Global Specialty Generics Market to grow with a CAGR of 9.70%
Increasing
healthcare infrastructure and a supportive regulatory environment are the major
drivers for the Global Specialty Generics Market.
According to TechSci Research report, “Global
Specialty Generics Market Industry
Size, Share, Trends, Competition, Opportunity and Forecast, 2018-2028”, Global Specialty Generics Market has
valued at USD 55.60 billion in 2022 and is anticipated to witness an impressive
growth in the forecast period with a CAGR of 9.70% through 2028. This can be due to collaborations and
partnerships among leading companies with a diverse approach to merge the
expertise of individual companies and to strengthen their position in the
market. The emergence of biologics and biosimilars has played a significant
role in driving the demand for the global specialty generics market. Biologics,
including monoclonal antibodies, vaccines, and therapeutic proteins, are highly
effective but often high-cost treatments for various medical conditions.
Biosimilars, which are similar but not identical to reference biologics, offer
more affordable alternatives, contributing to the growth of the specialty
generics market. Biologics are
often among the most expensive drugs in healthcare. Biosimilars, as specialty
generics of biologics, typically offer significant cost savings, making these
life-saving treatments more accessible to patients and healthcare systems.
The entry of biosimilars into the
market introduces competition, which can lead to price reductions for both the
biosimilar and the reference biologic. This competition benefits patients by
lowering treatment costs. Biosimilars expand treatment options for patients,
giving them access to effective therapies that may have been previously
unaffordable. This is particularly important in the treatment of chronic and
complex diseases. Over
time, healthcare providers and patients have become more accepting of
biosimilars due to the growing body of evidence demonstrating their safety and
efficacy. This increased acceptance drives demand. Pharmaceutical companies are launching
biosimilars in various regions and emerging markets, further increasing their
accessibility to a global patient population.
Browse over XX market data Figures and spread through 110 Pages and an in-depth TOC on " Global Specialty Generics Market.”
Once a
medicine loses its patent protection, it becomes a specialty generic. These
medications are used to treat a variety of chronic or complicated medical
illnesses, such as autoimmune disorders, epilepsy, HIV, hepatitis, multiple
sclerosis, rheumatoid arthritis, and cancer. Since they don't need high-priced
research and marketing expenses, specialty generics are more affordable than
their branded counterparts. Due to their sophisticated production needs,
greater capital expenditures, and generally lower quantities as a result of a
smaller patient population, specialist generics have a more competitive market
than regular generics. In July 2020, Sun Pharmaceutical Industries Ltd. (Sun
Pharma), the fourth-largest specialty generic pharmaceutical company in the
world, and Hikma Pharmaceuticals PLC (Hikma), a multinational pharmaceutical
company, have announced that they have entered into an exclusive licencing and
distribution agreement for ILUMYA, a novel biologic product, for the Middle
East and North Africa (MENA) region. A novel IL-23p19 monoclonal antibody
authorized by the USFDA called ILUMYATM (tildrakizumab) is used to treat people
with moderate-to-severe plaque psoriasis who are eligible for systemic therapy
or phototherapy. According to the licencing agreement, Sun Pharma will oversee
product supply while Hikma will oversee product registration and
commercialization in all MENA countries. Both upfront and milestone payments
are available to Sun Pharma. This contract has a 15-year duration starting with
the first sale, with two-year automatic renewal periods. This partnership
strengthens our dermatology and biotech-immunology strategies in MENA and
expands our range of psoriasis treatments with a cutting-edge biologic product.
Market
access and reimbursement are significant challenges in the global specialty
generics market segmentation. Specialty generics, including biosimilars and
complex small-molecule drugs, face specific hurdles related to pricing,
reimbursement policies, and market entry. Specialty generics aim to offer cost-effective
alternatives to expensive brand-name specialty drugs. However, pricing them
competitively while ensuring a sustainable business model can be challenging.
Developers of specialty generics must provide robust evidence of cost savings
compared to the reference specialty drugs. Convincing payers and healthcare
providers of the economic benefits can be complex. Specialty
generics must navigate diverse regulatory pathways in different countries. Each
regulatory agency may have specific requirements for approval, making it challenging
to achieve global market access. Establishing interchangeability with reference
drugs and demonstrating therapeutic equivalence can be demanding. Achieving
regulatory approval for substitution policies may also vary by region.
Global Specialty
Generics Market segmentation is based on
Route
of Administration, Indication, Distribution channel, and Region. Based on Indication, Global Specialty Generics Market is
segmented into Oncology, Autoimmune Diseases, Infectious Diseases, and others.
Specialty generics play
a crucial role in the treatment of autoimmune diseases. Autoimmune diseases are
conditions in which the immune system mistakenly targets and attacks healthy
tissues and organs, leading to chronic inflammation and a wide range of symptoms.
Specialty generics, including biosimilars and complex small-molecule drugs, are
used to manage these diseases effectively. Specialty generics are used in the
management of SLE (Systemic Lupus Erythematosus). Hydroxychloroquine, an
antimalarial drug, is a complex small-molecule generic often prescribed to
manage symptoms and reduce disease activity. Specialty generics are used in the treatment
of autoimmune hepatitis. Immunosuppressive drugs like azathioprine and
mycophenolate mofetil may be prescribed as complex generics to reduce immune
system activity and control liver inflammation.
Based on Region, North America dominated the Global Specialty
Generics Market. North
America has well-established market access and distribution networks, which
facilitate the commercialization and distribution of pharmaceutical products,
including specialty generics. The
region's advanced healthcare infrastructure and high-quality healthcare
services create a conducive environment for the introduction and utilization of
specialty generics. North
America is home to numerous pharmaceutical companies and research institutions,
enabling the development of innovative specialty generics. These companies
invest in research and development to bring new products to the market. Patients and healthcare providers in
North America tend to have relatively high awareness of generic medications,
including specialty generics. This familiarity can drive acceptance and
adoption of these products. Several
major pharmaceutical companies are headquartered in North America, and many of
them have ventured into the specialty generics market, either by developing
their own biosimilars and complex generics or through strategic partnerships
and acquisitions.
Asia-pacific region to witness fastest growth in the
Global Specialty
Generics Market. The
Asia-Pacific region is home to a significant and rapidly aging population. As people age, the prevalence of chronic
and complex diseases increases, driving the demand for specialty medications,
including specialty generics, to manage these conditions effectively. Many
countries in the APAC region have been increasing their healthcare spending to
improve healthcare infrastructure and access to advanced treatments. This has
led to greater investments in specialty drugs and specialty generics. The APAC
region has been a hub for the development and adoption of biosimilars.
Regulatory agencies in countries like India and South Korea have established
clear pathways for biosimilar approvals. Biosimilars are an integral part of
the specialty generics market. Healthcare
providers, governments, and patients in the APAC region have become more
accepting of biosimilars due to their cost-effectiveness and demonstrated
safety and efficacy. This has accelerated market growth.
Some of the major companies operating in
the Global
Specialty Generics Market include:
- Teva Pharmaceuticals Industries Ltd
- Viatris Inc.
- Novartis AG
- Hikma Pharmaceuticals PLC
- Bausch Health Companies Inc.
- Dr. Reddy’s Laboratories Ltd.
- Endo Pharmaceuticals Inc.
- Apotex Corp.
- Sun Pharmaceutical Industries Ltd
- STADA Arzneimittel AG
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“Certain
areas, particularly in North America, are projected to exert significant demand
for specialty generics. The growth in the competitive landscape and the
presence of well-established companies in the market, committed to enhance the overall
wellbeing of people each year, are expected to contribute to a remarkable
growth of the Global Specialty Generics Market in the forecast period,"
said Mr. Karan Chechi, Research Director with TechSci Research, a
research-based Global management consulting firm.
Specialty Generics Market – Global Industry Size, Share, Trends,
Opportunity, and Forecast, 2018-2028 Segmented
by Route of Administration (Injectable, Oral, others), By Indication (Oncology, Autoimmune Diseases, Infectious Diseases, others), By Distribution
Channel (Retail Pharmacies, Specialty Pharmacies, Hospital Pharmacies), by
region, and Competition evaluated
the future growth potential of Global Specialty Generics Market and provides
statistics & information on market size, structure, and future market
growth. The report intends to provide innovative market intelligence and help
decision makers take sound investment decisions. Besides, the report also
identifies and analyzes the emerging trends along with essential drivers,
challenges, and opportunities in Global Specialty Generics Market.
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