs should meet four out of seven criteria such as the treatment should be initiated by a specialist, it should be very expensive, generally not taken orally, patients may need reimbursement assistance, requires special handling, requires excessive patient counselling or follow-up, and limited distribution. Specialty drugs should help in treating chronic as well as complex conditions.
The road ahead
The future of specialty drugs for treating complex, chronic diseases such as cancer, HIV, and rheumatoid arthritis will continue to increase as patients look for targeted treatments for their diseases.
The specialty pharmaceuticals market has now evolved into a burgeoning multi-million-dollar industry from its niche beginnings. Although the field may be hard to define, pharmacists should try to understand the place of specialty pharmaceuticals within the industry.
“India has already established itself as the pharmacy of the world. However, I believe reverse pharmacology holds tremendous potential going forward as it will allow the industry to reinvent and re-innovate many medicines with the help of chemicals/plants.
It will also allow us to repurpose a number of generics which will be the biggest differentiator for ‘Made in India’ generics,” says Dr. R B Smarta, Managing Director, Interlink Marketing Consulting. While collaborations between hospitals, specialty pharmacies, manufacturers, and retail settings are becoming increasingly commonplace, they can help in enhancing patient access to specialty pharmaceuticals and the high-touch services a specialty pharmacy can provide, which in turn would help in improving patient care.
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