Specialty pharmaceuticals are branded (on patent) injectable, infusions or oral medication that, with high cost, high complexity, and high touch, with limited or exclusive availability and distribution, are used to treat chronic or rare diseases such as cancer, AIDS (Acquired Immunodeficiency Virus Syndrome), Hepatitis C, Crohn’s disease, rheumatoid arthritis, etc. Specialty pharmaceuticals can be biotechnology products, orphan or ultra-orphan drugs, and medication that are included in the drug class strategy of specialty therapeutics and are typically biology-based that structurally mimic or are analogues of compounds found inside the human body. High touch management is essential for specialty pharmaceuticals as they require; temperature control; safe and specialized handling, shipping, and distribution; appropriate injection or administration technique for medication; drug management by pharmacist or physician having in-depth education of patient as well as the medical condition; and better side-effect management. Specialty pharmaceuticals are available only through ‘specialty’ wholesalers, while pharmacies can have access to specialty pharmaceuticals through specialty wholesalers with special contract having different price structures and unique terms and conditions.

The specialty pharmaceuticals market is estimated to witness a lucrative growth due to the plateauing of generic dispensing rate. Moreover, fast-track development of new pharmaceutical industries, major merges and acquisitions among pharmacies, and improvement in pharmacy benefit management (PBM) and healthcare plans, are anticipated to bring about consolidation in the specialty pharmaceuticals market. The specialty pharmaceuticals market in the U.S is anticipated to play a significant role in the global specialty pharmaceuticals market. For instance, according to a report published by, IMS Health, National Sales Perspectives (June 2016), of the top 20 pharmaceutical products or drugs sold in the U.S (2015), about 11 were specialty pharmaceuticals, which included, Harvoni, Humira, Enbrel, Remicade, and Copaxone.

Drug spending on novel drugs is another factor driving the specialty pharmaceuticals market, due to the increase in number of launches of high-priced specialty drugs. For instance, specialty drugs contribute to less than 2.0% of the total prescriptions in the U.S, but according to a report published by America’s Health Insurance Plans (AHIS) (2016), specialty pharmaceuticals accounted for approximately one-third of the total spending on the commercial prescription pharmaceuticals in 2015 (US$ 337.0 Bn), while it was also reported that about 225 new specialty pharmaceuticals are estimated to be launched in the next five years. Moreover, according to a report published by National Conference of State Legislatures (NCSL) in Jan 2016, cancer, multiple sclerosis, and inflammatory conditions are rated as the top three specialty therapy classes ranked by number of members on annual basis, while the conditions accounted for more than 60.0% of the total expenditure for specialty pharmaceuticals billed through pharmacy benefit. Thus, rising spending on pharmaceutical as well as anticipated launch of high number of novel specialty drugs is likely to fuel the specialty pharmaceuticals market. Necessity of special handling, storage, and administration of specialty drug, and high cost of specialty pharmaceuticals are key restraints of the specialty pharmaceuticals market, as high cost treatment is unaffordable for a majority of the population, thus opting for low-cost alternatives. For instance, a specialty drug treatment regimen of about 2 to 8 weeks for Hepatitis C virus infection costs around US$ 65,000 to US$ 189,000 in California. Moreover, ravicti, carbaglu, lumizyme, actimmune, and soliris, are considerably expensive specialty pharmaceuticals that costs about US$ 793, 632, US$ 585,480, US$ 626,400, US$ 572,292, and US$ 542,640, per patient, per year, respectively. Ravicti and carbaglu specialty pharmaceuticals function to inhibit buildup of nitrogen in the bloodstream, preventing death due to coma. Lumizyme is employed to treat muscle weakness, preventing heart and respiratory failure. Actimmune is utilized to treat conditions that disrupt normal bone marrow formation and immune system functioning. Soliris is used to prevent progressive destruction of red blood cells and related life-threatening conditions.

The specialty pharmaceuticals market has been segmented on the basis of disease indication, mode of administration, distribution channel, and region. In terms of disease indication, the specialty pharmaceuticals market can be segmented into oncology, autoimmune disorders, viral hepatitis, HIV (human immunodeficiency virus) antivirals, multiple sclerosis, and others. In terms of mode of administration, the specialty pharmaceuticals market can be segmented into oral and injectable/infusions. In terms of distribution channel, the specialty pharmaceuticals market can be segmented into hospital pharmacies, retail pharmacies, specialty pharmacies, drug stores, and e-commerce. In terms of region, the specialty pharmaceuticals market can be segmented into Asia Pacific (APAC), Europe, Middle East & Africa (MEA), North America (NA), and Latin America (LA). Key players operating in the global specialty pharmaceuticals market include Otsuka America Pharmaceutical, Inc., AbbVie Inc. Gilead, Pfizer Inc., Amgen Inc., AstraZeneca, Janssen Global Services, LLC, Teva Pharmaceutical Industries Ltd., and rEVO Biologics, Inc.

This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.

Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:

  • Customer Experience Maps
  • Insights and Tools based on data-driven research
  • Actionable Results to meet all the business priorities
  • Strategic Frameworks to boost the growth journey

The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.

The following regional segments are covered comprehensively:

  • North America
  • Asia Pacific
  • Europe
  • Latin America
  • The Middle East and Africa

The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.

Below is a snapshot of these quadrants.

1. Customer Experience Map

The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

2. Insights and Tools

The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.

3. Actionable Results

The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.

4. Strategic Frameworks

The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.

The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:

1. What can be the best investment choices for venturing into new product and service lines?

2. What value propositions should businesses aim at while making new research and development funding?

3. Which regulations will be most helpful for stakeholders to boost their supply chain network?

4. Which regions might see the demand maturing in certain segments in near future?

5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?

6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?

7. Which government regulations might challenge the status of key regional markets?

8. How will the emerging political and economic scenario affect opportunities in key growth areas?

9. What are some of the value-grab opportunities in various segments?

10. What will be the barrier to entry for new players in the market?

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.

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Specialty Pharmaceuticals Market

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