A lot of drugs have emerged as a crucial weapon to battle regular diseases and some have gained reputation by being the choicest one for major chronic diseases. But some always remain on the border. These are drugs that no one talks of. People hardly get to know about these drugs in their time. Yes, they are this much sidelined. These drugs are for rare diseases. As per the rules set by the European Union, a disease is rare only when it happens to one in every two thousand people. It may not sound that much enthralling. But this is just a benchmark. There are diseases, to contract which, one has to be really unfortunate. Unfortunate like one in a million.
Researchers have made discoveries in some cases and formed drugs accordingly. But manufacturing drugs have their own pros and cons. Mass-scale production of a drug, that too within a budget and without the surety of ever recuperating the expenditure, can loom large on the head of a pharmaceutical company. Especially when there are cases of economic turbulence that one has to take care of. Their manufacturers do not want to adopt the production procedure regularly as that would incur a huge loss. Hence, they are known as orphan drugs.
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Orphan Drugs Market Analysis
The global orphan drugs market is predicted to touch USD 2,23,646.51 million at an 11.50% CAGR over the forecast period (2018-2023), in accordance with the latest Market Research Future (MRFR) report. Orphan drugs, simply put, are medicinal drugs that are intended to diagnose, prevent, or treat serious or life-threatening disorders or diseases which are rare. The reason these drugs are called orphan is owing to the fact that they are manufactured in minimal quantities with the pharmaceutical sector having little interest in them.
Orphan drugs are not made by pharmaceutical industries for economic reasons yet which respond to the need of public health. Often, orphan drugs are progressive, chronic, and also disabling. Most of the orphan diseases have curative or effective treatment and above all have high complexity and low prevalence.
Various factors are propelling the orphan drugs market growth. These factors, in accordance with the MRFR report, include the rising emphasis of pharmaceutical companies on orphan drug improvement, rising incidences of rare diseases, and various initiatives undertaken by the government for orphan medicine. Additional factors pushing market growth include improving regulatory framework, growing awareness regarding rare disease, growth in the pharmaceutical and biotechnology sector, and increase in drug development and research and development investment.
On the contrary, poor healthcare systems in middle and low-income countries, lack of specificity, and stringent FDA regulation are factors that may restrict the orphan drugs market growth over the forecast period.
Then What Makes the Market Tick?
The concerned diseases in some regions are also known as orphan diseases. But these can have a major outbreak in certain scenarios. It can either be triggered by a change in the climate, or it can be used as a weapon in creating terror. But a massive outbreak is possible. And if its cure is not at hand then the turn of events may result in headwinds for the government. For instance, the past decade witnessed an Anthrax attack, which is also known as Amerithrax from the FBI files. It is a rare disease that occurs from bacterium Bacillus anthracis. Terrorist activities caused the outbreak. A quick reaction to the outbreak was needed and that actually happened but still, quite a lot died.
When Ebola Virus Disease (EVD) happened, not many were aware of the crisis as they had no clue about the disease. In just 10 months, the Republic of Congo witnessed the death toll crossing the 1500 mark in 2019 alone. In the 2014-15 session, the DRC Ministry of Health recorded almost 11310 deaths in just West Africa. Such cases are always keeping governments on their toe as an outbreak in one place can quickly travel to others. The US had faced this in 2014-15. As a result, millions to limit the outbreak.
How Ready We Are?
These outbreaks require quick action as they provide little time to respond. The state cannot ignore even one because such diseases can impact much in a very short span of time. That is why governments have made regulations to ensure that pharmaceutical companies have ready setup to produce such medicines to prevent such outbreaks. In many countries, it is mandatory to keep a particular stock of each orphan drugs to make sure that the treatment does not get bogged down by the lack of medicine.
Orphan Drugs Market Segmentation
The MRFR report provides a complete segmental analysis of the orphan drugs market report on the basis of therapy class, drug, sale, and drug type.
Based on drug type, the orphan drugs market is segmented into non-biologics and biologics. Of these, the biologics segment will have the largest share in the market over the forecast period.
Based on sale, the orphan drugs market is segmented into prescribed and generics.
Based on drug, the orphan drugs market is segmented into adcetris, spinraza, pomalyst, jakaf, soliris, imbruvica, Keytruda, opdivo, Rituxan, and Revlimid.
Based on therapy class, the orphan drugs market is segmented into respiratory, cardiovascular, endocrine, central nervous systems, blood, and oncology.
By region, the orphan drugs market report covers the latest trends and growth opportunities across the Americas, Europe, the Asia Pacific (APAC), and the Middle East and Africa (MEA). Of these, the Americas will dominate the market over the forecast period. This is chiefly owing to the rising occurrence of rare disorders in the region.
The orphan drugs market in Europe is predicted to have the second-largest share in the market over the forecast period. This is owing to the growing number of pharmaceutical companies that are exporting products within or outside Europe. The majority of the companies in Europe are engaged in R&D of orphan drugs as per the needs of the patients. Moreover, strong clinical pipeline, unmet medical necessities, reimbursement, favorable pricing, and introduction of innovative technologies are also pushing market growth.
The orphan drugs market in the APAC region is predicted to grow at the fastest pace over the forecast period. This is owing to increasing population, growing prevalence of other diseases including respiratory disorders, cardiovascular & lymphatic systems, and endocrinology.
Orphan Drugs Market Key Players
Leading players profiled in the orphan drugs market report include Bristol Meyer Squibb, Pfizer Inc., Vertex Pharmaceuticals Inc., Alexion Pharmaceuticals Inc., Janssen Global Services LLC, Sanofi, Shire Pharmaceutical, Eli Lilly and Company, Merck KGaA, Takeda Pharmaceutical Company Limited, Biogen, Novartis AG, Celgene Corporation, Mylan, and F. Hoffmann-La Roche AG, among others. Key players have used some strategies to cater to the growing needs of orphan drugs and also strengthen their position in the market. These strategies include research and development, product innovations and launches, mergers and acquisitions, partnerships, collaborations, joint ventures, and many others.
September 2019: Leading pharmaceutical company, Glenmark Pharmaceuticals has recently received the orphan drug designation GBR 1342, its antibody candidate that is under development to treat patients having multiple myeloma and have received prior therapies.
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